ECM Therapeutics Receives FDA 510(k) Clearance for ECMT-100 WMD

WARRENDALE, 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.

The clearance represents a significant milestone for ECM Therapeutics and reflects decades of scientific advancement in extracellular matrix-based technologies led by Stephen F. Badylak, DVM, MD, PhD, Chief Medical Officer of ECM Therapeutics and a pioneer in the field of regenerative medicine. Dr. Badylak's research has helped establish the scientific foundation for the use of extracellular matrices in a wide range of clinical applications and has contributed to the development of numerous commercially available medical products across multiple surgical specialties.

ECMT-100 WMD is composed of extracellular matrix processed into a ready-to-use flowable hydrogel designed to contour to irregular wound geometries that can be challenging to treat with traditional wound management approaches. The ECMT device retains the structural and biochemical components that provide mechanical support and a suitable microenvironment for wound management.

"For more than two decades, our research has focused on understanding how the extracellular matrix promotes healing and helps to restore a healthy tissue state," said Dr. Badylak. "ECMT-100 WMD represents an important milestone in translating that science into a formulation that can be readily applied in clinical practice."

Extracellular matrix technologies have historically been delivered as sheets, patches, and particulate products. ECMT-100 WMD expands those options through a flowable hydrogel designed for controlled placement and conformity within complex wound geometries and environments.

"The FDA clearance of ECMT-100 WMD marks a defining milestone for ECM Therapeutics and validates our approach to translating extracellular matrix science into practical clinical solutions," said Paul Fagan, Chief Executive Officer of ECM Therapeutics. "As our first commercial product, ECMT-100 WMD advances our extracellular matrix hydrogel platform, establishes a foundation for future growth, and creates new opportunities to expand the application of our technology through strategic partnerships."

In addition to ECMT-100 WMD, ECM Therapeutics is advancing a portfolio of regenerative medicine technologies derived from extracellular matrix biology across tissue repair and ophthalmology. As the company enters its next phase of growth, it is engaging potential strategic partners to help accelerate development, commercialization, and the expansion of these technologies into additional clinical applications.

About ECM Therapeutics

ECM Therapeutics is a regenerative medicine company developing products derived from extracellular matrix biology to support tissue repair and constructive remodeling. Founded on pioneering research in extracellular matrix science, the company is advancing technologies designed to harness the body's natural healing mechanisms across a range of clinical applications.

About Stephen F. Badylak, DVM, MD, PhD

Stephen F. Badylak serves as Chief Medical Officer of ECM Therapeutics and is internationally recognized for his contributions to extracellular matrix biology and regenerative medicine. Over the course of his career, he has authored more than 500 peer-reviewed scientific publications and helped establish the scientific principles underlying the use of extracellular matrix technologies in tissue repair and reconstruction.

Forward-Looking Statements

This press release contains forward-looking statements regarding future commercialization activities, product development programs, market opportunities, strategic partnerships, and business prospects. Actual results may differ materially from those expressed or implied by such statements.

Media Contact & Partnership Interest
Name: Katie Collins
Title: Co-founder and VP, Business Development
Email: kcollins@ecmtherapeutics.com

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