SAM #7599226SN106

ARPA-H SBIR/STTR Solicitation for Innovative Health Research Solutions

The Advanced Research Projects Agency for Health (ARPA-H), under the Department of Health and Human Services, is seeking innovative research and development proposals from small businesses through its SBIR/STTR program: - Government Buyer: - Advanced Research Projects Agency for Health (ARPA-H), Department of Health and Human Services - No specific OEMs or commercial vendors are named; the opportunity is open to all eligible small businesses with relevant expertise - Products/Services Requested: - Development of an annual, biomarker-based fertility test for women - Creation of versatile, antimicrobial surgical bioadhesives with reversible and degradable properties - Design of a universal synthetic biology platform (UNI-PLAT) for adaptive, programmable microbial toxin removal - Commercialization of non-invasive, curative therapies for endometriosis - Advancement and translation of ARPA-H lineage technologies into commercial products - Rapid, comprehensive diagnostic tests for multi-system autoimmune diseases suitable for primary care - Development of a high-resolution virtual human brain model for neurosurgical robotics - Unique/Notable Requirements: - Set aside for small businesses, with emphasis on commercialization and broad health sector impact - Proposals must demonstrate technical innovation, clear commercialization pathways, and eligibility under SBIR/STTR guidelines - Awards range from $600,000 to $3.5 million, with project durations from 12 months up to 3-5 years depending on topic - Some topics allow Direct-to-Phase II or Fast Track proposals combining phases - Focus on solutions with high impact, regulatory planning, and defined reimbursement strategies

Description

DISCLAIMER: This posting and its attachments are for informational purposes only. This posting, the draft solicitation, and its attachments are DRAFTS and not final copies. All information embedded in this posting and its attachments are subject to change. This is not a formal request for Solution Summaries or Technical Presentations. Any submissions will not be considered at this time.

Feedback/Questions for this draft posting will be accepted until May 6, 2026, 5:00PM ET. You can submit feedback/questions to https://solutions.arpa-h.gov/ask-a-question.

Proposers Day information can be found in the attachment titled: Proposers Day Special Notice

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.

SOLICITATION 75N99226R00002 is anticipated to be made available on TBD through SAM.gov. This solicitation is anticipated to have a closing date of TBD for receipt of proposals.

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 RESEARCH TOPICS ARE ANTICIPATED TO BE INCLUDED IN THIS SBIR CONTRACT SOLICITATION

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 surgical glues with antimicrobial properties to combat infections due to surgery. In addition, the novel multifunctional surgical glue will also have desired properties such as controllable reversibility and degradability and be tissue/organ agnostic to stop bleeding with unknown sources. Overall, successful completion of this SBIR project will not only support the clinical implementation of bioprinted organs but also provide novel solutions to tackle unmet clinical needs in managing surgical leaks and infections and reduce overall medical costs.    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. 

ARPA-H 04 - Breaking Ground: The First Curative, Non-Invasive, Long-Lasting Therapy for Endometriosis – The purpose of this topic aims to advance progress in the endometriosis field by identifying and commercializing non-invasive therapeutics that address the root cause of the disease. Proposers are expected to develop a first-of-its-kind, non-invasive therapy capable of reducing the size of endometriosis lesions, deactivating endometriosis tissue, and/or preventing regrowth thereby ideally achieving curative outcomes. Additionally, proposers need to showcase a solution that has precise, targeted specificity, ensuring the treatment accurately locates and addresses endometriosis lesions without causing adverse effects elsewhere in the body.

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.

ARPA-H 06 - Rapid Comprehensive Diagnostic Test for Multi-System Autoimmune Disease -The overall 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.   ARPA-H 07 - Virtual Human Brain for the Development of Neurosurgical Robotics - The overall purpose of this topic aims to take a first step toward AI-assisted intracranial microsurgery, which will ameliorate patient outcomes as described in point 5 above, by creating a high-resolution, physically and anatomically accurate virtual human brain.

Additional Links:ARPA-H SBIR/STTR Press Release

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