A swallowable capsule to x-ray and identify warning signs of colorectal cancer is edging closer to the American market, promising an Israeli-led revolution in colorectal cancer prevention.
The small C-Scan capsule, developed by Isfiya-based Check-Cap, is simply swallowed by a patient to generate three-dimensional maps of the inner lining of the colon, and detect any pre-cancerous polyps or other abnormalities.
Far from the invasive and unpleasant nature of a colonoscopy, the x-ray capsule requires no preparation and autonomously communicates with a wearable tracking unit. After swallowing, the patient can continue with their daily routine and allow the technology to do its work.
The company is currently working with the US Food and Drug Administration (FDA) toward a pivotal trial in late 2020, and the innovative technology could be commercialized in the United States by 2022. The solution was granted CE approval in early 2018, and has already been approved for sale in Israel.
"The number of people willing to do a colonoscopy is less than half - it is a problem looking for a solution," Dr. Yoav Kimchy, founder and CTO of Check-Cap, told The Jerusalem Post. "The idea was to find a way to look for polyps and not to look for cancer. Polyps are like a warning sign and you don't want to wait for the cancer."
Colorectal cancer is the third leading cause of cancer-related deaths in the United States among both men and women, and over 53,000 deaths are estimated from the disease in the US alone this year. If polyps are identified early, however, it can be one of the most preventable cancers of all. Typically-benign polyps can be present in the colon for a decade before developing into invasive cancer.
Kimchy's idea to establish the company, now listed on Nasdaq, followed years of expertise gained as an officer in the Israeli Navy, focusing on underwater warfare, and a doctorate in signal processing and brain waves.
"The idea was to try and find some way to see through murky water, without the need for preparation," he said, emphasizing that the ultra-low dose of radiation from the capsule is comparable to a single chest x-ray. "Nobody has done this kind of reconstruction or imaging before. Instead of adapting the patient to the technology, we adapt the technology to the patient."
Boasting a wide portfolio of patents, the easy-to-swallow capsule houses masses of technology, including a miniature motor, x-ray technology, radio communication, electronic detectors and a miniature tracking device. Unlike the Israeli-produced PillCam, which relies on an optical image camera, Check-Cap's solution does not necessitate the typical preparation required to make the "colon as clear as water."
"The mission is to prevent colorectal cancer, which is different from much of the competition. The easiest way to prevent cancer is through precancerous polyp detection and resection," said CEO Alex Ovadia. "There aren't that many solutions that are compelling enough for the patient. We believe our patient friendly solution exhibits significant advantages compared to existing solutions."
Check-Cap announced positive results from a US pilot study of the system in late December 2019, conducted at the NYU Grossman School of Medicine and Mayo Clinic in Rochester. While the primary purpose of the study was to evaluate its safety, all 40 patients reported full compliance and higher satisfaction with the procedure compared to colonoscopy.
In a recent post-CE approval study, the C-Scan capsule identified 76% of polyps measuring above 10mm in size, and all polyps measuring at least 40mm. The study compared the results with a fecal immunochemical test (FIT), a common stool-based test for detecting pre-cancerous polyps, which identified 29% of patients with polyps above 10mm in size, and only 25% of polyps exceeding 40mm.
"When we ask patients and physicians, we get a clear answer that the device has the potential to change the natural history of colon cancer screening," said Ovadia. "Since the device is safe, not an intervention and there is no need for preparation, we have resolved most of the barriers preventing any patient of the recommended age from undergoing screening. There is no reason now for a patient not to perform the study."
According to Prof. Nadir Arber, the principal investigator for C-Scan clinical trials and the head of the Health Promotion Center and Integrated Cancer Prevention Center at Tel Aviv Sourasky Medical Center, the C-Scan system "can change the landscape of colorectal cancer prevention worldwide."
"Although colorectal cancer can be prevented through the detection of precancerous polyps, screening adherence remains low due to the bowel preparation, sedation and invasiveness associated with current screening methods, and Gastroenterologists certainly struggle with that," Arber told the Post.
"There is a great unmet need for a patient-friendly and preparation-free screening option that can detect polyps in the colon before they become cancerous, and enable to perform colonoscopy only on those who have polyps. I look forward to seeing this 'swallow and forget' product - allowing patients to continue with their normal routine, with no pain, embarrassment or preparation - available in clinics worldwide."
The capsule offers physicians a range of two-dimensional and three-dimensional methods to analyze the findings and identify any polyps. Should polyps be found, patients can then be referred for a colonoscopy and additional treatment.
"First of all, the solution has a potential to increase screening adherence," said Ovadia. "Once you have a suspicious finding, you may not argue regarding the colonoscopy."
Looking forward, the company is eager to shrink the footprint of the solution even further and develop it into an entirely homecare-based procedure, with data transmitted wirelessly to a virtual analysis center.
"The capsule has been developed over the years, where the tracking process evolved from a cumbersome belt to this small footprint," Ovadia said. "Normal life can continue, which is excellent compared to the other solutions that we know."