Navigation Links
MiMedx to meet with FDA in Mid-October
Date:9/12/2013

MARIETTA, Ga., Sept. 12, 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 has a meeting scheduled with the Food and Drug Administration ("FDA") to discuss the recent Untitled Letter it received from that agency.

The FDA has scheduled the meeting for October 16, 2013. Parker H. Petit, Chairman and CEO, said, "In the meantime, we will continue to communicate with the FDA in preparation for the scheduled meeting. MiMedx has already responded in writing to the FDA regarding the Untitled Letter. In our correspondence, we provided clear support for our position that our micronized products are minimally manipulated, and we reiterated our desire to work with the agency to resolve this issue as quickly as possible."

As the Company gains clarification through interaction with the FDA, MiMedx will communicate updated information to its shareholders.

About MiMedx

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 170,000 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 support for its position that its micronized products are minimally manipulated 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 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. 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, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. MiMedx Announces Conference Call To Discuss FDA "Untitled Letter" And Reiterate Guidance
2. MiMedx Addresses FDA Untitled Letter And Reiterates 2013 And 2014 Guidance
3. MiMedx Group, Inc. Announces Release Date for 2013 Second Quarter Results
4. MiMedx Announces 2012 Results
5. MiMedx Group to Present at the 6th Annual OneMedForum
6. MiMedx Group to Present at the Stifel Nicolaus 2012 Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/5/2016)... -- Progra m m e ... , s mosquito in Cayman Islands ... by 96 %   Oxitec and the Cayman Islands ... Aedes aegypti, the dangerous mosquito that spreads dengue, Zika and chikungunya, ... Grand Cayman .  MRCU, a global leader in mosquito control, is planning ...
(Date:5/5/2016)... Research and Markets has announced the addition of ...  report to their offering.  ,     (Logo: http://photos.prnewswire.com/prnh/20160330/349511LOGO ... Emission Tomography (PET) scanner and cyclotron install base in ... the current known number of PET scanners and cyclotrons ... also contains a detailed breakdown of this equipment by ...
(Date:5/5/2016)... DUBLIN , May 5, 2016 ... Markets has announced the addition of the  ... Highlights - 2016"  report to their ... http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ,The latest ... Landscape Highlights - 2016, provides comprehensive ...
Breaking Medicine Technology:
(Date:5/5/2016)... ... ... Chronic stress can have a silent, yet dangerous, impact on men’s heart ... increase inflammation, both of which raise the risk of heart attack and even stroke,” ... Harvard-affiliated Massachusetts General Hospital. Chronic stress also can lead to other issues that indirectly ...
(Date:5/5/2016)... Rochester, NY (PRWEB) , ... May 05, 2016 ... ... app is now available for iOS and Android devices. VisualDx is the ... expanded to include diagnostic support across general medicine. The system speeds diagnosis, ...
(Date:5/5/2016)... ... May 05, 2016 , ... CURE Media Group , ... announced a new collaboration with Imerman Angels to expand outreach and emotional ... world. , “Imerman Angels provides an emotional lifeline to patients and families facing the ...
(Date:5/5/2016)... (PRWEB) , ... May 05, 2016 , ... If you ... stretch marks on your skin, you may want to consider a treatment that some ... of Advanced Dermatology P.C. , Microneedling, also known as skin needling, is ...
(Date:5/5/2016)... Ill. (PRWEB) , ... May 05, 2016 , ... Dermatologic ... percent more than 2014 and up 27 percent since 2012. , The results of ... – including another annual increase in skin cancer treatments and the growing popularity of ...
Breaking Medicine News(10 mins):