EndoQuest Robotics has won an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing the company to commence a clinical trial evaluating its surgical robotic system.
EndoQuest plans to test its technology on an estimated 50 participants enrolled across five sites in the US.
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The company’s robot will be assessed for both safety and performance in robotic endoscopic submucosal dissection (ESD) procedures for the removal of colorectal lesions. The primary outcome of the trial is the percentage of target lesions across all subjects that are excised in a single specimen, as per a ClinicalTrials.gov entry (NCT06133387).
EndoQuest refers to its robot platform, the Endoluminal Surgical (ELS) system, as one of the “next frontiers of minimally invasive surgery” on its website. The Texas-based company says it has designed the system to solve challenges associated with complex endoluminal procedures such as ESD. These include difficulty in accessing lesions based on anatomical location, patient tolerability, and a steep learning curve for specialists to achieve proficiency.
“This technology represents the evolution we have been waiting for to finally perform endoluminal surgery, which could redefine what’s possible in minimally invasive colorectal procedures and potentially allow a significant number of patients to avoid invasive operations like colectomies,” said EndoQuest Robotics’ chief medical officer and chairman of the scientific advisory board Dr Todd Wilson.
EndoQuest has already touted preclinical evidence that suggests its ELS system had superior procedural outcomes, a shorter learning curve, and reduced procedure time versus the conventional technique. The company’s system uses the body’s natural orifices, such as the mouth and anus, or transumbilical incisions to reach lesions. EndoQuest states this approach minimises incisions through healthy tissues as seen in open, laparoscopic, or robotic surgery.
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By GlobalDataEndoQuest raised $42m in financing in December 2023 to advance its endoluminal robotics technology. Investors included CE Ventures Limited, McNair Interests, and Puma Venture Capital.
Robotic landscape in healthcare
Globally, the robotics industry is growing at a compound annual growth rate of 29% and will be worth $568bn by 2030, according to a report by GlobalData. One of the most valued areas of robotics in healthcare is surgical procedures, with the surgical robotics market estimated to be worth $8.6bn in 2022 and projected to reach $10bn globally by the end of this year.
Intuitive Surgical, which was the first to gain approval for soft tissue robot technology with its famous Da Vinci line in 2000, generated revenue of around $7.1bn in 2023. The company dominates the robotic surgery sector, occupying a 60% share of the global robotic surgery market, according to analysis by GlobalData.
Johnson & Johnson is looking to enter the surgical robotics space – the company is set to conduct a clinical trial with its Ottava system after winning an IDE last month. Microbot, an emerging company in the sector, meanwhile is seeking FDA clearance for its disposable endovascular robotic system called LIBERTY.
