Atom | Catalyze: Product Definition Medical Device Prototype Optimization (R33

Funder: National Institutes of Health

Funding Amounts: Up to $300,000 direct costs per year for up to 2 years; minimum 0.25:1 non-federal cost match required.

Summary: Supports optimization and validation of medical device prototypes, diagnostics, and research tools for heart, lung, blood, and sleep (HLBS) diseases; clinical trials are not allowed.

Key Information: Requires a letter of support from an Accelerator Partner and a cost-matching commitment; applications without these will not be reviewed.

Description

This opportunity, offered by the National Heart, Lung, and Blood Institute (NHLBI) under the NIH Catalyze program, funds the optimization and validation of medical device prototypes, diagnostic assays, and research tools targeting heart, lung, blood, and sleep (HLBS) diseases. The program is designed to help transition basic science discoveries into viable products ready for preclinical in vivo testing, with the goal of advancing them toward human use. The initiative emphasizes translational research, product development, and the development of researchers with expertise in entrepreneurship and regulatory strategy.

Projects must focus on late-stage prototype optimization, assay development, or research tool improvement, and are expected to provide a clear path toward preclinical testing. Clinical trials are not permitted under this funding opportunity.

Due Dates

Standard Deadlines (New, Renewal, Resubmission, Revision):
- June 18, 2025
- October 21, 2025
- February 11, 2026
- June 18, 2026
- October 21, 2026
- February 11, 2027
- June 17, 2027
- October 21, 2027
AIDS-Related Applications:
- August 21, 2025
- December 22, 2025
- April 21, 2026
- August 21, 2026
- December 23, 2026
- April 23, 2027
- August 23, 2027
- December 23, 2027
Letter of Intent: 30 days prior to the application due date (optional but encouraged)

Funding Amount

Direct Costs: Up to $300,000 per year
Project Period: Maximum of 2 years
Cost Matching: Minimum 0.25:1 non-federal cash match of the federal direct costs requested is required (e.g., $75,000 non-federal match for $300,000 federal direct costs)
Total Anticipated Awards: Up to 8 new awards per year (subject to NIH appropriations and merit)

Eligibility

Eligible applicants include:

Public and private institutions of higher education
Nonprofits (with or without 501(c)(3) status)
For-profit organizations (including small businesses)
State, county, city, township, and special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Native American tribal governments and organizations
Faith-based and community-based organizations
Regional organizations
U.S. territories and possessions

Restrictions:

Non-domestic (non-U.S.) entities are not eligible to apply as the primary applicant.
Non-domestic components of U.S. organizations and foreign components (as defined by NIH) are allowed.
Applicants must complete all required registrations (SAM, eRA Commons, Grants.gov) prior to submission.

Application Process

Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
Required Attachments:
- Letter of support from at least one Accelerator Partner (commercialization expert/mentor)
- Documentation of cost-matching commitment from non-federal sources
- Intellectual property and regulatory strategy attachment
Format: Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the funding announcement.
Budget: Must include both the federal and non-federal (cost-matching) components, with detailed justification.
Review: Applications are peer-reviewed for scientific merit, feasibility, and alignment with program goals.

Additional Information

Scope: Projects must be beyond initial prototype development and focus on optimization, validation, and readiness for preclinical in vivo testing.
Non-Responsive Activities: Early-stage prototype development, therapeutic agent development, biomarker discovery, and clinical trials are not supported.
Milestones: Applicants must propose clear, measurable milestones and a project management plan.
Accelerator Partner: Required to provide commercialization guidance and mentoring; a letter of support is mandatory.
Cost Matching: Must be non-federal and documented; federal funds cannot be used as matching.
Intellectual Property/Regulatory: Applicants must describe their IP and regulatory strategies, even if preliminary.

External Links

Contact Information

Topic/Role	Name/Title	Email	Phone
General Questions	Mike Pieck, Ph.D.	nhlbi_catalyze@nih.gov	301-827-7986
Blood Diseases	Nitin Agrawal, Ph.D.	hillpryorc2@nih.gov	301-443-9337
Cardiovascular Sciences	Rahul Thakar, Ph.D.	rahul.thakar@nih.gov	301-827-8151
Sleep Disorders	Lawrence Baizer, Ph.D.	lawrence.baizer@nih.gov	301-435-0199
Lung Diseases	Sidd Shenoy, Ph.D.	sidd.shenoy@nih.gov	301-435-0202
Peer Review	Director, Office of Scientific Review	nhlbichiefreviewbranch@nhlbi.nih.gov	—
Grants Management	Ron Caulder	caulderr@nhlbi.nih.gov	301-827-8020
Grants Info (NIH)	—	grantsinfo@nih.gov	301-480-7075
eRA Service Desk	—	—	301-402-7469 or 866-504-9552

Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)