NHLBI Catalyze RFA-HL-26-019: Product Definition for Medical Devices, Diagnostics and Research Tools

Status: Open. Next due dates October 21, 2026 and February 11, 2027, 5:00 PM local time. Up to $300,000 in direct costs a year per phase. Companies of any size, universities and nonprofits are eligible.

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What is the NHLBI Catalyze Product Definition program for medical devices?

The NHLBI Catalyze Product Definition program (RFA-HL-26-019) is an NIH grant from the National Heart, Lung, and Blood Institute that funds early-stage development of medical device prototypes, diagnostic assays, and research tools for heart, lung, blood, and sleep (HLBS) diseases and disorders.

It uses a two-phase R61/R33 structure. The R61 phase supports initial prototype design and testing, disease target identification, and pilot work on research tools. The R33 phase supports continued development, larger-scale testing, and data integration, with the goal of positioning the product for preclinical development such as the NHLBI Catalyze Preclinical Program.

Unlike SBIR and STTR, Catalyze is open to for-profit companies of any size as well as universities and nonprofits, and it puts heavy weight on milestones, regulatory planning, and commercialization partners.

What are the key dates and funding amounts?

• Next recommended deadline: February 11, 2027 (5:00 PM local time of the applicant organization)
• Remaining due dates: October 21, 2026, February 11, 2027, June 17, 2027, and October 21, 2027
• Earliest start dates: July 2027 (October 2026 cycle), December 2027 (February 2027 cycle), April 2028 (June 2027 cycle), July 2028 (October 2027 cycle)
• Budget: up to $300,000 in direct costs per year in both the R61 and R33 phases
• Project period: up to 3 years combined, with no more than 2 years in either phase
• NHLBI plans up to $4,466,000 per fiscal year (FY 2026 through FY 2028) for up to 8 new awards per year across this NOFO and its companion NOFOs
• Notice expires December 24, 2027

Who is eligible to apply?

• For-profit organizations, including small businesses and larger companies
• Public and private institutions of higher education
• Nonprofits, with or without 501(c)(3) status
• State, local, and tribal governments, federal agencies, and certain other organizations

Foreign organizations are not eligible, although non-U.S. components of U.S. organizations are allowed. Any individual with the needed skills and resources can serve as PD/PI, and every PD/PI needs an eRA Commons account. An organization may submit multiple applications if each is scientifically distinct.

What does Catalyze Product Definition fund?

Medical devices

R61 work can include key component testing, a first prototype or benchtop unit, in vitro and acute in vivo testing, and small animal studies. R33 work can include system integration, design for manufacturing, performance comparison against gold standard devices, chronic in vivo and large animal testing, and an FDA pre-submission meeting.

Diagnostics and assays

R61 work can include testing with limited human samples, building a working prototype, and incorporating assays onto an existing sensing platform. R33 work can include validation in large sample panels or clinical datasets, sensitivity and precision improvements, and an FDA pre-submission meeting.

Research tools

R61 work can include algorithm design, smartphone interface development, limited user and focus group testing, and pilot feasibility studies. R33 work can include large population testing, EHR integration, extension to iOS or Android, and multi-site studies.

What is out of scope

• Therapeutic agent development (covered by companion NOFOs RFA-HL-26-017 and RFA-HL-26-018)
• Development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers
• Clinical research and clinical trials

How does the R61 to R33 transition work?

Applicants propose two separate sets of quantifiable milestones, one for R61 and one for R33. Milestones must be specific, measurable, and time-bound, and every Specific Aim needs at least one. Specific Aims or activity lists alone do not count as milestones.

NHLBI decides whether to fund the R33 phase based on three factors:

• Achievement of the R61 milestones
• Third-party investment, shown by a recommended minimum 0.25:1 non-Federal cash match of R33 Federal direct costs (in-kind contributions do not count toward the match)
• An Accelerator Partner, a commercialization expert who mentors the team on business development, regulatory submissions, IP, reimbursement, and market analysis

Neither the cash match nor the Accelerator Partner is required at application, but the application must explain how a partner would fill development gaps, and NHLBI expects you to secure one early in the R61 phase.

How do you apply?

• Register your organization in SAM.gov, Grants.gov, and eRA Commons well before the deadline
• Contact NHLBI program staff early to confirm your project fits the HLBS scope
• Build R61 and R33 milestone plans and place the project timeline as the last element of the Research Strategy
• Prepare the required "IP and Regulatory Strategies.pdf" attachment covering IP position, patents, third-party IP limits, and your planned FDA pathway (for example 510(k) or IDE). Applications without it will not be peer reviewed.
• Submit through Grants.gov using NIH application forms by 5:00 PM local time on the due date

Reviewers score importance of the research, rigor and feasibility (including whether milestones are measurable and timelines realistic), and expertise and resources. Applications may be triaged, with only the top half discussed.

Is this a fit for your company?

Catalyze Product Definition suits medtech, diagnostics, and digital health companies with a heart, lung, blood, or sleep application, solid preliminary data, and a clear path to an FDA pathway. It is especially useful for companies that are not SBIR eligible or have already used SBIR, because there is no company size limit. The milestone plan, IP and regulatory attachment, and Accelerator Partner strategy are where many applications win or lose.

BW&CO has helped clients secure $350M+ in non-dilutive funding. Book a free funding fit call and we will tell you whether Catalyze, NIH SBIR, or another program is the strongest route for your technology.

Frequently asked questions

How much funding does NHLBI Catalyze Product Definition provide?

Up to $300,000 in direct costs per year in each of the R61 and R33 phases, over a combined project period of up to 3 years with no more than 2 years in either phase.

When is the next deadline for RFA-HL-26-019?

The remaining due dates are October 21, 2026, February 11, 2027, June 17, 2027, and October 21, 2027, each at 5:00 PM local time of the applicant organization.

Can companies apply, or only universities?

Companies can apply. For-profit organizations of any size, including small businesses, are eligible, along with universities, nonprofits, and government entities. Foreign organizations are not eligible.

Do I need an Accelerator Partner or cost match to apply?

No. Both are needed to transition from R61 to R33, not at application. NHLBI recommends a minimum 0.25:1 non-Federal cash match for the R33 phase and requires an Accelerator Partner before R33 funding.

Does Catalyze fund therapeutics or clinical trials?

No. Therapeutics are covered by companion NOFOs RFA-HL-26-017 and RFA-HL-26-018. Clinical trials, clinical research, and biomarker development are not responsive to this NOFO.

What attachment is required with the application?

An "IP and Regulatory Strategies.pdf" attachment describing your IP position and planned FDA regulatory pathway is required. Applications without it are considered incomplete and will not be peer reviewed.

NIH Highlighted Topic: Advancing Precision Research for Lung Cancer in Never Smokers and Its Risk Factors

Overview

The National Institutes of Health (NIH) is encouraging precision cancer research and technology development for lung cancer in never smokers (LCINS). The goal is to identify risk factors, understand the biology, develop early detection and prevention strategies, and advance diagnosis and therapy.

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LCINS accounts for roughly 10% to 20% of U.S. lung cancers each year and is estimated to be the eighth leading cause of cancer death in the United States. Many patients are diagnosed at an advanced stage, and the disease responds differently to therapies, including immunotherapy, than smoking-associated lung cancer. Companies with diagnostic, therapeutic, or AI technology can pursue this through the NIH SBIR program.

Key dates and funding

• Next SBIR due dates: January 5, 2027 and April 5, 2027 (5:00 PM local time of your organization)
• Application route: NIH, CDC and FDA Parent SBIR (R43/R44), PA-27-100, Clinical Trial Optional
• Project period: normally up to 6 months for Phase I and up to 2 years for Phase II
• Topic window: NIH lists this Highlighted Topic through October 4, 2028, so it can support more than one submission cycle

Budget guidelines in PA-27-100 vary by participating Institute or Center. Total costs (direct, indirect, and fee) normally stay within these amounts:

• National Cancer Institute (NCI): Phase I $700,000, Phase II $2,500,000
• National Institute of Environmental Health Sciences (NIEHS): SBA guideline for both phases
• National Institute on Minority Health and Health Disparities (NIMHD): SBA guideline for both phases

Who is eligible?

Only United States small business concerns can apply through the NIH Parent SBIR announcement. In plain terms, your company must meet these requirements:

• A for-profit business with a place of business in the United States and no more than 500 employees, including affiliates
• Generally more than 50% owned and controlled by U.S. citizens or permanent residents, or by qualifying venture capital, hedge fund, or private equity owners under SBA rules
• The Principal Investigator is primarily employed by the small business at the time of award and for the duration of the project
• No foreign organizations, foreign components, or foreign subawards (unfunded foreign collaborators and foreign consultants are permitted)
• Companies selected for funding submit the SBA foreign affiliations disclosure during the Just-in-Time process

Focus areas by NIH Institute

NCI: biology, detection, and precision therapy

• Biological and environmental factors, including sex and ancestry, behind LCINS initiation and progression
• Mechanisms that distinguish LCINS biology from tobacco-associated lung cancer
• Early detection and diagnostic strategies, including biomarker development
• Mechanism-driven interventions such as overcoming therapeutic resistance, targeting rare mutations, cancer vaccines, and immunotherapies
• Human-relevant research models, databases, computational methods and AI, and other emerging technologies

NIEHS: environmental carcinogens

• New Approach Methodologies to identify chemicals and exposures that are potential lung carcinogens
• Early detection based on disease characteristics in patients exposed to known lung carcinogens

NIMHD: disparities

• Interventions to improve risk prediction, early detection biomarkers, imaging, prevention, treatment selection, and guideline-concordant care
• NIMHD may give special consideration to meritorious applications

How to apply

NIH Highlighted Topics are not funding opportunities on their own. Small businesses apply through the NIH, CDC and FDA Parent SBIR announcement (PA-27-100) and write the application to match the interests of at least one participating Institute or Center. Read the full NIH Highlighted Topic before you start.

• Register early: SAM.gov (which issues your UEI and can take six weeks or more), Grants.gov, eRA Commons (a Signing Official plus a PI account with a linked ORCID iD), and the SBA Company Registry (proof of registration is attached to the application)
• Talk to the program officer: the topic lists a central NCI contact plus NIEHS and NIMHD contacts, and ODP also participates but does not award grants
• Check the budget: contact the participating Institute or Center early if you plan to request more than the SBA budget guideline
• Submit electronically: through NIH ASSIST, a system-to-system solution, or Grants.gov Workspace by 5:00 PM local time on January 5, 2027 or April 5, 2027

Is this a fit for your company?

This topic suits companies developing liquid biopsy or other early detection assays, imaging and AI risk prediction tools, targeted therapies, cancer vaccines, or immunotherapies, including approaches to rare mutations and therapeutic resistance, and human-relevant models such as organoids. NCI's $700,000 Phase I guideline makes it the strongest target for most product companies.

If that sounds like your company, book a free funding fit call with BW&CO. Our team has helped secure $350M+ in non-dilutive funding and can tell you quickly whether this topic, and which Institute, is the right target for your January or April submission.

Frequently asked questions

Is the NIH lung cancer in never smokers Highlighted Topic a funding opportunity?

No. It is an NIH Highlighted Topic, which signals scientific interest but is not a notice of funding opportunity. Small businesses apply through the NIH Parent SBIR announcement (PA-27-100), with the next due dates on January 5, 2027 and April 5, 2027.

How much NIH SBIR funding is available for lung cancer in never smokers research?

Under PA-27-100, NCI allows up to $700,000 for Phase I and up to $2,500,000 for Phase II. NIEHS and NIMHD follow the SBA guideline.

Which NIH Institutes participate in the lung cancer in never smokers topic?

NCI, NIEHS, and NIMHD are the awarding participants. ODP also participates but does not award grants.

What research does NIH want on lung cancer in never smokers?

Risk factors and biology, early detection and diagnostic biomarkers, precision therapies including immunotherapies and cancer vaccines, environmental carcinogen identification, and human-relevant models, databases, and AI.

Who is eligible to apply through NIH SBIR?

U.S. for-profit small businesses with no more than 500 employees, majority owned and controlled by U.S. citizens or permanent residents (or qualifying investors under SBA rules), whose Principal Investigator is primarily employed by the company. Foreign organizations and foreign subawards are not allowed.

Can BW&CO help with an NIH SBIR application for this topic?

Yes. BW&CO helps small businesses choose the right NIH Institute, align the Specific Aims with the Highlighted Topic, and build a competitive SBIR application. The firm has helped clients secure $350M+ in non-dilutive funding. Book a free funding fit call to see if your technology is a match.

Medical CBRN Defense Consortium (MCDC)

What is the Medical CBRN Defense Consortium (MCDC)?

The Medical CBRN Defense Consortium (MCDC) is a Department of Defense Other Transaction Agreement (OTA) consortium that funds prototype medical countermeasures, diagnostics, delivery devices, and enabling technologies against chemical, biological, radiological, and nuclear (CBRN) threats. Members compete for awards through Requests for Prototype Projects (RPPs).

The main customer is the Medical Countermeasures Systems (MCS) Joint Project Management Office within the Joint Program Executive Office for CBRN Defense (JPEO-CBRND). Other customers, including the Defense Threat Reduction Agency's Joint Science and Technology Office (DTRA JSTO), also release solicitations through MCDC. Advanced Technology International (ATI) manages the consortium.

Because MCDC awards are made under an OTA instead of the Federal Acquisition Regulation, they can be executed faster than traditional contracts, and the consortium actively recruits non-traditional defense contractors. That makes it one of the most direct routes for commercial biotech, pharma, diagnostics, and medical device companies to win DoD prototype funding for dual-use products.

Key dates and funding

• Deadline: Rolling. Membership is open year-round. Each RPP sets its own due date, and every RPP closes at 12:00 noon with no late submissions.
• Current status: As of early October 2026, MCDC lists no open RPPs, draft Statements of Objectives, or RFIs. Two opportunities are forecast for FY2027.
• Award size: Varies by RPP. Prototype awards MCDC posted in 2025 and 2026 ranged from about $3.2 million to $47.8 million. Member commercialization awards are up to $50,000.
• Funding instrument: Prototype project agreements under the MCDC OTA, executed through the consortium management firm.
• Membership fee: $250 per year, renewed each fiscal year.

What MCDC opportunities are coming next?

MCDC publishes a forecast of possible future solicitations. These dates are tentative, and the Government decides later whether to run each one through MCDC.

Threat Agnostic Host Directed MCMs (tentative Q2 FY2027)

Requiring office: JPM CBRN Medical. A CBRN resilience effort seeking medical countermeasures that act on the host rather than a single threat, helping the body withstand, mitigate, and recover from the overlapping physiological effects of CBRN exposure.

Advanced Differential Diagnostics (tentative Q4 FY2027)

Requiring office: JPdL-Diagnostics and JRO-CBRND. A host response based test that predicts how severe an illness will become.

What technologies does MCDC fund?

MCDC's published technical areas of interest include:

• Therapeutic medical countermeasure prototypes against viruses, bacteria, and biological toxins, plus the technologies that enable them
• Single and multiple drug autoinjector delivery devices
• Vaccine manufacturing platforms
• Products for prophylaxis, treatment, and diagnosis of CBRN threats, including Acute Radiation Syndrome and chemical nerve agents
• Systems that make agent identification and disease diagnosis faster, more accurate, and more reliable
• Advanced development and manufacturing capabilities

Past MCDC RPPs show the range: mRNA vaccines, monoclonal antibody platforms, broad spectrum therapeutics, autoinjectors, point of need and breath-based diagnostics, multi-organoid toxicity models, animal model development, and manufacturing optimization.

Who is eligible?

• Large businesses, small businesses, traditional and non-traditional defense contractors, academic research institutions, and nonprofits can join MCDC.
• Membership is limited to U.S. companies or U.S.-based affiliates of foreign companies, because every member must hold a DD Form 2345 (Militarily Critical Technical Data Agreement).
• You must be an active member in good standing to submit as the prime on an RPP.
• Applications move fastest when your SAM.gov, UEI, CAGE, and DD2345 are already current.

How do I apply to MCDC?

• Step 1: Get your registrations in order. Confirm SAM.gov, UEI, and CAGE are active and obtain a DD Form 2345 if you do not have one.
• Step 2: Join the consortium. Submit the online member application and pay the $250 annual fee. A complete application can be processed in 1 to 2 business days.
• Step 3: Engage on the draft Statement of Objectives. Before most RPPs, the Government posts a draft SOO to members. Submitting a one-page abstract can earn a one-on-one session with the requirement owner and candid feedback before you invest in a full proposal. MCDC calls this step imperative if you plan to propose.
• Step 4: Submit to the RPP. Final RPPs go to members and are submitted through the MCDC BIDS portal by 12:00 noon on the due date.
• Step 5: Selection and negotiation. Selected offerors receive a Selection Announcement Letter, followed by statement of work and cost negotiations. Some proposals not selected right away go into a basket and can be pulled for award later.

Communication with the Government is permitted and encouraged, except during the evaluation period after a submission deadline.

Is MCDC a fit for your company?

MCDC is a strong fit for biotech, pharma, diagnostics, and medtech companies whose products serve both a commercial health market and a military CBRN need: infectious disease therapeutics and vaccines, host response and point of need diagnostics, drug delivery devices, and biomanufacturing platforms. Companies working on host directed therapeutics or severity-predicting diagnostics should join now so they are ready for the FY2027 draft SOO engagements.

Not sure whether your technology maps to an MCDC requirement, or how to position a commercial product for a DoD prototype award? Book a call with BW&CO to talk through your funding fit.

Frequently asked questions

What is the Medical CBRN Defense Consortium (MCDC)?

MCDC is a Department of Defense Other Transaction Agreement (OTA) consortium that funds prototype medical countermeasures, diagnostics, delivery devices, and enabling technologies against chemical, biological, radiological, and nuclear (CBRN) threats. Its main customer is the Medical Countermeasures Systems (MCS) Joint Project Management Office under JPEO-CBRND, and DTRA also releases solicitations through it.

How much funding does MCDC award?

Award size depends on each Request for Prototype Projects (RPP). Prototype awards MCDC posted in 2025 and 2026 ranged from about $3.2 million to $47.8 million, and its member commercialization awards are up to $50,000.

Who can join MCDC and how much does it cost?

Large and small businesses, traditional and non-traditional defense contractors, universities, and nonprofits can join. Membership is limited to U.S. companies or U.S.-based affiliates of foreign companies, because every member needs a DD Form 2345. The membership fee is $250 per year.

Do I have to be an MCDC member to submit a proposal?

Yes. You must be an active MCDC member in good standing to submit as the prime on an RPP. Subcontractors and research partners can support a member's proposal.

Is there an open MCDC solicitation right now?

As of early October 2026, MCDC lists no open RPPs, draft Statements of Objectives, or RFIs. Two opportunities are forecast for FY2027: Threat Agnostic Host Directed MCMs (tentatively Q2 FY2027) and Advanced Differential Diagnostics (tentatively Q4 FY2027).

How long does it take to become an MCDC member?

MCDC says a complete application can be processed in as little as 1 to 2 business days. It can take several weeks if you still need a DD2345, need to renew SAM.gov, UEI, or CAGE registrations, or operate under foreign ownership, control, or influence (FOCI).

Additional resources

• About MCDC
• MCDC business opportunities, forecasts, and past awards
• How to join MCDC

NIH Small Business Transition Grant for New Entrepreneurs (PAR-27-039 / PAR-27-040): SBIR and STTR Funding for First-Time PIs

The NIH Small Business Transition Grant for New Entrepreneurs funds small businesses that put a first-time Principal Investigator in charge of a research project, then pays for that person's mentorship and entrepreneurial training alongside the R&D. NIH and CDC have announced it is returning for fiscal year 2027 as PAR-27-039 (SBIR) and PAR-27-040 (STTR), and both versions will allow clinical trials.

Deadline: NIH expects to post the full solicitation around November 5, 2026, with applications due around January 5, 2027. These dates are NIH estimates, and applications are not being accepted yet, so now is the time to line up your PI and mentor.

Why This Opportunity Matters

Most SBIR and STTR reviewers want to see a PI with a track record of leading funded research. That puts many startups in a bind when their best technical person is a recent PhD, postdoc, clinician, or engineer who has never been an independent PI. This program flips that around: it is reserved for first-time PIs and rewards companies that commit to developing them.

It also pays for things a standard SBIR award usually does not emphasize, including the PI's salary, entrepreneurship courses, and a structured mentoring team. For a founder hiring their first scientist, or a company promoting an internal researcher, it can fund the R&D and the leadership development at the same time.

Key Facts at a Glance

• Sponsors: National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC), with many participating Institutes and Centers
• Solicitations: PAR-27-039 (SBIR, R43/R44) and PAR-27-040 (STTR, R41/R42), both Clinical Trial Optional
• Status: Forecasted. NIH is not accepting applications yet
• Estimated posting date: November 5, 2026
• Estimated application due date: January 5, 2027
• Estimated award start: July 1, 2027
• Award types: Phase I and Fast-Track (CDC does not support Fast-Track). Direct to Phase II was not allowed in the prior cycle
• Award size: Not yet published. In the prior cycle, Phase I awards normally could not exceed $306,872 and Phase II $2,045,816 in total costs, with some Institutes allowing more on approved topics
• Cost share: Not required

What the Program Funds

Each award supports three things at once:

• Research and development: A Phase I feasibility project, or a Fast-Track project, that fits the mission of one of the participating Institutes or Centers and has clear commercial potential.
• Mentorship: At least one mentor with real entrepreneurial and mentoring experience must be on the team with measurable committed effort. The mentor can be a company founder or executive, but does not have to be.
• Entrepreneurial training: A career development plan for the PI built from courses, workshops, NIH entrepreneurship programs, or similar training.

In the prior cycle, every aim needed quantitative milestones for both the research and the PI's entrepreneurial development. Participating Institutes ranged from NHLBI, NIA, NIDDK, NIDA, NICHD, NEI, NHGRI, NIEHS and NLM to NCATS, NCCIH and CDC's NIOSH, so the program covers devices, diagnostics, digital health, data science, therapeutics, and occupational safety technologies. Some Institutes funded Phase I only.

Is Your Company a Fit?

This program is a strong fit if most of these are true:

• You are a U.S. small business with 500 or fewer employees that meets SBA ownership rules for SBIR or STTR.
• Your proposed PI has never been an independent PI on an NIH or CDC research grant, or a comparable peer-reviewed research grant elsewhere.
• Your PI is a U.S. citizen or lawful permanent resident.
• Your PI has real research or technology development experience but limited entrepreneurial or independent leadership experience. Recent PhDs, postdocs, clinicians, engineers, and public health practitioners are typical.
• You can name a mentor with entrepreneurial experience who will commit measurable time to the project.
• Your technology fits the mission of at least one participating Institute or Center.

The program is not meant for experienced PIs or seasoned founders, who are steered to the standard NIH SBIR and STTR parent solicitations instead. Foreign organizations cannot apply.

How to Prepare Now

1. Pick your PI. Confirm they have never led an NIH or CDC research grant and meet the citizenship requirement. They can be a new hire or an existing employee stepping into a real leadership role.
2. Recruit your mentor. NIH is giving advance notice specifically so companies can line up industry mentors and training resources. Secure a commitment letter early.
3. Choose the right Institute. Match your project to a participating Institute or Center and contact its program officer before you write.
4. Get registered. SAM.gov, the SBA Company Registry, Grants.gov, and eRA Commons accounts for the company and the PI can take six weeks or more.
5. Watch for the November posting. When PAR-27-039 and PAR-27-040 are published, confirm the final due date, budget limits, and participating Institutes before you finalize your application.

How BW&CO Helps

BW&CO helps life science and health technology startups decide whether the Transition Grant or a standard NIH SBIR or STTR application is the better path, pick the right Institute, and build the mentorship and career development plan reviewers expect. We start early so your team is ready the day the solicitation posts. With $350M+ in non-dilutive funding secured for our clients, we help first-time founders and first-time PIs compete for NIH funding.

Frequently Asked Questions

What is the NIH Small Business Transition Grant for New Entrepreneurs?

It is an NIH and CDC SBIR and STTR program that funds small businesses led on a project by a first-time PI, combining research and development funding with mentorship and entrepreneurial training for that PI.

When is the deadline?

NIH estimates the solicitation will post around November 5, 2026, with applications due around January 5, 2027. Applications are not being accepted yet, and dates may change when the final solicitation is published.

Who can be the PI?

Someone who has never been an independent PI on an NIH or CDC research grant, or a comparable peer-reviewed research grant, and who is a U.S. citizen or lawful permanent resident. Early-career scientists, engineers, clinicians, and public health professionals are the intended applicants.

Is a mentor required?

Yes. Key personnel must include a mentor with entrepreneurial experience who commits measurable effort to the project.

How much funding is available?

NIH has not published amounts for the new cycle. In the prior cycle, Phase I awards normally could not exceed $306,872 in total costs and Phase II awards $2,045,816, with some Institutes allowing more for approved topics.

What happened to the previous version of this program?

The prior solicitations (PAR-24-131 through PAR-24-134) expired early on November 17, 2025, when SBIR and STTR authority lapsed. NIH has forecast the program's return as PAR-27-039 and PAR-27-040.

ARPA-H SPECTRA ARPA-H-SOL-26-163: Autism Technology and Research Funding Guide for Startups

ARPA-H's Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program aims to understand how autism develops across the lifespan and to act on that knowledge earlier and more precisely. The first open call is for Technical Area 4: everyday technologies such as wearables, communication devices, eye tracking, and AI speech tools that people want to use, and that generate assessment data as they are used. Companies, universities, and nonprofits are eligible.

Deadline: TA4 Solution Summaries are due October 18, 2026 at 5:00 PM ET. TA1 and TA2 summaries are expected December 2, 2026, and TA3 summaries January 18, 2027.

Why This Opportunity Matters

About 1 in 31 U.S. children is diagnosed with autism, and an estimated 25 to 30 percent of autistic people are minimally verbal or nonspeaking. Diagnosis often comes late, data sit in silos, and most assessments do not work well for the people with the highest support needs. SPECTRA is designed to change that by connecting biology, environment, real-world data, and targeted interventions into one program.

For health technology companies, TA4 is the immediate opening. It is one of the rare federal programs that funds consumer-grade tools built for real homes and classrooms, not just clinics, and it rewards products that families actually keep using.

Key Facts at a Glance

• Sponsor: Advanced Research Projects Agency for Health (ARPA-H), Proactive Health Office
• Solicitation: ARPA-H-SOL-26-163, Innovative Solutions Opening
• Award type: Other Transaction (OT) agreements, with phased reviews and possible down-selects
• Award size: Not published. Proposers request funds across all phases on the Solution Summary cover page
• Program length: About four years, with TA4 gates at Months 12, 24, and 48
• TA4 Solution Summary due: October 18, 2026, 5:00 PM ET (portal open now)
• TA1 and TA2 Solution Summary due: December 2, 2026, 5:00 PM ET (details by amendment, expected late October)
• TA3 Solution Summary due: January 18, 2027, 5:00 PM ET (details by amendment, expected early December)
• Full proposals: Dates will be announced after Solution Summaries are reviewed
• Cost share: Resource sharing is encouraged but not required

What SPECTRA Funds

TA4: Technologies for Communication, Quality of Life, and Embedded Assessment (open now)

TA4 funds everyday tools that improve communication and daily function while collecting meaningful data in the background. ARPA-H names examples including wearables for sleep, movement, and autonomic state, augmentative and alternative communication (AAC) and speech interfaces, eye tracking on tablets and phones, low-channel EEG usable at home, camera-based analysis of movement and behavior, and immersive virtual environment tools. Multimodal combinations are encouraged.

