AC5™ provides a new option for the treatment of topical wounds
FRAMINGHAM, Mass., Dec. 17, 2018 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel liquid, gel and solid hemostatic and wound care devices, today announced that the 510(k) premarket notification for AC5™ Topical Gel has been reviewed and cleared by the U.S. Food and Drug Administration (FDA), allowing for the product to be marketed. AC5 Topical Gel is a topical dressing indicated for use in the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.
Chief Executive Officer, Terrence W. Norchi, MD, said, “We are pleased to have received 510(k) clearance for AC5 Topical Gel, having obtained important feedback from the FDA throughout the process.”
Marketing clearance, which requires the provision of necessary documentation and data to the FDA, is an essential milestone to the path to commercialization.
Norchi added, “We believe that AC5 can add an important option to healthcare providers’ tool kits for the treatment of wounds. We continue to develop our commercialization plans and look forward to expanding the AC5 product family both in the US and abroad, where we have filed our first application for a CE mark in Europe.”
About Arch Therapeutics, Inc.
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. Arch's development stage product candidates include AC5™ Topical Gel, AC5™ Topical Hemostat1 and AC5™ Surgical Hemostat1.
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Source: Arch Therapeutics, Inc.
- AC5 Topical Hemostat and AC5 Surgical Hemostat are currently investigational devices and are limited by federal law to investigational use.