Orthopedic News Roundup 23-Mar-06
BY HUYEN NGUYEN, MARCH 23, 2006
This week at HealthpointCapital, we compiled a brief synopsis of the 2006 Orthopedic Industry, projecting that total revenue in 2006 will grow by 12% for the year.
Appointment: Two notable extremities companies named their new CEOs this week: Wright Medical Group, Inc. ("WMGI") appointed Gary D. Henley as their new President and CEO. Prior to joining WMGI, Mr. Henley was with Orthofix International N.V. Ascension Orthopedics, Inc. named Robert Martin as CEO; previously, Mr. Martin was president of the Company. WMGI also appointed David D. Stevens as a new audit committee member to its Board of Directors. Mr. Stevens is an independent director of the Company. Innovative Spinal Technologies (IST) has elected Paul G. Thomas, President and CEO of LifeCell Corp., as Chairman of IST's Board of Directors.
Clinical Update: BioMimetic Therapeutics initiated three clinical trials to determine the preliminary safety and effectiveness of its GEM OS1™ Bone Graft for use in foot and ankle fusion procedures. The treatment is intended to treat unstable distal radius fractures.
Development & Distribution Agreement: OsteoBiologics, Inc. (OBI) and Alphatec Spine signed a U.S. distribution agreement for OBI's PolyGraft® material technology. Under the agreement, Alphatec will have the exclusive U.S. distribution and marketing rights to certain spine products from this technology. ORTHOsoft and one of its existing customers signed an amendment to their development and distribution agreement, resulting in ORTHOsoft taking in $2.5 million in revenues for 2006 fiscal year. Orthovita ("VITA") and Aastrom Biosciences ("ASTM") signed an agreement to jointly develop VITA's VITOSS synthetic matrices and ASTM's Tissue Repair Cells (TRCs) for the orthopedics market.
Earnings: Earlier this week, Biomet reported its 3Q:06 with net sales increased 5% ($506 million vs. $482 million) compared to 3Q:05. As adjusted, net income for the quarter increased 4% ($106 milllion vs. $102 million) compared to a year ago. In 3Q:06, reconstructive devices grew 10% worldwide: knee grew 9%, hip 11%, extremity 20%, dental 16%, while bone cement and accessories decreased 8%. Fixation products grew 2% worldwide: internal fix grew 7% while external fix declined by 10%, craniomaxillofacial products increased 5% as well as electrical stimulation products up by 1%. Spinal products increased 3% worldwide: spinal implants and orthobiologics increased 9%, while spinal stimulation declined by 4% worldwide. Biomet's other products included arthroscopy, softgoods and bracing products increased 8% worldwide: arthroscopy increased 12%, softgoods and bracing was up 2% for the quarter.
Legal: Synthes announced that it has received a subpoena from the United States Department of Justice United States Attorney's Office in Philadelphia regarding its Norian XR® and related products.
Mergers & Acquisitions: Zimmer Holdings, Inc. acquired the surgical assisted device line from MedTech S.A. for an undisclosed amount. This product is known as Zimmer® BRIGIT™ Bone Resection Instrument Guide.
Product Introduction & Update: PLUS Orthopedics USA, Inc., a subsidiary of PLUS Orthopedics Holding, AG, announced that it has assisted over 1,000 total knee replacement surgeries with its PiGalileo™ Computer-Assisted Orthopedic Surgery System, which was officially launched in the U.S. in February 2005. Integra LifeSciences launched the B-BOP® Basal Osteotomy Plating System at the American College of Foot and Ankle Surgeons annual meeting in Las Vegas. The B-BOP® system is intended to correct the abnormality of the big toe or hallux-valgus defect.
At the AAOS annual meeting this week, many companies are eager to show off their innovative products line at Chicago's McCormick Place. Amongst them are dj Orthopedics' knee braces, Regeneration Technologies' allograft products line, Smith & Nephew's interference screws and suture anchor devices, CONMED's powered surgical tools, Artimplant's rotator cuff device, Integra LifeSciences' arthrodesis nail, and Zimmer's first women friendly knee implant and its metal technology.
Regulatory Update: Q-Med AB submitted a PMA of its joint therapy product, DUROLANE, to the FDA. DUROLANE is a single-injection viscosupplementation/joint fluid therapy product which is intended for patients suffering from osteoarthritis (OA) of the knee. Inion Oy received 510(k) clearance for its Inion Hexalon 6mm Interference Screw. The Hexalon is intended for cruciate ligament repair applications. Wright Medical received marketing clearance for its ALLOMATRIX® Custom Biocomposite bone graft. This clearance allows surgeons to use the ALLOMATRIX® as an extender in the spine.
Miscellaneous: At the 73rd Annual Meeting of the AAOS in Chicago, new approaches to treating ankle injuries among the elderly and young patients were among many orthopedic related topics discussed. Orthopedic players are positioning themselves to market their implants to women patients. U.S. Spine Inc.'s business venture was a primary topic in the TechJournal Florida. Due to gained popularity on the issue of the artificial disc, LDR Spine is releasing a website educating the public about this technology.
