ECM Therapeutics Reports Promising Results in Fistula Repair

Interim findings highlight ECM hydrogel’s potential for patients with limited treatment options

WARRENDALE, Pa., Oct. 13, 2026 (GLOBE NEWSWIRE) -- ECM Therapeutics, Inc. today announced early clinical results suggesting its extracellular matrix (ECM) hydrogel, ECMT-100, could meaningfully improve treatment for patients with anorectal fistulas, an area of significant unmet clinical need.

Patients with anorectal fistulas can face prolonged seton drainage, repeat surgery, and compromised quality of life. ECMT-100 is a hydrogel composed of complete, acellular ECM, the natural framework that supports maintenance and restoration of healthy tissue. The flowable form of the hydrogel allows for rapid catheter delivery into the fistula tract, where it conforms to the tract’s shape and provides support for rapid and sustained tissue repair, and avoids the need for invasive surgery.

The ongoing, single-arm FDA approved feasibility study at the University of Pittsburgh Medical Center (UPMC) and Dartmouth-Hitchcock Medical Center has treated 22 patients with follow up ranging from 8 weeks to 10 months. The treated patients had setons in place from 4 months to 8 years before receiving ECMT-100. To date, all patients have shown improvement with safety and efficacy as the measured endpoints of the study.

The study’s principal investigators, David Medich, M.D., Chief of the Division of Colon and Rectal Surgery at UPMC and Associate Professor of Surgery at the University of Pittsburgh, and Matthew Z. Wilson, M.D., a colorectal surgeon at Dartmouth Hitchcock Medical Center and Associate Professor of Surgery at Dartmouth’s Geisel School of Medicine, described the early results as encouraging, noting that “all patients treated were observed to have achieved complete or near complete healing.” Wilson also noted “fewer fistula associated symptoms such as perianal discomfort and drainage.”

“Our goal is to translate the potential of our ECM technology into better care for patients who have had limited options for lasting fistula repair,” said Paul Fagan, Chief Executive Officer of ECM Therapeutics.

Improving fistula care is also the first focus of the American Society of Colon and Rectal Surgeons (ASCRS) Quality Collaborative, an initiative featured at its 2026 Annual Scientific Meeting.

ECMT-100 is not currently FDA-cleared for treatment of anorectal fistulas. ECM Therapeutics is preparing a 510(k) submission and exploring licensing and commercialization partnerships.

About ECM Therapeutics

ECM Therapeutics is a regenerative medicine company developing complete extracellular matrix (ECM) technologies to support tissue repair. Building on more than three decades of research led by co-founder Dr. Stephen Badylak and technology licensed from the University of Pittsburgh, the company has developed FORMatrix™, an FDA-cleared hydrogel for wound management. For more information, visit ecmtherapeutics.com.

Media and Strategic Partnerships:
Katie Collins, Chief Strategy Officer - kcollins@ecmtherapeutics.com