FDA rejects TransEnterix’s SurgiBot robot

Morrisville robotics developer TransEnterix said Wednesday that federal regulators rejected the company’s application to manufacture and sell a surgical robot it has been developing for the U.S. market.

According to TransEnterix, the Food and Drug Administration said the company’s SurgiBot did not meet the criteria for “substantial equivalence,” based on data TransEnterix submitted last year and this year in response to follow-up questions from the agency.

“The FDA’s decision is extremely disappointing,” said TransEnterix CEO Todd Pope in a statement. “We are in the process or reviewing all aspects of the FDA’s communication.”

TransEnterix said it will provide more information on May 10 when it announces first-quarter earnings.

The surgical robot industry has been dominated by a single surgical robot, called the da Vinci system, for about 15 years. SurgiBot was generating interest because it would have been the second such device approved to perform general surgery on patients in this country.

The 156-employee company announced the FDA decision after close of market trading. TransEnterix stock dropped by 50 percent of its value in after-hours trading, Bloomberg reported.

Several Wall Street analysts said Wednesday they did not know why SurgiBot failed to meet federal approval and had no other details beyond the company’s brief announcement.

The “substantial equivalence” standard means that a device is at least as safe and effective as those already approved.

Most surgeries are still performed manually, but the use of robotics to aid surgeons is expected to become more common in the coming years. The devices insert claspers, cutters and other instruments into the body through incisions, and guide the surgeon’s actions by means of a laparoscopic camera.

TransEnterix had announced plans to apply for approval to use SurgiBot in Europe as well as the U.S. The company also plans to apply for U.S. approval for a second robot, the ALF-X, it bought for $100 million last year that is already approved in Europe but is not yet being sold.

The ALF-X would not be sold in this country until 2017 at the earliest, if it is approved by the FDA.

The FDA’s rejection of SurgiBot renders the ALF-X the company’s most viable product. TransEnterix had already hired about two dozen sales and marketing employees to promote the ALF-X in Europe, where the device has been used in more than 200 colorectal and gynecological procedures.

However, SurgiBot would cost an estimated $500,000 and would be designed for smaller hospitals and surgery centers. The ALF-X and the da Vinci system each cost around $2 million.

TransEnterix had planned to introduce SurgiBot slowly, in just several U.S. hospitals this year, to give surgeons and TransEnterix officials an opportunity to monitor the robot’s performance on live patients.

TransEnterix has built eight complete SurgiBot systems and over 1,200 instruments.

The company employs 20 in Europe and 136 at its Morrisville headquarters, where it designs, builds and tests its robots.

This story was originally published April 20, 2016 at 5:17 PM with the headline "FDA rejects TransEnterix’s SurgiBot robot."