NIH Highlighted Topic: Quantum Information Science & Technologies for Biomedical Applications

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 applying Quantum Information Science (QIS) and quantum technologies to biomedical research, diagnostics, imaging, sensing, therapeutics, and computational biology. This highlighted topic supports multidisciplinary projects aimed at leveraging quantum physics principles to dramatically improve the precision, sensitivity, speed, and scalability of biomedical technologies and healthcare systems.

NIH is particularly interested in projects that integrate quantum technologies with classical biomedical systems to enable breakthroughs in disease detection, physiological sensing, biomolecular simulation, imaging, computational modeling, and therapeutic discovery. Companies developing quantum sensing platforms, quantum-enhanced imaging systems, quantum computing software, hybrid quantum-classical AI systems, biointerfaces, microfluidics, or advanced biomedical diagnostics may be strong candidates for funding.

Areas of interest include quantum-enhanced imaging, quantum biosensing, lab-on-a-chip diagnostics, quantum algorithms for biomolecular simulation, quantum computing for therapeutic discovery, optoelectronic biointerfaces, neural sensing technologies, quantum-enabled AI and predictive analytics, personalized medicine platforms, and translational quantum biomedical systems. NIH is also encouraging projects focused on portability, scalability, reproducibility, benchmarking against classical systems, and integration with clinical workflows and biomedical data infrastructures.

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

This highlighted topic is supported by multiple NIH Institutes and Offices including NIBIB, BRAIN Initiative, NCATS, NCI, NEI, NHLBI, NIDCR, NIGMS, and ODSS, all of which are seeking transformative innovations that advance quantum-enabled healthcare technologies, diagnostics, computational biology, imaging systems, and biomedical research infrastructure.

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 quantum biomedical technologies, quantum computing platforms, sensing systems, imaging tools, diagnostics, and computational biology solutions.

Eligible activities may include:

• Quantum-enhanced biomedical imaging systems

• Quantum biosensing and ultrasensitive diagnostic platforms

• AI-enabled hybrid quantum-classical computational systems

• Quantum algorithms for biomolecular simulation and therapeutic discovery

• Quantum-enabled lab-on-a-chip and microfluidic diagnostic technologies

• Optoelectronic biointerfaces for physiological monitoring and modulation

• Quantum sensing systems for neural recording and neuromodulation

• Portable quantum diagnostics and point-of-care testing platforms

• Quantum imaging for cancer, cardiovascular, neurological, ocular, and craniofacial diseases

• Hyperpolarized MRI, photon-counting CT, and quantum optical coherence tomography technologies

• Quantum computing platforms for predictive analytics and personalized medicine

• Wearable and implantable quantum-enabled biomedical devices

• Biomedical data integration and quantum-enabled AI/ML infrastructure

• Real-time biomarker detection and physiological monitoring systems

• Translational quantum technologies integrated into clinical workflows

• Benchmarking, reproducibility, and scalability frameworks for quantum biomedical systems

• Prototype development, translational studies, and clinical validation research

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

Funding may also support personnel, software engineering, quantum hardware development, cloud computing infrastructure, AI model development, laboratory testing, computational modeling, biomedical imaging research, device prototyping, bioinformatics analysis, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable quantum healthcare or biomedical 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: Enhancing Scientific Rigor, Transparency and Replicability

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 scientific rigor, transparency, reproducibility, and replicability across the biomedical research enterprise. This highlighted topic supports multidisciplinary projects that develop new tools, standards, methodologies, training programs, AI-enabled systems, and collaborative frameworks designed to strengthen the quality, validity, and reliability of scientific research outcomes.

NIH recognizes that reproducible and transparent research practices are essential for accelerating biomedical discovery, improving translational success, reducing bias, and maximizing public trust in science. The initiative is particularly interested in technologies and strategies that improve experimental design, metadata quality, protocol standardization, analytical reproducibility, AI validation, data interoperability, and dissemination of rigorous scientific practices.

Companies developing AI-driven research platforms, scientific workflow software, reproducibility analytics systems, metadata infrastructure, laboratory automation tools, benchmarking frameworks, biomedical informatics systems, open science technologies, or research collaboration platforms may be strong candidates for funding.

Areas of interest include AI-assisted rigor assessment, FAIR and TRUST-aligned data standards, automated metadata generation, reproducibility benchmarking, workflow traceability, protocol sharing, sex as a biological variable (SABV) frameworks, community-based training systems, common data elements (CDEs), multimodal data harmonization, laboratory automation, digital provenance tracking, and implementation science approaches that improve adoption of rigorous research practices. NIH is also encouraging projects supporting reproducibility in genomics, neuroscience, mental health, environmental health, imaging, clinical trials, aging, substance use research, and AI/ML evaluation frameworks.

Funding is available through the NIH SBIR/STTR Program and related NIH research, education, and conference mechanisms, including opportunities for Phase I and Phase II commercialization support depending on project scope and translational impact.

