EndoQuest Robotics announced today that it has acquired an investigational device exemption (IDE) from the FDA for a clinical trial involving its robotic surgical system. This exemption permits the Houston, Texas-based firm to study its Endoluminal Surgical (ELS) system specifically for colorectal procedures. This key study is set to evaluate the ELS system’s safety and effectiveness during robotic endoscopic submucosal dissection (ESD) for the excision of colorectal lesions.
The company plans to involve 50 participants in this trial, which will be conducted at five prominent U.S. medical centers: Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and HCA Healthcare (Houston).
With its focus on addressing unmet needs in gastrointestinal and other endoluminal surgeries, EndoQuest has engineered a surgical robot platform designed to enhance the precision and adaptability of medical procedures, ultimately improving patient outcomes. Its unique technology facilitates navigation and execution of procedures within the body’s luminal spaces, enabling minimally invasive techniques.
The platform grants therapeutic endoscopists and surgeons the capability to operate using trans-oral or trans-anal approaches. One year ago, EndoQuest secured $42 million in funding to advance this technology.
“Securing this IDE approval represents a pivotal moment in our quest to transform minimally invasive surgery,” said Eduardo Fonseca, interim CEO of EndoQuest Robotics. “Our adaptable robotic technology promises to revolutionize colorectal surgery, equipping doctors with cutting-edge tools for less invasive, scar-free operations. We look forward to advancing to human applications and ever closer to a new era in surgical practices.”