Strong TA4 proposals personalize to each user on the device, adapt over a lifetime, keep users in control of their data, and share data through the program's common data model. A goal is to push validated early identification about ten months earlier than today's 16-month floor. An optional speech component calls for open-source, on-device speech recognition tuned for child and atypical speech. Tools that require users to perform an assessment task belong in TA1, not TA4, and closed ecosystems that cannot export data are out of scope.

TA1: Multi-Factor Analysis and Trajectory Identification (coming)

Multimodal analysis of genetic, biological, environmental, and medical factors to define autism trajectories. TA1 is analysis only and requires datasets and partners already in place.

TA2: Population-Scale Modeling and Data Integration (coming)

A federated, privacy-preserving national data network built on health data standards, with at least 10 live nodes and fast multisite queries.

TA3: Precision Intervention and Trajectory Testing (coming)

Adaptive platform trials stratified by trajectory, prioritizing sleep, seizures, GI issues, pain, anxiety, crisis, and regression.

Is Your Company a Fit?

TA4 is a strong fit for:

• Wearable and biosensing companies focused on sleep, autonomic state, or seizure and overload alerts
• AAC and communication device makers, especially for minimally verbal and nonspeaking users
• Speech AI teams willing to build open, on-device models
• Eye tracking, low-channel EEG, and computer vision companies with tools that run on common phones and tablets
• VR and immersive learning companies

ARPA-H asks for prior experience building technology for autistic people or comparable populations, plus pilot or usability data from the intended users, so teams with real-world deployments will be most competitive. Looking ahead, AI and multi-omics analytics companies fit TA1, federated data and privacy companies fit TA2, and clinical trial platforms and therapeutics companies fit TA3.

FFRDCs and government entities cannot participate, entities from covered foreign countries are excluded, and ARPA-H prioritizes work performed in the United States.

How to Apply

1. Register on the ARPA-H Solutions site. The TA4 portal is open now at solutions.arpa-h.gov. A UEI is not required for the Solution Summary but is required before award.
2. Submit a TA4 Solution Summary by October 18, 2026. Use the required Attachment A1 template, up to 7 pages for the concept, innovation and impact, proposed work, and team. The cover page, cost estimate, resource share strategy, and references do not count toward the limit.
3. Receive an encourage or discourage response. ARPA-H says its view should carry significant weight in your decision to continue.
4. Submit a full proposal. Requirements and deadlines will be released by amendment after summaries are reviewed.

You may submit to more than one technical area, but each must be a separate, standalone submission. Questions go through the Ask a Question page on the ARPA-H Solutions site.

How BW&CO Helps

BW&CO helps digital health, wearable, and AI companies decide which SPECTRA technical area fits, frame their real-world evidence for ARPA-H reviewers, and deliver a compliant Solution Summary on a tight timeline. We also track the TA1 through TA3 amendments so clients are ready the day each call opens. With $350M+ in non-dilutive funding secured for our clients, we help health technology founders compete for ARPA-H programs.

Frequently Asked Questions

What is the ARPA-H SPECTRA program?

SPECTRA (Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency) is an ARPA-H program to understand and act on autism trajectories across the lifespan through analysis, data integration, precision interventions, and everyday assistive technologies.

When is the SPECTRA deadline?

TA4 Solution Summaries are due October 18, 2026 at 5:00 PM ET. TA1 and TA2 summaries are expected December 2, 2026, and TA3 summaries January 18, 2027. Full proposal dates will be announced later.

What does SPECTRA TA4 fund?

Everyday technologies such as wearables, AAC and speech interfaces, phone and tablet eye tracking, low-channel EEG, computer vision, and immersive tools that improve communication and quality of life while generating real-world assessment data.

Can startups apply to SPECTRA?

Yes. ARPA-H is primarily interested in proposals from commercial performers, academic institutions, and nonprofits. FFRDCs and government entities cannot participate.

How much funding does SPECTRA provide?

ARPA-H has not published award sizes. Awards are Other Transaction agreements, and proposers request total funds across all phases in their Solution Summary.

How long is the SPECTRA TA4 Solution Summary?

Up to 7 pages using the required Attachment A1 template. The cover page, cost estimate, resource share strategy, and references are not counted.

ARPA-H UNIQUE ARPA-H-SOL-26-162: Quantum Entanglement Imaging Program Guide for Startups

ARPA-H's UNifying Imaging with QUantum Entanglement (UNIQUE) program wants to expand what medical imaging can measure. It funds teams that capture quantum correlations in the 511 keV photon pairs produced in PET-style positron annihilation and use AI to turn those signals into new information about tissue health, such as metabolism, oxygenation, and microstructure. Small businesses, larger companies, universities, and nonprofits are all eligible, and early-career investigators are preferred.

Deadline: Solution Summaries are due October 29, 2026 at 5:00 PM ET through the ARPA-H Solutions site. Full proposals are due December 15, 2026 at 5:00 PM ET.

Why This Opportunity Matters

CT, MRI, and PET show anatomy and function, but they cannot fully characterize the tissue microenvironment where diseases like neurodegeneration, chronic traumatic encephalopathy, and pancreatic cancer begin. By the time those diseases are visible, damage is often substantial. Recent research shows that photon pairs from positron annihilation can retain measurable quantum correlations, and those correlations may carry biological information that conventional contrast misses.

The field is still largely at the proof-of-concept stage. That is exactly where ARPA-H invests. UNIQUE is a short, focused 18-month program, which makes it a realistic way for a detector, photonics, or imaging AI company to build a position in quantum medical imaging before the field matures.

Key Facts at a Glance

• Sponsor: Advanced Research Projects Agency for Health (ARPA-H), Health Science Futures Office
• Solicitation: ARPA-H-SOL-26-162, Innovative Solutions Opening (Amendment 01)
• Award type: Other Transaction (OT) agreements. Multiple awards are anticipated
• Award size: Not published. Proposers submit a rough order of magnitude cost with the Solution Summary
• Program length: 18 months in two 9-month phases, with Phase 2 continuation based on Phase 1 results
• Proposers' Day: October 16, 2026, 8:30 AM ET, with lightning talks and sidebars from 3:00 to 5:00 PM ET
• Solution Summary due: October 29, 2026, 5:00 PM ET (required)
• Full proposal due: December 15, 2026, 5:00 PM ET
• Cost share: Required only for for-profit companies with more than 1,000 employees
• Human subjects: Not anticipated. Work is done in phantoms and on the benchtop

What UNIQUE Funds

Every proposal must address both technical areas in a single integrated plan, so most competitive teams will combine hardware and AI expertise.

Technical Area 1: Imaging Core

Generate and measure quantum-derived contrast from entangled 511 keV photon pairs, positronium-sensitive interactions, and decoherence in controlled phantom and benchtop systems. Phase 1 targets include an entanglement witness above 1.6, coincidence timing resolution under 300 picoseconds (stretch goal under 150), entangled pair flux of 100,000 to 1,000,000 pairs per second, and measurable differences across at least 3 phantom states. Phase 2 moves to ghost image reconstruction in phantoms, higher usable coincidence rates, stronger signal to background, and repeatability within 10 percent.

Technical Area 2: Quantum AI Interpretation and Fusion

Build AI-driven reconstruction that fuses anatomical, functional, molecular, and quantum-derived signals into unified multidimensional images. Phase 1 calls for a simulation-to-reconstruction pipeline, prototype voxel-level quantum contrast maps, and statistically distinguishable clustering of at least 3 phantom states. Phase 2 calls for a preliminary quantum contrast atlas, datasets above 1,000,000 correlated events, and 3D localization of 2 to 3 millimeters or better.

An ARPA-H independent verification and validation team will supply benchmark phantoms and test results against these metrics.

Is Your Company a Fit?

UNIQUE is a strong fit for companies working in:

• PET, gamma, or Compton detectors, fast-timing scintillators, SiPM readout, or sub-300 picosecond coincidence electronics
• Positron sources, radioisotopes, or imaging phantoms
• Quantum photonics or ghost imaging, if the team can work at 511 keV
• Tomographic reconstruction, physics-informed AI, or multimodal image fusion for sparse, low-count data

Because one proposal must cover both technical areas, a small company will often lead or join a team with an academic PET physics or quantum lab. Each organization may lead only one proposal. Optical-only quantum imaging teams are a weaker fit unless they can adapt to annihilation photons. FFRDCs and government entities cannot participate except in rare, justified cases, and entities from covered foreign countries are excluded. Proposals that offer incremental improvements will not be funded.

How to Apply

1. Attend Proposers' Day on October 16, 2026. It is optional, but the lightning talk and sidebar sessions are the best place to find teaming partners.
2. Submit a Solution Summary by October 29, 2026. It is limited to 3 pages, plus a cover page, rough order of magnitude cost by phase, team qualifications, and references. It must answer what health problem you are solving, how it is done today, and what is new about your approach.
3. Receive an encourage or discourage response. You may still submit a full proposal either way.
4. Submit the full proposal by December 15, 2026. It includes a 12-page technical and management volume, a cost volume with no page limit, and an administrative and policy volume.

All submissions go through the ARPA-H Solutions site, and an active SAM.gov registration is required. Questions go to UNIQUE@arpa-h.gov.

How BW&CO Helps

BW&CO helps imaging, photonics, and AI companies decide whether UNIQUE fits their roadmap, assemble teams that cover both technical areas, and write Solution Summaries that make a clear case for disruptive impact. We also manage full proposal development, cost volumes, and OT negotiation support. With $350M+ in non-dilutive funding secured for our clients, we help deep tech founders compete for programs like this one.

Frequently Asked Questions

What is the ARPA-H UNIQUE program?

UNIQUE (UNifying Imaging with QUantum Entanglement) is an 18-month ARPA-H program that funds teams to measure quantum correlations in 511 keV photon pairs and use AI to turn them into new medical imaging contrast for tissue health.

When is the UNIQUE deadline?

Solution Summaries are due October 29, 2026 at 5:00 PM ET, and full proposals are due December 15, 2026 at 5:00 PM ET. A Solution Summary is required.

How much funding does UNIQUE provide?

ARPA-H has not published an award size or total budget. Awards are Other Transaction agreements, multiple awards are anticipated, and proposers estimate their own costs by phase.

Can small businesses apply to UNIQUE?

Yes. Small businesses, larger companies, universities, and nonprofits are all eligible, and early-career investigators are preferred. Companies with more than 1,000 employees must provide meaningful cost share.

Do I need to address both technical areas?

Yes. Every proposal must cover both the Imaging Core and the Quantum AI Interpretation and Fusion technical areas in one integrated plan, so teaming is common.

Does UNIQUE involve human subjects research?

No. Human subjects research is not anticipated. Work is done with phantoms and benchtop systems, using benchmark phantoms supplied by an ARPA-H independent verification and validation team.

ARPA-H Emerging Health Innovators (EHI) 2026, ARPA-H-SOL-26-150: Up to $1.05M for Early-Career Researchers

ARPA-H's Emerging Health Innovators (EHI) initiative funds bold, early-stage health research led by early-career investigators, and pairs every award with an ARPA-H Program Manager who acts as project manager and mentor. Companies, universities, and nonprofits can all lead, as long as the Project Lead is within 8 years of their first terminal degree. Each award is worth up to $1,050,000 over three years, across 16 topic areas spanning devices, diagnostics, biotech, and clinical AI.

Deadline: Solution Summaries are due October 30, 2026 at 2:00 PM ET through the ARPA-H Solutions site. Full proposals are due February 10, 2027 at 2:00 PM ET.

Why This Opportunity Matters

Most ARPA-H programs are built for large, experienced teams. EHI is the exception. It is designed to bring new researchers into the ARPA-H model, fund ideas that are still too early for traditional grants, and train the next generation of ARPA-H performers and Program Managers. For a startup with a young technical lead, it is one of the few ways to win a direct ARPA-H award without competing against established multi-institution teams.

EHI also comes with something money cannot buy: a monthly working relationship with an ARPA-H Program Manager. For a company planning to pursue larger ARPA-H programs later, that relationship and the track record of delivering on an ARPA-H agreement can be a meaningful advantage.

Key Facts at a Glance

• Sponsor: Advanced Research Projects Agency for Health (ARPA-H), Office of Commercialization
• Solicitation: ARPA-H-SOL-26-150, Innovative Solutions Opening (Amendment 1)
• Award type: Fixed-price Other Transaction (OT) agreements paid on milestones
• Award size: Up to $1,050,000 total, including indirect costs
• Structure: 24-month base period (up to $350,000 per year) plus an optional 12-month Director's Award (up to $350,000) for top performers
• Number of awards: Multiple. ARPA-H expects to fund 20 or more awards per year through EHI
• Proposers' Day: October 13, 2026 (virtual, register by October 12)
• Solution Summary due: October 30, 2026, 2:00 PM ET (required)
• Full proposal due: February 10, 2027, 2:00 PM ET
• Tentative selections: April 30, 2027, with awards starting around June 30, 2027
• Cost share: Not required

The 16 EHI Topic Areas

Every submission must target exactly one topic. Ideas outside these topics are not accepted.

Devices, Implants, and Neurotechnology

• Topic 1, Precision Control of Skin Inflammation: Networked biomaterials in the skin that sense inflammation and deliver localized, reversible therapy without systemic exposure.
• Topic 2, Internal Sensing and Targeted Control of Inflammation: Injectable or ingestible micro and nano scale platforms that sense inflammation and deliver therapy under closed-loop or external control.
• Topic 3, Deep Brain Stimulation for Sleep (Deep Sleep): Using DBS to record and modulate deep brain activity during sleep and test personalized, closed-loop therapy.
• Topic 15, ICAT In-Cavity Adjuvant Therapy: Implantable systems placed in the tumor resection cavity that deliver steep, tunable therapy and sense residual disease, with glioblastoma as the example model.

Diagnostics and Women's Health

• Topic 9, SMILE: Low-cost detection of early tooth decay and oral microbiome imbalance, or bio-inspired enamel repair that outlasts fillings.
• Topic 10, Ectopic Pregnancy First-Visit Diagnosis: Same-day point-of-care tools, biomarker panels, or imaging approaches that distinguish viable pregnancy, early loss, and ectopic pregnancy.
• Topic 11, Transforming the Well-Woman Exam: Objective at-home or primary care screening for conditions such as endometriosis, fibroids, and perimenopause. Standalone AI tools are discouraged.
• Topic 14, Non-Contact Sterility Testing: Measuring sterility in sealed containers fast enough for in-line distributed manufacturing, replacing tests that take 3 to 14 days.

Biotech, Immunology, and Tissue Platforms

• Topic 4, CLEAR-MIND: Preclinical work to restore the brain's drainage system and rebalance immune response after injury.
• Topic 5, HIND: Host-pathway interventions, biomarkers, and CNS delivery for neurotropic diseases such as rabies, EEEV, and prion disease.
• Topic 7, Engineering DRTs: Programmable, protein-templated DNA synthesis as a new medical countermeasure strategy.
• Topic 8, Alpha-Gal Syndrome: Mapping, predicting, preventing, and treating tick-bite triggered alpha-gal allergy.
• Topic 12, Biotransport for Organ Preservation: Uniform, low-toxicity delivery and removal of cryoprotectants through thick tissues and whole organs.
• Topic 13, Organs-in-Action: Organ and system scale human tissue platforms, beyond organoids and chips, for aging, disease, and therapy discovery.

Artificial Intelligence and Data

• Topic 6, Protecting Patient Data in Life Science AI: Defenses against membership inference and model inversion, leakage measurement, machine unlearning, and agentic AI security.
• Topic 16, Causally Grounded Alignment for Clinical Generative AI: Causal alignment constraints, evaluators, and mechanistic auditing for clinical generative AI tools.

Is Your Company a Fit?

EHI is a strong fit if most of these are true:

• Your proposed Project Lead completed their first terminal degree (typically a PhD, MD, or equivalent professional degree) within the last 8 years. Leave, postdoc, residency, and fellowship periods can be excluded.
• The Project Lead is a working researcher, not an administrator, and is not currently a postdoc or clinical trainee.
• The Project Lead has never been the prime lead on an award from any ARPA agency (ARPA-H, DARPA, IARPA, ARPA-E).
• Your organization and every team member are employed at a U.S. institution.
• Your idea fits one of the 16 topics and aims for a revolutionary advance, not an incremental improvement.
• Your company has, or can quickly get, an active SAM.gov registration and UEI.

Things that rule a team out: FFRDCs, UARCs, national labs, and government entities cannot apply or team. Subawards, consultants, and vendors together cannot exceed 30 percent of the total agreement value. The concept cannot already be funded or selected for funding by another agency.

How to Apply

1. Register on the ARPA-H Solutions site. All submissions go through solutions.arpa-h.gov. Start your SAM.gov registration now if you do not have one, since it can take more than 14 business days.
2. Submit a Solution Summary by October 30, 2026. The summary is limited to 2 pages plus a cover sheet, names one topic, and must be completely anonymized. Identifying information about the Project Lead, company, or team goes on the cover sheet only, and references are not allowed.
3. Wait for an encourage or discourage decision. ARPA-H does not provide written feedback. Discouraged proposers may still submit but are strongly advised not to.
4. Submit the full proposal by February 10, 2027. It includes pitch slides, an 8-page technical and management proposal, a task description document, a milestone payment schedule, administrative and research security forms, and a signed organizational letter of support.

Each organization may submit more than one proposal, but each must have a different Project Lead, and each Project Lead may submit to only one topic.

How BW&CO Helps

BW&CO helps deep tech and life science companies decide whether EHI is the right ARPA-H entry point, choose the strongest topic, and write a Solution Summary that stands out in a blind review. We also build milestone payment schedules that ARPA-H can approve and help teams prepare the full proposal package if they are encouraged. With $350M+ in non-dilutive funding secured for our clients, we know how to position early-stage ideas for agencies that fund breakthroughs.

Frequently Asked Questions

What is the ARPA-H Emerging Health Innovators (EHI) initiative?

EHI is an ARPA-H mentorship and funding initiative for early-career investigators. It funds revolutionary health research across 16 topic areas through Other Transaction agreements, and each award is paired with an ARPA-H Program Manager who serves as mentor and project manager.

How much funding does EHI provide?

Each award can be worth up to $1,050,000, including indirect costs. That includes a 24-month base period of up to $700,000 and an optional 12-month Director's Award of up to $350,000 reserved for exceptional performers.

When is the EHI 2026 deadline?

Solution Summaries are due October 30, 2026 at 2:00 PM ET. Full proposals are due February 10, 2027 at 2:00 PM ET. A Solution Summary is required before submitting a full proposal.

Can a startup or small business apply to EHI?

Yes. EHI accepts proposals led by early-career investigators at industry, academic, and nonprofit organizations. There is no small business size requirement, but the organization and all team members must be employed at a U.S. institution.

Who counts as an early-career investigator for EHI?

An individual within 8 years of completing their first terminal degree. Leaves of absence, postdoctoral, residency, and fellowship periods can be excluded. Current postdocs and clinical trainees cannot serve as Project Lead, and anyone who has already led an award from any ARPA agency is not eligible.

Is cost share required for EHI?

No. The solicitation does not require cost share.

How long is the EHI Solution Summary?

Two pages, not counting the cover sheet. It must be fully anonymized, with identifying information only on the cover sheet, and it cannot include references.

MedTech Innovator Vantage Non-Dilutive Funding Program: Up to $200K for Health Security Diagnostics and Devices

MedTech Innovator Vantage is a joint partnership between MedTech Innovator and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services. Vantage is one of five specialized hubs in the BARDA Accelerator Network. Its Non-Dilutive Funding Program awards $50,000 to $200,000 for six-month, milestone-based projects that develop, evaluate, and validate diagnostic and medical device technologies for health security, preparedness, and response.

Deadline: Proposals are due October 15, 2026. Off-cycle applications for BARDA-aligned technologies are also accepted on a rolling basis.

Why This Opportunity Matters

Most early-stage medtech companies chase SBIR as their first federal dollar. Vantage is a faster, smaller entry point. A $50K to $200K award gives a startup proof-of-concept or validation data, a BARDA-aligned project record, and six months of project management and mentoring from subject matter experts. That record strengthens a later BARDA BAA, DRIVe, or SBIR application.

Key Facts at a Glance

• Sponsors: MedTech Innovator and BARDA (HHS), through the BARDA Accelerator Network
• Award size: $50,000 to $200,000
• Project length: 6 months, milestone-based
• Who can apply: Early-stage startups and university-backed projects
• Proposal window: September 1 to October 15, 2026
• Guided revisions: January 2027, with subject matter experts
• Award announcements: Anticipated March to April 2027
• Support included: Project management support and regular expert mentoring during the award
• Contact: vantage@medtechinnovator.org

Priority Technology Areas

Vantage funds diagnostic and medical device technologies that strengthen U.S. health security. Current priority areas include:

• Continuous patient monitoring: Platforms with advanced sensors, with emphasis on radiation injury and acute radiation syndrome
• Multiplexed point-of-care rapid tests: High-sensitivity tests, including botulinum toxin detection that distinguishes serotypes
• Deployable diagnostics: Low-cost tools for resource-limited settings
• Rapid triage diagnostics: Including low-throughput next-generation sequencing platforms for pathogen identification

What Is Out of Scope

• Oncology and chronic disease research
• Gain-of-function research involving pathogen manipulation

Is Your Company a Fit?

Vantage is a strong fit if your company:

• Is an early-stage startup or a university-backed spinout
• Is building a diagnostic, patient monitoring, or medical device technology with a clear health security use case
• Can define concrete, measurable milestones achievable in six months
• Plans to pursue larger BARDA or other federal funding after proof-of-concept

If your device targets cancer or a chronic disease without a preparedness or emergency response angle, other programs such as NIH SBIR are a better match.

How to Apply

1. Confirm alignment. Review BARDA's mission and the DRIVe target product profiles to map your technology to a stated health security need.
2. Define six-month milestones. Reviewers fund projects with specific development, evaluation, or validation outcomes that a $50K to $200K budget can deliver.
3. Submit by October 15, 2026. Proposals go to MedTech Innovator during the September 1 to October 15 window.
4. Revise with experts. Selected applicants refine proposals with subject matter experts in January 2027.
5. Award decision. Announcements are expected March to April 2027.

How BW&CO Helps

BW&CO has helped deep-tech, medtech, and biotech founders secure $350M+ in non-dilutive funding. We help you test fit against BARDA priorities, frame milestones reviewers trust, and plan the path from a Vantage award to BARDA BAA, DRIVe, and SBIR funding.

Frequently Asked Questions

What is the MedTech Innovator Vantage Non-Dilutive Funding Program?

It is a BARDA-aligned funding program run by MedTech Innovator that awards $50,000 to $200,000 for six-month projects developing, evaluating, and validating diagnostic and medical device technologies for health security.

When is the Vantage application deadline?

The 2026 proposal window runs September 1 to October 15, 2026. Off-cycle applications for BARDA-aligned technologies are accepted on a rolling basis.

Who is eligible to apply?

Early-stage startups and university-backed projects developing diagnostic or medical device technologies aligned with BARDA's health security mission.

Is Vantage funding dilutive?

No. Vantage awards are non-dilutive, so companies do not give up equity.

What technologies does Vantage prioritize?

Continuous patient monitoring for radiation injury, multiplexed point-of-care rapid tests such as botulinum toxin detection, low-cost deployable diagnostics, and rapid triage diagnostics including low-throughput NGS pathogen identification.

What is excluded from Vantage funding?

Oncology and chronic disease research, and gain-of-function research involving pathogen manipulation.

When are Vantage awards announced?

Selected applicants complete guided revisions in January 2027, and awards are anticipated in March to April 2027.

TRISH Catalyst Grants Program: NASA-Funded Space Health Awards for Companies and Researchers

The Translational Research Institute for Space Health (TRISH) funds disruptive, high-impact technologies and studies that protect astronaut health. TRISH is led by Baylor College of Medicine's Center for Space Medicine and funded through a NASA cooperative agreement with the NASA Human Research Program (HRP). The Catalyst Grants Program supports proof-of-concept projects and directed technology development. Tier 1 awards reach up to $150,000 over 12 months, and Tier 2 awards are $150,000 or more for larger projects.

Deadline: Rolling. Preliminary proposals are reviewed quarterly, and TRISH is accepting submissions through December 2026.

Why This Opportunity Matters

Many medtech problems in spaceflight mirror problems on Earth: remote monitoring, point-of-care diagnostics, blood clot prevention, behavioral health, and care with no specialist nearby. TRISH lets medtech and healthtech companies fund that work with NASA money, without the SBIR calendar. The two-page first step is light, U.S. companies are eligible, and a TRISH award builds a NASA track record that supports later NASA SBIR/STTR and HRP proposals.

Key Facts at a Glance

• Sponsor: TRISH at Baylor College of Medicine, funded by NASA's Human Research Program
• Tier 1: Under $150,000 total, up to 12 months
• Tier 2: $150,000 or more total, up to 18 months
• Budget rules: All direct and indirect costs count toward the total; minimum 10% cost share (cash or in-kind)
• Who can apply: U.S. institutions and companies with a documented base of ongoing R&D
• Submission: Rolling, with quarterly Step-1 reviews, through December 2026
• Notification: About 3 to 4 months after a Step-2 full proposal
• Contact: spacehealth-info@bcm.edu

What TRISH Funds

Catalyst projects must address critical human system risks on the NASA HRP roadmap, represent a unique, high-impact idea, and fall outside other open TRISH solicitations. Recent example topics include:

Ground-Based Research

• Countermeasures for internal jugular venous flow reversal
• Decompression sickness prevention
• Managing behavioral emergencies in remote environments
• Early detection of behavioral health decline

Flight Research

• Continuous characterization of venous flow during spaceflight
• Comparing venous thromboembolism countermeasures
• Evaluating post-flight motor control recovery

Is Your Company a Fit?

TRISH Catalyst is a strong fit if your company:

• Builds wearables, remote monitoring, point-of-care diagnostics, vascular, neuro, or behavioral health technology
• Can show how the technology reduces a specific spaceflight health risk
• Has ongoing R&D and preliminary data
• Can commit at least 10% cost share
• Wants a NASA relationship that extends into Earth-based clinical markets

How to Apply

1. Map to an HRP risk. Tie your technology to a named human system risk on the NASA Human Research Roadmap.
2. Submit a Step-1 preliminary proposal. Two pages maximum covering specific aims, deliverables, an implementation roadmap, TRISH alignment, and spaceflight health benefits. No institutional sign-off is required.
3. Prepare a Step-2 full proposal if invited. Tier 1 allows an 8-page project description and Tier 2 allows 15 pages, plus NASA SciENcv biosketches, Current and Pending Support, budget justification, a 2-page data management plan, and research security training certification.
4. Merit review. Reviewers score innovation, significance to NASA risk reduction, approach, and team, then assess budget, timeline, and data management.
5. Award. Decisions come about 3 to 4 months after Step-2, and start dates may shift with NASA budget availability.

