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.