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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 27-May-10 BY LAUREN UZDIENSKI, MAY 27, 2010

Earnings
Medtronic reported F4Q:10 revenue of $4.2 billion, up 6% over the year-ago period and in line with estimates. Spine revenue declined by 2% to $880.0 million. The company noted that OUS spine increased by 6%, which was attributed to kyphoplasty sales in Western Europe. Growth rates exclude the effects of currency. On a non-GAAP basis, net income was $986.0 million, or $0.89 per share, increasing 8% and 9%, respectively. Analysts had forecast EPS of $0.88.

M&A
Exactech acquired Brighton Partners for $5.5 million in an all-cash transaction. Brighton is the exclusive supplier of the direct compression molded polyethylene bearings used in Exactech's Optetrak knee. In 2009, Optetrak contributed $75.0 million to Exactech's $177.3 million in sales.

Funding
VentureMD, a "seed-stage medical device business accelerator" based in North Logan, Utah, has closed on a fund. The group did not release the size of the fund. They described their focus as the orthopedic, spine, endoscopy and dental markets.

Regulatory
KFx Medical received 510(k) clearance for the AppianFx line of products, indicated for soft tissue repair and reconstruction in the knee.

X-spine received 510(k) clearance for its Fixcet Spinal Facet Screw System, which the company describes as a featuring a "one-piece screw design [that] provides active compression of the facet joint and improved apposition of the facet surfaces compared to other systems." The device can be implanted with a traditional open or MIS approach.

Product Introduction and Update
Arthrosurface announced that over 20,000 patients have now been treated with the company's cartilage resurfacing systems.

Citing registry data, the UK released a medical device alert noting that DePuy's ASR acetabular cups have a higher-than-expected revision rate. While regulators anticipated a revision rate of about 3%, the actual rate has been closer to 4-5%. In addition to the registry data, two of the UK clinical sites that implant the device have echoed the higher failure rate. DePuy has been marketing the device in the UK since 2003.

Intellectual Property
Applied Spine Technologies received two new U.S. patents. The first covers "stiffness and travel" in a spring-based dynamic stabilizer, and the second covers "connection between the spring and cap assembly of the device."

Clinical
DFine summarized two abstracts presented at the 2010 International Osteoporosis Foundation relating to the company's Radiofrequency (RF) Kyphoplasty procedure when used with the company's StabiliT Vertebral Augmentation System for the treatment of VCFs. The first cohort was treated with RF Kyphoplasty with vertebroplasty as a control. The authors concluded that both procedures showed significant pain reduction and functional improvement at three months, though "RF Kyphoplasty resulted in the added benefits of height restoration and lower cement leakages." The second abstract identified "significant and sustained pain relief and functional improvement through six-month follow-up compared to pre-operative measurements" in patients with oncologic-related VCFs . No symptomatic cement leakage was reported in that cohort.

Vertos Medical released data from its IDE study of the mild system for the treatment of lumbar spinal stenosis. The prospective, 75-patient study showed that patients reported statistically significant improvement "in both their physical and mental well-being", based on the SF12-v2 and Zurich Claudication Questionnaire, at six weeks following the mild procedure.

Collaborations
curasan and Matricel co-developed a composite bone graft substitute that consists of Cerasorb, a beta-tricalcium phosphate, and collagen.

Appointments
SpineGuard elected Alan Olsen as Chairman of the Board. Mr. Olsen served as a Director of the company since November 2009 and was founder and president of Danek Medical, Inc.

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