Good morning, thank you all for joining us here today and for attending our session on Cardiac Arrest, the Next Digital Health Frontier. I'm Mina Chung, I'm a cardiac electrophysiologist at Cleveland Clinic and Vice President of Heart Rhythm Society. This is a really important topic and we have a fantastic panel here and I'm gonna ask each one of our panelists to introduce themselves with Richard. Good morning, everybody, I'm Richard Price. I'm the founder and president of PulsePoint, PulsePoint Foundation, it's a 501c3 organization. PulsePoint is a 911 connected platform that has near real-time awareness of cardiac arrest and we use that information with a mobile app to alert people who are near cardiac arrest, CPR-trained people, AD-equipped people and we'll get into that more, but that's what PulsePoint does. Hi, Jennifer Kozen, Assistant Director of the External Heart Rhythm and Rate Team at the FDA. Hi, I'm Jill Root, Jill Schaefer. I'm a nurse practitioner at Penn Medicine, Lancaster General Health. Happy to be here. My name's Jake Sunshine. I'm a research scientist at Google and also a physician and also have a faculty appointment at the University of Washington. Hello, I'm Sumit Chugh. I'm also a clinical electrophysiologist like Meena and I have a strong interest in predicting and preventing cardiac arrest, so at our Center for Cardiac Arrest Prevention, we've been funded by NIH for about two decades and that's what we do. Thank you. Cardiac arrest, sudden cardiac arrest is really a huge problem. We see some statistics up here. In the US, there are over 356,000 cardiac arrests a year, so that comes out to be 1,000 per day. We've all heard about some high-profile cases, but many of us here in this room probably have been affected by family members or friends or acquaintances that you know who have had sudden cardiac arrest. And the problem with it is that over the US, the survival rate is under 10%. Overall, it's only 9.3% for survival to hospital discharge, so this is a really huge problem in our field and all of cardiovascular medicine in the world and we really need to come together, I hope, to really try to make additional advances in it. Three quarters of these episodes happen at home and half are unwitnessed. With that, the prognosis is even worse because by the time we get there, it's already too late. So the challenge is for us to really try to figure out how we can improve this. In cardiac electrophysiology and cardiology, we have made some progress. We've done a lot of randomized clinical trials that have identified high-risk people, people who have had an MI, a heart attack, or have low heart function to a certain degree, and we've done randomized trials and shown that those people can benefit from an implantable defibrillator, which is a device that can be implanted and monitors the heart rhythm 24-7 and if they have a cardiac arrest, it can shock them out of it. I tell patients it's their own personal paramedic in a box. The problem is that the people who actually have these are the vast minority of the people that actually have sudden cardiac arrest. Most of the people who have sudden cardiac arrest are in our general population or that have an intermediate risk. Maybe they have mild coronary disease or they have mild heart dysfunction and they don't reach the high enough level to really be able to qualify for a defibrillator. So how do we protect or treat those? That is really the real question. And this forum, HRX, is really perfect, really to try to bring together a lot of the technologies that you have heard and innovators to try to tackle this problem. We're at a real inflection point, I think, and that's why we're here today on this stage. There are a lot of digital technologies out there that could potentially be applied to sudden cardiac arrest detection. And I learned about this first when my husband tripped and his watch said, you know, fell and was gonna call EMS. I said, what's that? I realized then that, you know, some of our digital technologies are connected to 911. We have lots of sensors out there. We have oxygen saturation, you've heard about through COVID. We have pulse detection, PPG. We even have agonal breathing detection, which Jake here has really helped develop. And we have ECGs that have been put into various devices. And they're not just in watches or on your smartphone. They're being incorporated into garments or smart bedsheets or shopping cart handles or your car steering wheel. So there are a lot of technologies that are out there and sensors that could be used for this. We also have some low-hanging fruit. We have implantable devices, implantable loop recorders. We have pacemakers, but they're not connected to EMS. They're not connected to emergency services. They're starting to get connected to cell phones. And as that happens, then we can hopefully connect them. But how do we actually do that path? And what are the barriers? Can we lower the barriers? Now I can see a point where these implantable loop recorders which now have a battery life of perhaps four years could have multiple sensors. And maybe when they get to having like a 10-year battery life. Many of us over age 65 or whatever at some intermediate risk group might say, I want one of those so it can connect me. So I think there's a lot of innovation out there that we can hopefully pull together. There are also advances in deployment. You're gonna hear a lot more about PulsePoint where CPR providers and AEDs, we can deploy those in the community. And that's already being done. In fact, in Europe, there were some studies that showed that these types of deployment platforms not only increase bystander CPR and bystander AED use, but also can improve 30-day survival. We haven't made a big impact on that in so long. So this is really getting there. And also there's research being done on drone delivered AEDs and work on miniaturizing, decreasing the size of AEDs so they're more portable and decreasing the cost of them. When that all happens, that could be very paradigm changing because you can have AEDs on every street corner in a lot of places. So hopefully we will get there. And this panel is really on the forefront of where we're going. And so I really look forward to our discussion. So let's start with Sunit. You've been working on prediction of sudden cardiac arrest and sudden cardiac death. Can you tell us a