-----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, DL0NF4KUQp6tn3YYjyf/PyEH+z2QnmopUmOxvERx+BtPGUNgocH8NeTj0ixvCtoj L8ic57x3qNvH3qiMQRcbxA== 0001047469-99-002064.txt : 19990126 0001047469-99-002064.hdr.sgml : 19990126 ACCESSION NUMBER: 0001047469-99-002064 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19990125 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19990125 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: 99512375 BUSINESS ADDRESS: STREET 1: 10 FORGE PK CITY: FRANKLIN STATE: MA ZIP: 02038 BUSINESS PHONE: 5084785991 MAIL ADDRESS: STREET 1: 10 FORGE PARK CITY: FRANKLIN STATE: MA ZIP: 02038 8-K 1 8-K 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 ------------------------------ PLC SYSTEMS INC. - ------------------------------------------------------------------------------- (Exact name of Registrant as specified in charter) British Columbia - ------------------------------------------------------------------------------- (State or other jurisdiction of incorporation) 1-11388 04-3153858 - -------------------------- --------------------------------- (Commission File Number) (IRS Employee Identification No.) 10 Forge Park, Franklin, Massachusetts 02038 - ------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (508) 541-8800 ----------------------------- Not Applicable - ------------------------------------------------------------------------------- (Former name or former address, if changed since last report) THIS DOCUMENT CONSISTS OF 5 PAGES. 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.
Exhibit Number Description -------------- ----------------------------------------------------------- 20.1 Press Release dated January 25, 1999.
2 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. ------------------------------------ (Registrant) Date: January 25, 1999 By: /s/ JENNIFER MILLER ------------------------------------ Jennifer Miller General Counsel EXHIBIT INDEX
Exhibit Number Description Page Number - -------------- --------------------------------------------- ----------- 20.1 Press Release dated January 25, 1999. 4
3 EX-20.1 2 EXHIBIT 20.1 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 4 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. ### 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 news@noonanrusso.com/ - --------------------- (1) The Heart Laser System is a trademark of PLC Medical Systems Inc. 5 -----END PRIVACY-ENHANCED MESSAGE-----