NIH Highlighted Topic: Advancing Mechanism-driven Translational Research of Beneficial and Detrimental Effect of Psilocybin on Cancer and Other Health Conditions

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 proposals focused on advancing mechanism-driven translational research into both the beneficial and detrimental effects of psilocybin on cancer and other health conditions. This highlighted topic supports rigorous human-relevant studies designed to improve scientific understanding of psilocybin’s biological activity, therapeutic potential, safety profile, and long-term health impacts.

NIH is particularly interested in projects investigating molecular pathways, receptor interactions, biomarkers, pharmacology, neurobiology, and translational models that can inform future clinical trial design and evidence-based human use. Companies developing psychedelic therapeutics, AI-enabled biomarker platforms, digital therapeutics, neuropharmacology technologies, translational drug development systems, computational biology tools, or precision medicine platforms may be strong candidates for funding.

Areas of interest include psilocybin’s effects on cancer therapeutics, pain management, mental health, neuroplasticity, substance use disorders (SUDs), chronic use and microdosing, pharmacokinetics, host genetics, immune modulation, and interactions with standard-of-care therapies. NIH is also encouraging projects focused on novel psilocybin analogs, human-relevant disease models, AI-enabled analytics, and translational research technologies capable of improving therapeutic precision and risk mitigation.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by the National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), and National Institute on Drug Abuse (NIDA), all of which are seeking transformative innovations that improve understanding, safety, therapeutic development, and evidence-based use of psilocybin and related compounds.

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 psychedelic therapeutics, translational research technologies, biomarkers, computational tools, and precision medicine systems related to psilocybin research.

Eligible activities may include:

• Psilocybin therapeutic development and translational drug discovery

• AI and machine learning platforms for psychedelic biomarker analysis

• Neuropharmacology and neuroplasticity research technologies

• Precision medicine and patient stratification systems

• Clinical decision support and dosing optimization platforms

• Human-relevant disease models and translational research systems

• Computational biology and systems pharmacology tools

• Biomarker discovery and predictive analytics technologies

• Pain management and symptom burden intervention platforms

• Substance use disorder (SUD) therapeutic development technologies

• Psilocybin analog, prodrug, and modified compound development

• Pharmacokinetic and safety profiling technologies

• Digital therapeutics and behavioral intervention integration systems

• Immune, tumor, and neurological response analysis platforms

• Cancer symptom management and supportive care technologies

• Longitudinal monitoring systems for chronic use and microdosing studies

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, medicinal chemistry, AI model development, software engineering, cloud infrastructure, clinical trial preparation, bioinformatics analysis, preclinical studies, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable biotechnology or therapeutic solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Enhancing the IMPROVE-funded Maternal Health Centers of Excellence

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 supplemental research proposals that enhance and expand the IMPROVE-funded Maternal Health Research Centers of Excellence and Hubs. This highlighted topic supports projects designed to accelerate research and innovation aimed at reducing maternal morbidity and mortality, particularly in underserved regions and populations with disproportionately poor maternal health outcomes.

The initiative is part of the NIH Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative and seeks to strengthen ongoing maternal health research through expanded geographic reach, collaborative partnerships, and integration of emerging maternal health technologies. NIH is especially interested in projects that expand research into maternity care deserts and regions with high rates of maternal mortality and severe maternal morbidity.

Companies developing maternal health technologies, remote patient monitoring systems, digital health platforms, AI-enabled maternal risk prediction tools, telehealth infrastructure, wearable devices, pregnancy monitoring technologies, clinical analytics systems, or healthcare coordination platforms may be strong candidates for funding.

Areas of interest include maternal mortality prevention, pregnancy-related complication monitoring, rural and underserved healthcare delivery, collaborative maternal health research networks, digital diagnostics, remote monitoring, and integration of technologies developed through the RADx maternal health challenge. NIH is also encouraging scalable technologies and interventions that improve maternal outcomes, access to care, and longitudinal pregnancy health monitoring.

Funding is available through the NIH SBIR/STTR Program and related NIH supplemental funding mechanisms, with opportunities for both translational research and commercialization support depending on project scope and alignment with existing IMPROVE-funded Centers and Hubs.

This highlighted topic is supported primarily by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which is seeking transformative innovations that improve maternal healthcare access, clinical outcomes, and implementation of advanced maternal health technologies.

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, implementation, and commercialization of maternal health technologies, remote monitoring systems, clinical analytics platforms, and healthcare delivery solutions designed to reduce maternal morbidity and mortality.

Eligible activities may include:

• Remote maternal monitoring and wearable pregnancy technologies

• AI and machine learning platforms for maternal risk prediction

• Telehealth systems for prenatal and postpartum care

• Digital diagnostics and point-of-care maternal health technologies

• Healthcare coordination and maternal care navigation platforms

• Expansion of maternal health programs into maternity care deserts

• Pregnancy complication monitoring and early warning systems

• Clinical decision support systems for maternal healthcare providers

• Integration of RADx maternal health technologies into care delivery

• Population health analytics and maternal outcomes tracking systems

• Community-based maternal health intervention technologies

• Longitudinal pregnancy and postpartum monitoring platforms

• Rural maternal healthcare access and infrastructure technologies

• Collaborative maternal health data-sharing and interoperability systems

• Equity-focused maternal health implementation and outreach platforms

• Prototype development, implementation studies, and translational research

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, wearable integration, clinical validation studies, telehealth deployment, healthcare systems integration, community engagement, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable maternal health solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Accelerating Hidradenitis Suppurativa 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 proposals focused on accelerating scientific understanding, diagnostics, predictive tools, and therapeutic development for Hidradenitis Suppurativa (HS). This highlighted topic supports multidisciplinary research designed to better understand the molecular, immunological, genetic, microbial, hormonal, metabolic, and environmental mechanisms driving HS development, progression, and disease flares.

HS is a chronic inflammatory skin disease affecting between 1% and 4% of the population and is associated with significant comorbidities including obesity, metabolic syndrome, hypertension, anxiety, and depression. NIH is particularly interested in projects that improve understanding of HS endotypes, inflammatory pathways, microbiome interactions, immune dysregulation, and environmental triggers while advancing precision diagnostics and targeted treatment strategies.

Companies developing dermatology diagnostics, AI-enabled predictive models, biomarker platforms, wearable health technologies, imaging systems, immunology tools, microbiome analytics, digital health platforms, or novel therapeutic technologies may be strong candidates for funding.

Areas of interest include immune signaling pathways, cytokine dysregulation, microbiome and biofilm interactions, genetic and exposome analysis, predictive analytics, wearable monitoring systems, point-of-care diagnostics, New Approach Methodologies (NAMs), clinical trial readiness platforms, and innovative translational research models. NIH is also encouraging development of common data elements (CDEs), sex-specific analyses, and collaborative research frameworks that improve future clinical trial execution and patient outcomes.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on project scope and translational impact.

This highlighted topic is supported by multiple NIH Institutes and Offices including the Office of Research on Women’s Health (ORWH), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and National Institute of Environmental Health Sciences (NIEHS), all of which are seeking transformative innovations that improve HS diagnosis, treatment, translational research, and patient quality of life.

