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Orthopedic and Dental Industry News

August 2006

Orthopedic News Roundup 31-Aug-06 BY HUYEN NGUYEN, AUGUST 31, 2006

Appointment: SpineVision® SA has hired Julian Mackenzie as its new Chairman and CEO. Previously, Mr. Mackenzie was with Wright Medical serving as Director General and CFO. Business Update: Donor Referral Services of North Carolina is at the center of a... more

Journal Editor's Departure Shines Light on Conflicts of Interest BY LAUREN UZDIENSKI, AUGUST 30, 2006

The journal Neuropsychopharmacology is looking for a new editor this week, as well as refining its policy on academics who fail to reveal their financial ties. Respected psychiatrist and editor-in-chief Charles B. Nemeroff is stepping down from his post after... more

OrthoLogic Announces Termination of its Phase IIb Dose Response Trial BY JOHN CHOPACK, AUGUST 30, 2006

Orthologic reported yesterday that an interim analysis of its Chrysalin Phase IIb dose response distal radius fracture healing clinical trial did not meet its primary efficacy endpoint of having a benefit over a placebo in time to removal of immobilization.... more

Synthes Acquires AO Foundation's Assets; Collaboration Agreement Still in Discussion BY ARIELLA P. GOLOMB, MD, AUGUST 29, 2006

Back in March, Synthes and the Association for Osteosynthesis (AO) Foundation announced that Synthes would acquire trade names and marks and substantially all of the intellectual property from the AO Foundation for approximately CHF 1.0 billion in cash and stock.... more

Allograft Industry Faces Another Donor Scandal BY ARIELLA P. GOLOMB, MD, AUGUST 28, 2006

Donor Referral Services of North Carolina is at the center of a new scandal surrounding donor tissue and was shut down by the FDA on August 18, 2006. The order forced the facility to cease manufacturing and to retain Human... more

Orthopedic News Roundup 24-Aug-06 BY HUYEN NGUYEN, AUGUST 24, 2006

Appointment: IsoTis OrthoBiologics has hired Gene B. Reu as Vice President of Operations. Prior to joining IsoTis, Mr. Reu served as Vice President & General Manager of Coblation Technologies with Arthrocare, Inc. Business Update: ArthroCare Corp. announced it has received... more

HealthpointCapital Announces the Purchase of DTI Dental Technologies Inc. BY EDITOR, AUGUST 24, 2006

NEW YORK, New York, and Vancouver, Canada, August 24, 2006 /PRNewswire/ -- HealthpointCapital, LLC ("HealthpointCapital") announced today its purchase of DTI Dental Technologies Inc. ("DTI" or "Company"). DTI custom designs and fabricates crowns, bridges, dentures, cosmetic appliances and orthodontic appliances... more

FDA Panel to Vote On Medtronic's Cervical Disc BY ARIELLA P. GOLOMB, MD, AUGUST 23, 2006

The FDA's Orthopaedic and Rehabilitation Devices Panel will be meeting on September 19, 2006. The committee will discuss, make recommendations and vote on a premarket approval application for Medtronic's Prestige ST artificial cervical disc. This metal on metal, ball and... more

HealthpointCapital Announces Purchase of BioHorizons Implant Systems, Inc. BY EDITOR, AUGUST 22, 2006

NEW YORK, New York, and BIRMINGHAM, Alabama, August 22, 2006 /PRNewswire/ -- HealthpointCapital, LLC ("HealthpointCapital") announced today the purchase of BioHorizons Implant Systems, Inc. ("BioHorizons" or "Company"). BioHorizons designs, produces and distributes oral reconstructive devices including dental implants and tissue... more

Botulinum Toxin's Orthopedic Applications BY ARIELLA P. GOLOMB, MD, AUGUST 22, 2006

You've heard about Botox being used to reduce wrinkles, but did you know it can also be used by orthopedic surgeons? "Botulinum toxin and its orthopaedic applications" was reviewed in this month's British volume of the Journal of Bone and... more

Orthopedic News Roundup 17-Aug-06 BY HUYEN NGUYEN, AUGUST 17, 2006

Earnings: Biologics: Tutogen reported 3Q:06 sales of $10 million and a net loss of $1.1 million, or $0.07 per fully diluted share compared to the same quarter last year. The Company would have experienced breakeven results without ~$1.1 million in... more

Orthopedic Industry's Q2 Results BY HUYEN NGUYEN, AUGUST 17, 2006

Twenty-six publicly traded orthopedic companies that we tracked during the March 1, 2006 to June 30, 2006 quarter* posted an aggregate 10% growth (as reported) for both top and bottom line. These companies took in a total $6.5 billion in... more

Synthes 1H:06 Results, Sales Up 15% BY HUYEN NGUYEN, AUGUST 16, 2006

Yesterday Synthes reported consolidated 1H:06 financials with sales of $1.2 billion, representing an increase of 14% (15% constant currency). Consolidated sales for 1H:06 in Europe, Asia Pacific, North America and elsewhere increased by 16.8%, 16.6%, 14.7% and 10.5%, respectively. For... more

Synthes PRODISC Receives FDA Approval BY JOHN MCCORMICK, AUGUST 15, 2006

Yesterday Synthes Spine received a letter from the FDA indicating that its PRODISC lumbar total disc replacement device PMA has been approved. Typically when a PMA is approved, the FDA attaches conditions and restrictions to use of the device and... more

