A Houston surgical robotics company has gotten a Investigational Device Exemption from the FDA to go forward with human trials.

This news allows EndoQuest Robotics to begin its Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM) study, which will be conducted at leading United States health care facilities, including Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and HCA Healthcare (Houston). The study will include surgeries on 50 subjects, who will hopefully begin to enroll in January.

“The foundational thesis is we're trying to make sure that the world's largest medical center is also the world's largest med tech innovation center,” Eduardo Fonseca, interim CEO of EndoQuest Robotics, tells InnovationMap.

His company is well on its way to helping to assure that, through making history of its own. EndoQuest is behind the world's first Flexible Robotic Surgical System, a technology that may one day transform surgery as we know it.

The idea to use these novel robots for surgery came from Dr. Todd Wilson, a surgeon at UTHealth Houston, who spent his medical education, residency, and fellowship at the institution.

“I had really focused in my practice on trying to do everything possible to improve outcomes for patients,” Wilson explains. “And there seemed to be a pretty good correlation that the smaller the incisions or the fewer incisions, the better patients would do.”

The stumbling block? The necessary small incisions are difficult for human surgeons to make with current technology. But UTHealth was part of the solution.

“Right there in the University of Texas was a microsurgical lab where they were focusing on trying to develop robotics, but the application was still a little bit fuzzy,” Wilson says.

Using their innovations to solve Wilson’s problem turned out to be the start of the company now known as EndoQuest Robotics.

The first indication for the system is for colon lesions. But in the future it could be used for practically any minimally invasive surgery (MIS). That means that the robots could help to perform anything from a tonsillectomy to cholecystectomy (gallbladder removal) to non-invasive colorectal procedures, should those lesions prove to be cancerous.

According to Fonseca, last year was the first on record that there were more MIS, including laparoscopic and robotic surgeries, than conventional ones in the U.S. The time is right to forge ahead with the flexible robotic surgical system. Days ago, the EndoQuest team announced that its Investigational Device Exemption (IDE) application for its pivotal colorectal clinical study was approved by the FDA.

“Our end point is a device that can be mass-manufactured and very safe for patients and has a short learning curve, so therefore, we intend to learn a lot during these trials that will inform our ultimate design,” says Fonseca.

He adds that it’s a “brilliant” group of engineers that has set EndQuest apart, including both teams in Houston and in South Korea.

“We can move twice as fast as anyone else,” jokes engineer Jiwon Choi.

Despite the extra brain power provided by the South Korea engineers, Fonseca says that EndoQuest’s beginnings are “as much of a Houston story as you could find.”