MARIETTA, Ga., Dec. 23, 2010 /PRNewswire/ -- MiMedx Group, Inc. (OTC Bulletin Board :MDXG ), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today that it has received notification of the Class III certification for a European product using the Company's proprietary HydroFix™ technology.
This certification for "post surgical adhesion inhibiting barriers" is in addition to the Company's previous certification for HydroFix™ Spine Shield designated as a Class IIb device for use in certain locations along the anterior spine as a plane of dissection during revision surgery. The new Class III certification is for use during posterior and anterior vertebral surgeries as a cover for the spine, including contact with the Central Nervous System ("CNS") and Central Circulatory System ("CCS"), to provide a plane of dissection during revision surgery.
"As with anterior spine surgeries, where patients are exposed to significant risks when revision surgeries are necessary, posterior revision surgeries pose similar significant risks to the patient. Adhesions from previous surgery can significantly interfere with surgical technique, increase operating time and cause subsequent complications as well," said Parker H. "Pete" Petit, MiMedx Chairman and Chief Executive Officer. "Posterior vertebral surgeries are more prevalent than anterior vertebral surgeries. With this latest certification, we can begin to market HydroFix™ Spine Shield for use in posterior surgeries. This will allow us to serve the demand for post-surgical adhesion inhibiting barriers in the much broader posterior surgical market."
Bill Taylor, MiMedx President and Chief Operating Officer, added, "In addition to revision surgery, the applications now available to surgeons with this latest certification include fusion surgery, trauma, laminectomy and implantation or removal of hardware. Since we began the commercialization of HydroFix™ Spine Shield with the original certification, physicians have expressed continual interest in the timing of the certification for an expanded product offering that is appropriate for contact with the CNS and CCS. We are pleased that we are now at that point."
Due to the contact with the CNS and CCS, the Medical Devices Directives of the European Economic Community mandate this as a Class III device requiring a design dossier to be reviewed/certified by a notified body prior to commercialization.
The HydroFix™ Spine Shield is a permanent and biocompatible implant which 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 may be sutured into place.
About the Company
MiMedx Group, Inc. ("MiMedx Group") is an integrated developer, manufacturer and marketer of patent protected biomaterial-based products. The Company is successfully emerging from a development-focused start-up into a fully integrated operating company with an experienced team poised to capitalize on its science and technology to generate rapid sales growth and profitability. Our mantra is "Repair, don't replace" because our biochemists, engineers, designers and physicians believe it is better to augment repair when possible rather than replace traumatized, but otherwise healthy tissues and structures. Our platform technologies, HydroFix™ and CollaFix™, have a vast number of potential applications in treating traumatized tissue and structures and we are focused on commercializing multiple applications of both technologies. In parallel, we are seeking strategic relationships, in selective categories, to more rapidly commercialize our technologies. HydroFix™ and CollaFix™ are trademarks of MiMedx Group, Inc.
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 expected market demand and opportunities, surgical applications and utilization by physicians for the Company's HydroFix™ Spine Shield device resulting from this additional certification. 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 level of physician demand and utilization of the HydroFix™ Spine Shield device does not meet the Company's expectations, that the breadth of the posterior surgical market is not at the level expected by the Company, that the Company may not receive other requisite regulatory clearances and/or approvals to be able to market a full range of products or that such clearances or approvals may be delayed, that the Company's products may not gain the anticipated acceptance in the marketplace or that acceptance may be delayed, 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, 2009. By making these forward-looking statements, MiMedx Group 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, Inc.