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Actionable news in HTWR: Heartware International, Inc.,

Regulation FD

HeartWare

or the

Company

), posted the following statement to the Investor Relations section of its corporate website (ir.heartware.com) in connection with its MVAD

Ventricular Assist System CE Mark clinical trial:

As previously disclosed on September9, 2015, HeartWare paused its MVAD clinical trial to address an MVAD controller manufacturing process issue. HeartWare is in the process of implementing manufacturing improvements as well as software updates, which were also described on September9, 2015.

Subsequent to that action and following discussions with the Companys trial investigators, HeartWare began investigating causes of reported adverse events in certain clinical trial patients. The events being analyzed are typical of those seen in other clinical trials for ventricular assist devices. HeartWare took similar actions successfully during its initial human study for the HVAD

System during the HVAD CE Mark clinical trial in 2007. Although HeartWare may not re-initiate enrollment in the MVAD clinical trial in November as it previously expected, HeartWare remains confident in its MVAD System and the...


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