RFA-HL-26-015: 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
This grant is closed. Who won this program's grants before is below, and similar open grants are at the end of the page. It is in our archive of National Institutes of Health notices from 2024.
National Institutes of Health offered grants to small businesses. Applications closed on November 17, 2025.
From the official notice on Grants.gov, last changed November 17, 2025. Checked November 7, 2026.
- Award amountsNot given on Grants.gov
- Cost sharingNot required
- Funding typeGrant
About this NIH notice
- Activity codeR44
- Clinical trialsOptional
- Funded byNHLBI
- Median yearly award$1.2 million
- Typical project length7.5 years
- R44, Small Business Innovation Research (SBIR) Phase II. Full research and development of an SBIR project after Phase I (or both phases at once, called Fast Track). Other open R44 notices.
Projects funded under RFA-HL-26-015 were run by National Heart Lung and Blood Institute (NHLBI, 3 projects). Contact the program officer at the institute that fits your project before you apply; the notice lists them.
Application due dates, page limits and budget limits are set in the notice. Read RFA-HL-26-015 in the NIH Guide.
Other notices with this title
| Notice | Posted | Deadline | Status |
|---|---|---|---|
| RFA-HL-23-008 | November 16, 2021 | Closed February 28, 2024 | Closed |
Key dates
| Posted | November 18, 2024 |
|---|---|
| Deadline | November 17, 2025 |
| Archived by Grants.gov | November 18, 2025 |
Who can apply
This opportunity was open to small businesses.
- Small businesses
Other Eligible Applicants include the following:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Is this a realistic fit?
- Most of the money in the 4 programs behind this notice (72% over five years) went to colleges and universities.
- No cost sharing or match is required.
What the grant funds
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.
Funded under RFA-HL-26-015 so far
NIH funded 3 projects under RFA-HL-26-015 in fiscal 2026, at 3 institutions. The median yearly award was $1.2 million.
| Project | Institution | Fiscal year | Award |
|---|---|---|---|
| DEVELOPMENT OF A PULMONARY FLOW RESTRICTOR FOR HYPOPLASTIC LEFT HEART SYNDROME | Starlight Cardiovascular, Inc. | 2026 | $1.2 million |
| SonoHeal: Smart Resonating Closed-loop Airway Clearance Technology | Cognita Labs, LLC | 2026 | $1.2 million |
| CardiaZn Stent: First-in-Baby Clinical Study | Pediastent LLC | 2026 | $1.5 million |
Who has won Cardiovascular Diseases Research grants before
From fiscal 2021 to 2025, Cardiovascular Diseases Research (93.837) awarded $15 billion across 11,798 grant awards, an average of $1.2 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Trustees of the University of Pennsylvania | Pennsylvania | 313 | $380 million |
| Brigham & Womens Hospital Inc | Massachusetts | 274 | $374 million |
| Regents of the University of Michigan | Michigan | 277 | $355 million |
| The Trustees of Columbia University in the City of New York | New York | 207 | $335 million |
| University of Pittsburgh - of the Commonwealth System of Higher Education | Pennsylvania | 295 | $320 million |
Who has won National Center for Advancing Translational Sciences grants before
From fiscal 2021 to 2025, National Center for Advancing Translational Sciences (93.350) awarded $3.1 billion across 867 grant awards, an average of $3.6 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| University of Pittsburgh - of the Commonwealth System of Higher Education | Pennsylvania | 15 | $95.3 million |
| Vanderbilt University Medical Center | Tennessee | 10 | $94.6 million |
| Duke University | North Carolina | 11 | $88.9 million |
| University of North Carolina at Chapel Hill | North Carolina | 16 | $74.5 million |
| The Johns Hopkins University | Maryland | 20 | $70.7 million |
Who has won Lung Diseases Research grants before
From fiscal 2021 to 2025, Lung Diseases Research (93.838) awarded $8.7 million across 5 grant awards, an average of $1.7 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The General Hospital Corporation | Massachusetts | 1 | $5.4 million |
| New England Research Institutes Inc | Massachusetts | 1 | $2.7 million |
| The Trustees of the University of Pennsylvania | Pennsylvania | 1 | $355,699 |
| University of Washington | Washington | 1 | $350,272 |
| The Trustees of Columbia University in the City of New York | New York | 1 | $319,659 |
Other programs behind this notice
- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
Applying now
This notice no longer takes applications. Agencies often post the same opportunity again under a new number, so check the program's notices on Grants.gov and the similar open grants below.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is RFA-HL-26-015 still open?
No. It closed on November 17, 2025.
Who can apply for 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)?
National Institutes of Health accepted applications from small businesses. The notice adds further conditions, so read its eligibility section.
What is the deadline for 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 November 17, 2025. Applications are no longer accepted; the program's newer notices are on this page when there are any.
Who has been funded under RFA-HL-26-015?
NIH RePORTER lists 3 projects funded under RFA-HL-26-015 in fiscal 2026, at 3 institutions. The most were at Starlight Cardiovascular, Inc., Cognita Labs, LLC, Pediastent LLC.
Who has won National Center for Advancing Translational Sciences grants before?
The largest recipients over five fiscal years were University of Pittsburgh - of the Commonwealth System of Higher Education, Vanderbilt University Medical Center, Duke University. The program made 867 awards worth $3.1 billion in that time.
Similar open grants
- Small Business Transition Grant for New Entrepreneurs (Parent R43/R44 Clinical Trial Optional)
- NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)
- Change of Recipient Organization (Type 7 Parent Clinical Trial Optional)
- Successor-in-Interest (Type 6 Parent Clinical Trial Optional)
- Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
- Data Coordinating Center for the Aging and Alzheimer’s Disease Mouse Brain Atlas (AD-MBA) (U24 Clinical Trial Not Allowed)