Navigation Links
MiMedx Receives Additional CE Certification for Its HydroFix™ Technology
Date:12/23/2010

MARIETTA, Ga., Dec. 23, 2010 /PRNewswire/ -- MiMedx Group, Inc. (OTC Bulletin Board: MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today that it has received notification of the Class III certification for a European product using the Company's proprietary HydroFix™ technology.

This certification for "post surgical adhesion inhibiting barriers" is in addition to the Company's previous certification for HydroFix™ Spine Shield designated as a Class IIb device for use in certain locations along the anterior spine as a plane of dissection during revision surgery. The new Class III certification is for use during posterior and anterior vertebral surgeries as a cover for the spine, including contact with the Central Nervous System ("CNS") and Central Circulatory System ("CCS"), to provide a plane of dissection during revision surgery.

"As with anterior spine surgeries, where patients are exposed to significant risks when revision surgeries are necessary, posterior revision surgeries pose similar significant risks to the patient. Adhesions from previous surgery can significantly interfere with surgical technique, increase operating time and cause subsequent complications as well," said Parker H. "Pete" Petit, MiMedx Chairman and Chief Executive Officer. "Posterior vertebral surgeries are more prevalent than anterior vertebral surgeries. With this latest certification, we can begin to market HydroFix™ Spine Shield for use in posterior surgeries. This will allow us to serve the demand for post-surgical adhesion inhibiting barriers in the much broader posterior surgical market."

Bill Taylor, MiMedx President and Chief Operating Officer, added, "In addition to revision surgery, the applications now available to surgeons with this latest certification include fusion surgery, trauma, laminectomy and implantation or removal of hardware. Since we began the commercialization of HydroFix™ Spine Shield with the original certification, physicians have expressed continual interest in the timing of the certification for an expanded product offering that is appropriate for contact with the CNS and CCS. We are pleased that we are now at that point."

Due to the contact with the CNS and CCS, the Medical Devices Directives of the European Economic Community mandate this as a Class III device requiring a design dossier to be reviewed/certified by a notified body prior to commercialization.

The HydroFix™ Spine Shield is a permanent and biocompatible implant which is suitable as an adhesion inhibiting barrier or plane of dissection between anatomical structures. The proprietary and patented manufacturing process produces a product that is pliable, constructed in a single-layer and hydrophilic. The product may be trimmed and fitted easily at the time of use and may be sutured into place.

About the Company

MiMedx Group, Inc. ("MiMedx Group") is an integrated developer, manufacturer and marketer of patent protected biomaterial-based products. The Company is successfully emerging from a development-focused start-up into a fully integrated operating company with an experienced team poised to capitalize on its science and technology to generate rapid sales growth and profitability.  Our mantra is "Repair, don't replace" because our biochemists, engineers, designers and physicians believe it is better to augment repair when possible rather than replace traumatized, but otherwise healthy tissues and structures.  Our platform technologies, HydroFix™ and CollaFix™, have a vast number of potential applications in treating traumatized tissue and structures and we are focused on commercializing multiple applications of both technologies. In parallel, we are seeking strategic relationships, in selective categories, to more rapidly commercialize our technologies.  HydroFix™ and CollaFix™ are trademarks of MiMedx Group, Inc.

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 expected market demand and opportunities, surgical applications and utilization by physicians for the Company's HydroFix™ Spine Shield device resulting from this additional certification. 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 level of physician demand and utilization of the HydroFix™ Spine Shield device does not meet the Company's expectations, that the breadth of the posterior surgical market is not at the level expected by the Company, that the Company may not receive other requisite regulatory clearances and/or approvals to be able to market a full range of products or that such clearances or approvals may be delayed, that the Company's products may not gain the anticipated acceptance in the marketplace or that acceptance may be delayed,  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, 2009. By making these forward-looking statements, MiMedx Group 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©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. MiMedx Group Announces Launch of its Paradis Vaso Shield(TM) Device
2. MiMedx Group Announces CE Mark for the HydroFix(TM) Spine Shield
3. MiMedx Group Announces Addition of Sales Director for Europe
4. MiMedx Group, Inc. Announces Release Date for Second Quarter Results
5. MiMedx Announces Agreement to Acquire Surgical Biologics
6. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
7. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
8. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
9. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
10. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
11. CryoCor Receives FDA Approval for Right Atrial Flutter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
(Date:6/23/2016)... 2016 Bracket , a leading clinical trial ... clinical outcomes platform, Bracket eCOA (SM) 6.0, at the ... – 30, 2016 in Philadelphia , Pennsylvania.  ... Assessment product of its kind to fully integrate with RTSM, ... eCOA 6.0 is a flexible platform for electronic clinical outcomes ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s ... setting the bar too high can result in disappointment, perhaps even self-loathing. However, those ... goal. , Research from PsychTests.com reveals that behind the tendency to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San ... Society and the Road To Recovery® program to drive cancer patients to and from ... adults to ensure the highest quality of life and ongoing independence. Getting to ...
(Date:6/24/2016)... New York, NY (PRWEB) , ... June 24, ... ... lifestyle publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as ... believes that “the most beautiful women in the world, and the most handsome ...
(Date:6/24/2016)... ... ... Venture Construction Group (VCG) sponsors Luke’s Wings 5th Annual ... Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The event raised funds ... been wounded in battle and their families. Venture Construction Group is a 2016 Silver ...
Breaking Medicine News(10 mins):