Musculoskeletal News Roundup 27-Oct-11
BY LAUREN UZDIENSKI, OCTOBER 27, 2011
Earnings
CONMED reported 3Q:11 sales of $172.8 million, down 2% over the year-ago period and missing estimates by $6.8 million. Arthroscopy scales decreased by 1% to $69.4 million. Growth rates exclude the effects of currency. Non-GAAP diluted earnings per share for 3Q:11 was $0.33, narrowing from $0.34 in 3Q:10 and beating estimates by $0.02.
Orthofix reported 3Q:11 revenues of $144.7 million, up 3% over the year-ago period and beating estimates by $1.8 million. Spine implants and biologics sales increased by 8% to $36.8 million; total spine sales, including spinal stimulation, declined by 1%. Additionally, orthopedic sales increased by 16%, and sports medicine sales increased by 8%. Growth rates exclude the effects of currency. Adjusted net income was $12.6 million, or $0.67 per diluted share.
RTI Biologics reported 3Q:11 revenues of $43.3 million, up 1% over the year-ago period and beating estimates by $1.8 million. Sports medicine sales increased by 2%; spine increased by 6%; dental decreased by 41% due to changes in a distributor agreement, but would have increased by 17% had the same agreement been in place in 3Q:10; and bone graft substitute and general orthopedic sales increased by 24%. Net income for the quarter was $2.7 million, or $0.05 per share, beating estimates by $0.02.
Zimmer reported 3Q:11 revenues of $1.0 billion, up 2% over the year-ago period and in line with estimates. Recon was up 1% overall, with knee flat, hip up 4% and extremities up 4%. Dental sales increased by 9%; trauma increased by 14%; and spine decreased by 5%. Growth rates exclude the effects of currency. Diluted earnings per share for 3Q:11 were $1.04 adjusted, an increase of 8% over the prior-year period. EPS beat estimates by a penny.
Product Introduction and Update
Internal Fixation Systems launched their initial modules, which consists of basic instruments, screws and 1/3 tubular plates. The company says the sets "make more efficient use of inventory" by standardizing instruments and surgical trays across product lines.
K2M will showcase a number of new products at NASS, including the EVEREST Degenerative Spinal System, a top-loading pedicle screw system; the CHESAPEAKE Anterior-Lumbar Stabilization System, a zero-profile PEEK and titanium interbody device; the ALEUTIAN TLIF II Interbody System; the ALEUTIAN Anatomically-Narrow (AN) Oblique Interbody System; and the SERENGETI Complex Spine Minimally Invasive System. Including the scheduled product debuts at NASS, the company will have introduced nine products over the past month.
Spineology will introduce the Threshold pedicular fixation system at NASS next week. The Threshold system accommodates mini-open and percutaneous implantation of screws and rods, utilizing over-the-wire techniques for device placement.
Zimmer announced the European launch of the PathFinder NXT System, an MIS pedicle screw system that can be used in both mini-open and percutaneous approaches. The company says the system "enables enhanced reduction, compression, distraction and bone decortications capabilities and gives surgeons the ability to efficiently complete multilevel constructs."
Clinical
Bacterin announced results from a two-year study showing that their OsteoSponge, a demineralized cancellous bone graft substitute, was equivalent to rhBMP-2 in achieving interbody fusion. Outcomes were evaluated based upon radiographic assessment, CT scans and quality of life scores. Further, the press release notes that patients receiving the OsteoSponge graft reported statistically significant less leg pain at one year relative to the rhBMP-2 group.
Collaborations
Orthofix announced that it will support the Society for Minimally Invasive Spine Surgery's prospective patient data registry related specifically to minimally invasive spine surgery. Globus previously announced that they would help fund the registry, which is expected to enroll 250 subjects receiving minimally-invasive spine procedures. Outcomes analysis will include a minimum two-year follow up.
Distribution
Bacterin received vendor status for its product portfolio by American Medical Concepts, which the press release describes as the "largest multi-specialty orthopedic, spine and neuro distributor in the northwestern USA." The vendor status enables Bacterin to market its products, consisting of bone graft substitutes and anti-microbial coatings, to the hospitals in AMC's network.
Investigations
According to a DOJ press release, DFine agreed to pay the United States $2.4 million to resolve allegations under the False Claims Act (FCA) that the company paid kickbacks to induce physicians to use certain of the company’s devices that are used in treating vertebral compression fractures.