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 diagnostics, biomarkers, predictive analytics platforms, therapeutics, digital health tools, and translational research technologies related to Hidradenitis Suppurativa (HS).

Eligible activities may include:

• AI and machine learning platforms for HS diagnosis and flare prediction

• Biomarker discovery and precision dermatology technologies

• Point-of-care diagnostics and wearable monitoring systems

• Imaging and digital dermatology assessment platforms

• Immunology and inflammatory pathway research technologies

• Microbiome, biofilm, and exposome analysis systems

• Computational biology and predictive modeling tools

• Genetic and epigenetic analysis platforms for HS research

• Digital health and remote patient monitoring technologies

• New Approach Methodologies (NAMs), organoids, and in vitro disease models

• Therapeutic target identification and translational drug development

• Clinical trial readiness tools and common data element (CDE) development

• Personalized medicine and sex-specific treatment approaches

• Environmental exposure and toxicology research platforms

• Omics analysis and systems biology technologies

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, software engineering, AI model development, cloud infrastructure, bioinformatics analysis, preclinical studies, microbiome research, wearable integration, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable dermatology or biotechnology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Advancing Toward a Cure for Acquired Neuropathy

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 proposals focused on advancing disease-modifying therapies, biomarkers, diagnostics, and clinical outcome measures for acquired neuropathy (AN). This highlighted topic supports multidisciplinary research aimed at improving understanding of neuropathy pathophysiology and accelerating the development of interventions capable of preventing, slowing, or reversing nerve damage associated with inflammatory, autoimmune, diabetic, and cancer-related neuropathies.

NIH is particularly interested in projects targeting major unmet needs in acquired neuropathy research, including biomarker discovery, improved clinical assessment tools, and regenerative or neuroprotective therapeutics. Companies developing neuromodulation technologies, AI-enabled diagnostics, biomarker analytics platforms, regenerative medicine solutions, digital health tools, peripheral nerve therapies, or advanced neurodiagnostic systems may be strong candidates for funding.

Areas of interest include diabetic neuropathy, chemotherapy-induced peripheral neuropathy (CIPN), autoimmune neuropathies, autonomic dysfunction, regenerative medicine, translational disease models, predictive analytics, wearable diagnostics, clinical monitoring systems, and novel therapeutic screening platforms. NIH is also encouraging projects that address disease heterogeneity, sex differences, socioeconomic influences, and personalized approaches to neuropathy treatment and monitoring.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported primarily by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI), and the Office of Research on Women’s Health (ORWH), all of which are seeking transformative innovations that improve acquired neuropathy diagnosis, monitoring, treatment, and patient outcomes.

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 diagnostics, biomarkers, therapeutics, neuromodulation systems, regenerative medicine technologies, and clinical monitoring tools related to acquired neuropathy.

Eligible activities may include:

• Biomarker discovery and predictive analytics platforms for neuropathy detection

• AI and machine learning tools for neuropathy diagnosis and progression monitoring

• Regenerative medicine and neuroprotective therapeutic development

• Neuromodulation and peripheral nerve stimulation technologies

• Clinical outcome measurement and digital assessment systems

• Wearable devices and remote monitoring technologies for neuropathy patients

• Translational animal models and organoid-based neuropathy research systems

• Therapeutics for diabetic neuropathy and autonomic neuropathy

• Chemotherapy-induced peripheral neuropathy (CIPN) prevention and treatment technologies

• Autoimmune neuropathy therapeutic platforms

• Computational biology and bioinformatics tools for neuropathy research

• Personalized medicine approaches for neuropathy management

• Imaging and diagnostic systems for peripheral nerve function assessment

• Drug screening and therapeutic validation platforms

• Pain management and sensory function monitoring technologies

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, software engineering, AI model development, cloud infrastructure, biomarker analysis, preclinical studies, wearable integration, bioinformatics pipelines, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable neurology or biotechnology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Advancing Research into the Cause and Treatment of Rare Skin Diseases

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 proposals focused on advancing the understanding, diagnosis, and treatment of rare skin diseases through multidisciplinary basic, translational, and clinical research. This highlighted topic supports projects aimed at uncovering disease mechanisms, identifying therapeutic targets, improving diagnostics, and accelerating the development of novel treatments for rare dermatological conditions that currently lack effective therapies.

NIH is particularly interested in projects investigating the genetic, molecular, cellular, and environmental factors contributing to rare skin diseases, many of which present in childhood and have limited or no FDA-approved treatment options. Companies developing dermatology therapeutics, gene therapies, AI-enabled diagnostics, biomarker technologies, organoid models, computational biology platforms, precision medicine systems, or regenerative medicine solutions may be strong candidates for funding.

Areas of interest include genetic studies, biomarker discovery, environmental exposure research, disease modeling, organoids and organ-on-chip systems, drug repurposing, gene editing, cell therapies, revertant mosaicism research, and therapeutics targeting shared molecular disease mechanisms across multiple rare skin disorders. NIH is also encouraging projects using New Approach Methodologies (NAMs), computational modeling, and translational platform technologies that can accelerate drug discovery and therapeutic development.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by multiple NIH Institutes and Offices including the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Environmental Health Sciences (NIEHS), and the Office of Research on Women’s Health (ORWH), all of which are seeking transformative innovations that improve rare skin disease diagnosis, therapeutics, translational research, and patient outcomes.

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 therapeutics, diagnostics, computational tools, disease models, and translational research platforms related to rare skin diseases.

Eligible activities may include:

• Gene therapy and gene editing technologies for rare skin diseases

• AI and machine learning platforms for dermatology diagnostics and biomarker discovery

• Cell therapy and regenerative medicine approaches

• Organoid, 3D tissue culture, and organ-on-chip disease modeling systems

• Computational biology and precision medicine platforms

• Biomarker discovery and disease progression monitoring technologies

• Drug repurposing and therapeutic screening systems

• Molecular and cellular pathway analysis tools

• Environmental exposure and exposome research technologies

• Translational platform technologies applicable across multiple rare diseases

• Basket trial infrastructure and shared molecular etiology therapeutic development

• Dermatology imaging and digital pathology systems

• Personalized medicine and genomic diagnostic platforms

• High-throughput drug screening and toxicology testing systems

• Autoimmune-associated skin disease therapeutic technologies

• Revertant mosaicism and disease reversal research platforms

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, software engineering, AI model development, cloud infrastructure, genomic sequencing, bioinformatics analysis, preclinical studies, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable dermatology or biotechnology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Advancing “Science of Science” Research to Understand and Strengthen the Biomedical Research Ecosystem

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 proposals focused on advancing the “science of science” — a growing field dedicated to understanding and strengthening the biomedical research ecosystem. This highlighted topic supports multidisciplinary projects that analyze how scientific discoveries are generated, translated, funded, disseminated, reproduced, commercialized, and sustained across biomedical research systems and institutions.

