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Orthopedic and Dental Industry News Complete Archive »

ReGen Biologics

Musculoskeletal News Roundup 2-Jun-11 BY LAUREN UZDIENSKI, JUNE 2, 2011

BioPoly receives CE mark for knee resurfacing system . . . ConforMIS receives CE mark for the iTotal CR . . . FDA clears Nimbic Systems' Air Barrier System . . Exactech launches the Proliant Polyaxial Pedicle Screw system . . . Zimmer showcases new products at EFORT more

ReGen Sues FDA BY LAUREN UZDIENSKI, JUNE 1, 2011

ReGen hinted in March that they were considering their legal options following the FDA's decision to rescind Menaflex's market clearance, and now they've officially filed suit in D.C. court. more

Beleaguered ReGen Files for Bankruptcy BY LAUREN UZDIENSKI, APRIL 12, 2011

Just weeks after turning down the FDA's offer for a hearing related to its Menaflex rescission and announcing that financial troubles meant the company couldn't file its annual report, ReGen Biologics filed for bankruptcy. more

ReGen Says "Enough is Enough" BY LAUREN UZDIENSKI, MARCH 22, 2011

ReGen called the FDA out for its "blatantly arbitrary and unfair" practices in a press release this afternoon, declining a hearing over the rescission of its Menaflex device. more

ReGen "Takes Exception" to FDA's Menaflex Rescission BY LAUREN UZDIENSKI, OCTOBER 19, 2010

ReGen put out a strongly-worded press release yesterday, saying they "take exception" to the FDA's "totally unbelievable" decision to rescind market clearance for their Menaflex device. more

FDA to Rescind Market Clearance for ReGen's Menaflex BY LAUREN UZDIENSKI, OCTOBER 15, 2010

Conceding that the agency succumbed to political pressure during their Menaflex review, the FDA has decided to rescind ReGen's clearance for the collagen-based meniscal device. This decision is unprecedented, with the New York Times noting that this is the first time the agency publicly admitted to wrongly approving a drug or device or that outside pressures influenced their review process. Menaflex will be the FDA's first rescission. more

Musculoskeletal News Roundup 25-Mar-10 BY LAUREN UZDIENSKI, MARCH 25, 2010

Bovie Medical, Custom Spine receive FDA clearances . . . Stryker resolves an FDA warning letter . . . Aesculap launches Spyder MIS retractor system . . . RTI Biologics opens reimbursement hotline . . . NASS surveys spine physicians about Medicare cuts . . . ConMed, Smith & Nephew and Stryker ink deals with Premier Purchasing Partners more

ReGen's Menaflex "Likely Safe"; FDA Weighing Next Steps BY LAUREN UZDIENSKI, MARCH 24, 2010

regen_logo.gifA CDRH panel convened yesterday to review the science behind the beleaguered Menaflex collagen meniscus implant, which has been the subject of near-constant scrutiny since its 510(k) clearance in December of 2008. more

Musculoskeletal News Roundup 4-Mar-10 BY LAUREN UZDIENSKI, MARCH 4, 2010

knee.jpg Corin, Osteotech and Integra report 4Q . . . Baxter to acquire ApaTech for up to $330.0 million . . . Intrinsic Therapeutics closes on $18.0 million of a $20.0 million round . . . FDA schedules Orthopaedic and Rehabilitation Devices Panel meeting for Menaflex . . . Aetna and United Healthcare reverse prior policies and announce that they will cover NuVasive's XLIF . . . Congress delays Medicare pay cut more

No Changes Imminent for the 510(k) Process BY LAUREN UZDIENSKI, DECEMBER 14, 2009

According to an editorial published in the Minneapolis Star Tribune, Dr. Jeffrey Shuren, acting director of the CDRH, has confirmed that no sweeping changes are imminent for the 510(k) process. The rigor of the 510(k) pathway has been a subject... more

Musculoskeletal News Roundup 8-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 8, 2009

Earnings TranS1 pre-announced 3Q:09 revenues, saying sales for the quarter would be in the range of $6.8 to $6.9 million. This represents a 15% increase over year-ago sales, though it is below 3Q:09 guidance of $7.4 to $7.9 million. Analysts... more