little bit about where we are with that and where we're going? So I think that wearing my clinician's hat, I could say that we've done a decent job with the long-term prediction where you judge if somebody has an elevated risk, you put in a defibrillator, and the defibrillator could fire not tomorrow or day after, could take five years, 10 years, 15 years for that defibrillator to actually fire. At the other end of the spectrum are these clever ways that Meena referred to, which is resuscitation and getting better at figuring out early who has collapsed so we can get to them. I would say that we're thinking of a little bit of a different way of tackling this problem. You have the long-term prevention and you have the resuscitation, and we've been working on having a focus in the middle somewhere. And that is something we call near-term prevention. And what we mean by that is, can you actually predict imminent cardiac arrest? And what I mean by that is in the hours to days to even a couple, four weeks before the cardiac arrest, can you figure out who's gonna have it so that you have more time to intervene? Right, is there a role for AI in this or how do you see that being implemented? Is it something that might go through Rich's pulse point, for example? Well, I think that's a very good question and the answer is always yes today because we think that AI is gonna solve all of our problems, but the reality is that AI is a tool. It's an outstanding tool. In the end, we have to work on it based on gaps in knowledge and how we can fill them in. And so I think there's several ways in which AI could step in and help us. The example that I can give, if I may, relates to some of the studies we've done. The first study that we did that made us sit up and pay attention was that when people have a cardiac arrest, in the time period before that, even if you take a month before that, at least 50%, maybe even more, of men and women have warning symptoms. So why is that important? Well, we also found out that when you have warning symptoms and somebody or you call 911 right away, well, it turns out you have a five to six-fold higher chance of being successfully resuscitated and making it out alive. So the question for us became, this was about a decade ago that we figured this out, how can we do that? Because if I have chest pain that's real and Jake has chest pain because springtime just came and he went to the gym and he really pulled too much weight and his chest pain is different from mine, but if everybody started calling 911, the city of Atlanta would be paralyzed in an hour, right? So these are very nonspecific. So what we've been doing is trying to solve this issue, which aspect of warning sign or symptom is more important and who's the one who should be calling? So in this, we are using AI because we have so much data and we compare different groups, people who end up having a cardiac arrest and people who don't end up having a cardiac arrest and that's how we're gonna try to use AI to get to ways of predicting this imminent cardiac arrest. Well, that's really interesting because who you deploy to, there may be some triage to that. But speaking of receiving some of this information, Rich, can you tell us a little bit about PulsePoint, what that is and where you are with that? Sure, thank you. So again, PulsePoint's a 911 platform that is connected to dispatch centers around the country and is aware of cardiac arrest in near real time. So I say near real time because it takes a call to 911, a dispatcher, a call taker determining that somebody is unconscious, not breathing normally, may need CPR to then trigger PulsePoint. So PulsePoint gets that alert. We have somewhere around 800 unconscious, unresponsive reports come into PulsePoint each day. PulsePoint uses that information to notify people who are nearby. These are people who are in the immediate vicinity that are trained in CPR or are AED equipped. And so these are people who are very close. They're in the building next door, they're on the floor above. And so we're trying to get people to the scene faster, more often. We're trying to get more people to the scene. It's obviously easier for two people to do CPR from a confidence level, from a taking turns level, to a more in-depth understanding of what's going on. So we're trying to get people to the scene faster, more often. We're trying to get more people to the scene in a way that they're more aware of the event. So we're trying to get people to the scene faster, more often. We're trying to get more people to the scene from a confidence level, from a taking turns level. CPR is physically difficult. So that's our goal. So today, our input is always from the 911 system. In the future, it's obvious that wearables will be also able to detect a cardiac arrest. Not just wearables, maybe implantables as well, but there'll be inputs besides 911. And a lot of those devices are looking to get into the 911 system, which will be very important, always parallel to anything else that's done. But there are a lot of trained responders that are nearby. So off-duty professionals, nurses, police officers, firefighters, physicians, we're alerting them every day. You look at a conference like this, if there's a cardiac arrest in the lobby just outside this room or in the bathroom or something, there's an awful lot of people here that are well-trained, but they're not gonna witness it. But if they were alerted, they're close enough where they would arrive far before Atlanta Fire, who's got to get dispatched, get through the traffic to get here, park, make their way inside the building, find that particular bathroom, get to the patient's side. And cardiac arrest is just one of these medical conditions that has an extremely short window of opportunity. So when you're thinking six, seven minutes before you have neurological damage, 10 minutes, probably no chance of survival, it may be very important to alert people that are in the immediate vicinity in parallel with your on-duty professional responders. But can you give us an idea of how well you've implemented, how it's implemented, the scale or the reach of your program? There's about 5,100 communities today that are connected to the network, and we're adding those all the time. There's about 3 million people that have opted in to be alerted if they're nearby. So when a community does connect to