NIH Highlighted Topic: Effects of Contraception as Treatment for Gynecologic Disorders
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is seeking innovative research proposals through the SBIR Program focused on the use of contraceptive therapies to treat gynecologic disorders such as endometriosis, polycystic ovary syndrome (PCOS), uterine fibroids, dysmenorrhea, and related women’s health conditions. NIH is particularly interested in technologies, clinical approaches, and data-driven solutions that improve understanding of the long-term effectiveness, safety, treatment optimization, and patient outcomes associated with hormonal contraceptive use for gynecologic disease management.
Although hormonal contraceptives are widely used off-label to manage gynecologic conditions, significant gaps remain regarding comparative effectiveness, personalized treatment strategies, biomarker identification, patient decision-making, and long-term health outcomes. Companies developing women’s health technologies, AI-enabled clinical analytics platforms, digital health solutions, biomarker tools, therapeutic approaches, data infrastructure, or precision medicine applications related to gynecologic disorders may be strong candidates for funding.
NIH is especially interested in projects utilizing artificial intelligence, machine learning, clinical datasets, biomarker discovery, molecular and cellular analysis, -omic technologies, and clinical evaluation approaches to improve treatment guidelines and patient-centered care. Research examining quality of life, treatment adherence, patient education, and long-term outcomes associated with contraceptive therapies is also encouraged.
Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.
This highlighted topic is supported primarily by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women’s Health (ORWH), both of which may give special consideration to high-impact applications advancing women’s health, gynecologic disease treatment, hormonal therapy optimization, and precision reproductive medicine.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of technologies and therapeutic approaches focused on gynecologic disorders and the use of hormonal contraceptives as treatment strategies.
Eligible activities may include:
AI and machine learning platforms analyzing treatment outcomes from clinical or medical record datasets
Biomarker discovery associated with improved responses to hormonal contraceptive therapies
Clinical studies evaluating different estrogen/progestin formulations or delivery methods
Research comparing continuous versus cyclic contraceptive treatment approaches
Technologies supporting treatment optimization for endometriosis, PCOS, uterine fibroids, dysmenorrhea, and related conditions
Digital health platforms supporting symptom tracking, treatment adherence, patient education, or personalized care
Precision medicine approaches for contraceptive selection and gynecologic disease management
Research evaluating quality of life, psychosocial outcomes, and patient-centered treatment effectiveness
Development of predictive analytics tools for treatment response and long-term outcomes
Molecular, cellular, genomic, proteomic, or other -omic approaches investigating gynecologic disease mechanisms
Clinical data infrastructure, patient registries, and real-world evidence studies
Validation, prototype development, translational research, and regulatory preparation activities
Commercialization planning and scale-up activities for women’s health technologies and therapeutics
Funding may also support personnel, software development, clinical data analysis, laboratory testing, prototype fabrication, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable solution aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
Triple your likelihood of success through proven strategy and insider-aligned proposal development
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Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.
