FRAMINGHAM – Arch Therapeutics, Inc., developer of novel liquid, gel and solid hemostatic and wound care devices, today, Dec. 17, announced that the 510(k) premarket notification for AC5™ Topical Gel has been reviewed andand 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, in a media release 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 said “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.”
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.
The mission of Arch Therapeutics is to develop products that will improve the lives of patients and enhance the quality of care offered by healthcare personnel. We intend to offer compelling options to healthcare institutions facing limited resources.
The company is based on Walnut Street in Framingham.