Neptune Medical Gets FDA Clearance for Triton 1 Robotic System

Triton is a gastrointestinal robotic endoscopy system engineered for intuitive navigation, precision, and control across the entire colon. | Source: Neptune Medical

Neptune Medical Inc. announced this week that it has received FDA clearance for its Triton 1 System. The company stated that the robot was developed for flexible endoscopy, supporting both diagnostic and therapeutic procedures throughout the colon.

Neptune Medical claims that Triton delivers robotic precision, stability, and control to access the entire colon. The Burlingame, Calif.-based company noted that the system enhances any endoscopist’s capabilities for screening, surveillance, and diagnostic colonoscopies, as well as complex procedures such as endoscopic mucosal resections (EMRs) and endoscopic submucosal dissections (ESDs).

“Triton has the potential to fundamentally transform colonoscopy, creating a better experience for both physicians and their patients. Achieving regulatory clearance in the U.S. brings us one step closer to that reality,” stated Alex Tilson, founder and CEO of Neptune Medical. “We are using this generation of the Triton system to build on the evidence from our recent trial and to learn from endoscopists how robotics should integrate into their workflow — insights that will directly shape our next-generation platform.”

Triton technology aids in diagnosing a common cancer

Colorectal cancer is the second leading cause of cancer death in the U.S. and increasingly affects adults under age 50. According to Neptune, colonoscopy remains the gold standard for diagnosing, preventing, and treating colorectal cancer, as it is the only procedure that allows for both detection and removal of precancerous lesions in a single session.

However, the company noted that current endoscopes have inherent design limitations that make them difficult to control, despite gastroenterologists undergoing years of specialized training. Endoscope instability can lead to incomplete visualization of the colon, missed adenomas (pre-cancerous lesions), and ultimately, an increased risk of cancer development.

In 2024, Neptune Medical raised $97 million in Series D funding and launched its subsidiary, Jupiter Endovascular Inc. The companies stated that this move allows Jupiter Endovascular to focus on its own technology platform.

Neptune reports results from Triton’s first in-human study

Neptune Medical presented its first-in-human CARE 1 study earlier this year. The study demonstrated that the Triton 1 System met its primary endpoints, with no adverse events and a 100% cecal intubation rate.

The company reported that the robotic system also achieved a high adenoma detection rate (ADR) of 54.2%, compared with the industry threshold of 35%. It was also effective in creating a highly favorable ergonomic environment for endoscopists, with a 67% lower average burden compared to manual colonoscopy (based on the NASA-TLX score), no patient repositioning, no abdominal pressure, and no conversion to manual colonoscopy.

“Bringing robotics to lower GI procedures is an exciting prospect for us,” said Jason B. Samarasena, M.D., chief of the Division of Gastroenterology and Hepatology at University of California, Irvine, who was part of Neptune’s CARE 1 clinical trial. “Triton showed us the possibility of one system that can screen and treat anywhere in the colon, efficiently, thoroughly, and with minimal burden. I look forward to participating in additional clinical research of the system that will support its progress along the path to commercialization.”