FDA Approves ECM Therapeutics for U.S. Study of ECMT-100 in Anorectal Fistula Treatment

ECM Therapeutics, Inc. has announced a significant advancement with the U.S. Food and Drug Administration's approval of its Investigational Device Exemption (IDE) application for ECMT-100. This novel hydrogel is designed to treat anorectal fistulas, a condition that presents considerable challenges and affects between 70,000 to 100,000 individuals in the United States annually. Traditional treatment methods for this painful ailment often require invasive surgical procedures and come with the risk of complications, such as the loss of continence.

The clearance from the FDA permits ECM Therapeutics to commence a first-in-human clinical study aimed at investigating the safety and initial efficacy of this innovative regenerative therapy, which does not involve surgery. Paul Fagan, the CEO of ECM Therapeutics, highlighted the significance of this milestone, stating that ECMT-100 has the potential to transform the current treatment landscape by offering a non-surgical alternative that supports healing while maintaining function.

The forthcoming open-label pilot study for ECMT-100 is scheduled to start in 2025 and will take place across two sites in the United States. This trial represents a vital step in applying extensive scientific research on extracellular matrix (ECM) to practical, real-world patient care, according to Dr. Stephen Badylak, Founder and Chief Scientific Officer of ECM Therapeutics. Dr. Badylak expressed enthusiasm for evaluating the clinical potential of this approach, which addresses a significant unmet medical need.

ECMT-100 is the inaugural clinical product developed from ECM Therapeutics' ECM hydrogel platform. Beyond this, the company's broader product pipeline includes initiatives focused on muscle regeneration, ocular repair, and the delivery of cell-based therapies. ECM Therapeutics holds exclusive global rights to a comprehensive ECM patent portfolio that was developed in collaboration with the University of Pittsburgh.

ECM Therapeutics, Inc., based in Warrendale, Pennsylvania, is a clinical-stage company specializing in regenerative medicine. It develops therapeutic products derived from naturally occurring extracellular matrix (ECM). The company operates with two primary technology platforms: ECM hydrogel and Matrix-Bound Nanovesicles (MBV), positioning itself at the forefront of regenerative medical innovation.