Musculoskeletal News Roundup 2-Jul-09
BY LAUREN UZDIENSKI, JULY 2, 2009
Earnings
Biomet reported net sales of $639.0 million for FQ4:09, which represents an increase of 1% as reported and 7% when adjusting for currency. Among segments, recon, excluding dental, increased 3% as reported and 11% constant currency. Dental decreased by 19% as reported and 13% constant currency. Hip sales were up 1% as reported and 9% constant currency, and knee was up 4% as reported and 11% constant currency. Spine increased 16% as reported and 18% on a constant currency basis.
Funding
Nerites Corp. of Madison received $99,990 in federal stimulus funds through a grant from the National Science Foundation to develop a synthetic bio-adhesive to aid in rotator cuff repair. The company says the product is designed to "distribute load along a repair site, thereby reducing the likelihood of sutures 'pulling through' the bone or tendon tissue."
Small Bone Innovations raised $108 million over several Series D Preferred Stock financing rounds. Investors included Goldman, Sachs & Co., Khazanah Nasional Berhad, the investment firm of the Government of Malaysia, Malaysian Technology Development Corporation (MTDC), an integrated Malaysian-based venture capital company, The Family Office of Bahrain and "certain other substantial investors."
SpineGuard raised $4.0 million from Delta Partners, which the company will use to further its goals of establishing the PediGuard device as the "standard of care for safer pedicle screw placement in spine surgery." In conjunction with the financing, the company has named two new directors: Maurice Bourlion, a co-inventor of PediGuard and Joe Mason, M.D., a Partner with Delta Partners.
Regulatory
Applied Spine Technologies has received the FDA's permission to proceed with enrollment in their IDE study of the Stabilimax NZ Dynamic Spine Stabilization System. The study has been suspended since August 2008 following reports of screw fracture, which the company says have been addressed by modifying the device's surface finishing technique.
The European Medicines Agency recommended Tigenix's ChondroCelect treatment for cartilage repair for approval by the European Commission. The Commission's approval, which almost always follows the Agency recommendation, would allow ChondroCelect to be sold on the European market. Following approval, the product should launch late this year or in early 2010.
Product Introduction and Update
K2M launched the CASPIAN Spinal System in the U.S., which the company calls an "all-inclusive system for rigid posterior fixation" for the treatment of cervico-thoracic spinal conditions. The system features two polyaxial screw options, the Mini DENALI and Mini MESA.
Vexim announced plans to launch the SpineJack device in Europe in the next few weeks. The SpineJack is a titanium implant inserted via a minimally-invasive procedure for the treatment of vertebral compression fractures. The company recently completed enrollment of 120 patients in two studies designed to evaluate the product, one of which is a multi-center European study.
Intellectual Property
Fate Therapeutics acquired exclusive intellectual property rights covering small molecule compositions and methods for inducing bone formation from UCLA. No financial terms were disclosed.
Legal
According to a statement from Medtronic, DFine Europe has accepted the terms of a preliminary injunction granted to Medtronic by a German court. The case is said to pertain to "misleading marketing claims" made by DFine regarding kyphoplasty.
A federal court ruled that will Medtronic will pay DePuy Spine $179.0 million to settle a patent dispute over Vertex screws. Penalties had previously been set at $226.3 million.
Clinical
Vertos Medical released data from a study of its mild (Minimally Invasive Lumbar Decompression) system for the treatment of lumbar spinal stenosis. The study compared ODI scores at three months from the mild system to scores at 12 months from an existing study of open surgical treatment for LSS.
Operations
BioSyntech Inc. announced that CEO Michel Lagueux and CFO Louis Lemire resigned following a net loss of approximately $3.0 million on revenues of $23,701 in the quarter ended March 31. The company said that if does not receive additional funding, it does not have enough money to operate for the next 12 months. BioSyntech is developing hydrogels for tissue repair.
Education
Biomet, Inc. and the Orthopaedic Research and Education Foundation (OREF) have partnered to provide a number of fellowships in the areas of trauma, shoulder and elbow, sports medicine, orthopedic oncology and spine. Biomet will contribute $25,000 to each grant.
