First Aust. `Artifical Heart` Trials Will Begin Early 2003 24/12/02 12:14:00 PM
VENTRACOR LIMITED 2002-12-24 ASX-SIGNAL-G
HOMEX - Brisbane
+++++++++++++++++++++++++ Australian heart company, Ventracor Limited (ASX:VCR), has received approval to begin human clinical trials of its VentrAssist(TM) 'artificial heart' device.
Ventracor Managing Director and Chief Executive Officer, Mr Michael Spooner, said the Ethics Committee of The Alfred hospital in Melbourne approved a clinical Pilot Trial of about 10 implants after a detailed review of Ventracor's submission in November.
Mr Spooner said in granting the approval, the Ethics Committee had requested a number of minor amendments and additions but he expected these would be resolved quickly.
He said precise timing for the first 'artificial heart' implant was now in the hands of The Alfred hospital medical team, led by Professor Don Esmore, and the patients themselves.
Mr Spooner said The Alfred was likely to now begin active recruitment of patients suffering end-stage congestive heart failure and that this process could take about 10 to 12 weeks.
"This Pilot Trial will be an independent assessment and so the timing for commencement, patient recruitment, performing the surgical procedure and post-operative care will all be at the discretion of The Alfred hospital medical team.
"Ventracor will assist Professor Esmore and his medical team wherever possible throughout the Trial process. At all times, Ventracor will undertake those actions necessary to ensure the confidentiality and wellbeing of patients and their families.
"This first Pilot Trial in Melbourne will be a precursor to a larger multi-centre global Pivotal Trial in other leading hospitals in Australia, Europe and the United States in the second half of 2003.
"Our goal is to get VentrAssist(TM) to global markets as early as is possible and start seeing the benefits flow to both doctors and patients.
"We have mapped out every element of the process, every aspect is being professionally managed, and the whole company remains totally focused and driven toward meeting every milestone before us", he said.
Mr Spooner added Ventracor was well positioned to significantly improve the quality of life for hundreds of thousands of people worldwide suffering heart failure, by obtaining a significant share of the left ventricular assist device (LVAD) market, which is expected to grow to between $US7.5 billion and $US12 billion annually in the next few years.
For further information, please contact:
Michael Spooner Julie Meldrum MANAGING DIRECTOR & CEO MANAGER, CORPORATE COMMUNICATIONS 02 9406 3100 02 9406 3100 or 0419 228 128
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