RenalGuard limited launch in Italy underway, with patients already treated FRANKLIN, Mass., May 15
FRANKLIN, Mass., May 15 /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
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(TM) 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(R) 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(TM) and RenalGuard System(TM) 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.
Contact: Mary T. Conway
Conway Communications
617-244-9682
mtconway@att.net
PLC SYSTEMS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended
March 31,
20082007
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 administrative970 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, December 31,
2008 2007
Cash and cash equivalents $6,840 $8,060
Total current assets9,828 10,733
Total assets 10,297 11,200
Total current liabilities 3,8623,811
Shareholders' equity4,2414,950
SOURCE PLC Systems Inc.