FDA: Menaflex Clearance Shows "Definite Threats" to the 510(k) Process BY LAUREN UZDIENSKI, SEPTEMBER 24, 2009

Yesterday the FDA issued a preliminary report on the process by which ReGen Biologics obtained 510(k) market clearance for its Menaflex device, concerns that were first publicized by the Wall Street Journal earlier this year. The Journal initially reported that... more

Musculoskeletal News Roundup 3-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 3, 2009

Regulatory Active Implants Corporation received a CE Class III Certificate for its TriboFit Hip System. The system is made from a low-wear polycarbonate-urethane material that the company says shares some of the characteristics of human cartilage. MEDICREA received 510(k) clearance... more

ReGen's Menaflex to Receive a CMS National Coverage Decision BY LAUREN UZDIENSKI, SEPTEMBER 1, 2009

CMS announced this week plans to initiate a national coverage determination on ReGen Biologics' Menaflex, a collagen scaffold for the treatment of meniscal tears. NCDs are relatively uncommon, with CMS issuing 18-24 decisions each year, and few of them relate... more

Musculoskeletal News Roundup 14-May-09 BY LAUREN UZDIENSKI, MAY 14, 2009

Earnings aap Implantate reported 1Q:09 revenues of EUR 8.4 million ($11.1 million), representing a 5% increase over the year-ago period. EBITDA for the quarter declined 47% to EUR 0.05 million ($1.1 million). The company says that for the full-year 2009,... more

FDA to Evaluate Clearance Process for ReGen's Menaflex BY LAUREN UZDIENSKI, MAY 13, 2009

The Wall Street Journal reports that the FDA will review its clearance of ReGen Biologics' Menaflex device. The Journal previously alleged that ReGen had undue influence on the regulatory process, making campaign donations to politicians who lobbied for the device's... more

Musculoskeletal News Roundup 23-Apr-09 BY LAUREN UZDIENSKI, APRIL 23, 2009

Earnings CONMED reported 1Q:09 revenues of $164.1 million, representing a 7% decrease over 1Q:08 and missing estimates by $9.5 million. Arthroscopic devices contributed $63.9 million in revenue, down 8% over 1Q:08, with the decline due largely to a 24% decrease... more

Musculoskeletal News Roundup 9-Apr-09 BY LAUREN UZDIENSKI, APRIL 9, 2009

Earnings Biomet reported FQ3:09 revenues of $615 million, a 7% (constant currency) increase over FQ3:08. Among segments, recon reported growth of 7%, with hip up 10%, knee up 9%, fixation up 4% and dental down 10%, which the company attributed... more

WSJ Reports on ReGen's Campaign Donations BY LAUREN UZDIENSKI, APRIL 7, 2009

The WSJ published additional details of its investigation into ReGen Biologics' FDA clearance for its Menaflex meniscal implant. New information out this morning includes details of campaign donations from ReGen executives to the New Jersey politicians who stood behind ReGen... more

The FDA Continues to Become More Conservative, Despite ReGen Experience BY DAVID KRESSEL, MARCH 13, 2009

In a recent Wall Street Journal article we blogged about last week, it was alleged that ReGen Biologics was able to put extreme pressure on FDA employees to ensure their Menaflex meniscus repair device was cleared via 510(k). If these... more

ReGen's 510(k) Clearance Under the Microscope at the WSJ BY LAUREN UZDIENSKI, MARCH 5, 2009

When ReGen Biologics received 510(k) clearance last December for its meniscal repair product, Menaflex, it looked like a happy ending for the company after two failed FDA submissions and a long back-and-forth with the agency. Now it appears the story... more

Musculoskeletal News Roundup 19-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 20, 2009

Earnings Exactech reported 4Q:08 revenues of $40.3 million, representing a 22% increase over 4Q:07 and beating estimates by $0.4 million. Net income was $3.1 million, or $0.24 per share, representing a 15% increase over 4Q:07 and beating estimates by $0.04.... more

