Opportunity Information: Apply for RFA HL 19 017
The NHLBI SBIR Phase IIB Bridge Award (R44, clinical trial optional) is a National Heart, Lung, and Blood Institute funding opportunity designed to help small businesses move an already-supported SBIR/STTR Phase II project through the expensive, high-effort steps that typically stand between a promising technology and real-world commercialization. The central idea is to "bridge" the gap where many health technologies stall: scaling development, preparing for market entry, and completing the kinds of studies and documentation that are often needed before a product can be sold or widely adopted. The program focuses specifically on technologies tied to the NHLBI mission areas, meaning they must address heart, lung, blood, or sleep disorders and related diseases, and they must be on a path that ultimately requires U.S. federal regulatory approval or clearance (for example, FDA pathways for drugs, biologics, devices, diagnostics, or certain digital health products, depending on how they are regulated).
A defining feature of this award is that it is built around outside investment and strategic partnering, not just government dollars. Applicants are expected to pursue, secure, or already have secured independent third-party funding and/or support from investors or strategic partners, and that outside support is expected to be at least equal to the amount of NHLBI funding requested over the Phase IIB Bridge project period. In practice, this means the institute is looking for projects that have both technical momentum and credible commercial traction, where the company can demonstrate that other funders or partners see enough value to commit meaningful resources alongside the federal award. The intent is to de-risk the final development stretch by combining NHLBI support with market-driven capital and expertise.
To apply, a small business must submit a Commercialization Plan. This plan is not a minor attachment; it is the backbone of the application and is expected to lay out a realistic, investor-aware route to market. It should describe the product and value proposition, the target customer and clinical need, the competitive landscape, intellectual property position, regulatory strategy, reimbursement and adoption considerations (where relevant), manufacturing or scale-up approach if applicable, and detailed milestones that connect the proposed Phase IIB work to a commercial endpoint. Just as importantly, the plan must explain the third-party funding picture: what has already been secured, what is anticipated during the award period, who the third parties are (investors and/or strategic partners), and how that non-NHLBI support will align with and strengthen the technical and commercialization milestones.
From a development standpoint, the opportunity is flexible in terms of stage as long as it fits the bridge-to-commercialization purpose. Projects can cover preclinical development, clinical development, or a combination, depending on what is most appropriate for the technology and its regulatory path. Clinical trials are explicitly allowed but not required, which signals that NHLBI is open to supporting everything from late-stage preclinical validation and design-for-manufacture work to early feasibility or other clinical studies, provided the work is justified and clearly advances readiness for regulatory submission and commercialization.
Administratively, this is a discretionary grant mechanism under the Department of Health and Human Services, National Institutes of Health, and it is aimed exclusively at eligible small businesses. The funding opportunity number is RFA-HL-19-017, and it falls under health-related assistance listings (CFDA/assistance numbers) including 93.233 and several 93.83x series entries associated with NHLBI programs. The award ceiling listed is up to $1,000,000, with an expected number of awards around five. The opportunity was created on May 16, 2018, and the original closing date was July 9, 2020. Overall, the program is best understood as a commercialization acceleration vehicle: it is meant for Phase II-derived technologies that need significant, capital-intensive work to reach the market and that can demonstrate serious external financial or strategic commitment alongside NHLBI support.Apply for RFA HL 19 017
- 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 Bridge 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, 93.837, 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 5 candidate(s).
- Eligible applicants include: Small businesses.
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