Clinical Studies

Evaluating
Efficacy & Safety

We are committed to rigorous clinical evaluation to demonstrate the regenerative potential of our extracellular matrix therapies across complex wound environments and procedural fields.

Anorectal Fistula IDE Study

Ongoing Study

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.

Study Locations

  • Dartmouth Hitchcock Medical Center
  • University of Pittsburgh Medical Center

Study Details

Compassionate Use Program

Expanded Access Policy

We recognize that some patients facing serious or life-threatening conditions may seek access to investigational therapies outside of a clinical trial setting. ECM Therapeutics may consider providing such access through our Compassionate Use (Expanded Access) Program in accordance with applicable laws and regulations.

Our investigational therapies are still in development and have not yet received regulatory approval. While clinical trials are the primary path to access our products, we understand that participation is not always possible. In limited cases, we may provide access to our investigational therapies for patients who meet specific criteria, including:

  • No Alternatives: The patient has a serious or life-threatening condition with no comparable or satisfactory alternative treatment options.
  • Ineligibility: The patient is not eligible for ongoing clinical trials.
  • Clinical Data: There is sufficient clinical data to support that the potential benefits justify the potential risks.
  • Non-Interference: Providing the investigational therapy will not interfere with or delay our ongoing clinical trials or regulatory submissions.
  • Physician Request: The request is made by a qualified and licensed physician on behalf of the patient.

How to Request Access

Requests for compassionate use must be submitted by a treating physician to ECM Therapeutics at: CUP@ecmtherapeutics.com

Each request will be carefully reviewed by our clinical and regulatory teams. We aim to respond in a timely and compassionate manner, while upholding our commitment to patient safety and scientific integrity.