Investors have pared 30.0% from HeartWare International (NSDQ:HTWR) since the company said yesterday that it may not be able to resume a trial of its MVAD implantable heart pump next month, 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, said it began investigating reports of adverse events in certain trial subjects, but didn’t explain the nature of the events other than to say that they’re “typical of those seen in other clinical trials for ventricular assist devices.”
“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,” the company said in a regulatory filing.
The news sent HTWR shares down -12.1% to a $44.03 close yesterday; the stock was off another -20.4% to $35.04 in early trading today.
HeartWare launched the prospective, non-randomized, single-arm study in July. It’s slated to enroll 60 patients, who will be implanted with the MVAD pump via sternotomy or thoracotomy, with a primary endpoint of survival at 6 months. Eleven patients are enrolled in the trial, CEO Doug Godshall told analysts at the Wells Fargo healthcare conference in Boston last month.
