PAVmed Inc. (PAVM) Earnings Call Transcript & Summary

Good afternoon and welcome, everyone. Thank you for joining. We're really excited. We have a great turnout today. We're think approaching 200 participants. My name is Lishan Aklog. I'm the Chairman and CEO of PAVmed and the Executive Chairman of Veris Health. Those of you who are a shareholders or follow PAVmed closely, we take pride in providing or trying to provide full and transparent information to the community. We've heard and would agree that it can be difficult to go into enough depth on various topics during our quarterly calls, especially given all of the recent activity around Lucid. That's why I'm really excited to be hosting this event, which will give us the opportunity to do a much deeper dive into a very important part of PAVmed's portfolio, our new digital health company, Veris Health, which I believe will contribute substantially to our shareholders' value in the coming years. We have a great panel today. Joining me are Dr. James Mitchell, who is the PAVmed Vice President of Digital Health and the Chief Medical Officer of Veris Health. He's also the co-founder and former CEO of Oncodisc, which is the company that Veris Health acquired. Joining us later will be Dr. Sumit Shah, who's an oncologist and a member of our Medical Advisory Board. He's the Director of Clinical Innovation Digital Health in the Division of Oncology at the Stanford Cancer Institute, Stanford Health Care. Also joining us is Tim Baxter, who's a member of PAVmed's Board of Directors. He's also the former President and CEO of Samsung Electronics, North America. And then finally, just joined us yesterday, as I welcome Sunny Webb, who's PAVmed's Vice President of Data and Analytics and also will serve as Veris' Chief Technology Officer. We have a pretty packed agenda today. So over the next couple of hours, we'll cover a lot of topics. I'll start with a corporate overview of PAVmed and its strategy, how our entry into the digital health space and acquisition of Oncodisc fits within that strategy. Dr. Mitchell will describe the Veris Health overall and its technology, the unmet clinical need, hardware, software as well as the business model and future applications. Ms. Webb will provide us with some insights on the opportunity to apply data analytics and health care, including some use cases. Then there's a pre-recorded session, where Dr. Mitchell and Dr. Shah will participate in what we'll call the clinician's corner, where 2 oncologists will discuss the opportunities to improve cancer care through using digital health tools. Then we'll have a panel discussion. We'll open it up to an audience Q&A. Any member of the audience will be able to submit a question through the chat and then I'll finally wrap things up at the end. So let's start with PAVmed. What is PAVmed after the Lucid IPO. I get asked that a lot. And that's really a question of what's our long-term growth strategy. So PAVmed, let's start with as a highly differentiated multiproduct commercial-stage medical technology company. We cofounded the company in 2014. PAVmed went public on NASDAQ in 2016 and has built up a diversified product portfolio of groundbreaking technologies that address important unmet needs. And we have a business model that's focused on speed to market. Although we started in the traditional medical device realm, we've expanded our portfolio to include medical diagnostics and now digital health. So PAVmed, we like to think of it as an innovation and value creation engine. We have a growing team. We're approaching 70 employees now and also a broad network or ecosystem that we work around that provides us with really the full spectrum of expertise and skill sets across the development of devices, diagnostics and now digital technologies from product design and development, clinical trials, regulatory manufacturing. We have a CLIA-certified laboratory as well as commercialization. Let's dive that into a little bit further what I mean by that. What I mean by that is that we feed PAVmed through internal innovation. So many of the products in our portfolio were invented by founders or other members of the company, as well as licensing or acquiring technologies, and we've done that so far 4 times in the history of the company. Those lead to a series of products within our portfolio. Some of them are still within PAVmed and others have been spun off into major subsidiaries. So when we talk to our shareholders and especially those long-term shareholders, what stands out with PAVmed where we have this innovation and value creation mentioned that works under a shared services model. What's attractive to our investors is it provides a diversified and expanding or expandable portfolio as we encounter technologies such as this one and others. It provides multiple shots on goal. Our success is not binary. It's not dependent on one particular FDA clearance or one particular clinical trial, but on success across the spectrum, which in turn provides risk mitigation and economies of scale. So our 2 major subsidiaries are in the diagnostic realm is Lucid Diagnostics, which is in the business of early detection of esophageal precancer. And of course, the topic of today in the digital health sector, Veris Health, which is a digital cancer care platform and intelligent vascular port. I would like to just digress briefly to Lucid to tell a bit of the Lucid story to set the stage for where we hope to take Veris. So Lucid is a commercial stage cancer prevention medical diagnostics company. We founded it in 2018 to license technologies underlying 2 products, EsoGuard and EsoCheck from Case Western Reserve University and representing an estimated $25 billion total addressable market opportunity. At the time, in 2018, we paid just $50,000 in cash and we were able to retain 82% equity in Lucid and the technologies that it licensed. Lucid was managed and financed by PAVmed since its inception and PAVmed put a total of approximately $30 million over that 3.5-year period. During that time, we were able to advance EsoGuard and EsoCheck from the research laboratory and a working prototype to the commercial realm with now active expanding sales force and activity across the country. We were able to secure an attractive $1,900 Medicare payment. And excitedly a couple of weeks ago, we were able to consummate a Nasdaq IPO on October 14. We were able to raise $70 million in growth capital to fund our growth strategy at a $467 million valuation. PAVmed's stake pre-IPO was 72.7%. And based on how we structured Lucid, its post-IPO stake actually rose to 75.5% despite the capital that was raised into the company. So again, what is our long-term strategy? What is PAVmed after the Lucid IPO? And the most exciting way to say it is more Lucid. That's really our strategy is to continue to create value through the licensing or our internal innovation of technologies and build them into either within PAVmed proper or increasingly through major subsidiaries. So why did we enter the digital health space or digital health and really smart devices. There's a revolution going on in these -- in this area. You don't have to spend too much time on in the media, and particularly the business media to know that. And there have been a variety of -- these are just 4 examples of really a -- remarkable examples of value creation in this space. Livongo went out just as recently as 2019 at a $350 million IPO and was acquired by Teladoc in 2020 for $18 billion. The multiples in the space have been really quite high, High Rhythm, similar story. It's a $100 million IPO in 2016, now it's worth about $7 billion. Flatiron, which actually is in the cancer space was founded in 2012 and was acquired by Roche in 2018 for over $2 billion. And BioTelemetry, a company has been around for a while, at a smaller IPO in 2008, was also acquired in 2020 in the $2.8 billion range. So large valuations, large multiples. And just like the diagnostics space, it was a hot sector in 2018 when we founded Lucid, we determined that this was really an upcoming sector, and we thought we wanted to get into it. We acknowledge there might be some hype and frothiness, but the fundamentals are solid. We have about 20% of the economy, which is what health care represents that's finally leveraging digital tools that have been long available in other sectors. And I think anyone who's paying attention would understand that COVID has accelerated and solidified this trend towards digitalization. And I think the markets have responded accordingly. So when we acquired Veris -- when we acquired Oncodisc and created Veris Health, there were numerous aspects of this transaction that we found attractive. And I'll go through them one by one, because I think it's important, particularly for the PAVmed investors on this call to understand what our thinking was in acquiring this technology. First, we acquired similar to Lucid, a very modest upfront consideration, we paid $155,000 and we retained almost exact same equity stake in Veris as we didn't lose it. The technology, as you'll see, is groundbreaking with good IP protection, large addressable initial market in cancer care that meets an unmet -- clear unmet need, a large population that benefits to both the physicians and patients. And there's a large expanded market opportunity, which we'll touch on a bit in renal failure and heart failure. The time lines were attractive, the hurdles in terms of regulatory hurdles were acceptable. And we felt we could advance this into commercialization with modest capital and resource investments. One thing that really caught our attention was the attractive reimbursement model at our existing established codes as we'll talk about a little bit more detail. There's a recurring revenue model here, and there is also existing CMS bonuses and incentives that we think will come into play. In addition to the reimbursement model, there are also large additional value creation opportunities through the monetization of data and also partnering with pharma to do clinical research support. And we also felt there were excellent synergies with PAVmed's infrastructure, particularly on the device development side. We inherited a very strong and esteemed Medical Advisory Board. You can see here, I won't go through all the names. Again, Dr. Shah from Stanford is joining us today, but you can see we have advisers from major institutions across the country, Dana Farber in Boston and others as well as busy, active, accomplished private practice clinician oncologists as well. Also I just wanted to highlight one aspect. This is a topic that comes up a lot in the digital health realm, and that's the notion of digital therapeutics. And when you use the term digital health care to contrast it from digital therapeutics. When we talk about digital health care, we're talking about using digital tools to improve care with an existing sort of facility doctor and patient paradigms. The digital platform is really important, but it's an enabling tool. It's not the therapy itself. And as a result, because we're working with an existing paradigms, we can leverage existing reimbursement models. And to the extent to which data monetization is important and which we think it is, it's really to expand on the value opportunity. In contrast, the whole realm of digital therapeutics is somewhat different than we don't think we need to go there. We think we have a really great differentiated opportunity without having to enter into the digital therapeutics realm. In digital therapeutics, you're creating an actual new digital treatment or digital treatment products, on the phone, an iPhone or Android or other technology, and it's primarily focused on patient self-care, not facilitating your interaction with doctors or health care facilities. So in a sense that digital platform is the therapy itself. And it really inherits sort of an eyeballs model and other app-based applications outside of health care and reimbursement and regulatory hurdles can be challenging. In sensor they're creating a new reimbursement model. And the data monetization in many examples is the primary value creator. There's not really the opportunity to create value just from the interaction of the patient with the device. It's is monetizing the data that's the primary source of value. So having made that contrast, I'm going to hand the reins over to Dr. James Mitchell, who's our Chief Medical Officer, will be talking -- giving you an overview of Veris Health. Jimmy, take it over for me.

