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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 7-Jan-10 BY LAUREN UZDIENSKI, JANUARY 7, 2010

Earnings
Biomet reported FQ2:10 (ended November 30, 2009) revenues of $696.0 million, up 5% over the year-ago period. Recon sales increased 6% to $528.4 million, with hip up 4%, knee up 8%, dental down 8% and extremity up 27%. Additionally, fixation decreased by 3% and spine increased by 6%. All growth rates exclude the effects of currency. Excluding special items, including stock compensation, adjusted net income more than doubled to $74.8 million in FQ2:10 from $34.0 million in the year-ago period.

M&A
Anika Therapeutics announced the acquisition of Fidia Advanced Biopolymers for $17.1 million in cash and 1.9 million shares of stock, which values the deal at roughly $34.0 million, or 3.1x 2009 revenues. Fidia's product line includes the Hyalograft C, a treatment for cartilage defects that consists of autologous tissue seeded on a hyaluron-based scaffold. Fidia's products have not been cleared for sale in the U.S.

Stryker closed its acquisition of Ascent Healthcare Solutions. Founded in 2005, Ascent describes its operations as encompassing reprocessing, including "cleaning, testing/verifying, packaging and sterilizing," and "remanufacturing," which the company defines as "disassembling, repairing and manufacturing."

Funding
MiMedx announced that its $5.0 million offering of common stock and warrants has been oversubscribed. Proceeds will support the launch of the Paradis Vaso Shield, a hydrogel covering for vessels following anterior vertebral surgeries, and regulatory clearance for the company's other products.

Regulatory
icotec received CE mark clearance for its ETurn Ti, a titanium-coated lumbar spacer made from carbon fiber and PEEK. The device is indicated for PLIF, TLIF and EPLIF procedures.

Product Introduction and Update
SpineGuard announced that the 10,000th case has been performed using its PediGuard device, which is designed to aid in pedicle screw placement.

Vertebral Technologies, Inc. announced that the 500th InterFuse Device was implanted in December via the company's Intraoperative Assembly technology, which allows the surgeon to assemble a large implant through a minimally invasive approach.

Supply Agreements
BioMimetic Therapeutics amended and restated its manufacturing and supply agreement with Novartis, which provides BMTI with rhPDGF-BB, the basis for its Augment bone graft. Among the revised terms, the contract was extended by three years with successive three-year extension periods, and either company must give a six-month termination notice to discontinue the agreement. If Novartis terminates the agreement, or if BioMimetic terminates for cause, Novartis will provide to a new manufacturer all Novartis technology and supporting documentation to produce PDGF. The companies also reduced certain minimum purchase obligations through 2011.

Appointments
Former CDRH Director Daniel Schultz, M.D. has been appointed Senior Vice President, Medical Devices and Combination Products at Greenleaf Health LLC, a regulatory consulting firm. Per the press release, Dr. Schultz will "provide strategic consulting services and work with Greenleaf clients to bring innovative devices to patients."

Vertiflex appointed Scott L. Blumenthal, MD, of the Texas Back Institute, and A. Nick Shamie, MD, of the UCLA Comprehensive Spine Center, as Co-Medical Directors of the company. The company says the surgeons will provide medical and strategic clinical direction to VertiFlex and assist in its "primary objective" of completing the Superion Interspinous Spacer IDE pivotal trial.

Zimmer appointed Jeffrey B. Paulsen Group President, Global Businesses. He will be responsible for Zimmer Spine, Zimmer Dental, Zimmer Trauma and Zimmer Orthopaedic Surgical Products and report to Zimmer president and CEO David Dvorak. Mr. Paulsen most recently served as Chief Operating Officer for MPS Group Inc., a privately-held environmental services and facility management firm.

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