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Orthopedic and Dental Industry News Complete Archive »

Orthopedic News Roundup 1-Mar-07 BY LAUREN UZDIENSKI, MARCH 1, 2007

Earnings
Biologics
LifeCell reported 4Q:06 product revenues of $39.3 million, an increase of 45% over $27.0 million in 4Q:05, but missed analysts' estimates of $39.5 million. The growth was attributed to increased demand for the Company's AlloDerm® Regenerative Tissue Matrix. Orthopedic product revenues, which include Graft Jacket® and AlloCraft™DBM, were $2.8 million in 4Q:06, a 39% increase from $2.0 million in the comparable quarter. 4Q:06 net income was $6.2 million, or $0.18 per diluted share, beating analysts' estimates of $0.17. In 4Q:05, net income was $3.8 million, or $0.11 per diluted share.

Anika Therapeutics' 4Q:06 product revenue was $5.08 million, up 6.4% compared with $4.77 million in 4Q:05. This was due to an increase in domestic ORTHOVISC® sales. Revenue for 4Q:06 was $5.89 million, missing analysts' estimates of $6.6 million, compared with $5.47 million in the 4Q:05. Net income was $1.05 million, or $0.09 per diluted share, compared with $.82 million, or $0.07 per diluted share, for 4Q:05. Analysts estimated EPS to come in at $.11.

Large Joints
Exactech announced 4Q:06 revenues of $26.2 million, in line with analysts' estimates of $26.3 million. The quarter's revenues demonstrate an increase of 13% over the $23.0 million reported in 4Q:05. Net income for the quarter was $2.3 million, or $0.19 per diluted share, beating analysts' estimates of $0.18. In 4Q:05, net income was $1.8 million or $0.16 per diluted share.

Other
Synthes reported consolidated sales growth for 4Q:06 of 17% (14.8% in local currency) to $628.9 million. In North America, 4Q:06 sales were $391.4 million, an increase of 14.6% (14.5% in local currency) from 4Q:05's sales of $341.5 million. The Trauma and Spine product lines both grew in 4Q:06; Trauma primarily due to the Locking Compression Plate (LCP) products, and Spine growth was attributed to sales in the Interbody Fusion, Anterior Thoracolumbar, Cervical and Biomaterials product portfolios. Additionally, the FDA approved the PMA for ProDisc-L in August 2006, and the product was rolled out in 4Q:06.

Integra LifeSciences announced 4Q:06 revenues of $125.4 million, a 72% increase over 4Q:05. Revenues beat analysts' estimates of $120.6 million. The company reported GAAP net income of $10.1 million, or $0.34 per diluted share, for 4Q:06, missing analysts' estimates of $.37 per diluted share. In 4Q:05, GAAP net income was $10.6 million, or $0.33 per diluted share. President and CEO Stuart M. Essig includes among the quarter's accomplishments the integration of Kinetikos Medical, Inc. (KMI) into Integra's Extremity Reconstruction sales channel, the launch of the U.S. pivotal study for the DuraGen Plus® Adhesion Barrier Matrix and the launch of a sales organization devoted to spine surgery products.

Funding
Cytori Therapeutics Inc. announced plans to raise $21.5 million through a stock offering, with proceeds to be used for purposes that include clinical trials, preclinical research and development, preparations for the commercialization the Celution System in Europe in early 2008 and general corporate purposes. Under the agreement, Cytori Therapeutics will issue 3.75 million shares of common stock at $5.74 per share. The offering has 50 percent warrant coverage, which represents up to 1.87 million additional shares. The warrants have a five-year term and are immediately exercisable at $6.25 per share.

Regulatory
On Friday, an FDA Advisory Panel voted to recommend FDA approval with conditions for Corin's hip resurfacing device, Cormet. Conditions include a post market approval study, surgeon training and labeling.

Service Agreements
Integra LifeSciences announced a three-year contract between Integra's Jarit Surgical Instruments subsidiary and Premier Purchasing Partners, LLP. Through the agreement, Premier will supply Jarit® surgical and laparoscopic instruments to its members.

Product Introduction & Update
During AAOS, Invibio® announced that the first implantable medical device using the Company's carbon fiber-reinforced (CFR) PEEK-OPTIMA® compound received regulatory approval from Japan's Ministry of Health, Labour and Welfare, the regulatory body covering all drugs and medical devices in Japan. This is the second orthopedic device using Invibio implantable biomaterials to be approved in Japan. In 2005, an arthroscopy device using unfilled PEEK-OPTIMA polymer was approved. It has been commercially available for more than 18 months.

Clinical
Data from ReGen Biologics' pivotal meniscus implant trial was shared at AAOS at the presentation titled "New Tissue Generated by the Collagen Meniscus Implant (CMI) Leads to Increased Activity Levels After Two Years." The data shows a correlation between an increase in Tegner activity levels over two years and percent total meniscus tissue in patients who receive the CMI implant and have greater than 50% total meniscus tissue remaining after meniscus treatment.

A Geneva University Hospital study showed that among patients who had a total of 2,495 hip replacements, obese patients, particularly women, were more likely to suffer complications. Published in the March issue of the journal Arthritis Care & Research, the study found that obesity was associated with: a substantially higher risk for infection in women; more dislocations (a greater number in women than in men); and more revisions due to septic loosening caused by infection.

Appointment
Biomet announced that Jeffrey R. Binder will assume the roles of President and Chief Executive, as well as Director. The SVP of Diagnostic Operations at Abbott Laboratories since January 2006, Abbott held posts as president of Abbott Spine from June 2003 and President and CEO of Spinal Concepts from 2000 until June 2003. He replaces Daniel P. Hann, who has been serving as interim president and CEO. Hann will remain as Executive Vice President of Administration and as a member of the board.

Medtronic announced its succession plan for its Chief Executive Officer and Chief Operating Officer positions. Effective August 23, 2007, William A. Hawkins, III will become president and CEO and Michael F. DeMane will become COO. Following the transition, current Chairman and CEO Arthur D. Collins will remain as a Director and Chairman of the Board until the annual shareholders meeting in August 2008.

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