Dive Brief:
- Neptune Medical said Wednesday it received Food and Drug Administration clearance for its Triton 1 robotic endoscopy system for diagnostic and therapeutic procedures in the colon.
- The system was developed to give physicians performing colonoscopy greater stability and control during the procedure.
- In addition to screening and surveillance, the robot is designed to assist in more complex procedures in the colon, including endoscopic mucosal resections and endoscopic submucosal dissections.
Dive Insight:
American Cancer Society researchers recently found colorectal cancer has become the top cancer killer of adults under the age of 50.
Colonoscopy remains the gold standard for colorectal cancer screening, according to the ACS, which recently updated its guidelines to add new at-home stool sample tests from Abbott’s Exact Sciences and Geneoscopy as well as Guardant Health’s Shield blood-based test.
Colonoscopy allows for both detection and removal of precancerous lesions in one session, unlike stool or blood tests. A positive stool or blood test result still requires follow-up with a colonoscopy.
Neptune said its Triton robotic system was designed to give gastroenterologists more control of the endoscope during a colonoscopy procedure. Endoscope instability can lead to incomplete visualization of the colon and missed adenomas, or pre-cancerous lesions, the company said.
Neptune’s 50-patient CARE 1 study of the Triton system, released in May, met its primary endpoints, with no adverse events. The robotic system demonstrated an adenoma detection rate of 54.2%, compared with the industry threshold of 35%, according to Neptune.
Founder and CEO Alex Tilson said Neptune is using this generation of the Triton system to build on the evidence from its recent trial and to learn from endoscopists how robotics should integrate into their workflow. The insights will shape the company’s next-generation platform, Tilson said.
“Triton has the potential to fundamentally transform colonoscopy, creating a better experience for both physicians and their patients,” the CEO said in a statement. “Achieving regulatory clearance in the U.S. brings us one step closer to that reality.”
Neptune raised $97 million in 2024 in a Series D financing. Investors included Olympus and Sonder Capital, co-founded by robotic surgery pioneer and Neptune Chairman Fred Moll.
Olympus co-founded Swan EndoSurgical in 2025 to develop an endoluminal robot to treat lesions and cancers in the gastrointestinal tract and recently formed a partnership to distribute EndoRobotics’ endoscopic robotic devices for gastroenterology.
