By a News Reporter-Staff News Editor at Clinical Trials Week -- Roy Jacobs & Associates announces that it has commenced an investigation as to whether the Board of Directors of HeartWare International, Inc. ("HTWR" or the "Company") violated their fiduciary duty and, if so, what legal action can be taken to protect shareholders' and the Company's interests (see also Roy Jacobs & Associates).
For further information, please call Roy L. Jacobs toll-free at 1-888-884-4490 or E-mail at firstname.lastname@example.org.
HeartWare is a medical device company that develops and manufactures miniature heart pumps that are implanted into the patient's body. It has been alleged that after the U.S. Food and Drug Administration ("FDA") issued a Warning Letter to the Company identifying numerous manufacturing and other regulatory failures at the Company's sole manufacturing facility, various officers and directors misled investors, in violation of their fiduciary duties, when they assured investors that the Company was addressing problems with HeartWare's manufacturing and other regulatory failures. The officers and directors repeatedly told investors that the items the FDA noted in its Warning Letter posed no risk to the clinical trials or timely approval of its new MVAD pump.
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. Finally, on January 11, 2016, the Company revealed that problems with MVAD caused 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 dramatically from its recent high to close at $34 per share on January 25, 2016.
If you are a long term holder of HeartWare shares and intend to hold your shares and wish to discuss potentially joining in an action to protect your rights, or have any questions concerning this notice, please contact Roy Jacobs. Mr. Jacobs will personally speak with you at no cost or obligation. View source version on businesswire.com: http://www.businesswire.com/news/home/20160126006269/en/
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