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)

The Small Business Innovation Research (SBIR) Program is an important funding mechanism that the National Institutes of Health (NIH) uses 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 Notice of Funding Opportunity (NOFO) invites SBIR grant applications from SBCs to support later-stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR Phase II awards 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 milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between SBIR Phase II awardees and third-party investors and/or strategic partners. Projects proposed under this NOFO MUST be relevant to the NHLBI mission (see B. Scientific/Technical Scope). This NOFO is specifically intended to benefit clinical practice by accelerating the commercialization of novel products that require ultimate approval/clearance by a Federal regulatory agency. This NOFO will give competitive preference and funding priority to applications deemed likely to result in a clinically-relevant commercial product as indicated by the applicants ability to secure independent third-party investor funds that equal or exceed the requested NHLBI funds (total costs).