the network, they do the outreach to their community, to their local hospitals, police and fire, and their CPR instructors and programs that are training people in CPR so that they can build up their responder network in their communities. So we kind of go community by community. We provide a lot of resources to emergency services in those communities to help them build their network of responders and add that to their parallel response. We've been doing that for a lot of years in the United States 20, 30 years of training people in CPR, deploying AEDs in our community, and we're just trying to amplify the effects of those things that we're already doing. So on a given day, how many do you actually respond to? So we have real-time stats on our website that are always, you know, pulsepoint.org.stat. You can see these in real time. It's typically around 800 reports of cardiac arrest today. Now, those are unconscious, unresponsive, so they're not always gonna be cardiac arrest. You know, you have a caller who's sometimes untrained, a dispatcher who has limited training, so it's really, are they breathing normally? No. Can you wake them? No. That's gonna activate PulsePoint. So it could be an overdose or other things, which, you know, sometimes it is. But about 800 of those reports a day. We typically notify 600, 700 people a day that are nearby across the U.S. and Canada, roughly the numbers. It's impressive. All of us could go on to PulsePoint and sign up, I suppose, right? Yes, so anyone can download the app. It's free. Opt in to be alerted to a nearby cardiac arrest, and that level of responder gets alerted to cardiac arrest in public places. So there's different levels of responders. So, Joe, you're an allied professional, and we know that it's through our allied professionals that a lot of implementation occurs, and I think you've been involved with implementing PulsePoint as well in your community, right? Yes, Penn Medicine, Lancaster General, had decided to fund PulsePoint in our community. And it was rolled out as part of sudden cardiac arrest week about two and a half years ago or so, and people could sign up. But I'll admit that I didn't really know what else has happened from that, so I did have the opportunity to talk to the EMS director in our program. Just for reference, our Lancaster County in Pennsylvania is about 525,000 people, and I was amazed to find out that already 4,000 folks in our community have signed up. About 600 of those are the off-duty police officers and EMTs. Nurses right now in our community, APPs would be under everyone else because there was some concern that we wanted people that were for the, we wanted things to be a safe environment because of the overdose situations and things like that. That was the decisions they made. But they have statistics in our community that four people have left the hospital alive that were resuscitated. There were anecdotes of two EMS paramedics that were just having dinner together in their home and down the street was a cardiac arrest that they were alerted to. And it basically, their phones go off just as soon as their beepers go off. They've kind of tested that, that that's how fast it is. And I thought in the beginning, it was like, well, how far away is close? And in our community, it's under half a mile. So you're not gonna be alerted for something 10 miles down the road and get nuisance alerts that you really can't respond to. So we've chosen, our community has chosen a half mile. So I think as allied professionals, it is important to kind of understand your local community. And as allied professionals, we are often educating patients talking about those things. So things about symptoms, what we know. As you know, EP is a team sport, right? You know, the physician may start the plan and the patients take a lot in. but my job every day is to keep repeating that plan and keep educating folks. And sometimes goals of care change, so I think allied professionals do have a seat at the table to continue that education and help people decide, you know, where they want to go with wearables, with implantable devices, with not minimizing symptoms. I share with folks at this forum is near and dear to my heart because my brother-in-law died of sudden cardiac arrest at 42 on the sofa, and my sister's children found him on that Labor Day weekend many, many years ago. So had symptoms that he minimized that he didn't tell anyone about, and so it strikes you in your heart as a family, and it's important that we do what we can. Absolutely. Can I ask a question related to the logistics of PulsePoint? And firstly, kudos to PulsePoint and to Penn Medicine, you know. PulsePoint has been an early initiator. So you know, when you receive a message from PulsePoint, you can help by doing CPR or going for the AED, and how do you know where all the AEDs are? So the other thing that PulsePoint does is it maintains the emergency AED registry. So our goal is to help communities build their AED registries and make those available to the dispatchers, to the call takers at the time of call processing. So we've been working for 15 years now building that registry and connecting it to all the different software packages that are in 911 centers. So their dispatchers stay in their normal workflow using products that they're aware of, but those products are interfaced to the emergency AED registry. You know, the dispatch system passes the location of the cardiac arrest, PulsePoint passes back an ordered list of AEDs that are in the immediate vicinity, so the dispatchers can give that to the caller. We also use that information when we alert you that there's a cardiac arrest. So if you've got an alert here for a cardiac arrest, you know, in the lobby, you'd also be told that there's, you know, an AED right at the entrance to the ballroom here. So you'd see the AEDs that were in your path on the way. And then we also work with the AED manufacturer, so any AED that's in the registry, we will also alert people who own that AED or are responsible for that AED that their AED is near the cardiac arrest. So about 50 percent of our work is on the response side, telling people where cardiac arrests are, and about half our work is around the AED registry. And again, the foundation's a non-profit, and they provide the registry, all the interfaces, the training, everything around that registry is provided