Small Business Funding Considerations and Contacts

NCATS supports research including, but not limited to, clinical technology, instruments, devices, and related methodologies that may have broad application to clinical research and better patient care. Our interests are in four main categories- (1) Preclinical Drug Discovery and Development; (2) Biomedical, Clinical and Health Research Informatics; (3) Clinical, Dissemination and Implementation Research and (4) Rare Diseases and Unmet Needs.
 

1. Innovative platforms for identification and prioritization of targets for therapeutic intervention with clear clinical impact.
2. Technologies to determine alternative uses for existing therapeutic interventions.
3. Tools and technologies to allow assaying of activities of compounds on currently “non- druggable” targets.
4. Phenotypic assay development, including stem cell technology platforms for human “disease in a dish” applications and the evaluation of toxicity.
5. Co-crystallization high-throughput screening techniques.
6. Small molecule and biologics analytical characterization.
7. Tools and technologies that increase the predictivity or efficiency of medicinal chemistry, biologic, or other intervention optimization.
8. Accelerate bioengineering approaches to the development and clinical application of biomedical materials, devices, therapeutics, and/or diagnostics.
9. Tools and technologies that increase the efficiency of human subjects research, including development of technologies that facilitate rapid diagnosis and/or clinical trial recruitment and subject tracking, IRB evaluation, and/or regulatory processes.
10. Novel platforms, technologies and tools for: (1) enabling clinical and translational research, particularly those with mechanisms for addition of patient reported data and (2) integration of patient data collected from multiple devices and wide-ranging clinical studies.
11. Searchable access to information about researchers and their expertise, including but not limited to their publications, published data sets, methods, patents, clinical trials, partnerships, collaborators, and clinical specialty/expertise (if applicable).
12. Tools for meaningful sharing of research data with low barrier for provision and user-friendly access.
13. Microphysiological Systems (MPS)/Tissue Chips.
14. Tools for building, maintaining, and utilizing knowledge networks, including but not limited to the use of large language models and other artificial intelligence software to mine the biomedical knowledge base, supporting NCATS goals such as drug repurposing for disease treatment.
15. Algorithms and validation frameworks for the application of artificial intelligence towards all stages of the translational pathway.

NCATS-SBIRSTTR
[email protected]
 

The NCCIH will support applications on the development of technologies and therapies relevant to complementary and integrative approaches. Complementary health approaches include a broad range of practices and interventions that can be classified by their primary therapeutic input, including nutritional and natural products (e.g., special diets, dietary supplements, botanicals, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, other force-based manipulations, or devices related to these approaches), or a combination of psychological and physical (e.g., yoga, tai chi, or some forms of art therapies, such as music-based interventions) input. Additionally, NCCIH will support applications that explore the impact of complementary and integrative health approaches on health promotion, resilience, and whole person health. Overall, NCCIH will support applications that include complementary and integrative health approaches, including multicomponent interventions that combine two or more complementary and integrative health approaches, or one or more complementary approaches integrated with one or more conventional care interventions. 

A. Novel technologies/methods to study the mechanistic effects of complementary and integrative health (CIH) interventions 
B. Research to enhance the safety, scalability, reproducibility, and translatability of CIH interventions 
C. Innovative methods and technologies to evaluate evidence-based CIH approaches 
D. Studies to optimize the impact of natural product(s) on target engagement(s) 
E. Development of diagnostic and prognostic technologies to support CIH interventions
F. Technologies to integrate CIH approaches into healthcare delivery
 

Name: NCCIH DER Funding Questions

Email: [email protected] 

NCI supports the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs by engaging domestic small business concerns in federal cancer research and development that has the potential for commercialization. 

A. Therapeutics (e.g., Small Molecules, Biologics, Radiomodulators, Gene/Cell-based Therapies and Drug Development-Related Tools, and Algorithm Development)
B. In Vitro and In Vivo Diagnostics (e.g., Companion Diagnostics, Prognostic Technologies, Treatment Monitoring and Diagnostic-Related Tools, and Algorithm Development)
C. Imaging Technologies (e.g., Agents, Devices, Software Tools, Algorithm Development, and Image-Guided Interventions)
D. Devices for Cancer Therapy (e.g., Interventional Devices, Drug Delivery Devices, Software Tools, Algorithm Development, Surgical, Radiation, and Ablative Therapies)
E. Agents for Cancer Prevention (e.g., Vaccines, but not “Technologies for Cancer Prevention”)
F. Development of Low-Cost Technologies for Low-Resource Settings. 
G. Development of Digital Health Tools
 

NCI SBIR Development Center

[email protected]

NEI supports research including, but not limited to, the following:

• Commercializable research and clinical innovations in ophthalmology and vision sciences
• Commercializable therapeutics including drugs, biologics, devices, or combination therapeutics that prevent or reduce blindness or improve ocular health
•  Market-ready technologies and diagnostic tools for predicting, identifying, or monitoring eye diseases and vision-related conditions
• Commercializable devices and services that assist people with blindness or visual impairments to improve quality of life Commercial-grade devices and support services that help individuals with blindness or vision impairments to improve and enhance their daily living experience
• Market-ready technologies that correct, enhance, or augment human vision

A. New or improved ophthalmic or surgical instruments for diagnosis and treatment of eye disorders.
B. Drug delivery systems; gene therapy, cell-based therapy or regenerative medicine.
C. New therapeutic approaches for inflammatory and degenerative diseases and for inhibition of abnormal angiogenesis in the retina and choroid.
D. New therapeutic approaches, artificial corneas, and drug delivery methods for the treatment of corneal injury, infection, dry eye, ocular pain, and other ocular surface disorders.
E. New approaches in the management of cataracts.
F. New therapeutic agents for treatment of glaucoma.
G. New or improved devices, systems, or programs that meet the rehabilitative and everyday living needs of blind or visually impaired persons.
 

