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Orthopedic and Dental Industry News

October 2007

Biomet, DePuy, Smith & Nephew, Stryker and Zimmer Disclose Payments Made to Consultants BY LAUREN UZDIENSKI, OCTOBER 31, 2007

Available on Biomet, DePuy, Smith & Nephew, Stryker and Zimmer's websites today are disclosures of the companies' payments to consultants. The public disclosure of consultant payments was among the terms in the deferred prosecution agreements (in Stryker's case, a non-prosecution... more


Last week, six members of our firm attended the North American Spine Society (NASS) annual meeting in Austin, TX talking to surgeons, companies and scientists about the latest technology, market and clinical developments in the spinal implant industry. We are... more

Questions and Controversies Still Loom Over Gainsharing BY LAUREN UZDIENSKI, OCTOBER 26, 2007

In a 2006 survey of 95 orthopedists, published in JBJS in September, 61% of respondents said they believed that gainsharing programs ("arrangements in which hospitals and physicians share in any cost savings achieved through greater efficiencies and physicians' effort") were... more

Musculosketal News Roundup 25-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 25, 2007

Earnings ArthroCare Corp. reported 3Q:07 total revenues of $78.5 million, an increase of 21% over the comparable quarter. Revenues missed estimates by $0.11 million. The company reported net income of $11.1 million, or $0.39 per share, up 28% over 3Q:06... more

Alphatec Holdings, Inc. Receives FDA 510(k) Clearance For the DYNAMO Rod System BY EDITOR, OCTOBER 25, 2007

Alphatec Holdings, Inc. (Nasdaq:ATEC), a medical technology company focused on the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration... more

Synthes Gets Approvable Letter from FDA for ProDisc®-C BY LAUREN UZDIENSKI, OCTOBER 25, 2007

Synthes announced this morning that they received an Approvable Letter from the FDA regarding their PMA application for the ProDisc®-C, the company's artificial cervical disc. A full approval order will be made once Synthes' manufacturing processes are reviewed by the... more

Etiology of isthmic spondylolisthesis BY EDITOR, OCTOBER 23, 2007

The article below was first published in ArgoSpine News in April 2006. As part of our sponsorship of ArgoSpine, we're republishing select ArgoSpine News content for our audience. Article by Professor Chrisitan Mazel, MD, Institut Mutualiste Montsouris, Orthopaedics Unit, Paris,... more

Highlights from DePuy's Third Quarter BY ARIELLA P. GOLOMB, MD, OCTOBER 18, 2007

This week J&J held a third quarter earnings meeting and Medical Device & Diagnostics Business review in New York. We thought we’d share some highlights from the DePuy franchise for our orthopedic audience. Overall, DePuy saw operational growth (excluding the... more

Musculoskeletal News Roundup 18-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 18, 2007

Earnings Biomet reported FQ1:08 sales of $552.3 million, up 9% over the comparable quarter. The company reported a net loss for the quarter of $42.9 million, down from an income of $104.4 million for FQ1:07. The company attributed the loss... more

TranS1 Priced Above Range in NASDAQ Debut BY LAUREN UZDIENSKI, OCTOBER 17, 2007

Wilmington, N.C.-based spine company TranS1 began trading on the NASDAQ today following Tuesday's IPO. The stock debuted at $15 per share, above the $12-$14 per share forecasted by underwriters Lehman Brothers Holdings Inc. and Piper Jaffray, and raised a total... more

At the Forefront of Orthopedics: Musculoskeletal New Ventures BY ELIZABETH VARLEY CAMP, OCTOBER 15, 2007

We attended the 5th Annual Musculoskeletal New Ventures conference this week in Memphis, home of Elvis, FedEx and Gibson Guitars. There were 190 attendees (same level as last year), including many of the orthopedic industry’s development leaders. Among them were... more

SEC Investigates Biomet for Possible Violations of the Foreign Corrupt Practices Act BY LAUREN UZDIENSKI, OCTOBER 12, 2007

Biomet announced yesterday in a preliminary earnings release for FQ1:08 that the company was under investigation for possible violations of the Foreign Corrupt Practices Act (FCPA). The investigation was said to be informal and involve other companies in addition to... more

AstraTech to Acquire Atlantis Components BY DAVID KRESSEL, OCTOBER 11, 2007

Sweden-based AstraTech, AstraZeneca's medical device subsidiary, announced it will acquire Atlantis Components for $71m. Atlantis, a Cambridge, MA-based producer of custom milled dental implant abutments, complements Astra's dental implant business by allowing Astra to offer a broader portfolio of restorative... more

Musculoskeletal News Roundup 11-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 11, 2007

M&A With certain conditions, the FTC will allow Kyphon to proceed with its planned acquisition of Disc-O-Tech Medical Technologies and Discotech Orthopedic Technologies Inc. Kyphon was directed to sell Disc-O-Tech's Confidence product lines to address antitrust concerns. When Kyphon announced... more

Warning Letters Encourage Spine Companies to Seek More Data, Tougher Indications BY LAUREN UZDIENSKI, OCTOBER 10, 2007

Two recent FDA warning letters issued in the spine space show regulators cracking down on industry marketing practices, putting pressure on devicemakers to conduct more trials and pursue harder-to-get indications for their products. In August, Spineology received an FDA warning... more

JBJS: ACI, Microfracture Show Comparable Outcomes at Five Years BY LAUREN UZDIENSKI, OCTOBER 8, 2007

JBJS published results from a prospective, randomized Norweigan trial where 80 patients were selected to receive either autologous chrondocyte implantation (ACI) or microfracture for the treatment of chronic cartilage defects. There were 40 patients in each group. - Five-year follow-up... more

Musculoskeletal News Roundup 4-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 4, 2007

M&A Orthofix acquired the rights to all of the intellectual property related to the InSWing™ interspinous process spacer. InSWing is designed to relieve pain associated with lumbar spinal stenosis and can be used in a minimally invasive surgical procedure. Orthofix... more

Scient’x Announces the Launch of 4 New Products BY EDITOR, OCTOBER 2, 2007

Scient’x, a privately-held company dedicated to spinal implants, has announced today that it will launch 4 new implants at the Eurospine meeting being held in Brussels on October 3-6. Among these 4 products are: - Lyra, an antero-lateral plate to... more

Human Factors Engineering: Accounting for "Use Error" in Medical Devices BY LAUREN UZDIENSKI, OCTOBER 1, 2007

Medical devices rely on proper use to be "safe and effective," which is why FDA has in recent years encouraged devicemakers to incorporate human factors engineering into their development processes. What is human factors engineering (or HFE)? FDA defines the... more

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