at no cost to anybody who might have need to know where AEDs are. Where I was going with that, Rich, was that anybody can buy an AED over the counter. Now, obviously, that brings a lot of inequity in who can buy it and who cannot. But if someone has it, it may not always be possible for a registry to be complete. So are there any plans of the AED having a homing signal so that everyone who's looking for an AED can actually find that AED? I think you're seeing a lot of innovation around AEDs. AEDs have been in place for many, many years. There's an awful lot of AEDs out there. So our approach today is kind of a couple different approaches. One is, if that AED is in the registry, so you buy an AED, you can register it yourself. You go to aed.new, enter that information, it will go in the local registry. You can download the PulsePoint AED app, add that record. And then, if you subscribe to notifications, if your AED is near a cardiac arrest, we will send you an alert. And we'll show you where that cardiac arrest is, and the idea is that you'll take that AED and use it. So that's something you can do today. The other thing that we do is we do work with the AED manufacturers, especially the next generation, because we know where the cardiac arrests are occurring, we can pass that information to those devices so the devices can be alerted, or their apps can be alerted. That's kind of the future, but we think it's important that all AEDs are alertable. That's kind of our approach. So you put it in the registry, it becomes an alertable AED, doesn't matter what the manufacturer is, what the model is, there's a record for it. We know where that device is, we know where the cardiac arrests are, and we can do that notification regardless of any advanced characteristics of the AED, which can drive the price of the AEDs up. I mean, we're looking for AEDs that people can purchase, and that threshold is very low. All the radios and always being listening for a signal, all that stuff can drive the price of an AED up. We're trying to drive the sort of simple capabilities and the alerting through the registry instead. Just a different approach. But we do both. It needs maintenance, too, right? So I don't know if help with that needs to stay charged up. Also, as you mentioned, there's a lot of innovation going on, and as Sumit brought up, if they have a tracking device, some of them are going to be more portable. They're going to be mobile. They're not going to necessarily be in one place. So is that... Yeah, I think what we do is we alert you based on where you are. So if you have an AED with you, if you have an AED in your car, if you have an AED wherever you are, at the gym, you're out hiking, you have an AED, we know where you are and we alert you. If you have an AED with you, great. So we don't care so much about the AED because we know where you are as the responder with that AED. Just a different way to think about it. But we also, if you have an AED at your home, for example, or at your business and you only want to be alerted to incidents that are near your home for your neighbor or something, then you would use... You'd register your AED and say, notify me if my AED is nearby. That doesn't know where you are, it knows where your AED is. So you can kind of do either approach. Great. Yeah, and as we head into incorporating all these wearables, you know, Jill, the case you brought up with your brother-in-law is tragic, but we hear a lot of these stories where like somebody was ill with a respiratory infection. So sleeping in a recliner downstairs and then found dead the next day. And in this case, the case I'm talking about, he had a watch and on interrogating the watch you could see the pulse or the O2 sat and pulse was going along and then plummeted. But there is no way to really connect that. So that's the challenge. And we heard a couple of weeks ago that Google is releasing a Pixel watch in Europe that is going to have a pulselessness app. And so that's really fantastic. And Jake, you know, you've been involved in development of that. Can you tell us a little bit about how you developed that? Yeah. Thanks so much. And I wanted to emphasize that announcement was, yeah, about three weeks ago. And it's only available in Europe. It's CE marked in Europe. It's not yet available in the United States. So just wanted to preface all of that before talking a little bit more about how we built it. So the system is designed to identify when someone has transitioned from a pulsatile state to a pulseless state. We've heard a couple of stories. This is tragically common. And so, you know, speaks to a real unmet need and was a motivation for building a system like this. There are a couple of research constraints around this. While these events are common at sort of a population level, individually they're rare. And that makes building a model to detect these somewhat challenging. And so we started by going first to an electrophysiology lab to try to understand what it looks like on a watched based PPG, you know, which is just different than what we use for sort of clinical monitoring. There are subsets of procedures when people may say have their defibrillator tested, where they are transiently in sort of a pulseless arrhythmia, you know, under medical supervision. And so, you know, under informed consent we were, for people who had previously had these procedures scheduled, we were able to identify what this signature looks like when people may be experiencing these events. And the key insight that we had was what that signature looks like when the heart has paused momentarily before being shocked back into a perfusing rhythm, is that that pulseless state looks quite similar to a pulseless state that could be, say, you know, induced by say a pneumatic tourniquet, where you have a peripherally pulseless state that's safe, you know, you're still perfusing your brain. And so that led to sort of an experimental model that looks very similar between a central pulseless state and a peripheral pulseless state. And so that, in some ways, can scale a lot more than a fairly uncommon procedure in an electrophysiology lab. So this was sort of the kind of foundational insight from which sort of the whole program was built off of. Another really important consideration is when you have something that, you know, may be tied into emergency medical services, it's