Surgical robot by Morrisville company could win approval this year

Katy Fitzgerald moves pegs using SurgiBot, a surgical robot designed by TransEnterix in 2016.
Katy Fitzgerald moves pegs using SurgiBot, a surgical robot designed by TransEnterix in 2016. 2016 News & Observer file photo

Morrisville surgical robot maker TransEnterix posted $1.9 million in revenue for the first quarter, mostly from the sale of its Senhance surgical device to a German hospital. The sale, in February, provides an indication of the machine’s retail cost, which is pegged to compete in a market almost exclusively dominated by a California robotics company for more than 15 years.

TransEnterix, which previously announced a Senhance sale to an Italian hospital in August, said this week it has $48 million in cash, enough to finance operations into the second quarter of 2018. TransEnterix is attempting to break into a robotics field dominated by Intuitive Surgical, a company that makes a robot called the da Vinci Surgical System.

TransEnterix expects a decision later this year from the Food & Drug Administration on whether its Senhance unit, which is approved for commercial sale in Europe, will be approved for the U.S. market. The FDA last year rejected TransEnterix’s application for another robot, called the SurgiBot, but TransEnterix officials told Wall Street analysts this week that they are confident the FDA will rule in their favor this time.

The reason for their confidence is that that the Senhance model has an established track record in Europe, and TransEnterix was able to submit data to the FDA from about 200 operations performed in Europe. The robot has been used by 18 surgeons, in seven hospitals, and in five specialties: gynecology, colorectal, general surgery, urology and thoracic.

“We are doing surgery safely and effectively each and every day,” TransEnterix CEO Todd Pope told analysts.

TransEnterix reported Wednesday that it lost $15.4 million in the first quarter, compared to a net loss of $12.9 million a year ago. Even though the company posted revenue of $1.9 million, the spent $1.3 million to generate that revenue through its field service organization, which supports robot sales and implementation. Also contributing to TransEnterix’s revenue are sales of Senhance instruments used in surgeries.

John Murawski: 919-829-8932, @johnmurawski