Medsider: Learn from Medtech and Healthtech Founders and CEOs - Creative Ways to Market Your Technology While Navigating the Regulatory Landscape: Interview with X-trodes CEO Ziv Peremen

Episode Date: January 12, 2023

In this episode of Medsider Radio, we sat down with Ziv Peremen, CEO of X-trodes.After completing his PhD in neurocognitive science with a specializaton in understanding consciousness, Ziv Peremen has spent the past 12 years focused on the intersection of data and physiology. Together with Professor Yael Hanein, an expert in the field of human-machine interface learning and inventor of innovative sensor technology, they founded X-trodes.In this interview, Ziv discusses his wireless wearable sleep diagnostic technology, commercializing a product before FDA clearance, and how to build the right company infrastructure from the start.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 life science 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 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 Ziv if you'd rather read it instead.

It gives us all kinds of other benefits that we understand now. You know, we got credibility, we got validation, we got understanding where are very good directions in the future. And it also gives, as organization, we are meeting the market earlier than other medical device companies. Because we already engaged. We have operation. We have support. We have all the components that needed for commercialization.

Welcome to Medsider Radio, where you can learn from proven medtech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott. In this episode of Medsider, I sat down with the CEO of X-Rodes, Ziv Paramin. After completing his PhD and neurocognitive science with a specialization on understanding consciousness, Ziv has spent the past 12 years focused on the intersection of data and physiology. Together with Professor Yale-Hanian, they founded Extrodes, makers of innovative sensor technology. Here are few of the things that we discussed in this conversation. First, when developing your technology, think about creative ways to potentially commercialize in advance of regulatory approval.

For Extrodes, that meant selling the product as part of a research kit, which has led to critical learnings for the company. Second, focus on building a solid company infrastructure from the start. Don't skip during this period as it's critical for discovering the kinks in your technology, receiving key feedback from end users and partnering with impactful players. Third, avoid manufacturing custom products that are not critical to your core technology stack. Invest more resources in finding off-the-shelf solutions rather than depleting your budget trying to recreate the wheel. Before we jump into this episode, I wanted to let you know that we recently released the second volume of Medsider mentors. What summarizes the key learnings from the most popular Medsider interviews over the last six months or so.

Look, it's tough to listen or read every single Medsider interview that comes out. 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 the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes. 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 AliveCore, and so many others. In addition, as a premium member, you'll get to join live interviews with these incredible medtech and health tech entrepreneurs. Learn more by visiting medsiderradio.com forward slash mentors. Again, that's medsiderradio.com forward slash mentors. Ziv, welcome to Medsider Radio. Appreciate you coming on, man.

Scott, I'm glad to be here today. Yeah, I'm really looking forward to this conversation. It's like a, we'll be going deep on your technology, and there's a lot of overlap between kind of the consumer health and more traditional kind of med tech space. So I'm super interested to dive into this conversation. But before we get too deep, let's start with a kind of a high-level overview about yourself, right? I provided a bio at sort of the outset of this episode. But tell us a little bit more about your professional background leading up to your current role as the C-E. of extrodes. Sure. I'm 44 years old. I studied physics philosophy and a PhD in neurocognitive

science. I focus in consciousness, understanding consciousness. Once I complete my PhD, I decided that I would like to move from the theoretical part of science into the applicative side. And I move to the fields that connect data and physiology. So over the last 12 views, I'm focused on the conjunction between data and physiology. I started in the field of brain, understanding the secrets or decipher the signals of our brain. Then I move to the field of neurostimulation and monitoring for brain to have a closed loop, both invasive and non-invasive technology to affect the brain. And several years ago, I met my co-founder, Professor Yale Chanin.

She is a ward expert in the field of human machine interface and a brilliant researcher. And she built some new sensor in order to fill the body in a new way, in a unique way. We had a small project and later on we decided there is some something bigger that we can have with this technology, and we decided together to establish extrode. So over the last three years, we are in this exciting process, this exciting advantage of extrodes. Got it. And you, you know, we're recording this in the back, the back half of 2022, and it looks like you started kind of X-roads about three years ago, correct? At least based on your LinkedIn profile, about mid-2018.

Yes. Got it, got it. Okay. Very good. So tell us a little bit more about what this technology is, what the devices are, and then sort of how this idea that you just referenced came about. So we develop a unique medical great wearable sensors that allow us to monitor the body. It can monitor your heart, your muscle, and even the brain. The current solutions that are available today at the clinic and hospitals are very common technology to measure this electrophysiology that we call the electrophysiology monitoring, but they are limited to the hospitals because it's very sensitive signals. And when you try to measure it in regular environment, usually you get a noise. So we develop a skin patch that allow us to

attach it to your skin. It's very comfortable. You can barely notice it. And it can measure your body signal in a very accuracy way. So our technology contains this skin patch, electronic device, and analytic layers that allows to make sense with all the patterns and the signals that we can extract from your body. Our main product that we are focused on is slip to have a full PSG, polysynography test, slip study at your home. but our product and the next products will be in many additional directions.

