RADNOR, PA / ACCESSWIRE / June 27, 2016 / The law firm of Kessler Topaz Meltzer & Check, LLP announces that a shareholder class action lawsuit has been filed against TransEnterix, Inc. (TRXC) ("TransEnterix" or the "Company") on behalf of purchasers of the Company's securities between February 10, 2016 and May 10, 2016, inclusive (the "Class Period").
Investors who purchased their TransEnterix securities during the Class Period may, no later than August 1, 2016, petition the Court to be appointed as a lead plaintiff representative of the class.
Shareholders who wish to discuss this action or request additional information about the lawsuit are encouraged to contact Kessler Topaz Meltzer & Check attorneys D. Seamus Kaskela or Adrienne O. Bell at (888) 299 - 7706 or online at: https://www.ktmc.com/new-cases/transenterix-inc#join.
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 TransEnterix and its executive officers 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.