HeartWare International Inc. (NSDQ:HTWR) shares continue to labor under hard downward pressure this afternoon as the company responded to reports that a Wisconsin hospital suspended clinical trials of its mechanical heart pump after a patient implanted with the device developed a blood clot that caused it to malfunction.
At last look, the stock was down nearly 4 percent to $84.13 a share, down $3.24.
Reuters, citing a source familiar with the situation, early today said Aurora St. Luke’s Medical Center in Milwaukee recently suspended new implants after the patient — who was also treated with a blood-thinning drug — later suffered an intra-crancial hemorrhage.
In a emailed statement to Reuters, HeartWare officials declined to confirm or deny the incident but said, “if an event occurs at a site, that event is reported to the Food & Drug Administration as appropriate.”
CEO Doug Godshall reportedly fielded several questions during a conference call this morning to discuss Q4 financial results at HeartWare, but also declined to directly address the moratorium. Reuters was reporting that Godshall noted that although clotting is relatively rare, physicians understand that it can — and does — occasionally occur.
The reported moratorium overshadowed HeartWare’s better-than-expected fourth quarter results, which included a 70.9 percent jump in revenues due to strong international sales. The ventricular assist devices currently are approved for use inside the European Union and now are being tested in the U.S. for regulatory review. Overall, the company reported a $7 million net loss on $20.9 million in revenues.
Bulls briefly carried the stock within range of yesterday’s close at $87.37 shortly after the opening bell, but soon yielded to steady selling as shares slid under $84 by 11 a.m. Another short-lived rally lifted the stock back near $85 during the noon hour, before selling brought HeartWare back near its current range.
