re: results due this week will run hard News from 7...

re: results due this week will run hard
News from 7 weeks`ago...so a flurry of news to be expected antime now

HeartWare anticipates receiving full Ethics Approval from Royal
Perth over coming weeks, at which time the company will apply to the
Australian Therapeutic Goods Administration to commence human implants in
Australia.
Within the same timeframe, HeartWare expects to make similar
submissions to the regulatory authorities in both Germany and the UK.
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.
"HeartWare's primary objective over the past year has been to
initiate our human clinical study during the first quarter of 2006," said
HeartWare's CEO Stuart McConchie.
"With receipt of regulatory approval so early in the year, we
remain confident of achieving this important milestone.
"Our surgeon training is scheduled for later this month, and we
expect to complete our internal compliance, verification and validation
procedures during February.
"By that stage we expect to have regulatory approval in at least
one additional jurisdiction.
"Subject then only to patient selection, we remain confident of
commencing our human implants in March 2006," Mr McConchie disclosed.
Over coming weeks HeartWare will provide regular updates on the
status of the company's Australian, German and UK regulatory submissions
and approvals.
The company will provide specific details of the hospitals and
the lead investigators at each, following confirmation of regulatory
approval in each jurisdiction.