Great. Yes. Thank you. Dr. Aklog for the background and the great introduction. And thanks to everyone who's joining today. I'm James Mitchell. I am the Chief Medical Officer of Veris Health, VP of Digital Health and PAVmed. My background is in radiation oncology. I have over 15 years of experience as a clinical oncologist also been developing medical technology for the last decade and very excited to be joining the PAVmed team and Veris Health and telling you today why we're building what we're building and giving you the details of our technology. So I'll start off by touching on the unmet need that we are addressing. Why are we building this platform at Veris Health. And really, it comes down to today, oncologists have a difficulty managing risks associated with cancer care and underlying the disease of cancer. Cancer patients largely undergo outpatient treatment. There are many months of multiple cycles of chemotherapy, immunotherapy, radiation therapy. And this episodic care means that most of the time, patients are at home and completely unmonitored, but at a high risk of developing complications. This can be infection or dehydration or uncontrolled pain. There's a whole list of potential complications that then lead to unplanned hospital admissions. So every year in the United States, there are about 1.5 million unplanned hospital admissions in cancer patients, and those become very expensive as they can cost up to $70,000 per patient on average. But we also know through cancer research that 19% to 50% of these hospitalizations are potentially preventable with appropriate, timely outpatient interventions. And so if we dive into this problem a bit deeper, why does this impact everyone in cancer care. It's clear that this is a problem for patients, but really this is a problem for all of the stakeholders in cancer treatment. For patients, it's clear. Patients who spend a lot of time in the hospital means that they're away from their family. They suffer poor quality of life. And we even see shortened survival. Often, we have to stop cancer treatment altogether to deal with complications and hospitalizations. The oncologists and the nurses themselves who are taking care of the cancer patients, not only is it demoralizing to have a lot of patients in the hospital suffering complications, it's also a very inefficient use of the care team's time and resources. It's very expensive and time-consuming to care for patients in the hospital, and it takes us away from the mission of caring for new cancer patients in the cancer clinic. For hospitals and health systems. Hospitals have to report quality metrics to Medicare and one of the key metrics that have to be reported is the rate of complication and hospitalizations in cancer patients undergoing chemotherapy. If hospitals don't report these metrics, they can take a 2% hit across the board from Medicare reimbursement. And if they do report metrics and their metrics are bad, that becomes public information and makes it difficult for those hospitals to negotiate contracts with private payors. And then in addition, as we move more towards value-based care, hospitals and health systems are taking on more of that financial risk of caring for patients and therefore, having to pay for complications out of pocket. With payors, it's pretty clear every time a patient gets hospitalized or we have to leverage resources to complications that hits payors at the bottom line. But as we widen the lens a little bit and we look at even pharmaceutical companies, every time we have to stop treatment to manage complications that's fewer doses delivered of the pharmaceutical companies' products. Now we actually have data in the oncology literature to show that using technology to connect patients and doctors can not only reduce cost of care, but also improve outcomes. One large study out of Memorial Sloan Kettering Cancer Center in New York showed that a simple online platform that allow patients to enter symptom data not only reduced visits to the emergency department cutting on costs, but prolonged overall survival by over 5 months in patients with advanced cancer undergoing chemotherapy. Now this is remarkable because that is a bigger survival benefit than we actually see with most new chemotherapy or immunotherapy drugs that get approved for use in cancer. We've also seen data that capturing objective parameters such as activity tracking can predict survival outcomes in cancer patients, but research shows that adherence to wearable or in-home technology starts off poor and falls quickly afterwards in cancer patients. One study out of UCSF looking at the use of Fitbit in breast cancer patients showed that 16% of patients never even turned the device on and only 44% actually used the technology during their chemotherapy. So we know that technology can provide benefits, but we also need a better solution. Now the cancer market is large and growing. Every year around the world, 17 million individuals are diagnosed with cancer and approximately 10 million of those will require first-line chemotherapy. And actually of those, over 7 million are potentially eligible for the newer immunotherapy drugs. And these numbers are increasing as we see an aging population and increasing cancer incidents. If we take a look at the global smart healthcare market. This is technology-enabled medical devices and other supporting equipment, data gathering tools. This market has skyrocketed much like the IoT market across the board, growing to about $170 billion in 2020. So let's look at our solution. The Veris Health Solution is truly a platform that integrates 3 parts. First is an intelligent, implantable device. We'll talk about the details in a moment. We have a software platform with interfaces for the patient as well as for the care team with those interface streamlined to meet the needs of each constituency and the data. The data is where we will unlock those insights that will allow oncologists to take better care of patients, but also provide