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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 2-Dec-10 BY LAUREN UZDIENSKI, DECEMBER 2, 2010

Earnings
Synovis Life Technologies reported F4Q:10 (ended 10/31/10) sales of net revenue rose to $18.1 million, up 21% over the year-ago period and missing estimates by $0.1 million. Orthopedic and wound sales (from the Pegasus acquisition) contributed $0.7 million to overall revenues. Net income for the quarter was $1.5 million, or $0.13 per diluted share, which compares to adjusted net income of $0.6 million, or $0.05 per diluted share, in F4Q:09 and was in line with estimates.

Funding
MiMedx received a $0.2 million Qualifying Therapeutic Discovery Project grant from the U.S. government. Funds will be used to support the development of CollaFix, a collagen fiber technology, as a drug delivery device.

Ortho Kinematics raised $1.0 million of a planned $5.1 million round of funding. Previous investors include PTV Sciences, the Texas Emerging Technology Fund and Gatebridge Investments. The company is developing a device to measure the quantity and quality of intervertebral motion.

Regulatory
Medtronic's CD HORIZON pedicle screw system received FDA clearance for use in adolescent idiopathic scoliosis. The company says that this is the first clearance for this product type since the FDA adopted a new category for pediatric AIS patients treated with posterior pedicle screw instrumentation.

Smith & Nephew received expanded CE mark clearance for DUROLANE, with new indications including use in arthroscopic joint surgery in the presence of osteoarthritis or at any point during the first three months following general arthroscopic joint repair. The expanded indications also include use of DUROLANE in OA patients experiencing pain in all sizes of synovial joints, including fingers, ankles and knees.

X-spine received FDA clearance for the AXLE Interspinous Fusion System. The system is designed for use in lumbar fusion procedures, including the treatment of degenerative disc disease, spinal tumors and trauma. The company says the system features a modular design allowing for implant customization and that the devices can be implanted through a one-inch incision.

Product Introduction and Update
DePuy Spine launched the MOUNTAINEER Laminoplasty System of implants and instruments for posterior decompression of the cervical spine.

SpinalVu, Inc. began production of two product systems for treatment of spinal disorders, the X-Wave Cervical Interbody System and X-Wave Lumbar Interbody System, which they plan to launch in 1Q:11. The devices are made from PEEK. The company has contracted with SMI of Ocala, Florida for manufacturing the products.

Clinical
A new study published in Spine shows the SCOLISCORE AIS Prognostic Test, a DNA test to determine the likelihood of curve progression in children with mild adolescent idiopathic scoliosis, is 99% accurate in predicting which children are least likely to progress to a severe curve. The test was developed by Axial Biotech and is distributed by DePuy Spine.

Smith & Nephew reported on data from the Australian large joint registry, noting that implants using ceramicized metal technology, such as Smith & Nephew's OXINIUM Oxidized Zirconium, in combination with polyethylene were successful in 98% of patients five years after surgery. The company noted that implants with bearings made from other materials had to be revised over the same period at higher rates.

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