NEI Extramural Research 

[email protected]

• Significant innovations in genomic methods or technology development. This includes, but is not limited to, advancements in nucleic acid sequencing, synthetic nucleic acid synthesis, functional genomics, single cell genomic analysis, transcriptomics, multi-omics, instrumentation, or molecular kits. 
• Tools and techniques that use genomics to improve patient health, such as approaches to incorporate genomic results into electronic medical records, clinical decision support tools, or genomic directed health care. 
• Strategies to enhance ethical, legal, and social aspects of genomics research or translation of genomics into health care. 
• Bioinformatics software or platforms for genomic, genetic, or sequence data processing or analysis, functional genomics, associations between genomic data and diseases or phenotypes, interpretation of variants, or genomic data integration into clinical decision making. 
• Databases and data management platforms for genomics research and application including platforms for sequence, functional, or phenotypic data or annotation of variants. 
• Development and application of methods for machine learning, pattern detection, or knowledge networks for genomics science or translation into health care. 
• Informatics methods and platforms that adopt data standards, enhance data sharing with privacy, and improve data exchange in genomics science or translation of genomics into health care. 
• Use of cloud and other computing models to improve scale, reproducibility, interoperability, cost-effectiveness, and utility of genomic and clinical data in genomics or translation into health care. 
• Development of curriculum and educational opportunities that increase the genomics knowledge of participants at the undergraduate, postbaccalaureate, graduate, postdoctoral, or professional levels. 

A. Significant innovations in genomic methods or technology development. This includes, but is not limited to, advancements in nucleic acid sequencing, synthetic nucleic acid synthesis, functional genomics, single cell genomic analysis, instrumentation, or molecular kits.  
B. Tools and techniques that use genomics to improve patients’ health, such as approaches to incorporate genomic results into electronic medical records, clinical decision support tools, or genomic directed health care. 
C. Strategies to enhance ethical, legal, and social aspects of genomics research or translation of genomics into health care. 
D. Bioinformatics software or platforms for genomic, genetic, or sequence data processing or analysis, functional genomics, associations between genomic data and diseases or phenotypes, interpretation of variants, or genomic data integration into clinical decision making.  
E. Databases and data management platforms for genomics research and application including platforms for sequence, functional, or phenotypic data or annotation of variants.  
F. Development and application of methods for machine learning, pattern detection, or knowledge networks for genomics science or translation into health care.  
G. Informatics methods and platforms that adopt data standards, enhance data sharing with privacy, and improve data exchange in genomics science or translation of genomics into health care.  
H. Use of cloud and other computing models to improve scale, reproducibility, interoperability, cost-effectiveness, and utility of genomic and clinical data in genomics or translation into health care.  
I. Development of curriculum and educational opportunities that increase the genomics knowledge of participants at the undergraduate, postbaccalaureate, graduate, postdoctoral, or professional levels. 
 

NHGRI Small Business

[email protected]

The National Heart Lung and Blood Institute (NHLBI) is interested in supporting the development of novel therapeutics, devices, diagnostics, digital health technologies, research tools, and other innovative solutions for advancing the prevention, diagnosis, and treatment of heart, lung, blood, and sleep (HLBS) diseases and disorders. 

Topics of particular interest for the NHLBI SBIR/STTR program include, but are not limited to, the following topics: 

• Technologies addressing HLBS complications relevant to maternal health and women’s health  
• Artificial Intelligence/Machine Learning technologies to improve the diagnosis, treatment, and prevention of HLBS diseases and disorders 
• Precision medicine approaches to treating HLBS diseases and disorders 
• New approach methodologies, tools, and point-of-care technologies to improve detection and therapeutic development for HLBS diseases and disorders 

A. Small and large animal testing of biomedical technologies for HLBS diseases and disorders.  

B. Human clinical studies for HLBS diseases and disorders.  

C. Development of therapeutics for HLBS diseases and disorders.  

D. Development of devices (including software and digital health tools) for HLBS diseases and disorders  

E. Diagnostics development for HLBS diseases and disorders.  

F. Investigation of biomarkers and biosignatures for HLBS diseases and disorders.  

G. Tools and technologies to enhance biomedical and clinical research for HLBS diseases and disorders.  

H. Tools, technologies, and novel strategies to improve the dissemination and implementation of evidence-based interventions for HLBS diseases and disorders.  
 

[email protected] 

The NIA is interested in proposals to develop and validate technologies that enhance the health and wellbeing of older adults. Areas of high interest include technologies intended to address unmet needs and have clear competitive advantages, development of commercialized solutions that are cost-effective and widely available, projects that include strong scientific rigor in the approach, projects that address gaps in NIA-funded research, and small businesses that are new to SBIR/STTR funding.

Scientific areas of interest include but are not limited to:

Alzheimer's Disease (AD), AD-Related Dementias (ADRD), and Age-Related Cognitive Decline:

Development of innovative tools, technologies, and interventions to prevent, diagnose, treat, monitor, or slow progression of AD/ADRD, cognitive decline, age-related sleep disorders, and delirium, including:

• Biomarkers, research tools, diagnostics, imaging technologies, and AI/ML methods for early detection and monitoring.
• Treatments, including cell and gene therapies, exosome-based therapeutics, behavioral and digital interventions as well as other novel approaches.

Aging Biology and Age-Related Diseases:

Development of technologies, therapeutics, biomarkers, and tools to measure, prevent, treat, or slow progression of age-related biobehavioral decline and conditions, including:

• Therapeutics targeting aging biology mechanisms and personalized medicine approaches.
• Research tools and data science technologies to understand aging and predict health outcomes.

