Musculoskeletal News Roundup 9-Jun-11
BY LAUREN UZDIENSKI, JUNE 9, 2011
M&A
Brainlab entered into a definitive agreement to acquire Voyant Health, which manufactures TraumaCad, a portal for orthopedic surgeons to plan and digitally template surgical procedures. The company also offers VoyantLink, which allows for the transfer for diagnostic images through the web.
Stryker announced plans to acquire French extremity manufacturer Memometal Technologies. Stryker will pay $150 million in cash for the company, plus up to $12 million in milestone payments. Memometal recorded about $30 million in sales last year.
Funding
SonicSurg Innovations closed on an initial equity offering totaling nearly $1.0 million. The company manufactures devices for the upper extremity market. Proceeds will support sales and marketing of the company's first product, Trigger Tome, which is indicated for the treatment of stenosing tenosynovitis, or "trigger finger".
Regulatory
ArthroCare received FDA clearance for the Spartan 6.5 Needled Anchor, a preloaded, threaded anchor indicated for fixation of soft tissue to bone in open repairs. The non-needled version, for which FDA clearance has previously been received, is for arthroscopic repairs.
Nextremity Solutions received FDA clearance for the NEXTRA Hammertoe Correction system, which the company calls a "key component to the company's forefoot reconstruction portfolio."
Product Introduction & Update
Mazor Robotics introduced the Renaissance, the company's next-generation spinal robotic surgical guidance system. Renaissance is equipped with a new design and human interface as well as next-generation hardware and software technologies. The company says these features are designed to increase safety as well as extend the range of clinical applications, enabling osteotomies and transfacet and translaminar-facet implant placements.
Clinical
BioMimetic Therapeutics announced that the company completed enrollment of 30 patients in a pilot study for the Augment Rotator Cuff Graft for the repair of large rotator cuff tears. Pre-clinical data on the use of Augment in bone-tendon healing will be published in the American Journal of Sports Medicine.
DFINE announced the results of a study evaluating the use of Radio Frequency Targeted Vertebral Augmentation with the DFINE StabiliT System for the treatment of VCFs in patients with multiple myeloma. Results showed that among 66 patients enrolled, the procedure demonstrated "safety and efficacy while removing the cement handling constraints and concerns associated with operator radiation exposure."
Investigations
The Wall Street journal reported that five Senators have asked HHS to investigate the legality of physician-owned distributorships. The article states that PODs exist in at least 20 states, with more than 40 operating in California alone.
Legal
Smith & Nephew announced that their ongoing patent infringement case against Arthrex for the violation of patents related to suture anchors will be heard this month in Oregon. The press release notes that Smith & Nephew is "seeking substantially more damages than originally awarded at the new trial." The company had previously been awarded $14.7 million.
Collaborations
Arteriocyte entered into a R&D agreement with the United States Army Institute of Surgical Research to investigate new stem-cell-based therapies for orthopaedic trauma and related battlefield injuries. The project is titled "The Use of Concentrated Bone Marrow Aspirate from a Point-of-Care Device in Orthopaedic Trauma" and will focus on the use of Arteriocyte's Magellan MAR01 system for bedside production of cellular therapies and the company's NANEX rapid stem cell expansion technology.
Distribution
HealthTrust Purchasing Group awarded Pioneer Surgical a spine implant agreement, beginning June 1, 2011. The agreement will cover a number of products, including cervical and lumbar plates, pedicle screw systems, interbody devices and Cross-Fuse, the company's a minimally-invasive lateral approach system.