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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 25, 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.
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Item 5. OTHER EVENTS.
BLUE CROSS/BLUE SHIELD PASSES FAVORABLE TECHNOLOGY REVIEW FOR TMR.
PLC Systems Inc. (the "Company") announced today that Blue Cross
and Blue Shield Association Technology Evaluation Center completed
a favorable assessment of transmyocardial revascularization ("TMR").
Although the Blue Cross and Blue Shield finding does not guarantee
reimbursement by third-party payers, it is a significant step that
could eventually lead to reimbursement of TMR procedures by
third-party payers. Please refer to the Company's press release dated
January 25, 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 25, 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 25, 1999 By: /s/ JENNIFER MILLER
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Jennifer Miller
General Counsel
EXHIBIT INDEX
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Exhibit Number Description Page Number
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20.1 Press Release dated January 25, 1999. 4
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Exhibit 20.1
News Release
FOR IMMEDIATE RELEASE
CONTACT: PLC Systems Inc.
(508) 541-8800
Robert Svikhart
Chief Financial Officer
Noonan/Russo Communications, Inc.
(212) 696-4455
Meredith, Milewicz, ext. 228
PLC Systems Announces Blue Cross/Blue Shield Passes Favorable Technology
Review For TMR
FRANKLIN, Mass., Jan. 25 /PRNewswire/ -- PLC Systems Inc. (Amex: PLC)
announced today that the Blue Cross and Blue Shield Association Technology
Evaluation Center (TEC) completed a favorable assessment of transmyocardial
revascularization (TMR). 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. The FDA's approval followed years of
clinical trials including a randomized trial in which patients with severe
angina treated with the PLC CO2 Heart Laser System exhibited significant
reductions in angina (chest pain), increases in myocardial perfusion and
improvement in quality of life measurements among patients with severe
angina.
The TEC concluded that TMR meets all five criteria used to evaluate new
medical technologies: (1) final approval from the U.S. Food and Drug
Administration; (2) scientific evidence of improvement in health outcomes;
(3) net benefit in health outcomes; (4) health outcomes at least as
beneficial with any established alternative; and (5) improvements achievable
outside investigational settings.
The TEC's determination that TMR meets its criteria is a significant step in
obtaining reimbursement for TMR by major payers. The TEC's conclusion was
based upon a review of data showing the safety and effectiveness of TMR by
the TEC program staff, and the TEC's assessment was approved by its panel of
independent medical advisors.
"Blue Cross and Blue Shield Technology Evaluation Center is one of the
largest technology assessment organizations in the country with a strong
reputation amongst the payer community. With this assessment, we anticipate
that this favorable evaluation will influence Blue Cross and Blue Shield
Plans, as well as other payers, to formally review this technology for
healthcare coverage," said William Dow, president and chief executive
officer of PLC Systems Inc. "We also believe this assessment may support a
favorable coverage determination by the Medicare
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program as the Health Care Finance Administration continues to review the TMR
technology."
The TEC program is sponsored by the national Blue Cross and Blue Shield
Association, whose members include local Blue Cross and Blue Shield plans
nationwide, as well as other major managed care organizations. The TEC
program conducts assessments of important new medical technologies to
determine whether the technologies meet their five evaluation criteria. The
TEC assessments are released as reports to TEC program subscribers. Nearly
all major payers in the US, including governmental payers, private third
party payers and managed care organizations, subscribe to the TEC program and
receive TEC assessment reports for use in their own coverage and payment
policy making.
TMR using The Heart Laser System(1) is performed on a beating heart,
generally through a small left chest incision. The Heart Laser System is used
to create between 20 and 40 one-millimeter-wide channels through oxygen-
deprived muscle (myocardium), into the heart's left ventricle, allowing blood
to flow into the heart muscle again, despite blocked arteries. The pulse of
the laser is synchronized with the beating of a patient's heart.
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. The Company is
also investigating TMR as an adjunct to cardiac bypass surgery. PLC, was
founded in 1981 and is located in Franklin, Massachusetts, and has 95
employees worldwide.
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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; or Meredith Milewicz, ext. 228, or Heather Hennessy,
ext. 274, both of Noonan-Russo Communications, Inc., 212-696-4455, or
[email protected]/
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(1) The Heart Laser System is a trademark of PLC Medical Systems Inc.
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