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Orthopedic and Dental Industry News

June 2004

HealthpointCapital Announces Purchase of 33% share in Scient'x S.A. BY EDITOR, JUNE 29, 2004

HealthpointCapital Announces Purchase of 33% share in Scient'x S.A., Developer of Innovative Spinal Implant Technologies Scient'x is leader in the developing field of motion preservation and dynamic stabilization for spine surgeries New York, NY., USA and Paris, France, June 29,... more

We Use RTI for Soft Tissue and LifeCell for DBM? BY ROBIN R. YOUNG CFA, JUNE 28, 2004

We couldn't help but come to the following conclusion after reading RTI's Stryker notice last week: Stryker has accomplished the interesting task of contracting with the industry's #2 bone void fill supplier for soft tissue, and the industry's soft tissue... more

HealthpointCapital Announces Purchase of 33% share in Scient'X S.A., Developer of Innovative Spinal Implant Technologies BY EDITOR, JUNE 28, 2004

Scient'X is leader in the developing fieldof motion preservation and dynamic stabilization for spine surgeries New York, NY., USA and Paris, France, June 29 -- HealthpointCapital Partners L.P., the private equity affiliate of HealthpointCapital, and Scient'x S.A., the spinal implant... more

Orthovita Contracts for Cash and Hemostat from AngioTech BY ROBIN R. YOUNG CFA, JUNE 28, 2004

Cash and hemostats stop two kinds of bleeding. Last week, Orthovita (VITA) added both in an important and impressive deal with AngioTech. This deal will bring a new product to its growing arsenal of biomaterials, as well as a whopping... more

RTI Unveils Key Surgical Product Innovation BY ROBIN R. YOUNG CFA, JUNE 28, 2004

The best source of replacement body parts is the patient. Whether it is skin, tendons, bone, blood or whatever, harvesting from one spot to implant in another spot of the same patient is the gold standard, for more reasons than... more

Errata: OP-1. HDE not PMA BY ROBIN R. YOUNG CFA, JUNE 28, 2004

Small errors are one thing, but confusing a Human Device Exemption (HDE) for PMA was a noticeable slip-up. I wish I could say that it was a test to see if you were paying attention; it wasn't. Actually, it was... more

NuVasive's Honeymoon Continues BY ROBIN R. YOUNG CFA, JUNE 21, 2004

The IPO was oversubscribed. Demand for the Company's 6.5 million share offering was so strong at $11 per share, that the company (at the underwriter's urging) was compelled to issue another 382,991 shares. This brought the total amount of money... more

DePuy, Stryker and Synthes Receive Most FDA Approvals YTDwhile Zimmer lags BY ROBIN R. YOUNG CFA, JUNE 21, 2004

Fill the salesman's bag. Advance the art and practice of orthopedics. Create superior returns for your shareholders. None of these are possible without the FDA's initial and ongoing approval. So far this year, the FDA has granted 214 orthopedic device... more

510(k) Approvals BY EDITOR, JUNE 21, 2004

  Device Applicant 510(k) Decision Date 1 acumed lower extremity congruent plate s acumed llc K033639 1/15/2004 2 titanium cannulated interference screw advanced biomaterial K033749 2/23/2004 3 aesculap absorbable craniofix aesculap, inc. K040080 3/31/2004 4 abc caudal and cranial extension... more

Laurence Fairey Gets Back in the Game. BY ROBIN R. YOUNG CFA, JUNE 21, 2004

Jumping back into the fray after 4 years of semi-retirement, former Sofamor Danek and Richards senior executive, Laurence Fairey has agreed to become President and Chief Operating Officer of Wright Medical today. Laurence Fairey is one of the best regarded... more

Good-Bye Interpore Cross BY ROBIN R. YOUNG CFA, JUNE 21, 2004

20 years ago, Interpore brought to market coral based bone void fill. The coral, which remains in abundant supply, came from some distant south pacific atoll. But what really turned the money key initially, and later the interest of shareholders,... more

ArthroCare Lands Key Ruling Versus Smith & Nephew: Raises 2005 Revenue Estimate BY JOHN MCCORMICK, JUNE 14, 2004

If you are looking to buy a Smith & Nephew Dyonics Control RF System, ElectroBlade or Saphyre™ you might as well go to ebay because Smith & Nephew has been barred from selling them by the U.S. District Court of... more

75% of Spine Fusion Patients Show Evidence of Adjacent Level Disease BY ROBIN R. YOUNG CFA, JUNE 14, 2004

Spinal fusion creates a new disease? Probably, yes. Increasingly, studies are pointing to recurrent problems in patients who have had fusion, including degeneration of the levels adjacent to the fusion. As Dr. Charles Ray, one of the spine industry's leading... more

ReGen Biologics Adds New Board Member BY JOHN MCCORMICK, JUNE 14, 2004

On Thursday, ReGen Biologics named William R. Timken, a founding partner of Hambrecht & Quist, to its Board of Directors. This is not necessarily a new relationship since Timken has been an investor and advisor to the Company for over... more

Only One Clinical Trial Counts with the Charite BY ROBIN R. YOUNG CFA, JUNE 14, 2004

The FDA panel's recommendation was unanimous. That's the bottom line. Based on a single clinical trial, each member of that panel voted for eventual commercialization of the Charité disc arthroplasty. And what a clinical trial: 304 patients, randomized, prospective, lead... more

Current Concepts in Joint Replacement (CCJR) BY JOHN CHOPACK, JUNE 7, 2004

Current Concepts in Joint Replacement (CCJR) is the best conference for hip, knee and shoulder reconstruction. The meeting allows for surgeons to present new data, debate topics and demonstrate new techniques via live surgery. Our major take-away is that surgeons... more

It's About Time! Mobile-Bearing Knee Is Headed for a Down Classification BY JOHN CHOPACK, JUNE 7, 2004

On Wednesday of last week, (June 2/2004) an FDA panel recommended to down classify both the tricompartmenal and unicompartmental mobile bearing knee by a vote of 6 to 2 and 5 to 3, respectively. Although this doesn't guarantee that the... more

Symmetry Medical to go Public BY JOHN MCCORMICK, JUNE 7, 2004

For an industry that only has a little over 20 publicly traded companies, orthopedic devices is doing well this year with its third major equity offering. This time Warsaw, Indiana based Symmetry Medical has filed its registration statement with the... more

Biomaterials Driving Orthopedic Returns BY ROBIN R. YOUNG CFA, JUNE 7, 2004

Biomaterials are a disruptive technology platform. Consider the effect of titanium implants on stainless steel. Better yet, consider the effect of ceramics today on titanium. Ceramics represent an incremental $2,000 - $4,000 in revenue per implant over titanium and an... more

FDA Panel Decides Charite Approvable with 5 Conditions BY ROBIN R. YOUNG CFA, JUNE 2, 2004

Despite being implanted in several thousand patients over the course of the past decade, it was a group of 205 Charité patients that the FDA panel scrutinized today before arriving at its recommendation to approve the Charité for commercial sale... more


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