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Biotech / Medical : PLC Systems -- Ignore unavailable to you. Want to Upgrade?

To: Tokyo VD who wrote (671)	4/24/1998 5:25:00 PM
From: prolific	Read Replies (1) \| Respond to of 1202

4/24 15:38 U.S. FDA PANEL BACKS PLC <PLC.A> HEART LASER FOR ANGINA MORE GAITHERSBURG, Md., April 24 (Reuters) - A Food and Drug Administration (FDA) advisory panel recommended conditional approval on Friday of PLC Medical Systems' heart laser to reduce chest pain. The FDA usually follows its panels' advice, but is not bound to do so. "This is getting approval by a hair's breadth," said panelist Alfred Parisi of Brown University, reflecting a lack of enthusiasm for the technology. Most panelists thought study data presented by PLC was flawed, and others were uncertain about the safety of the process. Panelists said they wanted to limit who received the procedure and how it was used, and said PLC should compile a registry of patients getting the procedure to assess safety. "The key is to figure out for whom this is a life-enhancing, life-prolonging procedure and for whom it is a morbid procedure," said panelist Samuel Casscells of the University of Texas Health Science Center. Panelists said the laser should not be used in conjunction with angioplasty or heart bypass surgery. The revolutionary technique, called transmyocardial revascularization (TMR), reduces pain by punching holes in heart tissue. In PLC's 191-patient trial, two-thirds of the 91 patients who had TMR had a substantial drop in severity of chest pain called angina. Some had almost total relief. A majority of the 100 patients given traditional drug therapy in the hospital had no change. It's a hard-won victory for PLC, whose data was called too skimpy for approval by the same committee in July 1997. PLC's stock dropped 60 percent in the wake of the decision. The company completed further study, answering most of the FDA's and panel members' criticisms. Panelists praised PLC's efforts. "I think the data here is an incredible turnaround from the previous presentation," said panel member Tony Simmons of the Bowman Gray School of Medicine. PLC estimates that as many as 250,000 Americans with end-stage heart disease may be eligible for TMR, creating a $1-2 billion market opportunity.