Aging in Place of Choice and Care Delivery:

Development of technologies and interventions that promote healthy aging, support aging in place of choice, improve care delivery, or reduce caregiving burden, including: 

• Assistive devices, robotics, sensors, digital health products, and technologies to enhance care.

A. Development of innovative tools, technologies, biomarkers, data science methods, and personalized and therapeutic approaches including but not limited to imaging, diagnostics, AI/ML, exosome-based therapeutics, and cell and gene therapies to measure, prevent, treat, or slow the progression of age-related diseases and conditions, including Alzheimer's disease and AD-related dementias.
B. Development and evaluation of technologies, devices, tools, and innovative measures including minimally intrusive sensors, assistive devices, robotics, digital health products, and interventions targeting social, behavioral, economic, environmental, and regional factors to promote healthy aging, support aging in place, improve care coordination and management, enhance quality of life, or reduce caregiving burden. 
C. Development and validation of research tools, technologies, and approaches that identify or predict age-related biobehavioral decline, dysfunction, diseases, and conditions, including Alzheimer's disease and AD-related dementias.
 

NIA Scientific/Research Contact: NIA Small Business Programs: [email protected] 

Financial/Grants Management Contact: NIA Grants Management: [email protected] 

Please include the NOFO number, formatted with hyphens, in the email subject line to ensure the message is routed to the appropriate contact. 

NIAAA-specific SBIR and STTR interests are tailored toward commercializing technologies that address the unique physiological, social, and clinical challenges of alcohol misuse.

The NIAAA specifically encourages small business applications in the following high-priority areas:

• Biosensors and Wearables: Developing non-invasive, wearable devices for real-time alcohol monitoring (e.g., transdermal sensors) that provide more accurate data than self-reporting for research and clinical use.
• Digital Health and Telehealth: Creating mobile applications, AI-driven platforms, and software for the remote delivery of evidence-based treatments, such as Cognitive Behavioral Therapy (CBT) or recovery support services.
• Pharmacotherapy Development: Advancing the discovery and testing of new medications to treat Alcohol Use Disorder (AUD), specifically focusing on those with commercial potential and lower side-effect profiles.
• Diagnostic Tools and Biomarkers: Innovating point-of-care diagnostic tests and biological markers for early detection of alcohol-induced organ damage (liver, brain, heart) and Fetal Alcohol Spectrum Disorders (FASD).
• Advanced Data Analytics: Utilizing machine learning and big data tools to analyze large health datasets to predict relapse, identify high-risk drinking patterns, or personalize treatment plans.
• Regulatory Support: Utilizing the Commercialization Readiness Pilot (CRP) to fund late-stage R&D, such as IND-enabling studies, manufacturing scale-up, or clinical trial verification required for FDA clearance.
• Behavioral Interventions: Developing tools designed to improve treatment adherence, reduce stigma, or provide prevention and therapies to treat alcohol use disorder

A. Development and testing of drug candidates for treating AUD and health-related effects of alcohol misuse or for diagnosing and evaluating conditions related to alcohol misuse.
B. Development, optimization, validation, and/or testing of novel technologies, devices, methods or applications for neuroscience research (e.g., the effects of alcohol on central nervous system structure and activities).
C. Development, optimization, validation, and/or testing of novel technologies, devices, methods or applications to support screening, brief intervention, referral to treatment, and recovery.
D. Development, optimization, validation, and/or testing of novel technologies, devices, methods or application to prevent harmful drinking during pregnancy.
E. Development, optimization, validation, and/or testing of novel technologies, devices, methods or application to identify prenatal alcohol exposure, and enhance outcomes of individuals with Fetal Alcohol Spectrum Disorder.
F. Development, optimization, validation, and/or testing of novel technologies, devices, methods or application for preventing or treating alcohol-induced tissue injury or for the treatment of AUD.
G. Development, optimization, validation, and/or testing of novel technologies, devices, methods or application for measuring alcohol consumption.
H. Development, optimization, validation, and/or testing of novel technologies, devices, methods or application for the prevention of death or serious injury due to extreme alcohol exposure/poisoning.
I. Development and validation of tools, models, and/or technologies for alcohol-related laboratory studies, such as animal strains, cell lines, stem cells, in vitro techniques, neuroimaging, ligands, in vivo detection of neuromodulators, or computational tools.
J. Development and validation of tools, models, and/or technologies for conducting and supporting research in alcohol field (e.g., mobile application and assessment development, electronic data management system, ecological momentary assessment).
K. Development of biomolecular signatures of alcohol exposure and alcohol-induced tissue injury.
L. Digital health therapeutics and/or devices to treat or diagnose AUD or alcohol misuse.
M. Genotyping of DNA samples from subjects with addiction and substance use disorders.
 

[email protected]

The NIAID Small Business portfolio supports product development and commercialization in the areas of: 

• The immune system, microbe biology, and host-microbe interactions, 
• Diagnostic and prevention strategies 
• Treatment and cure strategies 