Musculoskeletal News Roundup 22-Jan-08 BY LAUREN UZDIENSKI, JANUARY 22, 2009

Earnings aap Implantate pre-announced 4Q:08 and full-year 2008 revenues of EUR 7.1 million ($10.0 million) and EUR 31.2 million ($44.0 million), respectively. 4Q:08 revenues declined 24% from the year-ago period, which the company attributed to "more orders from global partners"... more

Musculoskeletal News Roundup 15-Jan-08 BY LAUREN UZDIENSKI, JANUARY 15, 2009

Earnings Alphatec Spine announced that, based on preliminary financial data, the company will report record consolidated quarterly revenues for 4Q:08 of approximately $28.4 million, an increase of approximately 33% over revenues from the prior year fourth quarter. For the year... more

Musculoskeletal News Roundup 24-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 23, 2008

M&A Medtronic completed its minority investment in Shandong Weigao Group. As a result of the investment, Medtronic now holds a 15 percent equity stake in Weigao. Medtronic purchased its 15 percent equity interest in Weigao for approximately HK$1.7 billion (or... more

Regen Biologics Gets FDA Clearance BY JOHN MCCORMICK, DECEMBER 22, 2008

This morning Regen Biologics announced that it received its long awaited FDA 510(k) clearance to market its collagen meniscus implant for the knee. This marks the end of a long and tortured back and forth between the company and the... more

Musculoskeletal News Roundup 20-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 20, 2008

Earnings Medtronic reported FQ2:09 revenues of $3.57 billion, up 14% (8% constant currency) over the year-ago period and missing estimates by $0.12 billion. Non-GAAP net earnings and diluted earnings per share were $758.0 million, or $0.67 per diluted share, missing... more

FDA Panel Recommends ReGen's Collagen Scaffold for 510(k) Clearance BY LAUREN UZDIENSKI, NOVEMBER 18, 2008

Last week the CDRH's Orthopaedic and Rehabilitation Devices Panel met to discuss ReGen Biologics' 510(k) application for its Collagen Scaffold, which is indicated for "reinforcement and repair of chronic soft tissue injuries of the meniscus." Beleaguered ReGen has received two... more

Musculoskeletal News Roundup 31-July-08 BY LAUREN UZDIENSKI, JULY 31, 2008

Earnings Cryolife reported 2Q:08 revenues of $27.2 million, up 18% over the year-ago period and beating estimates by $1.4 million. Orthopedic tissue processing revenues declined 76% to $0.3 million, as the company has discontinued that segment of the business. Net... more

JBJS: ReGen's Collagen Meniscus Implant Improves Clinical Outcomes for Some Patients BY LAUREN UZDIENSKI, JULY 8, 2008

A new JBJS study comparing ReGen Biologics' collagen meniscus implant, Menaflex, with partial meniscectomy was published this week, and the publication comes as a rare bit of good news for the struggling ReGen. At 311 patients, the multi-center study was... more

Musculoskeletal News Roundup 3-Apr-08 BY LAUREN UZDIENSKI, APRIL 3, 2008

Earnings aap Implantate reported 2007 revenue of EUR 28.0 million ($41.24 million), an increase of 52% over 2006. Net profit for the year was EUR 1.5 million ($2.21 million), down from EUR 1.6 million ($2.36 million) in 2006, which the... more

Musculoskeletal News Roundup 28-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 28, 2007

Legal Federal prosecutors announced on Thursday the terms of a settlement with Zimmer, Depuy, Biomet, Smith & Nephew and Stryker following an investigation into physician compensation practices. Zimmer, Depuy, Biomet and Smith & Nephew entered into deferred prosecution agreements and... more

FDA Throws ReGen Biologics Another Curveball BY DAVID KRESSEL, SEPTEMBER 25, 2007

ReGen Biologics today announced it received a "Not Substantially Equivalent" (NSE) letter from the FDA in response to the 510(k) premarket notification the company submitted for its meniscal repair implant. In a press release and conference call, a clearly frustrated... more

