MiMedx Group, Inc. Receives CE Certification for Its CollaFix(TM) Surgical Mesh CD
KENNESAW, Ga., Jan. 10, 2012 /PRNewswire/ — MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it has received the certification for the Company’s proprietary CollaFix(TM) Surgical Mesh CD. This certification of CollaFix(TM) Surgical Mesh CD, which is a Class III product in Europe, was issued by the Company’s notified body, AMTAC Certification Services, Limited, based in the United Kingdom.
This certification is the first for the Company’s CollaFix(TM) platform technology.
Parker H. “Pete” Petit, Chairman and CEO commented, “We are very pleased to receive our first regulatory certification for our unique CollaFix(TM) technology. Our collagen fibers, that are the size of human hair, are fabricated in continuous lengths and have similar strength and stiffness to human tendons. The fibers are bio-compatible and resorbable. We expect this certification to be the first of many in a line of products using our CollaFix(TM) technologies to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.”
CollaFix(TM) Surgical Mesh CD has not been cleared for use in the United States.
About the Company
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include the device technologies HydroFix® and CollaFix®, and our tissue technologies, AmnioFix® and EpiFix®. Our tissue technologies, processed from the human amniotic membrane, utilize our proprietary Purion® process that was developed by our wholly-owned subsidiary, Surgical Biologics, to produce a safe, effective and minimally manipulated implant. Surgical Biologics is the leading supplier of amniotic tissue, having supplied over 60,000 implants to date to distributors and OEMs for application in the Ophthalmic, Orthopedics, Spine, Wound Care and Dental sectors of healthcare.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the potential for future clearances of the Company’s other product submissions and the outcomes achieved from the use of the Company’s products. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the failure to receive certifications or the pace of such certifications of future products from the Company’s other submissions, the inability of the products to achieve desired outcomes and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2010 and its most recent Form 10-Q. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
SOURCE MiMedx Group, Inc.