Musculoskeletal News Roundup 19-Jan-12
BY LAUREN UZDIENSKI, JANUARY 19, 2012
M&A
Zimmer acquired Synvasive Technology, whose portfolio includes STABLECUT surgical saw blades and the eLIBRA Dynamic Knee Balancing System for soft tissue balancing. Terms of the transaction were not disclosed.
Funding
Carticept Medical completed a $10.0 million round of financing led by existing investors Domain Associates, New Enterprise Associates and SonoSite, Inc. Funds will be used to support the commercial launch of the company's Navigator Delivery System. The computer-controlled drug delivery system is scheduled for release in 1Q:12.
DiFusion raised $5.2 million from a planned $16.0 million offering. The company is developing CleanFUZE antimicrobial technology for use in orthopedic implants.
Regulatory
DePuy received an FDA warning letter in December alleging that the company has been manufacturing custom hip and knee components in violation of FDA regulations. The company has said that while they believe they were in compliance with the FDA, they plan to stop producing custom devices. Custom devices are intended to be manufactured for one patient, and such devices are generally exempt from market clearance.
Product Introduction & Update
KFx announced that results from a biomechanical evaluation of its APPIANFx Femoral Implant for ACL Reconstruction will be presented at ORS next month. The company describes the study as utilizing a "biomechanical test method that can accurately resolve and directly quantify the individual displacement components of ACL reconstructions under controlled cyclic and ultimate loading," and results include a "comparative outcome versus the current market leader in ACL aperture fixation."
MedShape announced the full U.S. commercial release of the ExoShape Soft Tissue Fastener, which the company describes as a two-part PEEK Altera interference fixation device that "greatly simplifies and improves soft tissue graft fixation during [ACL] reconstructive surgery."
VG Innovations launched VerteLoc v2.5, an update to their facet fusion device that the company says incorporates a series of holes for infusion of the allograft implant interface.
Intellectual Property
SANUWAVE received U.S. patent number 8,092,401, titled "Method and Apparatus for Producing Shock Waves for Medical Applications." The company says the patent has a term extending to February 2027 and relates to a "new method of producing shock waves utilizing a mechanically pressurized fluid." SANUWAVE is focused on the development and commercialization of "noninvasive, biological-response-activating devices" for tissue repair and regeneration.
Legal
Stryker settled with the U.S. Attorney's Office for the District of Massachusetts over felony charges against Stryker Biotech relating to misbranding of OP-1. As part of the settlement, Stryker has agreed to plead guilty to one misdemeanor charge and pay a non-tax deductible fine of $15.0 million. The DOJ will dismiss all thirteen felony charges against Stryker Biotech contained in a 2009 federal grand jury indictment.
Distribution
Artimplant announced that the company has taken over the sales of their products on the Nordic market from former distributor NMS, which filed for bankruptcy.
Nextremity Solutions established Nextremity Solutions Europe GmbH in Julich, Germany, which will serve as the platform for launching Nextremity Solutions products in Germany and other European markets. The company launched their NEXTRA Hammertoe Correction System in Europe last week.
Collaborations
Austen BioInnovation Institute in Akron formed APTO Orthopaedics, the first medical device company created out of the Institute. The company's first device is designed to externally adjust implanted devices in pediatric patients being treated for spinal deformities, rather than subject the patients to multiple surgeries.
Appointments
Alphatec Spine announced that Mark Francois has been named the company's Senior Director of Investor Relations. Mr. Francois will be responsible for providing overall strategic direction and leadership to Alphatec Spine's global investor relations program to effectively communicate the company's value proposition to the investment community. Since 2002, Mr. Francois held the position of Director of Investor Relations for DJO Global, Inc.
Zyga Technology appointed Jim Bullock President and CEO. Mr. Bullock joins the company from Atritech, Inc., which was recently sold to Boston Scientific and where he served as President and CEO. Prior to Atritech, Mr. Bullock was President and CEO of Endocardial Solutions, Inc., which was acquired by St. Jude Medical.
