ECM Therapeutics Receives FDA 510(k) Clearance for ECMT-100 WMDWARRENDALE, Pa., June 23, 2026 (GLOBE NEWSWIRE) -- ECM Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K253521) for ECMT-100 WMD, a flowable extracellular matrix hydrogel intended for the management of wounds.
ECM Therapeutics Receives FDA IDE Approval for U.S. Feasibility Study of ECMT-100 in Treatment of Anorectal Fistulas
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.
