TransEnterix FDA rejection could put Titan neck-and-neck for clearance

The FDA’s rejection of TransEnterix‘s (NYSE:TRXC) 510(k) application for its SurgiBot robotic surgery system could have tightened the race between it and Titan Medical (CVE:TMD) as both companies look release a robotic system to compete with robotic surgery big-fish Intuitive Surgical (NSDQ:ISRG).

The FDA rejection resulted in an over 50% share drop at TransEnterix, who seemed sideswiped, saying that it would update on its regulatory strategy during its Q1 earnings call on May 10.

The delay could push back the date for approval for Surgibot as far as 12 months, according to medtech analysis group EP Vantage. The firm said the delayed date could put both TransEnterix and Titan Medical on a similar timeframe for U.S. clearance for their robotic systems.

Both companies are seeking to produce surgical robotic platforms that are smaller and cheaper than Intuitive’s da Vinci, though TransEnterix was expected to hit the market 1st.

Titan Medical’s device is not expected to be cleared for sale until next year – which will fall closer to TransEnterix’s release if the company resubmits its application, EP Vantage said. The closer timeframe for release could sway more people to Titan Medical’s system, which is more similar to the da Vinci, EP Vantage said.

“If TransEnterix had had a year or so on the market before Titan entered, it might have been able to build a following for a system quite far removed from the dominant da Vinci, especially considering its much lower price – da Vinci platforms go for around $2m. If SurgiBot and Sport hit roughly together, though, surgeons might prefer the more familiar-seeming Sport system,” EP Vantage wrote.

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