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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 26-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 26, 2009

Earnings
Artimplant reported 4Q:08 revenues of SEK 4.6 million ($0.6 million), down from SEK 5.0 million ($0.8 million) in 4Q:07. During the quarter, the company reported sales of 900 Artelon Spacers (down from 1,100 in 4Q:07) and 300 units of Artelon Tissue Reinforcement (up from 200 units in 4Q:07.) The net loss for the quarter was SEK 6.0 million ($0.8 million), up from SEK 2.1 million ($0.33 million) in the year-ago period.

DJO announced 4Q:08 revenue of $247.0 million, a 45% increase over 4Q:07, which the company attributed primarily to the acquisitions of IOMED, Inc. and The Saunders Group, Inc. Surgical implant sales grew 5% over 4Q:07, driven by knees and shoulders, but the company said sales growth was impacted by a delay in certain new product launches. The company reported a net loss of $38.4 million, narrowing from a net loss of $57.3 million in 4Q:07.

NuVasive announced 4Q:08 revenues of $74.6 million, up 59% over 4Q:07 and beating estimates by $0.4 million. Sales were boosted by Osteocel, which contributed $10.0 million to 2H:08, exceeding prior guidance of $9.0 million. The company reported GAAP net income of $3.7 million, or $0.10 per share.

RTI Biologics announced 4Q:08 revenue of $37.4 million, up 47% from 4Q:07 and beating estimates by $0.2 million. The growth was attributed to the acquisition of Tutogen. Net loss was $102.5 million, widening from a loss of $2.6 million in 4Q:07. Net loss per diluted share was $1.89. Adjusted net income was $5.1 million, or $0.10 per fully diluted share. Analysts had anticipated the company would break even.

Symmetry Medical announced 4Q:08 revenue of $99.7 million, representing a 24% reported increase over 4Q:07 (31% constant currency) and beating estimates by $1.4 million. Net income was $11.3 million, or $0.32 per share. Adjusted EPS was $0.12, beating estimates by $0.05.

TranS1 announced 4Q:08 revenue of $7.4 million, representing an increase of 48% over 4Q:07 and beating estimates by $1.0 million. Net loss for the quarter was $4.5 million, or $0.22 per share, widening from a net loss of $2.2 million, or $0.14 per share, in 4Q:07. Adjusted EPS for 4Q:08 was $0.20, missing estimates by $0.05.

Regulatory
Benvenue Medical received the CE mark for the Kiva Vertebral Compression Fracture Treatment System. The PEEK implant is introduced using a percutaneous, over-the-wire technique, and the company says it "reduces and stabilizes the fracture and is designed to provide containment during delivery of PMMA bone cement."

Biocomposites received State Food and Drug Administration approval to market for their synthetic bone graft material, geneX, in China.

CUREXO Technology Corporation submitted a 510(k) application for its ROBODOC Surgical System for Total Knee Arthroplasty.

ETEX received the CE mark for Beta-bsm Injectable Paste and Gamma-bsm Moldable Putty. Both products are based on nanocrystalline calcium phosphate technology.

Product Introductions and Updates
CONMED announced the launch of several products at AAOS, among them the CONMED Linvatec hip system for labral repair in hip arthroscopy, which includes the Bio Mini Revo suture anchor; the Paladin Suture Anchor for rotator cuff repair; the Zen Wireless Footswitch and Adaptor; and ReAct Arthroscopic Shaver Blades.

CUREXO launched the ROBODOC Surgical System for hip and knee (knee available OUS) procedures, which can guide operative planning for implant fit and sizing, as well as off-set and leg length.

Globus Medical, Inc. launched the INDEPENDENCE Spacer System into the MILDER ALIF product line. INDEPENDENCE features a stabilization plate and a PEEK interbody spacer in a preassembled system and can be implanted in a less-invasive procedure.

Incisive Surgical, Inc. launched a new version of the INSORB Absorbable Staple, which is 25% stronger than previous versions, which the company says results in improved wound integrity.

MAKO Surgical introduced the RIO Robotic Arm Interactive Orthopedic System and the RESTORIS MCK MultiCompartmental Knee System for bicompartmental knee resurfacing. Previously, the MAKO system was available only for the medial knee compartment.

