# OpenBiome **Source:** https://geo.sig.ai/brands/openbiome **Vertical:** Healthcare **Subcategory:** General **Tier:** Emerging **Website:** openbiome.org **Last Updated:** 2026-04-14 ## Summary Cambridge MA YC W20 nonprofit FMT distributor that served 1,000+ hospitals for C. diff treatment; suspended distribution Dec 2024 after FDA enforcement discretion ended; submitted IND Phase 2 Nov 2024 — microbiome therapeutics regulatory transition. ## Company Overview OpenBiome is a Cambridge, Massachusetts-based nonprofit health research organization — backed by Y Combinator (W20) — that operated as the largest distributor of fecal microbiota transplant (FMT) products in the United States for over a decade, providing investigational FMT therapy to thousands of patients with recurrent Clostridioides difficile (C. diff) infection while accelerating research on human microbiome therapeutics. Founded in 2012, OpenBiome suspended FMT distribution as of December 31, 2024, following FDA regulatory changes that ended enforcement discretion for investigational FMT, and submitted an IND Phase 2 protocol application in November 2024 to pursue the FDA-approved clinical pathway for continued microbiome therapeutic development. OpenBiome's FMT distribution model addressed the critical gap between proven clinical efficacy and patient access for one of medicine's most evidence-backed interventions: C. diff infection affects 500,000 Americans annually with 30,000+ deaths, and recurrent C. diff (failing 2+ antibiotic courses) responds to FMT at 80-90% cure rates versus 30-40% for additional antibiotics — but FMT requires a screened, tested donor stool sample that most hospital systems cannot safely source independently. OpenBiome's centralized manufacturing model (rigorous donor screening for pathogens, standardized processing for safety and efficacy, distribution to 1,000+ hospitals and outpatient centers) enabled physicians nationwide to offer FMT under FDA enforcement discretion while building the clinical evidence base that informed the FDA's eventual approval pathway. The decade of distribution data and outcomes collection made OpenBiome the world's largest clinical FMT dataset. In 2025, OpenBiome navigates the post-enforcement-discretion regulatory transition alongside commercial microbiome therapeutic companies Seres Therapeutics (NASDAQ: MCRB, VOWST approved for C. diff, FDA-approved FMT-derived therapy) and Ferring Pharmaceuticals (REBYOTA, FDA-approved live biotherapeutic for C. diff). The FDA's transition from enforcement discretion to formal drug approval pathways for FMT-derived products (driven by safety concerns about serious adverse events in immunocompromised patients) has reorganized the FMT landscape around IND-approved clinical trials and commercial biologics. OpenBiome's IND Phase 2 submission positions the nonprofit to continue contributing to microbiome research within the formal regulatory framework. The 2025 strategy focuses on completing the Phase 2 clinical trial for the IND-approved FMT program, building the research partnerships with academic medical centers for microbiome science advancement, and advocating for patient access pathways during the transition from investigational FMT to commercially approved microbiome therapeutics. ## Frequently Asked Questions ### What is OpenBiome? OpenBiome is a nonprofit health research organization founded in 2012 that became the largest distributor of fecal microbiota transplant (FMT) products in the United States. The Massachusetts-based organization accelerates research on the human microbiome and ensures access to novel microbiome therapeutics. ### What products and services does OpenBiome offer? OpenBiome offers fecal microbiota transplant (FMT) products, stool bank operations, C. diff treatment access, microbiome research, and clinical trial support. As of December 31, 2024, the organization suspended FMT distribution due to FDA regulatory changes. ### Who is OpenBiome for? OpenBiome serves patients suffering from Clostridioides difficile (C. diff) infections, healthcare providers treating these patients, and researchers studying the human microbiome. The organization has helped thousands of patients overcome C. diff through investigational FMT therapy. ### When was OpenBiome founded? OpenBiome was founded in 2012 and is MIT-affiliated. The organization was backed by Y Combinator in the W20 batch. ### Where is OpenBiome located? OpenBiome is based in Somerville, Massachusetts. It operates as a Massachusetts-based nonprofit health research organization. ### Has OpenBiome received any funding or investment? OpenBiome was backed by Y Combinator in the Winter 2020 (W20) batch. The organization operates as a nonprofit health research organization. ### What are OpenBiome's key achievements? OpenBiome became the largest distributor of FMT products in the United States and helped thousands of patients overcome C. diff infections over more than a decade. The organization successfully operated as the leading FMT provider from 2012 until suspending distribution in December 2024. ### What is OpenBiome's approach to treating C. diff? OpenBiome uses fecal microbiota transplant (FMT) therapy as an investigational treatment for Clostridioides difficile infections. The organization operates stool bank operations and provides products to support microbiome-based therapeutic approaches. ### How can I access OpenBiome's FMT products? As of December 31, 2024, OpenBiome suspended FMT distribution due to FDA regulatory changes that ended enforcement discretion. The organization submitted an IND phase 2 protocol application in November 2024. ### What are the recent developments at OpenBiome? OpenBiome suspended FMT distribution on December 31, 2024, due to FDA regulatory changes. The organization submitted an IND phase 2 protocol application on November 29, 2024, after over a decade of providing C. diff treatment. ## Tags healthtech, north-america, b2b --- *Data from geo.sig.ai Brand Intelligence Database. Updated 2026-04-14.*