TransEnterix Inc. said Thursday that it hopes to begin selling its robotic surgical device in the U.S. in 2018.
The company received Food and Drug Administration approval last month. It must notify the FDA of its intent to market a medical device at least 90 days in advance.
“There is a significant opportunity for the Senhance in the U.S., with millions of laparoscopic procedures done each year using basic manual tools,” said CEO Todd M. Pope.
“As we look to 2018, we are focused on the clinical and commercial success of Senhance in the U.S. while continuing to build on our commercial momentum in Europe and Asia.”
For the third quarter of 2017, TransEnterix reported revenue of $183,000, compared to $1.4 million in the same quarter of 2016. The decrease was associated with deferred service revenue from previous system sales, which aren’t reported until clinical use of each system commences.
During the third quarter, TransExterix sold one Senhance system in Taiwan, but does not yet have approval for clinical use. Clearance is expected in 2018.
The company reported quarterly net loss per share of 26 cents, compared to net loss of 11 cents in the third quarter of 2016. Wall Street analysts expected net loss per share of 9 cents.
TransEnterix is a medical device company that uses robotics to improve and facilitate minimally invasive surgery.
The company’s stock closed Thursday at $2.89 per share, up 20 cents, or 7.43 percent.
TransEnterix stock is trading at $3.02 per share, up 9 cents or 3.11 percent, in after-hours trading.
The filing can be found here.