-----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, B1Pa4xLER9QsxoydoyDLMJrXEux0k+B2MPFFNkaToY3XPfaNuqDTnBTay6b+Scdo GZ4uBQaxqHsoBySWa7YyKw== 0001104659-09-063866.txt : 20091110 0001104659-09-063866.hdr.sgml : 20091110 20091110092926 ACCESSION NUMBER: 0001104659-09-063866 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20091110 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091110 DATE AS OF CHANGE: 20091110 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: 1934 Act SEC FILE NUMBER: 001-11388 FILM NUMBER: 091170501 BUSINESS ADDRESS: STREET 1: 10 FORGE PK CITY: FRANKLIN STATE: MA ZIP: 02038 BUSINESS PHONE: 5085418800 MAIL ADDRESS: STREET 1: 10 FORGE PARK CITY: FRANKLIN STATE: MA ZIP: 02038 8-K 1 a09-33210_18k.htm 8-K

 

 

UNITED STATES
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):  November 10, 2009

 

PLC Systems Inc.

(Exact Name of Registrant as Specified in Charter)

 

Yukon Territory, Canada

 

1-11388

 

04-3153858

(State or Other Jurisdiction of
Incorporation)

 

(Commission File Number)

 

(IRS Employer
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

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02.  Results of Operations and Financial Condition

 

On November 10, 2009, PLC Systems Inc. announced its financial results for the quarter ended September 30, 2009.  The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01.  Financial Statements and Exhibits

 

(d)                                 Exhibits

 

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

 

99.1         Press release issued by the Registrant on November 10, 2009

 

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.

 

 

 

 

Date: November 10, 2009

By:

/s/ James G. Thomasch

 

 

James G. Thomasch, Senior Vice President,

 

 

Finance and Administration and Chief

 

 

Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release issued by the Registrant on November 10, 2009

 

4


EX-99.1 2 a09-33210_1ex99d1.htm EX-99.1

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

Contact:  Mary T. Conway

 

Conway Communications

 

617-244-9682

 

mtconway@att.net

 

PLC SYSTEMS REPORTS THIRD QUARTER 2009 RESULTS;
ANNOUNCES DISTRIBUTION AGREEMENT FOR RENALGUARD® IN BRAZIL

 

FRANKLIN, Mass., November 10, 2009 — PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today reported financial results for the three and nine month periods ended September 30, 2009.

 

Third quarter 2009 total revenues were $1,023,000, down from $1,598,000 in the third quarter of 2008. The net loss for the third quarter of 2009 was $358,000, or $0.01 per diluted share, compared to a net loss of $285,000, or $0.01 per diluted share, in the third quarter of 2008.

 

Mark R. Tauscher, president and chief executive officer of PLC Systems Inc., stated, “This past quarter saw the first public release of very positive preliminary data from the clinical trial of our RenalGuard System™ in Italy. The data was presented at two significant medical conferences: in Spain in late August and a month later in the U.S., providing us with important opportunities to respond to growing interest from practitioners and potential distributors about RenalGuard®.  In the initial data, only 4.6% of patients treated with RenalGuard in the trial acquired Contrast- Induced Nephropathy (CIN) whereas 14.9% of the patients in the control group were determined to have acquired CIN, thus demonstrating an advantage to using RenalGuard with the ever-growing segment of at-risk patients undergoing imaging procedures.”

 

He added, “We have always believed that positive data from the Italian clinical study would drive additional distributor agreements, and our announcement today of a distribution agreement in Brazil, a very large potential market for RenalGuard, confirms our confidence. Based upon the number of discussions in which we are now engaged for potential distribution around the world, we are very pleased with the results of our participation in these conferences As the number of distributors has increased, with RenalGuard now on the market in Italy, Spain, Bangladesh and Pakistan, we also hope to use the heightened interest to generate stronger sales.”

 

Separately, PLC announced today that that it has entered into a five year exclusive agreement with DISCOMED Comercio de Produtos Hospitalares Ltda., of Porto Alegre, Brazil, for distribution of its RenalGuard System™  in Brazil.  DISCOMED is an established distributor of medical technology and devices in Brazil. DISCOMED is applying for an import license through ANVISA, the Brazilian registration authority, and expects approval in approximately 9 months.