How BW&CO Helps

BW&CO has helped deep-tech, medtech, and aerospace founders secure $350M+ in non-dilutive funding, including NASA awards. We help you frame your technology around NASA HRP risks, write a sharp two-page Step-1, and connect a TRISH award to NASA SBIR/STTR and Earth-based commercialization.

Frequently Asked Questions

What is the TRISH Catalyst Grants Program?

It is a NASA-funded program run by the Translational Research Institute for Space Health at Baylor College of Medicine that funds proof-of-concept projects and technology development addressing astronaut health risks.

Can companies apply for TRISH Catalyst grants?

Yes. U.S. institutions and companies are eligible if they have a documented base of ongoing research and development in science, healthcare, or technology.

How much funding does TRISH Catalyst provide?

Tier 1 awards are under $150,000 for up to 12 months. Tier 2 awards are $150,000 or more for up to 18 months. All direct and indirect costs count toward the total.

Is cost share required?

Yes. TRISH requires a minimum 10% cost share, which can be cash or in-kind.

What is the TRISH Catalyst deadline?

Submissions are rolling with quarterly Step-1 reviews, and TRISH is accepting applications through December 2026.

What does the Step-1 preliminary proposal require?

A two-page document covering specific aims, deliverables, an implementation roadmap, alignment with TRISH, and spaceflight health benefits. No institutional sign-off is needed.

How long does a TRISH award decision take?

Award notification is expected about 3 to 4 months after the Step-2 full proposal is submitted.

GRA Development Grant: Executive Summary for Georgia Startups

Executive Summary

Sponsor: Georgia Research Alliance (GRA), Innovation & Entrepreneurship Program
Award size: $10,000 to $250,000 per grant
Deadline: Six review cycles per year
Eligible applicants: Faculty researchers at accredited public or private universities in Georgia
Funding type: Non-dilutive grant (GRA takes no financial stake in the project)

The GRA Development Grant funds milestone-driven projects that move a Georgia university technology toward commercialization or startup formation. It is built for teams that have moved past the idea stage and now need to reduce technical risk, prove a competitive advantage, and generate the evidence that investors and federal reviewers expect to see.

What the Development Grant Funds

Projects are organized around a defined set of milestones. Typical activities include:

• Prototype refinement and technology validation
• Preclinical testing for medtech and biotech technologies
• Pilot manufacturing and scale-up studies
• IP landscape and regulatory pathway analysis
• Customer pilots and market validation

GRA may award more than one Development Grant to the same project as it continues to hit milestones, which makes the program a practical bridge from lab result to fundable company.

Who Should Apply

• Faculty founders at Georgia institutions such as Georgia Tech, Emory, the University of Georgia, Augusta University, Georgia State, and Kennesaw State
• Pre-spinout teams preparing to license university IP and form a company
• Deep-tech, biotech, medtech, and dual-use researchers whose technology shows commercial promise but still needs validation before outside investors will engage

Companies that were not founded on Georgia university technology are not eligible for GRA grants.

Where It Fits in the GRA Funding Ladder

• Exploratory Grant (up to $10,000, rolling): answers focused go/no-go questions on technical feasibility, early customer discovery, or lightweight whitespace analysis
• Development Grant ($10,000 to $250,000): advances commercialization or startup formation through defined milestones
• Startup Loan (up to $250,000): available after company formation to Georgia companies built on Georgia university technology, released in milestone-based tranches with a modest warrant and an option to convert in a future financing

Why It Pairs Well With SBIR and STTR

Federal SBIR and STTR reviewers reward proposals backed by strong preliminary data, a clear commercialization path, and evidence of customer demand. A GRA Development Grant pays for exactly that work. Georgia teams that use GRA funding to validate their technology are better positioned to pursue NIH, NSF, DoD, DOE, and NASA SBIR/STTR awards, and STTR in particular is a natural next step because it already requires a research institution partner.

GRA-backed projects have attracted more than $2.3 billion in follow-on investment, and GRA reports that 87% of its startups are still operating after four years.

How to Apply

• Download the Development Grant Application (MS Word) from the GRA Innovation & Entrepreneurship documents page
• Follow the instructions on pages 1 and 2 and complete the proposal inside the application file, not in a separate document
• Submit ahead of one of the six annual review cycles
• Plan for a progress report six months after funding begins and every six months after that
• Direct eligibility questions to Andrew Short, GRA Director of Innovation Programs, or grants@gra.org

Frequently Asked Questions

What is the GRA Development Grant?

The GRA Development Grant is a non-dilutive award of $10,000 to $250,000 from the Georgia Research Alliance Innovation & Entrepreneurship Program. It funds milestone-driven projects that advance Georgia university technologies toward commercialization or startup formation.

Who is eligible for a GRA Development Grant?

Faculty researchers employed by accredited public or private universities in Georgia are eligible. Companies not founded on Georgia university technology are not eligible for GRA grants.

What activities can a GRA Development Grant fund?

Typical activities include prototype refinement, technology validation, preclinical testing, pilot manufacturing, IP and regulatory analysis, and customer pilots.

When are GRA Development Grant applications reviewed?

GRA holds six Development Grant review cycles per year. Exploratory Grants of up to $10,000 are accepted on a rolling basis.

Does GRA take equity in exchange for a Development Grant?

No. GRA grants are non-dilutive and GRA holds no financial stake in grant-funded projects. GRA Startup Loans, available after company formation, do include a modest warrant component and an option to convert in a future financing.

How does a GRA Development Grant help with SBIR and STTR funding?

A Development Grant pays for the preliminary data, validation, and customer evidence that SBIR and STTR reviewers look for. Georgia faculty and spinouts can use GRA funding to strengthen proposals to NIH, NSF, DoD, DOE, and NASA. BW&CO helps teams build that full non-dilutive funding strategy.

Turn Your GRA Award Into Federal Funding

BW&CO helps Georgia founders and faculty map a GRA Development Grant into a full non-dilutive funding strategy, from milestone planning to SBIR and STTR proposals across NIH, NSF, DoD, DOE, and NASA. With more than $350M in funding secured for our clients, we know what reviewers look for.

NIH Highlighted Topic: Improving Diagnostic Safety and Quality in Healthcare

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging research that closes critical gaps in diagnostic safety and quality, particularly diagnostic failures that contribute to patient harm. The topic prioritizes three strategic areas: technology and innovation, infrastructure and system design, and advancing the science of diagnosis.

On the technology side, NIH highlights AI-enabled tools including large language models, telehealth and other digital health solutions, point-of-care diagnostic testing, enhanced data sources, sensors, and analytic methods, and other novel diagnostic tests. System-level priorities include coordinating care across the full diagnostic trajectory, integrating clinical tools with patient-reported information, and improving communication among patients, clinicians, and care teams.

NIBIB, the lead institute, focuses on technologies with broad applicability, such as AI to improve point-of-care imaging quality, motion correction for radiological imaging, 3D-printed phantoms, AI surveillance of diagnostic errors, workflow platforms that reduce diagnostic delays, and VR and AR visualization tools. NCI seeks faster, more accurate cancer diagnosis, including rare and early-onset cancers and quicker follow-up after abnormal screening results. NIDA is interested in AI, digital biomarkers, and neuroimaging for detecting substance use disorder and related conditions.

How to apply: This is a Highlighted Topic rather than a standalone NOFO, so it has no dedicated solicitation or deadline of its own. Small businesses should apply through the NIH SBIR omnibus (PA-27-100) or STTR omnibus (PA-27-102) and reference this Highlighted Topic by name in the Specific Aims or Significance section so program staff can connect the application to this priority. We also recommend contacting the central NIBIB scientific contact or the relevant institute contact to confirm fit before writing.

This highlighted topic is led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) with participation from NCI, NIDA, NIDCR, and the Office of Behavioral and Social Sciences Research (OBSSR). NIDCR notes it may give special consideration to meritorious applications in this area. The topic is active from July 28, 2026 through July 28, 2028.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of diagnostic technologies and workflow tools that reduce diagnostic errors and delays.

Eligible activities may include:

• AI and large language model tools for diagnostic decision support and error surveillance

• Point-of-care diagnostic tests and imaging quality enhancements

• Motion correction, phantom, and advanced visualization technologies for radiology

• Workflow and reporting platforms that close the loop on abnormal test results

• Telehealth and digital health diagnostic solutions

• Clinical validation studies using real-world data

• Regulatory strategy, commercialization planning, and market validation

Funding may also support personnel, materials and supplies, equipment, contract research, academic collaborations, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable diagnostic product aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. The next standard deadline is January 5, 2027. This Highlighted Topic remains active until July 28, 2028. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have 500 or fewer employees including affiliates.

• Are more than 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute's specific research mission, including an explicit connection to this Highlighted Topic.

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120 to 200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50 to 80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

Breakthrough T1D Industry Discovery and Development Partnership (IDDP): Funding, Eligibility, and How to Apply

Below is a brief summary. Please check the full program details before applying (link in resources section).

Quick Answer

The Breakthrough T1D Industry Discovery and Development Partnership (IDDP) is a non-dilutive R&D funding program for for-profit companies developing therapeutics or devices to cure, treat, or prevent type 1 diabetes (T1D) and its complications. Inquiries are accepted year-round on a rolling basis. Award size and duration are negotiated project by project, and companies must commit their own funds equal to or greater than the amount requested. Breakthrough T1D takes no equity. Instead, it receives a modest, capped royalty tied to successful commercialization, and the company keeps ownership of its IP and product rights.

Program Overview

Breakthrough T1D (formerly JDRF) is the largest nonprofit funder of type 1 diabetes research. Most of its grant programs fund academic investigators. The IDDP is the exception: it is built specifically for biotech, pharma, medtech, and other for-profit organizations, whether public or private.

The program pairs a company's ability to move products toward market with Breakthrough T1D's scientific expertise, clinical networks, and advocacy reach. Its stated goals are to accelerate the development of therapeutics and devices for T1D and to build long-term collaborative relationships with industry.

For SBIR and STTR companies, the IDDP is a strong complement to federal funding. It is milestone-driven, it is negotiated rather than scored against a fixed solicitation, and it comes with a strategic partner that knows the T1D market, patient community, and regulatory landscape.

What Breakthrough T1D Is Looking For

Projects must closely align with Breakthrough T1D's priority research areas and address the discovery or development of therapeutics or devices that cure, treat, or prevent T1D, including its complications.

Cell Therapies

Approaches that replace or restore insulin-producing beta cells, including stem cell-derived islets, encapsulation, and strategies that reduce or eliminate the need for immunosuppression.

Disease-Modifying Therapies

Therapeutics that delay, prevent, or halt the autoimmune process behind T1D, including immunotherapies and interventions for people at risk or newly diagnosed.

Devices and Monitoring Technologies

Devices that improve daily management and outcomes. Recent Breakthrough T1D calls have focused on combined continuous glucose monitor (CGM) and insulin pump devices and on continuous C-peptide monitoring, which signals strong interest in medtech and digital health.

Complications

Products that address T1D-related complications, such as cardiovascular, kidney, eye, and nerve disease.

Funding and Award Structure

• Award amount: Not fixed. Budgets are approved project by project based on scope.

• Duration: Open. Timelines are set in the partnership agreement.

• Matching requirement: The company must commit funds equal to or greater than the amount requested from Breakthrough T1D for the full funding period.

• Milestone-based payments: Funding is released against agreed research and development milestones.

• Return on investment: Breakthrough T1D receives a modest ROI based on successful commercialization or agreed inflection points, typically through royalties. Royalties are capped at a proportion relative to the size of the award.

• No equity: The IDDP does not take an ownership stake, which keeps it non-dilutive.

Intellectual Property

The company owns the discoveries, IP, and product rights that come out of the funded research. If the company abandons development of the funded program, Breakthrough T1D gains access rights, including the ability to sublicense the IP to another party so the technology can still reach patients.

Eligibility

• For-profit organizations, public or private, including biotech, pharmaceutical, and medical device companies

• Companies may partner with academic investigators or contract research organizations

• Projects must align with Breakthrough T1D's priority research areas

• Companies must be able to meet the one-to-one (or greater) matching requirement

• Companies should be prepared to provide audited financial statements and financial projections during due diligence

Timeline

There is no fixed deadline. Breakthrough T1D welcomes inquiries year-round and reviews opportunities on a rolling basis. Timing depends on how quickly a company moves through the pre-LOI, LOI, peer review, and agreement stages.

How to Apply

1. Pre-LOI discussion: Contact Breakthrough T1D and share a non-confidential pitch deck. Staff assess whether the project fits the research strategy.

2. Letter of Intent: If invited, submit an LOI through Breakthrough T1D's RMS360 grant system. This stage may include negotiation of a non-binding term sheet.

3. Full proposal: Incorporate LOI feedback into a full proposal, which goes through confidential external peer review with a rebuttal opportunity.

4. Agreement: After a positive review, the parties finalize a definitive agreement covering governance, milestones, IP, and commercialization terms.

IDDP vs. the T1D Fund

Breakthrough T1D also runs the T1D Fund, a venture philanthropy fund that makes equity investments in T1D companies. The IDDP is different. It funds specific research programs through milestone-based agreements and a capped royalty, not equity. Companies that want to protect their cap table should start the conversation with the IDDP.

Why SBIR and STTR Companies Should Consider the IDDP

• Stackable funding: An IDDP partnership can extend runway alongside NIH SBIR and STTR awards, including NIDDK programs focused on diabetes.

• Rolling access: There is no need to wait for a federal receipt date.

• Strategic validation: A partnership with the leading T1D research funder strengthens investor and acquirer conversations.

• Device-friendly: Unlike many disease foundations, Breakthrough T1D actively funds devices and monitoring technologies.

How BW&CO Consulting Supports IDDP Applicants

BW&CO Consulting helps deep-tech, biotech, and medtech founders build non-dilutive funding strategies that combine federal SBIR and STTR awards with foundation and state programs. For the IDDP, we assess alignment with Breakthrough T1D's priorities, shape the non-confidential pitch deck, structure milestones and matching funds, and prepare a competitive LOI and full proposal. With $350M+ in funding secured for our clients, we know how to position R&D programs for funders who expect a clear path to patients.

If you are developing a T1D therapeutic or device, book a call to see whether the IDDP fits your roadmap.

Frequently Asked Questions

What is the Breakthrough T1D IDDP? The Industry Discovery and Development Partnership is a Breakthrough T1D program that funds for-profit companies conducting research on therapeutics or devices to cure, treat, or prevent type 1 diabetes and its complications.

Who is eligible for the IDDP? Public and private for-profit organizations, including biotech, pharma, and medical device companies. Companies may partner with academic investigators or CROs.

When is the IDDP deadline? There is no fixed deadline. Breakthrough T1D accepts inquiries year-round on a rolling basis.

How much funding does the IDDP provide? There is no published cap. Budgets are approved project by project, and companies must match the requested amount with their own funds, dollar for dollar or more.

Is the IDDP non-dilutive? Yes. Breakthrough T1D does not take equity. It receives a modest royalty tied to commercialization, and that royalty is capped relative to the award amount.

Who owns the IP from an IDDP project? The company owns the discoveries, IP, and product rights. Breakthrough T1D gains access rights only if the company abandons development of the funded program.

Does the IDDP fund medical devices and digital health? Yes. The program covers therapeutics and devices, and recent Breakthrough T1D calls have targeted integrated CGM and pump systems and continuous C-peptide monitoring.

How do I apply for the IDDP? Start with a pre-LOI conversation and a non-confidential pitch deck. If invited, submit an LOI through RMS360, then a full proposal for external peer review, followed by agreement negotiation.

Can I combine the IDDP with SBIR or STTR funding? The IDDP is a separate program from federal SBIR and STTR, so companies can pursue both. Confirm with Breakthrough T1D whether federal award dollars can count toward the company match.

What is the difference between the IDDP and the T1D Fund? The T1D Fund makes equity investments. The IDDP funds specific research programs through milestone payments and a capped royalty without taking equity.

Can BW&CO Consulting help with an IDDP application? Yes. BW&CO helps companies assess fit, build the pitch deck, structure milestones and matching funds, and prepare the LOI and full proposal.

Resources

• Breakthrough T1D Funding Opportunities

• IDDP Program Overview

• Breakthrough T1D Grant Handbook

NIH Highlighted Topic: Microphysiological System Pilot Studies in Diabetes Research

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging collaborative research that applies human microphysiological systems (MPSs), often called organ-on-chip or tissue-chip platforms, to cell and tissue types relevant to diabetes and its kidney and urologic complications. MPSs are a New Approach Methodology (NAM) that support long-term culture of human cells under physiologically relevant conditions, enable real-time observation, biosensing, and frequent sampling, and can connect multiple tissue or organ models.

A central goal is pairing engineering and device developers with biology and physiology researchers so MPSs can be more widely adopted in diabetes research. High-priority areas include systems with at least two diabetes-relevant human tissues that demonstrate stability and durability, validation of diabetes pathophysiology through biosensors and multiplexed monitoring, studies of crosstalk between tissues, models with mature cell types and interacting compartments such as vasculature, nerves, and stroma, disease phenotypes created through gene editing or environmental perturbation, and multi-tissue models of diabetic kidney disease and urologic complications.

Relevant tissues include pancreatic islets, liver, adipose tissue, gut, vasculature, and skeletal muscle. The topic is part of the NIH MAHA Chronic Disease Initiative and NIH's broader push for NAMs, which NIH, FDA, and EPA have all committed to using where appropriate.

How to apply: This is a Highlighted Topic rather than a standalone NOFO, so it has no dedicated solicitation or deadline of its own. Small businesses should apply through the NIH SBIR omnibus (PA-27-100) or STTR omnibus (PA-27-102) and reference this Highlighted Topic by name in the Specific Aims or Significance section so program staff can connect the application to this priority. NIDDK asks that responsive projects be tightly focused and short in duration (1 to 3 years) to establish proof of concept and demonstrate feasibility, which fits naturally with a focused SBIR Phase I scope. STTR is a strong option for company and university engineering partnerships. We also recommend contacting the listed NIDDK scientific contacts to confirm fit before writing.

This highlighted topic is supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). NIDDK notes it may dedicate funds to this area, depending on availability and the number of meritorious applications, and may give special consideration to meritorious applications. The topic is active from September 10, 2026 through September 10, 2028.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of microphysiological systems, biosensors, and enabling tools for diabetes research.

Eligible activities may include:

• Multi-tissue MPS platforms incorporating two or more diabetes-relevant human tissues

• Integrated biosensors and multiplexed sampling for real-time metabolic readouts

• Vascularized or innervated tissue models built with mature human cell types

• Disease-phenotype models created through gene editing or environmental perturbation

• Models of diabetic kidney disease and urologic complications

• Standardization, reproducibility, and validation studies against human data

• Commercialization planning and market validation with pharma and research end users

Funding may also support personnel, materials and supplies, equipment, contract research, academic collaborations, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable microphysiological system product aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. The next standard deadline is January 5, 2027. This Highlighted Topic remains active until September 10, 2028. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have 500 or fewer employees including affiliates.

• Are more than 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute's specific research mission, including an explicit connection to this Highlighted Topic.

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120 to 200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50 to 80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Digital Twins for Biomedical, Biological and Behavioral Research

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research and prototype development of digital twin technologies for biomedical, biological, and behavioral research and human health. NIH uses the 2023 National Academies definition: a digital twin is a virtual model that mimics a real system, is dynamically updated with data from its physical counterpart, has predictive capability, and informs decisions. The two-way link between the virtual and the physical is central.

NIH wants fit-for-purpose digital twins that accelerate discovery, support intelligent medical technologies, and enable decision support across clinical, laboratory, and healthcare settings. Priority areas include verification, validation, and uncertainty quantification (VVUQ), real-time assimilation of multimodal and longitudinal data, interoperable and scalable computational architectures, and responsible governance of digital twin technologies.

Institute interests are broad. NCI wants cancer digital twins that predict treatment response and inform clinical trial design. NHLBI highlights patient-specific modeling and medical device design. NEI is interested in twins for glaucoma, macular degeneration, and diabetic retinopathy. NIBIB supports sensor-linked physical assets and readiness evaluation tools, while NIDDK, NIMH, NIDA, and NIGMS each outline uses ranging from clinical decision support to virtual clinical trials and drug-response prediction.

How to apply: This is a Highlighted Topic rather than a standalone NOFO, so it has no dedicated solicitation or deadline of its own. Small businesses should apply through the NIH SBIR omnibus (PA-27-100) or STTR omnibus (PA-27-102) and reference this Highlighted Topic by name in the Specific Aims or Significance section so program staff can connect the application to this priority. The Office of Data Science Strategy does not award grants itself, so applications must also fit the mission of at least one participating Institute or Center. We recommend contacting the relevant ICO scientific contact to confirm fit before writing.

This highlighted topic is led by the NIH Office of Data Science Strategy (ODSS) with participation from NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIAAA, NIAID, NIBIB, NIDA, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NLM, and ORWH. NCCIH, NIDA, NIDCR, NIDDK, and NIMHD note they may give special consideration to meritorious applications in this area. The topic is active from September 10, 2026 through September 10, 2028.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of digital twin platforms, software, and enabling tools for biomedical research and healthcare.

Eligible activities may include:

• Fit-for-purpose, bidirectional digital twin prototypes for a defined disease, organ system, or care setting

• Verification, validation, and uncertainty quantification (VVUQ) tools and benchmarking frameworks

• Real-time data assimilation pipelines linking sensors, wearables, imaging, and EHR data to virtual models

• Interoperable, modular digital twin architectures and reusable software platforms

• Virtual clinical trial and in silico testing tools for drugs, devices, and interventions

• Clinical decision support prototypes and usability testing with clinicians and research end users

• Commercialization planning, regulatory strategy, and market validation

Funding may also support personnel, materials and supplies, equipment, contract research, academic collaborations, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable digital twin product aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. The next standard deadline is January 5, 2027. This Highlighted Topic remains active until September 10, 2028. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have 500 or fewer employees including affiliates.

• Are more than 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute's specific research mission, including an explicit connection to this Highlighted Topic.

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120 to 200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50 to 80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Advanced Biomaterials for Biomedical Research

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research on advanced biomaterials that overcome a core limitation of today's research tools: traditional biomaterials fail to recapitulate the tissue complexity, heterogeneity, and dynamic change seen in living systems. This highlighted topic seeks new materials that let material scientists and biomedical researchers work together to solve fundamental biological problems.

NIH is particularly interested in biomaterials that enable dynamic physical properties, detect and respond to tissue-specific changes, behave in robust and predictable ways, and improve reproducibility in disease models. Multidisciplinary teams that combine materials scientists, physical scientists, bioengineers, and biomedical researchers are strongly encouraged.

Areas of interest include responsive and programmable biomaterials (pH, thermal, light, electrostatic, and stiffness responsive), functionalized materials that model the transition from normal tissue to tumor microenvironment, biomaterials that modulate immune, nerve, vascular, or lymphatic components, and approaches that pair material science with synthetic biology to study cancer.

How to apply: This is a Highlighted Topic rather than a standalone NOFO, so it has no dedicated solicitation or deadline of its own. Small businesses should apply through the NIH SBIR omnibus (PA-27-100) or STTR omnibus (PA-27-102) and reference this Highlighted Topic by name in the Specific Aims or Significance section so program staff can connect the application to this priority. STTR is a natural fit for company and university materials science partnerships. We also recommend contacting the listed NCI or NIDCR scientific contact to confirm fit before writing.

This highlighted topic is supported by the National Cancer Institute (NCI) and the National Institute of Dental and Craniofacial Research (NIDCR). NIDCR notes it may give special consideration to meritorious applications in this area. The topic is active from September 9, 2026 through September 9, 2028.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of advanced biomaterials, engineered tissue models, and enabling research tools that more faithfully reproduce living tissue.

Eligible activities may include:

• Stimuli-responsive and programmable hydrogels, scaffolds, and matrices

• Materials with tunable stiffness, porosity, and degradation for disease modeling

• Engineered tumor microenvironment models for cancer research and drug testing

• Biomaterials that incorporate immune, vascular, lymphatic, or nerve components

• Material platforms combined with synthetic biology and engineered cells

• Embedded sensing materials that detect and report tissue-specific changes

• Dental, oral, and craniofacial biomaterials and tissue models

• Standardized, reproducible biomaterial kits for research laboratories

• Scale-up and manufacturing process development for research-grade materials

• Characterization, quality control, and validation studies

• Prototype development and usability testing with research end users

• Commercialization planning and market validation

Funding may also support personnel, materials and supplies, equipment, contract research, academic collaborations, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable biomaterial product aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. The next standard deadline is January 5, 2027. This Highlighted Topic remains active until September 9, 2028. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have 500 or fewer employees including affiliates.

• Are more than 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute's specific research mission, including an explicit connection to this Highlighted Topic.

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120 to 200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50 to 80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

North Carolina SBIR/STTR Phase I Incentive Funds Program: Complete FY 2026-2027 Solicitation Guide

Executive Summary

The One North Carolina Small Business Program reimburses North Carolina companies for up to $12,000 of the money they spend preparing and submitting a federal SBIR or STTR Phase I proposal. It is not a competitive grant, it is a reimbursement. If your company is eligible, your proposal was received by a participating federal agency, and your paperwork is complete, you get paid. You do not have to win the federal award to qualify.

The FY 2026-2027 solicitation (Funding Opportunity Number NCBSTI-FY2627I) was released on September 14, 2026 by the North Carolina Board of Science, Technology & Innovation. It covers qualifying federal Phase I proposals submitted from July 1, 2026 through June 30, 2027, and it is funded at $210,000 total. Awards are made on a rolling, first-come, first-served basis until that money runs out.

At a Glance

• Program name: One North Carolina Small Business Program, SBIR/STTR Phase I Incentive Funds Program

• Funding Opportunity Number: NCBSTI-FY2627I

• Administering agency: North Carolina Board of Science, Technology & Innovation, supported by the Office of Science, Technology & Innovation at the N.C. Department of Commerce

• Authorizing statute: N.C. Gen. Stat. Section 143B-437.80

• Release date: September 14, 2026

• Solicitation period: July 1, 2026 through June 30, 2027

• Closing date: June 30, 2027 at 11:59 p.m. EST, or earlier if funds are exhausted

• Total funds available: $210,000

• Maximum award: $12,000 per company

• Reimbursement rate: 75 percent of eligible costs in Development Tier 1 and Tier 2 counties, 50 percent in Tier 3 counties

• Award basis: Rolling, first-come, first-served, non-competitive

• Submission system: CyberGrants, with online applications available as of September 14, 2026

What the Incentive Program Actually Does

Writing a competitive SBIR or STTR Phase I proposal is expensive before a single dollar of federal money arrives. Companies spend real cash on consultants, staff time, literature searches, dedicated lab or prototyping space, and supporting materials, and they spend it with no guarantee that the agency will fund the work. Federal SBIR success rates at most agencies sit well under 20 percent, so most of that spend is a sunk bet.

North Carolina created the Incentive Funds Program to take some of that risk off the table. The state reimburses a percentage of documented proposal preparation costs, which lowers the cost of entering the competition and makes it rational for a company to submit more proposals, to more agencies, at higher quality. The program goals written into the solicitation are explicit: increase the number and quality of North Carolina Phase I applications, pull in applicants from economically distressed counties, and raise the state's presence at federal agencies where North Carolina is underrepresented in Phase I awards, with the Department of Defense named as the specific example.

