CGCP - up in PM on news:
New Clinical Data Demonstrates Long Term Efficacy of CardioGenesis TMR; Should D
/FROM PR NEWSWIRE LOS ANGELES 213-626-5500/
TO BUSINESS AND MEDICAL EDITORS:
New Clinical Data Demonstrates Long Term Efficacy of CardioGenesis TMR;
Should Dispel Fears of Placebo Effect
After Five Years, 96% of Surviving Patients Continued to Show Improvement
of at Least Two Angina Classes With Trend Toward Improved Survival Over
Medically Managed Patients
FOOTHILL RANCH, Calif., Jan. 9 /PRNewswire-FirstCall/ --
CardioGenesis Corporation (Nasdaq: CGCP), the market leader in
angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous
Myocardial Revascularization (PMR), today announced that the first long-term
follow up data of a randomized, controlled TMR clinical trial show that
96 percent of surviving patients exhibited an improvement (reduction in pain)
of at least two angina classes five years after their initial TMR treatment.
The data also showed that incremental reductions in pain occurred after one
year.
Keith B. Allen, M.D., a cardiothoracic surgeon at St. Vincent's Hospital
in Indianapolis, one of the two centers that have completed long-term follow
up of the CardioGenesis Ho:YAG TMR versus Medical Management Trial, presented
the five-year follow-up data in December at the Global Angiogenesis Workshop
in New York, a scientific meeting of leading angiogenesis researchers from
around the world.
The data included all 94 randomized patients enrolled in the trial
conducted at St.Vincent's and Louisville-based Jewish Hospital, two centers
that were part of the pivotal clinical trial that served as the basis of the
FDA approval of the CardioGenesis Ho:YAG system in March 1999. The pivotal
clinical trial was conducted at 18 centers and the 12-month results of the
that trial, which were published in the New England Journal of Medicine in
October 1999, showed that 76 percent of the patients treated with TMR improved
at least two angina classes from their baseline. Five-year follow-up was
conducted on all patients in the initial study at these two prominent
cardiovascular centers and included a blinded angina assessment, which
compared the medically managed group of patients with the TMR-treated group.
CardioGenesis will continue to collect long term follow-up data from other
centers included in the pivotal trial.
Dr. Allen said the enduring relief from angina pain demonstrated by the
new data should help dispel any lingering fears that TMR's benefits are
transitory or due to a placebo effect.
"This is clear evidence of the long lasting efficacy of TMR as a means of
relieving the crippling pain of angina," Dr. Allen said. "I believe this
dramatic improvement over time, increasing from 12 months to five years,
should help support the awareness of TMR as a significant clinical tool and
support a widespread adoption of the procedure for patients suffering from
late stage cardiovascular disease."
Other highlights of the long term follow-up data include:
-- Mean angina class in the TMR treated patients consistently improved
from 4.0 at baseline, to 1.5 (the larger number indicates more severe
pain) at one year, and 1.1 at five years, a statistically significant
improvement in angina status.
-- Survival at 5 years in the TMR group was 57% compared to 44% in the
medical treatment group.
Dr. Allen noted that the study provides for the first time five-year
follow up results on a prospective, randomized TMR clinical trial. Previously
reported five-year results for the CO2 TMR technology have been on a treated
patient series only, with no follow up provided for the control group, and
those results presented have been censored for patients who died or received
additional revascularization procedures.
Robert D. Dowling, M.D., the principal investigator of the Ho:YAG TMR
trial at Jewish Hospital, said the long-term persistent improvement
demonstrated in the study provides important information for the
cardiothoracic surgeon and referring physician.
"Undergoing a surgical procedure includes inherent risks, and the long
term persistent benefit of TMR demonstrated in this study provides significant
validating data as to why TMR is an important and highly effective late stage
coronary artery disease (CAD) disease treatment option," Dr. Dowling said.
"These 5 year results demonstrate the robust effectiveness of TMR with the
CardioGenesis Ho:YAG system, providing an impressive level of scientific and
clinical evidence supporting the use of this laser revascularization therapy."
Michael J. Mack, M.D. of Medical City Hospital in Dallas, who has utilized
TMR since the approval of the CardioGenesis Ho:YAG system in 1999, said the
results will support increased use of the system in the future. He
characterized this evidence of the long-term benefit of TMR with the
CardioGenesis Ho:YAG system as "A significant step forward in validating TMR
as a relevant and increasingly important clinical tool in the treatment of
late stage CAD. The cardiothoracic surgeon faces more complex clinical and
technical challenges as patients suffering from CAD are being referred to
surgery later in the progression of the disease. TMR is an innovative and
effective tool to help the surgeon achieve optimal patient outcomes in the
treatment of late stage disease."
