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:8/18/2017)... CA & CARMEL, IN (PRWEB) , ... August 18, 2017 , ... ... on its 36th annual list, the most prestigious ranking of the nation's fastest-growing private ... been included in the exclusive Inc. 5000 ranking . This year’s ranking reflects ...
(Date:8/18/2017)... ... August 18, 2017 , ... “Three Narrow Roads”: a vivid and ... of published author, Rev. Dr. Burnett King Sr., is currently the pastor-teacher-visionary at Simply ... the Faith Track Club, Inc., a track-and-field program geared towards youth. , King shares, ...
(Date:8/18/2017)... ... August 18, 2017 , ... “Kingdom Mandate for Kingdom Builders”: ... “Kingdom Mandate for Kingdom Builders” is the creation of published author, John F. ... Eastern Europe as a missionary in 1983. He spent three decades training pastors ...
(Date:8/17/2017)... ... August 17, 2017 , ... Riccobene Associates ... location in Goldsboro, NC to its family of practices. Residents of Goldsboro will ... starting August 15, 2017. , Riccobene Associates Family Dentistry, founded by Dr. ...
(Date:8/17/2017)... MA (PRWEB) , ... August 17, 2017 , ... ... will come together on September 19, 2017 for Anti-Infectives Rx. This off-the-record networking ... B. Martin Conference Center at Harvard Medical School. , Industry leaders and decision ...
Breaking Medicine News(10 mins):
(Date:8/7/2017)... 7, 2017 Zimmer Biomet Holdings, Inc. (NYSE and ... that its Board of Directors has approved the payment of ... of 2017. The cash ... about October 27, 2017 to stockholders of record as of ... of dividends are subject to approval of the Board of ...
(Date:8/4/2017)... -- Agragen, LLC, a Cincinnati -based ... and aquacultural feed sectors, announces a significant step ... AGR131.  This drug is designed to trap and ... patients suffering from inflammatory conditions such as rheumatoid ... Biological pharmaceuticals currently used ...
(Date:8/2/2017)... , Aug. 2, 2017 CaryRx, a next-generation full-service ... delivery service for patients in the Washington D.C. ... retail pharmacy by providing delivery of medications through the convenience ... future delivery or delivered within one hour to any location ... excited to bring this invaluable service to Washington ...
Breaking Medicine Technology: