Pierre-Alexandre Fournier
For those who don’t know Hexoskin, we’re the number one smart clothing company in the world for health monitoring. We’re also providing digital biomarkers, diagnostics, and artificial intelligence development services to pharma companies and government agencies. Today I’m going to speak about digital health, of course, but more specifically, clinical evidence generation. The things I’m going to share apply both to healthcare and clinical research. Evidence is what makes medical discoveries possible. That’s how we measure safety and efficacy, and that’s how we measure efficacy gains in healthcare delivery. When we lower the cost of medical evidence, we make care more accessible and affordable. This is fundamental, and wearables can do that. So I’m also going to share what we’ve been doing at Hexoskin to solve the evidence gap for healthcare and clinical trials with a few examples and how it applies to clinical trials more specifically. First, I’m going to say something very important that I’ve been telling pharma executives for the past 10 years. Pharma companies are data companies. The molecule you’re working on is not worth anything if you don’t have the evidence to prove that it’s safe and that it solves a medical problem. So, the way you manage data as a pharma company is essential to your business, is essential to your cost structure and your efficacy. And healthcare systems, of course, are data-driven, and more and more so. And I would say we started working with pharma companies about seven years ago. Pharma was behind healthcare systems in terms of adoption of digital health, and I could hear chief data officers from health networks saying to pharma companies, we know more about your products than you do, because we’re collecting all that data, and you don’t. And we all have the real-world evidence in real time about your product. And for pharma companies, it was a huge blind spot, because imagine that you launch a product and you don’t have all that data, and this is going to affect how you’re going to get paid for your product. This is arguing, you may have a drug that you think is worth $5 billion, but maybe it’s only worth $500 million, and it makes a huge difference in your business. So regarding clinical trials, about seven years ago, there was a lot of confusion about regulation, technology, and logistics, and most clinical trials were still run on a paper, there was a lot of suspicion about patient-reported outcome. And I would say, pharma has caught up. There was a huge investment over the past seven years in digital health by pharma companies. Pharma companies that were mostly lab companies working on paper seven, 10 years ago, now have huge department only doing data science. And this is great. This is great news for the industry. This is great news for pharma. This is great news for healthcare. So, this is an example of conversation we had seven years ago compared to now regarding digital health. So, it’s getting a lot more sophisticated. And regarding wearables, seven years ago, people were thinking, oh, can I use Fitbit to count steps and activity in a clinicaltrial? How do I do that? And now, pharma companies are comfortable using dozens of types of wearable to track hundreds of different endpoints or digital biomarkers in their clinical trials, Phase I, II, III, and IV. So, this is great news. So now, about every clinical trial that’s happening in the US is using some form of digital health. Patients install apps on their phones and they can fill out questionnaires. And there’s even this bold prediction here by Kaiser Associates that says that most clinical trials in the coming years will be using wearable devices to follow patients at home. So, we are not only collecting data onsite now, we can follow the patient home for weeks, for months, for a whole year, if needed. So, at Hexoskin, we’ve been focusing mostly on cardiac and respiratory diseases. Of course, it leads to millions of hospitalizations every year in the US. A lot of these hospitalizations are preventable. So, every evidence we can gather about it is useful and valuable. And of course, there’s a lot of clinical trials that looks at these aspects. So, the patient experience today is not great. I’m sure many of you have worn a Holter ECG monitor in the past. They put a lot of tape on you. Thankfully, over the past 10 years, there’s a few products that came out that are somewhat better and easier to use, but they’re more limited in terms of data collection that they can do. There are only one or two leads, one or two channels usually. And still, you put that on patients and most of the time, it doesn’t lead to diagnosis. So, you have to do the test again. And if you still don’t have a diagnosis, either the patient will quit or if the problem is really acute, you’re going to go for an implantable monitor, which is very costly. It’s over $10,000 and it’s invasive, of course, it requires surgery. So, this is the problem we were looking at Hexoskin and we thought, how do we solve this? How do we do long-term cardiac monitoring and ideally also pulmonary monitoring? We have to find another way. And we were looking at what we wear on this part of our chest every day. And the solution came up after a few design iteration that almost everybody is comfortable with a t-shirt or tank top or some kind of undershirt directly on their skin. So what we what we did what we did is basically we took a t-shirt and we hid the sensors inside these t-shirts so it’s easy to use for a patient. If your patient can get dressed, they can use it. If they cannot get dressed, well, somebody’s doing it for them. So, it applies for almost every patient, it works for almost every patient. The shirt has a ECG, breathing sensors and activity sensors and I’m wearing one right now under my dress shirt here, it’s very comfortable to use and while I’m speaking to you here in New York I have like my ECG and breathing signals streaming on my phone and this data could be used in real-time by a doctor in Australia or Switzerland while I’m talking with you here in New York City. So of course this has a use and interests for clinical trials and for diagnosis. One reason is that it bridges the gap between adhesive based sensors and implantables. So, adhesives are good if you need to monitor a patient for a couple of days maybe a couple of weeks