Opportunity Information: Apply for RFA HL 19 018
The NHLBI SBIR Phase IIB Small Market Award (R44; clinical trial optional) is a National Institutes of Health funding opportunity from the National Heart, Lung, and Blood Institute designed to help small businesses push promising health technologies closer to real-world use when the target market is inherently limited. It specifically supports companies that already completed a Phase II SBIR or STTR award and are now working on products tied to NHLBI priorities in heart, lung, blood, or sleep disorders and diseases, with a clear emphasis on either rare diseases or conditions affecting very young pediatric populations. The central idea is to fund the additional technical and clinical validation work that is often still needed before private investors, strategic partners, or other non-federal sources are willing to fully finance the next steps toward commercialization.
A key requirement is that applicants submit a detailed Commercialization Plan. This plan is not a formality; it is meant to show a credible path to market and to demonstrate that the company is actively building financial and strategic support beyond NIH. The announcement expects independent third-party funding either already in hand or anticipated during the project period, and the expectation is that this outside support will total at least one-third of the NHLBI funds requested over the life of the award. In practice, that means the program is looking for projects that are scientifically and operationally ready for late-stage development and that have enough market and investor interest to attract meaningful non-government backing, even though the eventual market may be small.
The funded work can cover preclinical development, clinical development, or a combination of both, depending on what is necessary to de-risk the product for commercialization. Clinical trials are allowed when they make sense for the technology and stage of development, but a clinical trial is not mandatory. Regardless of whether the work is preclinical or clinical, projects must involve a product that will ultimately require federal regulatory approval or clearance, such as through the FDA. This requirement signals that the program is aimed at true translational commercialization efforts (for example, drugs, biologics, devices, diagnostics, or certain digital health products that fall under regulatory oversight), rather than basic research or tools that do not require a regulatory pathway.
Administratively, this is a discretionary grant opportunity (not a contract) offered by the U.S. Department of Health and Human Services through NIH/NHLBI. Eligible applicants are small businesses. The opportunity number is RFA-HL-19-018. The listed award ceiling is $1,000,000, and NHLBI anticipated making about 2 awards under this announcement. The program is associated with CFDA numbers 93.233, 93.350, 93.837, 93.838, 93.839, and 93.840. The opportunity was created May 16, 2018, with an original closing date of July 9, 2020.
Overall, the opportunity is best understood as a targeted “bridge” for SBIR/STTR Phase II graduates working in small-market areas, where traditional financing can be more difficult because revenue potential is constrained by rarity of disease or limited patient populations. NHLBI funding is meant to help generate the validation evidence and regulatory progress needed so the product can continue forward with private funding after the NHLBI support ends.Apply for RFA HL 19 018
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "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)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.350, 93.837, 93.838, 93.839, 93.840.
- This funding opportunity was created on May 16, 2018.
- Applicants must submit their applications by Jul 09, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Small businesses.
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| NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 - Clinical Trial Optional) Apply for RFA HL 19 017 Funding Number: RFA HL 19 017 Agency: Department of Health and Human Services, National Institutes of Health Category: Health Funding Amount: $1,000,000 |
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