The practical effect for a founder is straightforward. Your out of pocket cost to run a serious federal proposal effort drops by half or by three quarters, capped at $12,000, and the check arrives whether or not the agency funds you.

Who Is Eligible

Company requirements

To qualify, an applicant must certify under oath, signed by an authorized official, that all of the following are true:

• The applicant is a for-profit small business with its principal place of business in North Carolina

• The applicant has not received concurrent funding from another source that duplicates the purpose of the Incentive award

• The applicant will conduct at least 51 percent of the activities described in the Phase I proposal in North Carolina, and will maintain significant North Carolina operations for the entire Phase I project if the federal award is made

• The applicant has a formal written policy addressing conflicts of interest

• The applicant has no overdue tax debts at the federal, state, or local level

The company must also have been registered with the North Carolina Secretary of State either before it submitted the federal SBIR or STTR application, or at least 90 days before it applies to the Incentive Program. Companies on the state's Suspension of Funding list are not eligible, and previous One NC Small Business Program recipients must be current on all prior award reporting.

Proposal requirements

• The proposal must be a Phase I or Fast Track SBIR or STTR proposal submitted to a participating federal agency

• The federal agency must have issued official notification of receipt during the solicitation period, meaning between July 1, 2026 and June 30, 2027

• Proposals submitted between July 1, 2026 and the September 14, 2026 release date are still accepted, as long as all other eligibility requirements are met and funding remains available

What does not qualify

• Direct to Phase II applications

• Phase II applications

• Proposals received by the federal agency outside the solicitation period

For STTR applications, the Board will only reimburse the fraction of expenses directly incurred by the small business applicant in the collaboration, not costs borne by the research institution partner.

Funding Allowance: How Much You Get Back

Reimbursement rates by county tier

Your reimbursement percentage depends on the North Carolina Development Tier designation of the county where your business is located. Tier designations are updated by the Department of Commerce every November and take effect the following January, so verify your county's current tier before you apply.

• Development Tier 1 and Tier 2 counties: 75 percent of eligible documented expenses, capped at $12,000

• Development Tier 3 counties: 50 percent of eligible documented expenses, capped at $12,000

What that looks like in practice

A company in a Tier 1 or Tier 2 county that documents $16,000 in eligible proposal preparation expenses receives the full $12,000, because $16,000 multiplied by 0.75 equals $12,000.

A company in a Tier 3 county needs to document $24,000 in eligible expenses to reach the same ceiling, because $24,000 multiplied by 0.50 equals $12,000.

If you document less than those thresholds, you receive the applicable percentage of whatever you actually documented. A Tier 3 company with $8,000 in documented eligible expenses receives $4,000.

Resubmissions

If a proposal that already received an Incentive award is revised and resubmitted, that resubmission is eligible for one additional award of up to $6,000, which is 50 percent of the statutory maximum. Eligible expenses on a resubmission are narrower than on an original: only additional data collection beyond what was gathered for the first proposal, and proposal preparation consulting fees paid to others.

Award limits

• One Incentive award per company during this solicitation period

• Ten Incentive awards per company over its lifetime

• A grant to a business partnered with a North Carolina public institution of higher education does not count against the lifetime maximum, subject to budget constraints

Eligible and Ineligible Expenses

Reimbursable costs

• Proposal preparation consulting fees paid to others. This is the single most important line item for most applicants. Fees paid to an outside grant consulting firm to develop and write the Phase I proposal are explicitly reimbursable

• Salaries paid to individuals directly involved in preparing the Phase I proposal, not to exceed the rate stated in the federal proposal budget, with proof of payment required

• Typing and word processing services

• Project related supplies and postage

• Database search fees for project related literature searches

• Rental of space or equipment directly related to preparing the federal proposal, such as dedicated lab space or a prototyping facility

• Educational program fees directly related to preparing the federal proposal

• USPTO utility patent application filing, search, examination, issue, and maintenance fees, for patents submitted within 36 months of the Phase I proposal submission and directly related to it

Non-reimbursable costs

• Travel

• Equipment purchases over $300

• Facility or leasehold improvements

• Legal fees, including legal fees associated with preparing a patent

• Fringe benefits

• Indirect costs, including rent paid for general operations

• In-kind services or deferred salaries

Documentation standards

Expenses that are incurred but not properly documented will not be reimbursed. Every receipt, invoice, or service contract must show that it was billed to the applicant with the applicant's address, the vendor name and address, the invoice date, a unique invoice number, quantity and description of the item or service with reference to the applicable SBIR or STTR proposal, unit price where applicable, total amount, and terms or due date.

Salary reimbursement requires proof of payment. That means pay stubs showing employee name, pay period dates, hours worked, rate of pay, total paid, and date and method of payment. In place of a pay stub or payroll service report, you can submit bank statements confirming the transaction plus the front and back of cleared company checks. If the hours you are claiming are less than the total hours on the pay stub, you must also submit a work log or certified statement identifying the hours that were directly related to federal proposal preparation.

USPTO receipts require payer name, payment date, payment amount, patent number, application number, fee code, fee code name, and attorney docket number.

Timeline and Key Dates

• July 1, 2026: Start of the eligible solicitation period. Federal Phase I and Fast Track proposals received by an agency on or after this date can qualify

• September 14, 2026: FY 2026-2027 Incentive solicitation released and online applications opened in CyberGrants

• Rolling, from September 14, 2026 forward: Complete applications are reviewed and approved first-come, first-served as they arrive

• Within 15 days of any request: Deadline to return supplemental materials requested by the Board or OSTI staff, or the application may be rejected without further review

• June 30, 2027 at 11:59 p.m. EST: Final deadline, or earlier if the $210,000 is exhausted before that date

• Within 30 days of federal Phase I award or denial notification: Final Report due in CyberGrants

• Three months after your fiscal year end: State Grant Compliance reporting due for the fiscal year in which you received or expended the award

Note that a separate FY 2027 Matching Funds Program solicitation is listed by N.C. Commerce with a December 14, 2026 release date. That is a different program with a different application. See the section below.

How to Apply

All applications are submitted electronically through CyberGrants, the Board's grant management system, linked from the One North Carolina Small Business Program page on the N.C. Commerce website. The system assigns an Application Reference Number when you begin. Applications missing any required response, document, or piece of information are considered incomplete and will not be funded.

The state requires DocuSign for electronic signatures. If you do not want to use DocuSign, you must use a wet signature. In-state virtual notarization is acceptable if it complies with the North Carolina Remote Electronic Notarization Act.

Required Application Documents

• A completed Grant Application and Agreement, generated by CyberGrants, including the sworn and signed eligibility attestation

• A Certificate of Existence or Certificate of Authorization from the North Carolina Secretary of State, issued no more than 90 days before your application date. This is the Certificate of Good Standing from the Secretary of State, not from the Department of Revenue, and first-time requesters need to create an Online Services account to obtain it

• A copy of the relevant pages of the federal SBIR or STTR Phase I solicitation showing the topic description, closing date, and topic reference number. A link to the solicitation does not satisfy this requirement

• A copy of the entire Phase I or Fast Track federal proposal, including the SF424 where applicable, submission cover, abstract, budget pages, key personnel, facility and performance site information, and the SBIR/STTR information page

• Evidence that the federal agency received your proposal, such as written or electronic confirmation showing the date of receipt

• A Supplier Electronic Payment Request Form with bank account verification

• A completed Certified Expense Table with supporting documentation in CyberGrants

• Copies of all receipts and supporting documents for every expense you are claiming

If your federal proposal contains proprietary or classified material that is not relevant to your Incentive eligibility, you may exclude it, but you must submit a notarized statement from an authorized official attesting that the excluded material is proprietary or classified and that economic harm or a violation of federal classification rules would result from submitting it. Applications that attempt to restrict dissemination of large amounts of information may be rejected.

How Applications Are Reviewed

There is no scoring panel and no competitive ranking. Applications are checked for compliance with the solicitation requirements and approved on a rolling, first-come, first-served basis through the end of the period or until funds are exhausted. Incomplete or non-compliant applications are rejected without further review, though the Board or OSTI staff may at their discretion request supplemental materials, which must come back within 15 days.

Once approved, the state issues payment electronically to the account listed on your Supplier Electronic Payment Form. If this is the first state payment your company has received, it may arrive as a paper check.

Reporting Requirements After Award

Recipients file a Final Report through CyberGrants within 30 days of being notified that the federal Phase I contract was awarded or denied. The report asks for the award date and contract amount if funded, an explanation if the contract was awarded but not accepted, whether the company will continue the research with its own resources if it was not funded, what material effect the Incentive award had on the firm, general comments on the program, and a summary of progress toward the original aims with significant results and any related publications.

Recipients that receive, use, or expend less than $1,000,000 in state funds in their fiscal year must also file State Grant Compliance reports within three months of fiscal year end, including a certification sworn by the treasurer and one other authorized officer, a State Grants Compliance report, and a Schedule of Grantee Receipts and Expenditures on a cash basis. Reporting delinquency is grounds for placement on the State Suspension of Funding list, which blocks future awards.

How Competitive Is It, Really

The program is non-competitive in the sense that applications are not scored against each other. The real constraint is the money. At $210,000 total and a $12,000 ceiling, this solicitation funds as few as 17 companies if applicants max out their awards.

Recent Incentive Program history gives a sense of the pace:

• FY 2026: 18 awards totaling $116,553

• FY 2025: 51 awards totaling $418,863

• FY 2024: 49 awards totaling $317,316

• FY 2023: 48 awards totaling $345,562

• FY 2022: 50 awards totaling $358,986

Across every year the Incentive Program has operated, 306 awards totaling roughly $1.8 million have gone out. Historical average awards have run well below the $12,000 ceiling, which means more than 17 companies will likely be funded this cycle. It also means companies that documented their expenses thoroughly captured substantially more than average. The two variables you control are how early you file and how completely you document.

What Comes Next: the Matching Funds Program

The Incentive Program is one half of the One North Carolina Small Business Program. The other half is the SBIR/STTR Phase I Matching Funds Program, authorized under N.C. Gen. Stat. Section 143B-437.81, which awards matching funds to North Carolina companies that have actually received a federal SBIR or STTR award. Its purpose is to bridge the funding gap between the final Phase I payment and the first Phase II payment, and to let companies intensify the Phase I research so they compete better for Phase II.

The Matching program is dramatically larger. In FY 2026 it made 32 awards totaling $2,368,507, and since 2006 it has made 662 awards totaling more than $42 million. Since its inception, the combined One NC Small Business Program has funded 525 North Carolina small businesses.

The sequence for a North Carolina company is therefore: submit your federal Phase I proposal, file for Incentive reimbursement of your proposal costs, and if you win the federal award, file for Matching funds. These are separate applications with separate solicitations and deadlines.

Common Mistakes That Cost Companies the Award

• Waiting. First-come, first-served with a hard funding cap means a complete application in October is worth more than a perfect one in May

• Thin receipts. An invoice without a unique invoice number, a vendor address, or a reference to the specific SBIR proposal is an invoice that does not get reimbursed

• Unproven salary claims. Claiming founder or staff time without pay stubs, cleared checks, or bank records, and without a work log separating proposal hours from other hours

• A stale Certificate of Existence. It expires for these purposes at 90 days, and first-time requests take time to process

• Submitting the wrong proposal type. Direct to Phase II and Phase II applications are not eligible, no matter how strong they are

• No conflict of interest policy on file. The solicitation includes a sample policy in its appendix. There is no reason to be missing this one

• Missing the 15 day supplemental materials window after the Board requests additional information

How BW&CO Helps

BW&CO Consulting is a non-dilutive federal funding advisory firm that has helped clients secure more than $350 million in government funding across NIH, NSF, DoD, NASA, DOE, and ARPA-H. Innovation Funding Simplified is not a slogan for us, it is the workflow.

For North Carolina companies, the two programs stack in a way that is worth being deliberate about. Proposal preparation consulting fees paid to an outside firm are an explicitly reimbursable expense under this solicitation, which means the state will cover 50 to 75 percent of what you spend on professional proposal development, up to the $12,000 cap.

When a company engages BW&CO to develop its federal SBIR or STTR Phase I proposal, we prepare and submit the North Carolina Incentive Funds application on your behalf at no additional cost. You focus on the science and the federal submission. We handle the expense table, the receipts package, the Certificate of Existence timing, the attestations, and the CyberGrants filing, and we file it early enough to matter.

Frequently Asked Questions

What is the One North Carolina SBIR/STTR Phase I Incentive Funds Program?

It is a North Carolina state reimbursement program that pays qualified North Carolina small businesses back for a portion of the costs they incurred preparing and submitting a federal SBIR or STTR Phase I proposal. It is authorized under N.C. Gen. Stat. Section 143B-437.80 and administered by the North Carolina Board of Science, Technology & Innovation. The FY 2026-2027 solicitation number is NCBSTI-FY2627I.

How much money can my company receive?

Up to $12,000. Companies in Development Tier 1 and Tier 2 counties are reimbursed 75 percent of eligible documented expenses, and companies in Tier 3 counties are reimbursed 50 percent. To hit the $12,000 ceiling, a Tier 1 or Tier 2 company needs $16,000 in documented eligible expenses and a Tier 3 company needs $24,000.

What is the deadline for the FY 2026-2027 solicitation?

June 30, 2027 at 11:59 p.m. EST, or earlier if the available funds are exhausted first. Because awards are made first-come, first-served against a $210,000 pool, the practical deadline is whenever the money runs out.

Do I have to win the federal SBIR award to get this money?

No. Reimbursement is triggered by proof that a participating federal agency received your qualifying Phase I or Fast Track proposal, not by whether the agency funds it. You do have to file a Final Report within 30 days of learning whether the federal award was made or denied.

Are SBIR consulting fees reimbursable under this program?

Yes. Proposal preparation consulting fees paid to others are the first item on the solicitation's list of reimbursable costs. Fees paid to an outside grant writing or proposal development firm qualify, as long as they are properly invoiced and documented.

Are Direct to Phase II or Phase II proposals eligible?

No. The FY 2026-2027 Incentive solicitation covers Phase I and Fast Track proposals only. Direct to Phase II and Phase II applications are explicitly excluded.

Is a Fast Track proposal eligible?

Yes. Fast Track proposals are eligible alongside standard Phase I proposals, provided the federal agency issued official notification of receipt during the solicitation period.

What proposals fall inside the eligible window?

Proposals for which a participating federal agency issued official notification of receipt between July 1, 2026 and June 30, 2027. Proposals submitted between July 1, 2026 and the September 14, 2026 release date are still accepted if all other eligibility requirements are met and funding remains available.

How do I find out which Development Tier my county is in?

The N.C. Department of Commerce publishes current County Distress Rankings, also called Tier designations. Tiers are recalculated each November and take effect the following January, so confirm your county's current designation before applying rather than relying on a prior year.

How many times can my company apply?

Once during this solicitation period, and no more than ten times over the life of the company. Awards to a business partnered with a North Carolina public institution of higher education do not count toward that lifetime limit, subject to budget constraints.

What if my proposal was declined and I want to resubmit?

A single resubmission of a proposal that already received an Incentive award can receive one additional award of up to $6,000. Eligible expenses on the resubmission are limited to additional data collection beyond what was gathered for the original proposal, plus proposal preparation consulting fees paid to others.

What expenses are not reimbursable?

Travel, equipment purchases over $300, facility or leasehold improvements, legal fees including patent preparation legal fees, fringe benefits, indirect costs such as general operating rent, and in-kind services or deferred salaries.

Do I need to be registered with the North Carolina Secretary of State?

Yes. Your company must have been registered with the North Carolina Secretary of State either before you submitted the federal SBIR or STTR application, or at least 90 days before you apply to the Incentive Program. Your application must include a Certificate of Existence or Certificate of Authorization issued no more than 90 days before the application date.

How is this different from the NC SBIR/STTR Matching Funds Program?

The Incentive Program reimburses what you spent writing the proposal and does not require a federal win. The Matching Funds Program, authorized under N.C. Gen. Stat. Section 143B-437.81, awards matching money to companies that have already received a federal SBIR or STTR award, to bridge the gap between Phase I and Phase II. They are separate programs with separate solicitations, and a company can use both in sequence.

How competitive is the program?

Applications are not scored against each other, so there is no competitive review. The constraint is the $210,000 funding pool and the first-come, first-served rule. Historically the Incentive Program has made between 18 and 51 awards per year, with average awards well under the $12,000 cap.

When should I apply?

As soon as you have official confirmation that the federal agency received your Phase I proposal and you have assembled complete expense documentation. Because funds are awarded in the order complete applications arrive, filing early in the period is a meaningful advantage over filing in spring.

Talk to Us Before You Spend the Money

The companies that capture the full $12,000 are the ones that decided how they would document the spend before they started spending. If you are a North Carolina company planning a federal SBIR or STTR Phase I submission this cycle, or you have already submitted one since July 1, 2026, we can tell you quickly whether you qualify and what your reimbursement is likely to be.

2027 NIA Start-Up Challenge and Accelerator: Complete Guide for Startups

Executive Summary

The 2027 NIA Start-Up Challenge and Accelerator is a prize competition from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), that awards up to $994,000 in non-dilutive cash prizes plus a five month entrepreneurial accelerator to early-stage innovators building technologies that improve the health and well-being of older adults. Submissions are accepted from December 1, 2026 through 11:59 p.m. ET on January 15, 2027. Up to 21 Stage 1 finalists each receive $24,000 and a seat in the accelerator, and up to 7 Stage 2 winners each receive an additional $70,000.

This is the fourth cycle of the Start-Up Challenge. It is run by the NIA Office of Strategic Extramural Programs under the America COMPETES Reauthorization Act of 2010, as amended (15 U.S.C. 3719). It is designed for researchers and innovators who are new to entrepreneurship, and it is explicitly built as a runway into the NIA SBIR and STTR programs.

Key facts at a glance

• Sponsor: National Institute on Aging (NIA), NIH, within the U.S. Department of Health and Human Services

• Program type: Prize competition and accelerator, not a grant or contract

• Total prize pool: Up to $994,000

• Stage 1 award: $24,000 each to up to 21 finalists, plus accelerator participation

• Stage 2 award: $70,000 each to up to 7 winners selected from the finalist pool

• Equity taken: None. Prize money is fully non-dilutive

• Submission window: December 1, 2026 to January 15, 2027 at 11:59 p.m. ET

• Informational webinar: December 3, 2026 at 1:00 p.m. ET

• Accelerator period: June 2027 through November 2027

• Who it is for: First-time or aspiring entrepreneurs with science-driven aging and healthspan technologies

• Key disqualifier: You cannot be the principal investigator on an active NIH SBIR or STTR award as of the close of the submission period

• Award Approving Official: NIA Director Richard J. Hodes, M.D.

Who should apply to the 2027 NIA Start-Up Challenge?

NIA is targeting a specific profile, and understanding that profile is the single largest driver of a competitive submission. The Challenge invites submissions from researchers and innovators who are new to entrepreneurship or actively seeking to pursue it, and who propose innovative, science-driven technologies with the potential to improve the health and well-being of older adults.

Unusually for a federal funding opportunity, the scoring rewards need as heavily as it rewards technical merit. Half of the Stage 1 score, 50 of 100 points, is allocated to the impact the Challenge would have on the submitter and the impact the submitter would have on NIA's small business research portfolio. A strong submission therefore has to make two arguments at once: that the technology is compelling, and that the applicant lacks the entrepreneurial training, mentorship, network, and capital that the Challenge provides.

Strong candidate profiles include:

• Academic investigators, postdocs, and clinician scientists with aging-relevant technology who have never commercialized

• Founders of very early stage companies with no prior NIH SBIR or STTR award as PI

• Teams with deep scientific expertise and acknowledged gaps in business, regulatory, or reimbursement strategy

• Innovators whose caregiving experience, clinical practice, or lived experience informs a differentiated approach to aging

• Individuals or teams planning to form a U.S. owned and operated small business ahead of an SBIR or STTR submission

Poor fits include established SBIR awardees, teams that already have institutional venture backing and full commercialization support, and applicants whose product is a modest variation on something already commercialized or already funded through the NIA SBIR and STTR programs.

What is NIA looking for? Detailed technology overview

NIA is seeking innovative tools, technologies, and interventions that prevent, diagnose, treat, monitor, or slow the progression of aging-related diseases and conditions, including Alzheimer's disease (AD) and AD-related dementias. The scope also extends well beyond disease treatment into the mechanics of daily life for older adults.

Core areas of interest

• Aging-related disease and condition management: prevention, diagnosis, treatment, monitoring, and slowing of progression, with explicit emphasis on Alzheimer's disease and AD-related dementias

• Healthy aging and healthspan: solutions that promote healthy aging across the population rather than treating a single endpoint

• Aging in place of choice: technologies that let older adults remain in the living setting they prefer

• Care delivery improvement: tools that improve how care is coordinated, delivered, and measured

• Caregiver burden reduction: solutions that reduce the practical, cognitive, and emotional load on formal and informal caregivers

Artificial intelligence is a stated priority

This cycle carries a particular interest in solutions leveraging artificial intelligence, including data-driven and machine learning approaches. NIA names four AI application areas specifically:

• Early detection of aging-related disease and decline

• Risk prediction and stratification

• Personalized interventions

• Rapid drug discovery and development

This interest is tied to a broader HHS priority to advance digital tools for the prevention of disease and to improve health status and health outcomes. If your technology has a credible AI or machine learning component, name it plainly and tie it to one of these four functions rather than describing AI as a generic feature.

Evidence, accessibility, and population reach

NIA asks submitters to prioritize evidence-based solutions that are broadly accessible and effective across the aging population. Reviewers expect you to account for the range of factors that determine whether a solution actually works in the field, including biological, social, behavioral, economic, environmental, and regional factors. A product that only performs for a narrow, well-resourced, technologically fluent subset of older adults will score poorly on reach.

Two differentiation requirements you cannot skip

Submissions must address both of the following, and weak submissions routinely ignore the second:

• Differentiation from existing commercialized products. Describe how your solution is substantially different from what is already on the market, not incrementally better.

• Expansion of the NIA SBIR and STTR portfolio. Describe how your approach would expand the types of technologies and approaches NIA already funds. NIA points applicants to the NIH RePORTER database to review existing and active NIA SBIR and STTR awards. Doing this research and referencing it directly is one of the cheapest ways to pick up points under the portfolio impact criterion.

Where this Challenge sits in the federal innovation pipeline

NIA positions the Start-Up Challenge as a bridge that prepares participants to pursue other programs, and it names several by way of context: the ACL Caregiver AI Challenge, FDA's READI-Home Innovation Challenge, a2 Collective pilot awards, and the NIA SBIR and STTR programs. Prior cohorts have gone on to raise follow-on venture capital, launch pilot studies, and win SBIR and STTR grants.

Funding allowance: how much money is available and how it can be used

NIA will award up to $994,000 in total cash prizes across two stages, alongside an accelerator program delivered at no cost to participants.

Stage 1: up to 21 finalists at $24,000 each

Up to twenty one Stage 1 finalists are selected from the initial submission pool. Each finalist receives a $24,000 cash prize and a seat in the five month accelerator. The prize is disbursed within three months of the start of the accelerator program, meaning cash typically lands during the summer of 2027.

The Stage 1 prize is intended to support critical early-stage business and product development activities identified during the program. At their discretion, finalists may also use a portion of the funds to cover participation in the two in-person events, including travel expenses.

Stage 2: up to 7 winners at $70,000 each

Up to seven Stage 2 winners are selected from the Stage 1 finalist pool, and each receives an additional $70,000 cash prize. Stage 2 is a closed competition among finalists, so no new applicants enter at this point. A single team that advances through both stages can therefore receive up to $94,000 in total prize money.

How prize money differs from grant funding

Because this is a prize competition rather than an assistance award, the money behaves differently from an SBIR or STTR grant. Points worth planning around:

• No line item budget or budget justification is submitted or approved

• No indirect cost rate, no fringe calculations, and no cost accounting requirements attach to the prize itself

• Prizes may be subject to federal income taxes. HHS and NIH comply with IRS withholding and reporting requirements where applicable, so plan for the tax treatment of the award

• Payment is by electronic funds transfer. Participants are encouraged, though not required, to obtain a free Unique Entity ID (UEI) through SAM.gov to expedite payment

• No equity, warrants, or repayment obligation. The award is fully non-dilutive

• Registration costs for both in-person events are covered by the program, but travel-related costs are paid by the participant

• NIH reserves the right to cancel, suspend, or modify the Challenge, and to decline to award prizes if no submissions are deemed worthy

What the accelerator program includes

The accelerator is arguably worth more than the Stage 1 cash prize for a first-time founder. It runs for approximately five months from June 2027 through November 2027 and is delivered at no cost to finalists.

• Weekly virtual education sessions led by industry experts

• One-to-one mentorship from experienced founders and investors

• Guidance on the NIH SBIR and STTR application process, requirements, and resources

• Business and regulatory guidance at no cost to the finalist

• In-depth pitch coaching

• A three-day entrepreneur bootcamp in June 2027, in person

• A three-day health innovation and investment conference in November 2027, in person

• Virtual and in-person networking with key industry partners

Time commitment

Finalists should expect to commit 6 to 8 hours per week for approximately five months, covering virtual education sessions, mentor meetings, and the two in-person events. This is a real operational load. Teams should decide in advance who will carry it.

Stage 1 learning objectives

By the end of the accelerator, participants should be able to:

• Assess the target market opportunity for the problem they have identified

• Develop a value proposition that solves an identified unmet need

• Create a scalable go-to-market strategy

• Evaluate applicable intellectual property, regulatory, and reimbursement pathways

• Generate basic pro forma financial projections and understand the principles of valuation

• Determine the legal and governance structure best suited to their venture

• Prepare and deliver a compelling 2 minute elevator pitch and 7 minute pitch presentation

• Understand the NIA SBIR and STTR grant application process, requirements, and resources

2027 NIA Start-Up Challenge timeline and key dates

• September 1, 2026: Challenge launched

• December 1, 2026: Registration and submission portal opens

• December 3, 2026 at 1:00 p.m. ET: Informational webinar, registration required

• January 15, 2027 at 11:59 p.m. ET: Submission deadline. Late submissions will not be accepted

• By May 2027: All submissions that reach technical review receive a brief summary of reviewer feedback

• May 2027: Stage 1 finalists announced

• June 2027: Accelerator begins, three-day in-person entrepreneur bootcamp

• June to November 2027: Stage 1 accelerator program, 6 to 8 hours per week

• By November 1, 2027: Stage 2 deadline to form an SBIR or STTR eligible company and meet with an NIH program officer

• November 2027: Three-day health innovation and investment conference, plus final Stage 2 submission and pitch due

• January 2028: Stage 2 winners announced

Practical planning note: the full arc from submission to Stage 2 award runs roughly thirteen months. Founders should treat the December 2026 to January 2027 window as the only entry point for this cycle.

Eligibility rules: who can win a prize

To be eligible to win a prize, a participant, whether an individual, a group of individuals, or an entity, must satisfy all of the following.

