HeartWare gets Austrian thumbs-up

By Helen Schuller
Wednesday, 11 January, 2006

Artificial heart firm HeartWare (ASX:HTW) has been granted its first regulatory approval to commence human implants of the HVAD left ventricular assist device from the Austrian Ministry of Health.

The Austrian regulatory approval follows granting of ethics approval from the Vienna General Hospital, associated with the University of Vienna.

Dr Georg Wieselthaler, the clinical director of the hospital's mechanical circulatory support program, will lead the HVAD implant program in Vienna. A member of HeartWare's medical advisory board, Wieselthaler is also the secretary general of the International Society of Rotary Blood Pumps and has extensive experience with a range of mechanical assist devices.

In addition to the Austrian regulatory approval, HeartWare has also received conditional ethics approval from Royal Perth Hospital.

"HeartWare will conduct its first human implant in March of this year," said HeartWare's director of corporate development, Howard Leibman. "This represents the most important milestone in the company's history to date. For the last 12 months we repeatedly indicated our aim of starting our European trial in the first quarter of 2006. Having now received our first regulatory approval in Europe we remain extremely confident of achieving this objective."

In mid-January HeartWare will be conducting its surgical training program at the Texas Heart Institute, during which the surgical teams from all hospitals participating in the first phase of the HVAD clinical trial will receive instruction on the HVAD implant procedure.

The company's largest single shareholder outside Appletree Partners has also increased his shareholding from over 5 million shares following HeartWare's IPO in January 2005 to 8 million shares and just over 5 per cent of the company's share registry.

HeartWare shares gained more than 15 per cent following the approval announcement to the ASX on January 5 and reached an all time high of AUD$1 on Monday. At time of writing HeartWare shares were trading at $0.915.