HeartWare International Inc. president and CEO Doug Godshall was upbeat in a letter to shareholders accompanying a securities filing, writing that the company is on sound footing despite a move by the U.S. Federal Trade Commission to block its proposed acquisition by Thoratec Corp.
Citing a more than 100 percent increase in consecutive-quarter revenues, which went from $1.4 million during the three months ended March 31 to more than $3 million during the just-ended second quarter, Godshall said a number of factors bode well for the firm.
HeartWare also boosted the capacity and scalability of its manufacturing operation, inked a new agreement with a Dutch logistics management firm that will help significantly reduce European distribution costs and implemented quality-assurance procedures that are coming to resemble those of a more established device maker.
And the rollout of its European sales operation, following the January receipt of CE Mark approval, is going according to plan. Five former clinical trial sites signed on as customers and five new sites have been trained on implanting the devices, with two starting to perform the procedures in July.
In the U.S., HeartWare began a clinical trial in earnest in January; to date 46 patients have received the device at 12 trial sites and the enrollment program is on track to finish by its April 2010 deadline.
Finally, Godshall wrote, two versions of the company’s miniature left-ventricular assist device are in pre-clinical trials and the winner is slated for large-animal testing during the first half of next year.