• Registered to participate under the rules published in the official Challenge announcement, and complied with all requirements set forth in it

• May not be the principal investigator on an NIH SBIR or STTR award that is active as of the submission period end date

• May not have been a finalist in a previous version of the NIA Start-Up Challenge

• Private entities must be incorporated in and maintain a primary place of business in the United States

• Individuals, whether competing alone or in a group, must be a U.S. citizen or permanent resident

• Non-U.S. citizens and non-permanent residents may participate as team members on an otherwise eligible team, but are not eligible to win a monetary prize in whole or in part. Their participation on a winning team may be recognized when results are announced

• May not be a federal entity or a federal employee acting within the scope of employment

• May not be an HHS employee, from any HHS component, acting in a personal capacity

• Employees of federal agencies other than HHS should consult an agency ethics official to determine whether federal ethics rules limit or prohibit accepting a prize

• May not be a Challenge judge, or any other party involved in the design, production, execution, or distribution of the Challenge, or an immediate family member of such a party, meaning spouse, parent, step-parent, child, or step-child

• Must be 18 years of age or older at the time of submission

Participation rules and federal funding restrictions

The small business formation commitment

By participating, each individual, group, or entity certifies that they have either already formed a U.S. owned and operated small business, or intend to form one by November 1, 2027, that meets the eligibility requirements to apply for NIH SBIR and STTR funding. You do not need an incorporated company at the time of submission, but you are committing to stand one up on that timeline.

Use of federal funds

• Participants may not use federal grant or cooperative agreement funds to develop a submission or to fund efforts supporting a submission unless that use is consistent with the purpose, terms, and conditions of the award

• Participants intending to use federal grant or cooperative agreement funds must register and participate as an Entity on behalf of the awardee institution or organization, not as an individual

• If federal grant or cooperative agreement funds are used and the participant wins, the prize must be treated as program income under the original award in accordance with 2 CFR 200

• Federal contractors may not use federal contract funds to develop a submission or fund supporting efforts

• Using federal facilities or consulting federal employees does not make a participant ineligible, provided those facilities and employees are available to all participants on an equitable basis

Risk, insurance, and compliance

• Participants assume all risks and waive claims against the federal government and related entities, except in cases of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits arising from participation

• No liability insurance, demonstration of financial responsibility, or indemnification agreement is required to participate in this Challenge

• Participants must follow all applicable federal, state, and local laws, regulations, and policies

• Participation constitutes full and unconditional agreement to abide by the Challenge rules, and winning is contingent on fulfilling all requirements

• Finalists and winners must complete and submit all requested winner verification and payment documents within 3 business days of formal notification. Missing that window can disqualify an otherwise winning submission

How to enter the 2027 NIA Start-Up Challenge

The registration and submission link opens December 1, 2026 on the official NIH Challenges page for this competition. Plan to register and submit by 11:59 p.m. ET on January 15, 2027.

Confidentiality warning

Do not include any confidential or proprietary information in your submission materials. By submitting, you agree to allow NIA to publish all or parts of your submission materials on nia.nih.gov. This has real consequences for intellectual property strategy. File provisionals before you describe protectable subject matter, and write the submission to be publishable.

For teams

Each team must identify a Team Lead who registers and submits on behalf of the team. The Team Lead manages all communication with Challenge sponsors and, if a cash prize is won, receives the full amount of the prize. The Team Lead must be a U.S. citizen or permanent resident to be eligible to receive a cash prize. If a dispute over the Team Lead's identity cannot be resolved to NIH's satisfaction, the submission is considered ineligible. Teams should settle internal allocation of prize funds in writing before submitting.

For entities

Each entity must identify a Point of Contact who registers and submits on its behalf and handles all communications. If a prize is won, payment goes to the entity, not to the Point of Contact. The entity must be incorporated in and maintain a primary place of business in the United States. Submitters intending to use federal grant or cooperative agreement funds must participate as an Entity on behalf of the awardee institution or organization.

Submission requirements

• Multiple submissions are allowed, but only one submission from each individual, team, or entity will be selected for participation as a finalist

• Late submissions will not be accepted

How submissions are scored

The four step review process

• Eligibility and programmatic review. NIA program staff review every submission for eligibility and programmatic relevance, conduct a preliminary evaluation, and assign an initial score. Only submissions with a competitive preliminary score advance

• Technical review. Submissions are individually evaluated and scored by reviewers with expertise in aging research, life science entrepreneurship and investment, business development, and product development, drawn from federal government, academia, industry, and other sectors

• Final evaluation by federal judges. A panel of federal employees reviews the submissions and technical evaluations, assigns a final score, and recommends top-performing teams for a screening call with NIA Challenge staff

• Screening and finalist selection. After screening calls, NIA Challenge staff recommend up to 21 finalists for approval by the Award Approving Official

Stage 1 evaluation criteria, 100 points total

• Significance, 0 to 15 points. How strong is the product's potential to address a significant unmet need in the older adult population, and to what extent does the scientific premise support the merits of the idea

• Innovation, 0 to 15 points. How novel is the idea, and what is the potential competitive advantage or the potential to refine the product to improve that advantage

• Commercialization, 0 to 10 points. How effectively is commercial potential explained, is there a clearly defined market, and does the business strategy have high potential for success

• Submitter or team, 0 to 10 points. Level of demonstrated commitment and collaboration, and relevant expertise each person brings

• Challenge Impact on the Submitter, 0 to 25 points. Does the submitter describe a scientific, technical, professional, or personal background, such as lack of access to resources and networks, that demonstrates a need for the training and resources the Challenge provides, and how they will significantly benefit at their stage of product development

• Challenge Impact on NIA Research and Development, 0 to 25 points. To what extent will participation enhance the impact and reach of NIA-funded small business research and development

The portfolio impact criterion, and how to earn it

For the 25 point Challenge Impact on NIA Research and Development criterion, submissions are evaluated on their potential to achieve at least two of the following:

• The submission addresses an underfunded area relevant to NIA small business research priorities. Active NIA SBIR and STTR awards can be reviewed in NIH RePORTER

• The product addresses a unique challenge or unmet need for older adults

• The individual or team brings relevant background, experience, or perspectives that would broaden and strengthen aging-related research and development

On that third point, NIA states that the race, ethnicity, or sex of the submitter may not be considered as part of any evaluation criteria. Permissible considerations named in the announcement include experience as a caregiver for older adults, including individuals with Alzheimer's disease or AD-related dementias; training or research experience that offers a complementary or innovative perspective; and lived experiences involving challenges or barriers that inform a unique approach to aging-related research and innovation.

Stage 2 requirements for finalists

To compete for the $70,000 Stage 2 prize, finalists must meet all of the following by the established deadlines:

• Form a company eligible to apply for an NIH SBIR or STTR grant, and meet with an NIH program officer to discuss the aims and objectives of a potential proposal, by November 1, 2027

• Successfully complete a comprehensive entrepreneurship training program and demonstrate proficiency in presenting the business concept to a wide public audience, including prospective partners and investors. Finalists are strongly encouraged to attend the in-person bootcamp and conference, but may propose an alternative comparable program with prior approval

• Submit a one-page document outlining the potential prize impact on advancing the business and innovation and on furthering the NIA mission

• Submit a 7-minute pitch video addressing the product's potential and the strength of the team

Stage 2 evaluation criteria, 100 points total

The Stage 2 panel is composed of NIA program staff, and it evaluates the one-page document, the 7 minute pitch, and a mentor assessment that offers an expert view on the anticipated impact of the prize based on the mentor's technical expertise and experience advising the finalist.

Mentor assessment and one-page document, 45 points:

• Prize Impact on Innovation Advancement, 0 to 30 points. Is there a clear, strong plan for how prize funds will play a critical role in accelerating development, through means including expanding the team, collecting pilot data, securing customers, and raising funds

• Prize Impact on NIA Research and Development, 0 to 15 points. Do the materials describe in detail at least one of the portfolio impact factors listed above

7-minute pitch video, 55 points:

• Significance, 0 to 15 points

• Innovation, 0 to 15 points

• Commercialization, 0 to 10 points, including strength of value proposition and clarity of the defined market

• Submitter or team, 0 to 10 points, including whether significant expertise gaps exist and how strong the plan is to fill them

• Pitch Delivery, 0 to 5 points, covering clarity of verbal delivery and visual slides

How to build a competitive submission

The scoring rubric rewards a specific kind of narrative. Based on how the criteria are weighted, the highest-leverage moves are:

• Lead with the unmet need in the older adult population, not the technology. Significance is scored on the need first and the scientific premise second

• Do the NIH RePORTER homework and cite it. Two separate criteria, one in each stage, reward showing that your approach sits in an underfunded area of the NIA SBIR and STTR portfolio. Very few applicants actually run this analysis

• Make the need for the Challenge explicit and specific. Twenty five points hinge on it. Name the gaps: no commercialization experience, no investor network, no regulatory or reimbursement expertise, no capital for pilot data. Vagueness is expensive here

• Tie AI claims to one of NIA's four named AI functions. Early detection, risk prediction, personalized interventions, or rapid drug discovery and development

• Address accessibility and population reach directly. Show that the solution works across the biological, social, behavioral, economic, environmental, and regional variation in the aging population

• Answer the differentiation question twice. Once against commercialized products, once against the existing NIA SBIR and STTR portfolio

• Write for publication. Since NIA may publish submission materials and confidential information is prohibited, sequence your IP filings before you submit

• Plan the operational load. Name who on the team will carry 6 to 8 hours per week from June through November 2027, and budget for travel to two three-day in-person events

How this fits a broader non-dilutive funding strategy

The Start-Up Challenge is best understood as an on-ramp rather than a destination. The $24,000 Stage 1 prize is real money for pilot data and formation costs, but the durable value is the SBIR and STTR readiness the accelerator builds and the Stage 2 requirement that you form an eligible company and meet with an NIH program officer by November 1, 2027. That program officer conversation is a standard precursor to a competitive NIH SBIR or STTR submission.

Two important caveats. First, NIA is explicit that Challenge participation or selection as a winner has no impact on grant funding decisions by NIA or any other NIH component. All grant applications remain subject to competition, peer review, and all other application and award requirements. Second, grant application technical assistance is not exclusive to Challenge participants. NIH resources are available to any entrepreneur through the NIH SEED program.

For teams that are already SBIR-ready, or whose PI holds an active NIH SBIR or STTR award and is therefore ineligible, the better path is to go directly at the NIA SBIR and STTR omnibus solicitations rather than at this Challenge.

Frequently asked questions

Is the NIA Start-Up Challenge a grant?

No. It is a prize competition authorized under the America COMPETES Reauthorization Act of 2010, as amended (15 U.S.C. 3719). There is no budget justification, no indirect cost rate, and no cost accounting requirement attached to the prize. Prize funds may be subject to federal income taxes, unlike most grant funds.

How much money can a startup win?

A single team can win up to $94,000, consisting of a $24,000 Stage 1 finalist prize and a $70,000 Stage 2 winner prize. NIA will award up to $994,000 in total across up to 21 finalists and up to 7 winners.

Does NIA take equity in exchange for the prize?

No. The prize money is fully non-dilutive. There is no equity, warrant, revenue share, or repayment obligation.

Do I need to have a company formed before I apply?

No. You may apply as an individual, a team, or an entity. By participating you certify that you have already formed a U.S. owned and operated small business or intend to form one by November 1, 2027 that meets NIH SBIR and STTR eligibility requirements.

Can I apply if I already have an NIH SBIR or STTR award?

Not if you are the principal investigator on an NIH SBIR or STTR award that is active as of the submission period end date of January 15, 2027. That is a hard eligibility bar.

Can previous NIA Start-Up Challenge finalists reapply?

No. Anyone who was a finalist in a previous version of the NIA Start-Up Challenge is not eligible to win a prize in this cycle.

Can international founders and non-U.S. citizens participate?

Non-U.S. citizens and non-permanent residents can participate as members of a team that otherwise meets eligibility requirements, and their participation on a winning team may be recognized publicly. They are not eligible to win a monetary prize in whole or in part. Individual participants must be U.S. citizens or permanent residents, and participating entities must be incorporated in and maintain a primary place of business in the United States.

When does the submission window open and close?

The submission portal opens December 1, 2026 and closes at 11:59 p.m. ET on January 15, 2027. Late submissions will not be accepted. An informational webinar is scheduled for December 3, 2026 at 1:00 p.m. ET.

How many submissions can I make?

Multiple submissions are allowed, but only one submission from each individual, team, or entity will be selected for participation as a finalist.

How much time does the accelerator require?

Participants should expect to commit 6 to 8 hours per week for approximately five months, from June through November 2027. That includes weekly virtual education sessions, mentor meetings, and two three-day in-person events.

Are travel costs to the in-person events covered?

Registration costs for both in-person events are covered by the program, but travel-related costs are paid by the participant. Finalists may use a portion of the $24,000 Stage 1 prize to cover travel.

Do I have to attend the in-person events?

Finalists are strongly encouraged to attend the June 2027 entrepreneur bootcamp and the November 2027 health innovation and investment conference. Finalists may propose an alternative, comparable training program or conference for prior approval.

Can I use federal grant funds to prepare my submission?

Only if that use is consistent with the purpose, terms, and conditions of the grant or cooperative agreement. If you do, you must register and participate as an Entity on behalf of the awardee institution, and any prize won must be treated as program income under the original award in accordance with 2 CFR 200. Federal contractors may not use federal contract funds for this purpose.

Does winning improve my chances of receiving an NIH SBIR or STTR award?

No. NIA states that Challenge participation or selection as a winner has no impact on funding decisions by NIA or any other NIH component. All grant applications remain subject to competition, peer review, and standard award requirements. Grant application technical assistance is also available to any entrepreneur through NIH SEED, not only to Challenge participants.

Is the prize money taxable?

Prizes awarded under this Challenge may be subject to federal income taxes. HHS and NIH comply with IRS withholding and reporting requirements where applicable. Prizes are paid by electronic funds transfer, and participants are encouraged though not required to obtain a free Unique Entity ID through SAM.gov to expedite payment.

What happens if I am not selected as a finalist?

All submissions that reach the technical review step will receive a brief summary of reviewer feedback by May 2027. That feedback is useful input for a future SBIR or STTR application.

Can I include confidential or proprietary information in my submission?

No. Confidential and proprietary information must be excluded. By submitting, you agree to allow NIA to publish all or parts of your submission materials on nia.nih.gov, so intellectual property filings should be sequenced before submission.

Who receives the prize money for a team submission?

For teams, the Team Lead receives the full amount of the prize and must be a U.S. citizen or permanent resident. For entities, the prize is paid directly to the entity rather than to the Point of Contact. Teams should document internal allocation of any prize funds in writing before submitting.

Official resources and next steps

• Challenge page: nih.gov/challenges/2027-nia-start-challenge-accelerator

• NIA program page: nia.nih.gov/research/sbir/start-challenge

• Challenge team email: niastartupchallenge@nih.gov

• Portfolio research: NIH RePORTER, to identify active NIA SBIR and STTR awards and underfunded areas

• Entity registration: sam.gov, to obtain a free Unique Entity ID

If you are weighing this Challenge against a direct NIA SBIR or STTR submission, or you want help building the portfolio gap analysis and need narrative that the scoring rubric rewards most heavily, reach out to our team. We help deep-tech, biotech, and medtech founders win non-dilutive federal funding, and we can tell you quickly whether this Challenge is the right entry point for your company or a detour.

FY2026 Reconstructive Transplant Research Program (RTRP): What Startups Need to Know

Executive Summary

The FY2026 Reconstructive Transplant Research Program (RTRP) is a Congressionally Directed Medical Research Programs (CDMRP) funding opportunity that supports research to advance the science and clinical practice of vascularized composite allotransplantation (VCA). The FY2026 appropriation is $12 million, and the program is soliciting applications through two separate award mechanisms: the Concept Award (up to $200,000 over 18 months) and the Investigator-Initiated Research Award (up to $1 million over 3 years). A Letter of Intent is required for both, due October 21, 2026, with full applications due November 4, 2026.

This is non-dilutive federal grant funding. Awards are made as grants under 31 USC 6304, so there is no equity, no repayment, and no cost sharing requirement. For-profit companies, including early-stage startups, are explicitly eligible.

What Is the Reconstructive Transplant Research Program?

Congress initiated the RTRP in 2012 to support research of high potential impact and exceptional scientific merit that refines approaches for, and increases access to, reconstructive transplants and state-of-the-art immunotherapy. Appropriations from FY2012 through FY2024 totaled $153 million. The FY2026 appropriation is $12 million.

VCA refers to the transplantation of multiple tissues such as muscle, bone, nerve, and skin as a functional unit, for example a hand or a face, from a deceased donor to a recipient with a severe injury. The program's stated goal is to return injured Service Members to duty and restore their quality of life, while also improving access, safety, and outcomes for Veterans and the American public.

Administratively, the program sits inside the CDMRP, which is located within Defense Health Agency Research and Development (DHA R&D), part of the Department of Defense. Both FY2026 announcements refer to DOD using the secondary title Department of War (DOW), so applicants will see "DOW" used throughout the solicitation documents. The Defense Health Agency Contracting Activity (DHACA) is soliciting applications under the delegated authority of 10 USC 4001. The Assistance Listing Number is 12.420.

The Two FY2026 RTRP Award Mechanisms

Both mechanisms share the same focus areas, the same deadlines, and the same submission process. They differ in eligibility, budget, duration, page limits, and, most importantly, whether preliminary data is allowed.

Concept Award (HT942526RTRPCA)

• Maximum funding: $200,000 in total costs for the entire period of performance, including direct and indirect costs

• Maximum period of performance: 18 months

• Expected awards: CDMRP expects to allot roughly $0.6 million to fund approximately 3 awards

• Eligible PI: Investigators at or above the level of postdoctoral fellow

• Preliminary data: Not allowed. Applications must instead demonstrate the ability to achieve interpretable results and provide a clear rationale

• Project Narrative: 2-page limit

• Clinical trials: Not allowed

• Announcement type: Modified. Version code CD26_01d

• Historical competitiveness: First offered in FY2015. Since then the program has received 196 Concept Award applications and recommended 26 for funding, a success rate of roughly 13 percent

The Concept Award exists to fund highly innovative new concepts or untested theories. It is designed for high-risk work that could reveal entirely new avenues of investigation, not the logical next step in an established research program. Innovation is the primary scored consideration, and research that represents an incremental advance on published data is explicitly not considered innovative.

Because the Concept Award is built for preliminary investigation, projects involving human subjects or human anatomical substances will not be supported unless they are exempt under 32 CFR 219.104(d) or eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110. Studies that do not qualify for exempt status or expedited review will be administratively withdrawn.

Investigator-Initiated Research Award (HT942526RTRPIIRA)

• Maximum funding: $1 million in total costs for the entire period of performance, including direct and indirect costs

• Maximum period of performance: 3 years

• Expected awards: CDMRP expects to allot roughly $8.0 million to fund approximately 8 awards

• Eligible PI: Independent investigators at all career levels

• Preliminary data: Required. Preliminary and/or published data relevant to reconstructive transplantation that support the rationale for the proposed work must be included

• Project Narrative: 10-page limit

• Clinical trials: Not allowed, although correlative studies associated with an existing clinical trial are permitted

• Announcement type: Initial. Version code CD26_01d

• Historical competitiveness: First offered in FY2016. Since then the program has received 253 applications and recommended 43 for funding, a success rate of roughly 17 percent

The Investigator-Initiated Research Award supports studies with the potential to make an important contribution to reconstructive transplant research, patient care, and quality of life. Applications may focus on any phase of research from basic through translational, including preclinical studies in animal models and clinical research in human subjects or human anatomical substances. Every project must demonstrate solid scientific rationale with military-relevant utility, a rigorous study design, and a statistical plan with appropriate power analysis.

FY2026 RTRP Deadlines and Timeline

Both award mechanisms follow the identical schedule. Note that the Concept Award deadlines were extended on August 11, 2026 so that both mechanisms share one receipt cycle.

• Pre-Application (Letter of Intent) deadline: October 21, 2026, 5:00 p.m. Eastern Time

• Full application deadline: November 4, 2026, 11:59 p.m. Eastern Time

• End of application verification period: November 9, 2026, 5:00 p.m. Eastern Time

• Peer review: January 2027

• Programmatic review: March 2027

• Funding recommendations posted to eBRAP: typically within 6 weeks after programmatic review

• Awards made: no later than September 30, 2027

• FY2026 funds expire for use: September 30, 2032

There are no grace periods. DHACA cannot make allowances or exceptions for submission problems encountered by the applicant, so registrations and portal access need to be resolved well ahead of October.

Who Is Eligible to Apply

Organizations: Extramural and intramural DOW organizations are eligible, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities. Awards are made to organizations, not to individuals.

Principal Investigators: Eligibility is set by mechanism. The Concept Award requires an investigator at or above the level of postdoctoral fellow. The Investigator-Initiated Research Award requires an independent investigator, and all career levels qualify. In both cases, eligibility applies regardless of ethnicity, nationality, or citizenship status, and PIs do not need to be affiliated with an academic organization.

Application limits: An investigator may be named as PI on no more than two Concept Award applications and no more than two Investigator-Initiated Research Award applications in FY2026. If more than two are received naming the same PI for a given mechanism, only the first two received will be accepted.

Cost sharing: Not required for either mechanism.

FY2026 RTRP Focus Areas: What the Program Is Looking For

Applications to either mechanism must address at least one focus area along with at least one of its accompanying sub-bullets. This is a compliance requirement, not a suggestion, and the focus areas are identical across both awards.

1. Improve or optimize VCA immunosuppression

• Define the unique targets and mechanisms of VCA immunogenicity and its regulation

• Develop novel tolerogenic agents or approaches for VCA immunosuppression

• Develop less toxic or personalized regimens for maintenance immunosuppression

2. Identify or validate biomarkers, methods, or tools for monitoring VCA graft rejection and immunosuppression

• Identify or validate reliable biomarkers for predicting and monitoring acute and chronic VCA rejection in the clinic, meaning in human clinical samples

• Develop assays, devices, or technology for clinical graft monitoring using biomarkers, with proposed devices accounting for human use factors unique to VCA recipients

• Identify or validate reliable approaches to measuring and monitoring in vivo or clinical immunosuppression levels

3. Advance VCA preservation strategies

• Develop promising static preservation strategies, active perfusion modalities, or other technologies for translation to the clinic

• Develop mitigation strategies for preservation-mediated injury, including immune activation or ischemia reperfusion injury

4. Develop tools for measuring VCA outcomes

• Performance or function-based measures

• Patient-reported measures

• Neurocognitive measures

Leveraging solid organ transplant findings

The RTRP explicitly allows applicants to bring novel findings from solid organ transplant research into a VCA setting, provided the rationale and benefits are justified. The solicitation offers three acceptable framings: explain why the anticipated result might be different in VCA, why it is important to confirm the result is the same in VCA, or why repeating the study in a VCA setting could produce new mechanistic insight into the unique aspects of VCA. If your company's platform was developed for kidney, liver, or heart transplant, this is the language to build your rationale around.

Funding Allowance and Budget Rules

Total cost caps include both direct and indirect costs. If your organization has a negotiated indirect cost rate, indirect costs must be budgeted in accordance with that rate. Collaborating organizations budget their own indirect costs at their own negotiated rates. All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

An applicant may request the full maximum funding amount even if the proposed period of performance is shorter than the maximum allowed. Budget appropriateness is assessed during peer review.

Travel that must be budgeted: Costs for the PI to present project information or disseminate results at one DOW-sponsored meeting, such as the Military Health System Research Symposium, during the period of performance. For planning purposes, assume the meeting will be held in the Central Florida area. For the Investigator-Initiated Research Award, assume this occurs in Year 2. This is in addition to allowable annual scientific meeting travel.

Travel that may be budgeted: Travel in support of multi-institutional collaborations, and costs for one investigator to attend one scientific or technical meeting per year in addition to the required DOW-sponsored meeting.

Costs that must not be requested: Travel beyond the limits above, and any clinical trial costs.

Separately, an organization may, at its own risk and without prior government approval, incur obligations and expenditures to cover costs up to 90 days before the start date of the initial budget period of a new award.

How to Submit: A Two-Step Process

Submission requires both a pre-application and a full application, and they go through different portals depending on your organization type.

Step 1: Pre-Application (Letter of Intent) through eBRAP

All pre-application components must be submitted by the PI through eBRAP. The Letter of Intent has a one-page limit and must provide a brief description of the research to be conducted along with the FY2026 RTRP Focus Area under which the application will be submitted.

eBRAP assigns each pre-application a unique log number. That log number is required for full application submission and must be entered in Block 4a, Federal Identifier, of the SF424 Research and Related form. The log number, application title, and all information for the PI, Business Officials, performing organization, and contracting organization must remain consistent across both submissions.

Two things worth understanding about the LOI: pre-applications are used for program planning purposes only, such as reviewer recruitment, and will not be screened. CDMRP will not issue an invitation to submit a full application. Applicants are encouraged to develop the pre-application and full application concurrently and submit the full application after the LOI has been successfully submitted. However, failure to submit the LOI results in automatic rejection of the full application.

Step 2: Full Application

• Extramural organizations, including startups and companies: must submit through Grants.gov Workspace

• Intramural DOW organizations only: may submit through eBRAP

An application from an extramural organization received through eBRAP may be administratively withdrawn, so the portal choice matters.

Step 3: Verify in eBRAP

Regardless of portal, the submitted application is transmitted to and processed in eBRAP, which can take up to 48 hours. The PI and organizational representatives then receive an email instructing them to log in, review, modify, and verify the submission. The Project Narrative and Research and Related Budget Form cannot be changed after the application deadline. Other components, including subaward budgets and justifications, may be changed until the verification period ends on November 9, 2026. Nothing can be modified after that.

Required registrations

Active SAM.gov, eBRAP.org, and Grants.gov registrations are required. Registration for each can take several weeks or longer. The applicant organization must be registered in SAM with an Active status and a Unique Entity Identifier before submitting through Grants.gov, and must maintain active SAM registration for as long as it has an active federal award or an application under consideration.

Application Components by Mechanism

Every attachment must be uploaded as an individual file using the exact filename specified, following the formatting guidelines in the General Application Instructions, version CD26_01.

Concept Award attachments

• Attachment 1: Project Narrative, 2-page limit, ProjectNarrative.pdf. Structured as Innovation, Hypothesis and Rationale, Aims and Objectives, Research Strategy, and Relevance

• Attachment 2: Supporting Documentation, Support.pdf. Includes References Cited, list of abbreviations, facilities and equipment, publications and patents, letters of support, Sex as a Biological Variable Strategy, Intellectual and Material Property Plan with optional Commercialization Strategy, and Research Sharing Plan

• Attachment 3: Statement of Work, 3-page limit, SOW.pdf

• Attachment 4: Innovation Statement, 1-page limit, Innovation.pdf

• Attachment 5: Post-Award Transition Plan, 1-page limit, Transition.pdf

• Attachment 6: Representations, Grants.gov submissions only, RequiredReps.pdf

• Attachment 7: Suggested Intragovernmental or Intramural Budget Form if applicable, IGBudget.pdf

Investigator-Initiated Research Award attachments

• Attachment 1: Project Narrative, 10-page limit, ProjectNarrative.pdf. Structured as Background, Rationale and Readiness, Hypothesis and Objective, Specific Aims, and Study Design and Feasibility

• Attachment 2: Supporting Documentation, Support.pdf. Same components as above, plus the Inclusion Enrollment Report if clinical research is proposed and, new for FY2026, a letter signed by the animal vendor or provider describing cost and timeline of availability for any proposed animal model

• Attachment 3: Technical Abstract, 1-page limit, TechAbs.pdf

• Attachment 4: Lay Abstract, 1-page limit, LayAbs.pdf

• Attachment 5: Statement of Work, 3-page limit, SOW.pdf

• Attachment 6: Impact Statement, 1-page limit, Impact.pdf

• Attachment 7: Military Relevance Statement, 1-page limit, MilRel.pdf

• Attachment 8: Animal Research Plan, 5-page limit, AnimalResPlan.pdf, required only for applications proposing animal studies

• Attachment 9: Post-Award Transition Plan, 1-page limit, Transition.pdf

• Attachment 10: Representations, Grants.gov submissions only, RequiredReps.pdf

• Attachment 11: Suggested Intragovernmental or Intramural Budget Form if applicable, IGBudget.pdf

Both mechanisms also require the Research and Related Senior/Key Person Profile with Biographical Sketches and Current and Pending Support, the Research and Related Budget, Project and Performance Site Locations, and subaward budget attachments where applicable.

