Formal pre-clinical trials started. That's the good news. But isn't this news release pushing the date for human trials back yet again?
First, a snip from coverage of World Heart's news release of January 8, 2001....
The Post's Ian Jack writes that chief executive Rod Bryden insisted on Friday that the Ottawa-based company will go ahead with a clinical trial by the end of 2001. "We're feeling very good about where the product is," he says. "We're highly confident in the second half."
Now read the timing in this one... human trials early next year, ie 2002. The possible delay of another couple months is not really the point. It's just it's always a moving target.
Attention Business/Financial Editors:
WorldHeart's HeartSaverVAD(TM) in Formal Pre-Clinical Trials
NEW YORK, March 27 /CNW/ - World Heart Corporation (NASDAQ: WHRT, TSE:
WHT) (WorldHeart) has commenced formal in vivo trials of its HeartSaverVAD(TM)
heart assist device. The company had forecast these trials to begin in the
current quarter.
WorldHeart President and CEO, Roderick M. Bryden today announced the
milestone achievement during his presentation to the New York Society of
Security Analysts' 5th Annual Health Care Conference.
Dr. Tofy Mussivand, Chief Scientific Officer and Chairman of WorldHeart,
in a prepared statement said that "the in vivo implants took place last week
at centers in the United States, and these will continue through the second,
and part of the third quarter of this year in both Canada and the US. We look
forward to completing these pre-clinical trials in order to commence the
clinical trials of HeartSaverVAD(TM) in Canada during the second half of this
year, subject to approval of Health Canada."
"As this program proceeds we will announce any events which materially
affect timing or success of the trials, but we will not otherwise comment on
the trial program," Mr. Bryden said.
World Heart Corporation is a global medical device company currently
focused on the development and commercialization of pulsatile ventricular
assist devices (VAD). In 1996, WorldHeart acquired the rights to the
HeartSaverVAD(TM) technologies from the University of Ottawa Heart Institute
and in mid 2000 WorldHeart acquired the Novacor Division of Edwards
Lifesciences. The Novacor(R)LVAS has been used in more than 1200 patients in
the United States, Canada, Europe and other countries. Eighty six (86) people
have been supported by the device for more than one year, of whom twenty have
been supported for more than two years, one for more than three and one for
more than four years. No other mechanical circulatory device has attained this
record of long term support.
The Novacor(R)LVAS is abdominally implanted and requires a percutaneous
lead for venting and connection to a battery pack. It is approved in the
United States and Canada for bridge-to-transplant and in Europe for both
bridge and alternative-to-transplant indications. Novacor(R)LVAS is currently
in clinical trials in the United States for long-term use as an Alternative-to-
Medical Therapy.
"The Novacor team, and the considerable clinical, regulatory and
development experience, has been of great value in completing the development
of HeartSaverVAD(TM), and the continuing growth of Novacor(R)LVAS implants
adds to our capacity to bring HeartSaverVAD(TM) to clinical use," Mr. Bryden
said.
"HeartSaverVAD(TM) is designed to provide pulsatile support for the left
ventricle as the Novacor(R)LVAS does. However, HeartSaverVAD(TM) is designed
to be fully implanted in the chest, next to the natural heart, and to be
remotely powered, monitored and controlled without openings in the protective
skin and tissue. Subject to approval of regulatory authorities in each
country, we believe that the features of HeartSaverVAD(TM) will permit the
product to assist many patients suffering from late stage heart failure,"
Dr. Mussivand said.
WorldHeart intends to commence clinical trials of HeartSaverVAD(TM) in
Europe early next year and to apply to the FDA for an Investigative Device
Exemption to commence clinical trials in the United States in the second half
of next year.
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
NOTE: An 8x10, 200 dpi JPG photo of HeartSaverVAD(TM) is available for
download and located with the news release on the WorldHeart website under
What's New, and Financial Highlights.
The presentation will be audio cast live from 10:35 - 11:15 E.S.T. on the
WorldHeart website under What's New, and Financial Highlights. It will also be
available for re-broadcast for the following 30 days.
-0- 03/27/2001
For further information: Media, Michelle Banning, Manager, Corporate Communications, World Heart Corporation, (613) 226-4278, ext: 2995, michelle.banning@worldheart.com; Investment Community, Corinna de Beer, Manager, Investor Relations, World Heart Corporation, (613) 226-4278, ext: 2010, corinna.debeer@worldheart.com |