 

PLC shipped 275 single use sets associated with its RenalGuard System internationally during the third quarter of 2009, along with nine consoles, associated with its launch of RenalGuard in Italy and Spain. In comparison, the company shipped 50 RenalGuard sets and five consoles in the third quarter of 2008.

 

During the third quarter of 2009, 223 disposable TMR kits were shipped, consisting of 218 kits shipped to hospitals in the U.S. by Novadaq Technologies, PLC’s U.S. TMR marketing and

 



 

distribution partner, and five kits shipped internationally by PLC. In comparison, a total of 409 disposable TMR kits were shipped worldwide during the third quarter of 2008.

 

PLC recorded no new domestic or international laser sales during the third quarter of 2009. In the same quarter of 2008, PLC shipped three new CO2 Heart Lasers (HL2). PLC ended the third quarter of 2009 with 168 HL2 lasers located at heart centers throughout the U.S.

 

Nine Months Results

 

For the first nine months of 2009, total revenues were $3,810,000, compared to $4,076,000 in the same period of 2008. The net loss for the first nine months of 2009 was $1,023,000, or $0.03 per share, compared to a net loss of $1,718,000, or $0.06 per share, in the first nine months of 2008.

 

Conference Call

 

PLC Systems will host a conference call today, November 10, 2009, at 11:00 a.m. ET to discuss these matters. The call may be joined by dialing (800) 561-2718, or internationally, (617) 614-3525 at least ten minutes prior to the start of the call. The passcode is 31036960. A live webcast of the call will be accessible at the investor relations section of the Company’s website at www.plcmed.com.  An archived webcast of the conference call will be available beginning one hour after the completion of the call in the same location.

 

About PLC Systems Inc.

 

PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina.  PLC’s newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device. Additional company information can be found at www.plcmed.com.

 

This press release contains “forward-looking” statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are intended to identify forward-looking statements. Our statements of our objectives are also forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, the current  clinical trials in Italy and the planned future U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, competitive developments may affect the market for our products, regulatory approval requirements may affect the market for our products, and additional risk factors described in the “Forward Looking

 



 

Statements” section of our Annual Report on Form 10-K for the year ended December 31, 2008, and our other SEC reports.

 

PLC Systems, PLC Medical Systems, PLC, CO2 Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.

 

Novadaq is a trademark of Novadaq Technologies, Inc.

 

#  #  #



 

PLC SYSTEMS INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

701

 

$

1,203

 

$

2,824

 

$

3,041

 

Service fees

 

322

 

395

 

986

 

1,035

 

Total revenues

 

1,023

 

1,598

 

3,810

 

4,076

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

311

 

647

 

1,059

 

1,290

 

Service fees

 

189

 

182

 

516

 

517

 

Total cost of revenues

 

500

 

829

 

1,575

 

1,807

 

Gross profit

 

523

 

769

 

2,235

 

2,269

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

702

 

619

 

2,667

 

2,420

 

Research and development

 

180

 

516

 

594

 

1,726

 

Total operating expenses

 

882

 

1,135

 

3,261

 

4,146

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(359

)

(366

)

(1,026

)

(1,877

)

 

 

 

 

 

 

 

 

 

 

Other income, net

 

1

 

11

 

3

 

89

 

Loss before income taxes

 

(358

)

(355

)

(1,023

)

(1,788

)

Benefit from income taxes

 

 

(70

)

 

(70

)

Net loss

 

$

(358

)

$

(285

)

$

(1,023

)

$

(1,718

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per share

 

$

(0.01

)

$

(0.01

)

$

(0.03

)

$

(0.06

)

Average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

30,351

 

30,332

 

30,351

 

30,331

 

 

CONDENSED BALANCE SHEET

 

 

 

September 30,
2009

 

December 31,
2008

 

Cash and cash equivalents

 

$

3,252

 

$

5,026

 

Total current assets

 

5,648

 

7,562

 

Total assets

 

5,924

 

7,913

 

Total current liabilities

 

2,941

 

3,364

 

Shareholders’ equity

 

2,302

 

3,191

 

 

# # #


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