How Applications Are Reviewed

All applications go through a two-tier review conducted by scientists, clinicians, and consumers. Peer review assesses technical merit against established criteria, with each application judged on its own merit. Programmatic review then compares high-merit applications for programmatic relevance. The highest-scoring applications from peer review are not automatically recommended for funding.

Concept Award review criteria, in decreasing order of importance

These criteria contribute to the overall evaluation but are not individually scored: Innovation, Relevance, Research Strategy and Feasibility, Personnel, Transition Plan, Research Sharing Plan, Budget, Environment, and Application Presentation.

Investigator-Initiated Research Award review criteria, in decreasing order of importance

Scored criteria: Study Design and Feasibility, Statistical Plan, Impact, Personnel, Transition Plan, and Research Sharing Plan. Unscored criteria that still contribute to the overall evaluation: Budget, Environment, and Application Presentation.

Programmatic review criteria for both mechanisms

• Ratings and evaluations of peer reviewers

• Adherence to the intent of the funding opportunity

• Program portfolio composition

• Programmatic relevance to military health and at least one FY2026 focus area

• Relative innovation for the Concept Award, or relative impact for the Investigator-Initiated Research Award

Compliance Traps That Sink Applications

CDMRP applies administrative actions mechanically. These are the failure modes to design around.

Automatic rejection: a missing Project Narrative, a missing Budget, or a Letter of Intent that was never submitted.

Automatic modification: pages exceeding stated limits are removed before review, and documents that were not requested are removed. Reviewers see what is left.

Possible administrative withdrawal:

• Including any URL outside the References Cited and Publications or Patents sections

• Proposing a clinical trial

• Submitting essentially the same research project to different funding opportunities within the same program and fiscal year

• Including classified research data, or proposing research that may produce classified outcomes or outcomes deemed sensitive to national security

• A PI who does not meet the eligibility criteria

• Involving a member of the FY2026 RTRP Programmatic Panel in concept design, application development, budget preparation, or supporting documentation. Panel members may only provide letters confirming PI eligibility and access to space, equipment, or resources as part of their regular institutional role

• Naming personnel from the CDMRP peer review or programmatic review contractors where conflicts cannot be mitigated

• Contacting persons involved in review or approval to obtain protected evaluation information or influence the process

• An extramural application received through eBRAP instead of Grants.gov

• Failing to conform to the program announcement description

• For the Concept Award only, human subjects or specimen work that does not qualify for exempt status or expedited review

Additional restrictions: Under Section 732 of the FY2026 National Defense Authorization Act, CDMRP does not support painful research in USDA pain category D or E involving domestic cats or dogs, except studies relating to military or service animals. Under National Security Presidential Memorandum-33, all applicant organizations must disclose foreign affiliations of every named key person. Failure to disclose leads to withdrawal of funding recommendations.

Post-Award Requirements

• Annual technical progress reports and quad charts, plus a final technical progress report and quad chart, prepared in accordance with the Research Performance Progress Report format

• A data management plan compliant with DoD Instruction 3200.12 will be requested if recommended for funding

• For the Concept Award, a Technical Abstract will be requested prior to award

• Annual In-Progress Review meetings held virtually, where award recipients may be invited to present progress to the Programmatic Panel

• For the Investigator-Initiated Research Award, an Award Expiration Transition Plan submitted with the final progress report, and PHS Inclusion Enrollment reporting if clinical research is proposed

• Research involving animals, human data, human specimens, human subjects, or human cadavers must be approved by the DHA R&D Office of Research and Regulatory Compliance in addition to local IACUC, IRB, or Ethics Committee review

• PI changes on a Concept Award are not allowed except under extenuating circumstances evaluated case by case. On the Investigator-Initiated Research Award, PI and organization changes are generally allowed case by case provided the intent of the mechanism is met

• Organizational transfer of an award is not allowed in the last year of the original period of performance or any extension

• New awards will not be issued to an organization with delinquent technical reporting on existing DHA or U.S. Army Medical Research and Development Command awards

Which Award Should a Startup Pursue?

Choose the Concept Award if your idea is novel but unproven, you have no preliminary data to show, and you need a small, fast award to generate the first interpretable results. At $200,000 over 18 months it functions as a de-risking step, and preliminary data is not merely unnecessary, it is prohibited. Innovation carries the most weight in review, so a genuinely new mechanism, target, or measurement approach matters more than a polished development plan. Early-career investigators are encouraged to apply.

Choose the Investigator-Initiated Research Award if you already have preliminary or published data supporting your rationale, your study design is mature enough to withstand scrutiny on controls, power analysis, blinding, and randomization, and you can articulate short-term and long-term impact. At $1 million over 3 years with roughly 8 awards expected, this is the mechanism that funds a real program of work. If you are developing a device, the application should explain how the design would support a regulatory filing with FDA or an international equivalent.

A note on pursuing both: the mechanisms have separate PI application limits, so a single investigator can be named on up to two applications in each. What is prohibited is submitting essentially the same research project to different funding opportunities within the same program and fiscal year. Two distinct projects, one high-risk and one data-backed, is a viable strategy. The same project dressed up twice will be withdrawn.

For both mechanisms, note that a Commercialization Strategy is an allowable component of the Intellectual and Material Property Plan, covering intellectual property, market size, financial analysis, strengths and weaknesses, barriers to market, competitors, and management team. Companies should use it. Multidisciplinary collaborations among academia, industry, DOW, and the Department of Veterans Affairs are highly encouraged, and collaboration with military researchers and clinicians is encouraged though not required.

Frequently Asked Questions

What are the FY2026 RTRP deadlines?

The Letter of Intent is due October 21, 2026 at 5:00 p.m. Eastern Time, and the full application is due November 4, 2026 at 11:59 p.m. Eastern Time. The application verification period in eBRAP ends November 9, 2026 at 5:00 p.m. Eastern Time. Both award mechanisms share these dates.

Is a Letter of Intent required?

Yes. A Letter of Intent is required for both the Concept Award and the Investigator-Initiated Research Award, and an application whose LOI was never submitted is administratively rejected. The LOI is limited to one page, is submitted by the PI through eBRAP, and must state the focus area being addressed. It is used for program planning only and is not screened, and no invitation to submit a full application will be issued.

Can a startup or for-profit company apply to the RTRP?

Yes. For-profit and nonprofit organizations, public and private entities, and foreign and domestic organizations are all eligible to apply to both FY2026 RTRP mechanisms. Awards are made to organizations rather than individuals, and the PI does not need to be affiliated with an academic institution.

How much funding can I request?

The Concept Award allows up to $200,000 in total costs over a maximum 18-month period of performance. The Investigator-Initiated Research Award allows up to $1 million in total costs over a maximum 3-year period of performance. Total costs include both direct and indirect costs, and all subaward direct and indirect costs must be carried in the direct costs of the primary award.

Do I need preliminary data?

It depends entirely on the mechanism. The Concept Award prohibits preliminary data, requiring instead a clear rationale and a demonstrated ability to achieve interpretable results. The Investigator-Initiated Research Award requires preliminary and/or published data that are relevant to reconstructive transplantation and support the rationale for the proposed work.

Are clinical trials allowed?

No. Neither FY2026 RTRP mechanism permits clinical trials, and proposing one may result in administrative withdrawal. Clinical trial costs must not be requested in the budget. The Investigator-Initiated Research Award does allow correlative studies associated with an existing clinical trial.

Is cost sharing required?

No. Cost sharing is not an eligibility requirement for either FY2026 RTRP award mechanism.

How many RTRP applications can one investigator submit?

An investigator may be named as PI on up to two Concept Award applications and up to two Investigator-Initiated Research Award applications in FY2026. If more than two are received for a given mechanism naming the same PI, only the first two received are accepted and the rest are administratively withdrawn. Submitting essentially the same project to more than one funding opportunity within the program in the same fiscal year is prohibited.

Can foreign organizations apply?

Yes. Foreign and domestic organizations are both eligible, and PI eligibility applies regardless of ethnicity, nationality, or citizenship status. All applicant organizations must disclose the foreign affiliations of every named key person under National Security Presidential Memorandum-33, and failure to disclose leads to withdrawal of any funding recommendation.

How competitive is the FY2026 RTRP?

CDMRP expects to fund approximately 3 Concept Awards from roughly $0.6 million and approximately 8 Investigator-Initiated Research Awards from roughly $8.0 million. Historically the Concept Award has received 196 applications and recommended 26 for funding, about 13 percent, while the Investigator-Initiated Research Award has received 253 applications and recommended 43 for funding, about 17 percent.

Where do I submit the LOI versus the full application?

The Letter of Intent is always submitted through eBRAP by the PI. Full applications from extramural organizations, including companies, must be submitted through Grants.gov Workspace. Only intramural DOW organizations may submit full applications through eBRAP, and an extramural application received through eBRAP may be administratively withdrawn.

Can I bring solid organ transplant research into an RTRP application?

Yes. The RTRP explicitly allows leveraging novel findings from solid organ transplant research for testing in a VCA setting, provided the rationale and benefits are explained and justified. Acceptable justifications include explaining why the result might differ in VCA, why confirming the same result in VCA matters, or why repeating the study in VCA could yield new mechanistic insight.

What happens if my application exceeds a page limit?

Pages exceeding the specified limits are removed before reviewers see any documents, and documents that were not requested are also removed. Including URLs anywhere other than the References Cited and Publications or Patents sections may result in administrative withdrawal.

When will FY2026 RTRP awards be made?

Peer review occurs in January 2027 and programmatic review in March 2027, with funding recommendations typically posted to eBRAP within 6 weeks after programmatic review. Awards supported with FY2026 funds will be made no later than September 30, 2027, and those funds expire for use on September 30, 2032.

What if my project involves animal studies?

Applications to the Investigator-Initiated Research Award proposing animal studies must include an Animal Research Plan of up to five pages addressing model justification, availability and access, procedures, controls, randomization and blinding, sample size with power calculations, and data handling. New for FY2026, the Supporting Documentation must also include a letter from the animal vendor or provider stating the cost and timeline for availability. CDMRP does not support painful research in USDA pain category D or E involving domestic cats or dogs, except for studies relating to military or service animals.

Next Steps

The FY2026 RTRP rewards applications that are technically strong and administratively flawless, and the compliance requirements alone remove a meaningful share of the competition before review begins. With the Letter of Intent due October 21, 2026 and the full application due November 4, 2026, the practical constraint is time: SAM.gov, eBRAP, and Grants.gov registrations can take weeks, and the Project Narrative and budget lock at the deadline.

BW&CO helps deep-tech, biotech, medtech, and dual-use companies pursue non-dilutive federal funding, with more than $350 million in funding secured for clients. Innovation Funding Simplified. If you are evaluating whether the Concept Award or the Investigator-Initiated Research Award fits your program, or you want a compliance review before you submit, reach out to start the conversation.

NIH Highlighted Topic: Health and Extreme Weather: Advancing Critical Research to Address the Direct and Indirect Health Impacts of Weather-Related Natural Disasters and Emerging Weather-Related Harms

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Health and Extreme Weather: Advancing Critical Research to Address the Direct and Indirect Health Impacts of Weather-Related Natural Disasters and Emerging Weather-Related Harms." It is issued under the NIH Health and Extreme Weather Program, led by NIEHS, and eleven NIH Institutes award grants under it while four additional offices participate without awarding.

For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, requesting assignment to one of the eleven awarding Institutes, and aligning your Specific Aims to that Institute's stated interests.

Say the hard part first. This is the least small-business-native NIH Highlighted Topic in the current cycle. The great majority of what is described is epidemiology, cohort analysis, natural experiments, community-engaged research, and implementation science, all of which belong in R01 and related mechanisms rather than SBIR or STTR. A company that reads the topic broadly and writes a proposal to match will lose a cycle.

That said, there are real product lanes, and they are unusually concrete where they exist. NIAMS names wearable devices and environmental sensors for personal exposure assessment. NIDDK names the health effects of care discontinuity from lack of medications or electricity-dependent treatments. The topic purpose names methods to advance the aggregation, linking, accessibility, and interpretation of health and weather-related data. NHLBI names integration of environmental and health datasets, NIMH names measurement methods and data sharing methods, and NIAID names vector-borne and waterborne pathogen behavior including changes in susceptibility to anti-infective interventions. Those are sensors, diagnostics, medical device resilience, and data platforms, all of which a company can own and sell.

The topic was posted on September 1, 2026 and expires on May 1, 2028, which is a notably short window and makes April 5, 2028 the last available submission cycle. NIEHS is the only Institute that made both available funding statements, saying it may dedicate available funds and may give special consideration.

At a Glance

• Topic title: Health and Extreme Weather

• Program: NIH Health and Extreme Weather (HEW) Program, with a published HEW Strategic Framework available on the NIH site

• Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services

• Awarding Institutes: NIEHS, NCCIH, NCI, NHLBI, NIA, NIAID, NIAMS, NIDDK, NIMH, NIMHD, and NINR

• Non-awarding participating offices: OBSSR, ODP, ORWH, and THRO

• Central scientific contact: Ashlinn Quinn, ashlinn.quinn@nih.gov, who is also the NIEHS contact

• Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.

• Post date: September 1, 2026

• Expiration date: May 1, 2028. Shorter than the usual two-year window.

• Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement

• Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot

• Standard annual due dates: January 5, April 5, and September 5

• SBA statutory guidelines this cycle: $323,090 Phase I, $2,153,927 Phase II, $4,191,495 CRP

• Institute limits vary widely and several published Institute pages still show older SBA figures. Use the current guideline for the dollar amount and treat Institute pages as authoritative for policy.

• Clinical trials: NIAMS accepts none under either parent. NIAID, NIDDK, and NIMHD do not accept them under STTR. NIDDK accepts them under SBIR. NCCIH restricts efficacy and effectiveness trials at Phase I. NIAID directs small business clinical trials to a separate cooperative agreement. Confirm before designing.

• Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.

• Equity dilution: none. This is non-dilutive federal funding.

• Profit or fee: allowable, must be in the budget at submission, and normally will not exceed 7 percent of total costs

• Funding signals: NIEHS stated both that it may dedicate available funds and that it may give special consideration. NIMHD stated it may dedicate available funds. NCCIH, NIDDK, and NINR each stated they may give special consideration. NCI, NHLBI, NIA, NIAID, NIAMS, and NIMH made no statement.

• Initiative alignment: none stated. This topic is not issued under the Make America Healthy Again initiative, so there is no policy framing to reference.

What This Opportunity Actually Is

An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that an area of science is a priority without creating a separate funding announcement, deadline, or review process. There is no topic-specific number to search on Grants.gov, and applications are not scored against other applications to the topic.

This one is unusual in being tied to a standing NIH program rather than a one-off priority statement. The Health and Extreme Weather Program has its own Strategic Framework published on the NIH site, and NIEHS effectively runs it, supplying both the central scientific contact and its own Institute contact in the same person. That matters practically: reading the Strategic Framework before writing gives you the program's own language, and a single call to the central contact can help route you among eleven Institutes.

Six Institutes went on record with a funding advantage. NIEHS is the only one making both available statements, which is consistent with it being the lead. NIMHD stated it may dedicate available funds. NCCIH, NIDDK, and NINR each stated they may give special consideration. The remaining six made no statement.

Note also what is absent. Most NIH Highlighted Topics in this cycle are issued under the Make America Healthy Again initiative and list named policy alignments. This one does not, despite the obvious thematic overlap with chronic disease and environmental health. Do not reference an initiative alignment the topic does not claim.

Is This Topic a Fit for a Small Business?

For most companies, no. For a specific set, yes and clearly so. This section is the most useful part of the page, and it is worth being blunt.

Work in this topic that is not a small business fit. Assessing short and long-term health risks across the life course. Analysis of NIA-supported cohorts, which NIA strongly encourages. Natural experiments evaluating naturally occurring events, which NINR names. Epidemiological and mechanistic studies of disease development and progression. Community-engaged research where the company would be a subcontractor. Health disparities characterization. Training and capacity building across disciplines. Research translation and collaboration as ends in themselves. All of this is wanted by NIH and none of it is an SBIR project, because the deliverable is knowledge rather than a commercial product with unresolved technical risk that a company will own and sell.

Work in this topic that is a genuine small business fit.

• Wearables and environmental sensors for personal exposure assessment. NIAMS names this explicitly, asking for studies using personal exposure assessment methodologies including wearable devices and environmental sensors to provide stronger causal evidence linking extreme weather and other environmental exposures to disease outcomes. This is the single clearest product invitation in the topic and it comes with a stated scientific rationale you can quote.

• Exposure biomarkers. NIAMS asks for biomarkers of environmental exposures such as temperature extremes, air pollution, and wildfires that are associated with worsened disease status, naming flares in psoriasis, atopic dermatitis, and lupus. An assay or panel is a product.

• Care continuity and medical device resilience. NIDDK names observational studies and clinical trials addressing health effects of care discontinuity from lack of medications or electricity-dependent treatments. The topic body separately names patients using electricity-dependent equipment as a heightened-risk population, and NCI asks about effects on healthcare delivery among patients undergoing cancer treatment. Backup power, portable or off-grid therapy delivery, medication cold chain, and treatment-interruption management tools all sit here.

• Health and environmental data linkage platforms. The topic purpose names methods to advance aggregation, linking, accessibility, and interpretation of health and weather-related data. NHLBI names integration of environmental and health-related datasets. NIMH names data sharing methods supporting rigorous and reproducible findings. NCCIH names integrating health and environmental data. Five separate parts of this topic ask for the same category of software product, which is a strong signal.

• Measurement instruments and methods. NIMH asks for methods to accurately measure short and long-term mental illness attributable to extreme weather events. A validated instrument, screener, or digital assessment is a product with a customer.

• Digital and remote intervention delivery. NIMH names intervention development and testing to reduce weather-related mental health sequelae and evidence-based practices in real-world settings including communities and schools. NIA names interventions and educational resources for specific older adult populations including within care facilities. NCCIH names multicomponent whole-person interventions and scalable delivery.

• Infectious disease diagnostics and anti-infective susceptibility tools. NIAID names zoonotic, food, water, and vector-borne pathogens with respect to reproductive capacity, transmissibility, epidemiology, and virulence, including changes in susceptibility to anti-infective interventions. Detection, surveillance, and resistance testing are products.

• In vitro and in silico models. The topic purpose names in vivo, in vitro, and in silico models to understand mechanistic underpinnings. A company with a modeling platform, organ-on-chip system, or computational exposure model has a lane, and this overlaps directly with the NIH New Approach Methodologies push.

The pattern is worth naming: the fundable products here are instruments, assays, sensors, devices, and software. Where the topic asks for understanding, it is asking academics. Where it asks for measurement, detection, linkage, or delivery, it is describing something a company can build.

Which Institute Should You Target?

Eleven awarding Institutes makes the assignment request the highest-leverage decision on the application. Group by what you sell.

Sensors, wearables, and exposure assessment: NIAMS is the primary door and the only Institute naming wearables and environmental sensors outright. NIEHS is the natural second, given its interest in identifying, characterizing, and quantifying the influence of weather and natural disasters on environmental exposures and how weather-related exposures contribute to the exposome across the life course. NHLBI for cardiopulmonary and sleep outcomes.

Data platforms and analytics: NHLBI for integration of environmental and heart, lung, blood, and sleep datasets. NIMH for measurement methods and data sharing. NIEHS for computational studies. NCCIH for integrating health and environmental data. NIA for economic and systems research on healthcare preparedness and health services delivery.

Care continuity, devices, and treatment delivery: NIDDK is the clearest, naming care discontinuity from lack of medications or electricity-dependent treatments, plus acute kidney injury, chronic kidney disease, and kidney stones. NCI for effects on healthcare delivery and outcomes among patients undergoing cancer treatment and survivors. NIA for healthcare preparedness and interventions within care facilities.

Diagnostics and infectious disease: NIAID for airway disease, atopic dermatitis, food allergy, autoimmune and autoinflammatory disease under pollutant, heat, and humidity exposure, and separately for zoonotic, food, water, and vector-borne pathogens including anti-infective susceptibility.

Behavioral health and community intervention: NIMH for mental health measurement, intervention, and resilience. NCCIH for complementary and integrative health interventions targeting stress-related, multisystem, and chronic consequences. NINR for community and organization-level interventions. NIMHD for interventions in populations experiencing disparities, subject to its specific requirement below.

A requirement specific to NIMHD. NIMHD states that projects must focus on NIH-designated populations experiencing disparities and must include validated behavioral, clinical, or biomedical outcomes. That is written as a requirement rather than a preference. It also emphasizes academic-community partnerships and names outdoor workers and rural or coastal residents as example high-risk communities. If you cannot satisfy both the population focus and the validated outcome requirement, target a different Institute.

Quick reference: awarding Institutes, funding signals, and contacts

• NIEHS. Lead Institute. Environmental exposures associated with weather phenomena, exposome, epidemiology, mechanistic and computational studies, and interventions including implementation science. May dedicate available funds and may give special consideration, the only Institute making both statements. Contact: Ashlinn Quinn, ashlinn.quinn@nih.gov

• NCCIH. Complementary and integrative health interventions for stress-related, multisystem, and chronic consequences, whole-person interventions, community partnership, data integration. May give special consideration. Restricts efficacy and effectiveness trials at Phase I. Contact: NCCIHDERFunding@nih.gov

• NCI. Weather-related exposures and cancer etiology and outcomes, susceptibility of patients and survivors, and effects on healthcare delivery during treatment. No stated signal. Contact: Curt Dellavalle, Ph.D.

• NHLBI. Cumulative exposures and heart, lung, blood, and sleep health, naming sickle cell disease, anemias, asthma, COPD, heart failure, myocardial infarction, arrhythmias, and hypertension, with emphasis on children, older adults, and pregnant women. No stated signal. Contact: nhlbihighlightedtopics@mail.nih.gov

• NIA. Older individuals and caregivers, aging-related processes, pace of aging, functional and cognitive ability, preparedness behavior, healthcare preparedness economics, and interventions in care facilities. Analysis of NIA-supported cohorts strongly encouraged. No stated signal. Contact: Emerald Nguyen, Ph.D., and three additional program contacts

• NIAID. Airway and allergic disease, atopic dermatitis, food allergy, autoimmune and autoinflammatory disease, and zoonotic, food, water, and vector-borne pathogens. No stated signal. Directs small business clinical trials to a separate cooperative agreement. Contacts: Adriana Costero-Saint Denis for microbiology and infectious diseases, Patrice Becker for allergy, immunology, and transplantation

• NIAMS. Arthritis, musculoskeletal, and skin disease onset, severity, and treatment response, with explicit interest in wearable devices, environmental sensors, and exposure biomarkers. No stated signal. Accepts no clinical trials under either parent. Contact: Rebecca Lenzi, PhD

• NIDDK. Care discontinuity from lack of medications or electricity-dependent treatments, plus acute kidney injury, chronic kidney disease, and kidney stones. May give special consideration. Accepts clinical trials under SBIR but not STTR. Contact: Susan Mendley, M.D.

• NIMH. Mental health measurement, children and adolescents, intervention development, risk and resilience in at-risk populations, real-world evidence-based practices, and data sharing methods. No stated signal. Contact: Laura Thomas, Ph.D.

• NIMHD. Solution-oriented disparities research with a mandatory focus on NIH-designated populations experiencing disparities and validated outcomes. May dedicate available funds. Does not accept clinical trials under STTR. Contact: NIMHDDIBBSScientificTeam@mail.nih.gov

• NINR. Community and organization-level interventions, conditions of daily life such as housing stability and neighborhood environments, and natural experiments. Explicitly welcomes scientists from any discipline. May give special consideration. Contact: CDR Nadra Tyus, DrPH, MPH

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match. On this topic, resolve the clinical trial question before you choose either.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route. Accepts Phase I, Phase II, Direct to Phase II, and Fast-Track. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Requires a formal collaboration with a nonprofit research institution, with at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. STTR permits the Program Director or Principal Investigator to be employed by either the small business or the partnering nonprofit while the award still goes to the small business, which is useful here because the exposure science, atmospheric science, and epidemiology expertise this topic calls for usually sits in universities. Note that companies more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination are not eligible for STTR.

The clinical trial picture for this topic. This is where applications become non-responsive.

• NIAMS accepts no clinical trials under either parent announcement, despite asking for causal-evidence studies using wearables and sensors. Design around this or use a NIAMS-specific announcement.

• NIDDK names clinical trials twice in its published interests for this topic and accepts them under the parent SBIR announcement but not under STTR. A project with an academic PI and a trial component cannot use STTR here.

• NIMHD does not accept clinical trials under STTR.

• NCCIH operates a Phase-specific policy: it will not support clinical trials aiming to test efficacy or effectiveness as part of an SBIR or STTR Phase I application, meaning a study powered on a primary clinical outcome. It does accept basic experimental studies in humans, human mechanistic studies, and pilot feasibility testing at Phase I, and accepts clinical trials of all types at Phase II and Fast-Track. Given that NCCIH's entire interest here is rigorous intervention evaluation, this shapes how you stage the work.

• NIAID requires direct confirmation. NIAID is not on the exclusion list in the parent SBIR announcement, but NIAID's own small business program guidance states that it supports clinical trial research performed by small businesses only through a separate NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement, and that other Institutes may fund small business clinical trials through the parent announcements while NIAID does not. These two sources point in different directions, so anyone planning a trial with NIAID must confirm the current position with NIAID program staff rather than relying on the parent announcement alone.

A distinction worth stating. NIH small business phases are separate from and not aligned with clinical trial phases. An SBIR Phase I is a feasibility award, not a clinical Phase I trial. Run the NIH clinical trial determination against your actual design first, then pick the Institute, then pick the announcement.

Direct to Phase II. Available if you already hold the feasibility data a Phase I would generate and never received a Phase I award for that project. SBIR only. For a sensor or software company with a validated product in another exposure context, this is often the fastest route into this topic.

Fast-Track. Phase I and Phase II submitted together, reviewed once. Poor fit where Phase I results would change the Phase II design. Note that Fast-Track is also the point at which NCCIH accepts trials of all types.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that completed an NIH SBIR or STTR Phase II and need a commercialization bridge. Requires documentation of not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award. Award periods must not exceed 4 years.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Late-stage technical assistance and product development not fundable through Phase II or Phase IIB, including Investigational New Drug and Investigational Device Exemption enabling studies, independent replication of key studies, clinical studies, manufacturing costs, and regulatory assistance. Relevant here for a sensor, diagnostic, or device requiring regulatory clearance.

