Written for and originally published on BioSpace
BioSpace recently spoke with Yoav Kimchy, founder and chief technology officer of Check-Cap, a company developing the C-Scan® system to detect precancerous polyps.
Q: What is your role at Check-Cap?
A: I founded the company in 2005. My background in high-energy physics was significant in finding a solution to the problem of people’s resistance to the colonoscopy. I am and have been involved in each step – from conceptualization to miniaturization to manufacture and trials.
Q: How did you get into colon screening?
A: I got to know the colonoscopy-- the colon cancer space, when I was trying to persuade my father to do a colonoscopy. His mother died of colon cancer and he's not a shy guy. Yet, it was difficult to persuade him, and I understood that there's a problem. People don't like this procedure. It's invasive and it's really not something that people are happy to do.
But, unlike other cancers, this cancer gives you a warning sign: something like 5 to 10 years before the cancer develops, you have polyps. If you find the polyps, you can prevent the cancer. It's something very rare in cancer. And this is a really big opportunity if you can avert this devastating disease. I understood that the idea should be to try to find polyps, not to find cancer. To find it before it becomes cancer, and to find it in a way that is patient-friendly, so people don't shy away from this procedure.
Q: Was it difficult to get backing for the concept of a capsule with these capabilities?
A: I started looking for investors in 2004. As it turns out, my real anchor was Dr. Walter Robb. He took GE Healthcare from a small company and developed the CT there, and the MRI. He headed GE Healthcare and the GE research center. In March 2020, he died of COVID. He was a very, very clever guy. It took him about 10 minutes in a café in New York to understand the concept. He jumped on it. He was excited. We had a lot of talks about the technology and how it works. He was a friend and mentor, and he was on our board for many years. His death was heartbreaking. We decided to name our conference room the Walter Robb conference room, in memory of this great man.
Q: Does the capsule you developed contain the equipment required to screen for polyps?
A: Yes, I have a background in high-energy physics and scattering and, naturally, I looked in that direction and came to realize that it's possible to use x-rays to see into the colon contents, so you don't need to clean it up. And this is the big hurdle for people who do colonoscopies.
So, you can think of the capsule as a submarine that goes inside a very dark place, and it uses sonar to understand what's around it. Not visually because it's a dark or murky water, but you can use sonar. In our application, it's x-rays that help look through the murky water and find what the colon walls look like. And if you find something that looks like a polyp or is suspicious, then it gives an alert so the physician can know where it is.
Q: You swallow this capsule and then what happens? And, how big is it?
A: The capsule is somewhat larger than the size of an omega-3 capsule. Inside, there's a whole lot of technology. There is an x-ray source, motor, scanner, detectors, electronics, processor, communication and positioning system like a GPS that connects with an external positioning and recording system. There is also a battery, of course, to power it. The trick was to make it so that you can swallow it, but we have worked to make it small and safe for human use. The capsule can detect when it is in the colon and it only scans while there. It requires no preparation or sedation, allowing patients to continue their daily routine with no interruption as the capsule is propelled through the gastrointestinal tract by natural motility.
Q: How do you retrieve the data? How do you know where the images were captured?
A: We have developed a GPS system that is a device that the patients put on their back. This GPS system has two functions. One is to locate the capsule within a centimeter of where it is. It's very accurate. You can walk with it, shower and sleep with it. It also has a two-way communication with the capsule so it knows where it is, if it's moving, it tells the capsule to scan, and then it collects all of the data from the capsule so you don't need to retrieve the capsule once excreted.
Q: What currently stands between you and being on the market in the U.S.?
A: We recently received IDE approval from the FDA to initiate a pivotal study for C-Scan® in the U.S., which we plan to initiate in late 2021 and should be the last step before commercialization, if approved.
We believe C-Scan® has the potential to significantly contribute to improving the current colorectal cancer screening landscape worldwide by offering a patient-friendly option that can detect precancerous polyps and enable early intervention and cancer prevention. The goal is to enable millions of people to avoid the disruption and morbidity associated with cancer treatment and its progression.
Most patient-friendly CRC screening tests currently available or poised to enter the market, such as fecal or liquid biopsy tests, are primarily designed to detect cancer and demonstrate low sensitivity in detecting precancerous polyps. They don’t necessarily provide patients with the time window to pre-empt the disease.
We believe there is a genuine unmet need for a patient-friendly screening option, such as C-Scan®, that can overcome barriers to colonoscopy screening while also enabling precancerous polyp detection. Recently, the American College of Gastroenterology (ACG) also updated its recommended CRC screening guidelines and recommended colon capsules as an option for CRC screening in people who are either unwilling or unable to undergo a colonoscopy or Fecal Immunochemical Test (FIT). As screening for precancerous polyps provides an opportunity for early intervention and cancer prevention, I believe C-Scan® could be considered as a relevant option for those individuals.