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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.
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(Exact Name of Registrant as Specified in Charter)
British Columbia, Canada 0-19561 04-3153858
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(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification Number)
10 Forge Park, Franklin, Massachusetts 02038
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(Address of Principal Executive Offices) (Zip Code)
(508) 541-8800
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(Registrant's Telephone Number, Including Area Code)
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TABLE OF CONTENTS
FORM 8-K
August 21, 1998
Item Page
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Item 5. Other Events 1
Item 7. Exhibits 1
Signature 2
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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
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99a Press Release of the Registrant dated August 21, 1997.
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SIGNATURES
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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
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William C. Dow, President
Chief Financial Officer
Date: August 21, 1997
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EXHIBIT INDEX
Exhibit
No. Title
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99a Press Release of the Registrant dated August 21, 1997.
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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
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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,
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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
