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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 12-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 12, 2009

Earnings
Alphatec Holdings, Inc. announced record consolidated revenue of $32.7 million in 3Q:09, which represents 27% growth over 3Q:08. U.S. revenue increased 21% over the prior-year third quarter and 28% over the first nine months of 2008. International revenue was $6.6 million in 3Q:09, which represents 52% growth over 3Q:08. Adjusted EBITDA for 3Q:09 was $3.6 million. Highlights from 3Q:09 included the U.S. market launch of the Illico SE percutaneous MIS system; a 510(k) submission for the OsseoScrew; and the initiation of patient enrollment for the OsseoFix U.S. clinical study.

M&A
Stryker announced the acquisition of OtisMed, a software company that manufactures custom cutting guides for total knee replacements. Financial terms of the deal were not disclosed.

Funding
Ortho Kinematics completed a $3.5 million funding round, with investors including PTV Sciences, the State of Texas Emerging Technology Fund and Gatebridge Investments. The company is commercializing the KineGraph Vertebral Motion Analyzer (VMA), which they describe as "[measuring] both the quantity and quality of inter-vertebral motion, providing spine surgeons a painless, non-invasive way to assess spine function." Ortho Kinematics recently relocated to Austin, Texas.

SpinalMotion closed a $27.4 million Series D round of funding, proceeds from which the company plans to use to complete the PMA application for its Kineflex/C cervical disc and for the developing of its next-generation artificial discs. Investors in the round include DAFNA Capital Management.

Regulatory
SpinalMotion filed a PMA for its Kineflex lumbar artificial disc. The company says its PMA study compared the Kineflex disc with another FDA-approved lumbar disc and involved 21 U.S. sites and a two-year follow-up period.

Spine Now received 510(k) clearance for its maxMorespine System, which is designed for a posterorlateral transforaminal approach to a foraminotomy. Spine Now entered an exclusive agreement with Hoogland Spine Products to distribute the maxMorespine System in the U.S.

Wright Medical received PMA approval for their Conserve Plus hip resurfacing device, which the company said was supported by clinical data on over 1,300 patients with up to eight years of follow-up. The company plans to initiate surgeon training on the device immediately.

Product Introduction and Update
Amedica introduced four new products at NASS this week: two vertebral body replacements, the Valeo OL and the Valeo C, which are manufactured from silicon nitride; the Valeo Concise Cervical Plating System; and the Valeo BP Synthetic Bone Putty, a beta-TCP.

ApaTech launched the Actifuse MIS Bone Graft Delivery System, which the company says provides "extended reach, controlled delivery and precise [graft] placement" in a number of procedures, including posterolateral fusion, bone void filling and acetabular cysts. The Actifuse MIS System comes pre-filled with Actifuse ABX, a silicate-substituted calcium phosphate.

Covidien launched the DuraSeal spine sealant, the first product approved by the FDA for intra-operative sealing of the dural membrane during spine procedures.

DePuy Spine introduced two new products at NASS: the UNIPLATE 2 Anterior Cervical Plate System, which the company describes as a "next generation single-screw midline fixation system", and the VERTIGRAFT VG2 Cervical Allograft. DePuy says this is the first allograft that can be stored at room temperature in a fully hydrated state.

Integra LifeSciences began a limited rollout of the Paramount Pedicle Screw Fixation System, which was acquired in September 2009 from Innovative Spinal Technologies, Inc. The Paramount system features a unique rod delivery system, wherein the rod is already attached to the screw head. The company will initiate a full launch of the product in 1Q:10.

K2M launched the TERRA NOVA Minimally Invasive Access System and the SERENGETI Disposable Kit. The company says the TERRA NOVA is a "minimally invasive spine-based access system used in conjunction with K2M’s revolutionary SERENGETI percutaneous retractor."

Life Spine launched the AVATAR Minimally Invasive Spinal System, which the company says offers a "novel screw delivery system with a variety of rod insertion mechanisms" and is designed for use in a number of surgical approaches.

Medtronic, Inc. launched the MASTERGRAFT Strip, a flexible ceramic scaffold intended for use in combination with autologous bone for fusing multiple levels of the posterolateral spine.

At NASS this week, Osteotech highlighted three specific applications for its MagniFuse bone grafting products: posterior cervical, posterolateral and spinal deformity procedures. MagniFuse is derived from an allograft source material that undergoes a proprietary process to increase its concentration of human growth factors. The technology features a resorbable, mesh bag delivery-containment system sized specifically for the procedure application.

Clinical
Anulex completed enrollment for its post-market study of the Xclose Tissue Repair System, which includes 750 patients from 34 U.S. facilities. The prospective, controlled, randomized study will compare discectomy patients that receive the Xclose annular repair device to those who do not undergo annular repair. The primary objective is to assess the rate of disc reherniation. Secondary endpoints include pain relief, functional improvement, patient satisfaction, disc height and economic benefit.

Facet Solutions has enrolled the 100th patient in its randomized, controlled ACADIA IDE study for the treatment of lumbar spinal stenosis. The company says this places them "well ahead" of their enrollment targets for 2009.

Operations
According to reports, DePuy Orthopaedics plans to close its manufacturing facility in Leeds, England and discontinue an older line of hip replacement and resurfacing products made there. Production of other products will be relocated to the company's Cork, Ireland facility. The company will lay off 280 workers at the site through 2010.

Collaborations
SpineSmith subsidiary Celling Technologies signed a new agreement with Tissue Genesis to research potential applications for adipose-derived mesenchymal stem cells, which include orthopedic, vascular and trauma indications. SpineSmith acquired the global rights in spine for Tissue Genesis' adipose-derived stem cell technology in November of 2007.

Distribution
K2M entered into an agreement with Smith & Nephew whereby Smith & Nephew will distribute K2M's products in Germany.

Appointments
NuVasive appointed Michael J. Lambert as Executive Vice President and Chief Financial Officer, effective November 9, 2009. Prior to joining NuVasive, Mr. Lambert served as Chief Financial Officer of Advanced Medical Optics.

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