Musculoskeletal News Roundup 15-Dec-11
BY LAUREN UZDIENSKI, DECEMBER 15, 2011
M&A
Baxter International announced plans to buy Synovis Life Technologies Inc. for about $325.0 million, which represents a 51% premium over Synovis' closing price on Monday. Synovis' orthopedics and wound healing division, formerly Pegasus Biologics, has a collagen scaffold platform with orthopedic applications.
Symmetry Medical announced plans to buy the surgical instrument portfolio and associated assets from J&J's Codman business. Symmetry will pay $165.0 million in cash for the line, which will report about $60.0 million in sales this year in a $1.0 billion worldwide market. The line will be renamed Symmetry Surgical and include instruments for a number of different surgical specialties.
Funding
A Kansas Bioscience Authority panel recommended the group invest $0.6 million in Spinal Simplicity LLC, which manufactures the Minuteman interspinous inter-laminar fusion device.
Regulatory
DePuy Orthopaedics received PMA approval for the new AOX Antioxidant Polyethylene material, which will be used with the company's SIGMA Rotating Platform Knee System and LCS COMPLETE Mobile Bearing Knee System. The company says AOX Polyethylene utilizes a "new antioxidant that stabilizes free radicals without affecting the mechanical properties or strength of the polyethylene."
Product Introduction & Update
Exactech announced the full market launch of its Gibralt spinal system at last week's Cervical Spine Research Society Annual Meeting. The company says the Gibralt Spinal System is a "comprehensive solution for posterior stabilization" and an adjunct to fusion of the cervical and upper thoracic spine.
Reimbursement
CMS announced a proposed rule whereby manufacturers of drugs, devices, biologicals, and medical supplies covered by federal health insurance programs to disclose payments or "other transfers of value" they make to physicians and teaching hospitals. Manufacturers and GPOs would also be required to disclose to CMS physician ownership or investment interests.
TranS1 announced that Medicare Administrative Contractor Palmetto GBA has reversed a prior non-coverage decision for the company's AxiaLIF and will now reimburse the procedure. Palmetto covers approximately nine million people in California, Virginia, North Carolina, South Carolina, Nevada, West Virginia and Hawaii.
Intellectual Property
MedShape received U.S. Patent No. 8,069,858, covering the "Method and Apparatus for Deploying a Shape Memory Polymer."
Legal
Spinal Kinetics announced that a jury in the U.S. District Court, Northern District of California, has found that the M6 Artificial Disc does not infringe on Synthes' U.S. Patent No. 7,429,270. The jury found the Synthes '270 patent invalid.
Clinical
Amp Orthopedics initiated two randomized, double-blinded, sham-controlled clinical trials, one evaluating patients undergoing total knee replacement and a second in patients having arthroscopic rotator cuff repair surgery. Both will evaluate the safety and effectiveness of the company's non-thermal pulsed radio frequency (PRF) technology to reduce narcotic (opioid) use, decrease pain and improve function and quality of life following surgical intervention. Results of both trials are anticipated in 2012.
SANUWAVE announced the publication of peer-reviewed, preclinical data that "demonstrate the ability of the company's extracorporeal shock wave technology (ESWT) to stimulate proliferation of periosteal progenitor/adult stem cells", which can then be harvested for tissue engineering and regenerative medicine applications.
VertiFlex announced the completion of enrollment in its pivotal IDE clinical trial of the SuperionInterspinous Spacer (ISS), data from which will be used to support the company's PMA application. The Superion IDE trial is a prospective, multi-center, controlled clinical trial studying the safety and efficacy of the Superion ISS compared to control arm X-STOP IPD in healthy adults suffering from at least six months of moderate lumbar spinal stenosis who have been unresponsive to conservative care.
Operations
LDR announced that it has moved into a new, larger office facility that "increases LDR's presence in Austin, Texas" and more than doubles the company's previous office and warehouse space. The new facility also features "significantly expanded training capacity" surgeons and salespeople.
The Memphis Daily News reported that Smith & Nephew laid off 80 employees at its Memphis location. In July, the company announced that they would reorganize their Memphis-based orthopedic reconstruction division and the Andover, Mass.-based endoscopy division into one unit.
Appointments
K2M appointed Don O'Hearn as Senior Vice President of Sales in the Americas. Mr. O'Hearn has previously held sales and operational leadership positions at AGA Medical and Medtronic.
