ARPA-H - SBIR/STTR Broad Agency Announcement (BAA)

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

Executive Summary:

This is the ARPA-H SBIR/STTR Broad Agency Announcement (BAA) for high-impact healthcare technologies across seven topic areas. It uses a two step application process (Solution Summary → Technical Presentation) and supports Phase I, Direct-to-Phase II, and Fast Track awards.

There is strong urgency to prepare early, but note:

• The Solution Summary Due: July 10, 2026 (11:59PM ET)

• The solicitation is currently a draft and not yet accepting applications

Because ARPA-H uses a gated, competitive process with strict technical novelty requirements, companies should begin positioning immediately—especially given topic-specific windows and evolving amendments.

How much funding would I receive?

Funding depends on phase and topic. Typical amounts are:

• Phase I: up to $600,000

• Phase II: up to $3,500,000

Some topics specify:

• ~$600k (Phase I) and $3.5M (Phase II) (Topics 1–4, 7)

• $3.5M (Phase II only) (Topics 5–6)

All awards are issued as Firm-Fixed-Price (FFP) contracts with milestone-based payments

Research Topics:

• ARPA-H 01 - Development of an annual test to inform women about their future fertility

  The purpose of this topic is to discover new biomarkers that provide women with actionable data for fertility planning.  Results from this work will help inform the program manager regarding the feasibility of future programs focused on enhancing natural fertility before the need of IVF and guiding the development of women’s health monitoring and improvement tools. This work will develop a diagnostic test that can assess fertility status and generate an estimated timeline for the onset of infertility. This topic seeks to develop a test that is affordable, suitable for at least annual use, and provides user-friendly results for patients and care teams to support childbearing decisions.   

• ARPA-H 02 - Versatile Bioadhesives

  The purpose of this topic is to develop surgical glues with antimicrobial properties to combat infections due to surgery. In addition, the novel multifunctional surgical glue will also have desired properties such as controllable reversibility and degradability and be tissue/organ agnostic to stop bleeding with unknown sources. Overall, successful completion of this SBIR project will not only support the clinical implementation of bioprinted organs but also provide novel solutions to tackle unmet clinical needs in managing surgical leaks and infections and reduce overall medical costs.   

• ARPA-H 03 - Universal Platform for Living Adaptive Toxin-removal (UNI-PLAT)

  The purpose of this topic area is to catalyze the development of a universal, “plug-and-play” synthetic biology platform that enables next-generation microbial chassis capable of performing a broad array of programmable functions. While this solicitation primarily uses toxin removal as a proof-of-concept in relation to chronic disease management, the platform is intended to be adaptable to a range of challenges across industries such as environmental remediation, biomanufacturing, agriculture, holistic medicine, and therapeutic discovery. The broader goal is to create a stable, reliable, and easily reprogrammable microbial platform that demonstrates potential for cross-sector impact beyond the initial use case. 

• ARPA-H 04 - Breaking Ground: The First Curative, Non-Invasive, Long-Lasting Therapy for Endometriosis

  The purpose of this topic aims to advance progress in the endometriosis field by identifying and commercializing non-invasive therapeutics that address the root cause of the disease. Proposers are expected to develop a first-of-its-kind, non-invasive therapy capable of reducing the size of endometriosis lesions, deactivating endometriosis tissue, and/or preventing regrowth thereby ideally achieving curative outcomes. Additionally, proposers need to showcase a solution that has precise, targeted specificity, ensuring the treatment accurately locates and addresses endometriosis lesions without causing adverse effects elsewhere in the body.

• ARPA-H 05 - ARPA-H Lineage Topic

  The purpose of this topic supports the advancement, commercialization, and translation of technologies that originated from ARPA-H funded efforts. It is intended to help small businesses and startups develop viable products based on these technologies. ARPA-H’s goal is to give small businesses an off-ramp to finish developing their technology/product, explore secondary or interim applications of the technology, and time to achieve self-sufficiency.

• ARPA-H 06 - Rapid Comprehensive Diagnostic Test for Multi-System Autoimmune Disease

  The overall purpose of this topic is to spur the development of novel, rapid diagnostic assays for multi-system autoimmune disease, which represents an unmet healthcare need. Moreover, in its ideal embodiment this diagnostic test might allow typical primary care physicians to diagnose and predict tissue-specific autoimmune disease manifestations, thereby streamlining referral of the patient to a specialist. This goal is made more feasible by recent technological developments incility to detect tissue-specific signatures of immune-mediated stress by assessing circulating cells and/or tissue-specific molecular products.  

