U.S. FDA grants approval to complete enrollment in EndoQuest’s ongoing PARADIGM Trial following the clinical study’s favorable interim safety review

EndoQuest Robotics, Inc., a pioneering leader in endoluminal robotic surgical technology, today announced that the U.S. Food and Drug Administration (FDA) has approved initiation of the next and final stage of its pivotal multicenter trial, the PARADIGM Trial (Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine). The PARADIGM Trial is an Investigational Device Exemption (IDE) study evaluating EndoQuest’s Endoluminal Surgical (ELS) System for use in endoscopic submucosal dissection (ESD) (Clinicaltrials.gov).

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Dr. Eric Haas performing the PARADIGM Trial’s first case in May 2025.

The FDA’s decision follows submission of a report on the safety results of the ELS System for the first set of subjects. This approval allows for completion of enrollment in advance of EndoQuest’s planned De Novo Classification Request for authorization to market the ELS System in the U.S.

This first set of procedures was completed by world-renowned pioneers in endoluminal surgery, including gastroenterologist Dr. Norio Fukami (Mayo Clinic Arizona), who became the world’s first gastroenterologist to perform a fully robotic ESD procedure as part of an IDE trial, and colorectal surgeons Dr. Matthew Albert (AdventHealth Orlando) and Dr. Eric Haas (HCA Houston Healthcare).

“Using the ELS System, I have been able to complete dissections and closures with surgical precision in anatomy that is typically challenging or impossible to address using standard transanal techniques,” said Dr. Haas, Chief of Colorectal Surgery at HCA Houston Healthcare and Houston Methodist Hospital, and lead enroller during the first stage of the PARADIGM Trial. “The platform feels like a natural extension of my robotics skillset as a colorectal surgeon, and I look forward to continuing this trial as we explore how it may expand what’s possible in minimally invasive colorectal procedures.”

John Magnasco, VP of Quality and Regulatory at EndoQuest Robotics, commented: “We continue to be pleased with our clear, timely and positive interactions with the FDA via their Safer Technologies Program (STeP). This approval reflects a collaborative approach that prioritizes patient safety and innovation. We look forward to working closely with the Agency as we move toward De Novo submission.”

The PARADIGM Trial is designed to evaluate the safety and effectiveness of the ELS System in robotic ESD procedures for the removal of lesions in the rectum and sigmoid colon. The study is enrolling 50 subjects across five leading U.S. healthcare institutions: HCA Healthcare (Houston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), Brigham and Women’s Hospital (Boston), and AdventHealth (Orlando).

Eduardo Fonseca, CEO of EndoQuest Robotics, commented: “With every case, we advance toward defining a new category of surgery and further build on our leading position to establish robotics in the endoscopic suite. This milestone brings us closer to delivering meaningful value for patients, physicians, and healthcare systems.”

“We are highly encouraged by the positive results of the first stage of our trial and the dedication of our investigators,” said Dr. Todd Wilson, Chief Medical Officer and Chairman of the International Advisory Board of EndoQuest Robotics. “Our mission is to redefine what’s possible in minimally invasive procedures and enable the next shift in patient outcomes. This approval to complete enrollment in our pivotal trial is a testament to the progress we have made towards achieving that goal.”

About the ELS System

The ELS System is designed to enable endoluminal procedures with the visualization, precision, and main tenets of conventional surgical technique, allowing for surgical tasks and maneuvers not currently possible in advanced therapeutic endoscopy. The ELS System combines the flexibility of endoscopy that can navigate the curvature of gastrointestinal anatomy with the conventional surgical technique and precision enabled by a robotic surgical system. The result is the capability to perform complex surgery in locations not previously possible via natural orifice access, avoiding external incisions and bringing the physician directly to the target of disease.

About EndoQuest Robotics

EndoQuest Robotics is a leading innovator in the development of transformative endoluminal robotic technologies. EndoQuest is focused on addressing unmet needs in gastrointestinal medicine and endoluminal surgery by enabling physicians with unprecedented surgical access, precision, and flexibility. The Company’s proprietary technology is designed to navigate and perform scar-free procedures through the body’s natural orifices, allowing for the least invasive surgical approach. For more information, visit www.endoquestrobotics.com.

EndoQuest’s Endoluminal Surgical System is an investigational device, has not been cleared by the FDA, and is not yet available for commercial sale in the United States.

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