PLC Systems' CO2 TMR Heart Laser Technology Receives Marketing Approval in Japan
17 Maio 2006 - 10:39AM
PR Newswire (US)
-- Ktec Corporation, PLC's Exclusive Japanese Distributor, Receives
Approval From Japanese Ministry of Health to Market Laser Based
Angina Relief Therapy -- FRANKLIN, Mass., May 17
/PRNewswire-FirstCall/ -- PLC Systems Inc. (AMEX:PLC), a leader in
cardiac laser technologies, today reported that Ktec Corporation,
PLC's exclusive distributor in Japan, received approval from the
Japanese Ministry of Health, Labor and Welfare (MHLW) to market PLC
Systems' first generation CO2 TMR Heart Laser System (HL1) in
Japan. CO2 TMR offers a treatment option for angina patients who
suffer from severe coronary artery disease. Coronary artery disease
is expected to increase as the worldwide population continues to
age. Working with leading researchers and premier heart centers
around the world, PLC developed the CO2 Heart Laser, which is the
world's first TMR angina relief device approved by both the
Japanese MHLW and the U.S. Food and Drug Administration. "We are
very pleased to announce Japanese marketing approval for our CO2
TMR Heart Laser," stated Mark R. Tauscher, president and CEO of PLC
Systems. "The Japanese approval process included a lengthy review
of a Japanese CO2 TMR clinical trial; our CO2 TMR U.S. Phase III
clinical trial; as well as scientific literature. We believe the
Japan Ministry of Health approval reinforces the strength of the
scientific data and clinical evidence that supports the use of CO2
TMR by cardiac surgeons for very sick heart patients." To date,
Tokyo-based Ktec Corporation (formerly known as Imatron Japan,
Inc.), has made investments in purchasing our Heart Lasers, funding
a clinical trial in Japan, and supporting the regulatory approval
process in Japan. Going forward, Ktec will manage the ongoing
regulatory, clinical, marketing, and sales activity for CO2 TMR in
Japan. For the remainder of 2006, Ktec will begin the process of
establishing the TMR market through hosting educational seminars,
attending scientific trade shows and conducting training events.
Currently, Ktec has 12 HL1s in Japan, which were purchased by Ktec
in the mid- 1990's. Ktec, which has more than 20 sales people in
Japan, can sell HL1 immediately. Tauscher continued, "We are
pleased that our angina relief technology is now available to the
Japanese market. TMR fits very well within the portfolio of tools
and technologies that surgeons have to treat the expanding
population of heart patients who have limited choices available for
revascularization therapies." About PLC Systems Inc. PLC Systems 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.
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 Ktec may decide not to
pursue or continue the sales and marketing activities for the Heart
Laser; Ktec may be unsuccessful in selling these products,
operational changes, competitive developments may affect the market
for our products, regulatory approval requirements may affect the
market for 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. Contact: John Jordan Director of
Investor Relations 508-541-8800, ext. 145 DATASOURCE: PLC Systems
Inc. CONTACT: John Jordan, Director of Investor Relations of PLC
Systems Inc., +1-508-541-8800, ext. 145 Web site:
http://www.plcmed.com/
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