Could this be because the implant is a major operation? Review...

Could this be because the implant is a major operation? Review of operations and results (continued)
Destination Therapy trial
The innovative EVERLAST™ US Destination Therapy Trial design is a step forward for the whole field of LVADs,
and has been asked for by the clinical community. It is the first multi centre prospective randomised clinical
trial which tests the idea that earlier implantation of an LVAD in ‘less sick’ patients will lead to better clinical
outcomes than waiting longer until drugs are no longer effective. The Company believes that this marketing
claim, if granted, will be a significant competitive advantage for Ventracor.
First enrolment under a conditional FDA approval was in September 2007, and the FDA granted unconditional
approval for the DT Trial on 17 March 2008. Unconditional approval removed an obstacle to reimbursement
in some centres.
Early ramp up of enrolment in the EVERLAST trial has not met the Company’s expectations to date, and it has
been learned that hospitals have preferred to gain experience with the VentrAssist LVAD on short term BTT
patients before advancing to longer term DT patients. The Company has added dedicated resources in the
US to educate physicians about the trial design and to encourage recruitment, and has seen improving
enrolment in recent months.
There are now 45 patients enrolled in this trial (a combination of patients implanted with the VentrAssist LVAD
and patients in the control arm). As more hospitals gain experience with the VentrAssist LVAD, and confidence
in clinical performance grows, the Company anticipates that enrolment in the EVERLAST Trial will accelerate.
The Company maintains its plan for completion of enrolment by mid 2010, which it is anticipated will lead to
a regulatory approval by the FDA in 2013.
Research and Development
On the 30 January 2008 the company restructured the Research and