Funding Allowance

Layer one, the SBA statutory guidelines for the current cycle:

• Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years

• Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years

• Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years

Total funding support means direct costs, indirect costs, and fee combined. A reasonable profit or fee is allowable but must be in the budget at submission and normally will not exceed 7 percent of total costs. NIH does not adjust budgets after submission, so a request at the wrong level cannot be corrected later.

A practical warning about published Institute figures. Several Institute small business pages, including NIDDK's and NIAID's, still display older SBA guideline amounts such as $314,363 for Phase I and $2,095,748 for Phase II, and some NIEHS-specific announcements reference figures older still. The SBA adjusts these annually. Use the current guideline for the dollar amount and treat Institute pages as authoritative for policy, waiver eligibility, and per-year constraints rather than for the headline number. When the two conflict, ask program staff.

Layer two, Institute-specific guidance for participants in this topic:

• Higher Phase I headroom. The participating component table in the parent SBIR announcement lists Phase I limits above the statutory guideline for several Institutes here, reaching $700,000 at the top tier, which includes NCI, NIA, NIAID, NIMH, and NCCIH. Others list $400,000 and some hold to the SBA guideline.

• NCI. Generally funds waiver-eligible Phase I up to $400,000 across up to 2 years and considers Phase II up to $2,250,000 across up to 3 years. NCI's separate Phase IIB Bridge Award, announced through its own solicitation, provides funding support up to $4,500,000 in total costs and accepts technologies previously funded under SBIR or STTR Phase II from any federal agency, which is a broader eligibility base than most bridge programs.

• NIAID. Applies a per-year constraint that reshapes budgets more than a total ceiling: NIAID will not generally allow Phase II or Phase IIB awards of any duration exceeding $1,000,000 in total costs per year. NIAID also notes that applicants are not limited to NIAID's own SBA-approved topic list, since all topics on the NIH list can be funded at a higher budget without a separate waiver request.

• NIDDK. Generally considers Phase I up to $350,000 across up to 2 years, Phase II up to $2,200,000 across up to 3 years, and Phase IIB up to $3,000,000, with Phase II and Phase IIB generally not exceeding $1,100,000 in any single year.

• NIEHS. Beyond the parent announcements, NIEHS runs targeted small business announcements that carry materially different terms, including some that accept Phase I applications only and some with substantially lower caps, such as its Superfund Research Program small business track. If NIEHS is your target, confirm which announcement you are applying under and what its budget language says before you build a budget, because the parent guideline may not apply.

• NCCIH, NHLBI, NIA, NIAMS, NIMH, NIMHD, NINR. Refer to the participating component table in the current parent announcement and confirm with program staff. These Institutes do not all maintain standing published SBIR budget pages, and NHLBI publishes its guidance through NOT-HL notices.

Two general cautions. A ceiling in a component table is not the number that gets awarded. BW&CO's analysis of a fiscal year 2026 NCI SBIR award slice found Phase I level awards ranging from roughly $305,000 to $404,000, with not one award in 44 records reaching the $700,000 headroom. And an Institute may reduce the recommended budget or shorten the award period for budgetary, administrative, or programmatic reasons even after a strong review score.

Timeline

The topic window runs from September 1, 2026 through May 1, 2028. That expiration is well short of the usual two years and sits between two standard due dates.

Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Since the topic posted on September 1, this cycle is not realistically available.

• January 5, 2027: the first realistic cycle for a company beginning preparation now.

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, the final cycle. The topic expires May 1, 2028, before the September 2028 date.

What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, so deferring a cycle is not costless. With five cycles remaining and a May 2028 expiration, the effective planning horizon here is shorter than on most topics.

Work backwards from your target date:

• 16 to 18 weeks out: read the HEW Strategic Framework, identify your target Institute, run the NIH clinical trial determination, confirm the Institute's clinical trial policy for your chosen mechanism, contact program staff, and start or verify federal registrations

• 12 weeks out: lock the Specific Aims page and circulate to program staff

• 8 weeks out: complete the research strategy, commercialization plan, community or Tribal partnership documentation if applicable, data use agreements for any linked datasets, letters of support, and human subjects planning

• 4 weeks out: full internal review, budget finalization, and subaward paperwork for any STTR or academic partner

• 1 week out: submit early to leave room for eRA Commons error correction

Registrations are the most common cause of a missed deadline. You need SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on the SBA Company Registry being complete first. Allow six weeks or more and begin before you write.

Also note the current SBIR parent, PA-27-100, closes in early April 2027, before this topic expires, so applicants targeting later cycles must confirm the active announcement number at submission.

Detailed Overview of What NIH Is Looking For

Program aims and scope

The HEW Program aims to support research increasing understanding of how extreme weather, including weather-related natural disasters and emerging weather-related harms, affects human health. Beyond mechanistic processes, the program prioritizes research to develop, test, implement, and evaluate interventions and prevention strategies protecting the health of communities and those at heightened risk for mortality, chronic disease, and lifelong health risks. It also prioritizes research connecting health and environmental data, training and capacity building, community engagement, research translation, and collaboration, and aims to promote collaborative science across biological sciences, atmospheric science, health economics, implementation science, and other disciplines.

The defined scope of extreme weather is broad and worth quoting in your Significance section because it is wider than most applicants assume. It covers extremes in temperature, precipitation, humidity, wind velocity, and other meteorological variables; wildfires, hurricanes, droughts, floods, heatwaves, harmful algal blooms, snowpack loss, and extreme storms; and weather's downstream influence on other environmental exposures and health-relevant outcomes.

That third element is the most useful for a company. A product that addresses a downstream exposure, air quality after wildfire smoke, waterborne pathogens after flooding, algal toxins, or heat-driven changes in medication stability, is in scope even if the product never measures weather directly.

The translational continuum

The topic states that projects may sit at different nodes on the translational continuum and names three application types: using in vivo, in vitro, and in silico models to understand mechanistic underpinnings; assessing short and long-term health risks across the life course and among populations at heightened risk; and developing, testing, implementing, and evaluating evidence-based interventions to prevent or reduce impacts.

It then adds two further categories: methods to advance the aggregation, linking, accessibility, and interpretation of health and weather-related data, and efforts to provide training and build capacity across disciplines. Community engagement, interdisciplinary collaboration, and research translation are encouraged throughout.

For a small business, the first and third of the named application types plus the data methods category are where products live. The second, risk assessment across populations, is epidemiology.

Priority populations, and why the list matters commercially

The topic names an unusually specific set of populations at heightened risk: children, people with chronic pre-existing medical conditions, pregnant women, newborns, agricultural and other outdoor workers, older adults, military personnel and veterans, first responders, patients using electricity-dependent equipment, residents of rural and urban areas, and those with limited economic resources.

Several of these are also identifiable customers or channels, which is unusual. Outdoor and agricultural workers imply an employer purchaser and an occupational health channel. First responders and military personnel imply institutional procurement and a possible bridge to Department of Defense funding. Patients using electricity-dependent equipment imply a payer, a durable medical equipment channel, and a device manufacturer partner. Care facilities, which NIA names directly, imply a facility purchaser. A commercialization plan that connects your named priority population to the entity that would actually pay is doing something most applications on this topic will not.

Institute reads worth acting on

NIAMS is the most product-friendly language in the topic. It asks for personal exposure assessment using wearable devices and environmental sensors specifically to provide stronger causal evidence, and adds that research advancing beyond associations and integrating cutting-edge exposure assessments, mechanistic insights, and longitudinal designs is encouraged. It names concrete disease endpoints, flares in psoriasis, atopic dermatitis, and lupus, which gives a sensor company a measurable clinical outcome to anchor to rather than a vague exposure metric. The constraint is that NIAMS accepts no clinical trials under either parent announcement, so the study design must stay observational, mechanistic, or technical.

NIDDK offers the clearest device and logistics problem. Care discontinuity from lack of medications or electricity-dependent treatments is a defined failure mode with identifiable products attached: backup power, off-grid or portable therapy delivery, cold chain integrity, and interruption management. NIDDK also names acute kidney injury, chronic kidney disease, and kidney stones, where heat and dehydration effects are well established. NIDDK stated it may give special consideration and accepts clinical trials under SBIR.

NIEHS is the lead and made the strongest funding statements, but its interests are the most academic. Exposome characterization, epidemiology, and mechanistic and computational studies dominate. The intervention bullet, studies focused on interventions to reduce health impacts of environmental exposures driven or exacerbated by weather including implementation science approaches, is the one to write against if NIEHS is your target. Also confirm which NIEHS announcement applies, since its targeted tracks carry different terms.

NIMH offers a measurement product opportunity that is easy to miss. Its first bullet asks for methods to accurately measure short and long-term mental illness attributable to extreme weather events. That is instrument development, not intervention research, and it is a distinct product category from the intervention bullets that follow. NIMH also names data sharing methods to support rigorous and reproducible findings.

NIAID splits into two very different lanes. The allergy and airway lane concerns immune responses under pollutant, heat, and humidity exposure across asthma, allergic rhinitis, chronic rhinosinusitis, respiratory viral susceptibility, atopic dermatitis, food allergy, and autoimmune or autoinflammatory disease. The infectious disease lane concerns zoonotic, food, water, and vector-borne pathogens, their reproductive capacity, transmissibility, epidemiology, and virulence, including changes in susceptibility to anti-infective interventions. That last clause is a resistance and susceptibility testing product. NIAID lists separate contacts for each lane, so call the right one.

NINR is the most discipline-open. It states that it supports research aligned with its mission conducted by scientists from any discipline, which is a lower barrier than most Institutes present, and it stated it may give special consideration. Its interest in conditions of daily life such as housing stability and neighborhood environments shaping resilience and recovery is largely academic, but community and organization-level intervention development and evaluation can support a delivery product.

What the non-awarding offices add

Four offices participate without awarding: OBSSR, ODP, ORWH, and THRO. Your application must be relevant to the objectives of at least one of the eleven awarding Institutes, and their interests function as additional strength.

ODP is the most directly useful to a product company, naming projects that develop, test, and implement preparedness, prevention, and recovery interventions, particularly for populations at heightened risk, and projects that evaluate strategies to prevent disruptions to screening and healthcare services following extreme weather events. That second bullet pairs precisely with the NIDDK care continuity and NCI healthcare delivery interests, and screening disruption is a defined operational problem.

ORWH gives priority to multidisciplinary studies using sex-disaggregated data, and names how extreme weather affects chronic conditions in women with risk varying by age, reproductive stage, and menopausal status; evaluation of disaster preparedness plans addressing women's mental health, chronic disease management, and reproductive health needs; resilience among women in rural and medically underserved communities; and effects of environmental displacement and changed living conditions. Sex-disaggregated analysis is a low-cost design decision that most applications will handle minimally.

THRO supports research on how extreme weather affects the health of American Indian and Alaska Native peoples, encouraging studies exploring Tribe and community-specific weather exposures, focusing on AI/AN people at heightened risk such as those who work outside or live in areas with severe weather, tapping existing resources and strengths, employing culturally grounded research approaches and health measures, and including AI/AN participants, practices, and ways of knowledge as much as possible. Claiming THRO alignment requires documented Tribal partnership, not an assertion of intent.

OBSSR participates without publishing specific interests for this topic.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States, and the primary research performed in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity structures may qualify for SBIR under specific conditions, but companies more than 50 percent owned by multiple such firms in combination are not eligible for STTR. Complex cap tables should be checked against 13 CFR Part 121.

• No more than 500 employees including all affiliates. A subsidiary counts its parent's employees.

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PD/PI may be primarily employed by either the small business or the partnering nonprofit research institution, with the award still made to the small business.

• For SBIR Phase I, the small business must perform at least two thirds of the research or analytical effort. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Additional constraints. NIH will not accept similar applications with essentially the same research focus from the same applicant organization, including derivative applications proposing a single product applicable to multiple purposes with non-substantive modification, which is a live risk on a topic where one sensor or data platform could plausibly be pitched to five Institutes. You may not simultaneously submit identical or essentially identical applications under both parent announcements, and duplicate or highly overlapping applications under simultaneous review are not accepted. Applicants must disclose overlapping federal work under the essentially equivalent work rule. Companies with a substantial award history should confirm they meet the Phase I to Phase II Transition Rate and commercialization benchmarks. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization.

What a Competitive Application Looks Like

1. A product, stated plainly, in the first paragraph. Most applications to this topic will propose research. Reviewers assigned to a small business application are looking for a commercial product with unresolved technical risk. Make the product unmistakable early, because the surrounding topic language invites drift toward a study.

2. A named priority population that maps to a payer. The topic lists eleven heightened-risk populations, several of which come with an obvious purchaser: employers for outdoor workers, institutions for first responders and military personnel, durable medical equipment channels and payers for patients using electricity-dependent equipment, facilities for older adults in care settings. Connecting the population to the payer is a commercialization argument almost no competing application will make.

3. Causal evidence, not association. NIAMS asks for stronger causal evidence and for research advancing beyond associations. NIMHD requires validated behavioral, clinical, or biomedical outcomes. If your product generates exposure data, state what clinical outcome it is validated against and how.

4. Data linkage handled as engineering, not aspiration. Five parts of this topic ask for health and environmental data integration. Naming the specific datasets, the linkage method, the spatial and temporal resolution problem, and the data use agreements you will need reads as a technical plan rather than a wish.

5. The clinical trial determination resolved before the mechanism is chosen. Five participating Institutes carry restrictions and NIAID's position requires direct confirmation.

6. The HEW Strategic Framework read and reflected. The program publishes its own framework. Using its language is free and most applicants will not bother.

7. Program officer contact before writing. Eleven Institutes, six different funding signals, five clinical trial complications, and a central contact who can route you. This call is worth more here than on almost any topic.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist

• Bringing an epidemiology, cohort analysis, or natural experiment project to a small business mechanism, where the deliverable is knowledge rather than a product the company will own and sell

• Proposing a clinical trial to NIAMS, which accepts none under either parent announcement

• Proposing a clinical trial to NIDDK or NIMHD through STTR, which neither accepts, when SBIR would have worked at NIDDK

• Proposing an efficacy or effectiveness trial to NCCIH at Phase I, which NCCIH does not support at that phase but does accept at Phase II and Fast-Track

• Planning a clinical trial with NIAID on the strength of the parent announcement alone, when NIAID's own guidance directs small business trials to a separate cooperative agreement

• Targeting NIMHD without a designated disparity population focus and validated behavioral, clinical, or biomedical outcomes, both of which NIMHD states as requirements

• Building a budget from an Institute page still displaying an older SBA guideline figure rather than the current amount

• Budgeting to the $700,000 Phase I ceiling rather than the roughly $400,000 that Institutes actually award, or concentrating Phase II costs in one year at NIAID, which will not generally allow more than $1,000,000 in total costs per year

• Applying to NIEHS under the parent guideline when a targeted NIEHS announcement with different terms and a lower cap actually governs

• Pitching one sensor or data platform to several Institutes at once, which runs into the prohibition on derivative applications proposing a single product applicable to multiple purposes

• Claiming THRO alignment without documented Tribal partnership, or community engagement without named partners and letters

• Referencing a Make America Healthy Again alignment that this topic, unlike most in the cycle, does not claim

• Starting federal registrations after drafting begins, then missing the receipt date on an eRA Commons validation error

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement, requesting assignment to one of the eleven awarding Institutes.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project depends on a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. If NIEHS is your target, confirm whether a targeted NIEHS announcement governs instead, since its terms and caps can differ.

Is this topic actually a fit for a small business?

For most companies, no. The majority of the described work is epidemiology, cohort analysis, natural experiments, community-engaged research, and implementation science, which belong in R01 and related mechanisms. Genuine small business lanes include wearables and environmental sensors for personal exposure assessment, exposure biomarkers, care continuity and medical device resilience for electricity-dependent treatments, health and environmental data linkage platforms, mental health measurement instruments, digital and remote intervention delivery, infectious disease diagnostics and anti-infective susceptibility testing, and in vitro or in silico models.

Which of the eleven Institutes should I target?

Sensors and exposure assessment point to NIAMS first, then NIEHS and NHLBI. Data platforms point to NHLBI, NIMH, NIEHS, NCCIH, or NIA. Care continuity and devices point to NIDDK, then NCI and NIA. Diagnostics and infectious disease point to NIAID. Behavioral health and community intervention point to NIMH, NCCIH, NINR, or NIMHD. NIEHS leads the program and is the only Institute that made both available funding statements.

How much money can my company request?

The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. Several participating Institutes list Phase I headroom to $700,000. NCI generally funds waiver-eligible Phase I near $400,000 and Phase II up to $2,250,000, and its separate Phase IIB Bridge Award provides up to $4,500,000. NIDDK publishes $350,000 and $2,200,000. NIAID applies a per-year constraint of $1,000,000 in total costs on Phase II and Phase IIB. Note that several Institute pages still display older SBA figures, so confirm the current amount.

When is the deadline?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic expires May 1, 2028, which is earlier than the usual two-year window and makes April 5, 2028 the final available cycle.

Can I include a clinical trial?

It depends on the Institute and the mechanism, and this topic has more complications than most. NIAMS accepts none under either parent announcement. NIDDK and NIMHD do not accept them under STTR, though NIDDK does under SBIR. NCCIH will not support efficacy or effectiveness trials at Phase I but accepts trials of all types at Phase II and Fast-Track. NIAID's own guidance directs small business clinical trials to a separate cooperative agreement, so confirm directly with NIAID before planning one. Run the NIH clinical trial determination against your design first.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest possible start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award.

What counts as extreme weather under this topic?

The defined scope is broad: extremes in temperature, precipitation, humidity, wind velocity, and other meteorological variables; wildfires, hurricanes, droughts, floods, heatwaves, harmful algal blooms, snowpack loss, and extreme storms; and weather's downstream influence on other environmental exposures and health-relevant outcomes. That third element means a product addressing a downstream exposure, such as post-wildfire air quality, post-flood waterborne pathogens, or algal toxins, is in scope even if it never measures weather directly.

Does my project have to involve a specific population?

Not universally, but the topic names eleven heightened-risk populations including children, people with chronic conditions, pregnant women, newborns, agricultural and other outdoor workers, older adults, military personnel and veterans, first responders, patients using electricity-dependent equipment, rural and urban residents, and those with limited economic resources. NIMHD, separately, requires a focus on NIH-designated populations experiencing disparities plus validated behavioral, clinical, or biomedical outcomes.

Does any Institute set aside dedicated funding for this topic?

Not guaranteed, but six made statements. NIEHS, the lead Institute, stated both that it may dedicate available funds and that it may give special consideration. NIMHD stated it may dedicate available funds. NCCIH, NIDDK, and NINR each stated they may give special consideration. NCI, NHLBI, NIA, NIAID, NIAMS, and NIMH made no statement. Treat these as a favorable tilt rather than a reserved pool.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR. A sensor or software product already validated in another exposure context is a common qualifying profile.

Does this topic align with the Make America Healthy Again initiative?

No. Unlike most NIH Highlighted Topics published in this cycle, this one lists no initiative alignment and no named policy efforts. It is instead tied to the NIH Health and Extreme Weather Program and its published Strategic Framework, which is what applicants should read and reference.

Do OBSSR, ODP, ORWH, and THRO award grants?

No. All four participate without awarding. Your application must be relevant to the objectives of at least one of the eleven awarding Institutes. ODP's interests are the most useful to a product company, particularly its focus on preventing disruptions to screening and healthcare services after extreme weather events.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA Company Registry first, so the sequence matters. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards.

On a topic this broad and this academically weighted, the first job is an honest fit assessment. If your project is research rather than product development, we will tell you so and point you at the right mechanism. If it is a sensor, diagnostic, device, or data platform, the work is Institute selection across eleven options with six different funding signals, resolving the clinical trial determination and the several Institute restrictions attached to it, confirming which NIEHS announcement governs, program officer engagement, Specific Aims development, full proposal build, budget and fee construction, commercialization planning that connects the priority population to an actual payer, and Phase IIB and CRP sequencing. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are building a product that measures, prevents, or manages the health effects of extreme weather and want a straight answer on whether this topic fits your company and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.

NIH Highlighted Topic: Next-generation Cellular Immunotherapy: Reprogramming Immune Cells Inside the Body

Executive Summary

The National Institutes of Health has published a Highlighted Topic titled "Next-generation Cellular Immunotherapy: Reprogramming Immune Cells Inside the Body." It signals that five NIH Institutes, NCI, NIAID, NIAMS, NIBIB, and NIDCR, want to fund basic research, preclinical development, and early clinical testing of in vivo immune cell engineering: approaches that reprogram T cells, natural killer cells, macrophages, and other immune cells inside the patient rather than extracting, modifying, and expanding them in a manufacturing facility.

The commercial thesis NIH lays out is unusually explicit. CAR-T therapies transformed treatment of hematologic malignancies, but current adoptive cellular therapies carry substantial practical barriers: lymphodepletion, leukapheresis, ex vivo cell modification and expansion, GMP manufacturing, specialized facilities, and weeks-long processing. NIH states that this complexity makes these therapies slow, costly, and inaccessible to many patients, and that in vivo engineering removes a major logistical bottleneck and offers true off-the-shelf cellular immunotherapy. That is a manufacturing and access argument as much as a scientific one, which makes this the most small-business-native Highlighted Topic NIH has published this cycle.

For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, requesting assignment to one of the five Institutes, and aligning your Specific Aims to that Institute's stated interests.

One structural fact should shape your plan before anything else. The topic explicitly invites early clinical testing, pilot clinical trials, and acceleration of clinical trials, yet only NCI among the five Institutes accepts clinical trial applications without restriction under the parent announcements. NIBIB accepts only early stage trials such as feasibility, first-in-human, and safety studies that inform early technology development. NIAID accepts clinical trials under SBIR but not under STTR. NIAMS and NIDCR accept no clinical trials under either parent announcement, despite NIAMS explicitly inviting clinical research. Matching your trial design to the wrong Institute or mechanism makes the application non-responsive and unreviewed regardless of scientific merit.

The topic was posted on September 2, 2026 and expires on September 2, 2028. If you build viral vectors, lipid nanoparticles or other synthetic nanocarriers, biodegradable nanomaterials, gene editing payloads, synthetic receptors or genetic circuits, biomaterials for immunotherapy, or microphysiological platforms for evaluating in vivo transduction, there is a well-signposted funding path here across multiple Institutes.

At a Glance

• Topic title: Next-generation Cellular Immunotherapy: Reprogramming Immune Cells Inside the Body

• Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services

• Awarding Institutes: NCI, NIAID, NIAMS, NIBIB, and NIDCR

• Non-awarding participating office: the Office of Autoimmune Disease Research in the Office of Research on Women's Health (OADR-ORWH)

• Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.

• Post date: September 2, 2026

• Expiration date: September 2, 2028

• Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement

• Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot

• Standard annual due dates: January 5, April 5, and September 5

• SBA statutory guidelines this cycle: $323,090 Phase I, $2,153,927 Phase II, $4,191,495 CRP

• Institute headroom: NCI and NIAID are among the components listing Phase I limits above the statutory guideline, up to $700,000. Limits differ by Institute and must be confirmed.

• Clinical trials: NCI accepts them. NIBIB accepts only early stage, feasibility, first-in-human, safety, or other small trials informing early technology development, and will not support pivotal, efficacy, or effectiveness trials. NIAID accepts under SBIR but not STTR. NIAMS and NIDCR accept none under either parent.

• Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.

• Equity dilution: none. This is non-dilutive federal funding.

• Profit or fee: allowable, must be in the budget at submission, and normally will not exceed 7 percent of total costs

• Funding signal: NIDCR is the only participating Institute that stated it may give special consideration to meritorious applications in this topic area.

• Initiative alignment: none stated. Unlike most Highlighted Topics published this cycle, this one is not issued under the Make America Healthy Again initiative, so there is no policy framing to reference.

• Central contact: none designated. Each Institute lists its own scientific contact.

What This Opportunity Actually Is

An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that an area of science is a priority without creating a separate funding announcement, deadline, or review process. There is no topic-specific number to search on Grants.gov, and applications are not scored against other applications to the topic.

What it does do is identify which Institutes are receptive, which determines your assignment request and your program officer conversations, and supply the vocabulary program staff already use internally, which your Specific Aims should mirror. On this topic only NIDCR went on record with a funding advantage, stating it may give special consideration to meritorious applications in the topic area. The other four Institutes made no such statement. That is a thinner set of stated signals than most topics carry, and it means Institute selection here rests on scientific and mechanism fit rather than on declared preference.

It is also worth noting what this topic lacks. Most NIH Highlighted Topics published in this cycle are issued under the Make America Healthy Again initiative and list named policy alignments that applicants can reference in a Significance section. This one does not. Do not manufacture an initiative alignment that the topic does not claim.

Why This Topic Is a Strong Small Business Fit

Most NIH Highlighted Topics require careful triage to separate the academically fundable work from the commercially fundable work. This one requires less of that, because nearly every area of interest across the five Institutes describes a product: a delivery vehicle, a payload, an editing tool, a receptor design, a biomaterial, or an evaluation platform.

NIH's own background section makes the commercialization case for you. It names lymphodepletion, leukapheresis, ex vivo modification and expansion, GMP manufacturing, specialized facilities, and weeks-long processing times as the barriers, and states that in vivo engineering offers true off-the-shelf cellular immunotherapy for rapidly progressing diseases where patients often cannot afford the wait. Cost of goods, manufacturing complexity, time to treatment, and site-of-care requirements are all named or implied. A commercialization plan that quantifies the delta between an ex vivo process and your in vivo approach is arguing exactly the case NIH already made.

The clearest product lanes across the five Institutes:

• Delivery vehicles. Viral vectors including lentiviral and adeno-associated viral vectors, engineered viruses, lipid nanoparticles, synthetic nanocarriers, biodegradable nanomaterials, and artificial cells. Named by NCI, NIBIB, and NIDCR.

• Targeting and specificity. Technologies increasing the specificity and efficiency of immune cell targeting and transduction in vivo, plus tissue, antigen, and cell specificity for enhancing protective immunity or eliminating and reprogramming pathogenic subsets. Named in the topic purpose and by NIAID.

• Payloads and editing tools. CARs, TCRs, costimulatory domains, other functional elements, mRNA and siRNA cargos, CRISPR/Cas9, base and prime editing, nucleases and genome editors, and epigenetic reprogramming. Named by NCI, NIBIB, and NIDCR.

• Synthetic biology and control. Synthetic receptors, transmembrane chimeric antigen receptors, and synthetic genetic circuits for engineering T cells, NK cells, and macrophages. Named by NIBIB. Control and reversibility of therapeutic activity is named by NIAID.

• Biomaterials. Biomaterials for enhancing immunotherapy, named by NIBIB.

• Evaluation platforms. Novel platforms to engineer immune cells in vivo using microphysiological systems to model and evaluate targeting, transduction efficiency, and therapeutic function. Named by NIBIB, and a distinct product category rather than a research method.

• Preclinical safety and biomarker work. Preclinical toxicity and safety studies, biodistribution improvement, and pilot clinical trials informed by biomarkers. Named by NCI and echoed in NIAID's safety priorities.

• Computational and AI tools. Advanced data science, artificial intelligence and machine learning, and computational modeling to elucidate mechanisms of action and optimize design and performance. Named by NIDCR, with a parallel interest from OADR-ORWH in computational interrogation of clinical trial data.

