Ventracor Release: US Destination Therapy Trial Protocol Approved For VentrAssist(TM) LVAD

SYDNEY, Dec. 22 /PRNewswire-FirstCall/ -- Ventracor today announced the United States Food & Drug Administration (FDA) has granted conditional approval of the protocol for the US Destination Therapy (DT) trial of the VentrAssist.

Ventracor's DT trial is a prospective randomized clinical trial aimed at evaluating the effectiveness and safety of VentrAssist as long-term circulatory support for patients with end stage heart failure who are not eligible for cardiac transplantation.

Ventracor Chief Executive Officer Peter Crosby said: "Unlike previous US DT Trials, Ventracor's trial design does not require prospective randomization only to a market released LVAD approved by the FDA for Destination Therapy.

"This revolutionary trial design has the potential to significantly shorten the time to FDA approval for destination therapy.

Ventracor's US DT protocol and strategy was developed in collaboration with the FDA and the International Centre for Health Outcomes and Innovation Research (InCHOIR) at Columbia University in New York. The DT trial will be conducted at multiple centres.

"This approval will allow the Company to start recruitment in the DT Trial next quarter, which is in advance of our previously stated milestones," Mr Crosby said.

About Ventracor

Ventracor is a global medical device company which has developed an implantable blood pump, the VentrAssist left ventricular assist device (LVAD), as therapy to improve the lives of heart failure patients and their families. Ventracor is dedicated to building partnerships with healthcare professionals to make the VentrAssist the standard-of-care worldwide.

Further information, please visit http://www.ventracor.com or contact: Graeme Fallet Chief Financial Officer or Andrew Geddes Investor Relations Ventracor Tel: + 61 2 9406 3100 or email: info@ventracor.com

CONTACT: Graeme Fallet, Chief Financial Officer, or Andrew Geddes,Investor Relations, Ventracor, +61-2-9406-3100, info@ventracor.com

Web site: http://www.ventracor.com/