Orthopedic News Roundup 15-Mar-07
BY LAUREN UZDIENSKI, MARCH 14, 2007
Earnings
Orthovita reported 4Q:06 revenues of $13.81 million, beating analysts' estimates of $13.76 million and reflecting 38% growth compared to $9.97 million in 4Q:05. Orthovita attributed the growth to increased U.S. sales of VITOSS® FOAM and VITAGEL®.
OrthoLogic announced 2006 financial results this week, reporting a net loss of $31.9 million, or $0.78 per share, compared to a net loss of $27.2 million, or $0.72 per share, in 2005. OrthoLogic attributed the increase in net loss for 2006 to the following: $2.8 million of stock compensation expense; recognition of a $2.1 million Chrysalin product platform patent impairment loss; $8.4 million of in-process research and development costs related to the acquisition of the AZX100 technology platform; and recognition of income tax expense related to the recording of a valuation allowance of $1.1 million for a deferred tax asset related to an Alternative Minimum Tax credit carryover.
M&A
Smith & Nephew agreed to purchase Plus Orthopedics Holding AG, a private Swiss orthopedic company, for a total of $889.0 million in cash, including assumed debt. Plus Orthopedics reported revenues of $300 million and EBIT of $36 million in 2006. In their press release, Smith & Nephew's stated that the acquisition would bring their share of the global orthopedic reconstruction market to around 12%.
HealthpointCapital, LLC announced the acquisition of MicroDental Laboratories, Inc. by its portfolio company, DTI Dental Technologies, Inc. MicroDental Laboratories is the world's leading cosmetic dentistry laboratory and maker of industry-leading MACVENEERS™. In the past 42 years, it has developed strong relationships with the nation's most-prominent cosmetic dentists and is renowned for supplying award-winning, custom-manufactured restorative, reconstructive and cosmetic dental products such as crowns, bridges, veneers, implants, and dentures. Prior to this transaction, MicroDental had been a portfolio company of Riverside Partners since 2001. Terms of the transaction were not disclosed.
Regulatory
Indications for Medtronic's INFUSE have been expanded by the FDA to include oral maxillofacial and dental regenerative bone grafting procedures. INFUSE has previously been approved for use in certain lumbar spine fusion and tibial fracture repair procedures. The Company plans to have the product available for surgeons trained in the indicated procedures by March 26.
Exactech received FDA approval for the Equinoxe® Reverse Shoulder, part of the Company's shoulder arthroplasty line. A reverse shoulder is designed for patients who have an irreparable rotator cuff and osteoarthritis, and the system is compatible with the Equinoxe primary stem. This allows surgeons to change from a primary to a reverse without removing the humeral stem.
Impliant received the CE mark for its TOPS-on-Fusion™ System, indicated for lumbar fusion and total posterior arthroplasty at adjacent levels. The approval follows clinical trials in South Africa, Belgium and Turkey.
Legal
Synthes' Spine Solutions unit filed a complaint against Medtronic on Wednesday over an artificial spinal disc. In their federal court filing, Spine Solutions claims that Medtronic's Maverick artificial disc infringes on a Spine Solutions patent. Spine Solutions is seeking cash compensation and an order to halt sales of the product.
Product Introduction & Update
Wright Medical Group, Inc. launched the ADVANCE STATURE™ Femoral Components, implants customized for stature and height. The latest addition to Wright's ADVANCE® Knee System, the new ADVANCE STATURE™ components are designed for patients with a more narrow knee anatomy or smaller skeletal frame. In their press release, Wright Medical references studies showing that patient size may be a more appropriate factor than gender to consider when choosing a knee implant.
Orthogroup released the Paralign™ Anterior Broach Handle for anterior approach surgical hip replacement. The product is specifically designed for minimally invasive procedures and has a patent-pending locking system that assists in the procedure. The handle is currently designed to fit all major implant systems.
Small Bone Innovations, Inc. launched its next generation RingFIX™ Circular Fixation System to treat disease and trauma of the lower limbs. The device is a modular, circular, external fixation system originally marketed in Europe under the Fixano brand.
Service Agreements
Tornier entered into a partnership with Bioretec Ltd, a Finnish biomaterials company. The partnership establishes Nexa Orthopedics, Inc., a wholly owned subsidiary of Tornier, as the exclusive distributor in the United States for a line of proprietary, bioresorbable surgical devices to be manufactured by Bioretec. The new product line to be marketed by Nexa will include pin and screw fixation systems.
Clinical
Mazor released results on their SpineAssist miniature robotic surgical guidance system that showed that implant placement with the device was 2.5 times more precise than freehand placement. Additionally, there was up to a 98% decrease in x-ray exposure compared to those using conventional minimally invasive techniques. The research on cadavers was conducted at the Cleveland Clinic, Texas Back Institute, Johns Hopkins University and UCLA Medical Center with 15 spine surgeons from throughout the US. It utilized minimally invasive and conventional techniques to place a total of 217 screws for spinal pedicular fixation in lumbar and thoracic fusion procedures. One group of surgeons worked with the guidance of the SpineAssist system, while another group performed the same procedures freehand.
Operations
Medtronic Spinal and Biologics purchased 35 acres near Memphis International Airport, which the Company will use to expand its distribution and related services. Over the next 18 months, Medtronic will renovate and expand the existing 210,000-square-foot facility, more than doubling its size. The added space will house a distribution operation, customer service center and some administrative functions.
Orthogroup Inc. completed relocation to a new facility in Cameron Park, California, a 6,800 square feet space that brings manufacturing, warehousing and corporate groups together in a new biotech industrial park. In conjunction with this relocation, the company has also made major investments in R&D, manufacturing and packaging equipment, including the most recent addition of a new Fadal Vertical Machining Center.
Appointment
ORTHOsoft appointed Yvan Beaudoin Chief Operating Officer. In his new role, Mr. Beaudoin's responsibilities will include continuing to accelerate the sale force deployment in the United States and Europe as well as implementing new strategies with ORTHOsoft's distributors, customers and partners.
