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Orthopedic and Dental Industry News

June 2007

Orthopedic News Roundup 28-June-07 BY LAUREN UZDIENSKI, JUNE 28, 2007

Regulatory Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components. The FDA approved new labeling for Genzyme's... more

HealthpointCapital Announces Closing of HealthpointCapital Partners II, L.P. BY EDITOR, JUNE 27, 2007

NEW YORK, June 27 /PRNewswire/ - HealthpointCapital is pleased to announce the closing of HealthpointCapital Partners II, L.P., at $420 million. This represents an increase of more than 2.5 times its prior fund, HealthpointCapital Partners, L.P., which closed in 2004... more

Swedish Medical Products Agency asks Nobel to Change its Labeling Again BY JOHN CHOPACK, JUNE 27, 2007

On June 25, 2007 the Swedish Medical Products Agency (MPA) published its review of Nobel Biocare's plan to improve information regarding its NobelDirect and NobelPerfect dental implants. The agency stated that the Company needs to provide more information than what... more

Supreme Court to Hear Medtronic Case; Charite Liability Claims Dismissed in CA BY LAUREN UZDIENSKI, JUNE 26, 2007

The Supreme Court announced yesterday that it will hear a Medtronic case involving a failed balloon catheter. The decision could have broader implications for the FDA's authority and product liability. The lawsuit emerged from a catheter failure during Charles Riegel's... more

HealthpointCapital's Weekly Research Email BY ANDREW BENKARD, JUNE 25, 2007

Each Friday, our Research team sends out a weekly email that summarizes and analyzes the most important news from the orthopedic and dental industry. I'ts free and you can sign up immediately below, in the box to the left.... more

Nobel Throws an Implant Party BY DAVID KRESSEL, JUNE 25, 2007

Nobel Biocare held its biannual World Conference in Las Vegas earlier this month. Typically, implant-focused organizations like the American Academy of Implant Dentistry typically have less than 5,000 attendees at their meetings, but Nobel hosted 10,000 in the largest implant-focused... more

Scient'x USA Announces Appointment of Federico P. Girardi, M.D. to Scientific Advisory Board BY EDITOR, JUNE 25, 2007

MAITLAND, Fla., June 25 /PRNewswire/ -- Scient'x USA, manufacturer of innovative spinal implant technologies, today announced that Federico P. Girardi, M.D. will be joining their Scientific Advisory Board. Dr. Federico Girardi is an Assistant Attending Orthopaedic Spine Surgeon at the... more

Hedge Fund invests $83 Million in DJO BY JOHN MCCORMICK, JUNE 22, 2007

It was announced today that hedge fund MMI Investments L.P. has acquired a 9.4% stake in market leading knee and ankle brace maker DJO Inc. for $82.8 million. It is possible that MMI could increase its stake in DJO to... more

Orthopedic News Roundup 21-June-07 BY LAUREN UZDIENSKI, JUNE 21, 2007

Regulatory TiGenix submitted an application to market ChondroCelect to European regulatory authority the European Medicines Agency for the Evaluation of Medicinal Products. The application is supported by clinical data comparing ChondroCelect to microfracture, where, according to the company, ChondroCelect was... more

Alphatec Holdings, Inc. Expands Its Spinal Disorder Solution Technology With the Launch of the New NOVEL-TL Spinal Spacer System BY EDITOR, JUNE 20, 2007

CARLSBAD, Calif., Jun 20, 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

New Provisions May Threaten Industry Support for MDUFMA II BY LAUREN UZDIENSKI, JUNE 19, 2007

At a House hearing last week, Advamed President and CEO Stephen Ubl voiced concerns over a draft of MDUFMA II, among them the possibility that the legislation will limit federal preemption. Preemption is the constitutional mandate that federal law, including... more

HealthpointCapital Sponsors ArgoSpine BY TIM BERKOWITZ, JUNE 15, 2007

As you may have noticed last week, HealthpointCapital is now featuring selected content from ArgoSpine News on our blog. We're happy to announce that we've become sponsors of ArgoSpine, the premier European-based organization dedicated to research in spine surgery. Our... more

An Interview with Jean-Pierre Elsig, M.D., President of the 11th Argos Symposium BY ANDREW BENKARD, JUNE 15, 2007

The interview below was first published in Argos Spine News in December 2006. As part of our sponsorship of Argos, we'll be bringing a series of Argos content to our audience throughout the year. In this entry, Dr. Jean-Pierre Elsig... more

FDA: Interbody Fusion Devices Now Class II BY LAUREN UZDIENSKI, JUNE 13, 2007

Effective July 12, intervertebral body fusion devices that contain bone grafting material will be reclassified from class III into class II. Interbody devices that contain a therapeutic biologic (e.g., bone morphogenic protein) will remain in class III. A guidance document... more

J&J Seeking a Bigger Hold on Device Industry BY LAUREN UZDIENSKI, JUNE 12, 2007

According to an article in the latest edition of BusinessWeek, J&J's aspirations for the device space could predict a new string of acquisitions ranging from small firms to major players, with the magazine naming Boston Scientific as a potential target.... more

Orthopedic News Roundup 7-June-07 BY LAUREN UZDIENSKI, JUNE 7, 2007

M&A The private equity consortium set to acquire Biomet increased its buyout offer to $46.00 per share in cash, or an equity value of $11.4 billion. The new offer represents a 32.3% premium over the April 2006 common stock closing... more

Offer for Biomet Increased to $46.00 Per Share BY LAUREN UZDIENSKI, JUNE 7, 2007

The private equity consortium acquiring Biomet increased their buyout offer from $44.00 per share to $46.00 per share, an equity value of $11.4 billion. The $46.00 offer represents a 32.3% premium over Biomet's April 3, 2006 closing price, the trading... more

Alphatec Holdings, Inc. Names Veteran Spinal Orthopedic Industry Executive Dirk Kuyper as President and Chief Executive Officer BY EDITOR, JUNE 6, 2007

CARLSBAD, Calif., Jun 6, 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

FDA Preps for Unique Device IDs BY LAUREN UZDIENSKI, JUNE 6, 2007

At MDMA's annual meeting, CDRH's Director of the Office of Science and Engineering, Dr. Larry Kessler, discussed FDA's goals for unique device identification and a multi-phase plan for establishing and implementing a UDI system. The talk followed bipartisan support for... more

Changes to European Device Safety Regulations; Reprocessing, Biologics to be Addressed in Future Legislation BY ARMELLE WIART, JUNE 5, 2007

The European Parliament recently approved 141 amendments to the Medical Device Directive, the legal framework created in 1990 to regulate device safety throughout Europe. The approval follows a public comment period on the first draft of the Directive, which was... more

SNN Completes Plus Orthopedics Acquisition, Looking For More... BY ARIELLA P. GOLOMB, MD, JUNE 4, 2007

After announcing the completion of its Plus Orthopedics acquisition last Friday, Smith & Nephew CEO Christopher O'Donnell made clear the company's aims to grow its global footprint: "We have at the moment 30 to 40 companies which are potential takeover... more


Complete Archive