NIH is particularly interested in projects that improve the efficiency, rigor, reproducibility, collaboration, workforce development, and commercialization outcomes of biomedical research. Companies developing research analytics platforms, AI-enabled scientific evaluation tools, workforce development technologies, collaboration software, data-sharing infrastructure, innovation measurement systems, or translational research optimization platforms may be strong candidates for funding.

Areas of interest include biomedical workforce development, team science, research reproducibility, data standardization, innovation analytics, translational bottleneck analysis, commercialization outcomes, research capacity building, AI and data science adoption, biomedical informatics, scientific collaboration networks, and economic impact assessment of research investments. NIH is also encouraging projects that strengthen underfunded research institutions, expand participation in biomedical research, and improve translational pathways from discovery to patient impact.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and implementation impact.

This highlighted topic is supported by multiple NIH Institutes and Offices including NIGMS, NLM, NIA, NIAID, NIBIB, NIDCR, NIMHD, NEI, ODSS, ORWH, and OBSSR, all of which are seeking scalable innovations that improve the effectiveness, sustainability, rigor, and impact of the biomedical research enterprise.

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 scientific analytics platforms, biomedical workforce technologies, research infrastructure systems, collaboration tools, and translational research optimization solutions.

Eligible activities may include:

• AI and machine learning platforms for research analytics and scientific evaluation

• Research reproducibility and scientific integrity monitoring systems

• Biomedical workforce development and training technologies

• Team science and interdisciplinary collaboration platforms

• Translational research optimization and commercialization analytics

• Data standardization, interoperability, and sharing infrastructure

• Research productivity and innovation measurement tools

• Scientific collaboration network analysis platforms

• Biomedical informatics and research data science technologies

• Economic impact and return-on-investment analysis systems for research funding

• Predictive analytics for scientific innovation and translational success

• Research capacity building technologies for underfunded institutions

• Health disparities and inclusive workforce development solutions

• Scientific publishing, peer review, and research dissemination tools

• AI-enabled tools supporting biomedical informatics and health AI adoption

• Workforce recruitment, retention, and career progression analytics

• Prototype development, translational studies, and implementation research

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, software engineering, cloud computing infrastructure, AI model development, data analytics, implementation research, collaboration systems development, workforce training programs, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable research technology or analytics solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Implementation Science to Optimize HIV Prevention and Treatment

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 proposals focused on implementation science strategies that improve the delivery, adoption, scale-up, and sustainability of HIV prevention and treatment interventions across real-world healthcare and community settings. This highlighted topic supports multidisciplinary projects aimed at closing the gap between proven HIV interventions and their successful implementation in diverse populations and care environments.

NIH is particularly interested in projects that optimize uptake of biomedical HIV prevention and treatment tools, including long-acting therapies, behavioral interventions, telehealth solutions, integrated care delivery models, and evidence-based HIV care practices. Companies developing digital health platforms, AI-enabled care coordination systems, remote monitoring technologies, patient engagement platforms, implementation analytics tools, telehealth infrastructure, or community-based healthcare technologies may be strong candidates for funding.

Areas of interest include HIV prevention implementation, treatment adherence, viral suppression strategies, aging with HIV, HIV and cancer care coordination, substance use disorder interventions, women’s health, rural healthcare delivery, behavioral health integration, healthcare systems optimization, implementation scalability, and community-led intervention models. NIH is also encouraging projects leveraging artificial intelligence, machine learning, natural language processing (NLP), electronic health records, geospatial technologies, and predictive analytics to improve care delivery and public health outcomes.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on project scope and implementation impact.

This highlighted topic is supported by numerous NIH Institutes and Offices including OAR, NIAID, NIMH, NLM, NIDA, NIA, NCI, NINR, ORWH, NIDDK, NIDCR, NIMHD, and others, all of which are seeking scalable innovations that improve HIV prevention, treatment adherence, integrated care delivery, and long-term health outcomes in real-world settings.

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, implementation, and commercialization of HIV prevention technologies, digital health systems, implementation science platforms, and integrated care delivery solutions.

Eligible activities may include:

• Digital health and telehealth platforms for HIV prevention and treatment

• AI and machine learning systems for treatment adherence and care optimization

• Long-acting HIV therapeutic delivery and monitoring technologies

• Remote patient monitoring and wearable health systems

• Clinical decision support and healthcare workflow management platforms

• Community-based HIV prevention and care coordination technologies

• Behavioral health and substance use disorder intervention systems

• HIV implementation science analytics and scalability platforms

• EHR integration, interoperability, and health data exchange tools

• Natural language processing (NLP) and predictive analytics for HIV care

• Patient engagement and viral suppression support technologies

• Women’s health and female-specific HIV prevention technologies

• Rural healthcare delivery and mobile care platforms

• HIV and oncology integrated care coordination systems

• Community-led and multi-sector intervention delivery platforms

• Population health analytics and implementation research infrastructure

• Prototype development, implementation trials, and translational studies

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, clinical implementation research, health systems integration, telehealth deployment, community engagement, data analytics, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare or digital health solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: BRAIN Initiative: Advancing Human Neuroscience and Precision Molecular Therapies for Transformative Treatments

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 proposals focused on advancing human neuroscience and precision molecular therapies through the NIH BRAIN Initiative. This highlighted topic supports multidisciplinary efforts to better understand human neural circuits, develop transformative neurotechnologies, and accelerate the translation of neuroscience discoveries into targeted clinical therapies and next-generation brain-interfacing technologies.

NIH is particularly interested in projects that generate new insights into human brain function, develop technologies for monitoring and modulating neural circuits, and create precision molecular therapies capable of correcting dysfunctional brain activity in neurological and neuropsychiatric disorders. Companies developing neurotechnology devices, brain-computer interfaces (BCIs), neural monitoring systems, optogenetic or chemogenetic therapies, precision neuromodulation platforms, AI-enabled neuroscience technologies, or molecular delivery systems may be strong candidates for funding.

Areas of interest include advanced neural effector technologies, genetic delivery systems, neural circuit mapping, precision neuromodulation, engineered control of neural activity, clinical neurotechnology platforms, early-stage human neuroscience studies, data integration systems, and personalized molecular therapies. NIH is also encouraging projects focused on interoperability, standardization, technology dissemination, and sex-specific neuroscience research to improve translation and adoption of novel therapies.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on project scope and translational impact.

This highlighted topic is supported by multiple NIH Institutes and Centers participating in the BRAIN Initiative, including NINDS, NIMH, NIBIB, NIA, NIDA, NIDCD, NEI, NCCIH, OBSSR, and ORWH, all of which are seeking transformative innovations that advance precision neuroscience, neural circuit therapeutics, and next-generation neurotechnology development.

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 neurotechnology platforms, neural therapeutics, precision molecular therapies, brain-computer interfaces, and neuroscience data systems.

