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.

NIH Highlighted Topic: Developing and Evaluating Evidence-Based Practice for Users of Augmentative and Alternative Communication (AAC)

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 focused on improving evidence-based practices and measurement tools for users of augmentative and alternative communication (AAC). This highlighted topic aims to advance technologies, assessments, interventions, and clinical strategies that improve communication outcomes, accessibility, literacy, quality of life, and long-term support for individuals who cannot rely on spoken language as their primary means of communication.

More than 5 million individuals in the United States with developmental, acquired, or degenerative communication disorders—including cerebral palsy, amyotrophic lateral sclerosis (ALS), and minimally verbal or non-speaking autistic individuals—may benefit from AAC technologies and communication systems. NIH is particularly interested in projects that use community-engaged research and user-centered design approaches to develop more personalized, adaptive, and effective AAC solutions.

Areas of interest include communication outcome measurement tools, AI-enabled AAC systems, speech-generating devices, literacy support technologies, communication partner training, clinical implementation strategies, and tools that help tailor AAC systems to an individual’s evolving needs across their lifespan. Projects leveraging mixed methods research, predictive analytics, digital health technologies, and precision assessment frameworks are highly encouraged.

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 impact and scalability.

This highlighted topic is supported primarily by the National Institute on Deafness and Other Communication Disorders (NIDCD) and the Office of Research on Women’s Health (ORWH), both of which are seeking innovative technologies and evidence-based interventions that improve communication accessibility, patient outcomes, and quality of life for AAC users.

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, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC 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: Supporting Research Using the Resources from the Osteoarthritis Initiative (OAI)

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 leverage the Osteoarthritis Initiative (OAI) database, clinical datasets, biospecimens, and imaging resources to advance osteoarthritis (OA) research and translational healthcare innovation. This highlighted topic is designed to expand the use of the OAI resource across the broader scientific and technology community, particularly through multidisciplinary and data-driven research approaches.

NIH is particularly interested in projects focused on novel analyses of osteoarthritis epidemiology and disease progression, integration of imaging and clinical data, biomarker discovery, predictive modeling, and the application of AI, machine learning, and advanced data science techniques to musculoskeletal health. Companies developing digital health platforms, AI-enabled diagnostics, medical imaging analytics, predictive healthcare software, biomarkers, wearable health technologies, or data integration tools may be strong candidates for funding.

Areas of interest include automated MRI and X-ray analysis tools, multimodal predictive modeling, disease trajectory analysis, biospecimen analytics, intervention effectiveness modeling, and real-world evidence studies using electronic health records (EHRs). NIH is also encouraging research addressing women’s musculoskeletal health, osteoarthritis progression during menopause, and sex-linked OA risk factors.

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 and commercialization funding depending on project scope and impact.

This highlighted topic is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute on Aging (NIA), and the Office of Research on Women’s Health (ORWH), all of which are seeking high-impact innovations that improve osteoarthritis diagnosis, monitoring, prevention, treatment, and long-term 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 technologies, software platforms, diagnostics, and data-driven solutions related to osteoarthritis research and musculoskeletal health.

Eligible activities may include:

• AI and machine learning tools for osteoarthritis diagnosis and prediction

• Automated MRI and X-ray image analysis platforms

• Predictive analytics for OA progression and intervention outcomes

• Biomarker discovery and biospecimen analysis technologies

• Multimodal data integration platforms combining imaging, genetics, and clinical data

• Computational modeling of osteoarthritis disease progression

• Real-world evidence platforms leveraging EHR and longitudinal patient data

• Clinical decision support software for musculoskeletal disorders

• Digital health and remote patient monitoring technologies

• Wearable devices for mobility, gait, and musculoskeletal tracking

• Data science tools for population health and epidemiological analysis

• Women’s health technologies focused on OA risk and resilience factors

• Research platforms supporting longitudinal cohort analysis

• Advanced statistical and bioinformatics tools for musculoskeletal research

• Translational studies supporting diagnostics and therapeutic discovery

• Prototype development, validation studies, and regulatory preparation

• Commercialization planning and market validation activities

Funding may also support personnel, clinical data analysis, cloud infrastructure, software development, imaging analytics, laboratory testing, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a commercially viable healthcare or medtech 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: Fundamental Science Research on the Neural Circuits Underlying Sensory Processing

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 seeking innovative research proposals through the SBIR Program focused on advancing mechanistic understanding of neural circuits underlying sensory processing. NIH is particularly interested in multidisciplinary technologies and research platforms capable of recording, analyzing, and modulating neural circuit activity at cellular and sub-second temporal resolution.

This highlighted topic encourages cutting-edge neuroscience research integrating advanced methodologies such as electrophysiology, optical imaging, optogenetics, chemogenetics, sonogenetics, magnetogenetics, pharmacologic modulation, computational modeling, and statistical analysis to better understand how sensory information is processed across neural systems. Companies developing neurotechnology platforms, brain imaging systems, biosensors, AI-enabled neuroscience tools, neural modulation technologies, computational neuroscience software, or advanced neural recording systems may be strong candidates for funding.

NIH is especially interested in projects involving interdisciplinary collaborations across biological sciences, engineering, computational biology, chemistry, physics, and bioethics. Mechanistic human studies, comparative cross-species models, and translational neuroscience approaches are strongly encouraged. Research focused on hearing, balance, taste, smell, vision, and sensory-system neural processing is of particular interest.

Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.

This highlighted topic is supported primarily by the National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Eye Institute (NEI), both of which may give special consideration to high-impact applications advancing sensory neuroscience, neural circuit analysis, neurotechnology innovation, and translational 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 technologies and research platforms focused on neural circuits, sensory processing, and advanced neuroscience methodologies.

Eligible activities may include:

• Development of neural recording and modulation technologies for sensory-system research

• Electrophysiology systems and high-resolution neural monitoring platforms

• Optical imaging technologies for real-time neural circuit visualization

• Optogenetics, chemogenetics, sonogenetics, and magnetogenetics research tools

• AI and machine learning platforms for neural data analysis and computational neuroscience

• Biosensors and wearable neurotechnology systems for sensory processing studies

• Computational models simulating neural circuit dynamics and sensory integration

• Pharmacologic modulation technologies targeting neural signaling pathways

• Cross-species and translational neuroscience research platforms

• Human mechanistic studies evaluating sensory-system neural activity

• Technologies supporting hearing, balance, taste, smell, and visual system neuroscience research

• Advanced statistical and bioinformatics tools for neural circuit analysis

• Brain-computer interface (BCI) and neuroengineering technologies

• Translational research supporting neurological diagnostics and therapeutic discovery

• Validation studies, prototype development, translational research, and regulatory preparation activities

• Commercialization planning and scale-up activities for neuroscience and neurotechnology solutions

Funding may also support personnel, laboratory testing, software development, computational infrastructure, prototype fabrication, neuroimaging systems, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable 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 Microbiome Science Through Multidisciplinary Mechanistic Investigations of the Human Microbiome in Health and Disease

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 seeking innovative research proposals through the SBIR Program focused on advancing mechanistic investigations of the human microbiome and its influence on human health and disease. NIH is particularly interested in technologies and therapeutic approaches that improve understanding of host-microbiome interactions and translate microbiome science into novel diagnostics, therapeutics, disease prevention strategies, and personalized medicine solutions.

The human microbiome plays a critical role in immune function, metabolism, neurological health, inflammation, cancer progression, and chronic disease outcomes. While many studies have identified associations between microbiome composition and disease, significant gaps remain in understanding the mechanistic pathways driving these interactions. NIH is encouraging multidisciplinary projects that move beyond correlation-based studies to investigate molecular mechanisms, microbial metabolites, host signaling pathways, and therapeutic interventions capable of modulating microbiome function.

Companies developing microbiome therapeutics, probiotics, prebiotics, AI-enabled microbiome analytics platforms, computational biology tools, biomarker technologies, organ-on-chip systems, multi-omic platforms, microbial engineering technologies, or precision medicine applications may be strong candidates for funding. NIH is especially interested in projects focused on infectious disease, autoimmune disorders, cancer, metabolic disease, neuropsychiatric conditions, aging, oral health, women’s health, and immune-mediated diseases.

Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.

This highlighted topic is supported primarily by the National Institute of Allergy and Infectious Diseases (NIAID), the National Center for Complementary and Integrative Health (NCCIH), the National Eye Institute (NEI), the National Institute on Aging (NIA), the National Institute of Dental and Craniofacial Research (NIDCR), the National Cancer Institute (NCI), and the Office of Research on Women’s Health (ORWH), all of which may give special consideration to high-impact applications advancing microbiome science, translational therapeutics, systems biology, and precision 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, and commercialization of technologies and therapeutic approaches focused on microbiome science, host-microbe interactions, and microbiome-based disease prevention and treatment.

Eligible activities may include:

• Development of microbiome-targeted therapeutics, probiotics, prebiotics, or microbial metabolite interventions

• AI and machine learning platforms analyzing microbiome composition, host interactions, and disease risk

• Multi-omic technologies integrating microbiome, genomic, metabolomic, epigenetic, and clinical data

• Organ-on-chip, tumor-on-chip, and advanced in vitro systems for microbiome research

• Biomarker discovery technologies for microbiome-associated diseases and treatment response

• Computational biology platforms modeling host-microbe interactions and microbial signaling pathways

• Research into microbiome impacts on infectious disease, autoimmune disease, cancer, metabolic disorders, neurological conditions, and aging

• Development of microbiome engineering and targeted pathogen elimination technologies

• Oral microbiome therapeutics for dental disease, periodontal disease, and oral cancers

• Studies evaluating microbiome effects on immune checkpoint inhibitors and cancer therapy response

• Nutritional, dietary, natural product, and complementary intervention research related to microbiome modulation

• Precision medicine approaches incorporating microbiome and microbial metabolite profiling

• Longitudinal microbiome monitoring systems and predictive analytics tools

• Translational research evaluating microbiome-driven treatment response and prevention strategies

• Validation studies, prototype development, translational research, and regulatory preparation activities

• Commercialization planning and scale-up activities for microbiome technologies and therapeutics

Funding may also support personnel, laboratory testing, software development, computational infrastructure, prototype fabrication, sequencing technologies, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable 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 the Impact of Immune Function on Neurocognition and Substance Use Disorder Risk Across the Lifespan (IMMUNE-LIFESPAN)

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 seeking innovative research proposals through the SBIR Program focused on understanding how immune system function influences neurocognition, neuroinflammation, and substance use disorder (SUD) risk across the lifespan. NIH is particularly interested in technologies, computational models, and translational research approaches that investigate the dynamic relationship between immune dysregulation, neural function, behavioral responses, and addiction vulnerability.

Emerging evidence demonstrates that the immune system and nervous system are deeply interconnected, influencing cognition, neural circuitry, stress responses, and behavioral outcomes through complex molecular and cellular mechanisms. Many environmental, developmental, and psychosocial risk factors associated with SUD—including chronic stress, substance exposure, infection, maternal health, and aging—also affect immune system function. NIH is encouraging projects that advance systems-level understanding of neuroimmune interactions and their role in addiction development, progression, relapse, and recovery.

Companies developing neuroimmune analytics platforms, AI-enabled computational models, biomarker technologies, neuroinflammation diagnostics, imaging systems, precision medicine tools, behavioral health technologies, or translational neuroscience platforms may be strong candidates for funding. NIH is especially interested in projects examining molecular, cellular, circuit-level, and lifespan mechanisms connecting immune dysregulation and SUD-related cognition and behavior.

Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.

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 may give special consideration to high-impact applications advancing neuroimmune science, addiction neuroscience, biomarker discovery, computational behavioral health, and precision intervention 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, and commercialization of technologies and therapeutic approaches focused on addiction neuroscience, sensory integration, and substance use disorder mechanisms.

Eligible activities may include:

• Development of neurotechnology platforms for studying reward circuitry and sensory processing

• AI and machine learning tools analyzing addiction-related neural activity and behavioral patterns

• Neuromodulation technologies targeting sensory-reward neural pathways

• Computational neuroscience models evaluating subjective reward processing and addiction progression

• Imaging technologies for studying interoception, sensory integration, and synaptic plasticity

• Behavioral assessment platforms measuring sensory-evoked responses and motivated behavior

• Research investigating neural adaptations associated with acute, chronic, and withdrawal-related drug exposure

• Technologies exploring multisensory influences on substance use and relapse vulnerability

• Genetic and molecular studies identifying enhancers or suppressors of reward and sensory systems

• Precision medicine and personalized intervention approaches for substance use disorders

• Sex-specific neuroscience research examining addiction-related neural processing differences

• Drug discovery and therapeutic development targeting sensory-reward neural circuits

• Digital health tools supporting addiction monitoring, behavioral intervention, and recovery management

• Validation studies, translational research, prototype development, and regulatory preparation activities

• Commercialization planning and scale-up activities for neuroscience, neurotechnology, and addiction treatment solutions

Funding may also support personnel, laboratory testing, software development, computational infrastructure, prototype fabrication, neuroimaging systems, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable 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 Circuits and Mechanisms Modulating Sensory Integration and Addiction

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 seeking innovative research proposals through the SBIR Program focused on understanding how sensory processing, interoception, and neural reward circuitry contribute to substance use disorders (SUDs) and addiction-related behaviors. NIH is particularly interested in technologies, models, and neuroscience tools that investigate how multisensory integration and subjective reward experiences influence addiction vulnerability, progression, relapse, and recovery.

Traditional addiction research has focused heavily on core reward circuitry, but emerging evidence suggests that sensory processing systems and integrated subjective experiences play a critical role in shaping drug-seeking behavior and loss of cognitive control. NIH is encouraging projects that explore the neural mechanisms linking sensory processing, interoception, synaptic plasticity, and reward contextualization across different stages of substance use disorder progression. Companies developing neurotechnology platforms, AI-enabled neuroscience tools, neuromodulation systems, computational models, imaging technologies, behavioral analytics platforms, or addiction therapeutics may be strong candidates for funding.

NIH is especially interested in projects examining multisensory processing, sensory-evoked neural plasticity, interoceptive signaling, chronic drug exposure effects, withdrawal-associated neural adaptations, and genetic influences on reward processing. Research focused on sex-specific neural mechanisms, personalized addiction interventions, and advanced behavioral models is also encouraged.

Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.

This highlighted topic is supported primarily by the National Institute on Drug Abuse (NIDA) and the Office of Research on Women’s Health (ORWH), both of which may give special consideration to high-impact applications advancing addiction neuroscience, neuromodulation technologies, sensory processing research, and precision behavioral health solutions.

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 and therapeutic approaches focused on addiction neuroscience, sensory integration, and substance use disorder mechanisms.

Eligible activities may include:

• Development of neurotechnology platforms for studying reward circuitry and sensory processing

• AI and machine learning tools analyzing addiction-related neural activity and behavioral patterns

• Neuromodulation technologies targeting sensory-reward neural pathways

• Computational neuroscience models evaluating subjective reward processing and addiction progression

• Imaging technologies for studying interoception, sensory integration, and synaptic plasticity

• Behavioral assessment platforms measuring sensory-evoked responses and motivated behavior

• Research investigating neural adaptations associated with acute, chronic, and withdrawal-related drug exposure

• Technologies exploring multisensory influences on substance use and relapse vulnerability

• Genetic and molecular studies identifying enhancers or suppressors of reward and sensory systems

• Precision medicine and personalized intervention approaches for substance use disorders

• Sex-specific neuroscience research examining addiction-related neural processing differences

• Drug discovery and therapeutic development targeting sensory-reward neural circuits

• Digital health tools supporting addiction monitoring, behavioral intervention, and recovery management

• Validation studies, translational research, prototype development, and regulatory preparation activities

• Commercialization planning and scale-up activities for neuroscience, neurotechnology, and addiction treatment solutions

Funding may also support personnel, laboratory testing, software development, computational infrastructure, prototype fabrication, neuroimaging systems, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable 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 Meaningful Outcome Measures in Adult Hearing Care

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 seeking innovative research proposals through the SBIR Program focused on advancing meaningful outcome measures in adult hearing care (AHC). NIH is particularly interested in technologies, assessment systems, and data-driven approaches that improve how hearing loss, hearing interventions, and quality-of-life outcomes are measured across clinical and research settings.

Current adult hearing care lacks standardized outcome measures that accurately reflect patient experience, functional hearing ability, and real-world quality-of-life impacts. This limitation has created challenges in evaluating intervention effectiveness, comparing treatment approaches, and building scalable data repositories capable of supporting advanced analytics and personalized hearing care. NIH is encouraging projects that develop, refine, validate, and implement clinically meaningful hearing outcome measures with broad applicability across populations, interventions, and care environments.

Companies developing digital audiology platforms, AI-enabled hearing analytics tools, patient-reported outcome systems, remote monitoring technologies, hearing assessment software, data harmonization platforms, or quality-of-life measurement tools may be strong candidates for funding. NIH is especially interested in projects that improve psychometric rigor, support implementation in low-resource settings, and engage clinicians and patients in real-world care environments.

Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.

This highlighted topic is supported primarily by the National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Institute on Aging (NIA), both of which may give special consideration to high-impact applications advancing adult hearing care, hearing intervention effectiveness, digital audiology, patient-centered outcomes, and healthy aging 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, and commercialization of technologies and systems designed to improve outcome measurement and intervention evaluation in adult hearing care.

Eligible activities may include:

• Development of standardized outcome measures for adult hearing care interventions

• AI and machine learning platforms analyzing hearing outcomes, intervention effectiveness, and patient-reported data

• Digital audiology tools supporting hearing assessment, monitoring, and treatment optimization

• Quality-of-life measurement systems related to hearing loss and hearing interventions

• Remote hearing assessment and teleaudiology platforms

• Data harmonization systems and large-scale hearing care repositories

• Psychometric validation and refinement of hearing outcome measures

• Real-world evidence platforms evaluating hearing aid, pharmaceutical, biologic, and auditory training interventions

• Patient engagement technologies supporting personalized hearing care

• Clinical workflow integration tools for hearing outcome tracking and analysis

• Technologies supporting hearing care implementation in low-resource and underserved settings

• Predictive analytics tools for treatment response and hearing health outcomes

• Research involving clinician and patient co-design of hearing assessment systems

• Translational studies evaluating hearing intervention effectiveness across populations and care settings

• Validation studies, prototype development, translational research, and regulatory preparation activities

• Commercialization planning and scale-up activities for hearing health technologies and assessment platforms

Funding may also support personnel, software development, clinical data analysis, prototype fabrication, digital health infrastructure, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable 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 the Use of 3D Technologies Using Human Auditory, Vestibular and Chemosensory Organoids to Create New Approach Models (NAMs) for 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 seeking innovative research proposals through the SBIR Program focused on advancing human auditory, vestibular, and chemosensory organoid technologies through the integration of 3D modeling systems, bioprinting, AI-driven in silico platforms, and other New Approach Methodologies (NAMs). NIH is particularly interested in technologies that accelerate development of more accurate, reproducible, and scalable models for studying hearing, balance, taste, smell, and related communication disorders.

Current limitations in model systems continue to slow therapeutic discovery and precision medicine advancement for auditory, vestibular, and chemosensory disorders. NIH is encouraging collaborative, interdisciplinary projects that combine human organoid systems with advanced 3D technologies, tissue engineering, computational biology, and artificial intelligence to create highly functional ex vivo models capable of improving translational research and accelerating clinical deliverables. Companies developing organoid platforms, AI-enabled drug discovery systems, 3D bioprinting technologies, biosimulation tools, tissue engineering platforms, precision medicine applications, or advanced sensory-system disease models may be strong candidates for funding.

NIH is especially interested in projects focused on improving organoid reproducibility, stability, functional cell mimicry, and personalized iPSC-based research approaches. Research exploring sex-specific biology, hormonal influences, and women’s health applications within sensory-system disorders is also encouraged.

Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.

This highlighted topic is supported primarily by the National Institute on Deafness and Other Communication Disorders (NIDCD) and the Office of Research on Women’s Health (ORWH), both of which may give special consideration to high-impact applications advancing organoid science, sensory-system therapeutics, AI-enabled biomedical modeling, and precision medicine 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, and commercialization of technologies and research platforms focused on auditory, vestibular, and chemosensory organoid systems and advanced New Approach Methodologies (NAMs).

Eligible activities may include:

• Development of human auditory, vestibular, and chemosensory organoid platforms

• 3D bioprinting technologies for tissue engineering and sensory-system modeling

• AI and machine learning platforms for organoid analysis, predictive modeling, and therapeutic discovery

• In silico simulation systems supporting precision medicine and molecular therapeutic development

• iPSC-based personalized medicine research platforms

• Development of biolinks, tissue replicates, and advanced ex vivo assessment systems

• Technologies improving organoid reproducibility, stability, and functional cellular mimicry

• Drug discovery and therapeutic screening platforms utilizing organoid and NAM technologies

• Biosensors and imaging technologies supporting organoid characterization and validation

• Research into hearing, balance, taste, smell, and sensory-system disorders

• Sex-specific and women’s health-focused organoid research investigating hormonal and biological influences across life stages

• Computational biology and multi-omic approaches supporting sensory-system disease modeling

• Translational studies evaluating therapeutic efficacy and safety using advanced organoid systems

• Validation studies, prototype development, translational research, and regulatory preparation activities

• Commercialization planning and scale-up activities for organoid, tissue engineering, and AI-enabled biomedical technologies

Funding may also support personnel, laboratory testing, software development, computational infrastructure, prototype fabrication, tissue engineering systems, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable 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.