This highlighted topic is supported by a broad coalition of NIH Institutes and Offices including NINDS, NLM, NIBIB, NHGRI, NCI, NHLBI, NIA, NIMH, NIDA, NIAID, NEI, NCCIH, ORWH, ODSS, ODP, ODS, NIGMS, NIEHS, and many others, all of which are seeking scalable innovations that improve scientific validity, transparency, interoperability, and translational reliability across biomedical 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, implementation, and commercialization of scientific rigor technologies, AI-enabled research infrastructure, reproducibility analytics platforms, metadata systems, and biomedical data science tools.

Eligible activities may include:

• AI and machine learning systems for assessing research rigor and reproducibility

• Automated protocol standardization and metadata generation platforms

• FAIR and TRUST-aligned data interoperability infrastructure

• Scientific workflow traceability and provenance tracking technologies

• Benchmarking and validation frameworks for AI/ML models

• Open science and collaborative research platforms

• Common data element (CDE) development and harmonization systems

• Biomedical informatics and multimodal data integration tools

• Laboratory automation and digital workflow capture technologies

• Research reproducibility analytics and variability assessment systems

• Clinical trial design optimization and statistical rigor tools

• Sex as a biological variable (SABV) reporting and analysis platforms

• Genomics, imaging, neuroscience, and environmental health reproducibility tools

• Community training, workforce development, and educational technologies

• Replication study infrastructure and scientific quality assurance systems

• Protocol sharing, versioning, and computational pipeline documentation platforms

• Prototype development, translational studies, and validation research

• Commercialization planning, implementation scaling, and regulatory preparation activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, biomedical data analysis, implementation science, standards development, stakeholder engagement, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable scientific infrastructure or biomedical research 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: GLP-1s: Implications for Nutritional Status and Metabolic Health 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 understanding how GLP-1 receptor agonists (GLP-1s) impact nutritional status, metabolism, chronic disease outcomes, and population health. This highlighted topic supports multidisciplinary projects designed to investigate the biological, behavioral, clinical, and societal implications of rapidly expanding GLP-1 use, including both prescription therapies and dietary supplements marketed as “GLP-1 mimetics.”

NIH is particularly interested in research examining how GLP-1 therapies influence nutrient metabolism, body composition, appetite regulation, gastrointestinal function, microbiome composition, metabolic biomarkers, and long-term health outcomes. Companies developing AI-enabled nutrition analytics platforms, metabolic monitoring systems, digital therapeutics, wearable health technologies, precision nutrition platforms, dietary supplement testing systems, or real-world evidence platforms may be strong candidates for funding.

Areas of interest include metabolic health biomarkers, obesity and diabetes management, cancer prevention and survivorship, cardiovascular risk reduction, aging and cognitive outcomes, musculoskeletal health, ocular disease mechanisms, oral health effects, microbiome changes, and lifestyle interventions supporting GLP-1 treatment. NIH is also encouraging projects focused on the safety, composition, efficacy, and biological mechanisms of supplements marketed as GLP-1 mimetics, including interactions with prescription GLP-1 medications.

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 numerous NIH Institutes and Offices including ODS, NCI, NEI, NHLBI, NIA, NIAMS, NIDCR, NIDDK, NINR, ODP, ONR, and OBSSR, all of which are seeking transformative innovations that improve metabolic health, nutrition science, chronic disease prevention, precision medicine, and evidence-based GLP-1 treatment strategies.

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 metabolic health technologies, nutrition science platforms, AI analytics systems, digital therapeutics, biomarker tools, and dietary supplement evaluation technologies related to GLP-1 therapies and metabolic outcomes.

Eligible activities may include:

• AI and machine learning platforms for GLP-1 treatment optimization and metabolic monitoring

• Precision nutrition and personalized dietary intervention technologies

• Biomarker discovery and metabolic risk prediction systems

• Wearable devices and remote monitoring technologies for nutrition and body composition

• Digital therapeutics supporting GLP-1 adherence and lifestyle interventions

• Microbiome, metabolomics, and multi-omics analytics platforms

• Dietary supplement testing, formulation, and bioavailability evaluation technologies

• Real-world evidence and longitudinal outcomes research platforms

• Cardiovascular, sleep, and metabolic disease prevention technologies

• Cancer prevention and survivorship intervention systems related to GLP-1 use

• Aging, cognitive health, and neurodegenerative disease research platforms

• Musculoskeletal, bone density, sarcopenia, and fracture risk monitoring technologies

• Oral health, ocular health, and inflammatory response assessment systems

• Behavioral health, appetite regulation, and satiety analytics platforms

• Drug interaction and safety assessment technologies for GLP-1 mimetics

• Clinical decision support systems integrating nutrition and metabolic biomarkers

• Prototype development, translational studies, and clinical validation research

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

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, laboratory testing, nutritional analysis, wearable integration, clinical research, bioinformatics analysis, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare, nutrition, 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: School Mental and Behavioral Health: Expanding Access to Evidence-Based Interventions and Services

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 expanding access to evidence-based mental and behavioral health interventions in school and afterschool settings. This highlighted topic supports multidisciplinary projects aimed at improving prevention, screening, intervention delivery, implementation, and long-term sustainability of school-based mental health services for children and adolescents.

NIH recognizes that schools often serve as primary access points for healthcare and mental health services, particularly in underserved communities. The initiative is particularly interested in scalable, research-informed approaches that can be rapidly deployed using existing school infrastructure, school personnel, behavioral health providers, and community partnerships.

Companies developing school mental health technologies, AI-enabled risk screening platforms, behavioral health analytics systems, telehealth solutions, decision support tools, digital therapeutics, student engagement platforms, implementation science technologies, or care coordination systems may be strong candidates for funding.

Areas of interest include mental health risk identification, intervention matching systems, multitiered support frameworks (MTSS), behavioral health decision support tools, substance use prevention, implementation science, fidelity monitoring, workforce training, community-engaged intervention models, and scalable school-based service delivery systems. NIH is also encouraging projects focused on health equity, workforce shortages, youth participatory research, and sustainable implementation models that improve access to care for vulnerable student populations.

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

This highlighted topic is supported by multiple NIH Institutes and Offices including NIMH, NIDA, NINR, NIAAA, NIMHD, ODP, and ORWH, all of which are seeking scalable innovations that improve school-based mental health care delivery, behavioral health prevention, implementation science, and long-term student well-being.

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, implementation, and commercialization of school mental health technologies, behavioral health intervention platforms, digital therapeutics, screening systems, and implementation science solutions.

Eligible activities may include:

• AI and machine learning platforms for student mental health risk screening

• School-based behavioral health assessment and monitoring systems

• Digital therapeutics and mental health intervention platforms

• Telehealth and virtual behavioral healthcare delivery technologies

• Decision support tools for matching students to interventions and services

• Substance use prevention and early intervention technologies

• Multitiered system of supports (MTSS) implementation platforms

• School-based care coordination and referral management systems

• Workforce training, supervision, and credentialing technologies

• Behavioral health implementation science and fidelity monitoring systems

• Student engagement and wellness support applications

• Community-engaged and youth participatory intervention technologies

• Mental health analytics and outcomes tracking platforms

• Equity-focused and culturally responsive behavioral health solutions

• Nurse-led and school staff-delivered intervention systems

• School-community partnership and integrated care delivery platforms

• Prototype development, implementation studies, and clinical validation research

• Commercialization planning, scalability testing, and regulatory preparation activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, implementation research, telehealth deployment, behavioral health analytics, school systems integration, stakeholder engagement, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable school mental health or healthcare 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: Tackling Acquisition of Language in Kids (TALK)

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, evaluating, and improving outcomes for children with late language emergence, commonly referred to as “late talking.” This highlighted topic supports multidisciplinary research aimed at advancing knowledge of early language development trajectories, identifying predictive factors for long-term outcomes, and developing more effective interventions and support systems for children experiencing language delays.

Late talking affects approximately 10% to 20% of children and may occur alongside conditions such as autism, speech-motor disorders, sensory disorders, developmental disabilities, or without any known underlying condition. NIH is particularly interested in projects that improve understanding of developmental variability, language recovery pathways, persistent language disorders, and the impact of social, cultural, and environmental factors on communication outcomes.

Companies developing speech and language technologies, AI-enabled developmental assessment platforms, digital therapeutics, augmentative and alternative communication (AAC) tools, predictive analytics systems, educational technologies, caregiver support platforms, or longitudinal child development analytics solutions may be strong candidates for funding.

Areas of interest include longitudinal developmental tracking, predictive modeling, early identification tools, culturally responsive interventions, developmental trajectory analysis, communication assessment technologies, caregiver guidance systems, implementation science, and novel approaches to supporting communication success in children with diverse developmental needs. NIH is also encouraging projects leveraging existing datasets, AI and machine learning, telehealth delivery systems, and scalable digital interventions to improve clinical and community-based support for late-talking children.

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 Institute on Deafness and Other Communication Disorders (NIDCD) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), both of which are seeking transformative innovations that improve childhood language development, developmental trajectory prediction, communication interventions, and long-term developmental 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 speech and language technologies, developmental assessment tools, AI analytics platforms, AAC systems, and child development intervention solutions related to late talking and language development.

