TransEnterix (NYSE:TRXC) yesterday said the FDA isn’t finished reviewing the 510(k) application for its SurgiBot robot-assisted surgery device, meaning the decision it had expected to come during the 1st quarter isn’t likely to happen until mid-April.
Research Triangle Park, N.C.-based TransEnterix claims SurgiBot as the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s bedside and operate through a single port. In February the company said it had finalized the clearance application and expected a decision before the end of March.
But after a recent FDA update the company said it’s revising its outlook on the timing.
“We have been engaged in constructive dialogue with the FDA throughout the entire submission process,” president & CEO Todd Pope said yesterday in prepared remarks. “We appreciate the proactive exchange with the FDA and look forward to their decision, and continue to expect clearance for the SurgiBot.”
Late last month, TransEnterix saw shares surge on speculation that the robot-assisted surgery company could be acquired by Johnson & Johnson (NYSE:JNJ), after J&J chairman & CEO Alex Gorsky said the healthcare conglomerate is back in the acquisition game now that valuations have come down. That fueled speculation that TransEnterix could be in J&J’s sights, even though the company is already in bed with Google‘s (NSDQ:GOOG) Verily Life Sciences to form robotic surgical venture Verb Surgical.
TransEnterix is battling with Titan Medical (CVE:TMD) in the race to challenge robot-assisted surgery’s dominant player, Intuitive Surgical (NSDQ:ISRG), and its da Vinci system. Titan is anticipating a mid-2017 debut for its Sport offering.