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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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, 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 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
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
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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