a precious public resource, you need to approach that really, really responsibly. And so from the beginning, we were getting insight into designing this feature from EMS experts, not just the leadership who oversees these, you know, systems, but also the people who might be on the receiving end of a phone call down to paramedics who actually might respond to something. So really important to get insight to sort of build something responsibly that involves a resource like that. Another really important consideration is, you know, minimizing false positives. And so fortunately, there's a lot of consented data at Google, you know, that you can run an algorithm retrospectively to see about opportunities for false positives. And so we were able to do that before doing a prospective evaluation, looking at sensitivity in a simulated environment among a diverse group of people, diverse based on skin tone, age, and actually enriched for older individuals who are, you know, slightly elevated risk. But to your point, this is something that can affect the general population across ages. And then having them, you know, wear a device in sort of a free living environment to get insight into opportunities for false positives. And so all of those things we sort of, you know, put together, and we've, you know, submitted our data for peer review. It's going to be turned on in the next couple of weeks in select countries in Europe. And we're looking, you know, forward to working with other medical regulators and other jurisdictions to try to bring it to more people. That's fantastic. Congratulations on that. And, you know, you've done so much work through the years. I was very impressed by your agonal breathing app, you know, how you did, took a similar approach and had recordings of agonal breathing, I guess, through EMS recordings, I'm not sure how you did it, and then used AI and recordings of sleep apnea and ambient noise. And your AUC, you're under the receiver-operator curve, the C-statistic was 0.995. And I'd never seen a curve like that. Yeah. That was really impressive. And hopefully that'll get deployed at some point if it's not already. But can you tell us how you're rolling it out in Europe? How are you connecting to EMS or is it being connected to responder networks like PulsePoint or does it go, you know, this is a question that's going to morph to Jennifer, too. But how are you doing it in Europe? Yeah. So, you know, our approach was probably not the most responsible thing, just to, like, turn it on and not let people know. So we've been trying to reaching out to EMS providers across Europe to let them know that this is coming, getting their feedback, answering their questions about it prior to turning it on. And then, you know, preceding all of that was, you know, reviewing our data with EU regulators prior to making our announcement a couple of weeks ago. And so we're just trying to take this incremental approach, starting with, you know, subset of countries in Europe and then building off of that. Fantastic. So this brings up, you know, the regulatory environment. And I want to invite everybody to put in questions in the app and we'll try to answer them as well. And so, Jennifer, what are some of the FDA considerations for these sudden cardiac arrest technologies? I mean, we know the fall apps are out there, but not necessarily, I don't know that they went through or required an FDA approval. Can you give us a little insight into the process there? Yeah. So, you know, as part of the FDA review process, I think there is a lot of different considerations for these types of technologies. So first of all, intended use. So is there an impact to the standard of care? So, you know, just any changes to that chain of survival. We want to be able to understand fully what your device is intended to do and how it's intended to be used. I would also say labeling considerations are really important. Making sure that people understand how to use your device, especially if it's intended to be OTC with lay users, that sort of thing. If there are any audible alerts, the language that you're using in those alerts and the messages, making sure that people understand, especially if it's intended to be interpreted by patients or bystanders, people who are not necessarily, you know, trained. I also think cybersecurity is a really important consideration. If there are any electronic interfaces, so if your device is intended to connect with Wi-Fi or cellular networks, even other medical devices, just making sure that any vulnerabilities that are associated with those connections are mitigated as much as possible. And then, you know, in terms of the supportive data as part of our review, just any bench testing, accuracy, what the expectations are around that. I think we would also, you know, be wanting to look at any type of alert testing that you might have for alarms, you know, what the time to alerting and alarming would be. And then also usability testing, making sure that people are really understanding how to use your device and they can do it appropriately. And then, of course, risk-benefit as well. I think that's part of all our decision-making at FDA, and especially in this space, it's especially important making sure that the benefits outweigh the risks. Great. So, how do companies work with the FDA as they are considering developing these technologies? Yeah, sure. So, you know, of course, you could always start here. There is a group of us from FDA that are at HRX right now. We have an FDA lounge in the back corner of the ballroom. Feel free to come talk to us, ask us questions. Hopefully we can answer most of them. If not, we also have a really good method of providing feedback to sponsors through the Q submission programs. You can come and send any questions that you have, and we essentially provide you some written feedback and have a teleconference to talk through those questions. And hopefully, you know, we can get a good insight into your device and really understand it and have a good conversation about what it is and what those expectations might be for when you're ready to come in with a submission. That's great. It's so wonderful to hear that the FDA is so open to hearing from everybody. So, I'm trying to understand in the future how we're going to be connecting these multiple sensors, multiple devices. Will there be, you