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Orthopedic and Dental Industry News Complete Archive »

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 had been forecasting revenues of $7.7 million.

M&A
Cardo Medical, Inc. acquired the assets of the bankrupt Vertebron for $1.3 million, which will be paid in cash. Vertebron has a number of pedicle screw, cervical plate and PEEK spacer products on the market, which generated approximately $11 million in revenues in 2008.

Funding
ReGen Biologics entered into a bridge financing agreement for up to $3.0 million, $250,000 of which will be immediately available. To preserve cash, the company is restructuring operations, which includes staff and expense reductions. These reductions are expected to have "significant impact on the company's ability to conduct certain aspects of its operations."

Maryland-based Suspension Orthopaedic Solutions raised $2.3 million to develop shoulder and knee implants, two of which it plans to bring to market in mid-2010. No further details were released.

Regulatory
The FDA is requiring manufacturers of dynamic-stabilization systems to conduct post-market studies to evaluate whether the systems offer sufficient spinal stability for fusion. JNJ, Medtronic and Zimmer are among the companies who will be collecting data.

ETEX announced that 510(k)-cleared indications for its EquivaBone have been expanded to include posterolateral spinal fusion. EquivaBone is a hard-setting bone graft substitute that consists of a mix of DBM and calcium phosphate.

Synovis Life Technologies completed its California Department of Public Health inspection, which allows the company to manufacture and sell the OrthADAPT Bioimplant and Unite Biomatrix soft tissue repair products acquired from Pegasus Biologics.

Product Introduction and Update
US Spine launched the Phantom Plus Interbody Fusion System, which the company says offers next-generation instrumentation and implants that complement US Spine’s posterior fixation systems. The implants are made from PEEK.

Intellectual Property
Minimus Spine was granted a U.S. patent covering its intradiscal ozone injections for the treatment of disc herniation. The company notes that "the literature indicates that ozone may be capable of reducing a disc herniation with a single injection," which could offer alternatives to patients in the market between conservative care and surgery.

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