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 utilizi
'/>"/>

SOURCE MiMedx, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

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:10/22/2014)... Calif. , Oct. 22, 2014 WHEN: ... EDTLOCATION: Online, complimentary registration available at: ... Leader Archana Vidyasekar and Visionary Innovation Research ... WiFi-like wireless electricity, self-assembling materials, nanobots and ... technologies which will transform our lives in ...
(Date:10/22/2014)... , Oct. 22, 2014  Regulus Therapeutics ... biopharmaceutical company leading the discovery and development ... that it has demonstrated human proof-of-concept with ... study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR ... hepatitis C virus infection ("HCV").  Interim results ...
(Date:10/20/2014)... Colo. , Oct. 20, 2014  Luoxis ... (NYSE MKT: AMPE), today announced that its academic ... clinical and research potential for its novel RedoxSYS ... potential (ORP) in the body in response to ... value of ORP as a clinical marker will ...
Breaking Medicine Technology:Futuristic Technologies That Will Transform Our World Beyond 2030 2Futuristic Technologies That Will Transform Our World Beyond 2030 3Futuristic Technologies That Will Transform Our World Beyond 2030 4A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 2A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 3A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 4A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 5A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 6A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 7A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 8Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 2Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 3Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 4Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 5
... YORK, Dec. 15, 2011  New York University and the ... they have appointed Theodore (Ted) Rappaport, 51, to lead ... Rappaport, currently the William and Bettye ... at Austin (UTA), is a leading educator and entrepreneur ...
... 15, 2011  Today, the Consumer Healthcare Products Association (CHPA), announced ... Five Moms campaign to raise awareness of ... of two teenage boys and a high school math teacher ... the dangers of substance abuse. Millions of ...
Cached Medicine Technology:Wireless Engineering Pioneer Joins NYU-Poly and NYU 2Wireless Engineering Pioneer Joins NYU-Poly and NYU 3Wireless Engineering Pioneer Joins NYU-Poly and NYU 4CHPA's Five Moms Campaign to Stop Medicine Abuse Welcomes New Mom Tammy Walsh 2CHPA's Five Moms Campaign to Stop Medicine Abuse Welcomes New Mom Tammy Walsh 3
(Date:10/22/2014)... TUESDAY, Oct. 21, 2014 (HealthDay News) -- The ... passengers arriving from Ebola-affected nations of West Africa ... screen them for infection with the virus. ... Jeh Johnson noted that 94 percent of air ... land at one of these five airports -- ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 With the Affordable ... national survey by the American Institutes for Research (AIR) finds ... how to use health insurance, but 42 percent say they ... plan’s details before signing up for coverage. , The AIR ... only 20 percent able to calculate correctly how much they ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 Losing Weight Your ... industry is staring you in the face, it certainly can ... not do your body an extra favor by doing it ... tempting crash diets. Instead, listen to your body, exercise regularly, ... Exercise is essential to losing weight; you need to exercise ...
(Date:10/22/2014)... Akeso Biomedical, Inc. , a ... of bacterial infections, microbial biofilms, and chronic wounds, announced ... of directors. , Dr. Sinskey is ... Massachusetts Institute of Technology, or MIT. He has been ... Sinskey also holds positions as Co-Director of the Malaysia-MIT ...
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. ... men may lead to increased blood pressure, according to a ... rise in blood pressure for young adult women or for ... women drank lightly or moderately, their risk of high blood ... finding parallels studies in older adult men and women," said ...
Breaking Medicine News(10 mins):Health News:Passengers From Ebola-Affected Countries Must Land at Designated U.S. Airports 2Health News:Passengers From Ebola-Affected Countries Must Land at Designated U.S. Airports 3Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 2Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 3Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 4Health News:ReductionGuruMD Presents Ways to Improve Your Weight Loss Results 2Health News:Akeso Biomedical Appoints Dr. Anthony J. Sinskey to Board of Directors 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 3Health News:Binge Drinking May Boost Blood Pressure in Young Men 4
... and played hide-and-seek Monday evening in a relatively rare astronomical ... ,As the cloud blanket gave way to an azure ... parks and from top of their houses - had a ... the Nehru Planetarium here, assisted by over a dozen amateur ...
... on men and the results of countless studies were ... the biological sex and gender differences between men ... 1990, the Society for Womens Health Research, a Washington, ... the need for including women in biomedical research studies. ...
... the highest level of health boosting antioxidants which could ... disease to cancer -- shows latest research. ... central and northern Europe and northern Asia. Scientists have ... nutritious than other fruits like apples, strawberries, mangoes or ...
... a tip from the Toronto police busted a global ... being abused. They rescued more than 31 kids.700 suspects ... an international child pornography network from a British-based ... room called "Kids the Light of Our Lives" that ...
... antigen (PSA) testing continues to be problematic. Even though ... reduce death, illness or disability from prostate cancer, testing ... ,A recent nation-wide survey indicates almost half of Canadian ... lifetime. In this review, Drs. Ian Thompson and Donna ...
... suspected it, and now a scientific study has backed them ... make teens feel older than they really are. Researchers at ... at the University of Victoria, carried out the study. ... a random sample of nearly 700 adolescents between 12 to ...
Cached Medicine News:Health News:Rare Womens Lung Disease May Yield Insights Into Common Diseases 2Health News:Thirty One Kids Rescued from a Pedophile Ring 2Health News:Dating, Drugs and Sex Make Teens Feel Older Than They are 2
QC HGB is an assayed quality control material for Hemocue analyzers. This control is a solution of stabilized human red cells and is available in 3 levels for monitoring analyzer performance at sever...
... the first and only contact lens designed ... to have difficulty reading small type and ... to enjoy the best vision possible, not ... glasses. Fortunately, Biomedics EPs unique optical design ...
... The table-mounted knee ... exposure for total knee ... flexible, open-frame design allows ... the knee during the ...
... contact lens-wearing patients to Bausch ... contact lenses with enhanced aspheric ... deliver the ultimate technology in ... provide your patients with exceptional ...
Medicine Products: