Musculoskeletal News Roundup 12-June-08
BY ARMELLE WIART, JUNE 12, 2008
M&A
Wright Medical Group, Inc. announced that it has acquired the foot and ankle product line of A.M. Surgical, Inc. The systems purchased address the decompression and soft tissue release procedures most commonly performed by foot and ankle surgeons. The purchase was made for an initial cash payment of $2.1 million and potential additional cash payments, not to exceed $700,000, based upon future financial performance of the acquired assets.
Regulatory
The FDA has announced that its Orthopaedic and Rehabilitation Devices Panel will meet on July 15, 2008 to discuss, make recommendations and vote on a premarket approval application for FzioMed's Oxiplex/SP Gel. Oxiplex is an absorbable gel that is applied to spinal nerve roots and creates a temporary, protective barrier against the damaging effects of excessive fibrosis, inflammation and other irritants that can lead to recurrent postoperative pain. Oxiplex is currently approved in 49 countries including Canada, where it was approved in March 2008.
Vertebral Technologies, Inc., received 510(k) clearance from the FDA this week for its InterFuse interbody fusion device. InterFuse is a modular device implanted through a small, posterior incision. Using VTI’s patented rail-and-slot technology and a minimally invasive unilateral posterior approach (UPLIFTM), the device components are locked together intra-operatively and create a large footprint across the vertebral endplates, a result previously achieved only with an anterior surgical approach (ALIF). A full marketing launch is scheduled for the fourth quarter this year.
AdvaMed, an industry group, fears that changes proposed by China's State Food and Drug Administration (SFDA) to strengthen device regulation relating to reregistration of devices and products that have had minor changes could result in unnecessary burdens on industry and delay or interrupt access to new technologies. According to the proposed regulation, devices that have had minor improvements over their four-year registration period would be subject to type testing even if those changes do not affect the safety or efficacy of the device. Currently, neither the U.S. nor Europe requires prior review for changes that do not affect safety or efficacy.
Product Introduction & Update
British scientists are developing a new type of glass that can dissolve, without leaving any trace of itself or any toxic chemicals, and release calcium and other elements such as silicon into the adjacent body fluids, stimulating bone growth. Further research is planned later this year in developing mechanically stronger versions of the glass that would be load bearing and available for medical use in the context of joint replacement. If the extensive research goes as expected, clinical trials could be in place in the next five years.
Biopure Corporation announced that the results from its Phase III orthopedic trial of the safety and efficacy of Hemopure as an option to avoid packed red blood cells in elective orthopedic surgery patients have been published in the June 2008 issue of the Journal of Trauma. The paper's authors concluded that Hemopure eliminated the need for transfusion in the majority of patients.
Investigations
Wright Medical Technology, Inc., received a letter from the SEC informing them that it is conducting an informal investigation regarding potential violations of the Foreign Corrupt Practices Act in the sale of medical devices in a number of foreign countries by companies in the medical device industry. With this letter, Wright joins the ranks of Biomet, Medtronic, Smith & Nephew, Stryker and Zimmer who all received similar notices from the SEC at the end of last year.
Legal
A U.S. District Court in Oregon found Arthrex guilty of willfully infringing Smith & Nephew's endoscopy patent. The lawsuit was launched three years ago and culminated in the jury's ruling to award Smith & Nephew $14.7 million for Arthrex's past infringement. Smith & Nephew plans on seeking an injunction prohibiting Arthrex from further manufacturing or selling the infringing devices in the United States.
Distribution
Misonix announced that it has entered into a new three year exclusive distribution and service agreement with privately-held SIAD Healthcare of Italy, for the distribution of the SonaStar Ultrasonic Surgical Aspiration System, the BoneScalpel Ultrasonic Bone Cutting System, and the SonicOne Ultrasonic Wound Care System. Misonix's minimally invasive technology enables the removal of abnormal tissue while sparing the surrounding vessels and cellular structures, and also has precise bone shaping and cutting devices. The agreement provides SIAD Healthcare with the right to sell in Italy and includes minimum purchase requirements.
Appointments
Scient'x S.A. announced that additional appointments of key management positions have recently been made to support Clinical Affairs and Surgeon relations. Mr. Nicholas Pachuda, VP Clinical Affairs Medical Education, has a 22-year background in orthopedics and most recently he served as the Senior Vice President of Medical Education and Clinical Studies at Small Bone Innovations. Mrs. Anca Mitulescu has been promoted to Director of Clinical Affairs after working 7 years as a Scientific Communication Manager for Eurosurgical, Scient’X and SpineNetwork. Dr. Mariana Castillo Beltran, Clinical Study Coordinator, brings with her 4 years of experience as a medical doctor and clinical researcher.
