Advanced Research Projects Agency for Health (ARPA-H) Small Business…

The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns (SBCs) that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward ARPA-H mission needs, Small Business Innovation Research (SBIR), and Small Business Technology Transfer (STTR) program objectives. Please see the cover page of the attachment "SBIR_STTR_BAA_FY26" for applicable Stage 1 and Stage 2 deadlines for each open topic.  Please see the cover page of the attachment "SBIR_STTR_BAA_FY26" for applicable Question and Answer (Q&A) period deadlines for the open topics.  The purposes of the SBIR and STTR programs are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth.  For purposes of the SBIR and STTR programs, a small business concern is any business concern that, on the date of award, (1) is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; (2) is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; (3) more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; AND, (4) has, including its affiliates,  no more than 500 employees.   Note: This size standard is established by law for the SBIR program, regardless of the NAICS Code assigned. See 13 C.F.R. § 121.702.  THE FOLLOWING ARE THE CURRENTLY OPEN RESEARCH TOPICS. PLEASE SEE SECTION 8 OF THE BAA FOR FURTHER INFORMATION ARPA-H 01 - Development of an annual test to inform women about their future fertility - The purpose of this topic is to discover new biomarkers that provide women with actionable data for fertility planning. Results from this work will help inform the program manager regarding the feasibility of future programs focused on enhancing natural fertility before the need of IVF and guiding the development of women’s health monitoring and improvement tools. This work will develop a diagnostic test that can assess fertility status and generate an estimated timeline for the onset of infertility. This topic seeks to develop a test that is affordable, suitable for at least annual use, and provides user-friendly results for patients and care teams to support childbearing decisions.   ARPA-H 02 - Versatile Bioadhesives - The purpose of this topic is to develop next-generation bioadhesive platforms that can safely and reliably seal, bond, and repair a wide range of tissues in challenging clinical conditions, including wet, bloody, and mechanically dynamic environments. These platforms may also be designed to deliver biologics or small molecules as part of treatment. The goal is to create bioadhesives with key performance attributes such as strong tissue adhesion, controlled degradation, reversibility, biocompatibility, and broad compatibility across multiple tissues and organs. If successful, this topic could enable widely deployable solutions for hemostasis, leak prevention, tissue repair, and device fixation, ultimately helping reduce complications and improve patient outcomes across many care settings  ARPA-H 03 - Universal Platform for Living Adaptive Toxin-removal (UNI-PLAT) - The purpose of this topic area is to catalyze the development of a universal, “plug-and-play” synthetic biology platform that enables next-generation microbial chassis capable of performing a broad array of programmable functions. While this solicitation primarily uses toxin removal as a proof-of-concept in relation to chronic disease management, the pl