Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: tuck who wrote (1198)	3/8/2001 9:56:23 AM
From: Rob C.	Read Replies (1) \| Respond to of 1202

PRESS RELEASE:PLC Systems Gets CE Mark OK For Laser Sys 08 Mar 09:45 PLC Systems Receives CE Mark Approval to Market Next-Generation CO2 Heart Laser 2(TM) System Throughout the European Union FRANKLIN, Mass., March 8 /PRNewswire/ -- PLC Systems Inc. (AMEX: PLC), the leader in carbon dioxide (CO2) transmyocardial revascularization (TMR), today announced that the Company received CE Mark approval for its next-generation CO2 Heart Laser 2. The CE Mark allows PLC to begin marketing the smaller, more mobile TMR laser throughout the European Union and other countries that base regulatory clearance on the European CE Mark. In January of this year, PLC announced that the Company received U.S. Food and Drug Administration (FDA) approval to market the next-generation CO2 Heart Laser 2 system. (Photo: newscom.com ) Building on the strong clinical performance of PLC's first-generation TMR laser, the next-generation CO2 TMR heart laser has greater mobility due to its significantly smaller size. PLC's first- and next-generation TMR heart lasers provide equivalent clinical outcomes. To address the worldwide TMR opportunity, PLC is introducing a stratified pricing structure and will continue to market and sell its first-generation heart laser. "The international TMR market is a great opportunity and we are excited to introduce our next-generation CO2 Heart Laser 2 to cardiac surgeons on a worldwide basis," said PLC Systems' President and CEO Mark R. Tauscher. "We believe the potential for the international TMR market is approximately 35,000 to 70,000 patients per year, which is based on an adoption rate of 10 to 20 percent of the total number of coronary artery bypasses performed each year. As a result of the CO2 Heart Laser 2 introduction, PLC pricing structure addresses the needs of different market segments and economic models. The first-generation heart laser will now be marketed to small volume or capital constrained heart center accounts that could not previously afford a heart laser." The CO2 TMR therapy is a surgical procedure that improves blood flow to the myocardium of the left ventricle of the heart, which relieves chest pain in severely debilitated heart patients. A cardiac surgeon utilizes the laser to create approximately 20 to 40 channels to allow oxygen-rich blood to reach previously deprived areas of the patient's heart. More than 7,000 patients have been treated with a CO2 heart laser. The CO2 heart laser is the only TMR laser that has reported and published long-term angina relief results. On November 15, 2000, Dr. Keith Horvath of Northwestern University Medical Center presented results from the first multi- center, long-term study on the efficacy of TMR using a CO2 heart laser. This data demonstrated that the CO2 TMR procedure provided patients angina relief for five years. Dr. Horvath provided the long-term data at the American Heart Association's Scientific Sessions 2000. PLC is the leader in the development of products for performing a surgical laser procedure known as CO2 TMR. TMR offers a treatment option for patients who suffer from severe coronary artery disease. Coronary artery disease, the leading cause of death in the United States and Europe, is expected to increase as the worldwide population continues to age. Working with leading researchers and premier heart surgery centers around the world, PLC developed the world's first FDA-approved TMR device, a high- powered laser known as the Heart Laser System. Designed to perform TMR in the safest manner possible, the CO2 Heart Laser 2 was approved by the U.S. Food and Drug Administration for the treatment of areas of the heart not amenable to direct revascularization, which is the same indication for use as PLC's first generation heart laser. For more information on PLC and its products, please visit the Company's Web site at www.plcmed.com. Note: Certain of the above statements are forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of factors, including operational changes, competitive developments, regulatory approval requirements, the ability to convince health care professionals and third party payers of the medical and economic benefits of The Heart Laser System, no assurance that all payers will reimburse health care providers who perform TMR procedures or that reimbursement, if provided, will be adequate, and risk factors described in the Company's annual report, SEC form 10-K for fiscal year ended December 31, 1999, and the Company's other SEC reports. SOURCE PLC Systems Inc. /CONTACT: John Jordan, Director of Investor Relations of PLC Systems Inc., 508-541-8800, ext. 145/ /Photo: NewsCom: newscom.com AP Archive: photoarchive.ap.org PRN Photo Desk, 888-776-6555 or 201-369-3467/ /Web site: plcmed.com (PLC) CO: PLC Systems Inc. ST: Massachusetts IN: MTC SU: PDT (END) DOW JONES NEWS 03-08-01 09:45 AM Copyright 2001 Dow Jones & Company, Inc.