ATLANTA--(BUSINESS WIRE)--MiMedx Group, Inc. (OTCBB:MDXG - News) announced today FDA clearance to market the Paradís Vaso Shield™ device, indicated for use as a cover for vessels following anterior vertebral surgery. The proprietary, patented, and biocompatible polyvinyl alcohol polymer (PVA) membrane may reduce the risk of associated injury following anterior vertebral surgeries by providing a vessel cover.
Protection of veins and arteries is a common issue associated with many types of surgeries. Protection of the aorta and iliac vessels and other important anatomy is particularly important in anterior spine surgery. The Paradís Vaso Shield™ was designed to help physicians protect vessels following anterior vertebral surgery.
Dr. Rebeccah Brown, COO of SpineMedica, a MiMedx Group subsidiary, said, “Anterior spine surgery involves risk of injury to patients due to complications associated with vessel management. It is our belief that this product is ideally suited to address this issue in patients undergoing surgery in this complex area of the body.”
Parker H. “Pete” Petit, Chairman, President and CEO, commented, “This is MiMedx Group’s first product to receive FDA clearance. In my opinion, the Company has a complement of exciting new technologies, and a number of our products will proceed to the clearance and approval process in 2009. We will keep our shareholders fully informed on our progress.”
The Paradís Vaso Shield™ is to be used by inserting it between specific anatomy, such as the anterior spine and adjacent aorta or iliac arteries (vessels). The product may be trimmed and fitted easily at the time of use and is sutured into place.
The Paradís Vaso Shield™ is a permanent and biocompatible implant which is suitable as a cover for vessels. The proprietary and patented manufacturing process produces a product that is pliable, constructed in a single-layer and hydrophilic.
The U.S. Food & Drug Administration (FDA) cleared via the 510(k) process the Paradís Vaso Shield™ as a vessel guard or cover, on April 20, 2009, and notified the Company on April 21, 2009. The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established.
About MiMedx Group, Inc.
MiMedx Group, Inc. is organized around three business/development groups: SpineMedica is developing products based on its propriety PVA technology; MiMedx is developing a proprietary collagen-based fiber that may be used to repair tendons and ligaments; and LeveL Orthopedics is developing implants for use in the upper extremities.
You may contact Mike Culumber, Chief Financial Officer of MiMedx Group, Inc., at 813-866-0000, for additional information.
Important Note regarding forward-looking statements and risk factors: This letter includes statements that look forward in time or that express management’s beliefs, expectations or hopes. Those statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include those regarding physician use of the Paradís Vaso Shield™ and the likelihood that the Company will receive FDA clearance for other products in 2009. These future events may not occur as and when expected, if at all, and, together with the Company’s business, are subject to various risks and uncertainties. These risks and uncertainties include that physicians may not accept the Paradís Vaso Shield™ and that the Company may not receive FDA clearance for other products in 2009 or at all. The risks and uncertainties also include the risk factors detailed in its Securities and Exchange Commission filings, including its Form 10-K filing for the year ended March 31, 2008, its most recent Form 10-Q filed on February 23, 2009, and the Company’s other SEC filings. The Company does not undertake to update its forward-looking statements.
Contact:
MiMedx Group, Inc. Mike Culumber, Chief Financial Officer, 813-866-0000EmailIM Bookmarkdel.icio.usDigg Buzz up!
