Musculoskeletal News Roundup 1-Apr-10
BY LAUREN UZDIENSKI, APRIL 1, 2010
Earnings
aap Implantate reported 2009 sales of EUR 33.1 million ($47.4 million), up 4% from 2008. Net profit for 2009 was EUR 1.9 million ($2.7 million), improved from a loss of EUR 5.2 million ($7.3 million) in 2008. The company says that during the year, milestones included a "strategic realignment" to the orthopedic, trauma and spine divisions of the business and the establishment of corporate center of excellence to "[optimize] cost and organizational structure."
Funding
Anulex raised $3.8 million in debt and options. Participating in the raise were 11 unnamed investors. The company recently launched a next-generation version of its Xclose anular repair device.
Carticept Medical closed a $20.0 million Series B round, with funds to be used for the launch of the company's Navigator Delivery System, which provides computer-controlled fluid delivery of medication, and to complete patient enrollment in their study of the Cartiva Synthetic Cartilage Implant. Participating in the round were new investor SonoSite, Inc. and existing investors Domain Associates and New Enterprise Associates.
M&A
Alphatec Holdings, Inc. announced the closing of its previously-announced acquisition of Scient'x Groupe SAS, a spinal implant company headquartered in France. The combined company will be the third-largest independent spinal company with a global span of product distribution. Scient'x is the largest privately held independent spine company outside of the United States with distribution in over 50 countries.
Regulatory
OrthAlign received 510(k) clearance for the latest design of its KneeAlign system. KneeAlign is a palm-sized, disposable computer navigation system intended to assist in component alignment during total knee arthroplasty.
Product Introduction and Update
Pioneer Surgical Technology announced that the first surgeries with its Contact Anterior Lumbar Plate have shown "favorable" results following the product's launch in February. The device is designed to complement the Pioneer Contact PEEK Anterior Interbody Spacer.
SpineAlign Medical changed the name of its vertebral implant system from the SpineAlign System to VerteLift. Currently pending clearance from the FDA, the device is made from nitinol and is designed to be implanted with a "transpedicular, minimally-invasive approach."
Intellectual Property
Eden Spine received a patent for its GIZA corpectomy device from the European Patent Office. The company says the GIZA is intended to replace a collapsed, damaged or unstable vertebral body due to tumor or fracture and can be used for cervical, thoracic and lumbar applications.
Reimbursement
Physicians are facing a 21% decrease in CMS payments after Congress failed to pass a patch to block the cuts by the April 1 expiration date of the prior short-term patch. CMS is expected to delay the processing of claims until after Congress returns from Easter recess, effectively giving them time to pass a retroactive patch.
Clinical
ArthroCare announced that patients participating in its two-year, multi-center, 90-patient study of their Plasma Disc Decompression products reported "reduced pain and better quality of life scores" compared to epidural steroid injections. Complete results were published in the April 2010 issue of the Journal of Neurosurgery: Spine.
Paradigm Spine completed patient enrollment in its coflex IDE study, which will compare the coflex interlaminar technology to instrumented posterolateral fusion for the treatment of spinal stenosis. More than 380 patients are enrolled at 21 sites within the United States.
Distribution
DFine, Inc., which is developing treatments for vertebral compression fractures, signed distribution agreements for the Netherlands and Saudi Arabia. The company says their products are now available in seven countries within Europe and the Middle East.
Appointments
MAKO Surgical appointed Richard Leparmentier Senior Vice President of Engineering, where he will oversee MAKO's research and development activities. Previously, Mr. Leparmentier served as U.S. VP of Design and Engineering for ASML, a Dutch manufacturer of lithography equipment, and has also held positions with GE Healthcare and Medicis Pharmaceutical Corp.
