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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 23-Jul-09 BY LAUREN UZDIENSKI, JULY 23, 2009

Earnings
Anika Therapeutics reported 2Q:09 revenue of $9.5 million, representing a 5% increase over 2Q:08 and missing estimates by $0.4 million. The company attributed revenue growth to both the ORTHOVISC and MONOVISC product lines, which contributed $5.6 million to total sales. Net income for the quarter was $0.96 million, or $0.08 per diluted share, up from $0.07 per diluted share in 2Q:08 and in line with estimates.

Genzyme reported 2Q:09 revenues of $1.23 billion, representing a 5% increase over 2Q:08 and missing estimates by $30.0 million. Non-GAAP income increased 117% to $232.5 million, or $0.85 per share, in line with estimates. Revenues for Synvisc and Synvisc-ONE were $82.4 million, representing a 16% increase over 2Q:08.

NuVasive reported 2Q:09 revenues of $88.5 million, representing a 54% increase over the year-ago period and beating estimates by $3.1 million. Net income for the quarter was $2.8 million, or $0.07 per share, up from a loss of $0.5 million, or $0.01 per share, in 2Q:08. Analysts had forecast a loss of $0.02. The company also raised full-year 2009 guidance to $360-$365 million from $355-$360 million.

Stryker reported 1Q:09 revenue of $1.63 billion, flat over the prior-year period and missing estimates by $20.0 million. Net earnings were $291.0 million, representing a decrease of 5%. EPS was flat at $0.73, beating estimates by a penny. Among segments, recon increased by 5%; hips increased by 5%; knee increased by 5%, trauma increased by 5%; and spine increased by 13%. All growth rates exclude the effects of currency.

Zimmer reported 2Q:09 revenues of $1.02 billion, representing a 1% decrease from the year-ago period and in line with estimates. Adjusted net earnings declined 9% to $215.5 from the year-ago period. Adjusted EPS was $1.00, beating estimates by $0.04. Among segments, recon declined by 2%, with knee down by -1%, hip down by 4%, extremity up 13% and dental down 12%. Additionally, trauma increased by 7% and spine increased by 23%. All growth rates exclude the effects of currency.

M&A
Synovis closed its $12.1 million purchase of Pegasus Biologics, which was announced earlier this month.

Regulatory
Integra LifeSciences received 510(k) clearance and CE mark certification for the HALLU-LOCK MTP Arthrodesis System. The product is indicated for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint.

Mesoblast has submitted a marketing application to Australia's regulatory body, the Therapeutic Goods Administration (TGA), to commercially manufacture and distribute its adult stem cell products in Australia.

Product Introduction and Update
LDR launched its ROI-C cervical cage, which is designed for use with the company's VerteBRIDGE plating to offer a zero-profile, stand-alone construct for fusion.

Medtronic announced that the FDA has classified the company's voluntary recall of the Intrepid Intervertebral Body Fusion Device as a Class II recall. The device was used in approximately 650 procedures and resulted in 12 complaints, among them adverse events associated with poor bone quality and surgeon reports of difficulty attaching the implant cover plate. The recall was initiated in February 2009, and all unused devices have since been recovered. Medtronic plans to revise the product labeling and modify the device design.

Legal
A Medtronic subsidiary was awarded $2.1 million in damages after a federal judge found that Globus Medical infringed two patents relating to Medtronic's Sextant System. The court denied a request for an injunction against Globus that would prevent them from selling the infringing products.

Distribution
Vexim signed an exclusive distribution agreement with Stryker EMEA for the sales and marketing of its SpineJack implant Austria, Ireland, Germany and the UK. No financial terms were disclosed. The SpineJack is used for the treatment of vertebral fractures.

Partnerships
Axial Biotech and the University of Utah entered into an agreement whereby Axial will be granted access to the Utah Population Database and other genetic resources. Axial will use the information to expand the indications and patient population for their ScoliScore AIS (adolescent idiopathic scoliosis) Prognostic Test.

Orthofix and Stout Medical entered into a License and Product Development Agreement to produce a new expandable vertebral body replacement and corpectomy device. Per the agreement, Orthofix will be granted exclusive global licensing rights to the device for an initial period of 15 years. No financial terms were disclosed. The product is expected to be introduced in 2H:10.

Clinical
According to a study published in the Journal of Arthroplasty, patients who received Zimmer's Trabecular Metal THA components had significant reductions in acetabular bone loss adjacent to the cup when compared to titanium cups with a similar geometry. Additionally, the Trabecular Metal cases showed a significant relative increase in bone mineral density following THA.

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