Eligible activities may include:

• Brain-computer interface (BCI) and neural interface technologies

• Neural monitoring and neuromodulation systems

• Optogenetic and chemogenetic therapeutic platforms

• Precision molecular circuit therapy development

• Genetic delivery systems for neurological treatments

• AI and machine learning platforms for neuroscience and neural analytics

• Neurotechnology devices for monitoring and modulating brain activity

• Advanced neural effector and stimulation technologies

• Personalized and sex-specific neurological therapeutic platforms

• Computational neuroscience and neural circuit modeling systems

• Human neuroscience research platforms and translational studies

• Neural data integration, interoperability, and standardization systems

• Wearable and implantable neurotechnology devices

• Clinical neurotechnology testing and validation platforms

• Neuropsychiatric and neurological disorder treatment technologies

• Early-stage human neuroscience and translational research systems

• Prototype development, preclinical validation, and pilot human studies

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, software engineering, cloud computing infrastructure, AI model development, neural device prototyping, clinical validation studies, genetic engineering research, bioinformatics analysis, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable neuroscience or neurotechnology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Advancing Treatment Options using Targeted Degrader Technologies

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 proposals focused on advancing targeted degrader technologies for the treatment of a wide range of diseases, including cancer, neurodegenerative disorders, infectious diseases, ophthalmic diseases, and craniofacial disorders. This highlighted topic supports multidisciplinary efforts to develop next-generation therapeutics capable of selectively degrading disease-associated proteins, RNA, and other pathogenic factors that have historically been difficult to target using traditional drug discovery approaches.

NIH is particularly interested in projects leveraging emerging targeted protein degradation (TPD) platforms such as PROTACs, molecular glues, LYTACs, AbTACs, HyTTDs, RIBOTACs, and antisense-mediated degradation technologies. Companies developing degraders, synthetic biology platforms, computational drug discovery systems, targeted therapeutics, protein engineering technologies, or biomarker discovery tools may be strong candidates for funding.

Areas of interest include selective degradation of toxic proteins, enhancement of proteostasis, degradation of pathogen-associated targets, targeted RNA degradation, druggable target discovery, translational biomarker development, computational modeling of degrader systems, tissue-selective therapeutics, synthetic biology approaches, and novel delivery strategies. NIH is also encouraging projects incorporating organoids, microphysiological systems, AI-enabled drug design, and New Approach Methodologies (NAMs) to improve efficacy, pharmacokinetics, tumor penetration, selectivity, and safety profiles.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by multiple NIH Institutes and Centers including the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Eye Institute (NEI), and National Institute of Dental and Craniofacial Research (NIDCR), all of which are seeking transformative innovations that improve therapeutic targeting, drug development, and treatment outcomes across multiple disease areas.

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 targeted degrader technologies, therapeutic platforms, computational drug discovery systems, and biomarker solutions.

Eligible activities may include:

• PROTAC, LYTAC, AbTAC, HyTTD, and molecular glue therapeutic development

• RNA-targeted degrader technologies such as RIBOTACs

• AI and machine learning platforms for degrader discovery and optimization

• Computational modeling and predictive therapeutic design systems

• Biomarker discovery and translational therapeutic monitoring tools

• Targeted therapeutics for cancer, infectious disease, ophthalmic disease, and neurodegenerative disorders

• Synthetic biology and protein engineering platforms

• High-throughput degrader screening and validation systems

• Drug delivery technologies for tissue-selective and targeted therapeutics

• Organ-on-chip, organoid, and microphysiological disease modeling systems

• Protein aggregation and proteostasis research platforms

• Pharmacokinetic, toxicity, and absorption optimization technologies

• Therapeutics targeting viral, bacterial, fungal, parasitic, or prion-associated disease mechanisms

• Craniofacial and dental therapeutic development technologies

• Novel linker chemistry and drug conjugation systems

• Prototype development, translational studies, and preclinical validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, medicinal chemistry, synthetic biology research, AI model development, cloud computing infrastructure, bioinformatics analysis, preclinical studies, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable biotechnology or therapeutic solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Technology Development for Genomics

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 proposals focused on advancing next-generation genomic technologies, computational genomics, and high-throughput molecular analysis systems that improve understanding of genomic variation, disease mechanisms, and precision medicine. This highlighted topic supports multidisciplinary projects developing transformative experimental and computational approaches for genomics, transcriptomics, epigenomics, metagenomics, synthetic biology, and multiomics research.

NIH is particularly interested in projects that dramatically improve the speed, scalability, resolution, throughput, and affordability of genomic technologies. Companies developing sequencing platforms, AI-enabled bioinformatics systems, functional genomics tools, genome editing technologies, multiomics platforms, spatial genomics systems, synthetic biology technologies, or genomic data integration software may be strong candidates for funding.

Areas of interest include high-throughput sequencing technologies, direct RNA sequencing, epigenomic analysis, chromatin accessibility mapping, genome editing, transcriptome editing, structural variation analysis, massively parallel reporter assays, spatial and temporal genomics, oligonucleotide synthesis, metagenomics, computational genomics, and predictive modeling of genotype-phenotype relationships. NIH is also encouraging scalable data harmonization tools and advanced computational methods capable of integrating diverse omics datasets across multiple biological systems and diseases.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on project scope and translational impact.

This highlighted topic is supported by several NIH Institutes and Centers including the National Human Genome Research Institute (NHGRI), National Library of Medicine (NLM), National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA), and the Office of Research on Women’s Health (ORWH), all of which are seeking transformative innovations that accelerate genomic discovery, precision medicine, disease prediction, and translational biotechnology development.

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 genomic technologies, sequencing systems, computational biology platforms, synthetic biology tools, and multiomics solutions.

Eligible activities may include:

• Next-generation DNA and RNA sequencing technologies

• Direct RNA sequencing and modified base detection systems

• AI and machine learning platforms for genomics and metagenomics

• Functional genomics and genome editing technologies

• Epigenomics, transcriptomics, and chromatin accessibility analysis tools

• Multiomics integration and bioinformatics platforms

• Spatial and temporal genomics technologies

• High-throughput genomic screening and phenotyping systems

• Predictive modeling of genotype-phenotype relationships

• Synthetic biology and oligonucleotide synthesis technologies

• Computational genomics and genomic epidemiology platforms

• Cancer genomics and biomarker discovery systems

• Infectious disease genomics and pathogen surveillance tools

• Gene therapy development and addiction genomics research technologies

• Data harmonization, interoperability, and scalable genomics infrastructure

• Massively parallel reporter assays and functional variant characterization systems

• Prototype development, translational research, and validation studies

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, sequencing infrastructure, AI model development, software engineering, cloud computing, computational biology research, bioinformatics pipelines, high-throughput assay development, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable genomics or biotechnology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Multidisciplinary Studies of HIV/AIDS and Aging

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 proposals focused on understanding the complex intersection of HIV/AIDS and aging, with the goal of improving prevention, diagnosis, treatment, long-term care, and quality of life for older adults living with HIV. This highlighted topic supports multidisciplinary research examining the biological, clinical, behavioral, social, and healthcare system factors influencing aging in people with HIV (PWH).

