UBS Global Life Sciences Conference In Brief
This article was originally published in The Gray Sheet
Executive Summary
Orthofix Cervical-Stim: Firm expects FDA approval of bone growth stimulator in the first half of 2004, CFO Thomas Hein states Sept. 24 at the UBS meeting in New York City. The company submitted the results of its pivotal clinical trial as the final module of a PMA for the pulsed electromagnetic field cervical fusion bone growth stimulator Sept. 2, pooling data from 323 patients at 13 centers. The objective of the study was to demonstrate safety and efficacy in high-risk subjects who had undergone cervical fusion for degenerative conditions. In August, Orthofix settled with TriCare and the Department of Justice, paying $1.7 mil., following a billing investigation which found that the company had improperly charged TriCare for off-label use of the company's Physio-Stim Lite and Spinal Stim Lite stimulation products for cervical bone growth stimulation (1"The Gray Sheet" Aug. 25, 2003, p. 9)...