Neptune Medical’s Triton Robotic Endoscopy System Performs Well in Study

Neptune Medical is reporting positive results from the 50-patient, first-in-human CARE 1 study (Colonoscopy with a Robotic Endoscope) of its Triton Robotic Endoscopy system. The Triton system met both of its primary endpoints, with no adverse events and 100% cecal intubation, enabling predictably complete procedures throughout the colon. The robotic system also demonstrated a high adenoma detection rate (ADR) and a highly favorable ergonomic environment for endoscopists.

Colorectal cancer is the second leading cause of cancer death in the United States and increasingly is being diagnosed more in the under-50 population. As the primary mode of detection, colonoscopy is considered the gold standard, as it is the only procedure that allows for both detection and removal of precancerous lesions in one session. However, current manual endoscopes have inherent design limitations that can make them difficult to control based on an operator’s skill level. Scope instability can result in incomplete procedures, missed adenomas (pre-cancerous lesions) leading to cancer development, significant endoscopist injuries due to the ergonomic strain of controlling the scope, and a steep learning curve for important but complex procedures.

“Colon cancer is growing in prevalence, and concerningly, it is increasing the fastest in younger people. Yet, the colonoscope hasn’t changed much in the last 50 years,” Neptune Medical Founder/CEO Alex Tilson stated. “GIs and their patients need better tools for navigation, inspection, detection and treatment. That is why we are driven by the singular mission of leading a robotic revolution in endoscopy to empower GIs and elevate the colonoscopy procedure.”

With this in mind, the CARE 1 study was initiated as a prospective, single‑arm, first‑in‑human study of 50 adults followed for 14 days post-procedure who underwent screening, surveillance, or diagnostic colonoscopy with the Triton robotic system at H-T Centrum Medyczne in Tychy, Poland. The study evaluated the safety and feasibility of the Triton system to successfully perform colonoscopy in adult patients, with both safety and efficacy endpoints.

Key CARE 1 findings:

• No adverse events after 14-day follow-up
• 100% cecal intubation and procedure completion
• No patient repositioning, abdominal pressure, or conversion to manual colonoscopy
• A 54.2% adenoma detection rate (ADR)
• A 67.5% polyp detection rate (PDR)
• A 100% polypectomy success rate (of polyps <2 cm in size anywhere in the colon)
• A 67% lower average burden compared to manual colonoscopy, based on NASA-TLX score

“In this first‑in‑human study, we used the Triton robotic system to safely complete colonoscopies in 50 adult patients. The Triton system demonstrated excellent safety and feasibility with 100% cecal intubation and no adverse events after 14-day follow-up,” said Marcin Romanczyk, M.D., gastroenterologist at H‑T Centrum Medyczne and CARE 1 principal investigator. “Using Triton as a first-time operator was a very comfortable experience for me, with minimal physical and mental burden throughout the trial. A robotic endoscopy system that enables screening and treatment anywhere in the colon with maximum control would elevate our skills and support our diagnostic and therapeutic goals.”

“Triton’s exceptional control and stability allowed for a thorough mucosal inspection enabling precise polyp and adenoma detection, and ultimately, successful removal of all lesions, regardless of tortuosity or location,” commented Jason B. Samarasena, M.D., chief of Division of Gastroenterology and Hepatology, University of California – Irvine, and a CARE 1 investigator. “These early promising results suggest that Triton may enable us to perform a large number of high-quality colonoscopies in a day with minimal fatigue, empowering us to respond to increasing colonoscopy demands in the United States.”

Triton is a GI robotic endoscopy system designed for easy and comfortable navigation, excellent precision, and control throughout the colon. It is designed to bring robotic precision and AI-assisted detection to the gold standard colonoscopy procedure to ensure that every patient receives a consistently thorough screening, regardless of their physician’s experience level. Triton is being developed to elevate any endoscopist’s capabilities for screening, surveillance, and diagnostic colonoscopies, endoscopic mucosal resections (EMRs), and endoscopic submucosal dissections (ESDs) in the lower GI tract. The Triton Robotic System is not available for sale anywhere in the world.

Neptune Medical is attempting to create the future of endoscopy with its proprietary Dynamic Rigidization technology, enabling unprecedented scope control in upper and lower GI procedures. Headquartered in Silicon Valley, Neptune Medical is a venture‑backed medical device company advancing minimally invasive care through innovation, designing, and manufacturing cutting‑edge devices that empower physicians and improve the patient and clinician experience.