News & Events

< Back to News Overview

Sunshine Heart on track for US trial following Pre-IDE Meeting with FDA

22 / 12 / 2006

Key points
Sunshine Heart achieved a significant milestone with a successful FDA meeting.
C-PulseTM was presented to the FDA by leading US and Australian clinicians
FDA provided positive feedback for the C-PulseT product and clinical focus
Sunshine Heart's C-PulseTM is on track to enter into a US clinical trial

Sunshine Heart (ASX:SHC) announced today that the C-PulseTM is on track to enter clinical trials in the USA.

This was confirmed by a recent pre-Investigational Device Exemption (pre-IDE) meeting with the US Food and Drug Administration (FDA) in Washington DC, USA. Sunshine Heart's pre-IDE meeting is the first formal interface with the FDA as the Company seeks to conduct clinical trials in the United States of America. A team of Australian, New Zealand and US clinicians presented the unique performance and features of the Sunshine Heart C-PulseTM at the meeting.

"We are very pleased with the constructive dialog with the FDA," said Dr William Peters, Sunshine Heart's Founder and Medical Director who presented at the FDA meeting.

Dr Peters forecasted that Sunshine Heart would submit the formal IDE submission in the first half of 2007.

Sunshine Heart's CEO Don Rohrbaugh said, "it is very encouraging that we have already aligned 8 to 10 experienced large prestigious university-based hospitals and regional referral
hospitals for the US trial."

"There is certainly a great need and desire for a C-PulseTM - type product in the US and we are confident that we will progress to US clinical trials in 2007" said Mr Rohrbaugh.