Medsider: Learn from Medtech and Healthtech Founders and CEOs - Lessons in Leadership — Building a Successful Team and Checking Your Ego at the Door: Interview with Check-Cap Founder and CTO Yoav Kimchy

Episode Date: October 6, 2022

In this episode of Medsider Radio, we sat down with Yoav Kimchy, Founder and CTO of Check-Cap.Yoav has more than 20 years of experience in the development and management of innovative medical device companies. In 2005, he founded Check-Cap, a clinical-stage medical diagnostics company that aims to change the colorectal cancer (CRC) screening landscape with its C-Scan ingestible capsule, tracing, and imaging system. In this discussion, Yoav shares how early feedback from regulators can help streamline your development efforts, why you should shift your team as the company grows, and the importance of knowing when to lead and when to follow.Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors sent to their door at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Yoav if you'd rather read it instead.

get the right people in the right positions in the company and it takes time and some of the people that you first engage with are very good at the start at the beginning because they're very technical but once you get to be more process oriented and regulation oriented and so on you need to to hire more people or to change your team or focus your team on being less. innovative and more tidy, so to speak. Welcome to MedSider Radio, where you can learn from proven

med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey everyone, it's Scott. In this MedSider interview, I sat down with Yoav, a PhD with more than 20 years of experience in the development and management of innovative med tech companies. In 2005, he founded CheckCAP,

a clinical stage medical diagnostics company that aims to change the colorectal cancer screening landscape with its C-scan ingestible capsule tracing and imaging system. Here for you the key learnings from my conversation with Yoav. First, take every opportunity to get feedback from regulatory professionals. Getting their input, especially early on, can help pinpoint what may or may not work, helping to streamline your development initiatives. Second, know when to lead and when to follow. Yoav realized soon after launch from Check Cap that he didn't want to run the company, so he hired someone to take on the CEO role. It was a good decision, he says, as it allowed him to focus on what he's good at,

R&D, while letting other more experienced people lead the business forward. Third, expand and diversify your team as the company grows. Over time, as you get further into the development process, you'll need to focus more on logistics and regulation rather than solely focusing on R&D, hire people accordingly. Okay, so before we jump into the discussion, I wanted to let you know that we just released the first volume of MedSider mentors. a print-based book that summarizes the key learnings from my favorite medsider interviews over the past six months. Look, I fully realize it's tough to listen or read every medsider interview that comes out. Even the best ones.

But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's a way for you to learn from the best thought leaders in our space in one central place. Here's a teaser of what you'll see in this first volume. Garh Hong Kong, founder of HealthQuest Capital, teaches you how to successfully pitch your startup. Patricia Ziliak, CEO of Ivinsons, discusses what you really need to know about clinical trials. Jared Bauer, CEO of Ionic Sciences, shares best practices for avoiding obstacles in your startup journey. That only scratches the surface, so if you're interested in learning more, head over to medsiderrady.com forward slash mentors.

If you're a premium medsider member, you'll get free digital access and a print version sent straight to your door. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider Mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David Albert, founder of LiveCore, and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors. Again, that's Medsider Radio.com forward slash mentors. All right, without further ado, let's get to the interview. Hi, Yoav. Welcome to Medsider Radio. Appreciate you coming on.

Thank you. Thank you for having me. Yeah, definitely looking forward to hearing a little bit more about your background and really the story around check cap. So let's start there. If you can provide sort of an elevator style overview of your professional background leading up to founding the company, that would be helpful. Sure. So I have a bachelor's degree in physics and mathematics from University of Jerusalem. a master's degree in biomedical engineering from the University of Tel Aviv and Ph.D.

and signal processing and of brainwaves from the Technion at the Institute in Haifa. Prior to studies, I was a Navy officer and I served on missile boats. I served for about six years. that's the professional part. Yeah. On your LinkedIn profile, I can see the, you know, you've got a profile image of like the, of what appears to be a Navy, a Navy ship that's in the,

it's in the, it's a sunk or something. It's a sunken, it's a sunken navy ship that was the command ship of the boats escaping from Sherbourg in 1969. Oh, wow. Okay, so that's a real image. Yeah, yeah, it's a real image. and we dived. I think we were about 250 divers going down there,

commemorate the 25th anniversary of that, of taking out the Sherbroke boats out of the, of Sherbrooke in France. My father would be, my father would be a commanding officer of that operation. Oh, wow, that's really cool. That's very cool. Yeah, for everyone listening, if you check out the show notes to this interview on Medsider. We'll link to Yoav's LinkedIn profile.

