Navigation Links
ReGen Biologics Clarifies Recent Press about the Menaflex Device
Date:8/5/2009

HACKENSACK, N.J., Aug 5 /PRNewswire/ -- ReGen Biologics, a Hackensack, NJ based orthopedic products company seeks to clarify several statements regarding its Menaflex collagen meniscus implant that were made in a press release that was issued on Tuesday, August 4, by a party unaffiliated with the company. ReGen was unaware of the press release until it surfaced yesterday in media reports and on the Internet. The statements made in the release do not represent the views of the company regarding the use of the Menaflex device. ReGen's Menaflex(TM) device is a resorbable collagen scaffold used in arthroscopic surgery to address the most common form of knee injury, a torn medial meniscus. The device is inserted after a partial meniscectomy to reinforce and repair the damaged meniscus by providing a scaffold that is replaced by the patient's own tissue.

The press release discusses use of the Menaflex device with protein rich plasma and potential use as a carrier for stem cells. Both of these uses are outside of the indications for use of the device that were cleared by the FDA. While surgeons may use a device outside of FDA cleared indications, based upon professional judgment, this sort of "off label" use is not condoned or promoted in any way by ReGen. The company is committed to ensuring that its products are used for their FDA cleared indications and in accordance with best medical practices.

Surgeon acceptance of the Menaflex device has been excellent and is reflected by the fact that in the past few months the company has trained over 120 surgeons in the proper use of the device. The surgeon training course provides background information about the product, hands-on experience in the proper surgical technique and discussion of patient selection in accordance with the FDA cleared indications for use. ReGen's extensive surgeon training program is designed to prepare surgeons to use the Menaflex device safely and effectively.

About ReGen Biologics, Inc.:

ReGen Biologics is an orthopedic products company that develops, manufactures and markets innovative tissue growth and repair products for U.S. and global markets. ReGen's Menaflex(TM) collagen meniscus implant employs proprietary collagen scaffold technology to facilitate tissue growth, thereby reinforcing and repairing the damaged meniscus of the knee. The Menaflex device has been approved for sale in Europe and other countries, and is marketed through ReGen's European subsidiary, ReGen Biologics AG. The FDA cleared the Menaflex device to be marketed in the United States in December 2008. Visit www.regenbio.com and www.menaflex.com for more information.


'/>"/>
SOURCE ReGen Biologics
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Regence BlueShield of Idaho Announces Executive Changes
2. Regence Wins Awards for Consumer Appeal to Transform Health Care
3. Eric Pettigrew to Lead Regences Community and Business Relations Efforts
4. Study in this Week's Issue of Cell Finds Injected Growth Factor Spurs Heart Regeneration
5. Regence Wins Four Telly Awards for Health and Wellness Videos
6. Regence Launches Effort to Further Health Care Debate
7. Alliance for Regenerative Medicine Launches
8. Fate Therapeutics Granted Exclusive License By The Regents of the University of California to Stem Cell Modulators for Osteo-Regeneration
9. Regence Adds New, Diverse Talent to Board of Directors
10. Regence Members in Oregon Can Now Access Provider Cost Information
11. Case Western Reserve University Receives $5M From Third Frontier Commission for the Center for Stem Cell & Regenerative Medicine
Post Your Comments:
*Name:
*Comment:
*Email:
(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):
(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: