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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 17-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 17, 2011

Earnings
ArthroCare reported 4Q:10 sales of $92.6, up 2% over 4Q:09 and beating analysts' estimates by $3.2 million. Sports medicine sales contributed $59.8 million to revenues, up 1% over the year-ago period, and other sales, which consist primarily of spine sales, declined by 19% to $3.4 million. Net income for the quarter was $10.1 million, or $0.30 per diluted share, beating estimates by $0.02.

DJO reported 4Q:10 sales of $249.8 million, down on an absolute basis from $257.2 million in 4Q:09, but up 4% after accounting for fewer selling days in 4Q:10. Among segments, without adjusting for selling days or foreign currency, bracing and supports sales were flat; recovery sciences declined by 3%; and surgical implant sales declined by 5%. The company reported a net loss for the quarter of $10.5 million, compared to $11.7 million in 4Q:09. Additionally, DJO announced that the company has changed its name from DJO Incorporated to DJO Global, Inc.

Genzyme reported 4Q:10 sales of $1.2 billion, up 23% over the year-ago period and missing estimates by $20.0 million. Synvisc sales increased by 11% to $95.4 million. Adjusted net income for the quarter was $221.1 million, or $0.82 per share, missing estimates by $0.04.

Orthofix reported 4Q:10 sales of $143.8 million, flat over the year-ago period and beating estimates by $1.2 million. After adjusting for currency, the company's exiting the vascular and anesthesia product lines and a prior-year event in the sports medicine division, sales increased by 5%. Total spine sales increased by 6%, with implants and biologics up 11%. Additionally, orthopedics sales increased by 8%, and sports medicine increased by 9%. Segment growth rates exclude the effects of currency. The company reported net income of $8.0 million, or $0.44 per diluted share, for 4Q:10, beating estimates by $0.01.

Symmetry Medical reported preliminary 4Q:10 revenues of about $96.2 million. This reflects a 26% increase over 4Q:09 and misses estimates by $0.3 million.

Synthes reported 4Q:10 revenue of $975.8 million, up 9% after adjusting for the effects of currency. The company noted that trauma, CMF and power tools delivered combined global sales growth of 13%. North American sales increased by 6%; Europe increased by 14%; AP increased by 7%; and ROW increased by 32%. For the full-year 2010, the company reported pro forma sales of $3.7 billion, up 7% over 2009, and earnings of $908.6 million, or $7.65 per share.

M&A
Sonoma Orthopedics acquired certain key assets of NovaLign Orthopaedics, Inc., which the company says are complementary to their WaviBody technology and relate to "novel intramedullary designs for least invasive fracture fixation." Terms of the transaction were not disclosed.

Genzyme has agreed to be acquired by Sanofi-Aventis for $74 per share, with the total deal valued at around $20.1 billion. The transaction represents a 48% increase over the close on July 2, before rumors began to circulate that Genzyme was an acquisition target, and about a 4.7x sales multiple.

Funding
Sonoma Orthopedic also closed a $22.0 million Series D financing round led by Ascension Health Ventures, who were joined by Split Rock Partners, Legacy Life Sciences, EDF Ventures, MedVenture Associates, DFJ InCube Ventures, Emergent Medical Partners and Asset Management Partners. In connection with the financing, Dr. Walter Lin of AHV has joined Sonoma's board of directors. Funds will support new product launches, the expansion of the U.S. sales network, key clinical trials and the NovaLign acquisition.

Regulatory
Anika Therapeutics provided a regulatory update on Monovisc, stating that while they still have not received a date for an FDA panel meeting, they expect the product to ultimately be approved. Additionally, the company is moving production from a Woburn, Massachusetts facility to a site in Bedford, Massachusetts, and because the FDA has not conducted inspection of the new facility, the company will have to operate two sites until June 2011. Finally, the company is still waiting on 510(k) reviews of three products.

ArthroCare received 510(k) clearance for its Spartan 5.5 Needled Anchor, a pre-loaded, threaded anchor with a screw-in design. It is made from PEEK and can be used for single- and double-row repairs.

DePuy received 510(k) clearance for the use of its GRIPTION TF, a commercially-pure titanium foam, in the Acetabular Augment System and the Universal GRIPTION TF Cones for the knee. These systems are intended for use in complex large joint procedures.

Reimbursement
Biomet was granted premium reimbursement pricing for the company's E1 Antioxidant Infused Technology hip bearing from Japan's Ministry of Health, Labor and Welfare.

Small Bone Innovations announced that CIGNA has revised its coverage policy to cover Total Ankle Replacement (TAR) using FDA-approved devices. The company manufactures the STAR ankle for total joint replacement.

Product Introduction and Update
Acumed launched its next-generation Acu-Loc 2 Volar Distal Radius Plating System and the Elbow Plating System at AAOS this week. The company says the Acu-Loc 2 system consists of two plate families that give the surgeon the option of distally or proximally fitting plates. According to the press release, the Elbow Plating system offers precontoured, indication-specific plates to address fractures of the distal humerus, olecranon and coronoid.

Bacterin launched the OsteoSponge SC, an acellular matrix scaffold made from allograft that is designed to replace damaged subchondral bone.

Cayenne Medical launched the AperFix II, its second-generation soft tissue repair device for multi-ligament repairs of the knee.

CONMED introduced the Concept Suture Passer, the Sequent Meniscal Repair System and the CrossFT BC for rotator cuff repair, among other products, at AAOS.

DePuy Mitek launched the HEALIX TRANSTEND implant system for the repair of partially torn rotator cuffs and the VAPR VUET system with COOLPULSE technology, a radiofrequency device. DePuy also launched the modular RECLAIM revision hip system.

Exactech displayed a number of new products at AAOS, including the next-generation Optetrak Logic PS knee; BIOLOX delta ceramic femoral heads; and the Equinoxe Fx Plate for the shoulder.

Integra launched the Trel-XPress Demineralized Bone Matrix. The product consists of particulate DBM, Integra's proprietary Accell Bone Matrix (ABM) and a reverse phase medium poloxamer

Lanx launched the Epic Anterior Thoracolumbar Plating System, a low-profile anterior fixation device for use in anterior thoracolumbar fusion procedures.

MiMedx launched AmnioFix, which the company acquired from Surgical Biologics. The device is processed from the human amniotic membrane and is designed for use as a resorbable scar tissue barrier in spinal surgeries.

Orthovita launched the Vitoss Bioactive Foam-2X Bone Graft Substitute, a non-structural bone void filler for use in the pelvis, extremities and posterolateral spine. The company says the new product offers increased levels of bioactive glass compared to Vitoss BA.

Pioneer launched a portfolio of biologic products, Legato, which is intended for us in extremity, trauma and general orthopedic indications. Legato is a resorbable, collagen-based implant.

SpineSmith will begin a national rollout of the VisuALIF, a two-piece, stand-alone device indicated for intervertebral body fusion of the lumbar spine. It offers an anterior open face, which the company says allows surgeons to visualize end plate preparation post-placement. The device was cleared by the FDA in October 2010.

Stryker presented the Tissue-Preservation Hip Arthroscopy Platform, which features the high- definition IDEAL EYES visualization platform, a new cannulated access system, SERFAS XL Ablation Probes, repair instrumentation and FORMULA XL blades. The company also introduced several iPad apps, including the Stryker Flipchart to aid in patient education.

Tornier highlighted six new products at AAOS, indicated for a range of joint replacement, joint repair and soft tissue repair needs for the upper and lower extremities. These include the bone-sparing Ascend Shoulder; the stemless Simpliciti Shoulder, which is available in the EU; and the Stabilis Ankle Fusion System.

Zimmer launched the PathFinder NXT System, an MIS pedicle screw system that facilitates both mini-open and percutaneous approaches. The company says that the system "enables enhanced reduction, compression, distraction and bone decortications capabilities, and gives surgeons the ability to efficiently complete multi-level constructs."

Clinical
Amedica/US Spine announced the first implantation of its silicon nitride total hip implant this week at the George Provincial Hospital in Western Cape South Africa.

Aperion Biologics is enrolling patients in its Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) Device study at eight sites in Europe and South Africa. The device is an "immunochemically modified" and porcine-based, and results from the study will be used to support regulatory approvals and market acceptance OUS.

BioSurface Engineering Technologies (BioSET) initiated a pilot study in Canada of AMPLEX to facilitate foot and ankle fusion surgery. AMPLEX is a bone graft substitute that combines BioSET's proprietary B2A, a synthetic growth factor, with a ceramic scaffold and carrier. The randomized, prospective, multi-center, controlled study will enroll 24 patients.

Medtronic announced results from two kyphoplasty studies this week. One study randomized Kyphon Balloon Kyphoplasty with non-surgical care in treating spinal fractures in cancer patients, determining that kyphoplasty was associated with "better back-specific function, more rapid back pain relief and improved quality of life compared with non-surgical care" at one month. The second study found that at two years, patients who underwent kyphoplasty to treat VCFs reported reduced back pain, increased patient satisfaction and improved mobility and quality of life compared to those who underwent non-surgical care. Both studies were published in the Lancet.

License and Distribution Agreements
DJO Global has reached an agreement with Lima Corporate, a European-based orthopedic implants company, for an expanded partnership for the United States implant market. The new agreement allows for an expanded range of DJO and Lima Corporate products to be jointly marketed in the U.S., including devices for joint replacement, extremities and fracture repair. DJO and Lima have had a partnership since 2009, with DJO distributing Lima's revision hip system in the U.S. and Lima distributing DJO Surgical's 3D Knee and Foundation Total Knee system in select European markets.

Integra LifeSciences entered into an exclusive worldwide license and development agreement with Stout Medical Group to develop and commercialize an expandable interbody device whose height can be adjusted during surgery. The license allows Integra to develop a device that surgeons could implant via a minimally-invasive procedure.

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