Orthopedic News Roundup 28-June-07 BY LAUREN UZDIENSKI, JUNE 28, 2007

Regulatory Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components. The FDA approved new labeling for Genzyme's... more

Orthopedic News Roundup 12-Apr-07 BY LAUREN UZDIENSKI, APRIL 12, 2007

Earnings Vertebron announced in a press release that 1Q:07 was its most profitable quarter ever. The Company attributes the growth to a significant sales increase over the comparable quarter last year as well as a company-wide restructuring in 3Q:06. Vertebron... more

Orthopedic News Roundup 5-Apr-07 BY LAUREN UZDIENSKI, APRIL 4, 2007

Earnings aap Implantate AG announced 2006 revenues of EUR 18.5 million, up 38% from the previous year. The aap Group attributed the growth to the Biomaterials segment, where sales increased by 64% to EUR 12.2 million. Biomaterials now generates two... more

Orthopedic News Roundup 8-Mar-07 BY LAUREN UZDIENSKI, MARCH 8, 2007

Earnings Orthofix International N.V. announced 4Q:06 revenue of $116.1 million, an increase of 45% over 4Q:05 and just missing estimates of $116.6 million. $28.1 million of 4Q:06's revenue can be attributed to the September 2006 acquisition of Blackstone Medical, Inc.... more

Orthopedic News Roundup 1-Mar-07 BY LAUREN UZDIENSKI, MARCH 1, 2007

Earnings Biologics LifeCell reported 4Q:06 product revenues of $39.3 million, an increase of 45% over $27.0 million in 4Q:05, but missed analysts' estimates of $39.5 million. The growth was attributed to increased demand for the Company's AlloDerm® Regenerative Tissue Matrix.... more

Orthopedic News Roundup 7-Dec-06 BY LAUREN UZDIENSKI, DECEMBER 7, 2006

Earnings Stryker announced this week that the Board of Directors has declared a year-end cash dividend of $0.22 per share, an increase of 100% over the $0.11 dividend declared in December 2005. The dividend is payable January 31, 2007 to... more

Orthopedic News Roundup 16-Nov-2006 BY LAUREN UZDIENSKI, NOVEMBER 16, 2006

Earnings: Langer reported their 3Q:06 results on Tuesday, which included a net loss of approximately $553,000, or $.06 per share on a fully diluted basis. Compared to 3Q:05, there was a net income $236,000, or $.02 per share on a... more

Orthopedics News Roundup 9-Nov-06 BY LAUREN UZDIENSKI, NOVEMBER 10, 2006

Earnings: Tissue Grafting: Regeneration Technologies, Inc. announced revenues of $18.1 million for 3Q:06, compared to $22.5 million for 3Q:05. RTI said the decrease in revenues was due to fewer tissues available for processing demand and reduced orders from primary distributors.... more

Orthopedic News Roundup 10-Aug-06 BY HUYEN NGUYEN, AUGUST 10, 2006

Earnings: Biologics: Orthovita reported 2Q:06 product sales came in at $11.2 million, up 32% compared to 2Q:05. On a non-GAAP basis net loss for the quarter was $5.1 million, or a loss of $0.10 per share. The Company did not... more

510(k) for ReGen Biologics' Collagen Scaffold Rejected BY HUYEN NGUYEN, AUGUST 9, 2006

On Monday, ReGen Biologics announced that it had received a letter from the FDA rejecting to approve the ReGen® collagen scaffold technology to be classified as a Class II medical device. In its exact words, the collagen scaffold technology, "is... more

Orthopedic News Roundup 4-May-06 BY HUYEN NGUYEN, MAY 4, 2006

Appointment: Scient'x USA appointed Tracy Brown as Vice President of Sales. Mr. Brown was formerly with Microtek Medical and Stryker Spine, both in the area of marketing and sales. Scient'x, SA is a HealthpointCapital portfolio company. Clinical Update: At the... more

Orthopedic News Roundup 30-Mar-06 BY HUYEN NGUYEN, MARCH 30, 2006

Dane Miller of Biomet called it quits a week after releasing its 3Q:06 earnings report. Last week, the Company reported earnings per share (EPS) of $0.43 which was in line with Street's estimate but did not meet analysts' expectation for... more

