Musculoskeletal News Roundup 4-Dec-08
BY LAUREN UZDIENSKI, DECEMBER 4, 2008
Earnings
Stryker announced a 2008 dividend of $0.40 per share, an increase of 21% over the 2007 dividend, which is payable January 30, 2009. President and CEO Stephen MacMillan said the increased dividend reflects the company's continued growth and strong financial position in 2008.
M&A
Ramius LLC criticized Orthofix's "irresponsible" management in a letter to shareholders, calling the Blackstone acquisition "a failure" and urging the company to sell Blackstone. Additionally, the letter called for the replacement of four unnamed members of the Board.
Funding
Xylos completed a preferred stock transaction valued at up to $4.3 million. A Dutch venture capital group consisting of both existing and new investors led the financing. The company received $1.8 million at closing and will receive the balance in two installments, subject to the achievement of certain milestones. The funds will be used to advance the commercialization of the company's technology, which includes initiating a clinical study for rotator cuff repair based on the company's biosynthesized cellulose technology and completing several ongoing preclinical studies.
Regulatory
A NASDAQ panel determined that ArthroCare can continue to be listed on the exchange, under the conditions that the company provide the panel with the results of an internal audit committee review by Dec. 22, 2008. Additionally, the company will have to make its restatements and file its 2Q:08 and 3Q:08 reports by Feb. 9, 2009.
MAKO Surgical Corp. received 510(k) clearance for both the Version 2.0 Tactile Guidance System, branded as the MAKO RIO, and its bicompartmental knee resurfacing implant system, branded as RESTORIS MCK. The company plans to launch the products in 1H:09.
Ortoviva received CE mark certification for their Distractor system, which "improves and simplifies the insertion of disc prostheses in the spinal column."
Product Introduction & Update
VG Innovations, Inc. announced that over 100 patients have been implanted with the VerteLoc Minimally Invasive Spine Stabilization System for facet fusion.
VERTICOR (formerly Interbody Innovations) provided an update on its VClipseTP Cervical Plating System. The company says the patent-pending device is in the final stages of testing and is an "easy-to-use new option for cervical fusion procedures." The device will be introduced in early 2009.
Legal
Medtronic has been sued by the family of a patient who claim the off-label use of Infuse caused the patient to suffocate due to severe throat and neck swelling. Among other claims, the complaint says that Medtronic marketed Infuse off-label.
License Agreement
Per an SEC filing, RTI Biologics has entered into an agreement with LifeNet Health whereby the company will license certain tissue processing IP. The deal is valued at $4.9 million to be paid in five annual installments.
Partnerships
Acrobot, which currently markets the Navigator system for guided knee and hip replacements, and Alliance Medical will collaborate on imaging systems ranging from CT scanning to navigated joint replacement systems. Alliance Medical operates CT equipment that can utilize Acrobot's software to create 3-D models of joints.
Clinical
Anika Therapeutics completed enrollment in its U.S. Monovisc clinical trial. The study is multi-center, randomized and double-blind and has enrolled approximately 350 patients. Anika plans to launch Monovisc in the U.S. in 2010. Monovisc is a single-injection viscosupplementation product.
BioSurface Engineering Technologies, Inc. initiated two pilot clinical trials, one U.S. and one in Canada, to evaluate the use of the AMPLEX osteo-promotive bone graft system in lumbar interbody fusions. The company describes AMPLEX as consisting of BioSET's B2A, a BMP-2 growth factor analog, combined with ultra high-grade ceramic bone scaffold.
Biospace med announced that their EOS 3D x-ray orthopedic imaging technology enables better image quality when compared to computed radiography, according to results from a clinical study. The EOS system uses about 10 times less radiation.
Operations
Interbody Innovations changed its name to VERTICOR, LTD. to reflect a broader product offering.
Sales and Marketing
Consumer advocacy group the Prescription Project challenged the legality of YouTube ads sponsored by Abbott Laboratories, Medtronic Inc. and Stryker Corp. The group says the ads showcase the benefits of the advertised devices without adequate warnings of their risks and called for more stringent regulatory oversight of web videos.
Appointment
Anulex appointed Richard Lunsford President and Chief Executive Officer He will also join the Board of Directors. Prior to Anulex, Lunsford was Senior Vice President and President of United States Commercial Operations at ev3, Inc. Previous Anulex CEO Michael McCormick "resigned to pursue other interests."
