HeartWare International Inc. (NSDQ:HTWR) continued along the road to solvency during the first quarter, posting another period in which it boosted sales and narrowed losses.
The Framingham, Mass.-based cardiac assist device maker reported sales of $10.7 million during the three months ended March 31, up 624.2 percent compared with $1.5 million during the same period last year.
Net losses were $4.5 million, or 35 cents per share, compared with $6.2 million, or 70 cents per share, during Q1 2009.
President and CEO Douglas Godshall said international sales accounted for about 75 percent of total revenues during the quarter and cited a pause in U.S. sales after the company finished enrollment in the Advance bridge-to-transplant trial of its left ventricular assist device ahead of schedule. The Food & Drug Administration cleared the company to enroll 54 more patients in the trial in early April. Godshall said the company resumed implantations of the HVAD device last week.
Also last week the company announced a limited, voluntary recall of some of the controllers for its device, after discovering that a 2009 re-design to make them waterproof inadvertently also made them airtight. When shipped via air, some of those controllers “may be quieter than expected,” according to a press release, which prompted HeartWare to add a vent in December 2009 and begin repairing or replacing affected devices.
Godshall said the company will be “diligent” in implementing the field action and that it expects to file a pre-market approval application with the FDA by the end of the year. FDA approval of a second clinical trial of its device, this time for use as a destination therapy, is expected during the second quarter, and Godshall said the study would begin “soon thereafter.”
