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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 24-July-08 BY LAUREN UZDIENSKI, JULY 24, 2008

Earnings
Anika Therapeutics reported 2Q:08 revenue of $8.38 million, representing a 32% increase over 2Q:07 but missing estimates by $0.4 million. The company attributed sales growth to the strength of the Orthovisc line. Net income for 2Q:08 was $0.81 million, or $0.07 per diluted share, beating estimates by a penny. Among the highlights for the quarter, the company launched Monovisc in Europe and plans to complete enrollment for the U.S. pivotal study in 4Q:08.

CONMED reported 2Q:08 sales of $192.8 million, representing a 14% increase (11% constant currency) over 2Q:07 and beating estimates by $6.3 million. Arthroscopy sales were $76.6 million, up 18% (14% constant currency) over the year-ago period, and endoscopic technologies were flat as reported (-1% constant currency.) Net income was $12.46 million, or $0.43 per share, beating estimates by $0.04.

Genzyme reported 2Q:08 revenue of $1.17 billion, representing a 25% increase over 2Q:07 and beating estimates by $0.1 billion. Sales of Synvisc and Synvisc-ONE were up 9% to $70.9 million. Non-GAAP net income was $268.5 million, or $0.98 per share, beating estimates by a penny.

NuVasive reported 2Q:08 revenues of $57.4 million, representing a 61% increase over the year-ago period and beating estimates by $6.7 million. CEO Alex Lukianov attributed the sales growth to the "continued maturation of the company's exclusive sales force." Net loss was $0.5 million, or $0.01 per share; analysts expected a loss of $0.04 per share.

RTI Biologics reported 2Q:08 revenues of $40.8 million, representing a 78% increase over the year-ago period but missing estimates by $2.8 million. The revenue growth was attributed to the acquisition of Tutogen. Net income was $1.5 million, or $0.03 per share, in line with estimates. Sports medicine contributed $9.9 million in revenues; spine $10.1; bone graft substitutes $4.0 million; dental $8.2 million; and general orthopedic $1.7 million.

Zimmer reported 2Q:08 revenues of $1.08 billion, up 11% (5% constant currency) over the year-ago period and beating estimates by $0.01 billion. Net earnings were $227.1 million, or $0.99 per share, in line with estimates. Recon grew 14% (8% constant currency) over 2Q:07, with growth among segments at 15% (10% constant currency) in knee; 12% (4% constant currency) in hip; 11% (9% constant currency) in spine; 18% (14% constant currency) in extremity; 9% (3% constant currency) in trauma; and 12% (6% constant currency) in dental.

M&A
Integra LifeSciences announced plans to acquire Theken Spine, LLC, Theken Disc, LLC and Therics, LLC for $75.0 million in cash at closing, subject to certain adjustments. Integra will also make up to $125 million in future performance-based payments. The acquisition is expected to close in 3Q:08.

Osiris Therapeutics, Inc. announced in an 8-k filing that Blackstone Medical, Inc. filed an action in the U.S. District Court seeking a temporary restraining order and a preliminary injunction to block Osiris from selling Osteocel to NuVasive. Among other claims, Blackstone says Osiris' sale of Osteocel breaches a distribution agreement in place between the two companies. Despite this action, NuVasive announced on Thursday that the sale of Osteocel had closed.

Regulatory
ArthroCare is the subject of an informal SEC investigation into "accounting matters" following the news of the company's plans to restate nine quarters of financial results. The company plans to cooperate fully with the investigation.

Biocomposites received 510(k) clearance for geneX, a resorbable bone graft substitute the company describes as having a negative surface charge that stimulates bone growth.

Inion received 510(k) clearance for its biodegradable Inion S-1 and Inion S-2 graft containment systems, which feature radiographic markers for visibility in x-rays.

Product Introduction and Update
Impliant, Inc. announced the first implantation of a less-invasive version of its TOPS System in the U.S., which features a reduced L5 crossbar configuration designed to "further reduce tissue retraction and operative time." Domagoj Coric, MD, of Charlotte, NC, performed the surgery as part of the company's ongoing IDE study.

K2M, Inc. launched the cobalt chrome RANGE Rigid Rod (R2 Rod). According to the press release, the cobalt chrome rod is compatible with titanium screws, offering the surgeon more flexibility in component selection. The company adds that cobalt chrome is more MRI-compatible than stainless steel.

Theken Spine announced the first implantation of the Vu aPOD on July 11, 2008. The Vu aPOD is an ALIF system that features an optional internal SpinPlate, which the company says is designed to enhance implant stability and reduce migration concerns. The surgery was performed by Mukund Gundanna, MD of College Station, TX.

Zimmer will voluntarily suspend sales of its Durom Acetabular Component in the U.S. while they update the labeling and conduct further surgeon training on the product.

Reimbursement
CMS proposed a national non-coverage decision for intradiscal electrothermic therapy (IDET), saying there is insufficient evidence that the procedure improves outcomes in the Medicare population. Comments will be accepted for 30 days, at which point a final decision will be released.

Operations
Zimmer announced plans to invest more than $19 million to add approximately 50,000 square feet to its foundry operations, which the company says will boost automation of the facility and increase annual output by approximately 1.3 million castings a year. The initiative should create nearly 100 new jobs by 2011.

minSURG Corporation has launched an international division to meet demand for truFUSE products in Canada, Brazil, Germany, Greece, South Korea, Netherlands, Singapore, Taiwan, Turkey and Japan, according to CEO Jim Doulgeris, who added that sales to Turkey and Greece have already been initiated.

Clinical
Alphatec Holdings, Inc. announced that the first surgery with the OsseoFix Spinal Fracture Reduction System was performed on July 21, 2008 at the Bogen Centre in Germany. The surgery was performed by Rudolph Bertagnoli, M.D., Chief of Spine, St. Elizabeth Klinikum, Straubing, Germany, and a world-renowned spine surgeon. Dr. Bertagnoli is the lead investigator in a 30-patient study of the OsseoFix that is being conducted by Alphatec in Germany.

Arthro Kinetics Plc. announced plans to initiate clinical studies in Japan and China evaluating the use of CaReS for the treatment of cartilage defects. In Japan, the company's joint venture partner PolarisRx recently submitted an application to Japanese Ministry of Health and Welfare seeking approval to begin the study; Chinese joint venture partner Arthro-ANDA Tinajin Biologics Technology Co. received a grant of 8 million yuan that will be used to fund the study, which is expected to begin in 2H:08.

DePuy Spine announced results of a study showing that the use of allograft processed with osteoprogenitor cells produces comparable rates of lumbar spinal fusion when evaluated against autograft. The company's CELLECT Device was used to mix the allograft matrix with stem cells obtained from the patient's bone marrow. Among other outcomes, the DePuy-funded study found a 94% fusion rate, and mental and physical functioning scores improved by 7% and 40%, respectively.

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