Orthopedic News Roundup 22-Sept-05
BY HUYEN NGUYEN, SEPTEMBER 22, 2005
Biomet usually is the first company in the orthopedic industry to report quarterly revenues, earnings and estimates. Analysts often rely on this as an indicator for how other competitors will report their results in the upcoming earning season. On Wednesday, Biomet reported 1Q:06 revenues increased by 11% ($484 million vs. $438 million) and adjusted net income rose by 10% ($100 million vs. $91 million) for the quarter. Biomet failed to meet analysts' expectation by $0.1 in diluted EPS, but was in line with revenues estimates. In 1Q:06, Biomet reported (excluding the impact of foreign currency) worldwide reconstructive sales grew by 15%, knee 17%, hip 12%, extremity 13%, dental reconstruction 15%, bone cement and accessories 16%, fixation 2% and spine 5%. Considering not meeting analysts estimates, Biomet stock did fairly well and was up by 3% at the close.
Acquisition: Vertebron announces the acquisition of spine related intellectual property product line from Nacor International. The product line from Nacor includes vertebral body replacement and stand alone interbody fusion products. Price of the acquisition was not disclosed.
Appointment: We are pleased to announce the appointment of Dr. William Blake Rodgers to our Scientific Advisory Board. Dr. Rodgers is currently a practicing spine surgeon in Spine Midwest, a clinic based in Jefferson City, MO. He brings to the team extensive knowledge in the area of spine surgery.
Award & Recognition: Smith & Nephew's Orthopaedics Division has received an award for its OXINIUM™ technology by The Materials Information Society ("ASM"). The ASM is a worldwide network of engineers who work with metals and materials.
Clinical: Chrysalin® is a novel synthetic peptide that is currently under FDA investigational device for bone and tissue repair. This week, the Journal of Cellular Physiology online version, published a study showing that Chrysalin® accelerates the growth of new blood vessels. OrthoLogic is a biopharmaceutical company that focuses exclusively in the research and development and potential commercial application of Chrysalin® product platform. At the 2005 meeting of the American Society for Surgery of the Hand (ASSH), Dr. Virak Tan will present a study of the MICRONAIL™ Intramedullary Distal Radius System, manufactures by Wright Medical. Preliminary results find that patients who were involved in this clinical study have faster return of wrist function compared to previously published study that involved in conventional plating. MICRONAIL™ Distal Radius System is intended for patients suffering from distal radius fractures of the wrist. Facet Solution specializes in development and commercialization of surgical devices for treating facet related spinal disorders; the Company announced its first clinical implantation of its Anatomic Facet Replacement System (AFRS™). The AFRS™ is indicated for patients with facet degeneration disease.
Distribution & Licensing Agreement: Competitive Technologies is a servicing and licensing company that identifies, develops, and commercializes innovative technologies in the areas of electronic, nanotechnology, and physical sciences. The Company has exclusively licensed to Soteira to manufacture and sell products using its nanotechnology bone material for applications in the area of the spine. Soteira, based in Dedham, Mass. develops and markets spinal products used in the treatment of degenerative diseases of the spine. Zimmer Holdings has received a worldwide exclusive distribution rights from Revivicor, Inc. for its genetically engineered xenograft technology for tissue regeneration. Formed in 2003, Revivicor was a spin out of PPL Therapeutics Plc. The Company specializes in the area of regenerative medicine with focus on xenotransplantation technology. Blackstone Medical and Osiris Therapeutics have signed a distribution agreement for the Trinity™ bone graft. Trinity™ is an allogeneic bone matrix containing viable stem cells.
Legal: Acumed, an extremity company based in Hillsboro, Ore. was awarded $458,853 in damages by a federal jury against Stryker for patent infringement suit. The dispute was that of a specialized rod used in treatment of bone fractures repair called, Polarus.
Product Introduction & Update: Millenium Biologix announced the European commercial launching of its Primacoll™ at the Eurospine 2005 Congress ("Eurospine") in Barcelona. Primacoll™ is a synthetically manufactured bioactive peptide combined with Skelite™, a synthetic bone graft substitute indicated for the treatment of skeletal tissue repair and replacement. Medtronic announced the introduction of the VERTEX® MAX Reconstruction System to the U.S. market. The VERTEX® MAX system is intended for patients suffering from disease of the spine. ArthroCare announced the launching of a new LabraFix System. This system is a knotless arthroscopic repair technology intended for treating patients with labrum tears.
Regulatory Update: Hyalgan® (sodium hyaluronate) is an injectable form of treatment for patients suffering from osteoarthritis (OA) of the knee. This week, the FDA has accepted the filing of a PMA approval for the expanded indication to include treatment in the area of shoulder pain due to osteoarthritis. Hyalgan® is manufactured by Fidia Farmaceutici, based in Italy, and Sanofi-aventis is the sole distributor in the U.S.
Miscellaneous: There will always be controversy over minimally invasive surgical procedure pertaining to hip replacement. Some doctors believe that manufacturers and surgeons who practice MIS are over-hyping this procedures to the patient community. The New York Times is revisiting the issue of possible kickback and gainsharing in the medical device industry. Read our previous posts on this interesting and controversial issue.
