PLC Systems Reports First Quarter 2008 Results
2008年5月15日 - 9:01PM
PRニュース・ワイアー (英語)
RenalGuard limited launch in Italy underway, with patients already
treated 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 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 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
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 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 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,
December 31, 2008 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
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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