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:9/23/2017)... Pa. , Sept. 22, 2017 Janssen ... a complete response letter from the U.S. Food and ... seeking approval of sirukumab for the treatment of moderately ... letter indicates additional clinical data are needed to further ... moderately to severely active RA. ...
(Date:9/22/2017)... Sept. 22, 2017 AVACEN Medical (AVACEN) announced ... now successfully helping those with the widespread pain associated ... diagnosed Amanda in Essex, England ... my hair, experiencing no sleep at all, tremendous pain, ... I cannot recommend [the AVACEN 100] enough, how this ...
(Date:9/19/2017)... Ky. , Sept. 19, 2017   ZirMed Inc ... predictive analytics, today announced that it has been ranked #1 ... Black Book™ Rankings 2017 User Survey. ZirMed was ... solution for large hospitals and medical centers over 200 beds ... Black Book,s healthcare technology user survey history. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer ... one of the most popular and least understood books in the Holy Scriptures, Revelation. ... descriptions that have baffled scholars for centuries. Many have tossed it off as mere ...
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
(Date:10/12/2017)... ... 2017 , ... The company has developed a suite of ... authorities worldwide. From Children’s to Adults 50+, every formula has been developed by ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, Preservative ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the technology: , ... to enable prevention of a major side effect of chemotherapy in children. Cisplatin ... patients. For cisplatin, hearing loss is FDA listed on-label as a dose limiting ...
(Date:10/12/2017)... ... ... On Saturday, October 21, the Health & Wellness Center at Florida Hospital ... for the American Heart Association Heart Walk. Teams of up to 10 people can ... their treadmills moving for 5 hours. Treadmills will start at 7:00 p.m. on Saturday, ...
Breaking Medicine News(10 mins):