Navigation Links
MiMedx Group Receives FDA Clearance to Market Its HydroFix™ Ortho Shield™ Device
Date:6/22/2011

MARIETTA, Ga., June 22, 2011 /PRNewswire/ -- MiMedx Group, Inc.  (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials including bioimplants processed from human amniotic membrane, announced today that the Company's proprietary device, HydroFix™ Ortho Shield™, has received 510(k) clearance. The Company also announced its receipt of two additional 510(k) clearances related to its HydroFix™ technology platform.

HydroFix™ Ortho Shield™ is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The patented HydroFix™ Ortho Shield™ is a biocompatible polyvinyl alcohol polymer (PVA) membrane that is indicated to minimize tissue attachment to the device in case of direct contact with the tissues. HydroFix™ Ortho Shield™ is a permanent protective sheet that minimizes soft tissue attachments to the device providing a protective environment for the repaired tendon to heal. The device is conformable, suturable, and biocompatible, providing surgeons with an easy to use option for tendon protection. The device also provides a smooth inner gliding surface for the tendon to move as part of normal motion.

Parker H. "Pete" Petit, Chairman and CEO, said, "We are pleased to receive these FDA clearances. Soft tissue attachments to repaired tendons can reduce the effectiveness of the repair and result in a reduced range of motion post surgery, so the HydroFix™ Ortho Shield™ meets an important clinical need. We are continuing to develop additional indications for this biomaterial in response to surgeon demand for a wide range of applications."

The two additional 510(K) clearances recently received from the FDA were for the Company's HydroFix™ Vaso Shield device. HydroFix™ Vaso Shield, indicated for use as a cover for vessels during anterior vertebral surgery, has now received clearance for an expanded range of sizes and for a higher temperature exposure limit.  Additionally, a large animal implantation study has demonstrated the ability of the device to minimize soft tissue attachments between the device and the surrounding soft tissue.

Bill Taylor, President and COO, stated, "Receiving these additional FDA clearances for our HydroFix™ technology is an important step in serving the needs and preferences of physicians that are utilizing our device in their surgical procedures. Surgeon feedback has included requests for new indications for use and new sizes for existing indications, and these new 510(k) clearances are a direct result of a portion of that surgeon feedback.  These FDA clearances are an integral part of our strategy of providing biomaterial solutions to unmet or underserved physician needs."

About the Company

MiMedx is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials including bioimplants manufactured from human amniotic membrane. The Company has an experienced team poised to capitalize on its science and technology to generate rapid sales growth and profitability.  Our tagline is "Innovations in Regenerative Biomaterials" because our biochemists, engineers, designers and physicians believe it is better to regenerate tissue when possible rather than replace traumatized, but otherwise healthy tissues and structures.  Our platform technologies, HydroFix™ and CollaFix™, and our newest platform technology, Purion® developed by our wholly-owned subsidiary, Surgical Biologics, have a vast number of potential applications in treating traumatized tissue and structures and MiMedx is focused on commercializing multiple applications for the Company's three technology platforms. In parallel, we are seeking strategic relationships, in selective categories, to more rapidly commercialize our technologies.  


'/>"/>
SOURCE MiMedx Group, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. MiMedx Announces Launch of AmnioFix™ Nerve Wrap
2. MiMedx to Attend International Society for the Advancement of Spine Surgery Annual Meeting
3. MiMedx Group, Inc. Announces Release Date for First Quarter Results
4. MiMedx Completes Acquisition of Surgical Biologics
5. MiMedx Receives Additional CE Certification for Its HydroFix™ Technology
6. MiMedx Announces Agreement to Acquire Surgical Biologics
7. MiMedx Group, Inc. Announces Release Date for Second Quarter Results
8. MiMedx Group Announces Addition of Sales Director for Europe
9. MiMedx Group Announces CE Mark for the HydroFix(TM) Spine Shield
10. MiMedx Group Announces Launch of its Paradis Vaso Shield(TM) Device
11. Foundation Venture Capital Group Invests in Company Developing Plaque-Reducing Dental Hygiene Products
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... , Jan. 19, 2017 This report on ... and future scenario of the global market. Large number ... consumption. Severe chronic constipation is a major side effect ... laxatives. Hence, novel targeted therapy has been prescribed to ... launch of targeted medicines, and growing awareness about the ...
(Date:1/19/2017)... NEW YORK , January 19, 2017 ... global market for cryotherapy is set to witness a CAGR of ... North America will continue to be the leading ... ... Suppliers are emphasizing on ensuring affordable and adequate supply ...
(Date:1/19/2017)... Fla. , Jan. 19, 2017  Sensus ... medical device company specializing in the treatment of ... as keloids, with superficial radiation therapy, today announced ... full year 2016 financial results on Thursday, February 2, ... Company will hold a conference call with the ...
Breaking Medicine Technology:
(Date:1/20/2017)... Boca Raton, FL (PRWEB) , ... January 20, 2017 , ... ... highest level of nutritional and bodybuilding supplements, announced it attended the January ECRM trade ... a respected bodybuilder and nutritional scientist who was determined to create a line of ...
(Date:1/20/2017)... ... January 20, 2017 , ... “Mary Magdalene: Grace is Greater than ... the woman who witnessed Jesus Christ firsthand. “Mary Magdalene: Grace is Greater than Sin” ... career as an educator interacting with countless women who had little knowledge of the ...
(Date:1/20/2017)... ... 2017 , ... D R Burton Healthcare Products LLC, makers ... in a study indicating superior performance against competitive products in secretion clearance. ... Positive Expiratory Pressure Devices During Simulated Breathing“ was published in the winter issue ...
(Date:1/20/2017)... ... January 20, 2017 , ... “The Land of More and More”: a ... world hunger, and shares the simple and achievable answer. “The Land of More and ... the Fairview Missionary Church in Angola, Indiana where he works with the children’s ministry ...
(Date:1/19/2017)... (PRWEB) , ... January 19, 2017 , ... Next week ... will be repealed by Congressional political games that circumvent health needs of over 30 ... Rally” capture the human anxieties and needs government public servants were suppose to prioritize. ...
Breaking Medicine News(10 mins):