TransEnterix's management details OUS commercialization of its ALF-X System--now rebranded as the Senhance Surgical Robotic System--and progress toward filing for FDA clearance.

TransEnterix, the Morrisville, NC-based company that had hoped to win FDA clearance for its SurgiBot system earlier this year, has continued its efforts to bring a surgical robotic system to the U.S. market. That plan appears to be on track, though FDA's request for more in-depth usability studies may mean a slightly longer timeline until a regulatory filing.

After shifting immediate focus from SurgiBot to the ALF-X System acquired in 2015, TransEnterix management said earlier this year that they anticipated filing a 510(k) submission for the ALF-X System with FDA by the end of 2016. Now, that filing has been pushed to early 2017 as the company conducts more work on the system's usability, according to management commentary on the company's third quarter earnings call this week. In addition, the ALF-X System was rebranded as the Senhance Surgical Robotic System in September. FDA clearance is still expected in 2017.

"In our view, the most important takeaway from our series of pre-submissions is that the FDA's expectations for completing the usability studies presents a very high bar," Todd Pope, TransEnterix president and CEO, explained, according to a Seeking Alpha transcript of the earnings call. "To best position ourselves for a favorable outcome of these studies for our Senhance submission, we believe we will need to increase the scope of work regarding usability."

Stifel analyst Rick Wise wrote in a Nov. 9 research note that successful usability studies will require surgical teams to be able to use the Senhance System safely. "Per FDA guidelines, these surgical teams have never worked together previously, and the company cannot be present during procedures," Wise added.

The Senhance System has CE Mark and uses direct sales representatives, indepedent sales agents, and distributors to sell the systems. With large capital equipment, the sales process can take much longer than other medical devices. Pope explained that the Senhance sales cycle seems to take about four to six quarters to end in a placement, and that the company saw an almost 40% increase in qualified prospective accounts in the third quarter.

This week, TransEnterix announced a Senhance System was installed through a partnership with Imperial College London and St. Mary's Hospital of the Imperial College Healthcare NHS Trust. Imperial College London will also be a site in the company's new Clinical Leadership Program, an effort to work with key thought leaders, increase system use for more types of procedures, and add to clinical data on the system.

Also this week, TransEnterix announced that Getz Healthcare will be the exclusive distributor for Senhance in Australia and New Zealand. The company also has distribution agreements--many of which come with minimum purchase requirements--in Taiwan, Kuwait, and the United Arab Emirates, Pope said.

TransEnterix hasn't forgotten about the SurgiBot, either. The company's management has been having "frequent and highly collaborative" discussions with FDA on that system and "we believe that we have a clear path forward towards a future SurgiBot 510-k clearance," Pope said. Still, he emphasized that Senhance is the company's main focus for now, and a 510(k) resubmission for SurgiBot will be considered after the Senhance filing.

[Image courtesy of TRANSENTERIX, INC.]