ATLANTA, March 9 /PRNewswire-FirstCall/ -- MiMedx Group, Inc. (OTC Bulletin Board: MDXG.OB) announced today that Karl-Matthias Moehlmann has joined the Company to lead the establishment of key distribution partners in Europe for the sales of the Company's HydroFix™ Spine Shield product. The Company was certified in Europe for design, development, and production of post-surgical adhesion inhibiting barriers, and 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.
Last week, MiMedx Group announced that it recently received the CE Mark for HydroFix™ Spine Shield, the Company's current product offering for the European market. The device is classified as a post-surgical adhesion inhibiting barrier and is used in specific spine surgeries. The CE Mark is a mandatory conformity mark on many products placed on the market in the European Union. The CE Mark certifies that a product conforms to the requirements of the Medical Device Directives for Europe. CE stands for Conformite Europeenne, "European Conformity" in French. The Company's product offering for the U.S. market is its HydroFix™ Vaso Shield product. On April 20, 2009, the FDA cleared the HydroFix™ Vaso Shield, via a 510(k), as a vessel guard or cover for anterior vertebral surgery.
Parker H. "Pete" Petit, Chairman and CEO, stated, "With the addition of the CE marked HydroFix™ Spine Shield to our previously cleared HydroFix™ Vaso Shield, MiMedx is now able to market in both the U.S. and Europe. The establishment of our relationship with Mr. Moehlmann will give us an experienced and influential partner to increase revenue through our distributors in Europe, as well as, represent MiMedx at major Euro Spine Society Meetings. He brings to the Company a wealth of experience and relationships. Mr. Moehlmann has an extensive orthopedic background with a number of leading international organizations, including Synthes Spine, Medtronic Kyphon and Depuy Spine, and he is based in Hannover, Germany. We are pleased to have Matthias as a part of the MiMedx organization."
HydroFix™ Spine Shield is only available in Europe and is not available in the United States. Conversely, HydroFix™ Vaso Shield is only available in the U.S. and is not available in Europe.
About MiMedx Group, Inc.
MiMedx Group, Inc. is an integrated developer, manufacturer and marketer of patent protected biomaterial-based products and is in the process of transitioning from a development-focused concern to an operating company focused on sales growth and profitability. The Company's assets include intellectual property protecting its CollaFix™ collagen-based technology for augmentation of soft and connective tissue diseases and trauma and intellectual property protecting a novel durable hydrogel technology. The Company has received FDA clearance for its first durable hydrogel product, the HydroFix™ Vaso Shield indicated for use as a cover for vessels following anterior spinal surgery. More information about MiMedx Group can be found at www.mimedx.com.
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, and the impact of the Company's sales director for Europe in leading the establishment of distributor partners in Europe and increasing the Company's revenues. 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 fails to establish key distributor partners in Europe and increase its revenues, 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.
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|SOURCE MiMedx Group, Inc.|
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