Advanced Research Projects Agency for Health (ARPA-H) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Program
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The contract solicitation issued by the Advanced Research Projects Agency for Health (ARPA-H) targets small business concerns under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. It seeks innovative research and development proposals that align with ARPA-H’s mission to stimulate technological innovation, strengthen small business roles in federal R&D, and foster commercialization of biomedical advancements. This presolicitation, designated with solicitation number 7599226SN106, invites small businesses (defined by specific ownership, U.S. presence, and employee count criteria) located within the United States to participate in a competitive award process expected to be announced on SAM.gov with deadlines yet to be determined. The contract emphasizes a total small business set-aside and mandates compliance with specific program certifications, life cycle certifications, foreign disclosure, and organizational conflict of interest requirements. The anticipated research topics under this SBIR contract cover a diverse range of cutting-edge biomedical and bioengineering challenges, including the development of an annual fertility assessment test for women, next-generation bioadhesive platforms for tissue repair, a universal synthetic biology platform for toxin removal, non-surgical therapies for endometriosis, promotion of commercialization of ARPA-H originated technologies, rapid diagnostics for multi-system autoimmune diseases, and the creation of a high-fidelity virtual human brain model to advance neurosurgical robotics. The contract supports multi-phase efforts with milestone-based payments tied to deliverables such as technical reports, presentations, and validation data. Evaluation criteria focus predominantly on technical merit and novelty, team expertise, impact pathways, and budget reasonableness, with trade-off decisions favoring proposals with superior technical innovation and feasible commercialization potential. Although the documentation lacks detailed Federal Acquisition Regulation (FAR) clauses or specific pricing information, it underscores strict requirements for data marking (including SBIR/STTR rights notices), adherence to Good Clinical Practice (GCP) when applicable, and rigorous disclosure of foreign affiliations for compliance and national security purposes. Proposal submissions are limited to electronic formats via the ARPA-H Solutions portal, with succinct page and slide limits defined for various submission components, reinforcing a structured and transparent competitive solicitation process.
General Info
Agency
NAICS
Place of Performance
Washington, DC, 20005, USASet-Aside
Timeline
Response Deadline
Organization & Contact Information
Full Description
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
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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.
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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
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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 platform is intended to be adaptable to a range of challenges across industries such as environmental remediation, biomanufacturing, agriculture, holistic medicine, and therapeutic discovery. The broader goal is to create a stable, reliable, and easily reprogrammable microbial platform that demonstrates potential for cross-sector impact beyond the initial use case.
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ARPA-H 04 - Breaking Ground: The First Curative, Durable, Non-Surgical Therapy for Endometriosis – The purpose of this topic aims to develop treatments for endometriosis that are non-surgical. Proposers are expected to develop novel, non-surgical therapies to decrease the size or deactivate endometrial implants, to decrease inflammation cause by implants, and / or prevent growth or regrowth of the lesions. Broadly, this should be a novel, non-surgical, curative treatment for endometriosis.
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ARPA-H 05 - ARPA-H Lineage Topic - The purpose of this topic supports the advancement, commercialization, and translation of technologies that originated from ARPA-H funded efforts. It is intended to help small businesses and startups develop viable products based on these technologies. ARPA-H’s goal is to give small businesses an off-ramp to finish developing their technology/product, explore secondary or interim applications of the technology, and time to achieve self-sufficiency.
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ARPA-H 06 - Rapid Comprehensive Diagnostic Test for Multi-System Autoimmune Disease -The purpose of this topic is to spur the development of novel, rapid diagnostic assays for multi-system autoimmune disease, which represents an unmet healthcare need. Moreover, in its ideal embodiment this diagnostic test might allow typical primary care physicians to diagnose and predict tissue-specific autoimmune disease manifestations, thereby streamlining referral of the patient to a specialist. This goal is made more feasible by recent technological developments including the ability to detect tissue-specific signatures of immune-mediated stress by assessing circulating cells and/or tissue-specific molecular products.
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ARPA-H 07 - Virtual Human Brain for the Development of Neurosurgical Robotics - The purpose of this topic aims to take a first step toward AI-assisted intracranial microsurgery by creating a high-resolution, physically and anatomically accurate virtual human brain.
