Musculoskeletal News Roundup 12-Feb-09
BY LAUREN UZDIENSKI, FEBRUARY 12, 2009
Earnings
Nobel Biocare reported 4Q:08 revenue of EUR 162.6 ($229.2 million), down 13% from 4Q:07. 4Q net profit of EUR 24.9 million ($32.3 million) was down 45% from the year-ago period and missed estimates of EUR 29.0 million ($40.9) million. The company noted that during the fourth quarter, they reduced discounts and trade receivables, and Nobel added that they could not provide reliable quantitative guidance for 2009 on account of deteriorating economic conditions.
Orthofix reported 4Q:08 revenues of $132.3 million, up 6% over 4Q:07 and in line with estimates. Orthopedic revenue was $32.2 million, up 16% over the year-ago period, which was driven partially by 35% growth in internal fixation sales. Additionally, spine sales for the quarter increased 2% to $65.8 million, with implant and biologic sales down 7% to $28.2 million. Sports medicine sales increased 6% to $24.3 million. Net loss was $717,000, or $0.04 per share. Adjusted net income was $6.8 million, or $0.40 per share.
Smith & Nephew reported 4Q:08 revenue of $960 million, in line with estimates and representing a 7% increase over 4Q:07. Orthopedic revenue was $550 million, up 6% over 4Q:07, which the company attributed to strong U.S. performance (10% revenue growth in the U.S. alone.) Among segments, recon increased 7% (10% excluding the impact of Plus), with hip up 5% and knee up 9%. Trauma revenues increased 6% (10% excluding Plus). Clinical therapies were flat (up 5% excluding Plus.) Endoscopy was up 9%, with arthroscopy up 10%.
Regulatory
K2M received 510(k) clearance for the CAYMAN Buttress Plate System and CAYMAN Thoracolumbar Plate System, designed to address trauma and tumor cases and indicated for the thoracolumbar, lumbar and sacral areas of the spine. Per the company's description, the buttress plate is designed to address graft expulsion, and the low-profile plate features K2M’s tifix Locking Technology, where each screw head forms an autogenic lock to the plate upon insertion and requires no additional locking mechanism.
Product Introduction and Update
Mikai, S.p.A. launched the Falena Interspinous Decompression Device for lumbar spinal stenosis. The device is made from titanium and PEEK and implanted in a minimally-invasive procedure.
Orthofix International will launch Trinity Evolution, its next-generation adult stem cell-based allograft, earlier than expected. The product was co-developed with the Musculoskeletal Transplant Foundation and will be introduced on May 1st, two months ahead of schedule.
Legal
An ex-sales representative from a Hopkinton, Mass.-based medical device manufacturer pleaded guilty this week to a single charge of felony misbranding of a medical device, with documents stating that he "promoted the use of these devices in a manner that was different from the FDA approved use." The former rep, who faces up to three years in prison and a $250,000 fine, is believed to have worked for Stryker.
Distribution
RTI Biologics, Inc. has signed an agreement to provide spinal allograft implants to Aesculap Implant Systems, Inc. Effective immediately, RTI will process cervical and lumbar spinal grafts from designs developed by Aesculap.
Operations
Orthofix announced that it has made a $7.0 million prepayment of its debt in addition to its regularly scheduled payments. The company also announced plans to close its Huntersville, N.C. office by the end of February 2010. Corporate accounting and finance functions at this facility have already been relocated, and employees will be relocated before the lease is up in 2010. Finally, the company said in an 8-k filing that they will call a Special General Meeting of the company's shareholders pursuant to requests from Ramius LLC. February 25, 2009 has been set as the record date for the Special General Meeting, and April 7, 2009 is the scheduled meeting date.
Appointments
Linares Medical Devices of Auburn Hills, Michigan announced that spine surgeon Richard W. Easton, M.D. has joined Perry W. Greene, M.D. on the company's Research and Development team. According to the press release, Dr. Easton is Board Certified by the American Academy of Orthopedic Surgery, has served as Chief of the Section of Spine Surgery at the Henry Ford Hospital Center for Athletic Medicine and is currently Director of the Division of Spine Surgery at William Beaumont Hospital, Troy, Michigan.
