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COMPANY

ECM Therapeutics

HQ: Warrendale, PA source · ecmtherapeutics.com ↗

FDA-cleared device company

Keywords: hydrogel Fistula in Ano ECMT-100

Location: Warrendale, PA · source · Oct 15, 2026

Profile checked Oct 10, 2026

1Trials (company is sponsor)1FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: ECMT-100 WMD — K253521, Jun 18, 2026. Applicant at approval: Ecm Therapeutics, Inc. source ↗
  2. Trial start Not phased (device or behavioral study): Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 1

RecordTitlePhaseStatusStartPrimary completion
NCT07035925Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal FistulasNot phased (device or behavioral study)RecruitingNov 24, 2025Feb 24, 2027 (estimated)

FDA records (last 2 years)

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