-----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, EvgYyIIpSif3inTiSaA8bz+HqNyckLn05Sldm5FhUsITyoqBCWLdp0w/J6edWQf4 ht1d/u1uaLFsq9Zli6qOKQ== 0001104659-08-033415.txt : 20080515 0001104659-08-033415.hdr.sgml : 20080515 20080515093044 ACCESSION NUMBER: 0001104659-08-033415 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080515 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080515 DATE AS OF CHANGE: 20080515 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: 08834283 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 a08-14463_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):  May 15, 2008

 

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 May 15, 2008, PLC Systems Inc. announced its financial results for the quarter ended March 31, 2008.  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 May 15, 2008

 

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: May 15, 2008

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 May 15, 2008

 

4


EX-99.1 2 a08-14463_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 FIRST QUARTER 2008 RESULTS

 

RenalGuard limited launch in Italy underway, with patients already treated

 

FRANKLIN, Mass., May 15, 2008 — PLC Systems Inc. (AMEX: PLC), a company focused on innovative cardiac and vascular medical device-based technologies, today reported financial results for the three month period ended March 31, 2008.

 

First quarter 2008 total revenues were $1,168,000 compared with $1,493,000 in the first quarter of 2007. The net loss for the first quarter of 2008 was $762,000, or $0.03 per diluted share, compared to a net loss of $686,000, or $0.02 per diluted share, in the first quarter of 2007.

 

Mark R. Tauscher, president and chief executive officer of PLC Systems, Inc., stated, “We have continued to make substantial progress on our RenalGuard™ program so far this year. In March, we received conditional approval from the U.S. Food & Drug Administration to begin our U.S. multi-center pivotal trial to study the effectiveness of RenalGuard in reducing the incidence of Contrast-Induced Nephropathy (CIN). This pivotal clinical trial is expected to continue through 2009. Meanwhile, we secured our first order for RenalGuard consoles and single use sets in Europe, as part of our limited launch in Italy that began in the first quarter.  Patients are already being treated by some of these early adopting hospitals, and we are eager to gauge market reaction to our new product.”

 

Mr. Tauscher added, “Our TMR business produced a modest sequential improvement in kit shipments in the first quarter this year.  Based upon our current penetration of the market as well as a tightening of capital spending by healthcare institutions, we believe that this business’ success going forward will be more dependent upon kits sales and services, where we see opportunity for growth, than in laser systems. While we believe the business is stable, we do expect variation in quarterly rates of kits sales and services, making evidence of clear progress more difficult to assess. We continue to believe TMR therapy adoption is positioned for long-term growth in the hands of our exclusive U.S. distributor, Novadaq Technologies, building upon the synergies between our TMR system and Novadaq’s SPY® Imaging Technology.”

 

During the first quarter of 2008, PLC shipped one new CO2 Heart Laser (HL2) to a U.S. hospital through Novadaq, compared to three new HL2s shipped in the first quarter of 2007 through Edwards Lifesciences Corporation, PLC’s previous U.S. distribution partner. PLC ended the first quarter of 2008 with 170 HL2 CO2 Heart Lasers located at heart centers throughout the U.S.

 

During the first quarter of 2008, 390 disposable TMR kits were shipped, consisting of 375 to hospitals in the U.S. by Novadaq, in addition to 15 kits shipped internationally by PLC. In comparison, a total of 372 and 457 disposable TMR kits were shipped worldwide during the fourth quarter of 2007 and the first quarter of 2007, respectively.

 



 

During the first quarter of 2008, PLC shipped 50 single use sets associated with its RenalGuard System internationally, along with five consoles, for its limited European launch of RenalGuard in Italy.

 

Conference Call

 

PLC Systems will host a conference call today, May 15, 2008, at 11:00 a.m. ET to discuss these matters. The call may be joined by dialing (800) 638-4930, or internationally, (617) 614-3944, at least five minutes prior to the start of the call. The passcode is 63587177. 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. A replay of the call can also be accessed telephonically by dialing 888-286-8010, or internationally 617-801-6888, using passcode 30142513, from 1:00 p.m. ET on May 15, 2008 through midnight on May 22, 2008.

 

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, Mass., PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. CO2 TMR offers a treatment option for angina patients who suffer from severe coronary artery disease. The CO2 Heart Laser is the world’s first TMR angina relief device cleared for commercial distribution by both the U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare, and to obtain a CE Mark for European distribution.

 

The company completed a pilot clinical safety study of its RenalGuard Therapy™ and RenalGuard System™ and has received its CE Mark Certificate for RenalGuard System. PLC recently received FDA conditional approval to commence a U.S. pivotal trial to study the effectiveness of its RenalGuard Therapy and Renal Guard System in the prevention of Contrast-Induced Nephropathy (CIN). RenalGuard Therapy is designed to reduce the toxic effects that contrast media can have on the kidneys. This therapy is based on the theory that creating and maintaining a high urine output is beneficial to patients undergoing imaging procedures where contrast agents are used. The real-time measurement and matched fluid replacement design of the RenalGuard System is intended to ensure that a high urine flow is maintained before, during and after these procedures. This should allow the body to rapidly eliminate contrast, reducing its toxic effects. The RenalGuard System, with its matched fluid replacement capability, is intended to minimize the risk of over- or under-hydration.

 

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 Novadaq may be unsuccessful in selling our products, the transition period following Novadaq’s new role as our exclusive US distributor may adversely affect our revenues, we and Novadaq may be unable to convince health care professionals and third party payers of the medical and economic benefits of performing TMR, there can be no assurance that all payers will reimburse health care providers who perform TMR procedures or that reimbursement, if provided, will be adequate, we may not receive necessary regulatory approvals to market our RenalGuard product, the clinical trials for that product may not be successful, 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 our Annual Report on Form 10-K for the year ended December 31, 2007, and our other SEC reports.

 

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

 

Novadaq and SPY are trademarks of Novadaq Technologies, Inc.

 

Edwards Lifesciences is a trademark of Edwards Lifesciences Corporation.

 

#  #  #

 

PLC SYSTEMS INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

 

 

 

Three Months Ended
March 31,

 

 

 

2008

 

2007

 

Revenues:

 

 

 

 

 

Product sales

 

$

806

 

$

1,134

 

Service fees

 

362

 

359

 

Total revenues

 

1,168

 

1,493

 

 

 

 

 

 

 

Cost of revenues:

 

 

 

 

 

Product sales

 

220

 

586

 

Service fees

 

185

 

208

 

Total cost of revenues

 

405

 

794

 

Gross profit

 

763

 

699

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

Selling, general and administrative

 

970

 

1,013

 

Research and development

 

608

 

491

 

Total operating expenses

 

1,578

 

1,504

 

 

 

 

 

 

 

Loss from operations

 

(815

)

(805

)

 

 

 

 

 

 

Other income, net

 

53

 

119

 

Net loss

 

$

(762

)

$

(686

)

 

 

 

 

 

 

Basic and diluted loss per share

 

$

(0.03

)

$

(0.02

)

 

 

 

 

 

 

Average shares outstanding:

 

 

 

 

 

Basic and diluted

 

30,329

 

30,311

 

 



 

CONDENSED BALANCE SHEET

 

 

 

March 31,
2008

 

December 31,
2007

 

Cash and cash equivalents

 

$

6,840

 

$

8,060

 

Total current assets

 

9,828

 

10,733

 

Total assets

 

10,297

 

11,200

 

Total current liabilities

 

3,862

 

3,811

 

Shareholders’ equity

 

4,241

 

4,950

 

 

# # #

 


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