Capsovision is requesting that the U.S. Food and Drug Administration (FDA) expedite the development of its CapsoCam UGI capsule endoscopy system as a potential tool for detecting early-stage pancreatic cancer.
The CapsoCam system is similar to a large pill containing four tiny cameras. A person swallows the pill, and the camera records images as it moves through the digestive tract. A special kit is used to collect the pill once it exits the body, and physicians can then download the images.
“Unlike traditional endoscopic or imaging procedures, CapsoCam UGI is completely non-invasive,” the company said in a press release. “Patients simply swallow a pill-sized camera, eliminating the need for sedation, intubation, or recovery time, while enabling physicians to review detailed images through a secure, cloud-based system.”
The system is currently used to detect issues within the intestines, but Capsovision is exploring whether it can also serve as a diagnostic tool for pancreatic cancer. It submitted an application asking the FDA to grant the CaspoCam system breakthrough device status, a designation intended to expedite the development of technologies that have the potential to improve medical care for life-threatening conditions without adequate alternatives.
“This submission represents an important milestone in CapsoVision’s mission to expand its capsule-based diagnostics platform beyond the small bowel and address some of the most challenging diseases in gastroenterology,” Caspovision said.
Early detection is rare
The pancreas is an organ located in the abdomen that is responsible for producing hormones and digestive enzymes. The most common type of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC), is one of the leading causes of cancer-related death.
According to Caspovision, fewer than 1 in 10 people with PDAC will survive more than five years after diagnosis. This is largely because the early stages of PDAC generally don’t cause noticeable symptoms, so most patients aren’t diagnosed until the cancer is advanced, at which point it’s much harder to treat effectively.
The CaspoCam UGI system can’t image the pancreas itself, but it can image the duodenal papilla, an area where enzymes from the pancreas flow into the intestines to aid in digestion. There’s some evidence that changes in this region may be indicative of PDAC, and Capsovision aims to explore the possibility that imaging this region using its system could enable earlier diagnosis of PDAC and facilitate better outcomes for patients.
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