MARIETTA, GA – MiMedx Group, Inc. (MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today that it has received notification by the FDA that the Company’s proprietary device, HydroFix™ Vaso Shield, has received 510(k) clearance for additional thicknesses and sizes.
In April 2009, the FDA cleared HydroFix™ Vaso Shield for use as a cover for vessels following anterior vertebral surgeries. The Vaso Shield is a permanent and transparent hydrogel product protected by multiple patents and patent applications, as well as a proprietary manufacturing process. During an anterior spinal implant procedure, the physician places the Vaso Shield between the spinal implant site and the vessels and then sutures it to the perivertebral, non-vascular soft tissue to secure the implant. The device is designed to protect the vessels in subsequent anterior revision surgeries.
Parker H. “Pete” Petit, MiMedx Chairman and Chief Executive Officer, said “In the initial 510(k) FDA submission, the device was presented with a thickness of 1.0mm. During the “soft launch” of HydroFix™ Vaso Shield, the physician receptivity was excellent and we received valuable feedback that they wanted to utilize the device in varying thicknesses. In response to their feedback, we submitted a subsequent 510(k) for the device. The FDA has now cleared HydroFix™ Vaso Shield for multiple thicknesses ranging from 0.4mm to 1.0mm and multiple sizes.”
“We are excited about the opportunity to expand the marketing of our product with the multiple thickness clearance and further serve the needs and surgical preferences of the physicians that utilize our devices”, added Petit.
The Company will also expand its European product offering of HydroFix™ Spine Shield to offer similar configurations as the HydroFix™ Vaso Shield.
MiMedx also reported that it has recently completed a Level 2 Comprehensive FDA Inspection of its Marietta, Georgia facility and was pleased with the results. William C. Taylor, MiMedx President and Chief Operating Officer, commented, “It is a very difficult job to establish a strong, compliant quality system in a start-up organization and it is even more difficult to ensure compliance with that system. We are very proud of our team. The results of the audit prove that our team has done a great job, and demonstrate management’s commitment to producing high quality products that meet or exceed applicable regulatory requirements”.
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 reception and utilization by physicians for the multiple sizes and thicknesses of the Company’s HydroFix™ Vaso Shield device. 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 Company currently requires additional capital to survive and achieve its goals, which may be difficult or impossible to obtain through the discount offer to certain warrant holders or otherwise, that the Company may not receive 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 cost reductions may not be sustained or be sufficient to enable the Company to achieve profitability, that the Company may not be able to establish an effective distribution system for its products in the U.S. or abroad, 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.
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