You can take a look at this image. It's pretty cool. So with that said, Yov, you started Check Cap. It looks like back in 2005. So we're, you know, gosh, close to 20 years into the kind of the arc of the company. So can you give us a sense for, you know, without getting too far into the weeds? Because we'll cover this in more detail as the kind of the discussion unfolds here. But give us a sense for what C-scan is and kind of how the idea for the device came to be. Sure. So C-scan is a capsule that you swallow. And basically you have a recorder on your back, which tracks the position and communicates with a capsule.

And it travels naturally in the colon and scans it when it's going there. it uses a miniature x-ray source to image the inside of the colon without requiring any bulk operation. So the patient or the person is free to do whatever he wants. While the capsule is traveling naturally and at the end it goes out, all the data is recorded and then reconstructed for the physician to look for potential polyps, which are the precursors of colon cancer. The idea is to find polyps before they become cancer. So you can prevent colon cancer.

You don't need to wait for the cancer to actually be there. So once somebody has a polyp, they can be taken out with colonoscopy and preventing colon cancer. Got it. I'm looking at the, you know, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, the, check. hyphen cap.com. So check hyphen cap.com is the site if you get a chance to look at it. It's a beautiful site and you get a sense for what this looks like. It's definitely pretty cool. And so you have, if I understand it correctly, the kind of the normal sort of patient journey is, you know, they're going to have to go in for a GI procedure of some type, right, where the gastroenterologist

is going to take some images. But with your device, they can do this a lot more, you know, minimally invasively, right, where they're, they basically just swallow this, swallow the C-scan, and it kind of records, travels through the colon and records data, and then the physicians view that after the fact. Am I understanding that correctly? That's correct. We view it as a device or a system for the GI physician. We still want them to be involved in the procedure and to do the, what is required in terms of analysis and so on. But the idea is to get those patients or to try to persuade patients who

refuse to do colonoscopy or are bad candidates or poor candidate for colonoscopy or have incomplete colonoscopy. So it's about 40% of the U.S. population. Okay, wow, it's that high. Wow, okay, got it. Yeah, my way back on, my mom was a GI She's retired now, but she was a GI nurse for the better part of, you know, 30 or 40 years. So I'm kind of loosely familiar with the space, just, you know, kind of being raised in that environment. So I understand kind of the, you know, a colonoscopy is not necessarily preferred by a lot of people, right, but necessary.

And so I can see how alleviating some of those constraints would be helpful. With that said, you have, can you give us a sense for where the company, where check cap is in terms of, in terms of sort of the life cycle of the company. I mentioned earlier, it looks like it was founded or he started it back in 2005. But can you give us a better idea of where you're at in terms of regulatory commercialization, et cetera? Sure. So in May of this year, we started almost a thousand patient clinical trial, which is the final pivotal study.

after getting an ID approval from the FDA, from the US FDA. And it's a two-stage clinical trial. The first one is collaboration. And then we're going to do the actual statistics or the trial that is going to work with the statistics to show the performance of the device. We had in the past, we did a C trial for Euro

European regulation, and we got that already. But we are focusing on the U.S. FDA trial or the U.S. market, because that's the most meaningful market and getting FDA approval is the stamp that you need in order to start their real sales. So in about, I would say, one and a half to two years, perhaps we'll be in a position that hopefully will get. the FDA approval, and we can start commercialization. Okay, cool.

And you said that 1,000 patient pivotal trial in the U.S., I presume all of the sites are based in the U.S. as well? About half of the sites are in the U.S. and the other half are in Israel. Okay. So we're doing it in parallel, yes. Got it. Very, very cool. And you're, you know, we're recording this in September of 2022, and you're enrolling

rolling patients currently? Yes, we are. We are rolling in a few sites in the U.S. already. Okay, very cool. Well, that's a helpful overview of kind of where the company is at currently and a little bit more about what the device is and the challenges that you're trying to solve for. So let's step inside the kind of the med-site or time machine,

if you will, and kind of go back to the formative years of check cap. and your efforts to design the C-scan, when you think about that journey, right, over the past, you know, 10 to 15 plus years, what are some of the key lessons that you learned when developing such an innovative device like C-scan? Well, the first thing that's the way that I looked at it is there is a real need for such a device or such a system because people are very reluctant to do. do colonoscopy, some are full candidates. So there's a real need and a real market for this kind of a device or such a technology. And I've looked at the barriers, what holds people

not to do colonoscopy. And I think the work, I know that the biggest barrier, and this is proven in quite a few studies is the preparation, colon preparation, which requires people to swallow material that cleans the bowel. It's not a pleasant process. It takes a few days and also the actual invasiveness of the procedure puts people off. So the combination of these two are the reasons that you need to look for the technology that can overcome this kind of these kind of hurdles. And coming from physics, I understood that you can think of the inside of the colon as murky water that you can somehow image or scan with sonar or radar or whatever. but it turned out only x-rays can do this to work.