know, is there a need for a common stream to EMS? They're going to get very overwhelmed if 100 companies or 100 types of devices are being funneled into them, and how is that going to be vetted? Might there be performance goals? And that's one of the questions somebody posed in our Q&A. Are there thoughts on that from any of you? So I think that's a really important question. We can be very innovative, and we can come up with all these things. But how is that going to be coordinated? And we had a taste of that recently because we, meaning I'm perfectly involved in this project that looked at legislation for AEDs around the globe. So this is a paper that will be coming shortly. I don't want to steal its thunder, but all I can tell you is that what we learned was that in the United States, there is so much opportunity that drives innovation, but that also brings about a challenge. Because in other countries, like you're in Europe right now, mostly there is a national health service. The nation takes care of it, you know? In the U.S., there is a lot of opportunity, but there has to be some kind of, if I may mean, might I call them an honest broker, you know? Or some, which could be the government, could be somebody, an organization, where all of these really need coordination, not just, yes, you definitely need to have standards, but if you just take the example of EMS, you take the example of all the signals that are coming to improve resuscitation, how are they going to be coordinated in a way that's uniform? So who is going to be that honest broker? That's the question. Right. That's been on the top of my mind for a while now. And so I've been working with HRS and AHA, and considering whether or not we need to put together a team that can develop some algorithm, and it doesn't necessarily, it may not be on the level of looking at everybody's raw data, because you wouldn't be able to do that, but possibly every company, you know, all the different devices would potentially need to give some information to whether or not it'd be the FDA or EMS or this honest broker, you know, what's the sensitivity and specificity? You have one sensor and three sensors, or whatever. What does that come, what does that look like? And is there an AI-assisted algorithm that can then feed into a pipeline to say, oh, this has a 95% chance that it's a sudden cardiac arrest and then go through the pipeline to EMS or to PulsePoint? I don't know how rational that sounds, if that is, but because I think, Rich, you know that there's a lot of effort in this space, so. Yeah, I think in the U.S. there's gonna be multiple paths into 911. It's just, you've got not one national dispatch system, but you have like 7,500, all with different capabilities. The common denominator today is voice. Every dispatch center can take voice, almost no dispatch centers can take data. So it's a big challenge, and we get around that today by using intermediate services. I think a good example is like an OnStar. Think about OnStar, vehicle gets in an accident, OnStar has lots of sensors in those vehicles, right? So there's rollover sensors, there's airbag detection, there's predictive algorithms around injuries that are likely to occur from the speed of the vehicle, there's GPS location, you've got all these systems, dozens and dozens, if not hundreds of sensors in those cars that are sending that data to OnStar's back-end services that are, you know, aggregating all that data and putting it in front of an advisor who is then making an informed call to local 911. And dispatch centers are used to getting calls from 911. They're a known source, but a dispatch center is never gonna be able to take all that data that like an OnStar system can provide. Or your home alarm system. You think you have an alarm at your home that it's going to 911, it's not. It goes to a monitoring center, an ADT, a Honeywell, you know, Bay Alarm, those kinds of things. They're in the middle, they're taking that sensor data, they know if it's a sliding glass door and is a perimeter alarm or it's a fire alarm in the upstairs hallway, they take those sensors, they take that information and then call 911. Again, that common denominator of a voice call to the correct 911 center. So today in the US, you've got these intermediate services. Some of those are very well-established, large companies. But there's also a lot of innovation in this space with new companies, Rapid Deploy, Rapid SOS, AT&T's doing a lot of work in this area. But there's a lot of them all trying to innovate in this area. So I think you can provide guidance through like FDA or through standards that organizations like HRS or APCO or NENA, these are 911 organizations, that can set standards, performance standards that various vendors would have to meet. But I don't think it's practical in the US to have one. I don't even think that that's going to be good for innovation and competitiveness and stuff. But it's a complicated field. And PulsePoint sees it as like, they're going to be parallel to those systems. We'll alert people who are nearby. 911 will get alerted and dispatch resources as well. So we see ourselves as an input there. But getting to 911, they call that the last mile or however you want to use it. That's not an easy piece there. And there's various technologies that are doing it. And whatever you do today, tomorrow it's going to be different. That is a very innovative space. AI is going to play a big role there. It's going to get better and better. I would say if you're building to get to 911, there are solutions today, but they're just solutions for today. One of the questions we have is like for implanted devices that alert, what would be the next steps to get it to alert through a system like PulsePoint? I guess that would be the case for wearables too. I think it's the same for any of the technologies that we're talking about. When you think about an implanted device, today those are not real time, right? They're bedside monitors, maybe a phone device, but from what I've seen, they're not real time yet. But you can sort of see the technology is the difference is just the time. The devices have the ability to communicate externally to a phone or to a monitor, and then those typically hop to a monitoring service. So it's not a big leap to see that is going to go to 911 to PulsePoint in the future. It's just all about speed, not 