Key Dates and Milestones

HeartWare's primary focus is the rapid progression of its lead product, the HVADTM Left Ventricular Assist Device, through clinical trials and towards regulatory approvals. The Company's key short term milestones in this regard are as follows:

 

Complete CE mark clinical trial enrolment (20 patients)

Submit applications for European regulatory approval

Receive EU reguatory approval (CE Mark)

Commence commercial sales in Europe

Submit IDE Application to US FDA

Commence US BTT Clinical Trial

Complete Enrolment in US BTT Clinical Trial

Q3 2007 (achieved)

Q3 2008 (achieved)

Q4 2008

Q1 2009

Q1 2008 (achieved)

Q3 2008 (achieved)

Q4 2009