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Our Story

When OpenBiome was founded in 2012, a silent crisis was unfolding. Patients suffering from recurrent Clostridioides difficile infections were trapped in a cycle of relapses, with one therapy—fecal microbiota transplantation (FMT)—offering real hope. But there was no safe, standardized way to deliver it.

No national supply chain. No regulatory framework. No clinical playbook.  

So we built one.

OpenBiome launched the first public stool bank in the United States, creating a scalable, rigorously-tested way for hospitals to offer investigational FMT to patients in need. We worked hand-in-hand with clinicians, researchers, and the FDA to develop protocols, inform policy, and unlock access across the country.

In doing so, we helped turn a promising experimental treatment into a recognized medical intervention—delivering more than 72,000 investigational treatments to over 1,300 hospitals and clinics.  

Our impact went beyond access. We helped define the field of microbiome therapeutics—building the infrastructure, standards, and momentum needed to bring this science into the mainstream.

2025

The OpenBiome Foundation is Born

OpenBiome evolves into a mission-driven foundation, focused on the future of microbiome science and therapies. 

Its commitments: 

    • Continue to champion access to FMT for C. diff patients, starting with advocacy for sound health policy, and new models for hospital-based FMT programs; 
    • Support pioneering research through targeted grantmaking and global collaborations; 
    • Build for the future by openly sharing our know-how and unparalleled biorepository to power the next generation of discoveries. 

    A Transformative Legacy 

    From revolutionizing FMT access to shaping policy and powering science, OpenBiome proved that microbiome innovation can—and must—serve patients first. 

    Now, as a Foundation, it carries forward that spirit: 

    Accelerating Science. Expanding Access. Transforming health. 

    Our Shift
    2024

    A Pivotal Transition

    • Despite physician and patient outcry, the FDA ends Enforcement Discretion for OpenBiome. 
    • OpenBiome ships its final clinical treatment in December, closing a historic chapter in public health service. 

    • Total treatments distributed: 72,507 
    2022–2023

    New Therapies, Same Commitment

    • The FDA approves the first commercial live-microbiota therapeutics—Rebyota (2022) and Vowst (2023). 
    • Even as the industry shifts, OpenBiome advocates for continued access to investigational FMT for patients excluded from these new therapies – those with severe or fulminant C. diff and pediatric cases. 
    2020–2021

    Responding to COVID-19

    When the pandemic hits, OpenBiome swiftly adopts new SARS-CoV-2 safety protocols and manages supply disruptions—ensuring continuity of care for patients in need.
    2014–2020

    National Reach, Global Standards

    • OpenBiome becomes the largest stool bank in the U.S., supplying over 1,300 hospitals and clinics and powering more than 40 research studies and trials. 
    • It sets the gold standard for donor screening, logistics, and safety, helping make FMT safe, scalable, and accessible. 
    2013

    FDA Declares FMT a Drug — and Grants Enforcement Discretion

    • The FDA announces that FMT requires an Investigational New Drug (IND) application. 
    • Amidst patient and physician outcry, FDA implements Enforcement Discretion for treatment of recurrent C. diff. 
    • OpenBiome scales up to meet the urgent need—distributing rigorously screened material to hospitals nationwide. 
    2012

    Founded with Purpose

    A coalition of scientists, physicians, and advocates from MIT and Harvard founded OpenBiome—the first public stool bank—with one mission: Expand safe access to FMT for patients battling recurrent C. difficile infection.