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Biotech / Medical : IMAT - ultrafast tomography for coronary artery disease -- Ignore unavailable to you. Want to Upgrade?

To: Steven Durrington who wrote (2512)	6/9/1998 8:56:00 AM
From: GREATMOOD	Read Replies (3) \| Respond to of 3725

IMATRON (Japan) in the news. I don't believe that this affects Imatron (USA) in any way. Please correct me if I'm wrong. Clinical Study of TMR Using PLC Systems' Heart Laser Completed in Japan Data Submission for Ministry of Health and Welfare Approval Expected Shortly FRANKLIN, Mass., June 9 /PRNewswire/ -- PLC Systems Inc. (Amex: PLC) today announced that the required 60 patient enrollment in the Japanese Ministry of Health and Welfare (MHW) clinical study has been completed. The patients received TMR using The Heart LaserTM System either as sole therapy or in combination with coronary bypass surgery. Fourteen leading research hospitals in Japan participated in the clinical study and they will continue to treat patients with The Heart Laser System. PLC Systems distribution partner, IMATRON Japan managed and funded The Heart Laser System study. PLC believes The Heart Laser System is the only product to complete a clinical study for TMR in Japan, which should secure a significant market lead for the Company. "Japan is the largest individual medical products market outside the U.S., and our lead over any competitors should secure share in this very lucrative market," said William C. Dow, president and CEO of PLC Systems Inc. The required MHW six month follow-up has been completed on the first 30 patients to receive TMR using The Heart Laser System. A meeting of all Japanese clinical investigators was held recently to prepare the data submission for the MHW. "We are very pleased with our progress in the regulatory arena both in the U.S. and internationally," continued Mr. Dow. "The Japanese clinical study has been well managed and supported by the top cardiovascular surgeons in the country, and we look forward to a timely approval by the MHW. PLC is also currently working with the FDA to ascertain full clearance of its premarket approval application for The Heart Laser System in the U.S. We believe that globally, The Heart Laser System has both a strong regulatory and marketing lead over any other TMR laser." TMR, or transmyocardial revascularization using The Heart Laser System is a new surgical procedure for patients with chronic, severe coronary artery disease with no treatment alternative. The procedure has been performed on approximately 4,000 patients worldwide. Since TMR using The Heart Laser System is typically less invasive than conventional open heart procedures, recovery is usually quicker and less traumatic than open heart procedures. Generally, no blood transfusion is needed and, since the procedure is performed on a beating heart, there is no need for a heart-lung machine. PLC Systems Inc. is a cardiac revascularization company that is pioneering, developing and supplying the systems and components for TMR. The Company is investigating TMR as a procedure with the potential to provide patients suffering from coronary artery disease a third alternative or adjunct to angioplasty and cardiac bypass surgery. PLC Medical Systems, Inc., a wholly owned subsidiary of PLC Systems Inc., has developed the CO2 Heart Laser System which uses PLC's patented 'heart-synchronized pulsed laser' technology. NOTE: Certain of the above statements may be 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 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, and risk factors described in the company's annual report, SEC form 10K for fiscal year ended December 31, 1997, and the Company's other SEC reports. SOURCE PLC Systems Inc. CO: PLC Systems Inc.; Japanese Ministry of Health and Welfare ST: Massachusetts, Japan IN: MTC SU: 06/09/98 08:02 EDT prnewswire.com