More than half of adults living with HIV in the United States are now over the age of 50, largely due to the success of antiretroviral therapy (ART). However, evidence suggests that HIV and long-term treatment exposure may accelerate aging processes and contribute to increased risk for cardiovascular disease, cancer, neurocognitive disorders, osteoporosis, metabolic disease, frailty, substance use disorders, and mental health conditions. NIH is particularly interested in projects that improve understanding of these interactions and develop evidence-based interventions to address aging-related HIV comorbidities.

Companies developing digital health platforms, remote patient monitoring systems, AI-enabled healthcare analytics, biomarker technologies, behavioral health interventions, care coordination systems, diagnostics, community-based care models, or precision medicine platforms may be strong candidates for funding.

Areas of interest include HIV-associated aging biomarkers, neurocognitive health, cancer risk, cardiovascular disease, substance use disorders, alcohol misuse, women’s health, social isolation, polypharmacy management, health disparities, implementation science, and community-centered interventions for aging populations living with HIV.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on project scope and translational impact.

This highlighted topic is supported by numerous NIH Institutes and Offices including NIA, NIAID, NCI, NHLBI, NIDA, NIMH, NIDDK, NINR, ORWH, OAR, and others, all of which are seeking scalable innovations that improve health outcomes, healthcare delivery, prevention, and quality of life for older adults aging with HIV.

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 healthcare technologies, diagnostics, digital health platforms, behavioral health tools, biomarkers, and intervention systems related to HIV/AIDS and aging.

Eligible activities may include:

• AI and machine learning platforms for HIV-related aging risk prediction

• Digital health and remote monitoring systems for older adults with HIV

• Biomarker discovery and aging-related diagnostic technologies

• Neurocognitive assessment and mental health intervention platforms

• Cardiovascular, metabolic, and frailty monitoring technologies

• Substance use disorder and alcohol misuse intervention systems

• Community-based and home-based HIV care coordination platforms

• Precision medicine and personalized treatment management tools

• Polypharmacy management and medication adherence technologies

• HIV survivorship and quality-of-life monitoring systems

• Women’s health technologies related to HIV and menopause

• Behavioral health and social isolation intervention platforms

• Healthcare implementation science and integrated care delivery tools

• Predictive analytics for comorbidities and chronic disease management

• Wearable sensors and longitudinal patient monitoring systems

• HIV-associated cancer risk and survivorship technologies

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, clinical data analysis, implementation research, wearable integration, biomarker testing, community engagement, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare or biotechnology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Advancing Nanotechnology Research to Improve Diagnosis and Treatment Options

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 proposals focused on advancing nanotechnology approaches to improve disease diagnosis, monitoring, drug delivery, and therapeutic development, with a particular emphasis on extracellular vesicles (EVs). This highlighted topic supports multidisciplinary research integrating nanotechnology, bioengineering, computational biology, AI, and advanced molecular analysis to accelerate the development of next-generation diagnostic and therapeutic platforms.

NIH is particularly interested in projects leveraging EVs and other nanoparticle technologies for early disease detection, biomarker discovery, targeted drug delivery, regenerative medicine, and precision therapeutics. Companies developing nanomedicine platforms, liquid biopsy technologies, engineered extracellular vesicles, targeted delivery systems, AI-enabled biomarker analytics, or advanced diagnostic tools may be strong candidates for funding.

Areas of interest include EV biogenesis and cargo analysis, multimodal biomarker discovery, nanoparticle-based diagnostics, engineered EV therapeutics, targeted drug delivery systems, cancer detection technologies, ophthalmic nanomedicine, regenerative therapeutics, digital flow cytometry, system-omics analysis, and computational modeling of nanoparticle behavior. NIH is also encouraging projects incorporating artificial intelligence, high-throughput assays, organoids, and New Approach Methodologies (NAMs) to better understand EV mechanisms and disease applications.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported primarily by the National Eye Institute (NEI) and the National Cancer Institute (NCI), both of which are seeking transformative nanotechnology innovations that improve diagnostics, disease monitoring, therapeutic delivery, and patient outcomes across cancer and ophthalmic diseases.

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 nanotechnology platforms, extracellular vesicle technologies, diagnostics, biomarker systems, and targeted therapeutic delivery solutions.

Eligible activities may include:

• Extracellular vesicle (EV) engineering and therapeutic platforms

• Nanoparticle-based diagnostics and liquid biopsy technologies

• AI and machine learning tools for biomarker discovery and analysis

• Targeted drug delivery systems and controlled-release therapeutics

• Cancer detection, monitoring, and prognosis platforms

• Ophthalmic nanomedicine and regenerative therapeutic technologies

• EV cargo characterization and multimodal omics analysis systems

• High-throughput screening and digital flow cytometry technologies

• Computational modeling and simulation of nanoparticle behavior

• Stem cell-derived EV therapeutics and regenerative medicine platforms

• Precision medicine and personalized therapeutic delivery systems

• Organ-on-chip, organoid, and microphysiological research systems

• Biomarker validation and treatment response monitoring technologies

• Anti-inflammatory and neuroprotective therapeutic delivery platforms

• Nanomaterials and bioengineered delivery vehicle development

• Prototype development, translational studies, and validation research

• Commercialization planning, regulatory preparation, and manufacturing scale-up activities

Funding may also support personnel, laboratory testing, nanomaterial fabrication, AI model development, software engineering, cloud computing infrastructure, bioinformatics analysis, preclinical studies, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable nanotechnology or biotechnology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Understanding and Combating Chronic Disease Burden: The Role of Trauma

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 proposals focused on understanding how trauma exposure contributes to chronic disease burden and identifying evidence-based strategies to prevent long-term physical and mental health outcomes associated with traumatic experiences. This highlighted topic supports multidisciplinary research exploring the biological, neurobiological, behavioral, cognitive, and social mechanisms linking trauma exposure to chronic disease development across the lifespan.

NIH is particularly interested in projects examining how trauma exposure increases risk for conditions such as PTSD, depression, cardiovascular disease, metabolic syndrome, diabetes, substance use disorders, and alcohol misuse. Companies developing behavioral health technologies, digital therapeutics, predictive analytics platforms, trauma assessment tools, AI-enabled healthcare solutions, remote monitoring systems, or personalized intervention platforms may be strong candidates for funding.

Areas of interest include trauma risk stratification, resilience and recovery modeling, longitudinal health monitoring, prevention and intervention strategies, substance use and alcohol misuse research, trauma-informed healthcare evaluation, health disparities research, women’s health, and translational behavioral health technologies. NIH is also encouraging rigorous scientific evaluation of commonly adopted trauma-related care approaches to determine effectiveness and long-term impact on health outcomes.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional follow-on funding and commercialization support depending on the project’s scope and translational potential.

This highlighted topic is supported by multiple NIH Institutes and Offices including the National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Aging (NIA), Office of Research on Women’s Health (ORWH), Office of Disease Prevention (ODP), and National Institute on Minority Health and Health Disparities (NIMHD), all of which are seeking scalable innovations that improve prevention, diagnosis, intervention, and long-term health outcomes for trauma-exposed populations.

