According to the law firm press release, TransEnterix is a medical device company that seeks to use flexible instruments and robotics to improve the outcome of minimally invasive surgery, including through its SurgiBot System (“SurgiBot”), a single-port, robotically enhanced laparoscopic surgical platform. On June 1, 2015, the Company announced that it had submitted its 510(k) application to the United States Food and Drug Administration (“FDA”) seeking “substantial equivalence” approval that would enable TransEnterix to begin marketing and selling the SurgiBot in the United States.
The complaint alleges that during the Class Period, defendants issued false and misleading statements and/or failed to disclose adverse information regarding key aspects of the Company’s business. Specifically, the complaint alleges defendants failed to disclose deficiencies within the Company’s 510(k) submission regarding the SurgiBot that undermined the likelihood that the SurgiBot would receive FDA clearance, which would 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 a result of these false statements and/or omissions, TransEnterix common stock traded at artificially inflated prices during the Class Period, reaching as high as $5.69 per share.