• ARPA-H 07 - Virtual Human Brain for the Development of Neurosurgical Robotics

  The overall purpose of this topic aims to take a first step toward AI-assisted intracranial microsurgery, which will ameliorate patient outcomes as described in point 5 above, by creating a high-resolution, physically and anatomically accurate virtual human brain.

Are there any additional benefits I would receive?

Yes. ARPA-H provides hands-on commercialization support, including:

• Entrepreneur-in-Residence (EIR) program (strategic guidance on IP, regulatory, market strategy)

• Regulatory and reimbursement support

• Customer discovery and stakeholder introductions

• I-Corps program participation (optional)

• Potential Technical and Business Assistance (TABA) funding

Support is not guaranteed and is provided at ARPA-H’s discretion

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

Key Dates

• Solution Summary Due: July 10, 2026 (11:59PM ET)

• Technical Presentation (if invited): September 9, 2026 (11:59PM ET)

Process Timeline

• Stage 1: Submit Solution Summary (4–6 pages)

• Stage 2: If invited → Technical Presentation + full materials

• ARPA-H response:

  • ~90 days after topic close for Stage 1 decision

  • ~30 days after presentation for final decision

• Awards targeted within ~180 days of topic closing

Funding Timing

• Payments are quarterly milestone-based, not upfront

Where does this funding come from?

Funding comes from:

• Advanced Research Projects Agency for Health (ARPA-H)

• Under the SBIR/STTR program, authorized by the U.S. Small Business Act

• Within the U.S. Department of Health and Human Services (HHS)

The program is designed to fund transformational health technologies with commercialization potential

Who is eligible to apply?

Core Eligibility

You must be a Small Business Concern (SBC) that:

• Has ≤500 employees

• Is majority U.S.-owned

• Performs work in the United States

SBIR Requirements

• PI >50% employed by small business

• Work share:

  • Phase I: ≥66% by small business

  • Phase II: ≥50% by small business

STTR Requirements

• Must include a research institution partner

• Work share:

  • ≥40% small business

  • ≥30% research institution

Additional Requirements

• SAM.gov registration

• SBA Company Registry

• Foreign affiliation disclosures

• Required certifications at submission

What companies and projects are likely to win?

ARPA-H is explicitly looking for:

• Non-incremental, breakthrough technologies

• Solutions with clear technical novelty and feasibility

• Teams with:

  • Proven ability to execute

  • Commercialization capability

• Projects that:

  • Address major unmet health needs

  • Have a credible path to market and impact

  • Can reach a commercial inflection point

Strong proposals demonstrate:

• Clear technical milestones and risk mitigation

• Evidence-backed claims

• A viable commercialization plan

Incremental or purely academic work is unlikely to be competitive

Are there any restrictions I should know about?

Key restrictions include:

• No incremental R&D—must be transformative

• No Phase III proposals

• Must follow topic-specific eligibility (phase/type)

• Strict foreign affiliation disclosure and national security review

• Funding may be denied for:

  • Security risks

  • Undisclosed foreign relationships

• Proposal cap: max 6 submissions per fiscal year across HHS

Other constraints:

• Must submit through ARPA-H Solutions site only

• No email or paper submissions accepted

How long will it take me to prepare an application?

Typical effort:

• Stage 1 (Solution Summary):

  • 4–6 pages

  • ~1–3 weeks for a prepared team

• Stage 2 (if invited):

  • Full technical package + presentation

  • ~3–6+ weeks

Additional prep time may be required for:

• Registrations (SAM can take >14 business days)

• Certifications and compliance documentation

How can BW&CO help?

BW&CO can support across the full lifecycle:

• Topic selection and win strategy positioning

• Translating your technology into ARPA-H-aligned narratives

• Writing:

  • Solution Summary

  • Technical presentation materials

• Building commercialization strategy aligned to ARPA-H expectations

• Preparing for technical Q&A and evaluation criteria

• Managing compliance and submission requirements

Additional Resources

Review solicitation here.