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 behavioral health technologies, digital therapeutics, predictive analytics platforms, trauma assessment tools, and intervention systems related to trauma exposure and chronic disease prevention.

Eligible activities may include:

• AI and machine learning platforms for trauma risk prediction

• Digital mental health and behavioral health intervention technologies

• Trauma assessment, screening, and monitoring tools

• Predictive analytics systems for chronic disease risk after trauma exposure

• Remote patient monitoring and wearable health technologies

• PTSD, depression, and substance use disorder intervention platforms

• Alcohol misuse prevention and recovery support technologies

• Resilience and recovery modeling systems

• Personalized behavioral health and prevention solutions

• Trauma-informed care evaluation and effectiveness research tools

• Longitudinal health tracking and population health analytics platforms

• Women’s health technologies addressing trauma-related chronic disease risk

• Health disparities and community-based intervention technologies

• Neurobiological and biomarker research platforms

• Digital therapeutics supporting trauma recovery and prevention

• Healthcare coordination and support systems for trauma-exposed populations

• Prototype development, validation studies, and translational research

• Commercialization planning, regulatory preparation, and implementation activities

Funding may also support personnel, software development, cloud infrastructure, AI model development, clinical validation studies, behavioral research, wearable sensor integration, data analytics, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare or behavioral health solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: BRAIN Initiative: Data Knowledgebase Ecosystem and NeuroAI Integration

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 proposals focused on advancing the BRAIN Initiative through the development of interconnected neuroscience data ecosystems, AI-enabled knowledgebases, and transformative NeuroAI technologies. This highlighted topic supports multidisciplinary efforts integrating neuroscience, artificial intelligence, computational modeling, neuromorphic computing, brain mapping, and large-scale data infrastructure to accelerate understanding of the human brain and improve human health outcomes.

NIH is particularly interested in projects that create federated neuroscience data commons, standardized brain mapping frameworks, neural connectivity atlases, cross-species ontologies, synchronized neural-behavioral datasets, and AI-powered discovery platforms. Companies developing NeuroAI systems, brain data infrastructure, neuromorphic computing technologies, computational neuroscience platforms, knowledge graphs, neural analytics tools, or advanced neuroscience software may be strong candidates for funding.

Areas of interest include interpretable AI models for neuroscience, energy-efficient neuromorphic platforms, brain-body systems modeling, real-time neural processing systems, predictive neuroscience analytics, cross-modal data integration, knowledge graph development, open-source neuroscience infrastructure, and computational tools that improve reproducibility and transparency in neuroscience research. NIH is also encouraging technologies that support bidirectional learning between biological neuroscience and brain-inspired computing architectures.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.

This highlighted topic is supported by multiple NIH Institutes and Centers participating in the NIH BRAIN Initiative, including NINDS, NIMH, NIBIB, NIA, NIDA, NIDCD, NCCIH, NEI, and ORWH, all of which are seeking transformative innovations that advance NeuroAI, computational neuroscience, brain mapping, and next-generation neurotechnology development.

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 NeuroAI platforms, neuroscience data ecosystems, computational tools, brain mapping technologies, and neuromorphic computing systems.

Eligible activities may include:

• AI and machine learning platforms for neuroscience research

• Federated neuroscience data commons and knowledgebase infrastructure

• Brain mapping and neural connectivity atlas technologies

• Cross-species neuroscience ontology and data integration systems

• Knowledge graph development for neuroscience applications

• Computational neuroscience and predictive brain modeling platforms

• Neuromorphic computing and brain-inspired hardware systems

• Real-time neural processing and adaptive monitoring technologies

• Brain-behavior data synchronization and analytics platforms

• Open-source neuroscience software and analytical tools

• Cross-modal neuroscience data integration systems

• Interpretable AI models for mechanistic neuroscience discovery

• Brain-body systems modeling and embodied intelligence research

• Neurotechnology platforms supporting health monitoring applications

• High-performance computing infrastructure for neuroscience data analysis

• Reproducibility and transparency tools for neuroscience research

• Prototype development, translational research, and validation studies

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, software engineering, cloud computing infrastructure, AI model development, data architecture, computational biology research, neuroscience validation studies, bioinformatics pipelines, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable NeuroAI or neuroscience technology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Research on Rare Cancers Across the Cancer Control Continuum

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 proposals focused on advancing prevention, diagnosis, treatment, survivorship, symptom management, and healthcare delivery for rare cancers across the cancer control continuum. This highlighted topic supports multidisciplinary research designed to improve outcomes, reduce disparities, and address major knowledge gaps affecting patients diagnosed with rare cancers.

NIH defines a rare cancer as one with an incidence rate of fewer than 15 cases per 100,000 individuals annually. Although individually uncommon, rare cancers collectively account for approximately 25% of all adult cancer diagnoses and all pediatric cancers in the United States. NIH is particularly interested in projects addressing the unique challenges associated with rare cancers, including delayed diagnosis, limited treatment options, fragmented care delivery, insufficient survivorship research, and disparities in patient outcomes.

Companies developing oncology diagnostics, AI-enabled cancer detection tools, digital health platforms, survivorship technologies, patient monitoring systems, healthcare analytics platforms, clinical decision support software, symptom management solutions, precision medicine tools, or population health technologies may be strong candidates for funding.

Areas of interest include cancer surveillance, behavioral and psychosocial research, healthcare delivery optimization, implementation science, translational prevention research, symptom management interventions, survivorship support, precision prevention, and population-level cancer outcome studies. NIH is also encouraging scalable technologies and evidence-based interventions that improve quality of life and long-term outcomes for patients with rare cancers.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on the project’s impact and translational potential.

This highlighted topic is supported primarily by the National Cancer Institute (NCI) and the National Institute of Dental and Craniofacial Research (NIDCR), both of which are seeking innovative solutions that improve rare cancer prevention, detection, treatment, survivorship, and healthcare delivery.

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 technologies, diagnostics, digital health platforms, analytics systems, and care solutions related to rare cancers.

Eligible activities may include:

• AI and machine learning platforms for rare cancer diagnosis and detection

• Precision oncology and biomarker discovery technologies

• Cancer surveillance and population health analytics systems

• Digital health platforms for survivorship and symptom management

• Patient monitoring and remote care coordination technologies

• Clinical decision support systems for oncology care

• Behavioral health and psychosocial support tools for cancer patients

• Precision prevention and early detection technologies

• Healthcare delivery optimization and interoperability platforms

• Real-world evidence and longitudinal cancer outcomes research tools

• Patient-reported outcome monitoring systems

• Translational and implementation science technologies

• Oncology workflow and care navigation platforms

• Symptom management interventions and supportive care technologies

• Rare cancer registry and data integration systems

• Community-based and home-based oncology support platforms

• Prototype development, pilot studies, and validation research

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, software development, cloud infrastructure, clinical data analysis, healthcare analytics, AI model development, implementation research, patient engagement studies, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare or oncology technology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Optimal Interprofessional Teaming and Care Coordination Strategies for Cancer Care Quality and Outcomes

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 proposals focused on improving interprofessional teamwork, care coordination, and collaborative healthcare delivery across the cancer care continuum. This highlighted topic supports research designed to improve cancer screening, diagnosis, treatment, survivorship, and patient outcomes through more effective coordination between healthcare professionals, care settings, and health systems.

