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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 19-Apr-12 BY LAUREN UZDIENSKI, APRIL 19, 2012

Earnings
Johnson & Johnson reported 1Q:12 revenues of $16.1 billion, up 1% over the year-ago period and missing estimates by $143.0 million. DePuy sales were flat at $1.5 billion. Among segments, hips were up 1%; knee was up 2%; and spine was down 3%. Growth rates exclude the effects of currency. Adjusted net earnings for the quarter were $3.8 billion, or $1.37 per share, an increase of 2% over the year-ago period. Analysts had forecast adjusted EPS of $1.26.

Stryker reported 1Q:12 revenues of $2.2 billion, up 7% over the year-ago period and beating estimates by $43.3 million. Recon sales increased by 5% to $958.0 million and by 3% when excluding the impact of acquisitions. Among segments, hip sales increased by 3%; knee increased by 5%; trauma and extremities increased by 10%; spine increased by 12%. Growth rates exclude the effects of currency. The company reported 1Q:12 adjusted net income of $379.0 million, or $0.99 per share, up 7% over the year-ago period. Adjusted EPS was in line with estimates.

M&A
The EU approved Johnson & Johnson's $21.3 billion purchase of Synthes. The announcement follows Biomet's offer to acquire DePuy's trauma business, which allayed anti-trust concerns. The transaction has now been approved in Europe, China, Japan and Canada, with only the U.S. decision still outstanding. As announced previously, J&J expects the deal to close in 2Q:12.

Regulatory
Custom Spine received 510(k) clearance for the Securis cannulated pedicle screw system, which marks the company's first entry into the minimally invasive spine market.

Extremity Medical received an FDA warning letter, with alleged violations concerning device reporting and quality systems.

NLT SPINE received CE mark certification for the eSpin discectomy device. The company says the powered tool evacuates the disc nucleus and can be used to prepare the disc space before placing interbody fusion implants.

Product Introduction and Update
DePuy Spine launched the VIPER F2 Transfacet Pedicular System (VIPER F2), a transfacet pedicular screw and polyaxial ring system designed to provide stabilization and fixation during degenerative lumbar spinal fusion procedures.

Integra LifeSciences announced the U.S. full market release of the Integra Vu aPOD Prime Intervertebral Body Fusion Device. The device is the company's first zero-profile, stand-alone IBD designed for anterior lumbar fusion procedures.

Medtronic launched the POWEREASE System, a system of electronic instruments designed for use in instrumented spine surgery. The system is compatible with the company's CD HORIZON SOLERA Spinal System and the TSRH 3Dx Spinal System and is integrated with the NIM-ECLIPSE neuromonitoring, O-ARM imaging, and STEALTHSTATION navigation systems.

SurgLine announced that the company has successfully completed its first sports-medicine-related surgical case at a physician-owned surgery center in the state of Indiana. SurgiLine, which sources and distributes "high-quality FDA-approved medical and surgical products at discount prices", says the case involved specialized plates and screws and "provided a substantial savings over the competition."

Clinical
Mesoblast has reached 50% of their patient enrollment target for their phase II clinical trial investigating the use of allogeneic Mesenchymal Precursor Cells (MPCs) for non-surgical restoration of degenerated intervertebral discs and treatment of low back pain. The company attributes the "rapid rate of enrollment" to the "major unmet medical need and to the relative simplicity of Mesoblast's non-surgical procedure." Enrollment is expected to be complete by early 3Q:12.

Distribution
The GPO Premier awarded an agreement for orthopedic bone cement, accessories and pulse lavage products to Zimmer. Stryker Orthopedics has a similar agreement. The Zimmer contract is effective April 1, 2012.

Education
Orthopaedic Research and Education Foundation announced plans to award more than $3.1 million in 176 educational grants through its Clinician Development Program (CDP). Grants include graduate medical education fellowship grants in a number of orthopedic subspecialties and residency enhancement grants. Biomet, DePuy, Medtronic, DePuy Spine, Stryker and Ferring are among the companies sponsoring the OREF grants.

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