Navigation Links
ReGen to FDA: 'Thanks, But No Thanks'
Date:3/22/2011

WASHINGTON, March 22, 2011 /PRNewswire/ -- ReGen Biologics, Inc. (ReGen), manufacturer of the popular and successful Menaflex Collagen Meniscus implant, today declined the U.S. Food and Drug Administration's (FDA) offer of a hearing under 21 CFR Part 16 before the agency formalizes its decision to rescind clearance of the device.

According to ReGen Chair and CEO Gerald E. Bisbee, Jr., Ph.D., the company's experience with the FDA over the past six years makes it clear that any such hearing would be futile. "The safety and effectiveness issues surrounding the clearance of our device were settled years ago at a November 14, 2008 Advisory Panel meeting.  The independent experts on that Panel were completely in Menaflex's favor," he said.  "The only issues that require remediation are the blatantly arbitrary and unfair processes of the FDA, and those aren't on the table in a Part 16 review.  Enough is enough."

ReGen's Menaflex device is a resorbable surgical mesh used in meniscus surgeries to reinforce damaged or weakened meniscal soft tissues, which provides a scaffold for replacement by a patient's own soft tissue.  It was approved in Europe in 2000 under the most stringent review classification for use in medial meniscus injuries, and in 2006 for lateral meniscus injuries.  To date, the device has been used successfully in over 3000 European surgeries, with no safety issues.  In fact, a recent independent publication from a prestigious European academic center shows that 10 years after surgery, Menaflex patients show superiority to patients receiving the standard of care, partial meniscectomy.

In December 2008, following 3 years of review under the 510(k) process including input from an Advisory Panel of independent experts, the FDA ruled that the product is as safe and effective as other surgical meshes and cleared it for use by surgeons in the U.S.  Two years later, following a change in top management at FD
'/>"/>