Eligible activities may include:

• AI and machine learning platforms for language development prediction and assessment

• Speech and language screening and diagnostic technologies

• Longitudinal developmental tracking and analytics systems

• Augmentative and alternative communication (AAC) technologies

• Digital therapeutics and communication intervention platforms

• Telehealth and remote speech-language therapy systems

• Caregiver guidance, education, and support technologies

• Developmental trajectory modeling and predictive analytics tools

• Autism, speech-motor, sensory, and developmental disability communication support systems

• Culturally and linguistically responsive language assessment platforms

• Educational technologies supporting early language acquisition

• Natural language processing (NLP) tools for child communication analysis

• Early identification and intervention systems for language disorders

• Clinical decision support and personalized treatment planning platforms

• Community-based and school-based language support technologies

• Data integration and enrichment tools for developmental research datasets

• Prototype development, translational studies, and clinical validation research

• Commercialization planning, implementation scaling, and regulatory preparation activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, speech analytics, telehealth deployment, developmental research, data analysis, caregiver engagement, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable pediatric health or communication 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: Characterizing Interactions between Biology and Electromagnetic Radiation

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 low-intensity electromagnetic radiation (EMR) interacts with biological systems across therapeutic, environmental, and physiological contexts. This highlighted topic supports multidisciplinary research aimed at characterizing both the beneficial and potentially harmful effects of electromagnetic radiation exposure while advancing technologies that improve EMR sensing, imaging, dosimetry, delivery, and safety assessment.

NIH is particularly interested in projects exploring how optical, electric, magnetic, radiofrequency, ultraviolet, and other forms of electromagnetic radiation influence biological processes such as inflammation, tissue regeneration, mitochondrial function, blood flow, cellular repair, neural activity, and immune responses. Companies developing EMR-based therapeutics, bioelectronic medicine platforms, AI-enabled dosimetry systems, sensing technologies, imaging systems, computational modeling platforms, wearable exposure monitoring devices, or quantum-enabled biomedical technologies may be strong candidates for funding.

Areas of interest include personalized EMR therapies, therapeutic field optimization, environmental exposure analysis, AI-assisted EMR transport modeling, tissue-level dosimetry, exposure-response characterization, quantum sensing technologies, wearable exposure analytics, and safety assessment frameworks. NIH is also encouraging projects investigating EMR exposure from environmental sources such as cell phones, Wi-Fi routers, wearables, ultraviolet light, and cell towers, including studies focused on developmental susceptibility, exposomics, genetic and epigenetic response variability, and long-term health effects.

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

This highlighted topic is supported primarily by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institute of Environmental Health Sciences (NIEHS), both of which are seeking transformative innovations that improve EMR-based therapeutics, environmental exposure science, computational modeling, biomedical sensing, and human health 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 EMR-based technologies, biomedical sensing systems, computational modeling platforms, imaging tools, and environmental exposure analytics solutions.

Eligible activities may include:

• AI and machine learning platforms for EMR dosimetry and exposure modeling

• EMR sensing, imaging, and delivery technologies

• Bioelectronic medicine and electromagnetic therapeutic platforms

• Quantum-enabled biomedical sensing and measurement systems

• Wearable EMR monitoring and exposure assessment devices

• Computational biology and tissue transport simulation platforms

• Personalized EMR treatment optimization technologies

• Environmental exposure and exposome analytics systems

• Therapeutic electromagnetic field delivery and targeting systems

• Optical, electric, and magnetic field therapeutic technologies

• Cell phone, Wi-Fi, wearable, and radiofrequency exposure assessment tools

• Genetic and epigenetic response modeling related to EMR exposure

• Imaging and tissue-level perfusion monitoring systems

• Inflammation, regeneration, and mitochondrial function analysis technologies

• Safety monitoring, adverse effect detection, and risk stratification platforms

• Digital twins and predictive biomedical simulation systems

• Prototype development, translational studies, and validation research

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

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, laboratory testing, biomedical imaging research, computational modeling, wearable integration, exposure analytics, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare, bioengineering, or environmental 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 Modeling of Complex Processes Across Biological Scales

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 computational modeling of complex biological processes across multiple spatial and temporal scales. This highlighted topic supports multidisciplinary projects developing advanced multiscale computational models that integrate molecular, cellular, tissue, organ, organismal, behavioral, and population-level processes to improve understanding of human health and disease.

NIH is particularly interested in projects that improve the rigor, reproducibility, transparency, interoperability, and reusability of computational multiscale models while fostering collaborative modeling communities across biomedical disciplines. Companies developing AI-enabled modeling platforms, systems biology software, digital twin technologies, computational biology tools, biomedical simulation systems, cloud-based modeling infrastructure, or advanced predictive analytics platforms may be strong candidates for funding.

Areas of interest include infectious disease modeling, cancer systems biology, cardiovascular and pulmonary modeling, neuroscience simulation, aging and Alzheimer’s disease research, autoimmune disease modeling, substance use disorder modeling, precision medicine, microbiome dynamics, organ-system interactions, and Novel Alternative Methods (NAMs) for therapeutic development and safety assessment. NIH is also encouraging projects integrating AI, machine learning, FAIR data practices, uncertainty quantification, cloud-native infrastructure, and interoperable data science workflows.

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 numerous NIH Institutes and Offices including NIAID, NCI, NHLBI, NIA, NIMH, NIDA, NIBIB, NLM, NIDCR, NCCIH, ORWH, and ODSS, all of which are seeking transformative innovations that improve computational modeling, biomedical simulation, translational research, and precision health 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 computational biology platforms, AI-enabled simulation systems, multiscale modeling infrastructure, and biomedical data science technologies.

Eligible activities may include:

• AI and machine learning platforms for multiscale biological modeling

• Computational biology and systems biology software development

• Digital twin and predictive simulation technologies

• Biomedical modeling infrastructure and cloud-native computational platforms

• FAIR data integration, interoperability, and reproducibility systems

• Cancer, infectious disease, cardiovascular, neurological, and autoimmune disease modeling tools

• Precision medicine and personalized health prediction platforms

• Organ-system and brain-body interaction simulation technologies

• Aging, Alzheimer’s disease, and lifespan modeling systems

• Novel Alternative Methods (NAMs) for therapeutic testing and safety evaluation

• Biomarker discovery and predictive analytics platforms

• Computational neuroscience and neural circuit simulation systems

• Microbiome, immunology, and host-environment interaction models

• Population health, epidemiological, and behavioral systems modeling

• Biomedical imaging integration and quantitative uncertainty analysis tools

• Open-source computational workflow and model-sharing infrastructure

• Prototype development, translational studies, and validation research

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

Funding may also support personnel, software engineering, cloud computing infrastructure, AI model development, computational simulation research, data harmonization, bioinformatics analysis, systems biology validation studies, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable computational biology or healthcare 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: Advancing Childhood and Adolescent & Young Adult (AYA) Cancer Research

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

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research proposals focused on accelerating childhood, adolescent, and young adult (AYA) cancer research across the full continuum of prevention, diagnosis, treatment, survivorship, and long-term care. This highlighted topic supports multidisciplinary projects designed to improve understanding of pediatric and AYA cancer biology while advancing precision medicine, AI-enabled analytics, therapeutic development, and patient-centered care approaches.

NIH is particularly interested in projects addressing the unique challenges associated with pediatric and AYA cancers, including rare disease subtypes, limited patient populations, lack of robust preclinical models, treatment-related toxicities, fragmented datasets, and disparities in access to specialized care and clinical trials. Companies developing AI and machine learning platforms, pediatric oncology diagnostics, precision medicine technologies, clinical analytics systems, digital health platforms, survivorship monitoring tools, or decentralized clinical trial infrastructure may be strong candidates for funding.

Areas of interest include multi-omics analysis, AI-ready data infrastructure, fusion-driven cancer biology, synthetic lethality approaches, immunotherapy, tumor microenvironment research, treatment resistance, decentralized clinical trials, survivorship studies, prevention of treatment-related toxicities, and long-term quality-of-life monitoring. NIH is also encouraging projects focused on oral and craniofacial cancer complications, healthcare access, and integration of real-world evidence and electronic health record (EHR) data into pediatric cancer research.

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 Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR), and the Office of Disease Prevention (ODP), all of which are seeking transformative innovations that improve pediatric and AYA cancer prevention, diagnosis, treatment outcomes, survivorship, and quality of life.

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of pediatric oncology technologies, AI platforms, diagnostics, therapeutics, clinical analytics systems, and survivorship care solutions.

Eligible activities may include:

• AI and machine learning platforms for pediatric and AYA cancer research

• Multi-omics data integration and predictive analytics systems

• Precision oncology diagnostics and biomarker discovery technologies

• Fusion-driven cancer and synthetic lethality therapeutic platforms

• Immunotherapy and tumor microenvironment research technologies

• Pediatric cancer imaging, pathology, and molecular analysis systems

• Decentralized clinical trial infrastructure and patient recruitment technologies

• Survivorship monitoring and long-term toxicity assessment platforms

• Digital health and remote patient monitoring tools for pediatric oncology

• Clinical decision support and treatment optimization systems

• Real-world evidence and EHR-integrated oncology analytics platforms

• Preclinical cancer models, organoids, and translational research systems

• Oral, dental, and craniofacial oncology technologies and treatment monitoring tools

• Prevention and mitigation technologies for treatment-related side effects

• Healthcare access and continuity-of-care platforms for pediatric cancer patients

• Data harmonization and AI-ready pediatric oncology research infrastructure

• Prototype development, translational studies, and clinical validation research

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

Funding may also support personnel, software engineering, cloud computing infrastructure, AI model development, genomic sequencing, laboratory testing, bioinformatics analysis, clinical trial preparation, survivorship research, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable pediatric oncology or healthcare 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: Training and Career Development in Dissemination and Implementation Science

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 training and career development proposals focused on dissemination and implementation (D&I) science. This highlighted topic supports projects designed to strengthen the biomedical and public health workforce by building expertise in how evidence-based innovations (EBIs) are effectively adopted, integrated, scaled, and sustained across clinical, community, and healthcare settings.

NIH recognizes that many proven healthcare interventions fail to achieve broad real-world impact due to barriers in implementation, adoption, scalability, and sustainability. This initiative seeks to advance D&I science through training programs, career development pathways, methodological innovation, and interdisciplinary research capacity building across a wide range of health specialties and populations.

Companies and organizations developing implementation science platforms, healthcare workforce training technologies, AI-enabled research tools, digital learning systems, clinical analytics platforms, healthcare quality improvement technologies, community engagement systems, or implementation evaluation software may be strong candidates for funding.

Areas of interest include dissemination and implementation frameworks, hybrid effectiveness-implementation trials, community-engaged research, pragmatic clinical trial design, qualitative and mixed methods research, human-centered design, adaptation measurement, implementation analytics, healthcare scalability models, and health disparities reduction strategies. NIH is also encouraging projects focused on implementation science for mental health, substance use, genomics, chronic disease management, HIV care, sensory disorders, neurological disease, and complementary health interventions.

Funding is available through multiple NIH training and career development mechanisms, including Fellowships, Career Development Awards, Institutional Training Grants, and Education Projects, with opportunities for translational and workforce-focused implementation science support depending on project scope and alignment.

This highlighted topic is supported by numerous NIH Institutes and Offices including NIDCD, NCCIH, NHGRI, NIDA, NIDDK, NIMH, NINDS, NINR, NCI, OAR, ODP, and others, all of which are seeking scalable innovations that strengthen dissemination and implementation science capacity, workforce development, and evidence-based healthcare adoption.

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, implementation, and commercialization of dissemination and implementation (D&I) science training platforms, workforce development technologies, healthcare adoption systems, and implementation analytics tools.

Eligible activities may include:

• Digital training and workforce development platforms for D&I science

• AI and machine learning systems for implementation analytics and healthcare adoption

• Community-engaged research and stakeholder collaboration technologies

• Hybrid effectiveness-implementation trial infrastructure

• Human-centered design and healthcare implementation tools

• Qualitative and mixed methods research platforms

• Clinical decision support and evidence-based practice integration systems

• Healthcare scalability, sustainability, and adoption analytics

• Research-practice partnership and collaboration platforms

• Dissemination strategy development and communication technologies

• Implementation outcome measurement and fidelity tracking systems

• Health disparities reduction and equitable care implementation tools

• Telehealth and digital health implementation research platforms

• Genomics, mental health, HIV, neurology, and chronic disease implementation technologies

• Healthcare quality improvement and organizational change management systems

• Community-based intervention delivery and engagement technologies

• Prototype development, pilot implementation studies, and translational research

• Commercialization planning, implementation scaling, and dissemination activities

Funding may also support personnel, software engineering, cloud infrastructure, AI model development, healthcare systems integration, implementation research, training curriculum development, data analytics, community engagement, intellectual property protection, and commercialization activities necessary to advance a scalable and commercially viable healthcare, education, or implementation science 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 Mechanism-driven Translational Research of Beneficial and Detrimental Effect of Psilocybin on Cancer and Other Health Conditions

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of psychedelic therapeutics, translational research technologies, biomarkers, computational tools, and precision medicine systems related to psilocybin research.

Eligible activities may include:

• Psilocybin therapeutic development and translational drug discovery

• AI and machine learning platforms for psychedelic biomarker analysis

• Neuropharmacology and neuroplasticity research technologies

• Precision medicine and patient stratification systems

• Clinical decision support and dosing optimization platforms

• Human-relevant disease models and translational research systems

• Computational biology and systems pharmacology tools

• Biomarker discovery and predictive analytics technologies

• Pain management and symptom burden intervention platforms

• Substance use disorder (SUD) therapeutic development technologies

• Psilocybin analog, prodrug, and modified compound development

• Pharmacokinetic and safety profiling technologies

• Digital therapeutics and behavioral intervention integration systems

• Immune, tumor, and neurological response analysis platforms

• Cancer symptom management and supportive care technologies

• Longitudinal monitoring systems for chronic use and microdosing studies

• Prototype development, translational studies, and clinical validation research

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Enhancing the IMPROVE-funded Maternal Health Centers of Excellence

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

Executive Summary:

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

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, implementation, and commercialization of maternal health technologies, remote monitoring systems, clinical analytics platforms, and healthcare delivery solutions designed to reduce maternal morbidity and mortality.

