Musculoskeletal News Roundup 24-Mar-11
BY LAUREN UZDIENSKI, MARCH 24, 2011
Earnings
China Kanghui Holdings reported 4Q:10 revenues of RMB 72.3 million ($10.9 million) from RMB 54.3 million ($7.9 million), up 33% over the year-ago period. The company noted that in 4Q:10, domestic sales of proprietary products increased 35% over 4Q:09, while international sales of proprietary products increased 39% over 4Q:09. Net income increased 65% to RMB 27.5 million ($4.2 million) from RMB 16.8 million ($2.5 million) in 4Q:09. EPS for the quarter was RMB 1.10 ($0.17) per diluted ADS2.
Corin reported 2010 revenues of GBP 44.8 million ($73.3 million), up 6% over the year-ago period. Among segments, hip was up 1% while knee declined by 13%.
M&A
Bacterin agreed on terms to acquire Robinson MedSurg LLC, a medical device distribution company focused primarily on maxillofacial and craniofacial surgery devices. Bacterin common stock valued at $1.0 million will be exchanged for all the assets of Robinson MedSurg LLC, including approximately $0.5 million of inventory, existing commercial agreements and intellectual property. RMS may also receive additional Bacterin common stock valued at $1.0 million with the achievement of certain milestones.
China Kanghui Holdings acquired a majority stake in Beijing Wei Rui Li Medical Device Co., Ltd., a provider of hip and knee systems in China. The company expects to acquire 60% of Wei Rui Li and has the option to acquire additional equity interest in Wei Rui Li at a pre-determined price, subject to the achievement of certain milestones. The transaction is expected to close by March 31, 2011, subject to the satisfaction of certain conditions.
FlexFix, a seed-stage medical device business accelerator owned by VentureMD, acquired certain intellectual property assets from Novalign Orthopaedic, Inc. The press release did not specify the acquired assets beyond "numerous U.S. and international patent filings," though Novalign has developed intramedullary nail technologies. FlexFix is developing proprietary implantable "flexible-to-rigid" technologies in the orthopedic and spine markets.
Rachiotek LLC, a newly-formed Delaware company, has acquired the assets of Applied Spine Technologies. Rachiotek plans to continue developing the Stabilimax Dynamic Spine Stabilization System, a pedicle-based posterior dynamic stabilization system.
Funding
Atlas Spine raised $3.5 million from a single investor. Atlas Spine has a line of fusion devices and instruments.
Core Essence Orthopaedics raised $11.5 million in a Series B financing led by Baird Venture Partners, who were joined by investors NewSpring Health Capital, Robin Hood Ventures and unnamed individual investors. The company will use the funds to commercialize its soft tissue and skeletal repair devices for sports medicine applications. In association with the round, Baird Partner Pete Shagory will join Core Essence's board.
Regulatory
LDR submitted its two-level Mobi-C cervical artificial disc PMA to the FDA. The company notes that LDR is one of only two companies to have completed a two-level randomized IDE trial with two-year follow up and is the first to submit its results.
TranS1 received 510(k) clearance for the AxiaLIF 1L+ product line, their next-generation instrumentation and implant system for L5-S1 lumbar fusion. The system offers a modular approach and tapered tip design that "allows for more precise distraction capabilities and improvement in pull out strength." The company will begin a limited release immediately and anticipates full commercial release in 2H:11.
Seikagaku received FDA approval for Gel-One, a single-injection viscosupplement composed of a cross-linked, viscoelastic hyaluronate hydrogel for the treatment of knee OA. The company says that the material has a "high viscosity, resulting in residual presence in the knee joint cavity, which enables long-term pain relief in a single injection." Zimmer will distribute the product in the U.S. beginning this year.
Product Introduction and Update
Aesculap Implant Systems launched the SecureSpan Laminoplasty Fixation System for the treatment of spine disorders such as cervical stenosis and myelopathy. The company says the system offers a secure screwdriver interface, color-coded instrumentation and implant set and an assembly device.
Pioneer Surgical launched the Streamline TL Spinal Fixation System, which is cleared as a pedicle screw system from T1-S2. The company says the system features a "friction-fit head that provides greater control during implantation, a robust reduction capability and a consistent locking mechanism."
Spinal Kinetics announced the 10,000th implantation of its M6 Artificial Spinal Disc. The disc incorporates both an artificial nucleus and annulus. The M6 was launched internationally in 2007, and the FDA has approved an IDE study in the U.S.
Reimbursement
Small Bone Innovations announced that 38 of the 39 independent member companies of the BlueCross and BlueShield Association will cover SBi's STAR Total Ankle Replacement system. This applies to 98.5 million insured in 49 states.
Clinical
Medtronic of Canada announced results from the first randomized, controlled trial comparing Kyphon Balloon Kyphoplasty with non-surgical care in treating spinal fractures in cancer patients. The study found that at one month, Kyphon Balloon Kyphoplasty provided cancer patients "better back-specific function, more rapid back pain relief and improved quality of life" compared with non-surgical care. The study enrolled 134 patients with various types of cancer and vertebral compression fractures at 22 sites in the U.S., Europe, Australia and Canada. The study was published in the March 2011 issue of The Lancet Oncology.
TranS1 announced that two clinical papers evaluating the safety and efficacy of their AxiaLIF procedure have been accepted for publication in peer-reviewed journals. One study, to be published in that SAS Journal, is a 9,152-patient retrospective safety demonstrating a 1.3% complication rate. The second study is a four-site, 156-patient efficacy study that showed a 94% fusion rate at two years. This paper has been accepted for publication in SPINE.
Distribution
Corin announced a new five-year distribution relationship with MAKO Surgical. Corin will manufacture hip implants, including the Metafix Hip System and the Trinity Acetabular Shell System, for MAKO's robotic Rio system. The Corin devices will be among other hip systems available for Rio. The new implants are expected to be commercially available in 2H:11.
Operations
As part of a restructuring program announced in January, Zimmer disclosed plans to phase out a plant in Statesville, N.C. that employs about 130 workers. The company said that it expects future hiring will more than offset the personnel reductions.
Collaborations
Zimmer is being granted a maximum of $13.5 million for a sole-source, indefinite-delivery/indefinite-quantity contract for orthopedic implantation products from the Department of Defense. The products will be used by the Army, Navy, Air Force and Marine Corps.
