Novoste's Beta-Cath
This article was originally published in The Gray Sheet
Executive Summary
Enrollment in the pivotal clinical trial of the radiation-based system for treatment of restenosis is expected to be complete by the end of the first quarter, President and CEO Thomas Weldon reports at a Jan. 11 session of the Hambrecht & Quist healthcare conference in San Francisco. As of Jan. 8, 881 patients were enrolled in the 1,100-patient study, which includes an eight-month patient follow-up period. "Our expectation is that we will do a filing for a PMA at the latest in Q1 2000," Weldon tells investors. Novoste also plans to finish enrollment by the end of the second quarter for a trial evaluating use of Beta-Cath for in-stent restenosis. As of Jan. 8, 144 of an anticipated 386 patients had been enrolled