Arch Therapeutics Receives Marketing Clearance from the US FDA Related to the AC5® Topical Gel Supply Chain
FRAMINGHAM, Mass., March 23, 2020 (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 U.S. Food and Drug Administration (FDA) provided clearance to market AC5® Topical Gel that is manufactured using an additional supplier and additional manufacturing processes. AC5 Topical Gel is to be used in the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.
To better harmonize US and European supply chains, Arch sought this marketing clearance from the FDA to use an additional supplier and manufacturing processes in the production of AC5® Topical Gel. Marketing clearances, such as this, require the provision of necessary documentation and data to the FDA, and they are essential milestones to the path to commercialization.
Chief Executive Officer, Terrence W. Norchi, MD, said, "This is an important step. While the review process took significantly longer than anticipated, we are pleased with the achievement, and we are awaiting comparable news from the Notified Body regarding a CE Mark.”
As previously indicated, the Company was recently notified that the Notified Body review team has completed its review of Arch’s technical documentation, provided the Company a draft of the CE certificate to review, and has recommended to its decision-making panel that CE Marking be granted.
Norchi added, “Despite the current pandemic that challenges us all, our staff has been enabled to work remotely, we are working with our supply chain to manage inventory, and we are assessing our roll-out strategy to consider the evolving needs of our key clinicians.”
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 Hemostat.1
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Source: Arch Therapeutics, Inc.
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Arch Therapeutics, Inc.
|1.||AC5® Topical Hemostat and AC5® Surgical Hemostat are currently investigational devices limited by law to investigational use.|