FRANKLIN, Mass., Nov. 2 /PRNewswire-FirstCall/ -- PLC Systems Inc.
(AMEX:PLC), a company focused on innovative cardiac and vascular
medical device-based technologies, today reported financial results
for the three and nine months ended September 30, 2006. Third
quarter total revenues this year were $1,567,000 compared with
$1,900,000 in the third quarter of 2005. The net loss for the third
quarter of 2006 was $80,000, or $0.00 per diluted share, compared
to a net loss of $397,000, or $.0.01 per diluted share, in the
third quarter of 2005. Total revenues for the first nine months of
2006 were $5,399,000 compared to total revenues of $5,825,000 for
same period in 2005. Net income for the first nine months of 2006
was $1,283,000, or $0.04 per diluted share, compared to a net loss
of $871,000, or $0.03 per diluted share, for the same period in
2005. 2006's net income reflects a gain of $1,432,000 in the first
quarter of 2006 from the sale of the company's Optiwave disposable
manufacturing assets to Edwards Lifesciences Corporation. "Our TMR
operations continue to provide a sustainable revenue base that
enables us to move ahead on our new product initiative that we
announced in mid-September, RenalGuard(TM)," said Mark R. Tauscher,
president and chief executive officer of PLC Systems. "We believe
RenalGuard has a major market opportunity in preventing
Contrast-Induced Nephropathy (CIN), which affects a portion of the
millions of patients undergoing imaging procedures. Our proprietary
technology received conditional Investigational Device Exemption
(IDE) approval last month, and is moving into clinical trials this
quarter. We hope to secure CE Mark approval in the first half of
2007, followed by international distribution starting in the second
half of 2007 and FDA approval and U.S. distribution in late 2008 or
2009. To this opportunity we bring a distinguished board of
advisors, a focused but aggressive marketing plan and a deep
understanding of the needs and adoption rates in the cath lab,
where the problem of CIN is most severe. With a growing patient
population in the U.S. and worldwide as more disease states require
both diagnostic and therapeutic imaging, we see a potential market
opportunity of some $500 million, and we are very excited about our
plan to pursue this market effectively." Tauscher added, "While the
revenue volume for the third quarter was lower, reflecting a
smaller number of new HL2 laser systems shipped, we believe that
new laser shipments in the fourth quarter this year will be at a
more customary level of 3-4 new HL2s. As we announced in the past
few months, surgeons are investigating new innovative research that
combines stem cells and CO2 TMR to determine if CO2 TMR provides an
increased improvement in cardiac function in heart failure patients
when compared to stem cells alone or stem cells with bypass
surgery. This cutting edge research was presented to U.S. cardiac
surgeons in Florida during the third quarter, and we continue to
hope that CO2 TMR will demonstrate that it should be the preferred
therapy to complement the use of stem cells, or biologics, within
the heart." During the third quarter of 2006, PLC shipped four CO2
Heart Lasers (HL2) to U.S. hospitals through Edwards Lifesciences,
PLC's exclusive U.S. sales and marketing partner. Two of these
shipments were new HL2 lasers and two were redeployed units. PLC
ended the third quarter of 2006 with 152 HL2 CO2 Heart Lasers
located at heart centers throughout the U.S. Also during the third
quarter of 2006, a total of 515 disposable kits were shipped
worldwide by Edwards and the Company. Edwards delivered 502 of
these kits to U.S. hospitals and PLC shipped 13 disposable kits to
international customers. In comparison, a total of 528 disposable
kits were delivered worldwide during the third quarter of 2005. PLC
Systems will be hosting a conference call today, November 2, at
11:00 a.m. Eastern Time to discuss these results and its new
product initiative. The call may be joined by dialing (866)
356-3093, or internationally, (617) 597-5381, at least five minutes
prior to the start of the call. The passcode is: 87855725. A live
webcast of the call will be accessible at the investor relations
section of the Company's website at http://www.plcmed.com.(ok/) 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
73772775, from 1 pm on November 2, 2006 through midnight November
9, 2006. About PLC Systems Inc. PLC Systems Inc. (AMEX:PLC) 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 approved by both the U.S. Food and Drug Administration and
Japanese Ministry of Health, Labor and Welfare. In a move to
broaden its market, the company recently announced its intention to
initiate clinical studies for its RenalGuard(TM) Therapy and
RenalGuard(TM) System. RenalGuard Therapy is designed to reduce the
toxic effects that contrast media can have on the kidneys. It 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 the procedure. This should allow for the contrast
to be rapidly removed from the body, and is intended to minimize
the risk for over- or under-hydration, during the millions of
imaging procedures that occur worldwide each year. Additional
company information can be found at http://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 our TMR
system may not prove efficacious for use in connection with stem
cell or bypass therapy, our sales of TMR systems may not increase
as expected in the fourth quarter of 2006, we may not earn
royalties under the modified business agreement with Edwards, 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,,; Edwards may decide not to
pursue or continue the sales and marketing activities for our
products; Edwards may be unsuccessful in selling our products,, we
may be unable to convince health care professionals and third party
payers of the medical and economic benefits of the CO2 Heart
Lasers, and 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, and additional risk
factors described in our Report on Form 10-K for the year ended
December 31, 2005, and our other SEC reports PLC Systems, PLC
Medical Systems, PLC and CO2 Heart Laser are trademarks of PLC
Systems Inc. Edwards Lifesciences is a trademark of Edwards
Lifesciences Corporation. Financial Tables Follow PLC SYSTEMS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per
share data) Three Months Ended Nine Months Ended September 30,
September 30, 2006 2005 2006 2005 Revenues: Product sales --
Edwards $1,115 $1,352 $3,717 $4,198 Product sales -- other 90 183
545 462 Service fees -- Edwards 337 313 1,034 984 Service fees --
other 25 52 103 181 Total revenues 1,567 1,900 5,399 5,825 Cost of
revenues: Product sales -- Edwards 344 564 1,172 1,580 Product
sales -- other 78 68 315 204 Service fees -- Edwards 133 153 405
435 Service fees -- other 35 30 111 114 Total cost of revenues 590
815 2,003 2,333 Gross profit 977 1,085 3,396 3,492 Operating
expenses: Selling, general and administrative 786 739 2,470 2,516
Research and development 394 810 1,385 2,030 Total operating
expenses 1,180 1,549 3,855 4,546 Gain on sale of manufacturing
asset - - 1,432 - Income (loss) from operations (203) (464) 973
(1,054) Other income, net 123 67 310 183 Net income (loss) $(80)
$(397) $1,283 $(871) Basic income (loss) per share $(0.00) $(0.01)
$0.04 $(0.03) Diluted income (loss) per share $(0.00) $(0.01) $0.04
$(0.03) Average shares outstanding: Basic 30,237 30,079 30,080
30,073 Diluted 30,237 30,079 30,518 30,073 CONDENSED BALANCE SHEET
September 30, December 31, 2006 2005 Cash and short-term
investments $10,244 $9,460 Total current assets 13,157 12,008 Total
assets 13,521 12,467 Total current liabilities 3,210 3,044
Shareholders' equity 7,015 5,543 Contact: Mary T. Conway Conway
Communications 617-244-9682 DATASOURCE: PLC Systems Inc. CONTACT:
Mary T. Conway of Conway Communications for PLC Systems Inc.,
+1-617-244-9682, Web site: http://www.plcmed.com/
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