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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 29-Jul-10 BY LAUREN UZDIENSKI, JULY 29, 2010

Earnings
CONMED reported 2Q:10 sales of $181.1 million, up 8% over the year-ago period and beating estimates by $4.1 million. Arthroscopy sales increased by 19% to $74.9 million. Growth rates exclude the effect of currency. Adjusted EPS of $0.32 improved from $0.17 in 2Q:09 and beat estimates by $0.06.

LDR reported that 2010 year-to-date sales have increased by 112% over the same period in 2009, which the company attributed to "widespread adoption of [the] ROI-A ALIF device coupled with the success of the ROI-C Cervical Cage." The company added that they have expanded their sales organization, adding Area Sales Directors and partnering with approximately 50 U.S. distributors.

Integra LifeSciences reported 2Q:10 sales of $178.6 million, up 8% over the year-ago period and beating estimates by $2.5 million. Orthopedics contributed $72.8 million in sales, representing a 12% increase over 2Q:09. Adjusted net income was $20.9 million, or $0.68 per diluted share, beating estimates by $0.13.

NuVasive reported 2Q:10 sales of $119.6 million, up 35% over the year-ago period and beating estimates by $2.0 million. The company also raised full-year guidance from $480.0-$500.0 million to $485.0-$500.0 million, with President and CEO Alex Lukianov noting, "Our strong momentum driven by continued adoption of the XLIF technology and increased traction from our biologics and international areas gives us the confidence to increase guidance." Net income in 2Q:09 was $17.0 million, or $0.42 per share, beating estimates by $0.13.

OrthoFix reported 2Q:10 sales of $142.8 million, up 4% over the year-ago period and missing estimates by $0.1 million. Total spine sales increased by 11%, with spine stim up 12% and implants and biologics up 10%; orthopedic sales increased by 11%; and sports medicine declined by 6%. Growth rates exclude the effect of currency. Net income for the quarter totaled $10.2 million, or $0.57 per diluted share, beating estimates by $0.03.

Ossur reported 2Q:10 sales of $90.0 million, up 12% over the year-ago period, with prosthetics up 15% and bracing and support up 11%. Growth rates exclude the effect of currency. The company reported net profit of $14.0 million, up from $2.0 million in 2Q:09.

Synthes reported 2Q:10 revenues of $892.2 million, up 7% over the year-ago period. Synthes does not report growth rates by product segment, though among geographies, North American sales increased by 4%; European sales increased by 8%; AP sales increased by 13%; and ROW increased by 27%. Growth rates exclude the effect of currency. For 1H:10, the company reported revenues of $1.8 billion, up 8% over 1H:09 and beating estimates by $3.1 million. Net earnings for 1H:10 were $424.6 million, or $3.58 per share, up 9% over the year-ago period and missing estimates by $0.07.

Funding
AxioMed raised $14.5 million in two tranches, which the company will use to complete enrollment for its IDE study of the Freedom Lumbar Disc, pursue CE Mark approval for its cervical disc, expand European sales of the Freedom Lumbar Disc and initiate European sales of the cervical disc.

Orthopedic devicemaker China Kanghui Holdings filed for an IPO of American depositary shares. The offering is valued at up to $75.0 million.

Regulatory
An FDA panel voted 6-5 in favor of approving Medtronic's Amplify, a BMP-2 with a different formulation and carrier than InFuse. Heading into the meeting, concerns circulated over a higher incidence of cancer in patients treated with Amplify, though the panel ultimately voted 9-4 in support of safety (with 1 abstention) and 10-3 (with 1 abstention) on efficacy.

Orthovita received FDA approval of a PMA supplement that will permit the company to operate a new collagen processing facility in Malvern, Pennsylvania. The facility will process the highly-purified form of collagen used in the VITAGEL surgical hemostat. The company says the approval gives the company "enhanced control over the supply and quality of a key raw material."

Product Introduction and Update
curasan initiated pre-marketing activities for their ATR (Advanced Tissue Regeneration), which the company describes as a "standardized system for extracting growth factors." The system includes applications for cartilage regeneration. The company is actively seeking distribution partners.

TranS1 launched the AxiaLIF 2L+ product line, its next-generation instrumentation and implant system for L4-S1 lumbar fusion. The system has been in limited release since receiving 510(k) clearance in January. Among the AxiaLIF's features, the device "allows a surgeon to provide controlled distraction during the operation to precisely restore lost disc height."

Clinical
Ortho Kinematics initiated a multi-site study of the KineGraph VMA, a diagnostic technology designed to be used in conjunction with MRI and x-rays. The study is designed to "help determine which types of patients are best evaluated with KineGraph VMA testing" and has already enrolled 23 patients.

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