NIH is particularly interested in projects that examine the behavioral, cognitive, technological, and organizational factors that influence effective interprofessional cancer care teams. Companies developing healthcare coordination platforms, oncology workflow systems, telehealth solutions, care navigation software, patient engagement tools, interoperability technologies, virtual tumor board platforms, AI-enabled clinical coordination systems, or health services analytics tools may be strong candidates for funding.

Areas of interest include team-based care coordination, health information technology integration, cancer care workflow optimization, patient-reported outcome monitoring, multidisciplinary oncology collaboration, longitudinal care management, healthcare operations analytics, telehealth-enabled cancer care, and interventions designed to improve care quality and patient outcomes across fragmented healthcare systems.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on project scope and translational impact.

This highlighted topic is supported primarily by the National Cancer Institute (NCI), the National Institute of Dental and Craniofacial Research (NIDCR), and the Office of Disease Prevention (ODP), all of which are seeking scalable innovations that improve cancer care coordination, interdisciplinary collaboration, healthcare quality, and patient outcomes.

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 healthcare coordination technologies, oncology workflow systems, digital health platforms, clinical decision support tools, and team-based cancer care solutions.

Eligible activities may include:

• Oncology care coordination and workflow management platforms

• AI-enabled healthcare operations and team collaboration tools

• Virtual tumor board and multidisciplinary care technologies

• Telehealth and remote oncology coordination systems

• Clinical decision support software for cancer care teams

• Patient navigation and care management platforms

• Health information exchange and interoperability technologies

• Patient-reported outcome monitoring systems

• Healthcare analytics and cancer care quality measurement tools

• Digital platforms supporting longitudinal cancer care management

• Workflow optimization technologies for cancer screening and treatment

• Communication tools connecting inpatient, outpatient, and community care settings

• Coordinated dental and oncologic care solutions for head and neck cancers

• Organizational and behavioral analytics tools for healthcare teams

• Cancer survivorship and post-treatment coordination platforms

• Community-based and home-based cancer care technologies

• Prototype development, pilot testing, and implementation studies

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, software development, cloud infrastructure, health data integration, clinical validation studies, implementation research, interoperability development, AI model training, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare or digital health solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Advancing Autoimmune Disease Research: Integrating Genetic, Environmental, and Immunological Factors to Improve Diagnosis and Treatment

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 proposals focused on advancing autoimmune disease research through the integration of genetic, environmental, immunological, computational, and clinical approaches. This highlighted topic supports multidisciplinary projects designed to improve understanding of autoimmune disease development, progression, diagnosis, monitoring, and treatment across a wide range of conditions affecting millions of individuals in the United States.

NIH is particularly interested in projects investigating the interplay between genetics, the immunome, and the exposome—the cumulative environmental exposures experienced throughout life—to better understand autoimmune disease risk, prodromal stages, disease flares, and co-occurring autoimmune conditions. Companies developing AI-enabled diagnostics, predictive analytics platforms, digital health technologies, wearable sensors, bioinformatics tools, imaging systems, computational biology platforms, or novel biomarkers may be strong candidates for funding.

Areas of interest include point-of-care diagnostics, multimodal data integration, machine learning and AI for autoimmune disease prediction, longitudinal cohort analysis, wearable monitoring systems, imaging technologies, computational immunology, exposomics, precision medicine, and New Approach Methodologies (NAMs) for disease modeling. NIH is also encouraging projects addressing women’s health, aging, cancer immunology, neurological autoimmune disorders, health disparities, pediatric autoimmune conditions, and organ-specific autoimmune diseases.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on project scope and translational impact.

This highlighted topic is supported by numerous NIH Institutes and Centers including ORWH, NIAID, NIBIB, NHGRI, NINDS, NCI, NIDDK, NIEHS, NIMH, NLM, and others, all of which are seeking transformative innovations that improve autoimmune disease diagnosis, prediction, monitoring, treatment, and patient outcomes.

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 diagnostics, computational platforms, digital health technologies, biomarkers, imaging systems, and therapeutic tools related to autoimmune diseases.

Eligible activities may include:

• AI and machine learning platforms for autoimmune disease prediction and diagnosis

• Biomarker discovery and precision diagnostics for autoimmune conditions

• Wearable sensors and remote monitoring technologies

• Point-of-care testing and mobile diagnostic platforms

• Computational biology and exposome analysis tools

• Multi-omics data integration and bioinformatics systems

• Imaging technologies for autoimmune disease monitoring

• Predictive analytics platforms for disease progression and flare detection

• Digital twins and computational disease modeling systems

• New Approach Methodologies (NAMs) for autoimmune disease research

• Clinical decision support tools and longitudinal patient monitoring platforms

• Technologies supporting women’s autoimmune health and sex-specific disease research

• Cancer immunology and autoimmune interaction research platforms

• Neuroimmune and neurological autoimmune disorder research technologies

• Pediatric and reproductive autoimmune health solutions

• AI-driven health disparities and population health analytics

• Data interoperability frameworks and collaborative research platforms

• Prototype development, translational research, and validation studies

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, software development, cloud infrastructure, laboratory testing, clinical data analysis, bioinformatics pipelines, imaging analytics, AI model development, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare or biotechnology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Drug Discovery for Nervous System Disorders

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 proposals focused on accelerating drug discovery for nervous system disorders through novel therapeutics, advanced screening technologies, computational modeling, and AI-enabled drug development approaches. This highlighted topic supports projects aimed at discovering and optimizing small molecules, biologics, and therapeutic platforms targeting the underlying molecular and cellular mechanisms of neurological and neuropsychiatric diseases.

NIH is particularly interested in projects targeting neuronal dysfunction, neuroinflammation, synaptic plasticity, neural connectivity, protein aggregation, neurotransmitter systems, ion channels, neural-glial communication, oxidative stress, and other biological mechanisms associated with nervous system disorders. Companies developing AI-powered drug discovery platforms, neurotherapeutics, computational biology tools, medicinal chemistry technologies, biologics, or advanced CNS delivery systems may be strong candidates for funding.

Areas of interest include high-throughput screening systems, virtual screening, machine learning-assisted lead optimization, medicinal chemistry, naturally derived therapeutic compounds, DMPK and toxicity studies, preclinical efficacy validation, and novel brain-targeted delivery technologies. NIH is also encouraging projects focused on Alzheimer’s disease, dementia, substance use disorders, mental health conditions, neurodevelopmental disorders, and visual system diseases.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on project scope and translational impact.

This highlighted topic is supported by several NIH Institutes including the National Institute on Aging (NIA), National Eye Institute (NEI), National Institute on Drug Abuse (NIDA), and National Institute of Mental Health (NIMH), all of which are seeking transformative innovations that improve therapeutic discovery and treatment outcomes for nervous system disorders.

