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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FAQs: NHLBI SBIR Phase IIB Bridge Award (R44, Clinical Trial Optional)
What is the NHLBI SBIR Phase IIB Bridge Award (R44)?
The NHLBI SBIR Phase IIB Bridge Award (R44, clinical trial optional) is a National Heart, Lung, and Blood Institute funding opportunity intended to help a small business move an already-supported SBIR/STTR Phase II project through the costly, high-effort steps that often sit between a strong technology and real-world commercialization.
What problem is this award designed to solve?
It is designed to "bridge" the common gap where many health technologies stall: scaling development, preparing for market entry, and completing the studies and documentation typically needed before a product can be sold or widely adopted.
Who is the sponsoring agency for this opportunity?
The opportunity is administered by the National Heart, Lung, and Blood Institute (NHLBI), which is part of the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services (HHS).
Who is eligible to apply?
This opportunity is aimed exclusively at eligible small businesses.
Does the project have to be related to specific disease areas?
Yes. The technology must align with NHLBI mission areas, meaning it must address heart, lung, blood, or sleep disorders and related diseases.
Does the technology need to require regulatory approval or clearance?
Yes. The technology 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).
Is this award intended for new ideas or for projects already supported under SBIR/STTR?
It is intended to advance an already-supported SBIR/STTR Phase II project, focusing on the later development work needed to reach commercialization.
What makes this award different from other SBIR/STTR support?
A defining feature is the emphasis on outside investment and strategic partnering alongside government funding. NHLBI expects applicants to pursue, secure, or already have secured independent third-party funding and/or support from investors or strategic partners as a core part of the bridge-to-commercialization approach.
How important is third-party funding or partner support in this program?
It is central to the program. Outside support is expected to be at least equal to the amount of NHLBI funding requested over the Phase IIB Bridge project period, signaling that NHLBI is looking for projects with credible commercial traction and meaningful external commitment.
Does the outside support have to be only cash investment?
The opportunity describes independent third-party funding and/or support from investors or strategic partners. The application is expected to explain what has been secured and what is anticipated, who the third parties are, and how that support aligns with the project milestones.
What is the purpose of combining NHLBI funds with outside investment?
The intent is to de-risk the final development stretch by pairing NHLBI support with market-driven capital and expertise, helping the technology reach regulatory-readiness and commercialization.
Is a Commercialization Plan required?
Yes. Applicants must submit a Commercialization Plan, and it is described as the backbone of the application rather than a minor attachment.
What should the Commercialization Plan cover?
The plan is expected to 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.
What third-party funding details must be addressed in the Commercialization Plan?
The plan must explain the third-party funding picture, including 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.
What stages of development can be supported under this award?
The opportunity is flexible as long as the work fits the bridge-to-commercialization purpose. Projects can include preclinical development, clinical development, or a combination, depending on what is most appropriate for the technology and its regulatory path.
Are clinical trials allowed under this award?
Yes. Clinical trials are explicitly allowed but not required (clinical trial optional).
If clinical trials are optional, what kinds of non-clinical activities might fit?
The description indicates NHLBI is open to supporting late-stage preclinical validation and design-for-manufacture work, as well as other development steps, as long as the work is justified and clearly advances readiness for regulatory submission and commercialization.
What is the maximum award amount?
The listed award ceiling is up to $1,000,000.
How many awards does NHLBI expect to make?
The expected number of awards is around five.
What is the funding opportunity number?
The funding opportunity number is RFA-HL-19-017.
Are there assistance listing (CFDA) numbers associated with this opportunity?
Yes. The listing includes 93.233 and several 93.83x series entries associated with NHLBI programs.
When was this opportunity created and when did it close?
The opportunity was created on May 16, 2018, and the original closing date was July 9, 2020.
What is the overall goal of the program?
It is best understood as a commercialization acceleration vehicle for Phase II-derived technologies that need significant, capital-intensive work to reach the market and can demonstrate serious external financial or strategic commitment alongside NHLBI support.
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