Orthopedic News Roundup 29-Mar-07
BY LAUREN UZDIENSKI, MARCH 29, 2007
Earnings
BioMimetic Therapeutics announced 4Q:06 financial results, reporting a net loss of $5.3 million or $0.34 per share and beating analysts' estimates of a loss of $0.37 per share. This compares to a net loss of $9.2 million, or $5.82 per share, for 4Q:05. Revenues were $1.9 million, compared to revenues of $0.6 million in 4Q:05.
Regulatory
BioMimetics also received clearance from the FDA to begin enrolling its U.S. pivotal trial with GEM OS®1 for foot and ankle fusions. The randomized, controlled trial is expected to include up to 280 patients. The study's objective is to determine the safety and effectiveness of GEM OS1 for bone regeneration in foot and ankle fusion procedures requiring open surgery; previous U.S. and Canadian trial data showed that fusion rates for GEM OS1-treated patients appeared to be at least comparable to patients treated with autograft.
M&A
Integra LifeSciences has agreed to acquire LXU Healthcare, Inc. for $30.0 million in cash. Separate LXU businesses manufacture surgical products, including fiber optic headlight systems, distribute surgical products and distribute critical care products. LXU will be operated as part of Integra's Jarit Surgical Instruments business activities.
Myriad Medical Holdings acquired Earth Medical for 20m rand ($2.7m.) Founded in 1991, Earth Medical distributes a variety of products across orthopedics and other medical device fields. Myriad Medical said that the acquisition will allow them to break into orthopedics, among other fields.
Paragon Medical Inc. has finalized the acquisition of OMC Precision Products Ltd. and Tutela Medica Inc., two Indianapolis-based companies that Paragon Medical announced plans to acquire in January. OMC provides close-tolerance machining and turning, finishing and assembly of spinal and other implants. Tutela offers product development services.
Funding
Axial Biotech, Inc. raised $15.3 million in Series B financing. This funding round, which will be split into two traunches, was led by new investor Johnson & Johnson Development Corporation with participation by existing investors vSpring Capital and Ohio Biotech Group, LLC. The funds will be used to accelerate Axial Biotech's product development efforts and to prepare for the launch of its scoliosis genetic test late next year.
Cytori Therapeutics entered into a strategic equity agreement with Green Hospital Supply, Inc., a Japanese medical equipment supplier, who will purchase 1.0 million shares of Cytori common stock at $6.00 per share. The transaction will close on or about April 12, 2007, subject to satisfaction of customary closing conditions.
Product Introduction and Update
Wright Medical Group launched the CAROLINA™ Jones Fracture System for foot and ankle surgery. The CAROLINA™ System is the first major product designed specifically for treatment of Jones fractures of the fifth metatarsal of the foot. The System was designed to overcome limitations posed by traditional screws, which, according to Wright's Senior Director of Extremities Marketing, include screws that are "not appropriately sized for the fifth metatarsal, may be difficult to insert, and sometimes break." Jones fractures are common in young, athletic patients and geriatric patients.
Smith & Nephew is recalling 539 RF Denervation probes in the U.S. The Company said the probes, used with the company's Electrothermal 20S Spine System in RF heat lesion procedures for the relief of pain, were mislabelled as sterile, which could possibly lead to infections. No injuries have been reported with use of the product to date.
Clinical
Doctors in China call their spinal-disc transplants on five patients a success, with the patients showing improved mobility and no immune problem at five-year follow-up. Cervical discs taken from the spines of three donors who had died suddenly from trauma were implanted in the necks of five patients by a University of Hong Kong-led team, the first operations of their kind. Surgeons said a refined procedure could emerge as an alternative to standard therapies in the cervical spine, but that it would be a challenge to transplant discs in the lumbar region of the spine.
Operations
Stryker opened its first Asian R&D center in Gurgaon, where Indian operations will include development of joint replacement, spine applications, neurological, endoscopic, communications and digital imaging systems. The center will also provide training for Indian surgeons and engineers. Stryker estimates its addressable Indian medical device market to be more than $160 million.
Knight Mechanical Testing has opened a new lab in Fort Wayne. The Company performs fatigue and static testing of implants, instruments and other medical devices according to industry standards, and the new center will create about 15 jobs in five years. Wade Lange, director of business development for the International Center of Orthopaedic Research at the Northeast Innovation Center, said in the statement that the new lab will help maintain the region as a center for the orthopedics industry.
Appointment
Orthovita appointed Paul Touhey to its Board of Directors. He is President, Chief Operating Officer and a member of the Board of Directors of Fujirebio Diagnostics, Inc., which is a subsidiary of Miraca Holdings, Inc., a healthcare holding company based in Tokyo, Japan principally engaged in laboratory testing services and in vitro diagnostic products.
Miscellaneous
Millennium Research Group conducted a detailed analysis of the US minimally invasive spinal fusion market in its US Markets for Minimally Invasive Spinal Fusion Technologies 2007 report. The report finds that the market will grow significantly at a compound annual growth rate of over 28% over the next 5 years. Currently, worth almost $345 million, they predict the market will skyrocket to over $1 billion by 2011.
