ATLANTA, March 1 /PRNewswire-FirstCall/ — MiMedx Group, Inc. (OTC Bulletin Board: MDXG) announced today that the Company received the CE Mark for its HydroFix™ Spine Shield device and was certified for design, development, and production of post-surgical adhesion inhibiting barriers. The HydroFix™ Spine Shield is indicated for use in specific locations as a cover of the spine to provide a plane of dissection during a revision surgery. The proprietary, patented, and biocompatible polyvinyl alcohol polymer (PVA) membrane may reduce the risk of injury that may be associated with anterior vertebral surgeries. By covering the spine at the surgical repair site in anterior spine surgeries, HydroFix™ Spine Shield creates a plane of dissection for revision surgeries.
Dr. Rebeccah Brown, Executive VP of Product Development, said, “Anterior spine surgery patients can require revision surgeries, during which these patients are exposed to significant risk. The HydroFix™ Spine Shield was designed to create a plane of dissection to help minimize risk during the revision surgery.”
Parker H. “Pete” Petit, Chairman, President and CEO, commented, “This is the first MiMedx Group product to receive a CE Mark for commercial sale. The Company’s strategy is focused on commercializing exciting new technologies, such as HydroFix™ Spine Shield, for orthopedic and other healthcare markets. Our focused development efforts include a number of advanced technology products that we plan to introduce worldwide following their progression through the clinical and regulatory clearance and approval processes .”
The HydroFix™ Spine Shield is a permanent and biocompatible implant that is suitable as an adhesion inhibiting barrier or plane of dissection between anatomical structures. The proprietary and patented manufacturing process produces a product that is pliable, constructed in a single-layer and hydrophilic. The product may be trimmed and fitted easily at the time of use and is sutured into place.
The Company received notification from TUV Rheinland® that it obtained approval to apply the CE Mark on February 12, 2010. HydroFix™ Spine Shield is not available in the United States.
Important Note regarding forward-looking statements and risk factors. 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 those regarding the effectiveness of the HydroFix™ Spine Shield in reducing the risks associated with revision surgeries, the prospect for the development and commercialization of additional products, and the prospects for receiving regulatory clearances or approvals for additional hydrogel or collagen fiber products. These risks and uncertainties including, the ability of HydroFix™ Spine Shield to perform as designed, that the Company currently requires additional capital to survive and achieve its goals, which may be difficult or impossible to obtain, that the Company may not develop additional products or receive requisite regulatory clearances and/or approvals to be able to market such products or that such clearances or approvals may be delayed, that the Company may not be able to establish an effective distribution system for its products, and that the Company’s products may not gain acceptance in the marketplace or that acceptance may be delayed. The risks and uncertainties also include the risk factors detailed in its Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended March 31, 2009, and its most recent Form 10-Q filed on November 16, 2009. The Company does not undertake to update its forward-looking statements.
SOURCE MiMedx Group, Inc.