TransEnterix shareholders who wish to discuss this action and their legal options are encouraged to contact Kessler Topaz Meltzer & Check, LLP (Darren J. Check, Esq., D. Seamus Kaskela, Esq. or Adrienne O. Bell, Esq.) at (888) 299-7706 or at email@example.com.
TransEnterix is a medical device company that seeks to use flexible instruments and robotics to improve the outcomes of minimally invasive surgery. On June 1, 2015, TransEnterix reported that it submitted a 510(k) application to the United States Food and Drug Administration ("FDA") for clearance of the Company's SurgiBot System (the "SurgiBot"), a single-port, robotically enhanced laparoscopic surgical platform. As detailed in the complaint, during the Class Period the defendants made numerous positive statements about the SurgiBot and its expected FDA clearance.
The complaint alleges that throughout the Class Period the defendants issued materially false and misleading statements and/or failed to disclose material adverse information to investors. Among other things, the complaint alleges that the defendants failed to disclose deficiencies within the SurgiBot 510(k) submission that undermined the likelihood that the SurgiBot would receive FDA clearance, which would thus leave the Company unable to commercialize the SurgiBot in 2016 and would impair the Company's ability to obtain approval for and commercialize its other robotic surgery platform in the United States.
As further detailed in the complaint, on April 20, 2016, TransEnterix disclosed that the FDA notified the Company that it had "determined that the SurgiBot System does not meet the criteria for substantial equivalence based upon the data and information submitted by TransEnterix in its 510(k) submission." Following this news, shares of the Company's stock declined $2.47 per share, or over 52%, to close on April 21, 2016 at $2.27 per share, on unusually heavy trading volume.
Subsequently, on May 10, 2016, TransEnterix reported that it "currently believes that a new 510(k) submission would be required to obtain clearance" for the SurgiBot, and that it had "decided to reprioritize its near-term regulatory efforts and focus" on a separate 510(k) submission for an alternative robotic surgical device. Following this additional news, shares of the Company's stock declined an additional 10%, to close on May 11, 2016 at $1.84 per share, again on heavy trading volume.
Members of the class may, no later than August 1, 2016, petition the Court to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. In order to be appointed as a lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class in the action. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.
Kessler Topaz Meltzer & Check prosecutes class actions in state and federal courts throughout the country. Kessler Topaz Meltzer & Check is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world. The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars). The complaint in this action was not filed by Kessler Topaz Meltzer & Check. For more information about Kessler Topaz Meltzer & Check, or for additional information about participating in this action, please visit www.ktmc.com.
Kessler Topaz Meltzer & Check, LLP
Darren J. Check, Esq.
D. Seamus Kaskela, Esq.
Adrienne O. Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087
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SOURCE Kessler Topaz Meltzer & Check, LLP