Check-Cap Medical DD | 2020-05-16 Answers paraphrased from phone call notes and for this reason I can’t guarantee 100.00% accuracy. Also note that I did not do any research myself on the medical product and am going off whatever they picked up in their research. Question: Is the product viable? I don’t know much on the medicine side so what looks like game- changing technology to me might in actuality lack merit. Answer (MD): Yes, the product is viable. While a colonoscopy is the golden standard, it is obviously invasive, takes time to prepare for, is generally unpleasant and many people actually opt-out of it. Check-Cap’s product is just a pill that takes 3D images of the bowels to sense if anything is generally wrong or unusual, which doesn’t require any of the cumbersome/intense prep that comes with a colonoscopy. The capsule senses irregularity in the bowel walls and produces a 3D reconstruction of what is scanned. It won’t tell us whether what we’re seeing is malignant or benign, we would need a biopsy (colonoscopy) to do that. Another point is that the results and next steps resulting from a colonoscopy test are based on some subjective evidence (from of course the doctor that administers the test) while Check-Cap’s product produces a more objective and unbiased result through its usage of artificial intelligence. The fact that the company is Israeli based is a huge catalyst, suggesting that their technology is likely globally leading. Answer (Med Student): it seems viable to me. The website does a really good job explaining where the current standards for GI screening exist. I’d be more excited about the potential this tech has than its current function. I briefly skimmed some of the papers they had on their site and I didn’t see any human trials, but I might have easily missed it. The #1 thing I’d want to see is how this actually works in human systems. Being able to move away from the current invasive approach is a huge positive. The fact that it emits less radiation than things like CT scans is also good. However, with any introduction to foreign objects into the body, there’s a risk of unfavourable response. Seeing results from a human study would be the deal breaker for me. Idea wise, it seems very viable and favourable, and I’m excited to see what comes of this. Question: Is there anything else like this on the market or in development, that you know of? Answer (MD): Have not seen anything exactly like this. There used to be pills that could capture images, which turned out to be difficult to use since the quality was not up to par. Check-Cap’s product uses X- Ray vision which negates the issue of poor camera quality. The radiation emitted from Check-Cap’s product is also much less intense than a CT Scan which is a huge positive. Answer (Med Student): never seen anything like it that’s progressed this far. I mentioned above that I’m more excited about the potential of this tech than it’s current use. Screening and stuff is sick if it works, but this tech, if approved and readily implemented, can potentially be used for site directed drug delivery which is kind of what my research background is in. Basically that just means that they can load this capsules with a drug, track it’s location, and release the drug via remote command when it’s at the desired location. Lots of people are doing work on this, and I think this is a cool way to implement it using technology instead of the general approach that’s all chemistry based. Question: Do you think this will get approved/are there any red flags associated with it that might slow down the process? Answer (MD): *Did not ask this question directly however there was no worry or risk of approval not being granted throughout the phone call. Answer (Med Student): can’t say for certain but there were no glaring red flags for me. I’m not 100% familiar with the approval process for med tech but I think as long as they can show that it works and doesn’t cause harm, there’s no reason it wouldn’t be. The earliest pub I saw from this was 2017 so I’d imagine more info will come to light about approval in the next few years at most. Again, that’s just based off my brief skimming. Question: Although this probably won’t replace the colonoscopy, could it at least act as a first line of defence/widely accepted screening process? Answer (MD): Yes. It will never replace the colonoscopy because there is no biopsy involved however it could be a popular screening option since it, if it can work as it claims to and produce high quality imagery, may possibly eliminate the need for some patients to get a colonoscopy. The main question regarding if public and/or private practices will start buying and using this product really revolves around the cost it takes to implement (as well as approval). A colonoscopy runs about a $1,000 cost factor and people usually get them every 10 years, and it works. For this to receive any meaningful uptake, it needs to be much cheaper than that, cost wise. But it could definitely be an effective pre-screening process. Answer (Med Student): *Did not ask this question directly however other responses imply yes. Question: Does the product have any use cases relating to COVID-19 in any way? Answer (MD): Not really. There are some weird diseases popping up such as Kawasaki disease found in children, as well as many forms of mutated coronavirus. These show odd symptoms and if any of these new sicknesses relate to the colon/colon cancer in any way, then Check-Cap’s tech could be used. Answer (Med Student): Tbh I don’t think this is applicable at all for COVID-19. They focus on GI screening using tech and to the extent of my knowledge, it’s not transferable. That doesn’t mean that they can’t switch gears and develop something new, but that would have to be a brand new unrelated technology. Question: Other points/notes Answer (MD): Product is cool – won’t replace colonoscopy but could act as a decent first line of defense if the costs are right. Israeli tech is a plus. Remark Holding’s technology (I had showed him this as well) is a slam dunk and will 100% be implemented everywhere immediately. I am totally sold on that. This tech is great as well but MARK was a “no brainer”. Answer (Med Student): Mentioned he has shown this to a colleague specializing in oncology and is awaiting his response.