24 hours. Every 24 hours, that device is checking in, but instantly. And also accuracy. Accuracy is a huge deal. You know, if you have a trampoline park in your district or you have a ski resort or you're getting overwhelmed by fall detection today, it's a serious problem. So accuracy is something I'm sure that FDA is gonna be looking at on these devices. They have to be highly accurate and they have to be fast. And those are the two things to overcome today. And it's an exciting time right now because we are right at that point where those things are possible, be possible in the very near future. Sounds like it's very possible right now, today and a few weeks in Europe. Yeah, I mean, a couple thoughts on that. You know, for loss of pulse detection, it can seem like a really sort of simple thing to do, but to your point about minimizing false positives, things like that, it's a really, really important consideration. You know, we've designed it so there are basically several algorithmic gates that you need to pass through before a classification is made. To give just sort of two examples, you know, a first gate looking for sort of a transition from a pulsatile state to a pulseless state. You know, these devices, they have several LEDs within them. They're not running all the time. That would fry the battery. You know, we have another algorithmic gate that is basically flooding the tissue with light, looking for any sort of pulsatility to see if, you know, there was not something that the person was doing that may have transiently made that signal go low. We also, you know, take advantage of the fact that these, you know, true positives are not consistent with sort of purposeful motion. And so we have another algorithmic gate that leads to sort of a haptic response on the watch that's basically trying to provoke motion, which can basically just deescalate the path. And so we basically set in all of these, you know, gates that people need to pass through with several easy off-ramps to deescalate it, to try to avoid that. But if you pass through all of these gates, remain sort of, remain persistently motionless and not responsive, only then will you sort of get a classification, and then still you have a countdown opportunities to clear it. So, you know, fully aware of some of these other systems in the marketplace that have led to excessive calls, and that's been sort of a guiding principle for us to prevent that, like from the beginning in building the system. So it's a fine balance, isn't it? The last thing you want to do is stifle innovation, but you also want discoveries, innovative discoveries to be real with a low amount of false positives and to be sustaining. So I think that having some standards as a clinician and a provider, we take care of patients, we have guidelines, they do make a difference, and having similar standards seems to me to be a good idea, but finding that fine balance, not just for evaluating technologies, but for providing education, for advocacy. So for example, I'm just throwing this out, the answer may be yes, but when you roll your wearable out in Europe, the watch, when I go to sleep, I don't know about you, but the first thing I do is take my watch off. The most vulnerable time is at night when there are no witnesses. So do you tell people, keep your watch on when you're asleep? We don't, and another really important thing, also getting to this, this is going to be an opt-in feature, so it's not going to be turned on for everybody, and so that's a deliberate decision that we've made to make it so people have a choice if they want to turn on this functionality or not. We're not providing reminders, it's really kind of up to the user if they want to wear a device like anything while they're sleeping, but yeah, no, it's a great point and great consideration. If I could add one thing to that, Mina, one of the most exciting aspects of this is the unwitnessed arrest, right? So about 50% of all cardiac arrests are unwitnessed. So when you think about having this watch or just having people who are home alone or even people who are on different floors in the same home, an unwitnessed arrest has almost no chance of survival. You saw 9.3% total survival of cardiac arrest out of hospital, but unwitnessed is, you know, somehow it's not zero. I don't know how I suppose people discover somebody who's unwitnessed, but it's essentially zero, and to have 50% all of a sudden, which not available today, available for an unwitnessed activation of pulse point, call the 911, those kinds of things, sounding an alarm that alerts people inside the home or people who are nearby in the office in the cubicle next door, those types of things are, you're gonna see that survival rate jump over the next few years because of the ability to alert unwitnessed and put all of a sudden 50% more people into play. And the witness ones, you're just going to start that chain of survival faster. You know, people aren't gonna go, what's going on? There's confusion around that emergency. Who's gonna call 911? What's really going on? I mean, that call's gonna happen, right? Things are gonna start moving immediately, and there's gonna be less, not just indecision, but people trying to understand what's happening, calling 911, they're confused, dispatchers trying to figure out, you know, is this somebody who fell? Is this, you know, actually a cardiac arrest? Those get missed all the time in 911. So the quality of the signal is gonna come way up. This is a very exciting time, I think, for cardiac arrest survival. You're gonna see a bump here, you know, because of the work that's happening here. And we've seen an increase in pulseless electrical activity, PEA, which has very poor prognosis. Maybe we'll see a little less of that. And I would suggest maybe when the watch is being at night and being charged, maybe that's when you should deploy your agonal breathing out, because that doesn't have to be worn, right? So think about that. I want to, Jill, did you have comments? I want to, in some of our last few minutes, there's some questions about like the coverage, what populations and communities that these new technologies and PulsePoint can cover. You know, what's the extent of our coverage? And there are health equity issues. Not everybody's gonna have a Pixel watch or an Apple watch. So how do we address that in terms of coverage in rural areas as well? How do we address those issues? I'll take maybe a first crack at that. I think one of the things to remember about PulsePoint is it doesn't do anything on its own. It requires CPR trained citizens. It requires AEDs. So in many ways, it makes good systems better. It's no shortcut to the things that you need to do in a community, to have citizens trained in CPR throughout the community, especially in rural areas, AED placement. So I think you have to think about that as you're implementing the basics. The fundamentals don't change here. With a lot of these technologies still having strong citizen response capabilities, it doesn't really change because of this short window of opportunity. You look at 9% survival rates, even with good EMS systems is very hard to get to the patient side really that fast. There are response times. So I think for me, a lot of that is making sure that when you are implementing programs in your community, that you're implementing them in equitable ways. Well, it's been brought up to me that maybe we need to develop a very inexpensive band because patients have come to me and said, look, I have this $50 watch that can record ECGs, some knockoff watch. So if you can do that, can we devise a very inexpensive band that can be very widely distributed? If it got down to $25, $50, I'd take it in my hospital. We'd give it out to everybody. So it could have a very large market. I mean, there's some disincentives to big companies who have expensive technology to sell, but. I think the same thing with AEDs. If we can get AEDs down to a few hundred dollars, instead of all these high-end features, just even if you had single-use, right? We're seeing some single-use, one-time-use AEDs in the few hundred dollar range. It's like, that's where I get more excited about AED innovation than sort of the higher-end, connected devices, I think. More, if a device could, one-time-use, it's like, how many times have we used our AEDs? I've carried AEDs for 20 years, never deployed it. So if I had a one-time-use, I'd be totally happy with that. So I think, yeah, driving price down, but with any innovation, it starts expensive. It starts, few people get it. We learn, and we have competition, and we get better and better, and the price comes down. I think where we are today, it's going to be, it's going to start at the top of the market. That's where much innovation begins, but it will lead there. And we just have to keep our mind focused on that. I've spoken to developers who are saying, when I said, well, you know, I found this AED that's being tested in Australia, where they're deploying high-frequency CPR providers with an AED, and I said, well, you know, it's like about $500. It goes, $500, you know, we're aiming for a $100 AED when it can be deployed just about everywhere. We did a study on that, and it's surprising. The price point is too low, right? It's way beyond reality right now, of where people would say, I'd buy that instead of, you know, a new TV. People don't really see, you know, it has to get very, very low, way beyond where it is today. Great, thank you. Any other comments from our panel here? I guess I, we hear all this exciting technology, and is there ever a time where we as medical professionals can prescribe a medical wearable that can do these things? Can do these things, and those patients don't quite meet the criteria in the trials, but yet we're worried about them. You know, their EF is 40, they have non-sustained VT, but they've never passed out. You know, those patients that are in a category of maybe something could happen, do you see any future for some of these wearable technologies to the public being an actual prescription device that medical professionals could use? They don't even need to be prescription. You know, because we're already recommending that for a lot of my people after AF ablation, or who have AF, or we're trying to figure out if they have AF, asking them to consider, I write it as, yeah, they can consider getting this or that wearable. I ask what kind of a smartphone they have, and you know, it's up to them to actually get it. It's a much more cost effective and portable, you know, solution for them than the monitors that we actually prescribe. And I guess my point in that was, if you have the health equity type thing, if somebody says, oh, you know, I'm not gonna buy a watch, I mean, because I can't, you know, is, I always feel bad, you know, for, what do we do instead? Is there something? I don't know the answer to that, but I think that, to your point of a cheap band, or something like that, that could be. I don't know if it's out there. I mean, I know companies are, you know, obviously doing good, but making money too, right? You know, so where does it get to the health equity for people who can't afford it, I guess, is the question that we're often asked. Yes, and I completely agree with you, but that horse, unfortunately, is well out of the barn. Okay. Because when we start this way, when we have the private sector developing these, and that's how innovation happens. However, I think what you're pointing towards is gonna come out of the so-called developing world. So there are manufacturers, thinkers, innovators in India, China, Indonesia. They, of necessity, their public cannot afford any of this. We sit on a pedestal in the US. So it will happen, and it will come out of there, is at least the way I'm thinking. Thank you, excellent point. So all of you innovators out there, you know, I hope that you have gotten inspired from this session, and really, I hope that you can think about your technology, your companies, and hopefully develop some connectivity, and we'll also work with you, all of us, you know, to try to figure out the pathway that can bring us to the day when we can really reduce the impact of sudden cardiac arrest before you or I or other loved ones have to experience it. So thank you very much for your attention. Thanks to all of our panelists. It's been a fantastic discussion, and hopefully, we can use HRX, and HRX Innovation Hub over the next year. We don't have to wait till next year to really try to come together and make progress for sudden cardiac arrest. Thank you very much.

Cardiac Arrest

Digital Health

Sudden Cardiac Arrest

CPR

PulsePoint

Pixel Watch

Health Equity

Wearable Devices

Emergency Response

AI-assisted Technologies