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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 25-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 25, 2010

Earnings
Alphatec Spine reported 4Q:09 revenues of $36.6 million, an increase of 29% from the $28.4 million reported in 4Q:08. U.S. revenues for the quarter were $28.3 million, an increase of 29% from the $22.0 million reported for 4Q:08. Asian revenues were $6.6 million, an increase of 38% from the $4.8 million reported for 4Q:08. European revenues in 4Q:09 were $1.7 million. Non-GAAP net earnings for the quarter was $0.6 million compared to a net loss of $4.9 million in 4Q:08. Non-GAAP EPS for 4Q:09 was $0.01 per share, compared to a loss off $0.11 per share for the year-ago period.

xray.jpgExactech reported 4Q:09 revenues of $48.3 million, up 20% over the year-ago period and beating estimates by $3.8 million. Among segments, knee was up 24%; hip was up 29%; biologic & spine was flat and extremity was up 29%. Adjusted EPS of $0.25 beat estimates by a penny.

Medtronic reported FQ3:10 revenues of $3.9 billion, up 6% over FQ3:09 and missing estimates by $12.0 million. Spinal revenue was down 1% to $842.0 million, with core spinal, including Kyphon, down 2% and biologics up 2%. All growth rates exclude the effects of currency. Net income increased 8% to $857.0 million, or $0.77 per share, beating estimates by a penny.

NuVasive reported 4Q:09 revenues of $106.9 million, up 43% over the year-ago period and in line with a pre-announcement. Adjusted earnings of $4.2 million, or $0.11 per share, beating estimates by $0.02.

Symmetry Medical reported 4Q:09 revenues of $76.4 million, down 23% over the year-ago period and beating estimates by $6.2 million. The company attributed the sales decline to "reduced customer demand across all segments of the business." Adjusted net income for the quarter was $1.9 million, or $0.05 per diluted share, down from $4.4 million, or $0.12 per diluted share, in the year-ago period and beating estimates by a penny.

TranS1 reported 4Q:09 revenues of $6.3 million, down 15% from the year-ago period and in line with a pre-announcement. The company attributed the sales decline to "concerns in the marketplace" surrounding AxiaLIF reimbursement, which the company is working to remedy with increased education. The company reported a loss of $0.28 per share, widening from a loss of $0.22 per share in 4Q:08 and beating estimates by $0.06. Additionally, it was announced that CFO Mike Luetkemeyer would depart as of March 31 to pursue other opportunities. No replacement has been named.

M&A
Memometal Technologies acquired the OrthoGlide Ankle Technology from Advanced Bio-Surfaces (ABS) Corporation for an undisclosed amount. According to the company, the OrthoGlide ankle is a less-invasive implant, intended for mid- to moderate intervention, "that may reduce the need for a later fusion or total ankle replacement."

Funding
TGS Knee Innovations is in the process of raising $1.0 million from the sale of equity, with $0.6 million from unnamed investors already closed. The company is developing the TGS UKA System, which is designed to "restore natural movement" with an implantation technique that "accommodates the soft tissue."

Regulatory
Small Bone Innovations received 510(k) clearance for two new products: the Mini-Rail Fixation System, intended for use in MTP joint arthrodesis and distraction, subtalar fusion and Jones fracture management; and the large Cannulated Screw System for use in lower limb reconstruction and repair procedures.

Product Introduction and Update
Anulex launched the Xclose Plus Tissue Repair System for anular repair, which the company says includes a number of modifications to "simplify implantation of the device, enhance the mechanical closure of the tissue and allow the surgeon to implant in more challenging tissue." The device utilizes the company's new Invisiloc Technology, a locking system designed to "reduce the total mass of the construct while enabling smooth tensioning of the system."

Ascension Orthopedics launched the MOVEMENT Hemi Great Toe Implant, which is available in four sizes and is designed to "maintain motion for patients with painful arthritic great toe joints."

Smith & Nephew Endoscopy launched the DYONICS Radiofrequency system, which the company says consists of a compact generator and a selection of probes for "aggressively removing defects and smoothing soft tissue during arthroscopic surgery."

Intellectual Property
BioPoly received a patent covering its self-lubricating polymer technology, which the company is using to develop a partial knee replacement.

Clinical
Vertos Medical announced that an observational study of 90 patients at 12 centers showed no complications related to the company's mild (Minimally Invasive Lumbar Decompression) system.

Collaborations
Amedica Corporation entered into a joint venture with Orthopaedic Synergy, Inc. to facilitate development, regulatory approval and distribution for articulating hip and knee implants made from Amedica's silicon nitride ceramic technology.

Appointment
Baxano appointed Frank M. Phillips, M.D. to the company's Board of Directors. He is currently Professor of Orthopaedic Surgery and Head of the Section of Minimally Invasive Spine Surgery at Rush University Medical Center. Baxano is currently in the process of launching its iO-Flex System for spinal decompression.

Pioneer Surgical Technology appointed Qibin "Chip" Bao, Ph.D. Chief Technology Officer. He has been with Pioneer since 2003, where he served as VP of Spine Development and oversaw development of the P3 (Pioneer PEEK-on-PEEK) technology for spinal motion preservation.

VertiFlex announced that William H. Duffell, Ph.D. joined the company as Vice President, Global Clinical Research, where he will be responsible for the Superion Interspinous Spacer IDE study as well as OUS clinical strategy. Previously, Dr. Duffell served as Sr. Vice President, Global Government Affairs and Global Regulatory and Quality Assurance with Gambro, a Swedish company that develops drugs, devices and biologics for hemodialysis, peritoneal dialysis and cell therapy.

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