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Orthopedic and Dental Industry News

November 2005

Ethics & Research in Orthopedics BY JOHN CHOPACK, NOVEMBER 30, 2005

In the November issue of the British Journal of Bone and Joint Surgery there were two very interesting editorials: "Ethics in Orthopaedic Surgery" by the Presidents' Council of the Combined Orthopaedic Associations and "Which Research is to be Believed" by... more

Osteotech's Difficult Road Ahead BY JOHN MCCORMICK, NOVEMBER 29, 2005

Last Wednesday, Osteotech announced that their beleaguered Chief Executive Richard Bauer will retire at the end of December - sooner than expected. While he will remain on the Osteotech board, Sam Owusu-Akyaw, the Company's current president and chief operating officer,... more

Nexa Orthopedics, Inc. and HealthpointCapital Announce Purchase of BIOProfile S.A. BY EDITOR, NOVEMBER 28, 2005

Nexa Orthopedics, Inc. is focused on developing innovative products to meet the unmet clinical needs of the extremity surgeon. New York, NY, USA and Grenoble, France, November 28, 2005 -- Nexa Orthopedics, Inc., ("Nexa") a HealthpointCapital portfolio company, announced today... more

Orthopedic News Roundup 23-Nov-05 BY HUYEN NGUYEN, NOVEMBER 23, 2005

This week has been a quiet week as Americans are preparing for the Thanksgiving holiday weekend. The stock market will be closed tomorrow (Thursday) and will only be open half a day on Friday in observance of the Thanksgiving holiday.... more

St. Francis Gets FDA Approval BY JOHN MCCORMICK, NOVEMBER 22, 2005

After and long and contentious approval process with the FDA, St. Francis Medical Technologies, Inc. announced this morning that it has received FDA approval to market its X STOP Interspinous Process Decompression System. X STOP (and the interpinous processes paradigm... more

Alphatec Spine Announces Appointments to Research and IT Positions BY EDITOR, NOVEMBER 22, 2005

Steven Reinecke to be VP of Research & Development, Brian Plotkin to be VP of Information Technology. CARLSBAD, California, November 22, 2005 /PRNewswire/-- Alphatec Spine, Inc. ("Alphatec"), a vertically-integrated spinal device company, today announced the appointments of Steven Reinecke as... more

Biomimetics gets FDA Pre-Market Approval BY JOHN MCCORMICK, NOVEMBER 21, 2005

Biomimetic Therapeutics, Inc. announced today that it has received approval from the FDA for GEM 21S, a fully synthetic regeneration system for the treatment of periodontal bone defects. According to the management, this is the first totally synthetic product combining... more

Alphatec Spine Adds Two Executives to Manufacturing and Legal Roles BY EDITOR, NOVEMBER 18, 2005

Herbert Bellucci to be VP-Manufacturing, Ebun Garner to be VP-Legal CARLSBAD, California, November 18, 2005 /PRNewswire/-- Alphatec Spine, Inc. ("Alphatec") today announced the appointments of two key executives, continuing the firm's remarkable growth from small contract medical device manufacturer to... more

The Latest on Reimbursement BY KAREN FEDER, NOVEMBER 18, 2005

Last week, we attended the 8th Annual Coverage and Reimbursement Conference in Washington, DC organized by MDMA, the Medical Device Manufacturers Association. Here's what we learned: Mark Miller, PhD., MedPAC Executive Director, talked about MedPAC recommendations to Congress to optimize... more

Orthopedic News Roundup 17-Nov-05 BY HUYEN NGUYEN, NOVEMBER 17, 2005

Regulatory Update: Osteobiologics received FDA clearance on its OsteoChondral Transplant (OCT) Comprehensive System Instruments. The system is intended for the treatment of osteochondral (cartilage) defects in the knee. BioSyntech received an approval from Health Canada, Therapeutic Products Directorate, Medical Devices... more

HealthpointCapital posts latest report: FDA Approval for Orthopedic Devices BY EDITOR, NOVEMBER 15, 2005

What the Process Demands and How to Adapt Your Strategy

Our latest report describes the entire FDA approval process for orthopedic devices, and gives you 21 questions that help make your approval effort more thorough. more

Osteotech Gets 510(k) Extension for Grafton BY DAVID KRESSEL, NOVEMBER 15, 2005

The FDA said they are giving Osteotech (OSTE) an extension to its previously announced November 15th deadline to get 510(k) clearance for its Grafton DBM. In a letter dated September 16, 2005, the FDA required all DBM manufacturers to have... more

S.O.F.C.O.T. Wrap-Up BY JOHN CHOPACK, NOVEMBER 15, 2005

We were able to attend the 80th Annual S.O.F.C.O.T. Conference in Paris, France last week. We found the conference both informative and entertaining in catching up with previous contacts and meeting new management teams. We were surprised to see the... more