The ordinary SBIR test still applies. There must be a commercial product with unresolved technical risk that your company will own and sell. On this topic that test is easier to pass than usual.

Which Institute Should You Target?

With five awarding Institutes, the assignment request drives review assignment, budget ceiling, and whether your clinical design is even reviewable. Group yourself by disease area first, then check the clinical trial constraint.

NCI, for oncology. NCI encourages development of in vivo immune cell engineering methods for testing in preclinical models and early clinical trials in both hematologic and solid tumors. Its named topics span viral vector delivery of DNA carrying tumor-specific CARs, TCRs, and costimulatory domains; nonviral delivery using LNPs or other synthetic nanocarriers for mRNA, siRNA, and other cargos; novel delivery vehicles including biodegradable nanomaterials; novel gene editing methods such as CRISPR/Cas9 and base or prime editing delivered with nanovehicles for genetic or epigenetic reprogramming; preclinical toxicity and safety studies and pilot clinical trials informed by biomarkers; and combination use with immune checkpoint blockade or agents modulating the tumor microenvironment. NCI is also the only one of the five that accepts clinical trials without restriction, which makes it the default target for any project with a clinical component.

NIAID, for infectious, autoimmune, and immune-mediated disease. NIAID encourages basic, translational, and early clinical research on engineered cellular therapies, including targeted modulation of protective or pathogenic immune responses that induce durable disease control while preserving protective immunity. Its three named strategies are improving tissue, antigen, and cell specificity for enhancing protective immunity or eliminating and reprogramming pathogenic immune subsets including autoreactive innate and adaptive cells; improving scalability, cost reduction, and expansion of access to off-the-shelf or in vivo approaches that minimize preconditioning; and improving safety, covering mitigation of off-target effects, unintended tissue injury, prolonged immune dysregulation, oncogenic risk, and improved control and reversibility of therapeutic activity. NIAID accepts clinical trials under SBIR but not under STTR.

Note how commercial NIAID's second bullet is. Scalability, cost reduction, and access are business metrics, and minimizing preconditioning is a direct attack on the lymphodepletion barrier. If your platform's advantage is that it removes preconditioning or lowers cost of goods, NIAID has invited that argument in its own words.

NIBIB, for platform and enabling technology. NIBIB is interested in technologies to engineer immune cells in vivo across a range of diseases, listing new types of engineered viruses and artificial cells for genetic material delivery; novel delivery methods using LNPs, nanocarriers, biodegradable nanomaterials, or other vehicles; novel gene editing methods, synthetic receptors, and transmembrane chimeric antigen receptors; nucleases and genome editors for DNA manipulation and regulation; synthetic genetic circuits for engineering T cells, NK cells, and macrophages for immune regulation and cancer therapy; biomaterials for enhancing immunotherapy; and development of novel platforms using microphysiological systems to model and evaluate targeting, transduction efficiency, and therapeutic function.

NIBIB is the right door for a company whose product is the enabling technology rather than a therapy for a named indication, since its framing is deliberately disease-agnostic. NIBIB's clinical trial policy is narrower than NCI's but well matched to this topic: it supports feasibility, first-in-human, safety, and other small trials that inform early stage technology development, and will not support pivotal trials, later-phase trials, or trials whose primary outcome is efficacy, effectiveness, or a post-market concern. Mechanistic trials are supported only where the primary focus of the project is technology development.

NIAMS, for rheumatic, autoimmune, autoinflammatory, and musculoskeletal disease. NIAMS encourages basic, translational, and clinical research advancing in vivo immune cell engineering-based cell therapy for rheumatic, autoimmune, autoinflammatory, and musculoskeletal and bone diseases and conditions. That is the entirety of its published language, which is notably brief relative to the other four. Critically, NIAMS accepts no clinical trials under either parent announcement, so its invitation to clinical research must be satisfied through work that does not meet the NIH clinical trial definition, or through a NIAMS-specific announcement designed for trials.

NIDCR, for dental, oral, and craniofacial disease. NIDCR seeks research and technology advancement for dental, oral, and craniofacial diseases and conditions, listing novel viral vector-based delivery platforms and nonviral approaches using LNPs and other synthetic nanocarriers for efficient targeted delivery of nucleic acids or protein cargos; innovative gene editing including CRISPR/Cas9 and base or prime editing for precise and durable genetic and epigenetic modification of immune cells in vivo; combination strategies integrating immune engineering with immune checkpoint blockade, autoantigen and antibody-based therapies, and cytokine and chemokine-mediated modulation; and advanced data science, AI and machine learning, and computational modeling to elucidate mechanisms of action and optimize design and performance. NIDCR is the only Institute here offering a stated funding advantage, and the only one naming protein cargo delivery alongside nucleic acids. It accepts no clinical trials under either parent.

Quick reference: awarding Institutes, clinical trial posture, and contacts

• NCI. Hematologic and solid tumors, delivery, editing, preclinical safety, combination therapy. Accepts clinical trials. No stated funding signal. Contact: Zhang-Zhi Hu, M.D., zhang-zhi.hu@nih.gov

• NIAID. Infectious, autoimmune, and immune-mediated disease, with emphasis on specificity, scalability and access, and safety. Accepts clinical trials under SBIR only, not STTR. No stated funding signal. Contact: Jeffrey Rice, Ph.D., Jeffrey.Rice@nih.gov

• NIAMS. Rheumatic, autoimmune, autoinflammatory, musculoskeletal and bone disease. Accepts no clinical trials under either parent. No stated funding signal. Brief published language, so a program officer call matters more here. Contact: Marie Mancini, Ph.D., Marie.Mancini@nih.gov

• NIBIB. Disease-agnostic enabling technology, synthetic biology, biomaterials, microphysiological evaluation platforms. Accepts early stage, feasibility, first-in-human, safety, and other small trials informing technology development only. No stated funding signal. Contact: Tuba Fehr, PhD, tuba.fehr@nih.gov

• NIDCR. Dental, oral, and craniofacial disease, delivery, editing, combination strategies, AI and computational modeling. Accepts no clinical trials under either parent. May give special consideration to meritorious applications. Contact: Zhong Chen, MD, PhD, nidcr-program@mail.nih.gov

Which NIH Mechanism Should a Small Business Use?

Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match. On this topic the mechanism choice interacts with the clinical trial question more than usual, so decide both together.

NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route. Accepts Phase I, Phase II, Direct to Phase II, and Fast-Track. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company. Under PA-27-100, NIAMS and NIDCR do not accept clinical trials, and an application proposing a clinical trial that aligns only with one of those missions is non-responsive and will not be reviewed.

NIH Parent STTR, currently PA-27-102 (R41 and R42). Requires a formal collaboration with a nonprofit research institution, with at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. STTR permits the Program Director or Principal Investigator to be employed by either the small business or the partnering nonprofit while the award still goes to the small business, which matters in this field because much of the foundational vector, editing, and receptor work sits in academic labs and the inventor often holds a faculty appointment. Under PA-27-102, NIAID, NIAMS, and NIDCR do not accept clinical trials, so a project with an academic PI and a clinical component cannot use STTR at NIAID even though SBIR would work.

A distinction worth stating plainly. NIH small business phases are separate from and not aligned with clinical trial phases. An SBIR Phase I is a feasibility award, and it is not the same thing as a clinical Phase I trial. NIBIB's policy supports clinical Phase I and first-in-human studies, which can be proposed within an SBIR Phase II or Fast-Track application. Confusing the two numbering systems is a common and expensive error on topics like this one that invite early clinical work.

Direct to Phase II. Available if you already hold the feasibility data a Phase I would generate and never received a Phase I award for that project. SBIR only, not available under STTR. For a company with a validated delivery platform in one context and new in vivo transduction data in an immune cell context, this is often the fastest route.

Fast-Track. Phase I and Phase II submitted together and reviewed once. Poor fit when Phase I results would change the Phase II design, which is frequently the case here because the choice of vector, payload, or dosing regimen often depends on what the first biodistribution and specificity data show.

Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that completed an NIH SBIR or STTR Phase II and need a commercialization bridge. Requires documentation of not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award. Award periods must not exceed 4 years. Given the capital intensity of gene-modified cell therapy development, a Phase IIB matching plan should be sketched early rather than discovered later. Note that not all Institutes accept clinical trials through Phase IIB.

Commercialization Readiness Pilot, currently PAR-27-098 (SB1). This mechanism deserves particular attention on this topic. CRP supports later-stage work not typically fundable through Phase II or Phase IIB, and NIH names Investigational New Drug and Investigational Device Exemption enabling studies, independent replication of key studies, clinical studies, manufacturing costs, and regulatory assistance among eligible activities. For an in vivo immune cell engineering program, IND-enabling toxicology and manufacturing are precisely the expensive steps that fall between a successful Phase II and a first-in-human study. CRP permits substantial subcontracting, though the small business must maintain oversight and management of the research throughout.

Funding Allowance

The ceiling depends on two layers.

Layer one, the SBA statutory guidelines for the current cycle:

• Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years

• Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years

• Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years

Total funding support means direct costs, indirect costs, and fee combined. A reasonable profit or fee is allowable but must be in the budget at submission and normally will not exceed 7 percent of total costs. NIH does not adjust budgets after submission, so a request at the wrong level cannot be corrected later.

Layer two, Institute-specific guidance. NIH holds SBA waivers permitting awards above the guideline for approved topics, and each Institute publishes its own limits.

• NCI. Among the components listing Phase I headroom above the statutory guideline, reaching $700,000 in the parent announcement's participating component table. NCI's own published guidance generally funds waiver-eligible Phase I applications up to $400,000 across up to 2 years and considers Phase II up to $2,250,000 across up to 3 years. NCI also runs a Phase IIB Bridge Award and caps its CRP support well below the government-wide figure.

• NIAID. Also listed in the higher Phase I tier, but NIAID publishes a per-year constraint that reshapes budgets more than a total ceiling does: NIAID will not generally allow Phase II or Phase IIB awards of any duration exceeding $1,000,000 in total costs per year. For a program with heavy vector manufacturing or toxicology costs concentrated in one year, this is a planning constraint worth designing around from the start.

• NIAMS, NIBIB, and NIDCR. Refer to the participating component table in the current parent announcement and confirm directly with program staff. These Institutes do not all maintain standing published SBIR budget pages, and NIBIB in particular has historically used targeted announcements with their own budget language for clinical work.

Two cautions. First, a ceiling in a component table is not the number that gets awarded. BW&CO's analysis of a fiscal year 2026 NCI SBIR award slice found Phase I level awards ranging from roughly $305,000 to $404,000, with not one award in 44 records reaching the $700,000 headroom. Budgeting to the ceiling budgets against an outcome that did not occur. Second, an Institute may reduce the recommended budget or shorten the award period for budgetary, administrative, or programmatic reasons even after a strong review score.

A candid note on capital adequacy. A Phase II at $2.15 million will not carry an in vivo gene-modified immunotherapy from concept to the clinic. The realistic financing picture is a Phase I or Direct to Phase II establishing specificity and transduction efficiency, a Phase II generating the preclinical package, CRP or Phase IIB covering IND-enabling studies and manufacturing, and private capital carrying first-in-human. Applications that show awareness of that full sequence read as commercially serious. Applications that imply a Phase II ends at an approved therapy do not.

Timeline

The topic window runs from September 2, 2026 through September 2, 2028.

Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.

Cycles available under this topic:

• September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Since the topic posted on September 2, this cycle is not realistically available.

• January 5, 2027: the first realistic cycle for a company beginning preparation now.

• April 5, 2027

• September 5, 2027

• January 5, 2028

• April 5, 2028, the last full cycle before the topic expires in September 2028.

What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, so deferring a cycle is not costless.

Work backwards from your target date:

• 16 to 18 weeks out: identify your target Institute, run the NIH clinical trial determination against your actual design, confirm the Institute's clinical trial policy for your chosen mechanism, contact program staff, and start or verify federal registrations

• 12 weeks out: lock the Specific Aims page and circulate to program staff

• 8 weeks out: complete the research strategy, commercialization plan, vector or material sourcing agreements, institutional biosafety planning, letters of support, and any human subjects documentation

• 4 weeks out: full internal review, budget finalization, and subaward paperwork for any STTR or academic partner

• 1 week out: submit early to leave room for eRA Commons error correction

Registrations are the most common cause of a missed deadline. You need SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on the SBA Company Registry being complete first. Allow six weeks or more and begin before you write.

Also note two moving parts. The current SBIR parent, PA-27-100, closes in early April 2027, well before this topic expires, so applicants targeting later cycles must confirm the active announcement number at submission. Separately, the 2026 reauthorization gave agencies authority to limit how many Phase I proposals a company may submit, and HHS has been reported to cap SBIR and STTR submissions at nine per small business per fiscal year. Confirm the current limit with program staff if you plan multiple submissions across Institutes.

Detailed Overview of What NIH Is Looking For

The problem NIH is trying to solve

The topic frames its case in two movements. The first is scientific. Adoptive cellular therapies such as CAR-T cells have transformed treatment of hematologic malignancies, but challenges remain in solid tumors because of poor immune cell trafficking, limited persistence, and immunosuppressive tumor microenvironments. Development for solid tumors is nonetheless expanding rapidly across autologous and allogeneic engineered T, NK, and other immune cells, and cellular therapies are being explored beyond oncology for autoimmune, infectious, and age-related disease and for regenerative medicine.

The second movement is logistical, and it is where the small business opportunity lives. NIH lists the practical barriers to current approaches directly: lymphodepletion, leukapheresis, ex vivo cell modification and expansion, GMP manufacturing, specialized facilities, and weeks-long processing times. It concludes that this complexity makes these therapies slow, costly, and inaccessible to many patients. In vivo engineering is presented as a transformative alternative that engineers immune cells inside the body using in vivo gene delivery, bypassing that process and offering true off-the-shelf cellular immunotherapy. NIH adds that this removes a major logistical bottleneck and enables treatment for rapidly progressing disease where patients often cannot afford the long wait.

Read strategically, that second paragraph is a specification. It names the incumbent's cost drivers and time drivers and identifies the patient population the incumbent cannot serve. A Significance section that quantifies your platform against those specific barriers, time from decision to dose, cost of goods, site-of-care requirement, and eligibility for patients too sick to wait for manufacturing, is arguing on the ground NIH chose.

The scope of the technology as defined

The topic's purpose statement is unusually detailed about what counts. It encourages basic and preclinical research and early clinical testing of in vivo immune cell engineering to reprogram immune cells within the body, including but not limited to T cells, NK cells, and macrophages, for cancer, autoimmune, infectious, and age-related disease and for regenerative medicine. Delivery may involve viral vectors such as lentiviral or adeno-associated viral vectors, or non-viral nanocarriers such as lipid nanoparticles, for delivery of genetic material such as DNA or mRNA. The genetic material could encode CARs, TCRs, or other functional elements, or gene editing machinery for in situ reprogramming.

The purpose statement then names four categories of acceptable work: development and testing of novel technologies and methodologies for increasing specificity and efficiency of immune cell targeting and transduction in vivo; improving biodistribution; improving safety; and enhancing efficacy and persistence of engineered immune cells in preclinical models and early clinical studies.

Two observations for an applicant. Macrophages appear alongside T and NK cells in the topic's own framing, which is a wider aperture than most CAR-focused programs and an opening for companies working outside the T cell mainstream. And specificity, efficiency, biodistribution, safety, and persistence are each named as standalone objectives. You do not need to propose a complete therapy. A Phase I that measurably improves one of those five parameters is responsive on its own terms.

The clinical trial constraint in detail

This deserves its own treatment because the topic invites clinical work that most of its participating Institutes cannot accept through the parent announcements.

The topic asks for early clinical testing in its purpose statement. NCI names pilot clinical trials informed by biomarkers. NIAID names early clinical research. NIAMS names clinical research. OADR-ORWH names acceleration of clinical trials for autoimmune disease. Against that, the parent announcements set the following:

• NCI. Accepts clinical trials under both SBIR and STTR. The only unrestricted door among the five.

• NIBIB. Supports only early stage clinical trials, specifically feasibility, clinical Phase I, first-in-human, safety, or other small trials that inform early stage technology development. Will not support pivotal trials, clinical Phase II, III, or IV, or trials whose primary outcome is efficacy, effectiveness, or a post-market concern. Mechanistic trials are supported only where the primary focus of the project is technology development. For a first-in-human study of a novel delivery platform, this policy is a good match rather than an obstacle.

• NIAID. Accepts clinical trials under the parent SBIR announcement but not under the parent STTR announcement.

• NIAMS and NIDCR. Accept no clinical trials under either parent announcement. An application proposing a clinical trial that aligns only with one of these missions is non-responsive and will not be reviewed.

The practical sequence is: run the NIH clinical trial determination against your actual design first, then choose the Institute, then choose SBIR or STTR. Doing it in the reverse order is how a strong application becomes unreviewable. Also confirm the definition rather than assuming, since NIH defines a clinical trial as a study prospectively assigning human subjects to one or more interventions to evaluate effects on health-related biomedical or behavioral outcomes, which captures more designs than founders expect.

What OADR-ORWH adds

The Office of Autoimmune Disease Research within ORWH participates but does not award grants. Your application must be relevant to the objectives of at least one participating Institute, which here means NCI, NIAID, NIAMS, NIBIB, or NIDCR. Its interests function as additional strength within an application already aimed at one of the five, and they are more specific than most non-awarding office statements.

OADR-ORWH is interested in design and engineering of next-generation cellular therapies including CAR-T and CAAR-T cells, regulatory T cells, NK cells, engineered CARs and TCRs, costimulatory domains, and other immunocytes and functional elements; development of data science and computational approaches to interrogate mechanisms of novel cellular therapies, including analysis of new or existing early-phase and pooled clinical trial data to define immunologic treatment windows and identify predictors of therapeutic response; and advancement of translational research to enable and accelerate clinical trials of cellular therapies for autoimmune disease. It strongly encourages engagement of people living with or at risk for autoimmunity to ensure direct relevance to human health.

Three things stand out. CAAR-T cells, chimeric autoantibody receptor T cells for depleting autoreactive B cells, are named explicitly and appear nowhere else in the topic, so a CAAR platform has a clear home. Regulatory T cells are named, which points toward tolerance induction rather than cytotoxic depletion. And the interest in analyzing existing and pooled early-phase clinical trial data to define immunologic treatment windows is a computational product opportunity that requires no wet lab at all, and it pairs naturally with NIDCR's parallel interest in AI and computational modeling. Patient engagement is cheap to do well and most applications will do it thinly or not at all.

Eligibility Requirements

To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:

• Organized for profit, with a place of business located in the United States, and the primary research performed in the United States

• More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity structures may qualify for SBIR under specific conditions. Note that companies more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination are not eligible for the STTR program, which is a distinction that catches venture-backed cell therapy companies specifically.

• No more than 500 employees including all affiliates. A subsidiary counts its parent's employees.

• For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PD/PI may be primarily employed by either the small business or the partnering nonprofit research institution, with the award still made to the small business.

• For SBIR Phase I, the small business must perform at least two thirds of the research or analytical effort. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.

Additional constraints. NIH will not accept similar applications with essentially the same research focus from the same applicant organization, including derivative applications proposing a single product applicable to multiple purposes with non-substantive modification. This matters on a platform topic, where the temptation is to submit the same delivery technology against several disease areas and Institutes. You may not simultaneously submit identical or essentially identical applications under both parent announcements, and duplicate or highly overlapping applications under simultaneous review are not accepted. Applicants must disclose overlapping federal work under the essentially equivalent work rule. Companies with a substantial award history should confirm they meet the Phase I to Phase II Transition Rate and commercialization benchmarks. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization, with additional scrutiny possible for STTR because of the research institution partnership.

What a Competitive Application Looks Like

1. A quantified comparison against the ex vivo process. NIH named the barriers: lymphodepletion, leukapheresis, ex vivo modification and expansion, GMP manufacturing, specialized facilities, weeks-long processing. State what your approach does to each one, in numbers where you can. This is the argument the topic was written to invite, and most applications will gesture at it rather than quantify it.

2. One of the five named parameters as a measurable endpoint. Specificity, transduction efficiency, biodistribution, safety, and persistence are each named as standalone objectives. Pick one or two, define the metric, and state the success criterion. A proposal that improves everything vaguely improves nothing measurably.

3. A safety and control story. NIAID names off-target effects, unintended tissue injury, prolonged immune dysregulation, oncogenic risk, and control and reversibility of therapeutic activity. In vivo editing raises safety questions that ex vivo manufacturing partially contains through release testing, and reviewers know it. Addressing reversibility or a control switch directly is a differentiator.

4. The clinical trial determination resolved before the mechanism is chosen. Run the NIH definition against your design, then pick the Institute and announcement. Four of the five Institutes carry restrictions.

5. An honest capital sequence. Phase I or Direct to Phase II for specificity and transduction, Phase II for the preclinical package, CRP or Phase IIB for IND-enabling studies and manufacturing, private capital for first-in-human. Naming the sequence signals that you understand what this class of product costs to develop.

6. Program officer contact before writing. Five Institutes, four clinical trial postures, and two Institutes with brief published language. The call determines assignment, budget realism, and reviewability.

Common Reasons Applications Miss

• Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist

• Proposing a clinical trial to NIAMS or NIDCR, which accept none under either parent announcement, making the application non-responsive and unreviewed

• Proposing a clinical trial to NIAID through STTR, which it does not accept, when SBIR would have worked

• Proposing an efficacy-powered or pivotal trial to NIBIB, which supports only early stage, feasibility, first-in-human, and safety trials informing technology development

• Confusing SBIR Phase I and Phase II with clinical trial Phase I and Phase II, which are separate and unaligned numbering systems

• Submitting the same delivery platform against multiple diseases and Institutes, which runs into the prohibition on derivative applications proposing a single product applicable to multiple purposes

• Applying for STTR while more than 50 percent owned by a combination of venture capital, hedge fund, or private equity firms, which is an STTR eligibility bar even where SBIR would permit it

• Designing a Phase II budget with costs concentrated in one year at NIAID, which will not generally allow more than $1,000,000 in total costs per year

• Budgeting to the $700,000 Phase I ceiling rather than the roughly $400,000 that Institutes actually award

• Omitting the fee from the budget or requesting the wrong level, neither correctable after submission

• Referencing a Make America Healthy Again alignment that this topic, unlike most others in the cycle, does not claim

• Implying a Phase II ends at an approved therapy, with no account of IND-enabling work, manufacturing, or the capital required to reach the clinic

• Starting federal registrations after drafting begins, then missing the receipt date on an eRA Commons validation error

Frequently Asked Questions

Is this a grant I can apply to directly?

No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement, requesting assignment to one of the five awarding Institutes.

Which funding opportunity number do I actually use?

For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project depends on a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. Confirm the active number at submission, since PA-27-100 closes in early April 2027 while this topic runs to September 2028.

Can I propose a clinical trial under this topic?

It depends entirely on the Institute and mechanism. NCI accepts clinical trials under both SBIR and STTR. NIBIB accepts only early stage trials such as feasibility, clinical Phase I, first-in-human, safety, or other small trials that inform early technology development, and will not support pivotal or efficacy-powered trials. NIAID accepts clinical trials under SBIR but not STTR. NIAMS and NIDCR accept none under either parent. Run the NIH clinical trial determination against your design before choosing an Institute.

Is an SBIR Phase I the same as a clinical Phase I trial?

No, and conflating them causes real problems. NIH small business phases are separate from and not aligned with clinical trial phases. An SBIR Phase I is a feasibility award. A clinical Phase I trial is a first-in-human safety study, which would typically be proposed within an SBIR Phase II, Direct to Phase II, or Fast-Track application, subject to the target Institute's clinical trial policy.

Which of the five Institutes should I target?

NCI for oncology, and the default for any project with a clinical component since it accepts trials without restriction. NIAID for infectious, autoimmune, and immune-mediated disease, especially where your advantage is specificity, cost reduction, access, or minimizing preconditioning. NIBIB for disease-agnostic enabling technology, synthetic biology, biomaterials, and evaluation platforms. NIAMS for rheumatic, autoimmune, autoinflammatory, and musculoskeletal disease. NIDCR for dental, oral, and craniofacial disease, and the only Institute here offering a stated funding advantage.

How much money can my company request?

The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. NCI and NIAID are among the components listing Phase I headroom to $700,000, though NCI's own guidance generally funds waiver-eligible Phase I near $400,000 and Phase II up to $2,250,000. NIAID applies a per-year constraint of $1,000,000 in total costs on Phase II and Phase IIB. Confirm with your target Institute before setting a budget.

When is the deadline?

There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic expires September 2, 2028, making January 5, 2027 through April 5, 2028 the realistic competing cycles.

How long until I receive funding?

Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest possible start date in the fall of 2027.

Do I have to give up equity or match the funds?

No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award.

My company is venture-backed. Are we still eligible?

For SBIR, possibly. Certain venture capital, hedge fund, and private equity ownership structures qualify under specific conditions, and complex cap tables should be checked against 13 CFR Part 121. For STTR, no: small business concerns more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are not eligible for the STTR program. This distinction affects venture-backed cell therapy companies more than most.

Can NIH funding cover IND-enabling studies and manufacturing?

Yes, primarily through the Commercialization Readiness Pilot. CRP supports later-stage work not typically fundable through Phase II or Phase IIB, and NIH names IND and IDE enabling studies, independent replication of key studies, clinical studies, manufacturing costs, and regulatory assistance among eligible activities. CRP permits substantial subcontracting, though the small business must maintain oversight and management of the research throughout the award.

Does my project have to target cancer?

No. The topic names cancer, autoimmune disease, infectious disease, age-related disease, and regenerative medicine, and covers T cells, NK cells, and macrophages. NIBIB's framing is explicitly disease-agnostic, NIAID covers infectious and immune-mediated disease, NIAMS covers rheumatic and musculoskeletal disease, and NIDCR covers dental, oral, and craniofacial conditions.

Does any Institute set aside dedicated funding for this topic?

Not guaranteed. NIDCR is the only participating Institute that stated it may give special consideration to meritorious applications in this topic area. NCI, NIAID, NIAMS, and NIBIB made no such statement. Treat the NIDCR statement as a favorable tilt rather than a reserved pool of money.

I already have feasibility data. Do I still need a Phase I?

Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR. A validated delivery platform plus new in vivo immune cell transduction data is a common qualifying profile.

Does this topic align with the Make America Healthy Again initiative?

No. Unlike most NIH Highlighted Topics published in this cycle, this one is not issued under the MAHA initiative and lists no named policy alignments. Applicants should not reference an initiative alignment the topic does not claim.

What registrations do I need, and how long do they take?

SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA Company Registry first, so the sequence matters. Allow at least six weeks, and start before you begin writing.

How BW&CO Helps

BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards.

On this topic the decisive work happens before drafting: resolving the clinical trial determination, selecting among five Institutes with four different clinical trial postures, choosing SBIR versus STTR against your ownership structure and your PI's employment, engaging program officers, and sequencing Phase I, Phase II, CRP, Phase IIB, and private capital into a financing plan that actually reaches the clinic. That work also includes Specific Aims development, full proposal build, budget and fee construction, commercialization planning, and Phase IIB matching capital positioning. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.

If you are developing an in vivo immune cell engineering platform and want a straight answer on which Institute to target, whether your clinical plan is reviewable where you intend to send it, and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.