HeartWare International, Inc. (HTWR)

[cjgaddy]

10-12-15: Heartware Updates on MVAD Trial; May Not Restart as Expected
Heartware (NASDAQ: HTWR) disclosed the following on Tuesday 10-13-15:
On Oct. 12, 2015, HeartWare Intl., 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 September 9, 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 September 9, 2015.

“Subsequent to that action and following discussions with the Company’s 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 potential for the MVAD design to meaningfully improve outcomes for ventricular assist patients. HeartWare intends to provide additional commentary related to the MVAD clinical trial on its third quarter financial results call and webcast scheduled for October 29, 2015. It has been, and remains, the intention of the Company to present and publish clinical data following the completion of enrollment and follow-up for all trial patients.”
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