CardioGenesis Chairman and CEO Michael J. Quinn said the Company is
committed to continuing the important research into understanding the
long-term effects of TMR and PMR, a catheter-based version of the treatment.
TMR and PMR are the only late stage therapy options for this patient group
that have been validated with a series of prospective, randomized clinical
trials, Quinn said.
"The quality and magnitude of these long-term clinical results provide
overwhelming evidence supporting the use of TMR and effectively dispels the
conjecture that the benefits may be transitory or a placebo," Quinn said.
"This data represents the first comprehensive report on the long term effects
of TMR from a prospective, randomized study. CardioGenesis is again providing
important scientific data to the medical community, showing substantial
scientific evidence supporting the clinical application of our Ho:YAG laser
technology -- which has not been made available to date for CO2 TMR or other
late stage therapeutic options. This study is clearly one of the most
important clinical developments in the Company's history as it provides us a
new set of important tools to use in our campaign to expand the use of TMR."
Quinn added that the company is focused on growing the TMR business. "As
the market leader, it is up to CardioGenesis to drive the awareness and
adoption of TMR," Quinn remarked. "We are accomplishing this through
important new studies that will provide patients and physicians with the data
to make informed treatment decisions. We are encouraged at the progress we
have made in 2002, and are working closely with clinicians and researchers to
provide more important new research regarding the CardioGenesis Ho: YAG TMR
system to the market going forward."
TMR and PMR are related procedures in which physicians use lasers to
create small channels in the heart muscle to trigger the mechanisms of
angiogenesis, or the creation of new blood vessels in the heart. The FDA
approved TMR, a surgical version of the procedure, in 1999. PMR is a
catheter-based version of the procedure that is not yet cleared by the FDA in
the U.S. but is CE approved. The Company is continuing to move ahead in its
efforts to gain FDA clearance this year to market PMR in the U.S. and extend
the benefits of that minimally invasive procedure well beyond the
2,000 patients who have already been successfully treated with PMR.
About CardioGenesis Corporation
CardioGenesis is a medical device company specializing in the treatment of
cardiovascular disease and is the leader in products that stimulate cardiac
angiogenesis. The Company's market leading Holmium: YAG laser system and
disposable fiber-optic accessories are used to perform a FDA-cleared surgical
procedure known as transmyocardial revascularization (TMR) to treat patients
suffering from angina. The CardioGenesis TMR procedure, which is marketed in
the U.S. and around the world, has been shown to reduce angina and improve the
quality of life in patients with coronary artery disease. The Company's
minimally invasive PMR procedure is currently being marketed in Europe and
other international markets.
For more information on the Company and its products, please visit the
CardioGenesis web site at cardiogenesis.com . For investor
relations information, visit the CardioGenesis pages in the "Client" section
of the Allen & Caron Inc web site at www.allencaron.com .
Any forward-looking statements in this news release related to the
Company's sales, profitability, the adoption of its technology and products
and FDA clearances are based on current expectations and beliefs and are
subject to numerous risks and uncertainties that could cause actual results to
differ materially. Other factors that could cause CardioGenesis' actual
results to differ materially are discussed in the "Risk Factors" section of
the Company's Annual Report on Form 10-K for the year ended December 31, 2001,
its Quarterly Report on Form 10-Q for the third quarter ended September 30,
2002, and the Company's other recent SEC filings. The Company disclaims any
obligation to update any forward-looking statements as a result of
developments occurring after the date of this press release.
For further information, please contact: investors, Mike Mason,
+1-212-691-8087, michaelm@allencaron.com, or media, Len Hall,
+1-949-474-4300, len@allencaron.com, both of Allen & Caron Inc, for
CardioGenesis Corporation; or Darrell Eckstein, President of CardioGenesis
Corporation, +1-714-649-5000.
SOURCE CardioGenesis Corporation
/CONTACT: investors, Mike Mason, +1-212-691-8087,michaelm@allencaron.com, or
media, Len Hall, +1-949-474-4300,len@allencaron.com, both of Allen & Caron Inc,
for CardioGenesis Corporation;or Darrell Eckstein, President of CardioGenesis
Corporation, +1-714-649-5000/
/Web site: cardiogenesis.com /
Jan-09-2003 12:32 GMT
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