So that's how it came about. Got it. So were some of your initial, help me unpack that a little bit. Or let's, I should say, let's unpack that a little bit. So you initially kind of, we're trying to leverage some like sonar-based technology, right, in terms of imaging the colon. But then you realize that that's not feasible? Yes.

Sound waves are not effective because the tissue and the colon contents are very similar and they don't have any contrast. So, and optics, of course, are not a possibility because then you need to clear the bowel. There's a capsule. It's called Pilcom 2, which requires the complete cleaning of the colon, and it's not a good procedure. So x-rays came out the only way to do that because with x-rays you can give a small amount of contrast agent and actually increase the contrast or differentiate between the colon content and the tissue and allow for this imaging to work. But it works a little bit different or differently than normal x-rays because the capsule looks at x-ray fluorescence and constant scattering and not the way normal x-ray work. So that's something that we had to develop from scratch.

It's a different imaging technology, basically. Got it. And so with something that represents a pretty high technical barrier, right? Like C-scan, what would be your advice to other med-tech entrepreneurs that are kind of, you know, trying to row a boat in similar water? like what's the, what's your, where do you see other people make the most mistakes? Or maybe when you think about kind of that, you know, getting over that technical feasibility hump, you know, what are some of your, you know, your best advice for other kind of startup,

MedTech startup founders? I think the biggest stroke of luck I had in the beginning was to find somebody who understood what I wanted to do any, and he was bold enough to put the money behind his mouth. The guy was the ex-CEO of G-Healthcare, Dr. Walter Robb, who in the past took the, to develop the X, the CET and the G-MRI. So this kind of a person that can say, this can work, and I'm backing it. This can help you a lot in starting a company with a very new and untested technology.

So that's a big advice. If you can find somebody like that, it's an anchor to anything that you want to do. It's a great way to describe it, right? Finding that champion, right? Or that anchor that can kind of be that, be that, whether it's a financial anchor or maybe even someone with, you know, with deep domain or clinical expertise, right, that can serve as that, uh, that key kind of contact moving forward. That's a really good point. Um, uh, let's transition a little bit to, to kind of the topic of regulatory. You mentioned earlier that you've got,

the company's been successful in getting a C.E mark and now you're focused on, on the U.S. regulatory pathway. When you think about, you know, what you've learned, I mean, it, this is a, this is a really innovative, you know, device, right? I mean, it's, it's, um, um, correcting me if I'm wrong, but I, I think it's probably the first of its kind. It appears to be the first of its kind sort of device, which typically represent pretty significant regulatory challenges. So when you think about your approach to the global kind of regulatory pathway, whether it's in Europe or now you're focused on the U.S.,

what are some of the most important lessons that you've learned along the way? Well, one thing that I wished we could have done was talk to the regulators earlier, off because that would have saved us a lot of ineffective journey. The point is that the regulation only takes you seriously once you have something which is tangible, it's already you're starting to look at people or humans. But the regulatory process is a very enduring one. It requires a lot of patience. The regulator is a good way to clean up your act when you do the, when you work correctly.

So, and I can see the company, when you start with a few guys and some ideas, your, your act is not very tidy. and once you get into put the regulation in place you've got to have something which is more stable, more reliable, and that's what you need when you put people, things in people, in humans. Okay, so if I'm hearing you correctly, you know, some of the, a couple big lessons for you was, for your team was definitely start early, right, and trying to get feedback from the various regulatory bodies. But maybe more interesting, I thought, was your point around, you know, regulatory being a function that sort of, you know, forces you to kind of, you know, get dialed in, right, and button things up, dot your eyes, cross your teeth. Is that correct? That's correct.

And actually, we've learned recently that the FDA has this process that is called breakthrough designation that allows you to start discussion with the FDA very early on. And unfortunately, we got it later. So we got it in about a year ago or something. So what we could have learned from the FDA and from discussion with the FDA earlier on, we didn't do that in the right timing. We did it later. So we could have been more effective working with us.

earlier on. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for Medsider Premium members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadine Miarid, CEO of CVRX, and so many others.

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