NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)
Closed Posted
- Opportunity number
- RFA-HL-26-015
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
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- 93.233 National Center on Sleep Disorders Research
- 93.350 National Center for Advancing Translational Sciences
- 93.837 Cardiovascular Diseases Research
- 93.838 Lung Diseases Research
- 93.839 Blood Diseases and Resources Research
- 93.840 Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
- Funding instrument
- Grant
- Category
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- Health
- Eligible applicants
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- Small Businesses
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Heart, Lung, and Blood Institute (NHLBI) is seeking Small Business Innovation Research (SBIR) Phase IIB grant applications from small businesses to support late-stage research and development of technologies addressing rare diseases or pediatric populations aged 0-12 years. This funding opportunity targets projects that have previously received SBIR or STTR Phase II awards and require federal regulatory approval, with the primary objective of advancing promising medical technologies toward commercialization. The evaluation criteria will include assessments of scientific merit, technical approach, investigator qualifications, technological innovation, commercial potential, budget appropriateness, and research environment. Competitive preference will be given to applications demonstrating the ability to secure independent third-party investor funds. The grant application deadline is November 17, 2025, and applications must be relevant to the NHLBI mission and require ultimate approval/clearance by a federal regulatory agency.
While specific award amounts are not explicitly stated, the Phase IIB Small Market Awards are designed to bridge the funding gap between Phase II research and commercialization for small market technologies. The grants will support projects aimed at pursuing regulatory milestones necessary to advance medical products, with a focus on promoting partnerships between small business awardees and third-party investors or strategic partners, including patient advocacy organizations. The research will be conducted at the recipient organizations' facilities, with the ultimate goal of developing clinically relevant commercial products in the heart, lung, blood, and sleep disorders domains. The grant mechanism is intended to accelerate the development of innovative medical technologies for rare diseases and young pediatric populations, potentially transforming healthcare solutions in these critical areas.
Synopsis
The Small Business Innovation Research (SBIR) Program is an important National Institutes of Health (NIH) funding mechanism used to develop innovative solutions that address public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of biomedical products is often impeded by a significant funding gap between the end of the SBIR Phase II award and the commercialization stage. This gap is increased by the barriers associated with technologies under development for small commercial markets, such as those focused on rare diseases or young pediatric populations. This Notice of Funding Opportunity (NOFO) invites small businesses to submit SBIR grant applications to support later stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR (Small Business Technology Transfer) Phase II awards that address rare diseases or young pediatric populations (aged 0-12 years and defined in Section IV, part 7), and will require eventual Federal regulatory approval/clearance. The goal of this NOFO and the resulting Phase IIB awards is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between small business awardees and third-party investors and/or strategic partners, including patient advocacy organizations. Proposed projects MUST be relevant to the NHLBImission(see B. Scientific/Technical Scope) and require ultimate approval/clearance by a Federal regulatory agency.
Files
| File | Type | Posted |
|---|---|---|
| RFA-HL-26-015-Full-Announcement.html | HTML file |
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