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:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned ... developed to enhance the health of felines. The formula is all-natural and is made ... in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... California (PRWEB) , ... June 25, 2016 , ... "With ... fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... customizable and all within Final Cut Pro X . Simply select a ProHand ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... A ... procedures that most people are unfamiliar with. The article goes on to state that ... but also many of these less common operations such as calf and cheek reduction. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- Dublin ... the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global market ... its applications in various applications. The report deals with ... main industries: pharmaceutical and biotechnology, food and beverage, and ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
Breaking Medicine Technology: