MiMedx Meeting With FDA Postponed Due To Partial Government Shutdown
MARIETTA, Ga., Oct. 16, 2013 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company's meeting with the Food and Drug Administration ("FDA") that was scheduled for today, October 16, 2013, to discuss the recent Untitled Letter has been postponed. The meeting was postponed as a result of the partial Federal government shutdown.
The FDA has not yet advised the Company when the rescheduled meeting will be held. Parker H. Petit, Chairman and CEO, said, "As part of the partial Federal government shutdown, some of the key participants in the meeting remain on furlough, and the meeting could not be held today. We are anxious to have the opportunity to meet with the FDA to discuss our position that our micronized products are minimally manipulated and should continue to be marketed solely under Section 361 of the Public Health Service Act and the FDA's regulation under 21 CFR 1271. We look forward to working with the FDA to resolve this issue as quickly as possible."
When the Company is advised of the rescheduled meeting date, MiMedx will communicate it to its shareholders. As the Company gains clarification following the rescheduled meeting with the FDA, MiMedx will provide an update to its shareholders.
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include the device technologies HydroFix® and CollaFix™, and our tissue technologies, AmnioFix® and EpiFix®. Our tissue technologies are processed from human amniotic membrane that is derived from the donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® process, to produce a safe, effective and minimally manipulated implant for homologous use. MiMedx® is the leading supplier of amniotic tissue, having supplied over 190,000 allografts to date to distributors and OEMs for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
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 Company's position that its micronized products are minimally manipulated, the prospects for a meeting with the FDA and the prospect for resolving this issue quickly. 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 meeting with the FDA is not rescheduled, that the issues raised by the FDA are not timely or favorably resolved, that the Company is unable to sell its micronized product under the current regulatory pathway, 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, 2012, and its most recent Form 10-Q. By making these forward-looking statements, the Company 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 Group, Inc.
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