Medicare Paying for Performance BY LAING RIKKERS, NOVEMBER 15, 2005

Medicare announced yesterday that it is paying special bonuses for hospitals that demonstrated higher quality care in a pilot study. Clinical measures were selected and based upon outcomes, hospitals received direct payments for top marks. Medicare believes that evidence-based medicine... more

Encore Medical to Buy Compex Technologies for $109 Million BY JOHN MCCORMICK, NOVEMBER 14, 2005

Encore Medical Corp. (nasdaq: ENMC) announced this morning that it is expanding its presence in the pain management business with the acquisition of Compex Technologies Inc. (nasdaq: CMPX)in an all-stock transaction valued at $109 million. Under the terms of the... more

Orthopedic News Roundup 10-Nov-05 BY HUYEN NGUYEN, NOVEMBER 10, 2005

The third quarter reporting season for public orthopedic companies has officially ended, with two more companies reporting unimpressive earnings results. Osteotech ("OSTE") came in well below expectation as their sales and earnings continue to falter; Orthovita ("VITA"), reported a decent... more

BMS Considering Medtech Acquisition BY DAVID KRESSEL, NOVEMBER 10, 2005

At an industry summit on November 8th, Bristol-Myers Squibb's CEO Peter Dolan said he was interested in diversifying into other areas of healthcare, particularly medical devices. This is ironic because just five years ago BMS spun off its medical device... more

Update on Surgeons' Subpoenas (DOJ Investigations) BY SUSAN BERSON, NOVEMBER 9, 2005

[Editor's note: We welcome attorney Susan Berson of Mintz, Levin as a guest blogger. See her profile here.] Earlier this year, the government announced investigations of several device manufacturers charging that the manufacturers were offering inappropriate incentives to referring physicians... more

Webcast as Marketing Tool BY DAVID KRESSEL, NOVEMBER 8, 2005

Although we are focused on the orthopedics industry, we recently came across the announcement of an alliance in the cardiovascular industry that interested us. Although the technology and deal size were noteworthy, we also noticed the company cited a webcasted... more

Orthopedic Fundamentals Remain Strong BY HUYEN NGUYEN, NOVEMBER 8, 2005

This article was co-authored by Huyen Nguyen and John McCormick. As we move into the fourth quarter earnings calendar, we look back to third quarter reported earnings with some interesting thoughts. (1) Due to natural disasters, some major orthopedic players... more

Patient Resources BY HUYEN NGUYEN, NOVEMBER 7, 2005

Lately we have received numerous inquiries from patients with questions about surgery, procedures and devices. As a financial firm, we cannot provide clinical advice and refer all patients to their physicians. We can, however, provide a list of websites that... more

Orthopedic News Roundup 3-Nov-05 BY HUYEN NGUYEN, NOVEMBER 3, 2005

We wrap up this quarter with aggregated earnings and sales in the public orthopedic sector of $560 million and $5 billion, respectively, as a few more companies reported this week. For 3Q:05, orthopedic sales were up by 13% ($5.0 billion... more

CMS Publishes Reimbursement Codes for Kyphoplasty BY JOHN MCCORMICK, NOVEMBER 3, 2005

Earlier this morning Kyphon (Nasdaq: KYPH) shouted from the mountaintop: CMS has posted new CPT codes for Kyphoplasty which effectively brings reimbursement to a national level. The codes include percutaneous vertebral augmentation, RVUs for additional thoracic of lumbar vertebral bodies,... more

Insiders Buying Stryker's Shares (EDITORIAL) BY JOHN MCCORMICK, NOVEMBER 3, 2005

It has never been empirically proven that insider (e.g. management and director) buying of a company's stock guarantees that the stock poised to rise, but it has also never been proven to be a bad sign. That's stating the obvious.... more

SpineMedica Gets $10.6 million in VC Funding BY JOHN MCCORMICK, NOVEMBER 1, 2005

SpineMedica Corp., a Florida-based artificial spinal disc developer, has raised $10.6 million in Series A funding. SpineMedica's artificial disc, called SaluDisc, is designed to mimic the mechanical and physical properties of the native disc. In late August, SpineMedica announced that... more

HealthpointCapital Attends the 5th Annual Inspiration Meeting in France BY TIM BERKOWITZ, NOVEMBER 1, 2005

Posted by Tim Berkowitz and Anne Villeneuve. We attended late last week the Inspiration (International Spine Research and Innovation) meeting in Cannes. More than 70 spine surgeons from twenty-three countries discussed: cervical spinal tumors canalar stenosis with degenerative scoliosis in... more


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