Orthopedic News Roundup 15-Dec-05
BY HUYEN NGUYEN, DECEMBER 15, 2005
Since we have one more week until the arrival of the holiday season, many companies are wrapping up their businesses as they patiently await for fiscal year 2005 to end. So far, December has been a good month for orthopedic stocks as companies are bouncing back from many negative publicity brought on by the media surrounding gainsharing, reimbursement and DOJ investigations.
Appointment: Cytori Therapeutics announced the appointment of John Ransom, Ph.D. to the position of Vice President of Research, Regenerative Cell Technology. Prior to joining Cytori, he was with Novasite Pharmaceuticals, Inc. as Vice President, Biology.
Business Update: Cytori Therapeutics and Olympus Corporation have completed a formal 50/50 joint venture to create Olympus-Cytori, Inc. The purpose of the merger is to develop and manufacture future generation devices based on Cytori's Celution™ System. After completing both Centerpulse and Implex acquisitions in the last two years, Zimmer announced that it is reorganizing these acquired businesses to complement its business model. A Swedish-based biomaterial company, Artimplant, announced that it is establishing a new U.S. division called, Artimplant USA, Inc., and it will be operational on January 1, 2006. Ranier Technology, a UK based non-fusion technology company, and Instron Corporation, a provider for testing equipment and devices, have announced a collaboration to install multiple Instron 8874 Axial-Torsional Test Systems with advanced fatigue software test Ranier's CAdisc artificial spinal disc system.
Financing: SpineMark announced the closing of the first $10 million in Series A $15 million offering. The initial funding will be used to finance a network of SpineMark Spine Centers of Excellence in the United States.
Mergers & Acquisitions: dj Orthopedics announced the acquisition of Newmed SAS in cash payment of €13 million (approximately $15.6 million). Newmed could also receive up to €1 million (approximately $1.2 million) based on achievement of certain revenue targets for 2006. Newmed is operating under the trade name Axmed, through its wholly-owned subsidiaries in France and Spain; Axmed is engaging in the business of orthopedic soft goods, bracing and rehabilitation devices. The deal is expected to close in early January 2006. Stryker Spine has bought the MANTIS™ Minimally Invasive Spinal Access Technology business from MedicineLodge for an undisclosed amount. The MANTIS™ is intended treat patients with degenerative spinal disorders.
Product Introduction & Update: Globus Medical announced the launching of its PIVOT™ MIS System. This system is a posterior stabilization system that allows the placement of polyaxial screws and rods using minimally invasive surgical (MIS) techniques. Zimmer Holdings announced that it has followed more than 2,500 Minimally Invasive Solutions™ (MIS™) 2-Incision™ Hip Replacement Procedure cases in active clinical study. The Company believes that since 2001, there have been more than 3,000 MIS procedures performed.
Regulatory Update: Artimplant has received an approval to market its Artelon® TMC Spacer in Australia. The spacer is intended to treat patients suffering from osteoarthritis (OA) of the thumb. Small Bone Innovations will market this product. Zimmer Holdings has received an approval letter from the FDA regarding its Trilogy AB® Ceramic-on-Ceramic Acetabular System. According to the letter, the FDA has allowed for a PMA approval on the Trilogy AB®, but Zimmer will be subjected to an FDA inspection relating to its facility sometimes in the future. Osteotech received 510(k) clearance for both its GraftCage™ ACX and Viagraf™ DBM Paste. The GraftCage™ is intended to restore a patient's collapsed vertebral body. Osteotech is expected to launch this product in the first quarter of 2006. The Viagraft™ is a bone paste that is intended to fill bony defects in fractures or traumatic injury of the bone. FzioMed has submitted its third PMA module to the FDA on the Company's Oxiplex/SP Adhesion Barrier Gel. According to the FDA, FzioMed needs to submit four modules in order to receive PMA for its product. The first three modules contained data relating to designs, development pre-clinical testing, quality assurance and manufacturing; the fourth module will require clinical results from the Oxiplex/SP Gel pivotal clinical trial currently in progress in the U.S.