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 therapeutics, drug discovery technologies, computational platforms, biologics, and neurotechnology solutions related to nervous system disorders.

Eligible activities may include:

• AI and machine learning platforms for CNS drug discovery

• High-throughput and virtual compound screening technologies

• Medicinal chemistry and lead optimization research

• Development of biologics and small molecule therapeutics

• Computational biology and molecular modeling systems

• Drug-target interaction and protein aggregation analysis tools

• Preclinical efficacy studies and disease model validation

• DMPK, pharmacokinetic, and toxicity assessment technologies

• Novel brain-targeted drug delivery systems

• Therapeutics for Alzheimer’s disease and dementia

• Neuropsychiatric and mental health therapeutic development

• Substance use disorder and addiction treatment platforms

• Ophthalmic and visual system therapeutic technologies

• Neural-glial communication and synaptic plasticity research tools

• Biomarker discovery and translational neuroscience platforms

• Natural product discovery and characterization systems

• Prototype development, validation studies, and translational research

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, laboratory testing, medicinal chemistry, AI model development, cloud computing infrastructure, software development, preclinical studies, bioinformatics, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable therapeutic or biotechnology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Novel Targets, Methods, and Pharmacological Approaches to Treat Substance Use Disorder

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 proposals focused on discovering novel therapeutic targets, pharmacological approaches, and advanced drug discovery methods for the treatment and prevention of substance use disorders (SUDs). This highlighted topic supports multidisciplinary efforts integrating molecular biology, computational modeling, artificial intelligence (AI), machine learning (ML), multi-omics analysis, and advanced screening technologies to accelerate the development of next-generation SUD therapies.

NIH is particularly interested in projects leveraging cutting-edge technologies such as single-cell and spatial transcriptomics, proteomics, virtual screening, generative AI, computational drug discovery, molecular simulations, DNA-encoded libraries, PROTACs, molecular glues, and big data analytics to identify and validate novel disease-relevant targets. Companies developing AI-enabled drug discovery platforms, computational biology tools, pharmacology technologies, precision medicine systems, or advanced therapeutic development platforms may be strong candidates for funding.

Areas of interest include target identification and validation, lead compound optimization, predictive pharmacokinetic modeling, drug repurposing, protein-ligand interaction analysis, treatment approaches for polysubstance use, and therapeutics addressing SUD comorbidities such as HIV, chronic pain, and neuropsychiatric disorders. NIH is also encouraging research focused on sex-specific molecular profiling and treatment responses in women.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on the project’s scope and translational potential.

This highlighted topic is supported primarily by the National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the Office of Research on Women’s Health (ORWH), all of which are seeking transformative innovations that improve the prevention, diagnosis, and treatment of substance use disorders and alcohol use disorder (AUD).

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 therapeutic platforms, computational drug discovery technologies, pharmacological tools, and precision medicine solutions related to substance use disorders (SUDs) and alcohol use disorder (AUD).

Eligible activities may include:

• AI and machine learning platforms for drug discovery and target identification

• Computational biology and multi-omics analysis tools

• Single-cell and spatial transcriptomics technologies

• Proteomics and molecular profiling platforms

• Virtual screening systems for ultra-large compound libraries

• DNA-encoded library screening technologies

• PROTACs, molecular glues, and induced-proximity therapeutic platforms

• Drug repurposing and predictive pharmacology systems

• Protein-ligand interaction modeling and molecular dynamics simulations

• Precision medicine approaches for SUD and AUD treatment

• Technologies addressing polysubstance use and co-occurring disorders

• Predictive ADME, pharmacokinetic, and drug-drug interaction modeling tools

• AI-enabled therapeutic design and lead optimization systems

• Biomarker discovery and molecular target validation platforms

• Neuropsychiatric and addiction-focused therapeutic development

• Sex-specific treatment response and women’s health research technologies

• Prototype development, preclinical validation, and translational research

• Commercialization planning, regulatory preparation, and scale-up activities

Funding may also support personnel, laboratory testing, cloud computing infrastructure, software development, computational modeling, medicinal chemistry, preclinical studies, data acquisition, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable therapeutic or health technology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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: Computational Approaches in Fundamental Neuroscience

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 proposals that integrate computational approaches into fundamental neuroscience research to better understand the molecular, cellular, and circuit-level mechanisms underlying brain function, aging, neurological disease, and mental health. This highlighted topic supports rigorous, hypothesis-driven multidisciplinary research combining advanced computational modeling, artificial intelligence (AI), machine learning (ML), and high-resolution experimental neuroscience techniques.

NIH is particularly interested in projects that model complex spatiotemporal interactions between receptors, ion channels, enzymes, signaling pathways, neurons, glia, and neural circuits across biological scales. Companies developing AI-enabled neuroscience platforms, computational biology software, neural simulation systems, neuroinformatics tools, predictive drug discovery technologies, or open-source analytical platforms may be strong candidates for funding.

Areas of interest include computational neuroscience, multiscale biological modeling, synaptic plasticity analysis, protein structure-function prediction, neural circuit mapping, brain aging research, Alzheimer’s disease modeling, neuropharmacology, substance use disorder research, and computational therapeutics development. NIH is also encouraging the development of advanced open-source tools and interdisciplinary collaborations between computational scientists and experimental neuroscientists.

Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for follow-on funding and commercialization support depending on the project scope and impact.

This highlighted topic is supported by multiple NIH Institutes and Centers including the National Institute of Mental Health (NIMH), National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA), National Center for Complementary and Integrative Health (NCCIH), National Eye Institute (NEI), and the Office of Research on Women’s Health (ORWH), all of which are seeking transformative innovations that advance computational neuroscience, AI-enabled therapeutics, and mechanistic brain research.

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 computational neuroscience technologies, AI platforms, analytical software, predictive models, and neuroinformatics tools.

Eligible activities may include:

• AI and machine learning platforms for neuroscience research

• Computational modeling of neural circuits and cellular processes

• Protein structure-function prediction and molecular pathway analysis

• Neural simulation and multiscale biological modeling systems

• Predictive analytics for neurological disease progression

• Computational drug discovery and virtual compound screening

• Neuroinformatics and large-scale brain data integration platforms

• Synaptic transmission and plasticity modeling technologies

• Brain aging and Alzheimer’s disease computational research tools

• Substance use disorder (SUD) predictive modeling and therapeutic discovery

• Advanced imaging analytics and neural signal processing platforms

• Open-source neuroscience analytical tool development

• Multimodal data integration systems across spatial and temporal scales

• AI-enabled pharmacokinetic, ADME, and drug interaction prediction tools

• Precision neuroscience platforms supporting diagnostics and therapeutics

• Experimental-computational integrated neuroscience research systems

• Prototype development, validation studies, and translational research

• Commercialization planning and regulatory preparation activities

Funding may also support personnel, cloud computing infrastructure, software engineering, AI model development, computational biology research, laboratory validation studies, data acquisition, bioinformatics pipelines, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable neuroscience or health technology solution 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. 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 employees including affiliates.

• Are > 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 or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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 120–200 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 50–80%, 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.