Eligible activities may include:

• Remote maternal monitoring and wearable pregnancy technologies

• AI and machine learning platforms for maternal risk prediction

• Telehealth systems for prenatal and postpartum care

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

• Healthcare coordination and maternal care navigation platforms

• Expansion of maternal health programs into maternity care deserts

• Pregnancy complication monitoring and early warning systems

• Clinical decision support systems for maternal healthcare providers

• Integration of RADx maternal health technologies into care delivery

• Population health analytics and maternal outcomes tracking systems

• Community-based maternal health intervention technologies

• Longitudinal pregnancy and postpartum monitoring platforms

• Rural maternal healthcare access and infrastructure technologies

• Collaborative maternal health data-sharing and interoperability systems

• Equity-focused maternal health implementation and outreach platforms

• Prototype development, implementation studies, and translational research

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Accelerating Hidradenitis Suppurativa Research

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

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research proposals focused on accelerating scientific understanding, diagnostics, predictive tools, and therapeutic development for Hidradenitis Suppurativa (HS). This highlighted topic supports multidisciplinary research designed to better understand the molecular, immunological, genetic, microbial, hormonal, metabolic, and environmental mechanisms driving HS development, progression, and disease flares.

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of diagnostics, biomarkers, predictive analytics platforms, therapeutics, digital health tools, and translational research technologies related to Hidradenitis Suppurativa (HS).

Eligible activities may include:

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

• Biomarker discovery and precision dermatology technologies

• Point-of-care diagnostics and wearable monitoring systems

• Imaging and digital dermatology assessment platforms

• Immunology and inflammatory pathway research technologies

• Microbiome, biofilm, and exposome analysis systems

• Computational biology and predictive modeling tools

• Genetic and epigenetic analysis platforms for HS research

• Digital health and remote patient monitoring technologies

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

• Therapeutic target identification and translational drug development

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

• Personalized medicine and sex-specific treatment approaches

• Environmental exposure and toxicology research platforms

• Omics analysis and systems biology technologies

• Prototype development, translational studies, and clinical validation research

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Advancing Toward a Cure for Acquired Neuropathy

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of diagnostics, biomarkers, therapeutics, neuromodulation systems, regenerative medicine technologies, and clinical monitoring tools related to acquired neuropathy.

Eligible activities may include:

• Biomarker discovery and predictive analytics platforms for neuropathy detection

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

• Regenerative medicine and neuroprotective therapeutic development

• Neuromodulation and peripheral nerve stimulation technologies

• Clinical outcome measurement and digital assessment systems

• Wearable devices and remote monitoring technologies for neuropathy patients

• Translational animal models and organoid-based neuropathy research systems

• Therapeutics for diabetic neuropathy and autonomic neuropathy

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

• Autoimmune neuropathy therapeutic platforms

• Computational biology and bioinformatics tools for neuropathy research

• Personalized medicine approaches for neuropathy management

• Imaging and diagnostic systems for peripheral nerve function assessment

• Drug screening and therapeutic validation platforms

• Pain management and sensory function monitoring technologies

• Prototype development, translational studies, and clinical validation research

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Advancing Research into the Cause and Treatment of Rare Skin Diseases

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of therapeutics, diagnostics, computational tools, disease models, and translational research platforms related to rare skin diseases.

Eligible activities may include:

• Gene therapy and gene editing technologies for rare skin diseases

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

• Cell therapy and regenerative medicine approaches

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

• Computational biology and precision medicine platforms

• Biomarker discovery and disease progression monitoring technologies

• Drug repurposing and therapeutic screening systems

• Molecular and cellular pathway analysis tools

• Environmental exposure and exposome research technologies

• Translational platform technologies applicable across multiple rare diseases

• Basket trial infrastructure and shared molecular etiology therapeutic development

• Dermatology imaging and digital pathology systems

• Personalized medicine and genomic diagnostic platforms

• High-throughput drug screening and toxicology testing systems

• Autoimmune-associated skin disease therapeutic technologies

• Revertant mosaicism and disease reversal research platforms

• Prototype development, translational studies, and clinical validation research

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Advancing “Science of Science” Research to Understand and Strengthen the Biomedical Research Ecosystem

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of scientific analytics platforms, biomedical workforce technologies, research infrastructure systems, collaboration tools, and translational research optimization solutions.

Eligible activities may include:

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

• Research reproducibility and scientific integrity monitoring systems

• Biomedical workforce development and training technologies

• Team science and interdisciplinary collaboration platforms

• Translational research optimization and commercialization analytics

• Data standardization, interoperability, and sharing infrastructure

• Research productivity and innovation measurement tools

• Scientific collaboration network analysis platforms

• Biomedical informatics and research data science technologies

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

• Predictive analytics for scientific innovation and translational success

• Research capacity building technologies for underfunded institutions

• Health disparities and inclusive workforce development solutions

• Scientific publishing, peer review, and research dissemination tools

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

• Workforce recruitment, retention, and career progression analytics

• Prototype development, translational studies, and implementation research

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Implementation Science to Optimize HIV Prevention and Treatment

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, implementation, and commercialization of HIV prevention technologies, digital health systems, implementation science platforms, and integrated care delivery solutions.

Eligible activities may include:

• Digital health and telehealth platforms for HIV prevention and treatment

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

• Long-acting HIV therapeutic delivery and monitoring technologies

• Remote patient monitoring and wearable health systems

• Clinical decision support and healthcare workflow management platforms

• Community-based HIV prevention and care coordination technologies

• Behavioral health and substance use disorder intervention systems

• HIV implementation science analytics and scalability platforms

• EHR integration, interoperability, and health data exchange tools

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

• Patient engagement and viral suppression support technologies

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

• Rural healthcare delivery and mobile care platforms

• HIV and oncology integrated care coordination systems

• Community-led and multi-sector intervention delivery platforms

• Population health analytics and implementation research infrastructure

• Prototype development, implementation trials, and translational studies

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: BRAIN Initiative: Advancing Human Neuroscience and Precision Molecular Therapies for Transformative Treatments

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of neurotechnology platforms, neural therapeutics, precision molecular therapies, brain-computer interfaces, and neuroscience data systems.

Eligible activities may include:

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

• Neural monitoring and neuromodulation systems

• Optogenetic and chemogenetic therapeutic platforms

• Precision molecular circuit therapy development

• Genetic delivery systems for neurological treatments

• AI and machine learning platforms for neuroscience and neural analytics

• Neurotechnology devices for monitoring and modulating brain activity

• Advanced neural effector and stimulation technologies

• Personalized and sex-specific neurological therapeutic platforms

• Computational neuroscience and neural circuit modeling systems

• Human neuroscience research platforms and translational studies

• Neural data integration, interoperability, and standardization systems

• Wearable and implantable neurotechnology devices

• Clinical neurotechnology testing and validation platforms

• Neuropsychiatric and neurological disorder treatment technologies

• Early-stage human neuroscience and translational research systems

• Prototype development, preclinical validation, and pilot human studies

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Advancing Treatment Options using Targeted Degrader Technologies

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of targeted degrader technologies, therapeutic platforms, computational drug discovery systems, and biomarker solutions.

Eligible activities may include:

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

• RNA-targeted degrader technologies such as RIBOTACs

• AI and machine learning platforms for degrader discovery and optimization

• Computational modeling and predictive therapeutic design systems

• Biomarker discovery and translational therapeutic monitoring tools

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

• Synthetic biology and protein engineering platforms

• High-throughput degrader screening and validation systems

• Drug delivery technologies for tissue-selective and targeted therapeutics

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

• Protein aggregation and proteostasis research platforms

• Pharmacokinetic, toxicity, and absorption optimization technologies

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

• Craniofacial and dental therapeutic development technologies

• Novel linker chemistry and drug conjugation systems

• Prototype development, translational studies, and preclinical validation research

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Technology Development for Genomics

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of genomic technologies, sequencing systems, computational biology platforms, synthetic biology tools, and multiomics solutions.

Eligible activities may include:

• Next-generation DNA and RNA sequencing technologies

• Direct RNA sequencing and modified base detection systems

• AI and machine learning platforms for genomics and metagenomics

• Functional genomics and genome editing technologies

• Epigenomics, transcriptomics, and chromatin accessibility analysis tools

• Multiomics integration and bioinformatics platforms

• Spatial and temporal genomics technologies

• High-throughput genomic screening and phenotyping systems

• Predictive modeling of genotype-phenotype relationships

• Synthetic biology and oligonucleotide synthesis technologies

• Computational genomics and genomic epidemiology platforms

• Cancer genomics and biomarker discovery systems

• Infectious disease genomics and pathogen surveillance tools

• Gene therapy development and addiction genomics research technologies

• Data harmonization, interoperability, and scalable genomics infrastructure

• Massively parallel reporter assays and functional variant characterization systems

• Prototype development, translational research, and validation studies

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Multidisciplinary Studies of HIV/AIDS and Aging

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

Executive Summary:

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

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of healthcare technologies, diagnostics, digital health platforms, behavioral health tools, biomarkers, and intervention systems related to HIV/AIDS and aging.

Eligible activities may include:

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

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

• Biomarker discovery and aging-related diagnostic technologies

• Neurocognitive assessment and mental health intervention platforms

• Cardiovascular, metabolic, and frailty monitoring technologies

• Substance use disorder and alcohol misuse intervention systems

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

• Precision medicine and personalized treatment management tools

• Polypharmacy management and medication adherence technologies

• HIV survivorship and quality-of-life monitoring systems

• Women’s health technologies related to HIV and menopause

• Behavioral health and social isolation intervention platforms

• Healthcare implementation science and integrated care delivery tools

• Predictive analytics for comorbidities and chronic disease management

• Wearable sensors and longitudinal patient monitoring systems

• HIV-associated cancer risk and survivorship technologies

• Prototype development, translational studies, and clinical validation research

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

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.