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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 (Date of earliest event reported) January 26, 1999
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PLC SYSTEMS INC.
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(Exact name of Registrant as specified in charter)
British Columbia
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(State or other jurisdiction of incorporation)
1-11388 04-3153858
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(Commission File Number) (IRS Employee Identification No.)
10 Forge Park, Franklin, Massachusetts 02038
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (508) 541-8800
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Not Applicable
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(Former name or former address, if changed since last report)
THIS DOCUMENT CONSISTS OF 5 PAGES.<PAGE>
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Item 5. OTHER EVENTS.
HCFA'S MEDICARE COVERAGE DECISION FOR TMR. PLC Systems Inc. (the
"Company") announced today that the Health Care Financing
Administration (HCFA) has released a decision memorandum recommending
that Medicare provide coverage for transmyocardial revascularization
("TMR") performed with FDA approved devices. The Company's CO2
Heart Laser(TM) System is the only device that has obtained FDA
approval for commercial use to perform the TMR procedure. Although
HCFA's recommendation is a significant step that will lead to
Medicare reimbursement of TMR procedures, there may be a delay before
hospitals and other health care providers actually receive
reimbursement for TMR procedures. Moreover, there is no assurance
that Medicare reimbursement, when provided, will be adequate to cover
the cost of TMR procedures. Please refer to the Company's press
release dated January 26, 1999, which is filed as Exhibit 20.1 to
this Current Report on Form 8-K and is incorporated by reference
herein.
Item 7. EXHIBITS.
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Exhibit Number Description
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20.1 Press Release dated January 26, 1999.
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SIGNATURE
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.
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(Registrant)
Date: January 26, 1999 By: /s/ JENNIFER MILLER
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Jennifer Miller
General Counsel
EXHIBIT INDEX
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Exhibit Page
Number Description Number
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20.1 Press Release dated January 26, 1999. 4
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Exhibit 20.1
News Release
FOR IMMEDIATE RELEASE
PLC Systems Inc. Announces HCFA's Medicare Coverage Decision for TMR
FRANKLIN, Mass., Jan. 26 /PRNewswire/ -- PLC Systems Inc. (Amex: PLC) announced
today the release by the Health Care Financing Administration (HCFA) of a
decision memorandum recommending that Medicare provide coverage for
transmyocardial revascularization (TMR) procedures performed with FDA approved
devices. PLC's CO2 Heart Laser(TM) System is the only device that has obtained
Food and Drug Administration (FDA) approval for commercial use to perform the
TMR procedure.
"As a leader in transmyocardial revascularization, PLC has been diligently
working with HCFA to reverse the TMR noncoverage instruction and implement a
Medicare policy to provide coverage for TMR," said William C. Dow, president and
chief executive officer of PLC Systems Inc. "We believe an affirmative TMR
coverage policy by Medicare will give Medicare beneficiaries access to this
important, new revascularization procedure."
The recommendation was made by staff in HCFA's Coverage and Analysis Group
following their review of scientific evidence on the medical effectiveness of
TMR. The coverage staff recommended the rescission of the current Medicare
national noncoverage instruction and the adoption of a new coverage policy to
allow payment for TMR consistent with FDA approved uses of the devices to
perform TMR.
The memorandum recommends coverage of TMR "as a late or last resort for patients
with severe ... angina ... which has been found refractory to standard medical
therapy, including drug therapy at the maximum tolerated or maximum safe
dosages. In addition, the angina symptoms must be caused by areas of the heart
not amenable to surgical therapies such as PTCA, stenting, coronary atherectomy
or coronary bypass."
Recognizing the ongoing research to assess appropriate uses of TMR and to expand
operative approaches to the procedure, HCFA staff propose a general instruction
allowing coverage of TMR for FDA-cleared uses of the devices used to perform
TMR. This will allow Medicare beneficiaries expanded access to the procedure as
FDA may clear new devices or claims. The HCFA staff recommendation is being
forwarded internally for final Agency approval and the issuance of a formal
instruction requiring coverage for TMR.
TMR using The Heart Laser System is performed on a beating heart, generally
through a small left chest incision. The Heart Laser System is synchronized to
the patient's heartbeat and is used to create between 20 and 40 channels through
oxygen-deprived muscle, into the heart's left ventricle. It is believed this
allows blood to flow into the heart muscle again, despite blocked arteries.
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TMR is intended for patients who cannot be adequately treated by other
revascularization procedures, such as coronary artery bypass graft (CABG) or
percutaneous transluminal coronary angioplasty (PTCA). The FDA's approval was
based upon findings from clinical trials of significant reductions in angina,
increases in myocardial perfusion and improvement in quality of life
measurements among patients with severe angina.
TMR using The Heart Laser System is considered less invasive heart surgery. It
usually involves a small left chest incision; generally does not necessitate a
blood transfusion; and, because it is performed on a beating heart, does not
require the use of a heart lung machine. Recovery is potentially quicker, less
traumatic and less costly than in open-heart procedures.
PLC Systems Inc. is a cardiac revascularization company that is pioneering,
developing and supplying the systems and components for TMR. Although not an FDA
approved indication, the Company is also investigating TMR as a potential
adjunct to cardiac bypass surgery. PLC, was founded in 1981 and is located in
Franklin, Massachusetts, and has 95 employees worldwide.
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, no assurance that
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 Registration Statement on Form S-3 (as filed with the Securities and
Exchange Commission on December 15, 1998 and any subsequent amendments thereto),
Annual Report and SEC Form 10-K for fiscal year ended December 31, 1997, and the
Company's other SEC reports.
/CONTACT: Robert Svikhart, Chief Financial Officer of PLC Systems Inc.,
508-541-8800, ext. 153; Meredith Milewicz, ext. 228, or Heather Hennessy, ext.
274, both of Noonan-Russo Communications, Inc., 212-696-4455, or
[email protected], for PLC Systems Inc./
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