Framingham Company Receives Approval Wound-Care Product in Europe

The following is a press release

FRAMINGHAM- Arch Therapeutics, Inc., a developer of novel liquid, gel and solid hemostatic and wound care devices, today April 13, announced receipt of the CE (Conformité Européenne) mark for its first-in-class would care product, AC5^TM Topical Hemostat (“AC5”).

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The CE mark provides authorization to commercialize AC5 in Europe as a dressing and to control bleeding in skin wounds in both out- and in-patient settings.

Chief Executive Officer, Terrence W. Norchi, MD, said, “Experts continue to describe their desire for a hemostatic wound dressing with the broad array of features and benefits that AC5 offers. We expect earliest adoption to be in complicated acute surgical wounds as well as wounds that require better sharp debridement and wound bed preparation.”

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AC5 is a clear, conformable therapy that can uniquely support chronic and complicated wounds across all phases of the healing continuum. AC5 contains a proprietary synthetic peptide that self-assembles into a contiguous physical-mechanical seal on tissue, where it becomes a nanofiber scaffold similar to the body’s native extracellular matrix. 

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Additional AC5 features include that it:

• is hemostatic in the presence of anti-thrombotic therapy,
• conforms to irregular wound geometry and provides a protective barrier,
• has utility across all phases of wound healing,
• contains no human or other animal sourced materials, and
• it is naturally resorbed from the wound bed.

Norchi added, “Arch appreciates approval of the CE mark, especially considering the ongoing regulatory backlog in Europe due to changes in statutes and the current Covid-19-related encumbrances.”

In addition to the broad benefits described above, AC5 may allow clinicians to better treat wounds at the bedside and temporize wounds in patients who cannot access an operating room by providing critical protection and optimize the microenvironment for healing.

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Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients.