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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 15-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 15, 2009

Earnings
Biomet reported FQ1:10 revenues of $630.0 million, a 7% increase over the year-ago period. Excluding dental, recon sales increased by 9%, with knee up 10%, hip up 6% and extremity up 23%. Dental decreased by 5%. All rates exclude the effects of currency. Net loss for the quarter was $22.8 million, improved from a net loss of $59.9 million for FQ1:09. Excluding special charges and stock compensation expense, adjusted net income in FQ1:10 was $49.2 million, up from $13.8 million in the year-ago period.

Johnson & Johnson reported 3Q:09 revenues of $15.1 billion, down 3% over the year-ago period and missing estimates by $100.0 million. Net income for the quarter was $3.4 billion, or $1.20 a share, beating estimates by $0.07 and up from $3.3 billion, or $1.17 a share, in 3Q:08. DePuy reported sales of $1.3 billion, up 7% over the year-ago period. Among segments, hip sales were up 6%, knee increased by 4%, spine was up 11% and sports medicine increased by 13%. All growth rates exclude the effects of currency.

Funding
Spine21 Ltd. has closed on a one-year, 8% loan for $0.2 million from its current investors. The company is developing the adjustable Bionic Spacer system, where the size of the spacer is adjusted using a radiofrequency control. It works between vertebrae to "[neutralize] the source of [back] pain."

Regulatory
Eden Spine received CE mark clearance for the Wellex, the company's interspinous process device designed to control extension in patients with spinal stenosis.

RSB Spine received FDA clearance to market its InterPlate C-Ti as an anterior cervical plate. The device was previously cleared as an interbody fusion device.

Product Introduction and Update
Celling Technologies launched the Res-Q device, a point-of-care cell processing system that "[provides] adult stem cell concentrations within minutes" while eliminating sterility issues with a functionally closed system.

DePuy Mitek launched
the VAPR Premier90, a low-profile, small-diameter radiofrequency electrode which provides soft-tissue ablation and coagulation during arthroscopic surgery.

Impliant announced that the first two implantations of its TOPS VersaLink System have been completed. The system combines the company's TOPS Total Posterior Arthroplasty device and the VersaLink Fixation System, which allows the surgeon to treat adjacent vertebral segments at different stages of degeneration.

Pre-clinical data indicated that SANUWAVE’s Pulsed Acoustic Cellular Expression (PACE) technology could be used as a "non-invasive technique to cause proliferation and thickening of progenitor stem cells" to be harvested for bone or cartilage regeneration.

US Spine launched the Facet Gun MAX, which delivers a locking Facet Bolt via a gun-shaped, reusable hand piece. The device is designed to lock a spinal segment following laminectomy.

Clinical
BioMimetic Therapeutics released positive results from its North American pivotal study of Augment bone graft, the company's fully-synthetic, PDGF-derived PMA candidate. The modified intent-to-treat analysis showed that at 24 weeks, Augment patients experienced a 61% fusion rate, compared 62% fusion rate for the autograft group, which is statistically non-inferior. The company is expected to submit the data to the FDA, completing Augment's PMA application, sometime in 4Q:09.

Medtronic announced that InFuse compares favorably to autograft when used in maxillary sinus floor augmentations. Researchers found that new bone was formed in both groups, and it was comparable to the native bone in density and structure. The InFuse patients had the benefit of avoiding donor-site pain and morbidity associated with the autograft harvest. InFuse has been approved for certain OMF and dental indications since 2007.

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