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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 3-Nov-11 BY LAUREN UZDIENSKI, NOVEMBER 3, 2011

Earnings
Alphatec Spine announced 3Q:11 performance highlights, noting that the company achieved revenue of $47.6 million in 3Q:11, which represented growth of 3% on a constant currency basis. Further, U.S. revenue of $32.7 million represented 9% growth over 3Q:10. International revenue of $14.9 million was up 1% versus 3Q:10. The company generated $1.8 million of cash from operations in 3Q:11 from strong US revenue growth, working capital management and operating expense control. Additionally, the company re-launched Alphatec Solus to global beta sites in October 2011 and launched three new products at NASS.

Anika Therapeutics reported 3Q:11 sales of $18.5 million, up 33% over the year-ago period. This growth was attributed to strong domestic and international sales of Orthovisc and increased shipments of Anika's ophthalmic and advanced wound care products. Net income in 3Q:11 rose to $3.0 million, or $0.22 per diluted share, from $1.2 million, or $0.09 per diluted share, in 3Q:10.

ArthroCare reported 3Q:11 revenues of $87.3 million, down 4% over the year-ago period and missing estimates by $3.9 million. Sports medicine sales increased by 2%, with the company noting higher international sales. Net income for the quarter was $1.6 million, or $0.05 per diluted share, in 3Q:11, which compares to $8.4 million, or $0.25 per diluted share, in 3Q:10. Analysts had forecast EPS of $0.23.

DJO reported 3Q:11 sales of $263.1 million, up 11% over the year-ago period. Among segments, proforma bracing and vascular sales were up 1%; recovery sciences sales declined by 5%; international sales increased by 3%; and surgical implant sales increased by 5%. Adjusted EBITDA for 3Q:11 was $61.0 million, flat over 3Q:10.

Exactech reported 3Q:11 sales of $47.3 million, up 13% over the year-ago period and beating estimates by $1.8 million. Knee sales were up 15%; extremity sales increased by 34%; hip sales increased by 22%; and biologic and spine sales decreased by 15%. Adjusted net income increased by 19% to $1.9 million, or $0.15 per share, missing estimates by $0.05.

Integra LifeSciences reported 3Q:11 sales of $202.2 million, up 7% over the year-ago period when adjusting for fluctuations in currency and missing estimates by $2.6 million. Orthopedics sales increased by 18% as reported to $86.4 million during the quarter. Adjusted net income for the quarter was $22.3 million, or $0.77 per diluted share, in line with estimates.

NuVasive reported 3Q:11 revenues of $132.9 million, up 11% over the year-ago period and missing estimates by $1.3 million. President and CEO Alex Lukianov says of the quarter, "We delivered industry leading growth and executed a strategic transaction [Impulse Monitoring] that will enhance the penetration of XLIF and NeuroVision for years to come." The company reported net income of $10.6 million, or $0.26 per share, for 3Q:11, beating estimates by $0.02.

Symmetry Medical reported 3Q:11 sales of $84.0 million, down 11% over the year-ago period and missing estimates by $2.4 million. The company attributed the year-over-year revenue decline to lower aggregate sales to the company's five largest orthopedic OEM customers, which they said was partially offset by aggregate double digit growth with all other orthopedic and medical device customers, favorable foreign currency exchange rate fluctuations and $0.7 million in sales from the recently-acquired Olsen Medical. Non-GAAP net income declined by 59% to $1.5 million, or $0.04 per share. Analysts had forecast EPS of $0.12.

TranS1 reported 3Q:11 sales of $4.7 million, down 26% over the year-ago period and missing estimates by $0.3 million. There were 387 TranS1 procedures performed globally in the quarter. The company called the spine market "challenging" and attributed the sales decline partially to limited reimbursement, but added that data published this year would support the AxiaLIF procedure. Net loss for the quarter was $3.3 million, or $0.16 per share, beating estimates by $0.06.

Wright Medical reported 3Q:11 revenues of $118.2 million, down 6% over the year-ago period and missing estimates by $7.7 million. Among segments, hips were down 7%; knees were down 10%; extremities were up 6%; and biologics were down 16%. Growth rates exclude the effects of currency. Adjusted net income for the quarter was $7.7 million, or $0.20 per share, up 5% from $0.19 per share in 3Q:10 and in line with estimates.

Funding
MX Orthopedics raised $1.0 million in seed funding from 35 unnamed investors. The company is developing shape-memory hip implants.

Regulatory
LDR received 510(k) clearance to market its ROI-A Oblique ALIF cage. Like the ROI-A ALIF cage, the stand-alone lumbar fusion technology is designed to reduce the need for additional anterior or posterior instrumentation.

Product Introduction and Update
Advanced Biologics launched the OsteoAMP Structural, which the company describes as the first load-bearing, mineralized, osteoconductive allograft spacer that "demonstrates osteoinductive properties in-vivo." Initial product offerings will include both parallel and lordotic options for use in cervical spine procedures.

This week at NASS, Alphatec Spine launched the Trestle Luxe Anterior Cervical Plating System, the company's next-generation anterior cervical fixation system; the Avalon Occipito-Cervico Plating System; the Epicage Minimally Invasive Posterior Interbody Spacer, which can be used for either TLIF or PLIF procedures; and the Alphatec Solus Anterior Lumbar Interbody Fusion (ALIF) System, a biomechanically-proven, industry-leading design in treating spinal column stability for internal fixation ALIF devices.

