Medical innovations addressing cardiovascular disease, respiratory conditions, blood disorders and sleep medicine can access substantial non-dilutive support through the National Heart, Lung, and Blood Institute Small Business Program.

NHLBI participates in NIH’s SBIR and STTR programmes and supports businesses developing products for the prevention, diagnosis and treatment of heart, lung, blood and sleep disorders.

Which Technologies Does NHLBI Fund?

NHLBI is interested in technologies including:

• Therapeutics;
• Medical devices;
• Diagnostics;
• Digital-health products;
• Research tools;
• AI and machine-learning systems;
• Technologies addressing women’s and maternal health complications connected with heart, lung, blood or sleep disorders.

A startup developing an AI cardiac diagnostic, for example, could potentially qualify where the proposal contains genuine R&D and falls clearly within NHLBI’s mission.

How Much Can NHLBI Fund?

Under the current NIH parent announcements, NHLBI’s normal maximum budgets are:

Phase I: $400,000.

Phase II: $3 million.

NHLBI generally supports Phase I projects for up to two years and Phase II projects for up to three years.

It also participates in later-stage funding.

Under the Parent Phase IIB Strategic Breakthrough Award, NHLBI’s listed limit is $4.5 million.

Its limit under the current CRP parent announcement is $500,000.

NHLBI also maintains targeted Phase IIB programmes for particular commercialisation circumstances.

Clinical Trial Rules

NHLBI currently accepts clinical trials through the standard SBIR and STTR programmes.

It also accepts clinical trials through Phase IIB.

However, NHLBI does not accept clinical trials under the current Parent CRP programme.

Applicants proposing human-subject studies should therefore speak with programme staff before choosing the grant mechanism.

Who Is Eligible?

As with other NIH small-business programmes, only qualifying U.S. small business concerns may receive the award.

Foreign companies are not directly eligible.

SBIR is usually more appropriate where the company performs most of the R&D itself.

STTR is appropriate where the project requires a substantial formal research partnership with a qualifying nonprofit institution.

Building a Competitive Application

Strong cardiovascular and medical-device applications should not focus only on technical performance.

Founders should describe the clinical workflow.

Who will use the product?

Who pays for it?

What does the current standard of care cost?

What evidence would change physician or hospital behaviour?

For regulated products, applicants should describe FDA strategy and identify the studies needed to reach the next regulatory milestone.

Digital-health and AI applicants should demonstrate genuine technical innovation and clinical value instead of simply adding algorithms to an existing workflow.

Support Beyond Funding

NHLBI’s Innovation and Commercialization Office coordinates support for applicants and funded companies.

The office assists with small-business applications, entrepreneurship resources and commercialisation programmes.

Engaging NHLBI staff before submission can help founders determine whether a proposal fits the institute and which mechanism is appropriate.

Deadlines

Applications through Parent SBIR and STTR use the standard NIH small-business cycle.

With September 2026 completed, the next opportunity is January 5, 2027, followed by April 5.

Applications are due by 5:00pm local time of the applicant organisation.

Explore the official NHLBI Small Business Program

For medical startups addressing major heart, lung, blood or sleep problems, NHLBI funding can finance the scientific evidence needed before venture capital, licensing or commercial partnerships become realistic.