According to the law firm press release, HeartWare is a medical device company that develops and manufactures miniaturized implantable heart pumps. The Complaint alleges that during the Class Period, HeartWare and certain of its senior executives violated provisions of the Exchange Act by making numerous false and misleading statements and omissions of material fact, including in press releases and in statements during conferences and conference calls with analysts and investors. Specifically, the Complaint alleges that after the U.S. Food and Drug Administration ("FDA") issued a Warning Letter identifying numerous manufacturing and other regulatory failures at the Company's sole manufacturing facility, Defendants falsely assured investors that the Company had addressed those problems, and that they therefore posed no risk to the clinical trials or timely approval of MVAD, a pump that HeartWare is presently developing.
The truth concerning the Company's failure to remediate the regulatory failures identified by the FDA and its impact on the viability of MVAD was revealed through a series of disclosures. On September 1, 2015, HeartWare announced a highly dilutive acquisition of Valtech Cardio, Ltd., a manufacturer of medical devices used to treat heart disease. The Complaint alleges that this disclosure revealed significant obstacles to the timely approval of MVAD. On September 9, 2015, HeartWare disclosed that it was halting enrollment in the MVAD trial because of a manufacturing problem with the device. On October 12, 2015, HeartWare disclosed that patients in the MVAD trial had suffered adverse events, and that the trial would be further delayed. And on January 11, 2016, the Company revealed that problems with MVAD had resulted in serious adverse events in nearly half of the patients so far implanted with the device, and that the trial would be delayed indefinitely. In response to each of these disclosures, the price of HeartWare's common stock declined significantly. In total, HeartWare's common stock fell 72% from its Class Period high to close at $26.50 per share on January 12, 2016.
On April 11, 2016, the Court issued an Order appointing Lead Plaintiff and approving Lead Counsel. Lead Plaintiff filed an amended complaint on June 29.