Tutogen Considers Zimmer's Buyout Inadequate, Quarterly Revenues Highest In Tutogen's History BY ARIELLA P. GOLOMB, MD, AUGUST 15, 2006

Late last week, Tutogen Medical Inc. rejected a bid from Zimmer Holdings, Inc. for $5-$6 per share. (Current 52 week range for the stock is between $2.50 - $6.29). Zimmer currently owns 33.2% of Tutogen's common stock, and back in... more

Physician Income Cut BY LAING RIKKERS, AUGUST 11, 2006

This week CMS proposed a 5.1% reduction in payments to physicians for 2007. The proposal will impact the 875,000 doctors who care for the elderly and disabled in the US. The explanation for the cut is that spending on physician... more

Orthopedic News Roundup 10-Aug-06 BY HUYEN NGUYEN, AUGUST 10, 2006

Earnings: Biologics: Orthovita reported 2Q:06 product sales came in at $11.2 million, up 32% compared to 2Q:05. On a non-GAAP basis net loss for the quarter was $5.1 million, or a loss of $0.10 per share. The Company did not... more

US Spine Enters Into GPO Agreement BY ARIELLA P. GOLOMB, MD, AUGUST 9, 2006

Group Purchasing Organizations have historically been responsible for purchases surrounding low preference commodity products such as bed linens and gloves. Over time GPOs have been migrating to higher physician preference items. Today's announcement by US Spine that they have entered... more

510(k) for ReGen Biologics' Collagen Scaffold Rejected BY HUYEN NGUYEN, AUGUST 9, 2006

On Monday, ReGen Biologics announced that it had received a letter from the FDA rejecting to approve the ReGen® collagen scaffold technology to be classified as a Class II medical device. In its exact words, the collagen scaffold technology, "is... more

Osiris Public Offering Raises $38.5M, Stock Trading Flat BY ARIELLA P. GOLOMB, MD, AUGUST 7, 2006

Osiris Therapeutics Inc. raised $38.5 million when it went public last Friday. The Company offered 3,500,000 shares of its common stock at a price of $11.00 per share and up to an additional 525,000 shares have been made available to... more

Orthofix to Buy Blackstone Medical for $333 Million BY JOHN MCCORMICK, AUGUST 7, 2006

This morning Orthofix International, NV (NasdaqGS: OFIX) announced that it has signed an agreement to acquire independent spinal implant developer Blackstone Medical, Inc. for $333 million in cash. Blackstone revenues were $22mm in 2Q:06 and EBIT was approximately $2mm. Trailing... more

Orthopedic News Roundup 3-Aug-06 BY HUYEN NGUYEN, AUGUST 3, 2006

Earnings: Biologics: IsoTis OrthoBiologics reported 2Q:06 revenue of $10.8 million, up 43% compared to $7.5 million in 2Q:05. Its U.S. division grew 22%, while international revenues grew 39%. The Company has three distribution channels: U.S. independent agents, international distributors and... more

Medical Device Space Breathes Sigh of Relief as CMS Issues Inpatient Reimbursement Revisions BY TODD BARTELS, AUGUST 3, 2006

As we have previously discussed in several posts, since April the Center for Medicare and Medicaid Services (CMS) has planned to release new Inpatient Prospective Payment System (IPPS) regulations for FY 2007. Late Tuesday CMS issued this much-anticipated IPPS rule,... more

Exactech's 2Q:06 - A Good Quarter BY HUYEN NGUYEN, AUGUST 2, 2006

On Tuesday, Exactech reported 2Q:06 revenues of $26.6 million, which represents an increase of 11% over 2Q:05. The Company reported $0.18 diluted earnings per share (EPS) and beat analysts' earnings estimates by $0.01. Net income for the quarter was a... more

Medtronic Whistleblower Suit Won't Go Away Easily BY DAVID KRESSEL, AUGUST 2, 2006

As we reported last week, Medtronic settled its whistleblower law suit with the DOJ. One condition of this settlement was that the DOJ would move to have a second similar whistleblower suit dismissed. Now, the lawyer representing the second plaintiff... more

US Set to Catch Up with International Coding Standards BY TODD BARTELS, AUGUST 1, 2006

As we have previously discussed, the US government for some time has been under pressure to adopt international coding standards that have been used by many other countries for over a decade. Finally, last Thursday Congress passed legislation ensuring that... more

Disc Dynamics Receives FDA Go Ahead for Nucleus Study BY JOHN MCCORMICK, AUGUST 1, 2006

Disc Dynamics, a Minnesota-based spine start-up, has just received an IDE from the FDA to commence a study on its DASCOR minimally invasive nucleus replacement technology. The DASCOR is a polyurethane device which has a modulus of elasticity similar to... more

Encore Medical's 2Q:06 Financials BY HUYEN NGUYEN, AUGUST 1, 2006

Encore Medical reported 2Q:06 sales of $95.9 million, representing an increase of 28.9% over 2Q:05. Encore reported $0.06 below analysts' expectations and reported a loss of $0.01 diluted earnings per share (EPS), or a net loss of $473,000 (continuing operations... more


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