NEW YORK, Jan. 25, 2016 /PRNewswire/ -- Attorney Advertising-- Bronstein, Gewirtz & Grossman, LLC notifies investors that a securities class action has been filed in the United States District Court for the Southern District of New York on behalf of the St. Paul Teachers' Retirement Fund Association against HeartWare International, Inc. ("HeartWare" or the "Company") (NASDAQ: HTWR) between June 10, 2014 and January 11, 2016 inclusive (the "Class Period").
HeartWare is a medical device company that develops and manufactures miniaturized implantable heart pumps.
The complaint alleges that Defendants violated Federal Securities Laws throughout the Class Period. More specifically, the plaintiff claims 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 plaintiff says that 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.
HeartWare reported that its annual Total Revenue rose from $110.92 million in 2012 to $278.42 million in 2014 and that its respective Net Loss declined from $87.72 million to $19.37 million.
On September 1, 2015, HeartWare International, Inc. announced the 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 had paused its MVAD clinical trial to address an MVAD controller manufacturing process issue.
On October 13, 2015, HeartWare announced that following the company's investigation of causes of reported adverse effects in certain clinical trial patients, HeartWare might not re-initiate enrollment in the MVAD clinical trial in November as it had previously planned.
On January 11, 2016, HeartWare provided corporate updates and announced preliminary revenue expectations for the fourth quarter of 2015.
The plaintiff says that the announcement 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.
Following each of these disclosures, HeartWare shares declined 72%, from $90.71 per share in late July 2015 to as low as $25.02 per share on January 12, 2016. On January 22, 2016, HeartWare shares closed at $34.50 per share.
No Class has yet been certified in the above action. If you wish to review a copy of the Complaint or join the action, please visit the firm's site http://www.bgandg.com/#!htwr/adgl7. To discuss this action, or for any questions, please contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484 or via email firstname.lastname@example.org. Those who inquire by e-mail are encouraged to include their mailing address and telephone number. If you suffered a loss in HeartWare International, Inc. you have until March 22, 2016 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.
Bronstein, Gewirtz & Grossman, LLC Peretz Bronstein or Yael Hurwitz 212-697-6484 | email@example.com
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