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

To: Mr. Giller who wrote (554)	3/4/1998 11:21:00 AM
From: Rob C.	Respond to of 1202

Here is the release... SUNNYVALE, Calif., March 4, /PRNewswire/ -- Eclipse Surgical Technologies, Inc. (Nasdaq: ESTI) announced today that its clinical trial studying Transmyocardial Revascularization (TMR) performed in conjunction with bypass surgery will be halted immediately due to positive findings by an independent Data and Safety Monitoring Committee (DSMC). The DSMC met to review the latest interim report on Eclipse's study comparing the effects of TMR combined with bypass surgery to bypass surgery alone. The DSMC was blinded as to which group of patients had TMR with bypass and which group had bypass alone. In the 221 patients currently enrolled in the randomized study, early mortality showed a seven times higher mortality rate in patients treated with only bypass surgery (Group A) compared to patients treated with TMR in addition to bypass surgery (Group B). "The DMSC instructed us to stop the trial for safety reasons, noting in their letter that 'the Committee felt that it is unlikely that this early mortality would ever equalize between the two groups ... if anything, there appears to be a slight trend that the patients in Group B do better than Group A even at later measurement points,'" said Dr. Douglas Murphy-Chutorian, Chairman and CEO of Eclipse. "We've notified the FDA of this event and have sent the data package to them as well. We have asked for their immediate guidance." The combination of TMR plus bypass surgery was postulated to produce a more complete revascularization than bypass surgery alone. Conventional bypass surgery is limited to the treatment of diseased arteries 2 millimeters in diameter or greater. Patients with smaller arteries include women, diabetics, people of small stature, and people who have had previous bypass surgeries. When an artery was too small to bypass, there was no other surgical option for these patients until now. TMR treats the heart muscle directly, "bypassing" the diseased arteries altogether. Using an Eclipse fiberoptic laser, the surgeon creates multiple small channels in the heart wall, allowing fresh blood to permeate the heart wall from the inside. Eclipse believes this procedure encourages cellular growth factors to be released at the treatment sites, stimulating the development of new blood vessels. This mechanism is called angiogenesis. The implications of this study on the potential market for TMR products is profound. It is estimated that approximately 800,000 bypass surgery procedures are performed annually worldwide. Although not all bypass surgeries would require TMR, the preliminary findings suggest that patients with areas of small vessel disease may be candidates for the combination therapy. All patients in this study had some territory of their heart where bypass surgery alone was not able to provide complete revascularization. Eclipse management will conduct a conference call for the investment community this afternoon at 4:15 p.m. eastern time to discuss this development. Those interested in participating should contact the Company directly for details. Eclipse is a medical device company specializing in cardiac revascularization products for the treatment of advanced cardiovascular disease and severe angina pain. TMR and Percutaneous Transluminal Myocardial Revascularization ("PTMR") are investigational laser heart treatments in which one millimeter channels are made in the heart muscle. It is believed these procedures encourage new vessel formation, or angiogenesis, and result in a reduction of angina pain. TMR is performed by a cardiac surgeon through a small incision in the chest. PTMR is performed by a cardiologist in a catheter-based procedure performed under local anesthesia. Eclipse has ongoing clinical trials in both of these areas. The Company submitted an application to the Food and Drug Administration (FDA) in July, 1997 requesting approval (PMA) for marketing of the Eclipse TMR laser system in the United States. Eclipse must obtain marketing clearance (PMA) from the FDA before its products for TMR and PTMR can be offered on a commercial basis in the United States. Any forward looking statements in this news release are based on current expectations and beliefs and are subject to numerous risks and uncertainties that could cause the actual results to differ materially. Factors that could cause actual results to differ materially include uncertainties associated with clinical trials, no assurance of market acceptance, no assurance of FDA approval, no assurance of third-party reimbursement of procedure costs, dependence on a single product line, potential third-party patent infringement claims and uncertainty regarding production of proprietary technologies, as well as additional risk factors, as discussed in the "Risk Factors" section of Eclipse's Annual Report on Form 10-K dated December 31, 1996, and Eclipse's quarterly reports filed with the U.S. Securities Exchange Commission (SEC).