Today there are more than 100 clinical uses of electrophysiology within the health system in the US. We believe that we can be the platform that address most of them, but from home. And you asked where it came from. So we started with a simple solution to measure the brain. to replace the EEG in a very simple way. But once we saw it and we saw the signal qualities that we get, and we understood there is larger potential here. And we found a way to integrate actually several systems in a single device.

So we can integrate both the heart activity ECG, muscle activity, EMG, and the brain activity EEG. in a very small device, and then we understood that there is something huge that we can have with such a platform. Got it. And I'm looking at your, you're sort of your wearable patches right now at X-Trodes.com. So if you're listening to this interview

and want to jump on the site after the fact, it's X, like the letter X-T-R-O-D-E-S dot com. So X-T-R-O-D-E-S dot com. X-R-O-D-S-R-R-S-R-R-S-R-S-R-R-S-R-S-R-S. So, Ziv, if I understand this, right, these are like little, little wearable patches and are, do they sync up sort of wirelessly with a different device? Or like, how do, as a user or a clinician, how do I read the data that's being sensed from,

that's being collected from these sensors? So you have sensors that you attach to your skin. It's important to emphasize that this sensor are flexible and softer than your skin. So you actually don't fit them and they keep the same location and attach to your skin in a very optimized weight even during movement. It's a dry electrode so you don't need gel so they can attach to our skin up to four days. And they connected to a small electronic device. We call it data acquisition unit that has a battery and a Bluetooth transmitter.

And then you can send the information either to Android device or PC and then to the cloud. So basically you can use our system in two modes. One is streaming, that you have a real-time signal of your body. The second one is logger. If you don't want to stream it, for example, it's during sleep. You can just collect the data on the device, and then in the morning, you connect it to USB, and then it upload to the cloud. Got it.

Okay. Very good. I think that's, and if you want to learn a little bit more about the technology, there's some great images on the website that I just mentioned. But Ziv, so I'm familiar with, and I think probably a lot of the listeners are familiar or wear an Apple Watch, right, to track, you know, certain data. I myself wear an or a ring. Woop is another popular wearable device, et cetera.

So without getting like too far into the wheeze or, you know, providing too much detail, I get the sense that your technology is just, it's better, right? It's sort of medical grade sensing technology that, you know, you're providing or giving access to people in their own homes. is that the best way to sum that up? Are there other sort of granular details that you want to provide about how extroids differ from some of those other more consumer wearables that I mentioned? I wouldn't say it better because they have some aspects that are better from our solution.

I think that when we talk about sleep, there are amazing solution on a wellness level. like rings, mattresses, watches, and so on that you mentioned. They are great, but they are still limited with the information that you can extract from them. And you can't use it for clinical use. The second layer of tools that are available today are tools, medical-grade solution, but focused only on your sleep apnea. But when you need information, even within sleep apnea, apnea, a better diagnostic, or on other sleep disorders, you are limited and you must go for a

sleep clinic. And this is where our tools provide a unique solution. To have a full PSG instead of clinic at your own bed. Got it. And with this medical grade, actually, it was one of our main challenges because we have a very cool device and when you will see it, you feel it, you see it's very cool. And we had to decide whether we're approaching a wellness device that goes to consumer level or to make it a medical device that go to the medical path.

And at the beginning, we try to decide which path is better for us. And at the end, we decide that we will start with the medical path. So we will start with a full medical device with regulatory approval, with FDA clearance, and so on. And after we will establish our credibility and our solution and the data from the medical, then we can expand to the other field. Got it. Got it. Very good.

And I mentioned earlier, you know, we're recording this about, you know, a little over three years since you started the company. Give us a sense for where you're at now in terms of, you know, development. regulatory commercialization, you know, just a better sense for the listeners around the life cycle sort of of the company. So we already have a product, available product. We are in the process with the FDA. We had a pre-sup with the FDA and it's a process for full submission. And regarding commercialization, we decided to have something that it's less common. So we decided not to wait until we have an FDA clearance. And we decided to sell a different product, subset of the product, for research purposes.

And it started from the fact that we publish actually EIL, the CTO and the co-founder, presented this technology in many conferences and many peers and other researchers ask to have access to such a technology, not only for sleep, but you can use it for many other electrophysiology uses, the field of EMG, EEG, and many other fields. So we decided that we would like to provide them access to the technology because we won't have the capacity to deal with all the more than 100

available application for such a technology. So at the beginning, we saw the prototypes, This year, we start selling it as a product. And actually, in next month, in the SFN, it's the biggest neuroscience conference. We will launch our research product together with EMotive. And we start to sell a full kit for research purposes. So in commercialization, we start to sell it for research. We believe that we will have more researchers and clinicians that we'll use

for research and to extend understanding of the product. And meanwhile, we're promoting our clearance to use the medical device. Got it. Very good. That's super helpful. So let's use that. Let's use kind of that overview as a kind of a transition point to sort of go back in time and learn a little bit more about your journey professionally, right, but also more specifically, you know, what you've learned over the past, you know, three years getting to this point with extrodes. So when you think about some of those first, you know, alpha and maybe even beta versions of your, of your, you know, the extra device, what are some of the key things that you've learned either developing those and maybe frame that up around, you know, in your experience, where do

most, you know, life science or med tech entrepreneurs specifically make the most mistakes when they're kind of iterating on those early concepts? At the beginning, our core IP was focused on the sensor, the skin patch that attached to the skin, and the analytic layer. We had to, we missed the electronics part, what is the amplifier or the data acquisition unit. At the beginning, we tried to find a solution of the shelf to integrate with our system. We tried, I think, three or four of them. and unfortunately, they didn't meet our needs. So at the end, we decided that we also develop our own electronics.

