Orthopedic News Roundup 19-Aug.-05
BY HUYEN NGUYEN, AUGUST 19, 2005
Earnings: The world's largest spinal implant technology player, Medtronic, reported 1Q:06 with revenues of $2.7 billion, a 15% increase from 1Q:05. Net income (excluding extraordinary charges) was $616 million compared to $530 million, which is a 16% increase YOY. Spinal implants sales grew 24% for the quarter with record sale of $504 million. Medtronic's artificial disc technology product line continues to gain momentum outside of the U.S. Allograft company, Tutogen Medical, reported strong third quarter as sales grew by 36% ($9.3 million vs. $6.8 million) compared to 3Q:04. Although the Company incurred a net loss of $1.4 million, Tutogen's dental implant business grew 112%, urology 84% and spine 8.6% for the quarter. Tutogen's stock price has been climbing for the past week and is now reaching the $3.60 mark. Formerly known as MacroPore Biosurgery, Cytori Therapeutics reported 2Q:05 with total revenues of $1.5 million, which is basically flat compared to 1Q:04. Product sale, however, which is primarily the HYDROSORB™ spine and orthopedic implant, reported at $1.48 million or 96% of total sales, grew by 67% for the quarter.
Acquisition and Divestiture: NuVasive has made another acquisition this week; the Company is acquiring the technology and assets of RiverBend Design LLC for 51,308 unregistered shares of NuVasive common stock. The acquired asset is relating to the intellectual property of RiverBend dynamic stabilization products. Coblation technology company, ArthroCare Corp., has acquired the business and technology assets of Applied Therapeutics, Inc. for $10 million in cash. Applied Therapeutics has products in the wound care markets relating to ear, nose and throat (ENT). . Read our analysis on both acquisitions. UK-based Smith & Nephew, along with Beiersdorf AG, announced the divestment of BSN medical. BSN medical specializes in orthopedic soft goods and wound care, and was formed as a 50/50 joint venture between the two companies in April 2001. In 2004, BSN's sales were €504 million, with operating profit of €70 million.
Regulatory Clearance:
510(k) - Regeneration Technologies, who owns the patented BioCleanse sterilization process, received 510(k) clearance for its xenograft chips and cubes. Under its trade name, STERLING® Cancellous Chips and Cancellous Cubes, these products are approved for use as bone void filler for the skeletal system due to traumatic injuries. Read our analysis of what this could mean for the Company. Irvine, Cal.-based sports medicine company, Pegasus Biologics, received 510(k) approval to market its OrthADAPT™ Bioimplants. This product is a biologic scaffold that is intended to repair and reinforce tissue in orthopedic and sports medicine applications. View our comment on Pegasus' previous announcement of a $10 million capital raised. IsoTis Biologics announced a 510(k) clearance for its DynaGraft II™ product for use in dental applications. The imaging and visualization technology company, Siemens Medical Solutions, received 510(k) clearance to market its ARCADIS Avantic, a new mobile C-arm system. This system is an advanced imaging technology intended for various and specialized type of surgeries. Orthometrix is a musculoskeletal pharmaceutical and pain management company, received a market approval application for its new Orbasone™ Pain Relief System in the treatment of chronic plantar fasciitis (foot pain). The Orbasone™ uses high-energy shock waves to relieve chronic heel pain.
CE Mark - A biodegradable implant technology company, Inion Ltd., received a CE Mark for its Inion S-1™ Anterior Cervical Fixation System for use in spinal applications. The Inion S-1™ is a biodegradable plate that is used in spinal fusion for cervical vertebrae. Abbott's arthritis drug, HUMIRA®, is now approved for sale in Germany, United Kingdom, Spain, Finland and Denmark. The European Commission has granted Abbott to market HUMIRA® for the treatment of patients suffering from psoriatic arthritis and early rheumatoid arthritis (RA). An Israel-based, rehabilitation, physical therapy and sports medicine company, Adante Medical Devices Ltd., received a CE Mark approval for its SmartStep™ gait technology. The SmartStep™ is a biofeedback device that is worn at the lower limb to assess and monitor, as a follow up, for post-operative patients who have undergone hip, knee or foot surgery, fractures and amputations and as well as sport injury patients.
Distribution and Licensing Agreement: A sports medicine cartilage repair company, SaluMedica LLC, announced that it has licensed its patented hydrogel Salubria® technology to SpineMedica, a newly formed spine company that is developing an artificial disc implant, based upon this technology. SaluMedica will receive cash and equity in exchange for the technology. Smith & Nephew Orthopaedics signed an exclusive agreement with Alexandria Research Technologies, LLC, (ART) to develop the next-generation minimally invasive knee arthroplasty. BioElectronics specializes in the electromagnetic therapeutic applications, has announced a distribution agreement with Zeon Healthcare Ltd. (U.K.) for its ActiPatch™ product in the U.K. The ActiPatch™ is a drug-free electromagnet patch that delivers continuous pulsed therapy for heel pain.
Funding: Last week MAKO Surgical raised $20 million in Series B funding from MDS Capital and various other investors. Headquartered in Hollywood, Fla., MAKO specializes in minimally invasive technology in the area of total joint market. The Company's proprietary technology called, Makoplasty™, targets early-stage knee therapy.
Marketing and Sales: Orthofix's bracing division, BREG, Inc., is co-marketing with Orthofix's European distributors to expand its products into the Latin America and Southeast Asia markets. Cell Factor Technologies, Inc. (CFT), a subsidiary of Biomet, is marketing ThermoGenesis Corp.'s Thrombin Processing Devices™ (TPD™) in Europe, Canada and Asia. The TPD is a centrifuge device that separate platelets in the blood.
Scientific Board: A U.K.-based artificial disc technology company, Ranier Technology, announced the formation of a Scientific Board of Advisors to assist the Company with the ongoing disc technology project. Ranier's artifical disc is called, CAdisc, which is a next generation lumbar disc replacement. The Board consists of five well-known experts in the areas of spinal surgery, biomechanics, and materials science.
Miscellaneous: The sentiment of The Street.com writer somehow always seems negative towards Zimmer. And this time it has to do with Zimmer's lack luster MIS approach to hip replacement surgery. Even the Canadians are suffering from obesity problem. The Canadian Institute for Health Information released a finding that between 2003 and 2004, majority of those who had joint replacement surgeries overweight and obese. In the Journal of Rheumatology, a French doctor found that the rate of developing the severity of rheumatoid arthritis in men and women are genetically similar. Having problem figuring how much your hip replacement operation actually cost? A patient's story on the run-around when dealing with a hospital's billing department. Read our opinion on the Sg2 - Orthopedic Intelligence Conference we attended and what we think of hospital administrators. If you have time to watch an operation, Wright Medical is hosting a live webcast on the diabetic foot ulcer treatment utilizing the Company's GRAFTJACKET® Ulcer Repair Matrix on Thursday, October 13, 2005 at 7:00PM Central Time. Finally, Smith & Nephew's Birmingham Hip Resurfacing implant system gets a chance to be reviewed by the FDA Orthopedic and Rehabilitation Devices Panel on September 8, 2005.
