Musculoskeletal News Roundup 27-Jan-11
BY LAUREN UZDIENSKI, JANUARY 27, 2011
Earnings
DJO announced preliminary 4Q:10 sales of $249.8 million, which were down from net sales of $257.2 million in 4Q:09; the company attributed the absolute decrease to fewer shipping days, noting that on the basis of average daily sales, 4Q:10 sales increased by 4% over the year-ago period. Among segments, bracing and supports sales increased by 5%; surgical implant sales increased by 5%; recovery sciences increased by 5%; and international sales increased by 7%. Growth rates exclude the effects of currency.
Johnson & Johnson reported 4Q:10 revenue of $15.6 billion, down 5% from the year-ago period and missing estimates by $0.5 billion. DePuy sales were down 1% to $1.4 billion, with hip down 6%, knee down 4% and spine down 3%. Growth rates exclude the effects of currency. Net earnings and diluted earnings per share for 4Q:10 were $1.9 billion and $0.70, respectively, in line with estimates.
Stryker reported 4Q:10 sales of $2.0 billion, up 9% over the year-ago period and in line with a pre-announcement. Orthopedic implant sales increased by 4% to $1.2 billion, with hip up 6%; knee up 3%; spine down 3%; and trauma up 8%. Growth rates exclude the effects of currency. Adjusted net earnings increased 13% to $372.0 million, or $0.93 per share, beating estimates by $0.02.
Zimmer reported 4Q:10 sales of $1.1 billion, up 3% over the year ago period and beating estimates by $20.0 million. Recon sales increased by 2% to $856.0 million, with hip up 4% and knee flat. Extremities sales increased by 10%; dental increased by 13%; trauma increased by 9%; and spine decreased by 4%. Growth rates exclude the effects of currency. Adjusted EPS increased by 13% to $1.27, beating estimates by $0.08.
M&A
Arthrex acquired Cardo Medical's joint arthroplasty division, which includes all of its hip and knee assets. Arthrex current manufactures a portfolio of sports medicine products. Terms were not disclosed.
Funding
Flex Biomedical raised $0.9 million in funding from new and existing investors, which will be used to continue the development of the Flex Polymer, a synthetic polymer viscosupplement for the treatment of osteoarthritis.
OrthoSensor raised $21.0 million in a Series B round led by Ziegler Meditech Equity Partners and an unnamed strategic investor. The company will use the funds to development and commercialization of its orthopedic devices, which offer sensor-assisted systems that "give surgeons new, real-time, actionable information about implant placement and performance."
Regulatory
LDR submitted its PMA for the single-level Mobi-C cervical artificial disc. The Mobi-C features a polyethylene insert that "[accommodates] the segmental instantaneous axes of rotation", which the company says precludes the need for screws or keels. The device was first introduced OUS in 2004 and has since been implanted in over 10,000 patients.
Mazor received 510(k) clearance to market their Emerald spinal implants, which are implanted with the company's robotic SpineAssist system. Mazor plans to begin marketing the devices in 2H:11.
Small Bone Innovations received 510(k) clearance for the radial Head (rHead) Extended Stem to be used in the correction of complex elbow instabilities and/or elbow reconstruction. The product is intended to be used in conjunction with SBi’s Elbow Management System (EMS).
Product Introduction and Update
Medtronic launched the CD HORIZON SOLERA Spinal System in the U.S. and initiated a limited market release in Japan. This product launch is part of the CD HORIZON family of fixation devices and is integrated with Medtronic's surgical navigation and imaging systems and the NIM-ECLIPSE neuromonitoring system.
Clinical
Kuros reported clinical results from a phase IIb study evaluating KUR-111, a bone graft substitute consisting of parathyroid hormone, fibrin sealant and hydroxyapatite/tri-calcium phosphate granules, in the treatment of tibial plateau fractures. At one year, radiological fracture union was present in 96.2% of patients treated with low dose KUR-111, 100% of those treated with high dose KUR-111 and 98.2% of those treated with autograft.. The company announced previously that the study achieved its primary endpoint of non-inferiority to autograft.
Appointments
Anika Therapeutics appointed Jeffery S. Thompson, Chairman and Chief Executive Officer of Advanced Bio-Technologies, Inc. to its Board of Directors. In addition to his role at ABT, Mr. Thompson is an Operating Partner for HealthEdge Investment Partners, a private equity firm focused exclusively in the healthcare industry.
Gary Fischetti has been appointed group chairman for Johnson & Johnson's DePuy orthopedics subsidiaries (DePuy Orthopaedics, DePuy Spine, DePuy Mitek and Codman & Shurtleff). Mr. Fischetti has been president of DePuy Spine since 2005.
SpineSmith and Celling Technologies appointed Chuck Reynolds Vice President of Sales. Mr. Reynolds has 20 years' experience in the spine, trauma and biologics markets and has most recently held executive sales and marketing positions with Osteotech, Lanx and Pioneer Surgical.
