Pioneering Study Indicates CO2 TransMyocardial Revascularization Combined with Gene Therapy Enhances Angiogenic Response and Imp
09 Junho 2005 - 1:45PM
PR Newswire (US)
Pioneering Study Indicates CO2 TransMyocardial Revascularization
Combined with Gene Therapy Enhances Angiogenic Response and
Improves Myocardial Function Innovative Animal Research Published
In The Journal of Thoracic and Cardiovascular Surgery FRANKLIN,
Mass., June 9 /PRNewswire-FirstCall/ -- PLC Systems Inc.
(AMEX:PLC), the leader in carbon dioxide (CO2) TransMyocardial
Revascularization (TMR) technology used to treat severe angina, or
heart pain, today announced that a study published in the May 2005
issue of The Journal of Thoracic and Cardiovascular Surgery reports
an increase in angiogenesis within the heart as a result of a
combination of revascularization therapies: CO2 transmyocardial
laser revascularization plus matrix adenoviral fibroblast growth
factor-2 (FGF-2) gene therapy. "Prior studies and clinical use have
demonstrated that CO2 TMR can be a positive influence on treating
ischemic myocardium. Other investigations have evaluated gene
therapies as treatments for ischemic heart disease," said Dr. Keith
A. Horvath, lead author of the study and Chief, Cardiothoracic
Surgery Branch, National Heart, Lung and Blood Institute, NIH. "We
believe the principal mechanism of action for both CO2 TMR and gene
therapy is the stimulation of angiogenesis. With this study we have
demonstrated that the combination of a growth factor formulated in
a collagen-based matrix and CO2 TMR will lead to enhanced
neovascularization and most importantly, improved myocardial
function." The study entitled, "Improvement of Myocardial
Contractility in a Porcine Model of Chronic Ischemia using a
Combined Transmyocardial Laser Revascularization and Gene Therapy
Approach," is a pre-clinical animal study that had four treatment
groups -- CO2 TMR alone, adenoviral FGF-2 in a collagen-based
matrix alone, adenoviral FGF-2 in a collagen-based matrix combined
with CO2 TMR, and saline-formulated adenoviral FGF-2. The study
demonstrated that a matrix adenoviral FGF-2 combined with CO2 TMR
treated areas had a 105 percent increase in arteriolar development
versus either alone treatment. In addition, the matrix adenoviral
FGF-2 combined with CO2 TMR treated areas had a 390 percent
increase compared with saline-formulated adenoviral FGF-2.
Contractility was significantly improved in matrix adenoviral FGF-2
plus CO2 TMR treated areas as measured by myocardial wall
thickening. This functional improvement was confirmed by cine
magnetic resonance imaging, in which a 90 percent increase in the
contractility of the treated area after matrix adenoviral FGF-2
plus CO2 TMR. The other treatments provided significantly less
restoration of myocardial function. "The research results published
in this study are very promising," stated PLC Systems' CEO and
President Mark R. Tauscher. "Gene therapies and biologics are
cutting-edge, emerging research areas that have a significant level
of interest and investment by academia, healthcare providers and
leading biotech companies. We believe this study demonstrates that
CO2 TMR can enhance the angiogenic response of a gene therapy or
biologic. As the research and development continues to evolve we
hope to demonstrate that CO2 TMR should be the preferred therapy to
complement or enhance gene therapies, autologous cells or biologics
within the heart." 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 that cardiac surgeons use to perform CO2
transmyocardial revascularization (TMR) to alleviate symptoms of
severe angina. Edwards Lifesciences (NYSE:EW) is the exclusive U.S.
marketer and distributor of PLC's next-generation CO2 Heart Laser 2
systems. To date, more than 13,000 cardiac patients have been
treated with a CO2 Heart Laser. 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 the animal study identified above may not prove
indicative of actual clinical results with humans, we may be unable
to successfully develop or manufacture products under our
agreements with Edwards; Edwards may decide not to pursue or
continue the sales and marketing activities for these products;
Edwards may be unsuccessful in distributing 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, 2004, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser are
trademarks of PLC Systems Inc. Edwards Lifesciences, and Edwards
are trademarks of Edwards Lifesciences. 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, +1-508-541-8800, ext. 145 Web site:
http://www.plcmed.com/
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