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Biotech / Medical : World Heart Corp - WHRT and TSE/WHT -- Ignore unavailable to you. Want to Upgrade?

To: Dan Hamilton who wrote (467)	5/24/2001 11:56:36 AM
From: Dan Hamilton	Read Replies (1) \| Respond to of 500

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. -30-