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Home » TransEnterix finalizes response to FDA over 510(k) for SurgiBot

TransEnterix finalizes response to FDA over 510(k) for SurgiBot

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TransEnterixTransEnterix (NYSE:TRXC) said today it finalized its response to the FDA in relation to the 510(k) application for its SurgiBot system.

Research Triangle Park, N.C.-based TransEnterix says the SurgiBot is the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s bedside and operate through a single port.

“We are pleased to have completed our response to the FDA and strengthened our balance sheet. We continue to expect FDA clearance for the SurgiBot System in the 1st quarter of this year, and our cash position allows us to accelerate our transition to commercializing both the ALF-X and the SurgiBot,” CEO Todd Pope said in prepared remarks.

The company touted a strengthened balance sheet, raising $18 million at an average of $3.23 per share under its $25 million ATM equity sales facility it established last year. TransEnterix said it is filing a new ATM facility, looking to raise up to $43.6 million through January 2017.

Late last month, TransEnterix saw shares surge on speculation that the robot-assisted surgery company could be acquired by Johnson & Johnson (NYSE:JNJ).

Johnson & Johnson chairman & CEO Alex Gorsky said this week that the healthcare conglomerate stayed off the mergers & acquisitions trail last year because valuations were too high. That’s not the case this year, Gorsky said.

“As we reflect back on 2015 we realize that the market was premium priced. We remained very active in a number of different areas. And while we didn’t necessarily close on a larger deal, I would not assume that we were not engaged and involved,” Gorsky said Jan. 26 during a conference call, according to Seeking Alpha.

That’s fueled speculation that TransEnterix could be in J&J’s sights, even though the company isalready 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. TransEnterix’s SurgiBot is expected to hit the U.S. market during the 1st quarter this year; Titan’s Sport offering is anticipated for mid-2017.

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