TransEnterix Inc. (NYSEMKT: TRXC) watched its shares in free fall on Thursday morning following a devastating judgment by the U.S. Food and Drug Administration (FDA). The company announced after the markets closed on Wednesday that the FDA notified TransEnterix that it has determined that the SurgiBot System does not meet the criteria for substantial equivalence based on the data and information submitted.
TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options.
The company is focused on the development and commercialization of the SurgiBot System, a single-port, robotically enhanced laparoscopic surgical platform, and the ALF-X System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye tracking camera control. The SurgiBot System is not yet available for sale in any market.
Todd M. Pope, president and CEO of TransEnterix, commented:
The FDA’s decision is extremely disappointing. We are in the process of reviewing all aspects of the FDA’s communication. We will work to complete this review, and will provide an update on the regulatory strategy for the SurgiBot System together with our first quarter 2016 financial and operating results during our quarterly conference call on May 10, 2016.
Shares of TransEnterix were traded down over 60% at $1.82 early Thursday morning, with a consensus analyst price target of $6.29 and a 52-week trading range of $1.54 to $6.10.
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