the foundation for broader insights and an expanded customer base. Our device is the world's first intelligent, implantable vascular access port. Vascular access ports are devices that are used every day today in cancer care. They are fully implanted inside the body and can stay in place for many, many months. On average, about 6 to 9 months typically for the full duration of a patient's cancer treatment. They provide the access to the blood vessels that is required to infuse anticancer medications, so that could be immunotherapy, targeted agents, CAR-T and traditional chemotherapy. You can draw blood through these devices to send to the lab for laboratory testing. You can even infuse contrast agents for diagnostic tests, such as MRI or PET CT imaging. There is existing workflow and existing reimbursement for these devices today and a very large proportion of cancer patients are undergoing implantation of these devices right now. Our device is the world's first intelligent implantable vascular access port. So vascular access ports today don't have any intelligent technology embedded in them. We are loading our device with sensor, data storage and data communication technology so that we can capture data on patient physiology from inside the body with unmatched accuracy and in an uninterrupted way that's going to provide oncologists with clinical insights that we've never had access to before, so that we can detect complications early like an early fever, trigger timely interventions and prevent those costly hospitalizations. Our 1.0 device will monitor an array of physiologic parameters, including core body temperature, heart rate, respiratory rate, activity which is an important predictive metric for cancer patients, central venous pressures which are the blood pressures of the veins draining into the right side of the heart, as well as the ability to capture heart sounds and breath sounds and the diagnostic information that we can glean from that. In the future, future devices will have a broader suite of sensor and data capabilities, including physical parameters such as oxygen saturation and cardiac rhythm as well as looking at biochemical processes of the body, such as glucose levels, lactate levels, which can be an early sign of critical infection, as well as pH and electrolytes. So where are we today? We closed our acquisition of Oncodisc by Veris Health in June of this year and accelerated development and have made remarkable progress in that time, a real testament to the people and the business model at PAVmed. Just recently, we completed a concept phase where we created and tested multiple different prototypes. We did in vivo testing of catheter-based prototypes with sensors, including temperature, pressure, electrodes to capture cardiac electrical activity, implanted microphones to capture those breath sounds and heart sounds as well as many tests around the ability to transmit all of this data wirelessly from an implanted location through the skin to a mobile device and characterizing the power consumption with different modes of data transmission. So our near-term R&D plan is to move aggressively into that design phase, along with our manufacturing partners, so that we can then move quickly into manufacturing, testing and filing for regulatory clearance. We expect that we will be going down the 510(k) pathway with the FDA and that we will be filing that in the second half of 2022. Now beyond the device, we're building an incredible software platform that will allow the oncology team to unlock those clinical insights, but we'll also keep patients engaged in their care and allow the ability to report symptoms. Now we're very excited about our partners in this development process. We're working with Microsoft as part of their global partnership solutions to build our platform on their Azure cloud database, utilizing the infrastructure that they've spent years developing with HIPAA-compliant cloud computing, data security and interoperability, as they build not just the foundation, but the data highways that are really going to unlock the health care of the future. We've seen a lot of this just recently as they announced a big partnership in interoperability with Cerner, and they're also building this out with Epic. Those are the 2 biggest electronic health records in the country. And we're building this in conjunction with Loka, a top-tier full-stack Silicon Valley-based software development firm. They're building the platform on Azure and leveraging their experience in healthcare as well as other cutting-edge technology industries to build the data platform of the future for cancer care and then beyond as we'll touch on in a moment. We look at some of the features for the patient-facing applications. This is largely a mobile application that will allow patients to not only view the data of their own health that's coming off of the device, the device will communicate directly with the patient's mobile phone, but will also allow patients to enter symptoms, which is critical to their care. And as we learned from that Memorial Sloan Kettering Cancer Center study can be critical in improving outcomes. So here we've shown an example of some of that workflow where we can either detect a problem or patients can initiate symptom reporting. They can provide structured data about those symptoms, so we can use it on our analytics platform. And then they can receive feedback either automated from the platform or directly from their care team. And then for the doctors and nurses taking care of cancer patients, we're building an interface that will integrate directly into their workflow, integrate with the electronic health record platforms that they're using in clinic today, but will also be designed to provide them concise, easily digestible, but most importantly, actionable information about their patients. They can triage patients virtually, so they know exactly which patients require their attention. And this is where we're really able to leverage our own