Musculoskeletal News Roundup 12-Jan-12
BY LAUREN UZDIENSKI, JANUARY 12, 2012
Earnings
Biomet reported F2Q:12 sales of $725.1 million, up 3% over the year-ago period. Reconstructive sales increased by 3% overall, with knee up 1%, hip up 6% and bone cement and other up 12%; sports medicine sales increased by 19%; extremity increased by 14%; trauma declined by 1%; spine declined by 6%; and dental increased by 1%. Growth rates exclude the effects of currency. EBITDA for F2Q:12 was $266.3 million, or 37% of net sales, compared to adjusted EBITDA of $263.7 million in F2Q:11.
MAKO Surgical announced that 18 RIO systems were sold during 4Q:11, 16 of which were sold to domestic customers. 2,258 MAKOplasty procedures performed during 4Q:11, which represents a 97% increase over 4Q:10.
NuVasive pre-announced 2011 sales of approximately $540.0 million, $8.5 million of which are attributable to the acquisition of Impulse Monitoring, Inc. Analysts had forecast annual sales of $538.7 million.
Orthofix pre-announced 4Q:11 sales of $151.3 million, up 5% over 4Q:10 and beating analysts' estimates by about $1.0 million.
Stryker pre-announced 4Q:11 sales of $2.2 billion, up 11% over the year-ago period (4% pro forma, excluding the effects of acquisitions) and missing estimates by $26.9 million. Reconstructive sales increased by 1%, while neurotechnology and spine sales increased by 49% and MedSurg sales increased 11%. Growth rates exclude the effects of currency.
Tornier pre-announced preliminary unaudited 4Q:11 sales of $69.0 million, up 12% over the year-ago period and in line with estimates. Extremity sales are expected to increase by 17% over the year-ago period.
Funding
Active Implants Corporation raised an additional $10.0 million in convertible debt from current investors to continue their NUsurface meniscus implant study. The company expects to enroll 100 patients and obtain two-year follow up data and reports that 35 patients have already been enrolled. Further, the company appointed Henry Klyce, a member of the company's Board of Directors since 2008, CEO. He will succeed Mike Mainelli.
Regulatory
Biomet received 510(k) clearance for two new products this week: E1 humeral bearing for use with the Comprehensive Reverse Shoulder System and the Comprehensive Segmental Revision System. The company says the E1 humeral bearing with exclusive Antioxidant-Infused Technology is "the first Vitamin E advanced bearing option for reverse shoulder applications." The E1 technology is already in use in the company's hip and knee products. The Comprehensive Segmental Revision System is described as a humeral replacement system "designed to address significant bone loss, both proximally and distally."
Ortho Kinematics received 510(k) clearance to market the KineGraph VMA (Vertebral Motion Analyzer) system, designed to evaluate vertebral motion in the entire range of spine bending. Click here for our 2009 interview with CEO Adam Deitz to learn more about the KineGraph VMA.
Intellectual Property
Lanx announced the hundredth implantation of the Durango Stand-Alone ALIF System, which the company says marks the "completion of the [Durango's] pre-launch evaluation". The company adds that a "full commercial launch of the system is underway."
Intellectual Property
Mazor Robotics received a European patent entitled "Miniature Bone-mounted Surgical Robot," which covers the company's Renaissance robotic surgical system for spine procedures.
RSB Spine received a notice of allowance of U.S Patent 8,100,976, which covers implant subsidence control of its line of InterPlate cervical and lumbar intervertebral fusion devices.
Clinical
Smith & Nephew announced the publication of a new study on the value of the VISIONAIRE system, which uses MRI and X-ray images to match total joint instrumentation to the patient. The study, published in the Journal of Arthroplasty, found that VISIONAIRE-fabricated implants were a full degree closer to neutral alignment and that the devices were associated with less time spent under anesthesia, a shorter hospital stay and shorter incisions in knee replacement surgery.
Collaborations
Cambridge Polymer Group and Massachusetts General Hospital announced that they have co-developed highly-crosslinked ultra-high-molecular-weight polyethylenes that incorporate vitamin E and are suitable for hip, knee, shoulder and spine arthroplasty applications. These technologies, generically termed CIMA, E-CIMA and Reservoir Vitamin E, are available for license.
Orthofix announced that the company will collaborate with tissue provider MTF to co-develop and commercialize a new bone technology that will be "complementary" to Trinity Evolution. Further, the company extended their MTF agreement, which supports Trinity Evolution, by an additional five years.
ThermoGenesis, a supplier of products and services that process and store human cell concentrates, entered into a five-year agreement with Arthrex, whereby Arthrex will market ThermoGenesis' Res-Q 60 System technology for use in the preparation of autologous Platelet Rich Plasma and Bone Marrow Concentrate.
Appointments
Lanx announced several appointments this week: Wayne Chrystal, formerly Vice President of Operations at Compex Technologies, was named Vice President of Operations; Michael Hughes, formerly of Biomet and Interpore Cross, has been appointed Senior Vice President of International; Pamela Snyder, formerly of Spineology, has been named Senior Vice President of Clinical & Regulatory Affairs; and Paul Hickey, formerly of Zimmer Spine, has been appointed Senior Vice President of Marketing and Research & Development. In addition, Lanx has expanded its corporate facility and combined its operations into a single 80,000 square foot facility in Broomfield, CO.
Pioneer Surgical Technology appointed Daniel Webber President and Chief Executive Officer, succeeding Jeffery Millin, who has served as President and CEO since January 2009. Mr. Webber has served as the company's Chief Financial Officer since joining the company in July of 2008.