So for alpha and beta, we entered to this adventure to develop our own electronics. So on one hand, it's amazing because you have exactly what you need. And if you see the electronics device that we have, it's like multi-modality system, six modality in a single system in the size of airports. But it's a real shift of resources. And we started to recruit more and more experienced technician and increase our R&D and to have more and more budget, to increase the budget in order to have this solution.

And at the end, it took us a year and a half and several millions in order to have the results that we have today. So it shifts our focus from what we are the best sensor and data. And we found ourselves in a new adventure of developing electronics. So if you ask me what is a lesson, I think that I would. look harder and invest more resources to find something off the shelf if we understand that it's not core part of our technology. Because any such decision takes so much effort and resources and time for your organization. I think this is my lesson. So if I'm hearing you right,

If it's not, like you said, if it's not a core, it's not the secret sauce, right? Or the core, kind of a core aspect of your technology, you know, spend, allocate enough time and budget towards trying to find an off-the-shelf solution. So you don't have to build it yourself. But on the flip side, if it is a key component, right? If it is part of that secret sauce, don't be afraid of spending the necessary, you know, funds or capital, right, to develop that yourself. Is that a fair, fair takeaway?

Yeah, absolutely. Okay, very good. Very good. Let's jump, let's jump to kind of this topic of clinical research, right? You just mentioned that, you know, it's next month. It sounds like you're, you know, you're going to be, you know, launching a device or kind of a partnership with emotive, you know, and you're, you've got a PhD, right? So I'm assuming you're, you're, you're, you're always going to look for scientific evidence that supports a certain device or how, you know, how, you know, the claims around a certain, a certain product. So talk to us a little bit more about kind of your approach to actually validating that X-Rodes does what it really, you know, what you say it does.

So I think that unlike many other solutions, they try to mimic original signals of electrophysiology. For example, when you measure heart activity, you can measure it with ECG or you can use all kind of other sensor in order to estimate your ECG, your heart activity. It's also for EEG and for EMG. So I think unlike other devices, our devices actually measure the direct measures that you measure in the hospital and in the clinic. So for us, the basic clinical study was to compare head-to-head our system with a golden standard system within the hospital. So I will take sleep as an example. We take patient.

We use a golden standard system, commercial systems that used today in the hospital. And on the same patient simultaneously, we use our electrode. So when we compare it, we compare it in two levels. One is a more physical level that we compare the wavelet. We compare that our EEG look exactly like the golden standard, the clinical standards. So this is the first level. The second level is to give this data in the output of our system and the output of the other system to an expert as a physician or a slip score and so on in order to see that they can extract the same clinical information from the data. So basically the process that we've done for each one of the modalities to compare it head to head with a golden standard.

standard systems. We also, so this is, I think, like the sum of our studies. We have other studies for specific clinical uses that we show that you can use

such technology at home for this application. And on top of it, we provide the system for other researchers and they do all kinds of crazy studies. We don't try to control it. We provide it for researchers and clinicians to do whatever they would like to do.

And there are so many cool studies. I can mention some of them. There is a very nice studies that are done in Tel Aviv universities that measure the facial expression with EMG and shows that you can learn about light detection in a better accuracy than a polygraph. And you have a studies that measures for back pain, the gesture of your back when you are sitting. So there are plenty of study in multiple fields, and we just enjoy to see how you can take advantage of such platform for so many different applications. That's super interesting. And so it sounds like you've had a fair amount of inbound interest, right, in using the technology

for clinical research. Is that, like, seeing some of those signals, I guess, from the market, is that, does that, factor into your decision to kind of pursuing more of this clinical research path from a commercialization standpoint? Yes, I think it started from the inbound request. And I think that, Yale, my co-founder, she's a researcher and, and, you know, and, she really likes this technology. And at the beginning, there was a frustration once we understand that we understood that

we can't apply and use this technology for so many applications. So I think that we understood that it's a reasonable thing to do, to give access to such a technology. And I think it gives us all kinds of other benefits that we understand now. You know, we got credibility, we got validation, we got understanding where are very good direction in the future. And it also gives, as organization, we are meeting the market earlier than other medical device companies because we already engage.

We have operation. We have support. We have all the components that needed for commercialization. Hey there. It's Scott. And thanks for listening in so far. The rest of this conversation is all. available via our private podcast for MedSider Premium Members.

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