The purpose of the NHLBI SBIR Phase IIB Small Market Award is to provide support to Phase II SBIR or STTR awardees developing NHLBI mission-related technologies that address a rare disease or young pediatric populations. The goal of this FOA is for these technologies to be further validated so that development can continue with private funding after NHLBI support ends. The Small Market Award encourages business relationships between applicants and third-party investors/strategic partners who can provide substantial financing to help accelerate the commercialization of promising new products and technologies that were initiated with SBIR funding. In particular, applicants are expected to leverage their previous SBIR support, as well as the opportunity to compete for additional funding through the NHLBI Small Market Award program, to attract and negotiate third-party financing needed to advance a technology toward commercialization. The applicant’s ability to secure independent third-party investor funds that equal or exceed one-third of the NHLBI funds being requested over the entire project period will help to validate the commercial potential that is essential for the SBIR projects solicited under this program. It is anticipated that many of the partnerships between small businesses and third-party investors will involve a considerable level of project due diligence by the private sector, thereby increasing the likelihood of commercial success for the funded projects. In light of these goals, the NHLBI strongly encourages applicants to establish business relationships with investors, strategic partners or both that have appropriate prior experience in commercializing biomedical technologies for rare diseases or pediatric populations.
Projects proposed in response to this FOA must require eventual Federal regulatory approval/clearance and be focused on rare diseases and/or young pediatric populations, and may address preclinical and/or clinical stages of technology development. Budgets up to $3 million in total costs over three years may be requested. Development efforts may include preclinical R&D, which is needed for regulatory filings (e.g., IND or IDE) and/or clinical trials.
For projects that do not address a rare disease or young pediatric population, the NHLBI SBIR Phase IIB Bridge Award may be more appropriate. Read more here.
An SBIR Phase IIB Small Market Award application must represent a continuation of the research and development efforts performed under a previously funded SBIR or STTR Phase II grant or contract award. The NHLBI welcomes applicants previously funded by any NIH Institute or Center or any other Federal agency, as long as the proposed work applies to the NHLBI mission. Applications may be predicated on a previously funded SBIR or STTR Phase II grant or contract award.*
*NOTE: Applicants who intend to submit an application that is predicated on an SBIR Phase II contract or any Phase II award from another Federal agency MUST contact the NHLBI prior to submission, so that the NHLBI can properly arrange for such applications to be accepted. See NIH SBIR FAQ page for additional information on submitting a grant application based on a contract award or award from another agency.