Orthopedic News Roundup 28-Dec-06
BY LAUREN UZDIENSKI, DECEMBER 28, 2006
M&A
Kyphon has signed definitive agreements to acquire all spine-related assets of Israeli company Disc-O-Tech Medical Technologies, Ltd. in a multi-stage transaction. Terms are summarized as follows: Kyphon will pay Disc-O-Tech $60 million upon execution of the definitive agreements; Kyphon will pay another $40 million upon the earlier of either (i) closing of the agreement concerning acquisition of the B- Twin and SKy Bone assets or (ii) February 1, 2007; Kyphon will then pay an additional $120 million in three equal annual installments beginning in January 2008 for the Confidence System assets; Kyphon, will pay a final $20 million in contingent payments based on the development of further technologies; Kyphon will finance the upfront payments with cash on hand and via escrow.
Service Agreement
RTI announced that they have signed an agreement to manufacture allograft implants for Blackstone Medical, Inc. Under the agreement, RTI will manufacture cervical spinal grafts from designs developed by Blackstone, a wholly-owned subsidiary of Orthofix International. New implant designs are currently being developed by Blackstone's engineers, with the first launch scheduled for April 2007. Additional implants are planned for release for the second half of 2007.
Product Introduction and Update
Impliant, Inc. announced the launch of the TOPS™ System in Germany. According to the press release, it is the first total posterior motion preservation system to address the leading pathologies of the posterior spinal column. The System is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from spinal stenosis with or without degenerative facet arthrosis, and spondylolisthesis up to grade I. The TOPS System has the CE mark and is approved for sale in Europe.
Appointment
Dr. Larry Kessler, a senior FDA scientist and manager, will chair the Global Harmonization Task Force (GHTF) for the next eighteen months. Dr. Kessler, director of the Office of Science and Engineering Laboratories in FDA's Center for Devices and Radiological Health (CDRH), assumed the chair of the forum of medical device regulators and trade associations on Dec. 22, 2006. GHTF is a voluntary group of representatives of national medical device regulatory authorities and trade associations of medical device manufacturers.
