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Orthopedic and Dental Industry News

July 2008

Musculoskeletal News Roundup 31-July-08 BY LAUREN UZDIENSKI, JULY 31, 2008

Earnings Cryolife reported 2Q:08 revenues of $27.2 million, up 18% over the year-ago period and beating estimates by $1.4 million. Orthopedic tissue processing revenues declined 76% to $0.3 million, as the company has discontinued that segment of the business. Net... more

Ex-Medtronic Employees File Whistleblower Lawsuit BY LAUREN UZDIENSKI, JULY 31, 2008

Two former Medtronic employees filed a qui tam lawsuit in a Boston federal court, alleging that more than 100 spine surgeons, neurosurgeons and distributors colluded with Medtronic to defraud Medicare and accepted kickbacks from the company. These are the same... more

MIT Study Advances Non-Surgical Stem Cell Treatments for Spinal Cord Injuries BY HAL BRIGHAM, JULY 30, 2008

A recent joint study out of MIT's Picower Institute for Learning and Memory and the Karolinska Institute in Sweden may pave the way for the development of revolutionary, non-surgical treatments for spinal cord injuries. Headed by Konstantinos Meletis, a postdoctoral... more

NY Times Calls for National Joint Registry BY LAUREN UZDIENSKI, JULY 29, 2008

Following Zimmer's announcement that the company would suspend sales of the Durom acetabular cup, the New York Times suggested this morning that the concerns about Durom could've been identified sooner if the U.S. had a national joint registry in place.... more

Alphatec Spine's OsseoFix Clinical Study Initiated BY EDITOR, JULY 24, 2008

Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., a leading medical technology company involved in the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders, with a focus on treating conditions affecting the... more

Musculoskeletal News Roundup 24-July-08 BY LAUREN UZDIENSKI, JULY 24, 2008

Earnings Anika Therapeutics reported 2Q:08 revenue of $8.38 million, representing a 32% increase over 2Q:07 but missing estimates by $0.4 million. The company attributed sales growth to the strength of the Orthovisc line. Net income for 2Q:08 was $0.81 million,... more

Theken is Taken: Integra to Buy for up to $200 Million BY LAUREN UZDIENSKI, JULY 24, 2008

Integra LifeSciences this morning announced plans to acquire the Theken family of businesses - Theken Spine, Theken Disc and Therics - for $75.0 million (2.2x 2007 revenues) plus up to $125.0 million in future performance-based payments (up to 5.9x 2007... more

CMS Proposes National Non-Coverage Decision for IDET BY LAUREN UZDIENSKI, JULY 24, 2008

CMS proposed a national non-coverage decision for intradiscal electrothermic therapy (IDET), saying there is insufficient evidence that the procedure improves outcomes in the Medicare population. IDET is a minimally-invasive treatment for low back pain where a catheter and a heating... more

Zimmer Suspends Durom Sales, Cuts Guidance BY LAUREN UZDIENSKI, JULY 23, 2008

Zimmer's announced yesterday that they would voluntarily suspend sales of the Durom Acetabular Component in the U.S. while they update the labeling and conduct further surgeon training on the product. As a result, the company is lowering full-year revenue guidance... more

More Trouble for ArthroCare as Company Announces Plans to Restate Financials BY LAUREN UZDIENSKI, JULY 21, 2008

ArthroCare's stock was off almost 40% in midday trading following an announcement this morning that the company would restate financials from 2006, 2007 and 1Q:08. The restatement stems from a number of issues, including how revenue from DiscoCare was classified,... more

Study Finds Hip and Knee Arthroplasty Worthwhile for the Elderly BY HAL BRIGHAM, JULY 21, 2008

A study published in the July 14, 2008 issue of Archives of Internal Medicine contends that hip and knee arthroplasty surgeries may be more beneficial to elderly patients than once believed. The study reports that surgery is not only more... more

Musculoskeletal News Roundup 17-July-08 BY LAUREN UZDIENSKI, JULY 17, 2008

Earnings Biomet reported FQ4:08 revenues of $635.6 million, an increase of 16% (10% constant currency) over the year-ago period. Sales increased 10% in the U.S and 24% (11% constant currency) OUS. Recon sales increased 17% worldwide (12% constant currency) to... more

FzioMed's Oxiplex "Not Approvable" According to FDA Panel BY DAVID KRESSEL, JULY 16, 2008

On Tuesday, we attended the FDA's Orthopaedic & Rehabilitative Devices Panel, Oxiplex/SP was voted "Not Approvable" by a 5-2 vote, based largely on the sponsoring company's inability to definitively demonstrate product effectiveness. The two dissenters would have voted it "Approvable... more

ACL Repair for Young, Active Patients: Heightened Risks Create Opportunity for Regenerative Technologies BY LAUREN UZDIENSKI, JULY 16, 2008

Researchers at the Mississippi Sports Medicine and Orthopaedic Center have found a failure rate nearing 24% for ACL reconstruction in young, athletic patients, according to a new study. Of 61 patients aged 15-39 who underwent ACL reconstruction, 14 were deemed... more

U.S. News and World Report Names 10 Best Ortho Hospitals BY LAUREN UZDIENSKI, JULY 14, 2008

Hospital for Special Surgery topped U.S. News and World Report's list of the best ortho hospitals in the country, boasting the most discharges of any orthopedic hospital, a large nursing staff and advanced technologies. A low mortality index (0.14), status... more

In a Turnaround, Senate Votes to Block Medicare Payment Cuts BY LAUREN UZDIENSKI, JULY 10, 2008

This year's saga of Medicare reimbursement cuts seems to be heading for a happy ending this week, as the Senate voted yesterday to block the scheduled 10.6% cut to payments (reversing a determination from several weeks ago that the cuts... more

Musculoskeletal News Roundup 10-July-08 BY LAUREN UZDIENSKI, JULY 10, 2008

IP Michigan-based Smart Disc, Inc. received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. patent application number 10/838,515, covering the company's artificial disc technology. The device can be implanted using a posterior approach and is... more

Summer Safer for Sports Injuries BY LAUREN UZDIENSKI, JULY 10, 2008

If you like to swim, hike or fish, summer is the season. And now the CDC has even more good news about these fun outdoor activities: you're probably not going to get hurt doing them. Summer sports are among the... more

JBJS: ReGen's Collagen Meniscus Implant Improves Clinical Outcomes for Some Patients BY LAUREN UZDIENSKI, JULY 8, 2008

A new JBJS study comparing ReGen Biologics' collagen meniscus implant, Menaflex, with partial meniscectomy was published this week, and the publication comes as a rare bit of good news for the struggling ReGen. At 311 patients, the multi-center study was... more

FDA Issues Warning Regarding Off-Label Use of rhBMP BY LAUREN UZDIENSKI, JULY 7, 2008

Last week the FDA released a public health notification regarding the off-label use of of rhBMP (InFuse, OP-1) in the cervical spine. The agency says that over the past four years there have been at least 38 reports of complications... more

Musculoskeletal News Roundup 3-July-08 BY LAUREN UZDIENSKI, JULY 3, 2008

Regulatory Interventional Spine announced that the FDA has conditionally approved its IDE application for the PercuDyn System, pending the company providing some additional information to the FDA. CEO Walter Cuevas commented that the company will now begin collecting data to... more

Patient Sues Surgeon, U Penn Health System Over Undisclosed Consulting Payments BY LAUREN UZDIENSKI, JULY 2, 2008

The Philadelphia Inquirer reported this week that Katrina McKenzie has filed a lawsuit against Jonathan Garino, M.D. and the University of Pennsylvania Health System following a hip replacement she received as a participant in a clinical trial. The suit alleges... more

Scient'x Strengthens its R&D Department BY EDITOR, JULY 1, 2008

Scient'x S.A., a privately-held company dedicated to spinal implants, announced today the strengthening of its R&D department. Scient'x, continuing its growth and expansion plans, has recently made two key additions to its Research and Development Team. Scient'x has always had... more

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