SOURCE ReGen Biologics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
2. ImmuneRegen BioSciences Reports Material Transfer Agreement with VaxGen, Inc.
3. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
4. Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
5. Acologix Presents Preclinical Data on Cartilage Regeneration by AC-100 at the OARSI 2007 World Congress on Osteoarthritis
6. Ceregene Presents Long-term Follow-up From Phase 1 Trial of CERE-120 in Parkinsons Disease
7. Tengion Launches Third Phase 2 Clinical Trial of Regenerated Human Bladder
8. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
9. Preclinical Data Demonstrate Ability to Regenerate an Entire Bladder With Tengion Neo-Bladder Replacement(TM)
10. Tengion Scientists Publish Key Preclinical Findings Demonstrating the Benefits of Organ Regeneration Vs. Repair
11. International Team Locates Key Player in Muscle Regeneration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... 2014 The report based on ... Share, Growth and Forecast, 2007 - 2017," elaborated by ... 20.8 billion in 2012 and is further expected to ... CAGR of 7.3% from 2012 to 2017. ... purposes, especially to prevent chronic diseases that may occur ...
(Date:9/30/2014)... , September 30, 2014 ... the CSF (Cerebrospinal Fluid) backflow of the Eldor spinal ... of the single hole pencil point spinal needles of ... Braun. Spinal anesthesia is an excellent type ... Orthopedics, Urology, General Anesthesia, etc. It is ...
(Date:9/30/2014)...   Acutus Medical, Inc. (ACM), a ... Cardiac Chamber Imaging and Dipole Density Mapping system to ... complex cardiac arrhythmias, including atrial fibrillation, announced it has ... imaging/mapping system as well as bring to market a ... to complete work on the AcQMap TM High ...
Breaking Medicine Technology:Nutraceutical Ingredient Market Will Reach USD 33.6 Billion Globally in 2018: Transparency Market Research 2Nutraceutical Ingredient Market Will Reach USD 33.6 Billion Globally in 2018: Transparency Market Research 3Nutraceutical Ingredient Market Will Reach USD 33.6 Billion Globally in 2018: Transparency Market Research 4Acutus Medical, Inc. Completes Additional $26.2M Series B Financing to Fund Portfolio Expansion 2Acutus Medical, Inc. Completes Additional $26.2M Series B Financing to Fund Portfolio Expansion 3
... When it comes to breast cancer, a physician,s ability ... of treatment depends on the quality of information revealed through ... the most advanced technology in breast cancer detection with positron ... PEM scanners in the Chicagoland area. Essentially, PEM ...
... BETHLEHEM, Pa., Nov. 1, 2011 Saladax Biomedical, Inc., ... assays to achieve the promise of personalized medicine for ... M.D., has accepted to chair the company,s scientific advisory ... as chief of the Division of Hematology/Oncology in the ...
Cached Medicine Technology:Palos Offers New Technology in the Fight Against Breast Cancer 2Saladax Biomedical, Inc. Names Edward Chu, M.D., Chair of the Company's Scientific Advisory Board 2Saladax Biomedical, Inc. Names Edward Chu, M.D., Chair of the Company's Scientific Advisory Board 3
(Date:9/30/2014)... Ohio (PRWEB) September 30, 2014 Life ... which provides CHL access to Life Length’s proprietary Telomere ... advanced and comprehensive telomere test on the market today, ... reports the percentage of short telomeres, providing the most ... Vice Chairman of the Department of Cell Biology at ...
(Date:9/30/2014)... Market Research Report on Global and ... in-depth market survey on Global and Chinese Cialis ... of Cialis including its classification, application and manufacturing ... top manufacturers of Cialis listing their product specification, ... The report further analyzes quantitatively 2009-2014 global and ...
(Date:9/30/2014)... 30, 2014 Catalent Pharma Solutions ... delivery technologies and development solutions for drugs, biologics ... agenda for the 25th Annual CPhI Worldwide Exhibition ... 6th to 9th. , Catalent is showcasing a ... during the show, including its facilities in China ...
(Date:9/30/2014)... (PRWEB) September 30, 2014 ADOAMNI, ... first “crowdfunding” campaign through GoFundMe. The campaign, which surpassed ... for a portion of the funds necessary to convert ... for the Stockton Unified School District (SUSD). The campaign ... provide a portion of the funds necessary for the ...
(Date:9/30/2014)... The American Parkinson Disease ... supporting seven Research grants to junior investigators pursuing ... support post-doctoral scientists whose research training holds promise ... and treatment of Parkinson’s disease, and eight Centers ... medical centers across the country intended to strengthen ...
Breaking Medicine News(10 mins):Health News:Life Length® Announces New Partnership with Cleveland HeartLab® to Offer Telomere Technology in North America 2Health News:Life Length® Announces New Partnership with Cleveland HeartLab® to Offer Telomere Technology in North America 3Health News:Cialis Industry (CAS 171596-29-5) Global and Chinese Analysis for 2014-2019 Now Available at LifeScienceIndustryResearch.com 2Health News:Cialis Industry (CAS 171596-29-5) Global and Chinese Analysis for 2014-2019 Now Available at LifeScienceIndustryResearch.com 3Health News:Cialis Industry (CAS 171596-29-5) Global and Chinese Analysis for 2014-2019 Now Available at LifeScienceIndustryResearch.com 4Health News:Catalent Showcases Advanced Technologies and Supply Capabilities at CPhI Worldwide Conference and Exhibition 2Health News:Catalent Showcases Advanced Technologies and Supply Capabilities at CPhI Worldwide Conference and Exhibition 3Health News:ADOMANI Raises More Than 100,000 Dollars Through GoFundMe to Convert a School Bus 2Health News:ADOMANI Raises More Than 100,000 Dollars Through GoFundMe to Convert a School Bus 3Health News:The American Parkinson Disease Association Awards $1.1 million in Research Grants and Continues to Lead the Way to Ease the Burden – Find the Cure for Parkinson’s Disease 2Health News:The American Parkinson Disease Association Awards $1.1 million in Research Grants and Continues to Lead the Way to Ease the Burden – Find the Cure for Parkinson’s Disease 3Health News:The American Parkinson Disease Association Awards $1.1 million in Research Grants and Continues to Lead the Way to Ease the Burden – Find the Cure for Parkinson’s Disease 4
... reason for hope, experts say , , FRIDAY, Sept. 28 ... to treat the autoimmune disease lupus is building up ... an upbeat tone, researchers from across the United States ... Research Institute (LRI) of the improving outlook for patients ...
... The Branded Pharmaceutical,Association (BPA) represents specialty manufacturers, ... of the BPA produce,market or distribute Legacy ... drugs, with a history of safety and ... these products are manufactured in FDA licensed ...
... YORK, Sept. 28 According to the ... nearly one million Latinos received,physician-administered aesthetic procedures ... Flor Mayoral, a board certified,dermatologist in Miami, ... it is important that women make informed ...
... Senior Living,Inc. (NYSE: SRZ ) today announced ... being conducted by the Special Independent Committee of ... Sarbanes-Oxley,Section 404 internal control review efforts and provided ... Investigation As previously disclosed, in December 2006, ...
... Calif., Sept. 28 TJ Enterprises, LLC,announced ... a safe,alternative in the treatment of baby ... This comes after the U.S. Food and ... unopened,retail samples of a non-homeopathic gripe water, ...
... Care,Management Association (PCMA) released the following statement today,supporting ... the,House Energy and Commerce Subcommittee on Health: ... earlier,this week that would fix the flawed Average ... Reduction Act. "PCMA supports the decision to ...
Cached Medicine News:Health News:Better Lupus Treatments on the Horizon 2Health News:Better Lupus Treatments on the Horizon 3Health News:Better Lupus Treatments on the Horizon 4Health News:The Branded Pharmaceutical Association Comments on Hydrocodone 2Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 2Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 3Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 4Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 5Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 6Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 7Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 8Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 9Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 10Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 11Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 12Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 13Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 14Health News:Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Management's Internal Control Review Efforts and on Legal Proceedings 15Health News:After Infant Gripe Water Recall Scare, Homeopathic Medicine Offers Safe Alternative 2
The VPAP III ST is a complete system solution for SDB, providing comfortable and effective bilevel treatment with additional treatment modes. The VPAP III ST is an effective business solution for cli...
The GoodKnight® 425 Bi-Level® device is suitable for travel and includes features such as automatic altitude compensation, optional cigarette lighter adapter and portable battery pack...
... The BiPAP Pro with Bi-Flex bi-level ... time that the BiPAP Pro takes to ... includes Digital Auto-Trak Sensitivity™ which automatically triggers ... expiratory pressures based on the patients breathing ...
... Electrophoresis System (PGGE) is designed to ... density lipoproteins (LDL) and high density ... using nondenaturing pore gradient gel electrophoresis. ... short DNA sequencing runs. Temperature control ...
Medicine Products: