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Orthopedic and Dental Industry News

May 2007

Orthopedic News Roundup 31-May-07 BY LAUREN UZDIENSKI, MAY 31, 2007

Regulatory CMS released a proposed non-coverage decision for lumbar artificial disc replacements following a review of Synthes' Pro-Disc-L. The agency found that LADR is not reasonable and necessary for Medicare recipients over 60 based on lack of relevant data and... more

Surgery Favored in Latest SPORT Data BY LAUREN UZDIENSKI, MAY 30, 2007

Spinal fusion is evaluated in the second of three SPORT studies, and patients who selected the surgery to treat degenerative spondylolisthesis had better outcomes when compared with nonsurgical treatment. However, when the results were analyzed on an intention-to-treat basis, there... more

On the CMS Lumbar Disc Non Coverage Proposal BY JOHN MCCORMICK, MAY 29, 2007

At the end of Friday, CMS published a sweeping proposal that denies coverage for all lumbar artificial discs in the age 60-and-over Medicare population. The proposal can be found here on the CMS website. Falling into line with its previous... more

Biomet Receives New Round of Federal Subpoenas BY ARIELLA P. GOLOMB, MD, MAY 29, 2007

Just as one DOJ investigation seemed to be coming to a close, Biomet reported late last week that the company is facing new subpoenas from federal prosecutors. The government is requesting documents from as far back as 1999 relating to... more

Star-Ledger: DOJ Settlement Could Come this Summer BY LAUREN UZDIENSKI, MAY 24, 2007

A DOJ investigation into surgeon compensation practices by Biomet, Depuy, Smith & Nephew, Stryker and Zimmer in 2005 could reach a settlement "as soon as this summer," according to the Star-Ledger's John P. Martin. Current terms of the settlement are... more

Orthopedics News Roundup 24-May-07 BY LAUREN UZDIENSKI, MAY 24, 2007

Earnings Medtronic reported FY2007 earnings of $12.3 billion, an increase of 9% over FY2006. Adjusted income was up 10% to $2.8 billion, or $2.41 per share, an increase of 15% over the previous year. For the fourth quarter, revenue was... more

Amedica Files for $75 Million IPO BY JOHN MCCORMICK, MAY 23, 2007

Yestderday, Utah-based Amedica Corp. filed an initial public offering Securities and Exchange Commission to sell up to $74.75 million in common stock. The company's technology platform is in silicon nitride ceramics as applied to various types of orthopedic implants including... more

AACD 2007: Cosmetic Dentistry's Showcase Event BY ELIZABETH VARLEY CAMP, MAY 22, 2007

We attended last week's American Academy of Cosmetic Dentistry (AACD) annual meeting. It is the leading cosmetic dentistry event of the year, with roughly 5,000 dentists in attendance. There were over 100 clinical seminars and live patient-based procedure training; some... more

MDMA Celebrates 15 Years: Past Achievements and Looking Ahead BY LAUREN UZDIENSKI, MAY 21, 2007

Last week's Medical Device Manufacturers Association Annual Meeting in Washington, D.C. gave us an opportunity to applaud the passion and dedication that defined MDMA's past accomplishments and will carry future negotiations on regulatory, reimbusement and marketplace issues for smaller device... more

Orthopedic News Roundup 15-May-07 BY LAUREN UZDIENSKI, MAY 16, 2007

Earnings BioMimetic Therapeutics reported a 1Q:07 net loss of $5.7 million or $(0.34) per share, beating estimates of $(0.37) and comparing to a net loss of $3.8 million, or $(2.22) per share, in 1Q:06. The company reported revenues of $0.25... more

Alphatec Holdings, Inc. Drives Spinal Disorder Solution Technology and Announces the Launch of the New CONNECT II Cervical Structural Allograft Product BY EDITOR, MAY 16, 2007

CARLSBAD, Calif., May 15, 2007 (PrimeNewswire via COMTEX News Network) -- Alphatec Holdings, Inc. (Nasdaq:ATEC), a leading medical device company focused on the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders, announced today the... more

Studies with Commercial Funding, U.S. Authors More Likely to be Published BY LAUREN UZDIENSKI, MAY 16, 2007

In what may be the first study to evaluate peer-review bias in orthopedics based on submitted, rather than published, studies, Joseph Lynch et al consider associations between scientific and nonscientific variables and outcome as well as acceptance for publication. Lynch... more

Vitamin E Poly Hits The Market BY DAVID KRESSEL, MAY 14, 2007

Biomet announced it gained FDA clearance to market the first vitamin E stabilized highly crosslinked polyethylene acetabular cup liner. Using the trade name E-Poly, Biomet's product uses the antioxidant vitamin E to reduce wear of the poly liner as oxidation... more

Orthopedic News Roundup 10-May-07 BY LAUREN UZDIENSKI, MAY 10, 2007

Earnings Biologics Integra LifeSciences announced 1Q:07 revenues of $123.0 million, beating estimates of $119.25 million and reflecting a 60% increase over 1Q:06. Net income for the quarter was $9.07 million, or $0.33 per share, meeting analysts' estimates. President and CEO... more

Orthopedic Valuations: An Update after 1Q:07 Earnings Call BY JOHN CHOPACK, MAY 9, 2007

We predicted in January 2007 that orthopedic stocks were poised for a good year. We thought we would revisit our prediction after most of the publicly traded orthopedic companies reported their 1Q:07 earnings. The table below clearly shows that the... more

Fine-Tuning Computer-Assisted Orthopedic Surgery BY LAUREN UZDIENSKI, MAY 8, 2007

The National Institute of Standards and Technology announced an initiative last week to improve the precision and reliability of computer-assisted orthopedic surgery (CAOS) instruments in hip replacement surgery. NIST researchers have built a "phantom" hip that can be used by... more

Greetings from Berlin: Notes from Spine Arthroplasty 7 BY JOHN MCCORMICK, MAY 4, 2007

In the past, the Spine Arthroplasty Society (SAS) conference was about spinal disc replacement and had a decidedly commercial tone. Disc replacement was the promised land and market forecasts predicting billions and billions proliferated. The future is now and the... more

Orthopedic News Roundup 3-May-07 BY LAUREN UZDIENSKI, MAY 3, 2007

Earnings Spine Kyphon reported that worldwide revenues in 1Q:07 increased 40% to $128.1 million, which includes $18.1 million in X-STOP® Interspinous Process Decompression (IPD®) sales from the St. Francis acquisition. In the U.S., revenues increased 34% to $101.1 million, while... more

Now it's Really Official-There is a New Guard in Orthopedics BY JOHN CHOPACK, MAY 3, 2007

Following Tuesday's announcement that David Dvorak and James Crines were replacing Ray Elliott and Sam Leno as CEO and CFO at Zimmer, Smith & Nephew announced today that its CEO for last the 10 years, Sir Christopher O'Donnell, will retire... more

It's Official--There is a New Guard in Orthopedics BY JOHN CHOPACK, MAY 1, 2007

Today, Zimmer announced the replacement of long-time President & CEO, Ray Elliott who will remain as Chairman of the Board until November 2007. His replacement will be David Dvorak who has been Group President, Global Businesses and Chief Legal Officer.... more

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