Company provides update on its Clinical Trials of RenalGuard(TM);
Announces New Study in Italy Starting in Early 2008 FRANKLIN,
Mass., Nov. 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 nine month periods ended September 30, 2007.
Third quarter 2007 total revenues were $1,331,000 compared with
$1,567,000 in the third quarter of 2006. The net loss for the third
quarter of 2007 was $499,000, or $0.02 per diluted share, compared
to a net loss of $80,000, or $0.00 per diluted share, in the third
quarter of 2006. "Our third quarter U.S. TMR revenues and kit
shipments to hospitals were down compared to the corresponding
third quarter in 2006. After detailed analysis and dialogue with
our new U.S. distribution partner, Novadaq Technologies, Inc., we
believe that we have identified the issues and that Novadaq is
taking the right steps to address them and position the business
for improved performance moving ahead," said Mark. R. Tauscher,
president and chief executive officer of PLC Systems. In March 2007
Novadaq succeeded Edwards Lifesciences Corporation as the Company's
exclusive distributor for all TMR products in the United States.
Tauscher stated, "We had anticipated from the beginning that there
would be at least one or two transition quarters where Novadaq
would need to gain experience as to how to best market our TMR
products and that this likely could impact our short term TMR
results. We believe that in large part this is what happened in the
third quarter on the disposables side of the business, and that
Novadaq is acting quickly to reorganize their field sales
structure, and add additional experienced staff, to better enable
them to drive increased kit volumes in ensuing quarters." He added,
"Novadaq senior management has also indicated to us that the
previously announced shortage in the availability of new ICG dye
throughout the third quarter likely adversely impacted the
placement by customers of combined orders for our TMR Heart Laser
and Novadaq's SPY(R) Intra-Operative Imaging System. The joint
marketing of both systems has been a key Novadaq sales strategy.
Novadaq announced on October 4, 2007 that all issues related to the
shortage of new ICG dye had been resolved and that they were moving
quickly to execute on the existing pipeline of new installations."
Regarding the Company's RenalGuard(TM) product initiative, Mr.
Tauscher said, "We expect to complete our pilot clinical safety
trial by late 2007 or early 2008, and then quickly move into a
larger 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 of our RenalGuard
System and RenalGuard Therapy is expected to continue through 2009
and should serve as the basis for our application to the FDA for
pre-market approval to market the product in the United States.
Having recently demonstrated RenalGuard to leading practitioners at
the two foremost tradeshows in the field in the U.S., TCT and Renal
Week, we are confident that RenalGuard is addressing a sizable
market opportunity. We were gratified by the level of interest
expressed by practitioners who attended the shows from around the
world." He added, "We are very pleased to announce today, that in
addition to our planned U.S. clinical trial work in 2008, a new
clinical study utilizing our RenalGuard System and Therapy is
expected to be initiated at the Centro Cardiologico Monzino (CCM-
University of Milan) in Milan, Italy, led by Drs. Antonio
Bartorelli and Giancarlo Marenzi, two of the world's leading
experts in CIN prevention. We anticipate that this study will
greatly increase the visibility of our RenalGuard System and
Therapy throughout the European Union, and will be instrumental in
supporting our initial limited launch of the product in Italy. We
believe we are still on track to receive CE mark approval for
RenalGuard before the end of the year, which we expect would allow
us to begin our launch in Italy in early 2008." The CCM clinical
study is expected to begin in the first quarter of 2008, pending
approval from the ethics committee at the hospital. The study is
designed to compare the effectiveness of induced high volume
diuresis using real-time matched fluid replacement provided by the
RenalGuard System with that of overnight hydration, a standard of
care prevalent in Europe, in preventing CIN in high risk patients.
PLC will be supplying the necessary RenalGuard devices to be used
in the study. Third Quarter TMR Laser and Kit Shipment Results
During the third quarter of 2007, PLC shipped three CO2 Heart
Lasers (HL2) to U.S. hospitals through Novadaq. Two of these
shipments were new HL2 lasers and one was a redeployed unit. PLC
ended the third quarter of 2007 with 165 HL2 CO2 Heart Lasers
located at heart centers throughout the U.S. During the third
quarter of 2007, a total of 315 disposable kits were shipped
worldwide by Novadaq and PLC. Novadaq delivered 313 of these kits
to U.S. hospitals and PLC shipped two disposable kits to
international customers. In comparison, a total of 454 and 515
disposable kits were delivered worldwide during the second quarter
of 2007 and the third quarter of 2006, respectively. Nine Months'
Results For the first nine months of 2007, PLC reported total
revenues of $4,756,000 compared to $5,399,000 in the same period in
2006. The net loss for the first three quarters of 2007 was
$1,548,000, or $0.05 per diluted share, compared to net income of
$1,283,000, or $0.04 per diluted share, in the first nine months of
2006, a period that also included a $1.4 million gain on the sale
of PLC's Optiwave disposable manufacturing rights to Edwards
Lifesciences. Cash and short term investments at the end of the
third quarter of 2007 totaled $8,712,000, down from $10,034,000 at
the end of December 2006. Conference Call PLC Systems will host a
conference call today, November 5, 2007, at 11:00 a.m. ET to
discuss these matters. The call may be joined by dialing (866) 510-
0710, or internationally, (617) 597-5378, at least five minutes
prior to the start of the call. The passcode is: 62121698. 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
67644934, from 1:00 p.m. ET on November 5, 2007 through midnight on
November 12, 2007. 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 is currently conducting a pilot clinical safety study of
its RenalGuard Therapy and 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 June 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. 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, 2007 2006 2007 2006 Revenues: Product sales $975
$1,205 $3,629 $4,262 Service fees 356 362 1,127 1,137 Total
revenues 1,331 1,567 4,756 5,399 Cost of revenues: Product sales
258 422 1,406 1,487 Service fees 210 168 631 516 Total cost of
revenues 468 590 2,037 2,003 Gross profit 863 977 2,719 3,396
Operating expenses: Selling, general and administrative 830 786
2,919 2,470 Research and development 637 394 1,684 1,385 Total
operating expenses 1,467 1,180 4,603 3,855 Gain on the sale of
manufacturing rights - - - 1,432 Income (loss) from operations
(604) (203) (1,884) 973 Other income, net 105 123 336 310 Net
income (loss) $(499) $(80) $(1,548) $1,283 Basic income (loss) per
share $(0.02) $(0.00) $(0.05) $0.04 Diluted income (loss) per share
$(0.02) $(0.00) $(0.05) $0.04 Average shares outstanding: Basic
30,323 30,237 30,315 30,080 Diluted 30,323 30,237 30,315 30,518
CONDENSED BALANCE SHEET September 30, December 31, 2007 2006 Cash
and short-term investments $8,712 $10,034 Total current assets
11,503 12,802 Total assets 11,955 13,176 Total current liabilities
3,817 2,953 Shareholders' equity 5,719 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, Web site: http://www.plcmed.com/
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