A. Asthma & allergy: Asthma, rhinitis, rhinosinusitis, IgE-mediated food allergy, eosinophilic gastrointestinal disorders, Food Protein-Induced Enterocolitis Syndrome, atopic dermatitis, urticaria & drug allergy. Diagnostic, prognostic, predictive, monitoring & response biomarkers, particularly in relation to immunologic interventions & approaches for detecting infants at risk for allergic diseases.
B. Basic immunology: Immune system development/function in humans & animal models, including computational/emerging technologies. Novel adjuvants. Preventative/therapeutic antibodies against pathogens; Biomarkers of immune protection/pathogenesis; Sample-sparing assays or organoids to study human immunity across the lifespan; Immunologic reagents for non-mammalian (e.g. Xenopus) & under-represented mammalian (e.g. ferret, bat) models. 
C. Autoimmunity, inborn errors of immunity (not HIV) & mucosal immunity: Mechanisms, diagnosis & treatment in animals/humans. Treatments, standardized diagnostic criteria, outcome measures, high throughput assays of immune cell activity. Prognostic, predictive, monitoring & response biomarkers.
D. Transplantation: Clinical research & translationally relevant animal/non-animal model research in organ, pancreatic islet allogenic, xenogeneic transplantation & vascularized composite allotransplantation. Immunomodulatory strategies promoting tolerance, graft survival, facilitating immunosuppression minimization; Non-invasive immune biomarkers/assays for subclinical graft rejection or predicting tolerance; Genetic approaches, analytical tools predicting transplant outcomes & improving donor/recipient matching.
E. Mitigation/treatment of radiation injuries: Preclinical research for radiation medical countermeasures (MCMs) & biodosimetry devices to generate data for FDA submission packages, focusing on diagnosing, mitigating or treating radiation injuries post-incident. Includes safety/efficacy studies, formulation optimization & biomarker development.
F. Chemical countermeasures: Preclinical MCM research to mitigate the acute and long-term health effects after exposure to Department of Homeland Security-designated Chemicals of Concern, including predictive disease models, response biomarkers and treatments.
G. Biomarkers: Infectious disease-related biomarkers. May utilize emerging data science technologies, computational methods or AI.
H. Diagnostics: Sensitive, specific & cost-effective clinical diagnostics including user-friendly point-of-care tools for detecting infections, such as HIV or toxin exposure. Assays for drug detection in human samples to monitor adherence. At-home self-testing tools for the detection/monitoring of infectious diseases.
I. Immunoprophylaxis: Developing/evaluating vaccine or immunoprophylaxis strategies/tools for infectious diseases.
J. Vector-borne pathogens: Arthropod monitoring, management/control to prevent transmission of vector-borne pathogens to humans.
K. Chemical prophylaxis: Long-acting (min. 30 days) sustained or extended-release pre-exposure prophylaxis, post-exposure prophylaxis & multipurpose prevention technologies for systemic protection from infection.
L. Therapeutics: Next-gen therapeutics (e.g. immunotherapeutics/biologics) to prevent infection/transmission or for infectious diseases treatment, including HIV. May utilize novel computational approaches to support development/evaluation.
M. Cure of persistent infections: Strategies to cure HIV & hepatitis B virus infections or achieve sustained remission w/o daily drug therapy. Detecting/quantifying persistent reservoirs of replication-competent latent virus in blood/tissues, including bioimaging techniques.
N. Formulation: Improved formulation/dosage technologies (e.g. less toxic, longer lasting) to prevent or treat infectious diseases, including HIV.
O. Implementation science: Behavioral/social sciences, epidemiology, implementation science & information dissemination related to infectious diseases.    

NIAID Small Business Team

[email protected]

The NIAMS small business program supports research and development of products and services for prevention, diagnosis and treatment of rheumatic, musculoskeletal and skin diseases. The research topics include, but are not limited to, the following: 

1. Rheumatic Diseases.  The NIAMS supports research on rheumatic and related diseases including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Lyme arthritis, viral arthritis, gout, calcium pyrophosphate deposition disease (CPDD), spondyloarthropathies, and systemic autoimmune diseases such as systemic lupus erythematosus (SLE), systemic scleroderma (SSc), and autoimmune myositis. 
2. Musculoskeletal Diseases.  The musculoskeletal system is composed of the skeleton, the muscles, and connective tissues such as cartilage, tendon, and ligament. The NIAMS supports research aimed at improving the diagnosis, treatment, and prevention of diseases and injuries of the musculoskeletal system and its component tissues. The topics in this area include research on musculoskeletal diseases such as osteoporosis, osteoarthritis, muscular dystrophy, and osteogenesis imperfecta; tissue engineered products; orthopedic devices and implants; and sports medicine and fitness.   
3. Skin Diseases. The NIAMS supports research on chronic inflammatory skin diseases such as psoriasis, rosacea, acne vulgaris, atopic dermatitis; autoimmune skin diseases such as pemphigus, vitiligo, and alopecia areata; skin repair and regeneration in treatment of chronic wounds and reducing scar formation; and skin cancer prevention such as products preventing skin cancer in early-stage development.

A. Research and development of new therapies using small molecules or biologics for arthritis, musculoskeletal and skin diseases.
B. Research and development of novel biomedical devices or tissue engineered products for arthritis, musculoskeletal and skin diseases.
C. Research and development of new biomarkers or novel imaging technologies for arthritis, musculoskeletal and skin diseases.
D. Research and development of innovative AI technologies to manage arthritis, musculoskeletal and skin diseases.
 

NIAMS does not accept clinical trials through any SBIR/STTR programs.

• Program Contact:  
  Email: [email protected] 
   
• Grants Management Contact:
  Email: [email protected]  

The NIBIB Small Business Program aims to translate cutting edge technologies into commercial products to address critical healthcare challenges. Through grants and contracts, the program supports the development of innovative biomedical technologies that improve human health. Areas of interest span biomedical imaging, medical devices, health informatics, diagnostic and therapeutic technologies, and related innovations at the intersection of biology and engineering. Projects should demonstrate strong commercial potential while addressing significant unmet clinical needs in biomedical imaging and bioengineering.

