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Orthopedic and Dental Industry News Complete Archive »

Orthopedic News Roundup 22-Mar-07 BY LAUREN UZDIENSKI, MARCH 22, 2007

Earnings
Inion announced year-end results for 2006 on Wednesday, reporting a 25% decline in revenues. 2006 sales totaled EUR 5.7 million, compared with EUR 7.6 million in 2005. R&D spending increased 17% to EUR 5.6 million from EUR 4.8 million in 2005. The Company attributed the increased R&D expenses on development of Inion OptimaPLUS™ bioactive and biodegradable materials platform. Operating loss before one-off items increased 4% to EUR 10.8 million, up from 2005's EUR 10.4 million. Including one-off items, operating loss increased to EUR 14.1 million. Inion announced a restructuring and cost-management program, a precuror to an broad strategy review. One product that did see growth was the Inion S-1™ Biodegradable Anterior Cervical Fusion system. Sales doubled to EUR 1.1 million in 2006 from EUR 0.5 in 2005.

Regulatory
Hip, knee and shoulder devices have been reclassified by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) as class III, meaning they will be more rigorously evaluated for safety and performance before the CE mark is issued.

M&A
Small Bone Innovations announced seven acquisition and licensing agreements intended to expand SBi's lower limb portfolio. Acquired technology includes a suite of fixation devices from Euromedic, reverse great toe prosthesis and hemi MTP joint. Licensing agreements cover the ROTO-glide™ great toe system, an ankle distraction system, plate and screw technology and a small bone void filler developed by Therics.

Funding
TiGenix announced that its public offer to subscribe to its capital increase closed early with the final offering price coming to EUR 5.00 per share. Pursuant to the offering, 8 million shares will be issued by TiGenix equivalent to EUR 40 million. If the over-allotment option is fully exercised, the total amount can increase to EUR 46 million, TiGenix said. Shares will start trading as of 22 March 2007 on the Eurolist by Euronext Brussels under the symbol TIG.

Orthovita filed a shelf registration that would allow it to periodically sell up to $100 million in debt securities, common and preferred stock, depositary shares, contracts, units and warrants. The Company said it may use the proceeds for product development, expanding its sales force and general corporate purposes, which may include potential acquisitions of products and technologies.

Service Agreements
Kensey Nash Corp. and Biomet Sports Medicine signed an exclusive marketing and distribution agreement Wednesday for its OrthoFill bone void filler. Under the agreement, Biomet will market and distribute the product and Kensey Nash will manufacture it. Financial terms of the deal were not disclosed.

Medtronic's Spinal and Biologics unit formed a development agreement with OsteoGenix, investing capital that will be used for pre-clinical research and clinical trials. Based in Palo Alto, OsteoGenix has developed a bone growth compound intended to speed healing in fractures.

Legal
This week a federal court of appeals ruled in favor of Medtronic in its on-going patent litigation against Biomet subsidiary Cross Medical Products Inc. The court ruled that Medtronic's current multi-axial pedicle screw products do not infringe Cross Medical US Patent No. 5,474,555 ('555). Those Medtronic products include the CD HORIZON LEGACY, VERTEX and CD HORIZON SEXTANT multi-axial screw products. The ruling allows Medtronic to continue to sell these products.

Clinical
The March 15 issue of Spine features a new retrospective study on the patients who received the CHARITE Artificial Disc between 1989 and 1995. The study showed that patients with the CHARITE disc have less pain and more mobility following the procedure when compared with fusion, with follow-up ranging from 10 and up to 16.8 years. The studied patients all had one-level (either at L4 - L5 or L5 - S1) lumbar degenerative disc disease and had failed non-operative treatment. 82.1% of 106 patients experienced "excellent or good" clinical outcomes, prosthesis mobility was 90.6%. Nearly 90% of patients eligible to work before surgery returned to work, more than three-quarters to hard labor. Additionally the rate of adjacent level disease requiring surgical intervention was about 10-times lower (2.8%) for CHARITE Disc patients.

Triangle Orthopaedic Associates in North Carolina has initiated a clinical trial to compare spinal fusion to the Applied Spine Technologies' Stabilimax NZ Dynamic Stabilization System. AST suggests that minimizing surgical trauma through a less invasive procedure like NZ can reduce morbidity and recovery time, providing faster recovery and return to activities. Stabilimax NZ utilizes a novel dual-spring and ball-and-socket mechanism that is intended to provide maximum stabilization to the spine, decreasing the motion that causes pain while preserving the patient's motion.

Operations
Doncasters Medical Technologies, a supplier to the OEM joint replacement and spinal prosthetic markets, announced the expansion of its technical capabilities in metal-on-metal resurfacing programs. The Company has boosted its manufacturing capacity for forging, casting, machining and polishing by transferring non-medical work from Doncasters' Oregon and Sheffield (UK) facilities to other sites within the Doncasters Group.

Appointment
Gary Sabins has been appointed President and CEO of Spinal Restoration, Inc. In his new role, Sabins will build his executive team, expand the company's Clinical and Scientific Advisory Boards and regulatory strategy. He will also expand distribution, design, development, manufacturing, clinical research and intellectual property. Spinal Restoration is developing a new biologic treatment for chronic discogenic pain, and an IDE for their first product, the Biostat™ Disc Augmentation System will begin in 2008.

Innovative Medical and Youngquist Medical have hired Scott Swanson as national sales manager. Based in Warsaw with more than 20 years of experience, Swanson will be responsible for representing both companies' services the orthopedics industry.

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