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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 21-Oct-10 BY LAUREN UZDIENSKI, OCTOBER 21, 2010

Earnings
Exactech announced that 3Q:10 revenues would be below guidance at around $42.0 million. The company attributed the shortfall to greater than expected costs associated with entry into new markets and distribution channel changes internationally, as well as softer business in several markets. Analysts had forecast revenues of $44.4 million for the quarter.

Genzyme reported 3Q:10 revenues of $1.0 billion, up 8% over 3Q:09 and missing estimates by $98.2 million. Sales of Synvisc increased 14% to $100.0 million during the quarter. Non-GAAP EPS was $0.42 per diluted share, up from $0.28 per diluted share in 3Q:09 and missing estimates by $0.10.

Johnson & Johnson reported 3Q:10 revenues of $15.0 billion, down 1% over 3Q:09 and
missing estimates by $197.8 million. As reported, sales were flat. DePuy sales were $1.3 billion, up 3% as reported and down 1% from the year-ago period when excluding effects of currency. The company announced segment growth as reported on their earnings call, with hip up 2%; knee up 3%; and spine flat. Diluted EPS of $1.23 increased by 3% over 3Q:09, beating estimates by $0.08.

Kensey Nash reported F1Q:11 revenues of $17.0 million, down 14% from the year-ago period and missing estimates by $0.3 million. Product sales totaled $10.9 million, down 19% from the year-ago period, with orthopedic product sales down 18%. Diluted EPS for the quarter was $0.41, in line with guidance and down from F1Q:10's EPS of $0.43. Analysts had forecast EPS of $0.42.

Medicrea reported 3Q:10 revenues of EUR 4.6 million ($6.3 million), up 48% over the year-ago period. 53% of the company's revenues were derived from the United States, with the company noting that U.S. penetration of its PASS LP thoraco-lumbar fixation system increased by 19 surgeons during the quarter. Net loss in 3Q:10 improved by 22% to EUR 1.4 million ($1.9 million).

Orthovita reported 3Q:10 revenues of $23.3 million, up 5% over the year-ago period and missing estimates by $0.4 million. Among product segments, Vitoss sales increased by 1%, biosurgery sales increased by 4%, and Cortoss sales increased to $1.0 million from $0.4 million in 3Q:09. Full financial results will be available on November 2, 2010.

Stryker reported 3Q:10 revenues of $1.8 billion, up 7% over the year-ago period and beating estimates by $20.0 million. Orthopedic implant sales increased by 1% to $1.0 billion during the quarter. Among segments, hip increased by 1%; knee was flat; trauma increased by 4%; and spine increased by 1%. Growth rates exclude the effects of currency. Adjusted diluted net EPS for the quarter was $0.80, which increased by 16% over the year-ago period and was in line with estimates.

Synthes reported 3Q:10 revenues of $907.2 million, representing a 5% increase over the year-ago period and missing estimates by $10.7 million. The company attributed revenue growth to a combined 7% increase in trauma and CMF sales, which was partially offset by global spine performance that reflects "market challenges" and delayed product launches. Growth rates exclude the effects of currency.

Regulatory
Biostructures received an FDA warning letter alleging that their osteoMATRIX Synthetic Bone Graft is misbranded and being marketed for unapproved uses.

curasan received CE mark clearance to market Ceracell, a synthetic, resorbable bone regeneration material. The company says that compared to its Cerasorb product, Ceracell has increased porosity and greater mechanical stability.

Product Introduction and Update
BioMedical Enterprises launched the HammerLock Intramedullary Nitinol Fixation System for use in the correction of hammertoes. The company adds that the BME HammerLock stabilizes the proximal joint of the toe without the need for exposed wires.

Salient Surgical announced the completion of the first human cases in Europe using its AQUAMANTYS 3 System, which adds cutting capabilities to its hemostatic TRANSCOLLATION technology. The cases consisted of a fusion revision, a lumbar disc replacement and a posterior lumbar interbody fusion and were performed in England.

Clinical
Mesoblast announced interim results from its phase II study of NeoFuse, its off-the-shelf mesenchymal stem cell product. The company noted that NeoFuse was found to be safe and effective when used in minimally invasive posterior lumbar spinal fusion. Additionally, CT scans at three months showed that approximately 90% of NeoFuse patients achieved successful bone bridging, and pain reduction scores were reduced by more than 20% in both the NeoFuse group and the control group.

Collaborations
Merlot OrthopediX, Inc., a Cleveland Clinic spin-off company jointly owned by Cleveland Clinic, Cleveland, OH, Frantz Medical Group, Mentor, OH and Dr. Isador Lieberman, M.D., M.B.A., Texas Back Institute, Plano, Texas, announced that it has entered into an exclusive agreement with Alphatec Spine, Inc. to develop and commercialize Merlot's novel bone anchorage technology for use in spine surgery.

Nanotope, Inc., a portfolio company of Arrowhead Research Corporation, has entered into an agreement with Smith & Nephew to develop a cartilage regeneration product based on the company's nanofiber technology. The press release states that Smith & Nephew will conduct and pay for preclinical and clinical studies. Nanotope will also receive up to $26.6 million in milestone payments, plus additional royalties. It will be the company's first commercial transaction.

Distribution
Cannuflow entered into an agreement with Specialty Surgical Instrumentation (SSi), a division of Symmetry Medical, whereby SSi will distribute the complete Cannuflow line of arthroscopy products in the United States and Canada.

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