The agreement calls for Research Triangle Park, N.C.-based TransEnterix to retain the distribution rights to SurgiBot, which it shelved last year, outside of the U.S. The FDA in April 2016 denied 510(k) clearance for SurgiBot, saying that the platform does not meet the criteria for substantial equivalence based on the data and information in the application.
The deal with Great Belief also calls for an up-front payment of $7.5 million this month and another $7.5 million by the end of March 2018, including a $3 million equity investment in TransEnterix at $2.33 per share. The $14 million balance represents minimum royalties due on Chinese regulatory approval or after five years, whichever comes first.
“The relationship announced today with GBIL will allow us to advance the SurgiBot System toward global commercialization while significantly reducing our required investment and simultaneously leveraging ‘in-country’ manufacturing in the world’s most populous country,” TransEnterix president & CEO Todd Pope said in prepared remarks. “This is a strong validation of the value of the SurgiBot platform, the world’s only abdominal surgical robot that allows surgeons to remain in the sterile field. We believe this relationship provides us with a significant opportunity to expand our product offerings of robotic solutions for hospitals and patients around the world.”
“We see a tremendous commercial opportunity for the SurgiBot System in China and are extremely enthusiastic to work with TransEnterix to bring this product to China along with the rest of the world,” added GBIL president Gary Wang. “The SurgiBot is unique in so many ways; we believe it can be transformational for our healthcare system.”