Houston, TX, May 15, 2025 (GLOBE NEWSWIRE) -- EndoQuest Robotics, Inc., a pioneering leader in the development of endoluminal robotic surgical technology, announced today the completion of the first procedures of its pivotal clinical trial, Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine (PARADIGM) (Clinicaltrials.gov).

Using EndoQuest’s Endoluminal Surgical (ELS) System, two colorectal endoscopic submucosal dissection (ESD) procedures were completed by Dr. Eric Haas, Chief of Colorectal Surgery at HCA Houston Healthcare Medical Center where the procedures were performed. Dr. Haas is also the Chief of Colorectal Surgery at Houston Methodist Hospital, the Program Director for Minimally Invasive Colorectal Surgery at the University of Texas at Houston, and a world-renowned pioneer in robotic colorectal surgery.

“I am honored to have performed the first procedures in this important clinical study” said Dr. Haas. “This novel robotic system has the potential to truly advance how we treat patients with colorectal disease, and we are eager to continue advancing this study and gathering data on its use in the clinical setting.” 

The first two robotic ESD procedures were performed on complex lesions located in the rectum and sigmoid colon, including one fibrotic lesion measuring over 5 cm.*

This investigational device exemption (IDE) approved study is designed to evaluate the safety and effectiveness of the ELS System in robotic ESD procedures for the removal of colorectal lesions. Fifty subjects will participate across five leading United States healthcare institutions, including Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and HCA Healthcare (Houston). Following completion of the PARADIGM trial, EndoQuest Robotics plans to submit a De Novo request for authorization to market the ELS System in the United States.

“We are grateful to Dr. Haas and the team at HCA Houston Healthcare for leading off this pivotal IDE Study,” said Eduardo Fonseca, Interim CEO of EndoQuest Robotics. “Our goal is to revolutionize surgery through enabling less invasive, more effective approaches, and these first procedures mark a significant milestone towards achieving that goal.”

“The data is clear that ESD is the ideal technique for removal of early colorectal lesions, yet ESD has not been widely adopted in the US, generally due to its steep technical difficulty and learning curve” said Dr. Todd Wilson, Chief Medical Officer and Chairman of the International Advisory Board of EndoQuest Robotics. “Our endoluminal robotic system is designed to solve these challenges, which should ultimately allow a greater number of physicians to adopt this minimally invasive technique and resultingly, replace a significant number of more invasive procedures, such as colectomies.”

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 (GI) 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.

* Lesion characteristics are reported for descriptive purposes only and are not indicative of clinical outcomes.

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 (GI) 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. Since EndoQuest Robotics was founded, the company has collaborated extensively with healthcare providers, researchers, and industry partners to advance the development of its revolutionary flexible robotic system with the goal of improving patient outcomes and redefining a new standard in minimally invasive surgery. For additional information, visit the company’s website at www.endoquestrobotics.com.

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

For media inquiries or further information about EndoQuest Robotics and its groundbreaking advancements in flexible endoluminal robotics, please contact:

Media Contact
Lisa Owens
The Mullings Group
lowens@mullingsgroup.com
+1-210-601-6647

Attachments

• First Procedures Completed with EndoQuest’s Endoluminal Surgical System in PARADIGM Trial
• EndoQuest’s Endoluminal Surgical (ELS) System

Eduardo Fonseca
EndoQuest Robotics
(713) 515-2065
eduardo.fonseca@endoquestrobotics.com