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) | RFA HL 26 015

Opportunity Information: Apply for RFA HL 26 015

The NHLBI SBIR Phase IIB Small Market Awards (R44, clinical trial optional) is a National Institutes of Health funding opportunity designed to help small businesses push promising, later-stage biomedical technologies past a common bottleneck: the financing and development gap that often appears after an SBIR or STTR Phase II project ends but before a product is ready for regulatory approval and real-world commercialization. This gap tends to be even worse for products aimed at small commercial markets, especially those serving rare diseases or very young pediatric populations, where traditional investors may be hesitant because the patient population is limited and the return on investment can be less predictable. Through this NOFO, the National Heart, Lung, and Blood Institute (NHLBI) is specifically trying to keep strong projects from stalling at this critical stage and to accelerate their path toward patients.

The award is targeted to U.S. small business concerns that already have a foundation of feasibility and development work, because applicants must be building on prior SBIR or STTR Phase II funding. The supported projects must address either rare diseases or conditions affecting young pediatric populations aged 0 to 12 years (as defined in the solicitation), and they must be developing a product that will ultimately require approval or clearance by a U.S. federal regulatory agency. In other words, this is meant for technologies on a credible, regulated product-development track, such as therapeutics, devices, diagnostics, or other regulated health technologies, rather than early exploratory science. The scientific focus also must align with the NHLBI mission area, meaning the work needs to be clearly relevant to heart, lung, blood, and sleep disorders and diseases.

A central feature of this program is its emphasis on commercialization readiness and external validation. NHLBI is not only funding additional R and D, but also explicitly encouraging applicants to form meaningful partnerships with third-party investors and strategic partners, which can include patient advocacy organizations. The idea is that Phase IIB funding should help a company hit the next set of value-creating milestones that matter for regulatory progress and market entry, while also leveraging outside partners who can bring capital, expertise, distribution channels, clinical networks, or disease-community engagement. This partnering emphasis is especially important for small-market technologies, where advocacy groups and mission-driven investors may play an outsized role in helping a product move forward.

The funding instrument is an SBIR grant under the R44 mechanism, and the NOFO indicates that clinical trials are optional, which means a project may include clinical trial activities if they are appropriate for reaching the next development milestone, but a clinical trial is not required for every applicant. The opportunity is listed as discretionary and falls within NIH health-related funding activity categories. It is administered by NIH with NHLBI as the relevant institute, and it is associated with CFDA numbers 93.233, 93.350, 93.837, 93.838, 93.839, and 93.840. The funding opportunity number is RFA-HL-26-015, and it was created on 2024-11-18, with an original closing date of 2027-02-26.

Eligibility is limited to small businesses, and foreign organizations cannot apply. In addition, non-U.S. components of U.S. organizations are not eligible to apply, although certain foreign components may be permitted under standard NIH policy definitions and restrictions. Overall, this program is best understood as a late-stage SBIR bridge intended to de-risk and propel small-market, NHLBI-relevant technologies from successful Phase II results into the regulatory and commercialization endgame, with a strong push toward real partnerships and a clear route to approval and market impact.

• The 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 2024-11-18.
• Applicants must submit their applications by 2027-02-26.
• Eligible applicants include: Small businesses.

Apply for RFA HL 26 015

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