HeartWare International Inc. landed a nod from the Food & Drug Administration for the Advance clinical trial of its ventricular assist system, allowing it to expand from 28 to 40 sites.
The Framingham, Mass.-based firm said the 150-patient bridge-to-transplant trial is examining whether the HVAD device is suitable to keep end-stage heart failure patients alive until transplantation of a new heart.
President and CEO Doug Godshall said the company anticipates finishing enrollment in the trial during the first half of 2010.
There are now 22 sites involved in the study, with 69 patients enrolled.
HeartWare had a busy summer, beginning with the implosion of its $282 million merger with Thoratec Corp. after the Federal Trade Commission said it would sue to stop the deal on anti-trust grounds.
The company wasted no time in lining its coffers, taking a loan and selling stock to help offset losses.
Its onetime suitor, Thoratec, agreed to a $4 million loan, and HeartWare raised $24 million in a private stock placement.
The company posted a $6.9 million net loss for the three months ended June 30, on about $3 million in sales.
Company officials said they expect the infusions to be sufficient to support its operations through the end of 2010.
