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) | RFA HL 23 009

Opportunity Information: Apply for RFA HL 23 009

The NHLBI SBIR Phase IIB Bridge Awards program (RFA-HL-23-009) is a National Institutes of Health grant opportunity designed to help small businesses push promising heart, lung, blood, and sleep-related technologies through the expensive, high-risk stretch between a completed SBIR/STTR Phase II project and real-world commercialization. The central problem it targets is the well-known "funding gap" that often appears after Phase II, when a product may be technically feasible but still needs substantial additional development, validation, and regulatory work before it can be sold or broadly deployed in clinical practice. This FOA supports later-stage research and development (Phase IIB) specifically for projects that are expected to require U.S. federal regulatory approval or clearance, meaning activities are aimed at generating the kind of evidence and documentation needed for pathways such as FDA clearance/approval (as applicable to the technology).

A key emphasis of the Bridge Award concept is commercialization readiness, not just additional research. The NHLBI is looking for projects that have already been de-risked by prior SBIR or STTR Phase II funding and now need targeted work to reach regulatory and market milestones. In practice, that typically means applicants should be planning a clear set of measurable, investor-relevant milestones that move the product toward approval/clearance and launch, such as design verification and validation, manufacturing scale-up steps tied to quality systems, clinical performance testing, pivotal or supporting clinical studies when appropriate, human factors/usability work for devices, and other development tasks that directly support a regulatory submission and market entry. The FOA is labeled "Clinical Trial Optional," which means a proposed project may include a clinical trial if it is necessary for the next milestone, but a clinical trial is not automatically required.

What makes this announcement distinct from earlier SBIR phases is the explicit push for partnerships with third-party investors and/or strategic partners. The NHLBI is signaling that it wants applicants to align public funding with private sector participation to accelerate commercialization. In other words, the award is structured to help companies reach a stage where investment, partnering, reimbursement planning, procurement, and adoption become realistic, and it encourages applicants to demonstrate credible external interest and a business case strong enough to attract non-federal support. This investor/partner focus also reflects the program's intent to shorten the time between the lab or prototype stage and an approved product that can actually improve health outcomes.

The primary eligible applicants for this FOA are U.S. small business concerns applying under the NIH SBIR mechanism (R44). The source information also lists a broad range of organizational categories under "EligibleApplicants" in the public-facing dataset (including certain government entities, nonprofits, higher education institutions, and for-profit organizations), but the core purpose and the text of the opportunity make clear that the invited applications are SBIR applications from small businesses for Phase IIB work tied to prior SBIR/STTR Phase II awards. On the foreign eligibility side, non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. However, foreign components, as defined by the NIH Grants Policy Statement, may be allowed in limited cases when they are strongly justified and consistent with NIH policy.

Administratively, the opportunity is run by the National Institutes of Health, with an NHLBI focus on conditions and diseases in the heart, lung, blood, and sleep space. It is a discretionary grant program under the health funding activity category, associated with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840. The Funding Opportunity Announcement was created on 2021-11-16, and the listed closing date in the provided record is 2024-02-28. The overall takeaway is that this FOA is meant for SBIR-funded companies that are beyond early feasibility, have a credible commercialization path, and need help completing the specific development and regulatory steps that most often stall progress right before market entry.

• The 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 2021-11-16.
• Applicants must submit their applications by 2024-02-28. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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