Custom Spine introduced a new auxiliary connector system for its ISSYS LP pedicle screw system. The company says this system allows the bone screw to be fully seated while maintaining full polyaxial motion of the screw head.

FzioMed has sold 250,000 units of Oxiplex, an absorbable gel applied to spinal nerve roots during lumbar laminectomy, laminotomy and discectomy procedures to prevent the formation of scar tissue and reduce inflammation.

Globus featured a number of new products at NASS, including CALIBER-L, a vertically-expanding minimally invasive lateral implant for use in the lumbar spine; the InterContinental Plate-Spacer for use in minimally invasive lateral fixation; the SP-Fix spinous process fixation device; and the REVERE Corrective Osteotomy Set is a comprehensive instrument set.

Invuity launched a line of surgical devices designed to provide surgeons with enhanced visibility during spinal surgeries, including the Eigr Saber, which "[brings] illumination inside the incision."

K2M launched the CHESAPEAKE Anterior-Lumbar, manufactured from biocompatible PEEK polymer and titanium, designed for anterior stabilization and fixation and featuring a zero-profile design. The company also debuted the BLUE RIDGE Hybrid Cervical Plate System, which features one-step locking technology acquired from Amendia and the EVEREST Degenerative Spinal System. The EVEREST is described as a top-loading pedicle screw system that can accommodate titanium and cobalt chrome rods of two different diameters and a screw thread pitch "designed to maximize both osteoporotic and dense bone fixation."

Lanx introduced the Timberline System, a lateral access fusion system featuring rectangular PEEK interbody spacer devices, a low-profile modular retractor system and a fiber optic lighting system. The company will launch a training initiative on the device in early 2012.

Life Spine initiated limited releases of the Pro-Link and Dyna-Link interbody cage/screw constructs as well as Aileron, a minimally-invasive adjustable InterSpinous Fixation System.

Mazor Robotics announced that their technology has been used to guide placement of more than 15,000 spinal implants, noting that there have been no reported cases of permanent nerve damage following the procedure.

Medtronic introduced a new procedure for minimally invasive spinal fusions, the MAST MIDLF procedure. The press release states that the procedure is a midline laminectomy approach, accessing the spine in the middle lower back and eliminating the need for a tubular retractor. The procedure can be utilized with Medtronic's platform of interbody, navigation, neuromonitoring and biologic options. Medtronic also launched the T2 ALTITUDE Expandable Corpectomy Device in the U.S. and Europe, describing the device as a self-locking expandable vertebral body replacement cage intended for use in the thoracolumbar spine in trauma or tumor cases. Finally, the company introduced the Aquamantys Mini EVS 3.4 Epidural Vein Sealer, which uses the Transcollation RF and saline technology acquired from Salient Surgical to reduce blood loss during spine surgery.

Orthofix launched the Collage Osteoconductive Scaffold, a synthetic bone graft substitute consisting of ss-TCP and type-1 collagen.

Spinal USA introduced the VAULT Stand Alone ALIF System and S-Lok PC Posterior Cervical System at NASS. The VAULT Stand Alone ALIF System is designed for use with autogenous bone graft and indicated for intervertebral body fusion of the spine in patients with DDD and up to grade I spondylolisthesis. The S-Lok PC Posterior Cervical System is indicated for use in the treatment of DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, revision of previous cervical spine surgery and tumors.

X-spine launched the Hgraft Spinal Implant system, which consists of structural allografts designed for insertion into the interspinous space for the purpose of creating an interspinous and interlaminar fusion.

Intellectual Property
Life Spine has been awarded seven new patents of more than 80 submissions.

Clinical
Relievant MedSystems enrolled the first patient in its SMART trial to evaluate the Intracept Basivertebral Nerve Ablation Procedure. The Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) trial is a level 1, prospective, randomized, double-blind, sham-controlled clinical trial evaluating the reduction of pain in patients with chronic axial low back pain. The trial is enrolling 200 patients in up to 20 centers across the U.S.

Spine Wave initiated a clinical study to gather data on a second-generation design of the NuCore Injectable Nucleus Device. The pilot study will be conducted in Europe and is intended to determine the feasibility of implanting the NuCore device via a proprietary percutaneous technique for the treatment of DDD.

Distribution
Baxano, which manufactures the iO-Flex System for spinal decompression surgery, announced that they will initiate a "rapid expansion of its sales infrastructure to meet the surging demand for its products." The company said their monthly sales have grown 300% during the first three quarters of 2011.

Spineology entered into an agreement with BioDlogics to distribute their line of allograft tissue forms.

Spine Wave entered into a private label and distribution agreement to sell an anterior cervical plate and a PEEK cervical interbody spacer. Spine Wave will initiate a limited launch of the cervical product family in January of 2012 with the full commercial launch expected in 2Q:12.

Collaborations
Bacterin announced that they will award a $100,000 grant to help fund the Resources for Medical Education and Collaboration (RMEC) Osteobiologics Registry. The company says the goal of the Osteobiologics Registry is to develop a multi-center, longitudinal, observational registry designed to collect data surrounding the application and efficacy of osteobiologics in spinal fusion surgery. The organization also seeks to educate surgeons on the use of biologics.

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