Breaking Ground: The First Curative, Durable, Non-Surgical Therapy for Endometriosis

Solicitation ARPA-H 04, titled Breaking Ground: The First Curative, Durable, Non-Surgical Therapy for Endometriosis, is a federal SBIR/STTR Phase I solicitation issued by the Advanced Research Projects Agency for Health under the Department of Health and Human Services. This total small business set-aside seeks the development of novel, non-surgical, and curative treatments designed to deactivate or decrease the size of endometrial implants, reduce associated inflammation, and prevent the regrowth of lesions. The program emphasizes transformative, high-ambition research rather than incremental improvements, requiring applicants to demonstrate technical merit, novelty, and a clear path to health outcomes. The contract structure allows for a Phase I period of up to 24 months, with Phase II and Sequential Phase II options extending up to 36 months each. Proposers must submit a solution summary limited to 4 pages, along with a cost proposal and a key personnel worksheet. Those advancing to the oral technical presentation stage are limited to 16 slides and must provide a Task Description Document and a GANTT chart. Evaluation is based on technical merit, novelty, team expertise, and commercialization strategy. Financial provisions include potential Technical and Business Assistance funding of up to 6,500 dollars for Phase I and 50,000 dollars for Phase II. All deliverables must comply with Revised 508 Standards for accessibility, and payment requests must be processed electronically via the Department of Treasury Invoice Processing Platform.