FRANKLIN, Mass., March 5 /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 twelve month periods ended December 31, 2007.
Fourth quarter 2007 total revenues were $1,248,000 compared with
$1,747,000 in the fourth quarter of 2006. The net loss for the
fourth quarter of 2007 was $819,000, or $0.03 per diluted share,
compared to net income of $36,000, or $0.00 per diluted share, in
the fourth quarter of 2006. For the full year 2007, PLC reported
total revenues of $6,004,000 compared to $7,146,000 in 2006. The
net loss for 2007 was $2,367,000, or $0.08 per diluted share,
compared to net income of $1,319,000, or $0.04 per diluted share,
in 2006, a period that also included a $1.4 million gain on the
sale of PLC's Optiwave disposable manufacturing rights to Edwards
Lifesciences Corporation. Cash and short term investments at the
end of the fourth quarter of 2007 totaled $8,060,000, down from
$10,034,000 at the end of December 2006. Mark R. Tauscher,
president and chief executive officer of PLC Systems, Inc., stated,
"We are very pleased with our substantial progress on our
RenalGuard(TM) product development efforts in the fourth quarter of
2007. We successfully concluded our pilot clinical safety trial
after enrolling 23 patients, and we secured a CE Mark for
RenalGuard in Europe. We recently announced that we had filed an
IDE supplement with 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 are awaiting
approval of the clinical study utilizing our RenalGuard System(TM)
and RenalGuard Therapy(TM) at the Centro Cardiologico Monzino (CCM-
University of Milan) in Milan, Italy. We anticipate that this study
will greatly increase the visibility of our RenalGuard System and
RenalGuard Therapy throughout the European Union, and will be
instrumental in supporting our initial limited launch of the
product in Italy starting later this quarter." Mr. Tauscher added,
"At the same time, 2007 was a year of transition for our core TMR
business. In March 2007, we began a new relationship with Novadaq
Technologies, Inc., replacing Edwards Lifesciences as our exclusive
U.S. TMR distribution partner. We had anticipated the transition
would take some time, and our expectations were correct. We are
pleased that fourth quarter 2007 HL2 system sales and TMR kit
shipments from Novadaq to U.S. hospitals increased sequentially
from the third quarter of 2007. We believe that Novadaq is working
hard to build this business for the long-term, since the synergies
between our TMR system and Novadaq's SPY(R) Imaging Technology are
strong. Those synergies, plus the increased experience of Novadaq's
sales force with the TMR technology, we hope will lead to improved
performance for this business in 2008." During the fourth quarter
of 2007, PLC shipped seven CO2 Heart Lasers (HL2) to U.S. hospitals
through Novadaq, compared to six HL2s shipped in the fourth quarter
of 2006. Three of the shipments in the fourth quarter of 2007 were
new HL2 lasers and four were redeployed units. PLC ended the fourth
quarter of 2007 with 169 HL2 CO2 Heart Lasers located at heart
centers throughout the U.S. During the fourth quarter of 2007, a
total of 372 disposable TMR kits were shipped, all to hospitals in
the U.S., by Novadaq. In comparison, a total of 313 and 466
disposable TMR kits were delivered to hospitals in the U.S. during
the third quarter of 2007 and the fourth quarter of 2006,
respectively. Conference Call PLC Systems will host a conference
call today, March 5, 2008, at 11:00 a.m. ET to discuss these
matters. The call may be joined by dialing (888) 713-4205, or
internationally, (617) 213-4862, at least five minutes prior to the
start of the call. The passcode is 25917459. A live webcast of the
call will be accessible at the investor relations section of the
Company's website at http://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 90665991, from 1:00
p.m. ET on March 5, 2008 through midnight on March 12, 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
recently concluded a pilot clinical safety study of its RenalGuard
Therapy and RenalGuard System. In late 2007, the company received
its CE Mark Certificate for RenalGuard System. 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
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 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 Report on Form 10-Q for
the quarter ended September 30, 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 Year Ended December 31, December 31, 2007 2006 2007 2006
Revenues: Product sales $ 935 $1,400 $ 4,564 $ 5,662 Service fees
313 347 1,440 1,484 Total revenues 1,248 1,747 6,004 7,146 Cost of
revenues: Product sales 423 544 1,829 2,031 Service fees 175 185
806 701 Total cost of revenues 598 729 2,635 2,732 Gross profit 650
1,018 3,369 4,414 Operating expenses: Selling, general and
administrative 875 544 3,794 3,014 Research and development 698 539
2,382 1,924 Total operating expenses 1,573 1,083 6,176 4,938 Gain
on the sale of manufacturing rights - - - 1,432 Income (loss) from
operations (923) (65) (2,807) 908 Other income, net 90 126 426 436
Income (loss) before income taxes (833) 61 (2,381) 1,344 Provision
(benefit) for income taxes (14) 25 (14) 25 Net income (loss) $
(819) $ 36 $(2,367) $ 1,319 Basic and diluted income (loss) per
share $(0.03) $ 0.00 $ (0.08) $ 0.04 Average shares outstanding:
Basic 30,326 30,268 30,318 30,170 Diluted 30,326 30,723 30,318
30,572 CONDENSED BALANCE SHEET December 31 December 31, 2007 2006
Cash and short-term investments $8,060 $10,034 Total current assets
10,733 12,802 Total assets 11,200 13,176 Total current liabilities
3,811 2,953 Shareholders' equity 4,950 7,129 Contact: Mary T.
Conway Conway Communications 617-244-9682 DATASOURCE: PLC Systems
Inc. CONTACT: Mary T. Conway of Conway Communications,
+1-617-244-9682, , for PLC Systems Inc. Web site:
http://www.plcmed.com/
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