Medartis, Inc. launched their APTUS Adaptive Adaptive Distal Radius System. Per the company, the system offers a watershed design and site-specific multi-axial fixation

RTI Biologics launched two new implants, the Matrix HD, which the company calls the first RTI dermis graft for sports medicine, and fresh-stored osteochondral talus allograft.

Salient Surgical launched the Aquamantys Epidural Vein Sealer for use in minimally invasive spine surgery. The device features the company's Transcollation technology for remodeling collagen to stop bleeding.

Smith & Nephew Endoscopy launched the OSTEORAPTOR Anchor for hip and shoulder repair. The company says the device is the first hip anchor to use polylactic acid hydroxyapatite.

Smith & Nephew's Orthopaedic Reconstruction & Trauma division launched the VISIONAIRE Patient Matched instrumentation for use in total knee replacement surgery. The VISIONAIRE system utilizes a patient's MRI and x-rays to create custom surgical instrumentation for use with Smith & Nephew knee implant portfolio.

VG Innovations announced that more than 230 patients in the U.S. have received the VerteLoc Minimally Invasive Spine Stabilization system for stabilizing facet joints. The company also introduced a new website for the VerteLoc system.

Wright Medical launched several new products this week: the Stature Modular Hip Reconstruction product line, designed to work with the company's Profemur line of modular necks; the Prophecy Pre-Operative Navigation Guides for knee replacements; and a number of extremity products, including the Inbone Total Ankle System and the G-Force Tenodesis Screw System for soft-tissue fixation procedures in foot and ankle surgery.

Zimmer unveiled the following products at AAOS: the DeNovo NT Natural Tissue Graft for focal cartilage defects in a variety of anatomic locations; the Zimmer Natural Nail system for long bone fixation; the Zimmer Periarticular Elbow Locking Plate System, featuring anatomically contoured plates, optimized screw positions and options to address most fracture types; and Trabecular Metal Glenoid, which the company describes as a glenoid component featuring "Zimmer's exclusive porous technology for biological fixation."

Intellectual Property
Bone Biologics Inc. received a US Patent Office Notice of Allowance of patent claims covering a method of production for the UCB-1 (NELL-1) recombinant protein that Bone Biologics uses in the bone repair/regeneration technology in its lead product. The platform technology is combined with DBX DBM to promote bone growth in spinal fusion.

Exactech, Inc. received U.S. Patent 7,422,605,B2 for its rotating bearing knee, Optetrak RBK. The company's IDE trial for the device has been ongoing since 2006 and will eventually support a PMA application for the product, which is currently marketed in Europe.

Collaborations
Exactech announced that it would extend its collaboration with Hospital for Special Surgery in New York, NY to introduce a new knee implant to its Optetrak product line. Limited release of the new knee is expected in 2H:09.

Smith & Nephew and BrainLAB announced that starting in March 2009, BrainLAB will become the exclusive vendor for developing and supporting computer-assisted surgical technologies for Smith & Nephew's high performance hip and knee implants.

License Agreements
Alphatec Spine, Inc. announced that it had entered into a license agreement with Helix Point, LLC, which provides Alphatec Spine with rights to develop and commercialize Helifix and Helifuse, proprietary concepts for two interspinous devices to treat lumbar spinal stenosis. Pursuant to the license agreement, Alphatec Spine is the exclusive worldwide licensee of the intellectual property, excluding the right to sell the product in the People's Republic of China.

Clinical
Kensey Nash Corporation submitted an IDE application to study the use of the company's biomaterials technology for treating articular cartilage defects of the knee. The clinical trial will utilize the company's Cartilage Repair Device, which consists of a proprietary bi-phasic, bioresorbable implant designed to treat chondral lesions.

Medtronic announced the publication of data from a multicenter, randomized controlled study of 300 patients comparing surgical intervention to non-surgical care for acute vertebral compression fractures. The company reports that patients undergoing balloon kyphoplasty showed superior improvement in quality of life, back function and back pain compared to those who had non-surgical care alone one month after surgery. The benefits of balloon kyphoplasty were sustained on average throughout 12 months. These results were published in the Feb. 24 online edition of The Lancet.

Appointments
Axial Biotech, Inc. appointed Roberto A. Macina, Ph.D. Vice President of Research and Development. Dr. Macina will report directly to Kenneth Ward, M.D., Chairman and Chief Scientific Officer. Previously, Dr. Macina worked with the molecular diagnostics department at SmithKline Beecham.

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