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Orthopedic and Dental Industry News

April 2007

Orthopedic News Roundup 26-Apr-07 BY LAUREN UZDIENSKI, APRIL 26, 2007

Earnings Large Joints Zimmer reported income of $233.4 million, or $0.98 per share, beating estimates of $0.93. The quarter compares to a profit of $205.6 million, or $0.82 per share in 1Q:06. Revenue rose 10% to $950.2 million from $860.4... more

FDA Recommends Approval of Link's S.T.A.R. Total Ankle BY JOHN CHOPACK, APRIL 26, 2007

The FDA recommended the approval of Link's Scandinavian Total Ankle Replacement System (S.T.A.R.) after a favorable advisory panel vote of 4-2. If approved, the device would be the first mobile bearing ankle marketed in the U.S. Although mobile bearing ankles... more

"Significant" Delay for Stryker's OP-1 Putty BY LAUREN UZDIENSKI, APRIL 25, 2007

Stryker's 1Q:07 earnings call last week highlighted strong profits, but Chief Executive Stephen MacMillan noted a potential snag in its pipeline - OP-1 putty, the company's bone morphogenic protein for spinal fusion indications, may not reach the market until late... more

Society for Biomaterials a Product Pipeline Crystal Ball BY DAVID KRESSEL, APRIL 24, 2007

Last week, we attended the Society for Biomaterials' annual conference. The event showcases the latest academic research and its broad applications across medical specialties. Roughly a third of the poster presentations focused on orthopedics, and most of the rest related... more

Orthopedic News Roundup 19-Apr-07 BY LAUREN UZDIENSKI, APRIL 19, 2007

Earnings Stryker announced 1Q:07 earnings on Wednesday. Net income increased to $243.5 million, or $0.59 per share, beating analysts' estimates of $0.58 per share. In the comparable quarter, net income was $147.5 million, or $0.36 per share. Revenues increased 13%... more

MicroDTI Announces Appointment of Edward Shellard as Chief Executive Officer BY EDITOR, APRIL 19, 2007

Vancouver, Canada, April 19, 2007 /PRNewswire/--MicroDTI announced the appointment of Edward Shellard as its Chief Executive Officer. Dr. Shellard is a well-respected dental industry executive and was most recently the President of Kerr. Ed had his own private practice in... more

Market Trends From NYTimes Hip Resurfacing Article BY ARIELLA P. GOLOMB, MD, APRIL 17, 2007

Hailing hip replacement as one of the "great success stories of modern medicine," the New York Times published an article on Saturday emphasing the benefits of hip resurfacing as an interim step before traditional total hip replacement. There are a... more

FDA Announces Recommendations for MDUFMA II BY LAUREN UZDIENSKI, APRIL 17, 2007

The Medical Device User Fee and Modernization Act (MDUFMA II) will expire this September, and yesterday the FDA submitted their proposed recommendations for the Act's reauthorization. MDUFMA is medical device user fee program, wherein industry pays fees to support the... more

CMS Proposes 2008 Increases BY JOHN MCCORMICK, APRIL 16, 2007

Late Friday, the Centers for Medicare and Medicaid Services (CMS) released the proposed 2008 Inpatient Prospective Payment System (IPPS) under which US hospitals are reimbursed under the DRG codes. As with prior years, this release is a draft statement and... more

Alphatec Holdings, Inc. Licenses Technology Focused On Minimally Invasive Spinal Surgery Market BY EDITOR, APRIL 13, 2007

CARLSBAD, Calif., Apr 12, 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 that... more

Orthopedic News Roundup 12-Apr-07 BY LAUREN UZDIENSKI, APRIL 12, 2007

Earnings Vertebron announced in a press release that 1Q:07 was its most profitable quarter ever. The Company attributes the growth to a significant sales increase over the comparable quarter last year as well as a company-wide restructuring in 3Q:06. Vertebron... more

Alphatec Holdings, Inc. Enhances Technology and Product Portfolio With Global Licensing Agreement BY EDITOR, APRIL 11, 2007

CARLSBAD, Calif., Apr 11, 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 that... more

Female Stem Cells Regenerate Muscle Better than Male BY LAUREN UZDIENSKI, APRIL 11, 2007

New research out of the University of Pittsburgh Medical Center show that female stem cells have an edge over male stem cells in regenerating muscle. Johnny Huard et al suggest in the Journal of Cell Biology that this research is... more

FDA Makes Post-Approval Device Study Info Public BY LAUREN UZDIENSKI, APRIL 10, 2007

Plans for more rigorous post-marketing policy are underway at the FDA with a new website that tracks post-approval device studies. The website names the manufacturer, device, study description and study status. There is no specific info on clinical studies because... more

Orthopedic News Roundup 5-Apr-07 BY LAUREN UZDIENSKI, APRIL 4, 2007

Earnings aap Implantate AG announced 2006 revenues of EUR 18.5 million, up 38% from the previous year. The aap Group attributed the growth to the Biomaterials segment, where sales increased by 64% to EUR 12.2 million. Biomaterials now generates two... more

Congress, Industry Aim to Broaden Pediatric Device Research BY LAUREN UZDIENSKI, APRIL 4, 2007

With a small market and conditions that are relatively rare, pediatrics hasn't drawn a lot of product development in the device space. As a result, children may receive devices that aren't appropriately sized for them or are lacking in data... more

What Does Backdating Options Really Mean for Biomet? BY LAUREN UZDIENSKI, APRIL 3, 2007

Preliminary findings from an investigation into Biomet's options backdating announced last week showed a $50 million discrepancy between 1996 and 2006, and CFO Gregory D. Hartman and Exective Vice President of Administration Daniel P. Hann have both resigned. What does... more

Spine Reimbursement: Lehman Brothers visits with CMS BY JOHN MCCORMICK, APRIL 2, 2007

The Lehman Brothers medical device research team had a fruitful visit to the beltway last week notably with Steve Phurrough, Director of the Coverage and Analysis Group at CMS and Herb Khun, CMS's Deputy Administrator. One of Lehman's findings related... more


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