HeartWare International (NSDQ:HTWR) said today that it’s on track to restart a CE Mark trial for its MVAD implantable heart pump.
Investors initially pared 30.0% from HTWR shares after the company said Oct. 12 that it might not be able to resume the trial as soon as was expected. Framingham, Mass.-based HeartWare, which put a hold on enrollment in its CE Mark trial Sept. 9 due to controller manufacturing and software issues, added that it began investigating reports of adverse events in certain trial subjects “typical of those seen in other clinical trials for ventricular assist devices.”
“Since then, we have identified a solution, tested the solution and as of this week, have passed our validation with 100% success and are now restarting production of controllers – on schedule. We wouldn’t be doing this obviously unless we expected to be restarting the trial,” president & CEO Doug Godshall told analysts today during a conference call. “As we finish up our controller work and determine what if any process, or other enhancements, we will make to the MVAD pump, we will be better able to provide specific projections for when the trial will restart.”
“We are also reviewing reported adverse events, which are typical of those seen in other clinical trials for ventricular assist devices, and we are confident that we will resolve the issues in order to resume the MVAD CE Mark clinical trial,” Godshall added in prepared remarks.
HeartWare also reported vastly wider 3rd-quarter losses of -$29.9 million, or -$1.73 per share, on a -5.0% sales decline to $65.2 million for the 3 months ended Sept. 30. Adjusted earnings per share were -$1.36, 79¢ off of the expectation on Wall Street, where analysts were looking for sales of $67.5 million.
“Our financial performance during the 3rd quarter demonstrated the underlying strength of our business but was impacted by anticipated headwinds, including clinical trial activity and foreign currency fluctuation,” Godshall said. “The HVAD system drove strong, double-digit international unit sales growth for the 2nd quarter in a row, signifying continued physician confidence in HVAD as the leading ventricular assist therapy for end-stage heart failure.
“In early August, we successfully completed enrollment in the 465-patient Endurance2 destination therapy study of our HVAD system. As a result, we sold 15 units for the destination therapy study in the 3rd quarter of 2015, compared to 62 units sold for this study in the 3rd quarter of 2014. Exclusive of Endurance2 trial units, U.S. unit sales increased by approximately 4% over the 3rd quarter of 2014,” he said.
HeartWare plans to submit 1-year follow-up data from Endurance2 next summer, ahead of a bid for pre-market approval from the FDA late in 2015, Godshall said.
HTWR shares were up 1.0% to $43.72 apiece today in late-morning trading.
