-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VB/g3/TbVpRjCf/V2LejA9Krc2FeY7zaBgJtKmgkovQ6pdg0e0OTOqxoNEtLOH0m m59OT2N0e3vhnu/mv6RukA== 0000950135-98-004896.txt : 19980824 0000950135-98-004896.hdr.sgml : 19980824 ACCESSION NUMBER: 0000950135-98-004896 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19980821 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19980821 SROS: AMEX FILER: COMPANY DATA: COMPANY CONFORMED NAME: PLC SYSTEMS INC CENTRAL INDEX KEY: 0000879682 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 043153858 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 001-11388 FILM NUMBER: 98696095 BUSINESS ADDRESS: STREET 1: 10 FORGE PK CITY: FRANKLIN STATE: MA ZIP: 02038 BUSINESS PHONE: 5084785991 8-K 1 FORM 8-K 1 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report: August 21, 1998 PLC SYSTEMS INC. ---------------- (Exact Name of Registrant as Specified in Charter) British Columbia, Canada 0-19561 04-3153858 ------------------------ ------- ---------- (State or Other Jurisdiction (Commission (I.R.S. Employer of Incorporation) File Number) Identification Number) 10 Forge Park, Franklin, Massachusetts 02038 -------------------------------------------- (Address of Principal Executive Offices) (Zip Code) (508) 541-8800 -------------- (Registrant's Telephone Number, Including Area Code) 2 TABLE OF CONTENTS FORM 8-K August 21, 1998 Item Page ---- ---- Item 5. Other Events 1 Item 7. Exhibits 1 Signature 2 i ITEM 5. OTHER EVENTS. The press release of the Registrant dated August 21, 1998, a copy of which is annexed hereto as Exhibit Number 99a, is incorporated by reference herein. The press release describes the notification from the Food and Drug Administration ("FDA") to the Registrant that the Registrant's application for commercial use of its proprietary Heart Laser(TM) has been approved. ITEM 7. EXHIBITS The following exhibits are filed herewith: Exhibit No. Title --- ----- 99a Press Release of the Registrant dated August 21, 1997. 1 3 SIGNATURES ---------- Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. PLC SYSTEMS INC. By: /s/ William C. Dow -------------------------- William C. Dow, President Chief Financial Officer Date: August 21, 1997 2 4 EXHIBIT INDEX Exhibit No. Title --- ----- 99a Press Release of the Registrant dated August 21, 1997. 3 EX-99.A 2 PRESS RELEASE 1 3 FDA Approves PLC Systems' Heart Laser For TMR - U.S.'s First Laser for New Heart Surgery - FRANKLIN, Mass., Aug. 20 -- PLC Systems Inc. (Amex: PLC) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for commercial use of The Heart Laser(TM) System for TMR (Transmyocardial Revascularization). On April 24, 1998 an independent advisory panel unanimously recommended that the FDA grant approval of TMR using The Heart Laser System. PLC is the first company to receive FDA approval for commercial use of a product for TMR, a new surgical procedure used to treat patients suffering from severe coronary artery disease with no treatment alternative. The Heart Laser System can now be marketed throughout the U.S. and used to treat the estimated 80,000 domestic patients each year who suffer from severe coronary artery disease (CAD) but can not be treated with conventional coronary revascularization techniques such as bypass surgery or angioplasty. "This FDA approval confirms PLC's position as the pioneer and leader in TMR," said William C. Dow, President and CEO of PLC. "We are the most experienced laser revascularization company in the world, based on our treatment of more than 4,000 patients and over 100 installed Heart Laser Systems worldwide. We intend to maintain our market leading position, expand our database of clinical information and seek FDA approval for expanded use of The Heart Laser System, including as an adjunctive therapy to bypass surgery." Analysts have estimated that the worldwide market potential for TMR could be as much as $1 billion annually. TMR using The Heart Laser System is a revolutionary new way of restoring blood flow to the heart. This high-energy carbon dioxide (CO2) laser is used by a cardiovascular surgeon to create between 20 and 40 new channels into the heart muscle. Clinical studies have demonstrated that the creation of these channels 2 allows blood to flow into the heart muscle, despite the blockage of arteries. The computer-controlled laser is synchronized with the patient's heartbeat and fires when the heart is relatively still and unresponsive to stimuli. "The Heart Laser System was developed specifically for TMR, and it can create a channel in the heart muscle with a single laser pulse," added Dow. "We believe that this feature and our synchronization technology provides meaningful clinical advantages to patients. Research conducted at The Texas Heart(TM) Institute indicates that synchronization may reduce the risk of harmful heart arrhythmia that has occurred when laser revascularization has been performed without synchronization." TMR using The Heart Laser System is considered less invasive heart surgery. The procedure generally does not necessitate a blood transfusion and, because it is performed on a beating heart, it does not require a heart- lung machine. Therefore, recovery is potentially quicker, less traumatic and less costly than in open-heart procedures. U.S. clinical studies have demonstrated the TMR procedure to be safe and effective in decreasing angina by two or more classes (angina is measured in classes from one to four, one being the least painful and four being the most) in nearly 75% of patients, and, in fact, eliminating all angina in one-third of patients. PLC estimates that each year approximately 120,000 patients worldwide are diagnosed with severe CAD which is not treatable by conventional revascularization techniques. CAD is a form of heart disease caused by the blockage of blood flow into the coronary arteries which supply oxygen-rich blood to the heart muscle. Typically, severe CAD patients experience excruciating spasmodic attacks of chest pain, or angina, and often shortness of breath and fatigue. No longer candidates for traditional surgery, these patients have been placed on maximum drug therapy. PLC Systems Inc. is a cardiovascular company pioneering, 3 developing and supplying the systems and components for TMR and related cardiac procedures. PLC Medical Systems, Inc., a wholly-owned subsidiary of PLC Systems Inc. developed the CO2 Heart Laser System for TMR, which uses PLC's patented 'heart-synchronized pulsed laser' technology. The company is investigating TMR as a technology with the potential to provide patients suffering from coronary artery disease an alternative or adjunct to angioplasty and coronary bypass graft surgery. PLC Systems Inc. has approximately 50 patents and/or patents pending worldwide for the company's innovative revascularization product and procedural accessories. 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 healthcare professionals and third-party payers of the medical and economic benefits of The Heart Laser System, and the risk factors described in the company's annual report, SEC form 10K for the fiscal year ended December 31, 1997, and the company's other SEC reports. CONTACT: Investor: Michele Fasano of PLC Systems Inc., 508-541-8800 or Media: Robert Borchert of Ludgate Communications, 212-688-5144 -----END PRIVACY-ENHANCED MESSAGE-----