Arch Therapeutics Receives ISO 13485 Certification for AC5
Company Completes a Critical Step in Its Progress Toward Commercialization of AC5
FRAMINGHAM, MA -- (Marketwired) -- 03/09/16 -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ ("AC5™"), today announces that it has received an internationally recognized ISO quality certification, marking completion of a critical step for Arch in its plans to commercialize AC5.
The certification, which was awarded by British Standards Institution Group America, Inc., attests that the Company's quality management system complies with the requirements of ISO 13485:2003 for the design and manufacture of AC5 for hemostasis. ISO 13485 is a quality management system standard accepted as the basis for CE marking medical devices under European Directives.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Receipt of the certification is a regulatory requirement that needs to be fulfilled before a medical device may be commercialized in the EU.
Dr. Terrence Norchi, President and CEO of Arch, stated, "Obtaining this certification is an important milestone and an essential component of Arch's strategy to obtain CE marking for our first product and patented technology. It is the culmination of a tremendous effort aimed at fulfilling consumer requirements, and resulting from the implementation and execution of improvements to our quality management systems. As previously disclosed, we have started to prepare a dossier of information for our CE marking application, which we intend to file this summer."
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate, known as the AC5 Surgical Hemostatic Device™, is being designed to achieve hemostasis in minimally invasive and open surgical procedures and is intended to be regulated as a medical device.
Find out more at www.archtherapeutics.com.
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On Behalf of the Board,
Terrence W. Norchi, MD
Arch Therapeutics, Inc.
ARTH Investor Relations
Toll Free: +1-855-340-ARTH (2784) (US and Canada)
Chief Financial Officer
Arch Therapeutics, Inc.
Source: Arch Therapeutics, Inc.