Specific program guidance includes:

• Technologies may be demonstrated using a specific indication or model system, but the core innovation must be broadly applicable without significant reengineering. 
• Applications fall outside NIBIB's mission if the primary focus is
  • developing technologies to elucidate basic biological functions or disease mechanisms, or
  • applying and testing previously developed tools or technologies.
• Per NOT-EB-21-005, NIBIB only supports early-stage clinical trials, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform technology development. NIBIB will not support applications with efficacy, effectiveness, or a post-market concern as an outcome.
• NIBIB may modify or decline funding applications for budgetary, administrative, or programmatic reasons. This includes reducing budgets, shortening award periods, or choosing not to fund applications.
• Awardees are strongly encouraged to contact NIBIB's Small Business Team about the Concept to Clinic: Commercializing Innovation (C3i) Program, a mentored, entrepreneurial training course that provides innovators with essential business tools to assess the commercial viability and potential business opportunity for their product.

NIBIB Small Business Team

[email protected]
 

NICHD supports research that includes, but not limited to the following:

• Reproductive health, including fertility, conception, contraception, and pregnancy
• Health of women before, during, and after pregnancy, and fetal development and infant survival
• Typical and atypical development and growth in children and adolescents, including experiences of trauma and critical illness 
• Gynecologic health and disease; safe and effective therapeutics and devices for children and pregnant and lactating women; dynamics of human populations across the lifespan
• Optimizing function in people with intellectual, developmental, and physical disabilities

A. Development of interventions, devices, tools, and technologies to inform screening, prevention strategies, and interventions aimed at making measurable improvements in child outcomes and promoting optimal development across infancy and toddlerhood, childhood, adolescence, and the transition to adulthood.   
B. Reproductive health-related applications proposing late-stage preclinical and clinical research (e.g., screening tools/diagnostics, investigational new drug/investigational device exemption enabling studies, good lab practice studies, complex in vivo experiments, clinical trials).
C. Develop innovative technologies and/or software to guide genetic and molecular diagnosis of structural congenital anomalies and inform targeted treatment.
D. Technology development to improve screening, diagnosis, treatment, and management of intellectual and developmental disabilities.
E. Development and evaluation of immune-preventative or therapeutic candidates and novel technologies towards screening, diagnosis, and management of chronic and acute infectious diseases in pregnant and/or lactating women, infants, children and adolescents, including but not limited to HIV, CMV, Syphilis, tuberculosis, viral hepatitis, and respiratory infections.
F. Complex prototyping of therapeutics (e.g., combination products).  Regulatory-quality product development, manufacturing and evidence generation.
G. Development of reliable technologies, methods, and AI approaches to understand the composition of human milk and optimize infant nutrition, particularly premature infant.
H. Development of tools and methods to accurately assess and measure linear growth and bone density and microarchitecture in childhood. Technological innovations in screening for nutritional disorders.
I. The development of devices, innovative therapeutic technologies, and behavioral interventions to improve patient outcomes in children exposed to trauma, injury and/or critical illness.
J. Methods for enhancing measurement, sampling approaches, the protection of participant privacy, and protections against fraud in research on sensitive topics or among hard-to-reach populations.
K. Development of devices, novel methods, or innovative treatments that enable early detection, diagnosis, enhanced monitoring, or interventions that improve health outcomes for pregnant, postpartum, and neonatal populations.
L. Development of medical rehabilitation interventions and biomedical technologies to improve rehabilitation treatment for restoration of function.
 

NICHD Small Business Program

Email: [email protected]

Consistent with NIH and Presidential priorities, the NIDA Small Business Program supports research and development of innovative medical and non-medical products and services for substance use disorders (SUDs) and adverse health consequences related to non-disordered drug use. Proposed solutions should improve access, affordability, and coordinated care across prevention, diagnosis, treatment, and recovery. NIDA prioritizes scalable solutions deployable within integrated delivery networks across healthcare, criminal justice, workforce, education, housing, and social service systems. Specific areas include, but are not limited to:

• Novel, mechanism-based treatments addressing the evolving overdose crisis (e.g., synthetic opioids, stimulants, polysubstance use)
• Best-in-class opioid use disorder treatments that improve retention and outcomes for individuals not adequately served by existing medications
• Innovative smoking cessation therapies that enhance adherence and long-term effectiveness
• First-in-class pharmacotherapeutics and medical devices for stimulant and cannabis use disorders
• Diagnostic tools for detection and quantification of drug exposure
• Medical devices, including digital diagnostics and therapeutics, and clinical decision support systems supporting SUDs and comorbid mental health conditions, with particular attention to pediatric populations.
• Digital health technologies addressing health-related social needs
• Human-biology-based new approach methodologies and other commercial research tools
• Forensic testing technologies identifying emerging drugs
• FDA Drug Development Tools and Medical Device Development Tools

NIDA strongly encourages applications that include early FDA engagement, consideration of regulatory pathways, payer engagement strategies, real-world evidence generation, and plans for sustainable adoption within integrated delivery networks and value-based care models.

A.    Drug Discovery and Development for SUD and medical consequences of drug use.

• Early discovery activities may range from target identification and validation through lead optimization to development of candidates.
• Assay development and validation.
• Preclinical and/or clinical drug development.
• New drug discovery and development-enabling technologies and tools, including Drug Development Tools (DDT), as defined by the FDA.

B.    FDA-regulated Medical Devices for SUD and medical consequences of drug use.

• New device development-enabling technologies and tools, including Medical Device Development Tools (MDDT), as defined by the FDA.
• Preclinical and clinical medical devices, including Software as Medical Device (SaMD).
   

