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Orthopedic and Dental Industry News Complete Archive »

Orthopedic News Roundup 29-Jun-06 BY HUYEN NGUYEN, JUNE 29, 2006

Appointment: Spine Wave announced that it has elected Ron Pickard to its Board of Directors. In addition to his role on the Board, Mr. Pickard will be actively involved in key projects including the development and commercialization of Spine Wave's NuCore™ Injectable Nucleus. Mr. Pickard was a longtime Chairman and CEO of Sofamor Danek Group.

Development & Distribution Agreement: Smith & Nephew Orthopaedics Trauma & Clinical Therapies (‚ÄúSNN‚Äù) and Q-MED AB entered into a strategic alliance to develop and commercialize Q-MED's proprietary technology for the production of stabilized non-animal hyaluronic acid, NASHA™ for orthopedic uses. PST GmbH, a subsidiary of Duravest, Inc., signed a distributing agreement with Groupe President Electronics for an order of at least six "Pulsed Signal Therapy" (PST™) machines to be distributed in the French market. PST™ is an innovative and patented technology that delivers a unique pulsed electromagnetic signal to stimulate connective tissue injuries.

Earnings: Biomet reported its 4Q:06 earnings totaled $0.46 per share excluding non-recurring items which was in-line with analyst estimates. Revenues increased 7%, as reported, and 10% on a constant currency basis to $540 million which was $5 million higher than analysts were expecting. Excluding currency, during the quarter reconstructive revenue showed strong YoY growth of 11% while the increases in other divisions' sales growth were lower: spinal products 5% (spinal implants/orthobiologics 7% and spinal stimulation 2%), fixation 5% (external fixation showed no growth) and other products (10%).

Financing: K2M, Inc. announced that it has raised a total of $21.5 million in a mezzanine round led by Ferrer Freeman & Company and joined by BETA. Proceeds will be used to support sales and marketing efforts as well as funding other projects for the development of next generation products including its spinal stabilization system. Oxford Performance Materials, Inc. (OPM), a Connecticut-based material science company, has closed an equity financing round from a consortium of investors (including DSM Venturing and Limburg Ventures) for an undisclosed amount. OPM specializes in the area of thermoplastic polymers, OXPEKK®, a type of biomaterial that can be used in medical device technology.

IPO: This week, Medicrea announced its Initial Public Offering (IPO) on the Euronext Exchange. A total of 1,459,396 new shares were issued at the price of €7.94 or a total of €11.58 million. Medicrea International is a manufacturer, marketer and developer of innovative products in the spine.

Legal: This week, the United States Department of Justice (DOJ), Antitrust Division, issued subpoenas to Stryker Corp., Biomet, Zimmer and DePuy (JNJ). The DOJ requested documents related to the manufacture and sale of orthopedic implant devices in possible connection to violations of federal criminal law, including possible violation of antitrust laws.

Medtronic announced that the United States Judicial Panel on MultiDistrict Litigation has issued a Transfer Order centralizing 49 separate federal lawsuits relating to the recovery, processing and distribution of allograft tissue. The cases include putative class actions by recipients of allograft tissues. Defendants include Regeneration Technologies Inc., (RTI); Tutogen Medical Inc.; and Spinal Graft Technologies (SGT), a subsidiary of Medtronic Sofamor Danek, Inc. The cases will be coordinated for pretrial proceedings in the District of New Jersey.

Regulatory Update: Stryker Corporation submitted to the FDA a pre-market approval (PMA) application for its OP-1 Putty in posterolateral lumbar spine fusion surgeries. Currently, OP-1 Putty is approved under a humanitarian device exemption (HDE) for a specific revision spine indication. NuVasive announced it has received an Investigational Device Exemption (IDE) to begin clinical trial enrollment of its NeoDisc cervical disc replacement device. The study will compare the NeoDisc to traditional anterior cervical discectomy and fusion. NuVasive plans to begin enroll patients by 4Q:06 with a two-year follow-up. Raymedica received an approval to begin enrolling patients in a US clinical study for its HydraFlex™ Nucleus Arthroplasty System™. The study will examine the potential benefit of this non-fusion technology. Spine Wave began enrollment in a second arm of its feasibility IDE clinical study for its NuCore™ Injectable Nucleus for degenerative disc disease. Previously, the Company announced that it has begun a first arm IDE clinical study of its NuCore™ Injectable Nucleus for use as an adjunct to microdiscectomy.

Miscellaneous: The Medical Device Manufacturers Association (MDMA) has elected Alex Lukianov, Chairman and CEO of NuVasive, and Jo Ellen Slurzberg, Vice President, Reimbursement and Health Policy for Almyra Inc. to its Board. The MDMA is a national trade association based Washington D.C. that represents and serves the medical device industry.

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