April 25, 2016      

TransEnterix Inc. has long been planning to seek approval for its surgical robots in Europe. SurgiBot was part of the company’s plan to develop two surgical robots simultaneously. However, last week’s rejection by the U.S. Food and Drug Administration was a significant setback for Morrisville, N.C.-based TransEnterix.

TransEnterix officials acknowledged that the robot maker’s application to produce and market SurgiBot for the U.S. market now stands canceled. According to the agency, the surgical robot failed to meet standards of “substantial equivalence,” based on the information that the company submitted last year and in answer to the agency’s follow-up questions.

The decision followed after the FDA asked TransEnterix to submit additional data in February, which led the company pushing back the deadline for SurgiBot approval from March to April 2016. The FDA decided to reject the bot under 510(k) guideline.

This automatically results in the FDA classifying the innovation as Class 3 equipment that needs to be clinically tested and subsequently approved via the strictest premarket consent, or PMA, pathway. To get a nod from FDA, TransEnterix must still prove that it surgical robot is equivalent to those already sold in the market.

Over the past few months, there was speculation that SurgiBot would be the second robotic device after Intuitive Surgical Inc.‘s da Vinci to be approved to conduct general surgery.

Johnson & Johnson was rumored to be considering TransEnterix as a potential acquisition target. Alex Gorsky, CEO of the drug giant, had said that his company is on the lookout for profitable takeovers, particularly in the medical equipment field. But the delayed approval is likely to jeopardize this. TransEnterix’s stocks dripped by approximately 50 percent during after-hours trading, as reported by Bloomberg.

The FDA scrutinizes surgical robots

This isn’t the first time the U.S. government has questioned the capabilities of surgical robots. The FDA has affected the market with safety recalls for early versions of the da Vinci, and it has been increasingly concerned about the level of training for medical practitioners.

Still, the FDA can be flexible. Jeffrey Shuren, who headed the office in 2011, established a mechanism for extensive review in which a case manager mentors each application and engineers have access to experienced agency scientists.

Medical devices are considered as one of the highly regulated portions of the electronics industry, and the FDA is one of the most respected regulatory bodies in the world. Obtaining FDA approval isn’t easy.

An applicant is expected to take a strict approach when it comes the early design controls, reporting through to production and final quality assurance, adhering to the QSR (Quality System Regulation) as well as the ISO 13485-2003 standard for manufacture of medical devices.

TransEnterix's ALF-X surgical robot

TransEnterix expects $2 million in European sales of its ALF-X surgical robot.

Next steps for SurgiBot, ALF-X

The FDA’s move on SurgiBot forces TransEnterix to take on expensive trials to prove its product’s safety and efficiency.

“We will work to complete this review and will provide an update on the regulatory strategy for the SurgiBot system together with our first-quarter 2016 financial and operating results during our quarterly conference call on May 10, 2016,” said Todd M. Pope, CEO and president of TransEnterix.

Following SurgiBot’s approval, the manufacturer had plans to apply for another surgical robot — ALF-X. This laparoscopic machine was purchased from Italy-based SOFAR SpA about $100 million last year.

While authorities have approved it for the European market, its sales are yet to commence. ALF-X is expected to generate about $2 million in sales.

Also, industry experts have said they believe that the FDA’s denial of the SurgiBot application would obstruct ALF-X’s approval, which is expected to be viable in Europe. Officials at TransEnterix have recruited over two-dozen sales and marketing professionals for the European market.

Sources revealed that company is reviewing different aspects of its communications with the FDA.

According to a report titled “World Surgical Robotics Market — Opportunities and Forecast, 2014 to 2020,” Big Market Research predicts that the industry will register a compound annual growth rate of 10.2 percent through 2020.

The surgical robotics sector was valued at $3.3 billion during the forecast period, the report also said. Research analysts studying the medical robotics industry forecast that the sector is likely to garner $6.4 billion in sales by 2020.

Prominent vendors covered in Portland, Ore.-based Big Market’s report include Stanmore Implants Worldwide Ltd., Blue Belt Technologies Inc., Zimmer Holdings Inc., and Hansen Medical Inc.

About the author: Pranjal Mehta is senior digital marketing engineer at Big Market Research.