beyond, but that patients quit. We have data from multiple payers showing that, and I’ve heard patients telling me I’d rather die than then wearing these stickers again. So, and the longer term is the implantable. So the smart shirt fills a gap here, and it allows continuous monitoring, it’s easy to use, it’s machine washable, it’s easy to put on and off, and patients can use it in multiple types of modalities. They can use our app to fill out questionnaires, look at data, we can customize it for clinical trials to collect different types of data points. So it’s very, very convenient. Sorry, I’m going fast, I only have 15 minutes. And Hexoskin is set up to provide services for remote patient monitoring and for clinical trials in the cardiac and respiratory space, but what we’ve discovered over time is that there’s a lot of diseases where monitoring cardiac activity and pulmonary activity tells us something about the disease. So we’ve been working for example in the neurological space and the rare disease space and we’ve been working with foundations and pharma companies to develop new digital biomarkers for specific diseases, and I think this is my prediction for the next 5-10 years we’re going to see an explosion of new digital biomarkers for specific diseases. If you think about it there are hundreds of opportunities to develop new digital biomarkers that are useful for patients and useful for clinicians to help them managing their diseases. I think one reason of the success of Hexoskin is that we’ve built the platform as an open platform. It’s very transparent. Our clients have access to every single data point that is being recorded with our devices. It’s been very successful in the academic world as well. It’s been the subject of over 200 publications for different types of health conditions so far. I’m going to give you a few examples of clinical trials that we’ve been involved with and we’re still involved with. One is in the respiratory space. We’ve been developing new digital biomarkers for chronic pulmonary disease. What’s interesting about the pulmonary space is that I think cardiology has been very supported. There’s about 50 vendors in the US that sell products for ambulatory ECG, but there’s none, there’s zero vendors except us today that sell a solution to continuously monitor breathing patterns. So we’re doing something very new here that has the potential to change the way we manage these chronic conditions, change the way we treat these diseases, but also change even the definition of these diseases and change the way we develop new therapies for pulmonary diseases. So I’m very excited by that. Another example that was quite surprising to us, but it makes a lot of sense. So we were involved in a few oncology trials where we’re looking at quality of life of patients. This example is with UHN in Toronto where we have patients on ongoing palliative therapy, palliative care therapy in oncology, and then we’re monitoring them to see treatment response. This is another project that’s very dear to me. It’s a project with a rare disease called the Rett syndrome. There’s only a few thousand patients in the US, and it’s a good example of where you need a virtual trial to collect the endpoints you’re looking for when you study a drug for a specific disease. So these kids are wearing Hexoskin shirts for a period of about six weeks. They are correcting that at home almost 24-7. And these amazing things at Vanderbilt in Nashville, Texas Children, Boston Children, but also many other children’s hospitals in the US have built the largest database of physiological signal for that disease. And we think that there’s hope now to develop really life-changing therapies for that disease. They’ve been working on it for decades, but there’s something happening now that’s very exciting, and we’re being solicited by other teams working on rare disease for the same thing. Very excited about pediatric research with that technology. So we have hundreds of research groups now that use Hexoskin shirts for research in different sectors. We have clients all over the world and we’ve done very exciting things too, like we’ve been working with Chris Hemsworth in his show Limitless, that’s available on Disney+, Nat Geographic. If you have Disney+, I recommend it. It’s a very good show. So he’s been wearing the Astroskin version of the Hexoskin shirt for that show to monitor his vital signs in a very stressful situation. I’m not going to tell you what it is because you have to watch the show. But the version he’s wearing is the same that we’re shipping to the International Space Station for monitoring astronauts in microgravity. So we have four clinical trials today in the International Space Station studying cardiac and respiratory health in microgravity during long-term missions in the space station. This is an international effort and this is — basically we’re collecting data to better prepare to missions to the moon and beyond, hopefully, to advance our knowledge of space medicine. So data collection on astronauts is very expensive. There’s very few astronauts. We’ve developed a system where their hands are free and they can do their work and the system doesn’t interfere with their astronaut’s time. And finally, so this is the Astroskin system on top of ECG and breathing monitoring. So the Astroskin is a very complete system. It also measures blood pressure, SpO2, PPG, and other parameters. So it’s a very comprehensive system to acquire vital signs in an ambulatory way that is being used now by dozens of research groups outside of the space sector as well. So, just final word. Today, the best analogy I have for digital biomarkers is the lab industry today. The lab industry is a $100 billion industry in the US, collecting blood sample, urine sample, and other things to help you get better care, to get you get a better diagnostic. What we think is that the digital biomarker industry will also become a $100 billion industry. And this will completely change the way we access care from home and in between clinic visits. And this has the potential to lead to huge savings in terms of how we provide care and to maintain the quality of care that we’ve known today. And of course, if you want to partner with Hexoskin for your projects, I have a label, I’ll be here today and tomorrow,and I’m very easy to find online. Thank you very much.