SBIR Phase II Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics, and Prognostics toward Commercialization (R44) | RFA CA 17 024

Opportunity Information: Apply for RFA CA 17 024

The SBIR Phase II Bridge Awards FOA (R44; RFA-CA-17-024) is a National Cancer Institute (NCI) funding opportunity designed to help small businesses push promising, federally funded cancer technologies past the traditional SBIR/STTR Phase II stage and closer to real-world commercialization. It targets projects that already completed an SBIR or STTR Phase II award from any federal agency and now need additional support to tackle the next, often capital-intensive development steps that commonly stand between a successful prototype and a market-ready product. In practice, this program is meant to function as a "bridge" between government-supported R&D and the funding, validation, and execution work typically required for launch, adoption, and scale.

The scope is focused specifically on cancer-related innovations in three broad areas. First, it supports cancer therapeutics, which can include drug candidates, biologics, and other treatment approaches that need further preclinical optimization, manufacturing readiness work, regulatory preparation, or clinical evaluation. Second, it covers cancer imaging technologies, interventional devices, and in vivo diagnostics, meaning technologies used inside the body or in real-time clinical settings, such as imaging systems, image-guided tools, minimally invasive interventional devices, and diagnostic methods performed directly in patients. Third, it includes in vitro and ex vivo cancer diagnostics and prognostics, which generally refers to tests and platforms performed on patient samples outside the body, such as tissue, blood, or other biospecimens, including tools that help detect cancer, stratify risk, guide therapy selection, or predict outcomes.

A central goal of the FOA is to accelerate commercialization by encouraging meaningful partnerships with third-party investors and/or strategic partners. The program is structured around the idea that companies at this stage should be aligning not only with scientific and technical milestones, but also with business, regulatory, manufacturing, and market milestones that investors and commercial partners care about. Because late-stage development is expensive, applicants are expected to bring in independent outside funding alongside the requested NCI support. The application must include a Commercialization Plan that lays out the product strategy and clearly explains the status of third-party financing, whether already secured or anticipated during the project period. Importantly, the FOA sets the expectation that the independent third-party funding will be equal to or greater than the NCI funds requested over the Phase IIB Bridge Award period, reinforcing that this mechanism is meant to de-risk the project and pull in substantial non-federal capital rather than act as a stand-alone funding source.

From a development standpoint, the FOA allows projects in either preclinical or clinical stages, depending on what is appropriate for the technology and what remains to reach commercialization. Companies can propose clinical trials if they are needed to demonstrate safety, performance, or clinical utility, but trials are not mandatory. This flexibility makes the program relevant to a wide range of products, from diagnostics that need analytical validation and clinical performance studies, to devices that need design finalization and regulatory testing, to therapeutics that may require IND-enabling studies or early clinical evaluation. The underlying theme is that the proposed work should directly support the transition to a commercial stage, such as preparing for regulatory submission, establishing manufacturing and quality systems, completing pivotal verification/validation work, or generating the evidence needed to attract buyers, partners, or investors.

In terms of logistics, the opportunity is offered as a discretionary grant under the SBIR R44 mechanism by the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), specifically the NCI. Eligible applicants are small business concerns. The FOA lists CFDA numbers 93.394 and 93.395, reflecting NCI funding streams. The posting information provided indicates it was created on April 12, 2017, with an original closing date of July 6, 2017. The stated award ceiling is $1,000,000, and the FOA anticipated making about 10 awards, signaling a competitive program aimed at a select set of projects with strong commercialization readiness and credible outside financing commitments.

Overall, this FOA is best understood as an NCI-backed commercialization accelerator for SBIR/STTR Phase II alumni in oncology. It is not meant for brand-new early research, but for projects with enough prior federal validation to justify a serious push toward market entry, ideally alongside investors or strategic partners who can help carry the technology through the expensive final stretch to commercialization.

• The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "SBIR Phase II Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics, and Prognostics toward Commercialization (R44)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394, 93.395.
• This funding opportunity was created on Apr 12, 2017.
• Applicants must submit their applications by Jul 06, 2017. (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 10 candidate(s).
• Eligible applicants include: Small businesses.

Apply for RFA CA 17 024

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