Progress report -- so far, so good...
Heart Assist Technology Trials Forge Ahead: World Heart Corporation
OTTAWA, May 24 /CNW/ - (NASDAQ: WHRT, TSE: WHT) - World Heart Corporation
(WorldHeart) today issued an update on the progress of pre-clinical trials
that are expected to lead to human clinical trials of HeartSaverVAD(TM) later
this year.
HeartSaverVAD(TM) is a pulsatile left ventricle assist device, designed
to be fully implanted in the chest to deliver part or all of the pumping
action of the left ventricle for life-long use by patients with heart failure.
The device responds to the body's changing demand for blood just as the
natural heart does, and delivers a pulse of blood with each beat, mirroring
the natural heart. The recipient will be free from the discomfort and risks of
external or abdominal placement of the pump and permanent body openings for
power and venting.
Pre-clinical trials began in March 2001 and are continuing. The result
from these trials will provide data to support an application to Health Canada
for clinical trials later this year. Clinical trials are expected to begin in
Europe early next year and in the United States in the second half of the
year.
"One of the in vivo trials has now passed the half-way, forty-five day
milestone, with five other trials also in progress. Additional implants are
continuing to be conducted. The overall performance of the device in the
trials maintains our expectation of beginning clinical trials later this
year," said Dr. Tofy Mussivand, WorldHeart's Chairman and Chief Scientific
Officer.
"In addition to the in vivo trial results, in vitro tests for the system
and a series of sub-systems will continue through the summer and fall to
demonstrate the pre-clinical effectiveness, safety and reliability of
HeartSaverVAD(TM) for long term use," he said.
In 1996 WorldHeart acquired the rights to the technologies for
HeartSaverVAD(TM) from the University of Ottawa Heart Institute and since then
has worked with the Institute to develop the device. In June 2000, WorldHeart
acquired the Novacor Division of Edwards Lifesciences LLC. This acquisition
gave WorldHeart one of only two approved abdominally implantable left
ventricular assist devices currently available, one of the most experienced
teams in the world in artificial heart technology, and state-of-the-art
facilities for testing and production.
With the Novacor acquisition in June 2000, WorldHeart announced that it
would reschedule introduction of HeartSaverVAD(TM) to provide time to absorb
the benefits of the technology and experience of Novacor into the
HeartSaverVAD(TM) product.
"The Novacor(R) LVAS system has successfully supported heart failure
patients for up to four years on their original pumps, and have supported more
than 1,200 patients in total," said Roderick M. Bryden, WorldHeart's President
and Chief Executive Officer.
"During the past year we have absorbed into HeartSaverVAD(TM) a number of
technical enhancements reflecting this experience," Mr. Bryden continued. "We
are also applying to HeartSaverVAD(TM) in vitro trials experience and
technologies for system and sub-system testing that have been successful in
assuring the long term reliability of Novacor(R) LVAS."
Novacor(R) LVAS is currently approved for use in Canada, United States,
Europe and several other countries. Eighty-eight people have been supported by
their original Novacor(R) LVAS for more than one year on their original
device.
World Heart Corporation, a global medical device company based in Ottawa,
Ontario and Oakland, California, is currently focused on the development and
commercialization of pulsatile ventricular assist devices. Its Novacor(R) Left
Ventricular Assist System (LVAS) is already well established in the
marketplace and its next generation technology, HeartSaverVAD(TM), is a fully
implantable assist device intended for long-term support of patients with
heart failure.
WorldHeart is a public company whose stock trades on the NASDAQ National
Market (ticker symbol: WHRT) and the Toronto Stock Exchange (ticker symbol:
WHT).
Any forward-looking statements in this release are made pursuant to the
safe harbour provisions of the Private Securities Litigation Reform Act of
1995. Investors are cautioned that all forward-looking statements involve risk
and uncertainties, including without limitation, risks in product development
and market acceptance of and demand for the Corporation's products, risks of
downturns in economic conditions generally, and in the medical devices
markets, risks associated with costs and delays posed by government
regulation, limitations on third party reimbursement, inability to protect
proprietary technology, potential product liability and other risks detailed
in the Corporation's filings with the U.S. Securities and Exchange Commission.
All financial figures are prepared in accordance with Canadian generally
accepted accounting principles (GAAP) and are expressed in Canadian dollars.
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