ECM Therapeutics Receives FDA IDE Approval for U.S. Feasibility Study of ECMT-100 in Treatment of Anorectal Fistulas

Business Wire

06-05-2025

WARRENDALE, Pa.--(BUSINESS WIRE)--ECM Therapeutics, Inc. ('ECMT') has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application for ECMT-100, a hydrogel derived from complete extracellular matrix (ECM) for the treatment of anorectal fistulas. This clearance allows ECMT to initiate a first-in-human clinical study evaluating the safety and early efficacy of this regenerative, non-surgical therapy.
Anorectal fistulas are a painful and difficult-to-treat condition affecting approximately 70,000 to 100,000 patients annually in the United States. Existing treatments typically involve invasive surgery and carry significant risks, including loss of continence.
'This is a major milestone for ECM Therapeutics and for patients who currently have few safe and effective options,' said Paul Fagan, CEO of ECMT. 'We believe ECMT-100 can change the treatment paradigm by offering a non-surgical solution that promotes healing while preserving function.'
The open-label pilot study will begin in 2025 and enroll patients across two U.S. sites.
'The IDE approval is a critical step in translating decades of ECM science into real-world patient impact,' said Dr. Stephen Badylak, Founder and Chief Scientific Officer of ECM Therapeutics. 'We're excited to assess the clinical potential of this approach in an area of true unmet need.'
ECMT-100 is the first clinical product from the company's ECM hydrogel platform. ECMT's broader pipeline includes programs in muscle regeneration, ocular repair, and delivery of cell-based therapies. The company holds exclusive worldwide rights to an extensive ECM patent portfolio developed at the University of Pittsburgh.
About ECM Therapeutics
ECM Therapeutics, Inc. (ECMT) is a clinical-stage regenerative medicine company developing therapeutic products from naturally derived extracellular matrix (ECM). The company has two core platforms, ECM hydrogel and Matrix-Bound Nanovesicles (MBV), and is headquartered in Warrendale, PA. For more information, visit ecmtherapeutics.com.