ReGen Goes for 510(k) BY DAVID KRESSEL, JANUARY 6, 2006

ReGen Biologics has decided to file for premarket notification (510(k)) for the sale of its CMI meniscus implant. In a conference call this week, the company explained its logic. ReGen had undertaken clinical studies to support an application for premarket... more

Orthopedic News Roundup 17-Nov-05 BY HUYEN NGUYEN, NOVEMBER 17, 2005

Regulatory Update: Osteobiologics received FDA clearance on its OsteoChondral Transplant (OCT) Comprehensive System Instruments. The system is intended for the treatment of osteochondral (cartilage) defects in the knee. BioSyntech received an approval from Health Canada, Therapeutic Products Directorate, Medical Devices... more

Orthopedic News Roundup 3-Nov-05 BY HUYEN NGUYEN, NOVEMBER 3, 2005

We wrap up this quarter with aggregated earnings and sales in the public orthopedic sector of $560 million and $5 billion, respectively, as a few more companies reported this week. For 3Q:05, orthopedic sales were up by 13% ($5.0 billion... more

A Follow-Up Interview with Gerald 'Gary' Bisbee, CEO of ReGen Biologics, Inc. BY JOHN MCCORMICK, OCTOBER 6, 2005

One of the leaders in this emerging meniscus repair market is ReGen Biologics. We recently had a chance to do a catch up with Gary Bisbee, CEO of ReGen Biologics who we interviewed last year. Disclosure: Individual members of HealthpointCapital,... more

Orthopedic News Roundup 29-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 29, 2005

It's all about spine this week. With NASS in full swing in Philadelphia, many companies eagerly issued press releases during the conference. Clinical: Cervical-Stim® is a post-operative cervical brace that generates a uniformed, low-level pulsed electromagnetic field (PEMF) at the... more

Orthopedic News Roundup 29-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 29, 2005

It's all about spine this week. With NASS in full swing in Philadelphia, many companies eagerly issued press releases during the conference. Clinical: Cervical-Stim® is a post-operative cervical brace that generates a uniformed, low-level pulsed electromagnetic field (PEMF) at the... more

ReGen Biologics Update: FDA Warning Letter BY JOHN MCCORMICK, SEPTEMBER 25, 2005

On Friday ReGen Biologics, Inc. reported that it received a warning letter dated September 16, 2005 from the FDA. The warning letter was a follow-up to the FDA Form 483 notice of inspectional observations received by ReGen and, along with... more

ReGen Biologics (OTC:RGBI) Reports Selected Financials for FY2004 and a Brief CMI Update BY HUYEN NGUYEN, MARCH 21, 2005

ReGen Biologics, Inc. (OTC:RGBI), a New Jersey-based tissue regeneration company, reported full year 2004 selected financial results on Friday of last week. In 2004, ReGen reported total sales of $504,000, a 72% increase over the $293,000 reported in 2003. Net... more

Cartilage Repair Comes of Age: An Interview with Gerald 'Gary' Bisbee, CEO of ReGen Biologics, Inc. BY JOHN MCCORMICK, OCTOBER 25, 2004

Cartilage repair is coming of age. One of the leaders in this emerging technology is ReGen Biologics. During the recent HealthpointCapital Biologics Summit, we spent a few quality moments interviewing Gary Bisbee, CEO of ReGen Biologics. JM: Introduce our Readers... more

Cartilage Repair Technologies Coming to Market BY ROBIN R. YOUNG CFA, AUGUST 30, 2004

Data from the largest clinical trial ever conducted on the human meniscus is starting to make its way into the FDA. The first module was submitted in early July. The next modules are being submitted over the course of 2004.... more

ReGen Biologics Adds New Board Member BY JOHN MCCORMICK, JUNE 14, 2004

On Thursday, ReGen Biologics named William R. Timken, a founding partner of Hambrecht & Quist, to its Board of Directors. This is not necessarily a new relationship since Timken has been an investor and advisor to the Company for over... more


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