Office of Translational Initiatives and Program Innovations (OTIPI)
[email protected]

NIDCD supports research including, but not limited to, the following:  

• Novel technologies for studying, diagnosing, and treating hearing loss, tinnitus, or balance disorders.  
• Novel diagnostic tools for testing human chemosensory function throughout the lifespan. 
• Novel technologies for studying, diagnosing, and treating voice, speech, and language disorders such as laryngeal dystonia (spasmodic dysphonia), phonotrauma, stuttering, dysarthria, developmental language disorders, and aphasia.   
• Innovative in vivo imaging capabilities that significantly advance visualization, diagnosis, and treatment of communication disorders in the clinic.  
• Novel systems of augmentative and alternative communication (AAC) for individuals with motor speech impairment, including a brain-computer interface (BCI) prosthesis for communication. 
• Novel assessments and interventions for late talking children or minimally verbal/ non-speaking individuals. 
• Novel applications of machine learning / artificial intelligence algorithms in hearing aids, cochlear implants, AAC devices, or for the analysis of voice, speech, and language. 

A.    Research and development for biomedical technologies (medical devices, diagnostic instruments, pharmaceuticals, drugs, therapeutics, vaccines, and biologics) that require approval or clearance by the FDA as a regulated product before commercial distribution.
B.    Development of novel open design hardware and software that facilitate rapid dissemination, reconfiguration, and enhancement to enable research beyond what can be performed with existing tools.
 

NIDCD SEED

Email: [email protected]

NIDCR supports small business–led development of technologies and products that translate dental, oral, and craniofacial (DOC) research into clinically actionable solutions across the lifespan. Emphasis is on feasibility, validation, regulatory readiness, and commercialization. Projects should align with NIDCR’s goal to rapidly translate oral health innovations toward clinical impact. Early engagement with program staff is encouraged to ensure alignment with mission and priorities. Scientific areas of interest include: 

• Targeted DOC diagnostics and therapeutic platforms for tooth-related diseases and periodontal/peri-implant conditions
• Orofacial pain assessment and management technologies, including clinical decision support
• Oral microbiome-based diagnostics and therapeutic platforms for polymicrobial diseases
• AI/ML-enabled predictive health and clinical decision support tools for DOC care
• Advanced dental materials, restorative technologies, and digital manufacturing systems
• Regenerative medicine technologies for craniofacial and dental tissue reconstruction
• Immunomodulatory and precision therapeutic delivery systems for oral and craniofacial conditions
• Digital behavioral and monitoring tools targeting DOC outcomes
• Real-world evidence and patient outcome data platforms to support clinical adoption, evidence generation, and downstream coverage considerations
• Implementation and dissemination technologies for priority-population oral health interventions
• Integrated oral–systemic health assessment and intervention platforms
• Regulatory and commercialization readiness tooling to support evidence generation, usability, and market adoption

Small Business Program

[email protected]

NIDDK is interested in projects that include robust timelines for commercialization, requisite fundraising, and all required regulatory milestones.

For those projects intended to support completion of research needed for an Investigational New Drug (IND) application, Investigational Device Exemption (IDE), or other regulatory clearance or approval, NIDDK is interested in projects that demonstrate how formal consultation with the U.S. Food and Drug Administration (FDA) has informed the research strategy.

NIDDK is interested in Phase IIB and Commercialization Readiness Pilot projects that propose to continue the process of developing products that ultimately require clinical evaluation and approval by a Federal regulatory agency, and that position the projects for independence from NIH support after the project period. 

A. Development or evaluation of pharmacological agents (i.e., drugs, therapeutics), gene therapies, novel formulations, cell-based or other biological technologies for intervention in or prevention of diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases.  
B. Development or evaluation of biomedical devices, tools, techniques, or instrumentation for intervention in or prevention of diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases.  
C. Development of biomarkers, assays, techniques, diagnostic technologies or associated reagents for assessing state or function in normal, developing, or diseased cells or tissues affected by diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases.  
D. Development or evaluation of imaging, screening, or evaluation techniques or technologies for assessing state or function in normal, developing, or diseased cells or tissues affected by diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases.  
E. Development or evaluation of animal or cell models for studying diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases.  
F. Development or evaluation of novel materials or material treatments (e.g., sterilization, coating, etc.) for use in devices or other tools or methods used to prevent, diagnose, or treat diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases.  
G. Development of cell- or data-banks for the biomedical research community for studying diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases.  
H. Development or evaluation of technologies, including software applications, for improving patient adherence in diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases.  
I. Development or evaluation of technologies for improving clinical research in diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases, including technologies for improving data collection and reporting of patient outcomes.  
J. Development or evaluation of –omics, informatics, or internet-based technologies for biomedical research or clinical applications in diagnosing or managing diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases.  
K. Development or evaluation of technologies to prevent or avert cell or tissue injury germane to diseases and disorders within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases during other disease states or surgical procedures.  
 

Program Contacts:

• Division of Diabetes, Endocrinology and Metabolic Diseases
  Email: [email protected]
• Division of Digestive Diseases and Nutrition
  Email: [email protected]
• Division of Kidney, Urologic, and Hematologic Diseases
  Email: [email protected]

Grants Management Contact

• Grants Management Branch
  Email: [email protected]

NIEHS SBIR/STTR grants help small businesses transform cutting-edge research into developing innovative and commercially viable products such as tools, technologies, assays, or services to translate and communicate environmental health research into improvements in human health. NIEHS SBIR/STTR program uses a combination of research & development, technology transfer, and communication strategies to aid the mission of NIEHS. 
The institute’s scientific areas of emphasis include, but are not limited to, the following: 
•    Tools/technologies such as sensors, computational methods, and exposomics approaches  for detecting and assessing human exposures to environmental hazards 
•    Innovative and/or alternative high-throughput or high-content assays/model systems,  computational toxicology approaches, and other related new approach methodologies (NAMs) for toxicity testing and understanding effects on human health and disease
•    Tools/methods/applications for evaluating environmental health and safety of engineered nanomaterials and micro/nanoplastics
•    Biomonitoring technologies   such as point-of-care approaches for personal exposure assessment and exposure mediated biological response biomarkers.
•    Intervention technologies and precision environmental health approaches to prevent or reduce human exposures or adverse health effects related to environmental stressors
•    Educational materials to promote or support understanding of environmental health science
The NIEHS Superfund Research Program (accepting SBIR applications only) focused on detection and remediation technologies for hazardous substances with relevance to Superfund and/or other contaminated sites

The NIEHS Worker Training Program (accepting SBIR applications only) also participates

A. Tools and technologies for toxicity screening of compounds
B. Devices and computational approaches for improved exposure assessment
C. Assays, complex in vitro systems, and computational approaches for predictive toxicology
D. Validation of sensor technologies, including field testing to improved performance characteristics and usability of the sensors
E. Intervention technologies to prevent or reduce exposures to environmental stressors
F. Tools and approaches for expanding environmental health literacy
 

[email protected]

NIGMS supports the development of technologies to address complex and interdisciplinary research questions in i) basic research, ii) clinical areas that impact multiple organs systems and iii) biomedical workforce development/training through educational activities, that may require additional resources.

A. Development of instrumentation and/or computational methods for detection, analysis, separation and/or manipulation of cells (e.g., flow cytometry). 
B. Development of software for improving the effectiveness of computational approaches in analysis of biomedical data. Areas of interest include, but are not limited to, genomics, proteomics, metabolomics, and electronic health records.
C. Development of new methods and materials directed toward the determination of macromolecular structures, assemblies, and complexes using methods including, but not limited to, x-ray diffraction, electron diffraction, cryo-EM, NMR and mass spectrometry.
D. Development of computational tools and methods for modeling, simulations and/or analysis of complex biological systems.
E. Development of methodology (technology) for genetic manipulation and analysis and detection of genetic polymorphisms, including disease genes (e.g., gene expression, probes) and/or detection of epigenomic changes (e.g, CRISPR).
F. Technologies for application of microscopy, spectroscopy, optical imaging, and single molecule analysis in basic biomedical research. Modalities of interest include, but are not limited to, fluorescence, scanning probe, electron paramagnetic resonance (EPR) and infrared (IR).
G. Development of technologies and methods to better achieve anesthesia and control of peri-operative pain.
H. Development of technologies to improve delivery of small molecules and biologics, not specific to an organ system or disorder (those projects should be directed to other categorical institutes of NIH).
I. Artificial intelligence and machine learning approaches to address early recognition of critical illness, including but not limited to sepsis, sepsis endotypes, patient trajectories, and resolution of sepsis.
J. Development of factors or therapies or devices involved in treating injuries not specifically linked to chronic illnesses, including tissue repair and wound healing.
K. Synthetic chemistry to efficiently produce methods for molecules of biomedical significance (including evaluation through pre-clinical testing).
L. Development of efficient, user-friendly, and culturally appropriate resources to enhance health science literacy.
M. Development of educational products for fostering biomedical entrepreneurship in under-resourced states.

 

NIGMS Small Business Program
[email protected]

NIGMS Grants Administration Branch
[email protected]

To advance its mission, NIMH supports small businesses to develop technologies, including, but not limited to, the following: 

• Neurotechnology development to enhance research on brain structure and function 
• Central nervous system (CNS) drug discovery/development for treating mental disorders – novel drug screening assays, novel compounds and drug targets; Research & Development (R&D) ranging from compound synthesis up to early stage clinical trials 
• Novel brain modulation methods/devices as potential therapeutics 
• Biological markers for CNS dysregulation/function and mental illness - objective, measurable biological indicators of physiological or disease processes to further assess replicability, reproducibility, stability, etc. at the subject level 
• Digital health technologies – as interventions or service delivery tools, to augment clinical care, and/or to enhance clinical research, and clinical trial design/implementation at the subject/patient level 
• Technologies addressing basic, behavioral, and implementation science related to people living with HIV – including all areas listed above 

A. Research and Development involving data collection from human subjects
B. Development of novel imaging probes to study brain structure and function at all levels, from the molecular to the whole organ, using any imaging modality, for preclinical and clinical use.
C. Development of complex technologies/ instrumentation including hardware, software, iterative user testing, and scale-up for manufacturing towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience or clinical practice. This also includes clinical research tools.
D. Preclinical and Clinical treatment/intervention development and testing with human subjects, also including testing/studies required by the FDA, or for reimbursement strategy.
E. Educational tools/technologies for neuroscience and mental health.
F. Novel screening assays for high throughput acquisition and analysis of data about behavior and the brain, from the level of genes to the level of behavior, including unbiased screening assays.
G. Neurotechnologies that support enhancing the understanding of central nervous system (CNS) structure, function, and behavior, including the goals of the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative.
H. Innovative research tools and technologies - including neuroimaging platforms, CNS-targeted therapeutics, neuroprotective agents, in vitro models, biomarkers, and informatics systems - for assessing HIV-associated neurocognitive and neuroimmune dysfunction, targeting and eliminating CNS viral reservoirs, and enabling the translation and integration of NeuroHIV interventions into preclinical and clinical neuropsychiatry practice.
I. Digital health tools, decision-support platforms, mobile technologies, predictive algorithms, and multipurpose prevention products to improve HIV prevention, care engagement, and treatment adherence; support mental health integration in HIV care; and deliver tailored, data-driven communication and education to individuals and communities most affected by HIV.
J. Biomarkers or data/behavioral markers (reliable, reproducible, stable) including composite measures, standardization of data collection, processing and analytics. These markers can identify at-risk individuals prior to disease onset, improve diagnosis, predict treatment response, or measure disease progression. Also needed are markers for clinical trials to identify dose ranges, to identify a specific subpopulation of subjects to enroll in a treatment trial, or to measure efficacy or toxicity/side effects.
K. Digital tools to support mental health screening, assessment, diagnosis, treatment, monitoring, clinical decision support, provider supervision/training, treatment fidelity or quality improvement/monitoring, or implementation of evidence-based practices. May also include software as a medical device and/or clinical trials to evaluate feasibility, acceptability, efficacy, or effectiveness of digital tools to support mental health treatment or service delivery.
L. Early stage, proof of concept clinical trials to advance the development of novel therapeutics. The clinical trials are expected to include biological/behavioral data to assess target engagement and to help determine potential success/failure before moving on to larger clinical trials.
 

NIMH Small Business Research Programs

[email protected]  

NINDS utilizes the SBIR and STTR programs to enable the commercial development of tools and technologies that serve the NINDS mission space. Priority is given to proposals with the greatest potential to advance the NINDS mission. 

NINDS is especially interested in the following, in no preferential order:

1. Novel and innovative technologies that address significant unmet needs 
2. Technologies in development for their first indication or initial market opportunity
3. Technologies with a compelling need for federal support, such as those at a stage of development requiring de-risking to attract private investment, New Approach Methodologies (NAMs), and those addressing underserved markets including rare and pediatric disease indications
4. Under-resourced technologies, indications, markets, and geographical regions within the NINDS SBIR/STTR portfolio and mission space
5. New applicants pursuing their first SBIR/STTR-funded technology
6. Applicants with a demonstrated track record of advancing technologies through commercialization milestones
7. For continuation applications, applicants who have achieved intended outcomes under prior funding
8. Applications demonstrating robust rigor in their approach and preliminary data

NINDS deprioritizes:

1. Incremental advances over existing technologies 
2. Technologies being developed for secondary indications without significant additional technological innovation
3. Applications lacking rigor in their approach and/or preliminary data
4. Direct-to-Phase 2 and continuation applications lacking rigor in their preliminary data
5. Applicants with substantial prior funding and/or a poor track record of commercialization progress
6. Applicants lacking focus on or expertise in the NINDS mission space

A. In vivo animal testing required for therapeutics and diagnostics development.    
B. Drug and biologics preclinical discovery and development activities to support regulatory approval, such as lead identification/optimization, preclinical efficacy testing, IND-enabling studies, and manufacturing for clinical trials.    
C. Device preclinical discovery and development activities to support regulatory approval, such as hardware prototyping, device/software verification, biocompatibility/sterilization testing, pre-clinical efficacy testing, large animal GLP safety testing, and preparing material/devices for human testing.   
D. Clinical testing of therapeutics (drugs, devices, or biologics), diagnostics, clinical and rehabilitation tools (i.e., intraoperative technologies, rehabilitation devices and programs, and brain monitoring systems), and technologies for clinical research. This would include clinical research studies to test scientific hypothesis that are not feasible or practical to conduct in animal models but would inform a final device design.  
E. In vivo animal testing of technologies for animal research and development of animal models for drug development and neuroscience research.   
F. Research that requires special facilities to contain hazardous or infectious materials.    
G. Development and validation of biomarkers and the technologies and approaches for measuring them. Biomarkers may include diagnostic, prognostic, monitoring, pharmacodynamic/response, risk, safety, and predictive biomarkers.    
 

Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative   
H. Development of research tools and technologies to understand the dynamic activity of neural circuits.   
I. Development of novel tools and technologies to facilitate the detailed analysis of complex circuits to provide insights into cellular interactions that underlie brain function.   
J. Development of invasive and non-invasive devices for recording and modulation in the human central nervous system.   

NINDS Small Business Program
[email protected]   

Applicants are encouraged to submit a one-page overview of their proposed project at least one month before application submission to confirm alignment with NINDS interests.

Areas of interest include innovative small business proposals as they relate to NINR research priority areas of intervening on the conditions of daily life that influence health, using multilevel or multi-sectoral approaches to prevent chronic conditions and improve the outcomes of those with chronic conditions, promoting healthy school environments, meaningful engagement of communities at all stages of the research process, and integrating technological advancements, particularly in artificial intelligence (AI), to streamline and improve healthcare outcomes.
 

A. Development of digital health technologies that explicitly aim to reduce health disparities in prevention and management of chronic disease
B. Development of digital health technologies that address the conditions where people are born, live, learn, work, play, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks to advance disease prevention and health promotion
C. Projects proposing clinical trials with a large number of participants

 

NINR Small Business Inquiries

• [email protected]
   

The NLM Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program supports the development of biomedical informatics tools and methods which are best disseminated through commercialization.

The program aims to encourage small businesses to develop innovative technologies, tools, methods, and software platforms that advance:

• Trustworthy, reproducible, and rigorous biomedical AI
• Biomedical data infrastructure at scale
• Sustainable biomedical reference resources and platform science
• Market innovative human-centered use and impact informed biomedical informatics tools and methods

Applications which utilize, integrate, or build upon data, resources, and tools fostered by NLM and NIH supported communities are encouraged. 

NLM does not accept budget cap waiver requests.

NLM Extramural Programs

[email protected] 

ORIP supports research projects to develop technology including, but not limited to, the following: 

• Create, characterize, or improve models of human disease; and develop new approach methodologies (NAMs) to complement or reduce the use of animal models in research. 
• Preservation, revival and monitoring of cells, tissue, organs or gametes from model systems. 
• Validate research models to enhance the rigor and reproducibility of pre-clinical studies. 
• Devices and technologies required for development and maintenance of conventional and NAM biological model systems, including those for advancing the care, welfare, housing, and management of these models; or sensor and monitoring technologies for the surveillance of models or environmental factors that lead to improved rigor and reproducibility for studies using these models.

General Inquiries:

ORIP Small Business

[email protected]