experience as clinicians and our amazing Medical Advisory Board to ensure that we are making the lives of the oncologists and the nurses easier as they take better care of their patients, and we're not disrupting their workflow. Now our business model is built upon existing reimbursement that exists today for both implantation of devices -- port devices as well as remote patient monitoring. And so we don't have to create any new codes or any new reimbursement to start selling immediately. Remote patient monitoring codes that are approved by Medicare provide the hospitals and oncology practices with recurring revenue and, in turn, allows us to build our model as a subscription-based recurring revenue model as well where ultimately, our gross margins will approach those of a typical software company at around 90% gross margins. Now if we look at those remote patient monitoring codes, these are, by and large, not being used today by cancer programs, because there is not a solution like ours that allows the hospitals or cancer centers to bill these codes. So we will actually be opening up a new revenue stream for the typical cancer program. So our sales team will be targeting oncologists in all different settings. We've segmented the oncology market. We know who are the integrated health systems, who are the large academic centers performing research, and who are the community practices that are likely to adopt this technology. And we will be selling directly to those oncology decision makers. And once we have a foothold in this market, we can expand this business model beyond patient care and Medicare or private payor reimbursement and look at really starting to monetize data. So how can we do that? Who is interested in this data that we are going to be aggregating and building analytics for? Well, this is really every stakeholder in cancer care and in health care in general. If we look at the pharmaceutical companies, they have demonstrated a real hunger for data-driven digital solutions that can be a companion to their existing pharmacologic products, but can also help them unlock insights into the current marketplace using real-world data. And very importantly, data that can support their clinical trial mission for the drug discovery process. You imagine the ability to, in real time, monitor every patient that's enrolled on a Phase III drug discovery clinical trial that would allow these investigators to identify adverse events in real time and address those adverse events and keep patients going on study. We've seen many acquisitions in the digital space by pharmaceutical companies as well as partnerships for research and commercialization. We saw Flatiron by Roche earlier in this presentation. Roche has actually acquired multiple digital companies, Bayer has as well, and every large pharmaceutical company today has a digital arm looking at this type of technology. Hospitals and health systems can not only use this data to improve individual patient care, but can look at their programs as a whole, look at both clinical outcomes as well as economic outcomes, and use this data to improve their own efficiencies and save on their expenses. And even payors, of course, payors are always looking for technology that's going to lower their expenses, their costs. But they also have to report their own metrics such as HEDIS metrics that are based on outcomes within their networks. And those are important as they then go on and negotiate new contracts with new clients. So where are we going in the future? We've talked a lot about cancer care today and our existing technology. We see a lot of ways to expand our cancer facing technology, either through new sensor technology or enhanced analytics of our data. The image that we see here is imagery around advanced catheter systems with electronics and sensors embedded in those catheters. Some of this will be used in our technology today and will grow in the future. But what really excites us is the opportunity to leverage this technology for new indications and other disease processes. So specifically looking at cardiovascular diseases like congestive heart failure and renal diseases such as patients with end-stage kidney disease who require hemodialysis. These are diseases that impact huge numbers of the population. There are extremely large healthcare costs associated with caring for these patients and like cancer patients, they are at very high risk of developing complications that lead to hospitalizations. But on top of that, these are also diagnoses and disorders where there is a tradition and a workflow around using devices and having that be part of the care pathway. So much like cancer care, we can seamlessly integrate into those care pathways and provide technology that's going to open up benefits to huge numbers of patients. So why did we decide to have this full platform with device, software and data, especially including the intelligent vascular access port? If we look at the other solutions that are out there today, there is no solution that really checks all the boxes. That provides the uninterrupted data that we need for true patient care. That tucks easily into the existing workflow. That leverages existing reimbursement and really takes advantage of some of the telemedicine and patient-reported outcomes technology that we've seen really hit its stride during COVID. Software-only solutions don't gather any data, and there's questionable reimbursement for software solutions. Wearable technologies don't really check any of the boxes. And there are intelligent implants on the market, but they aren't for cancer care. These are very specific to targeted patients with things like cardiovascular diseases or diabetes. So what will this look like for a typical patient who develops a complication? Well, let's look at dehydration, which is a very common complication in cancer patients and can lead to bigger problems such as kidney failure. So we have Rebecca. Rebecca is a lung cancer patient, who is undergoing both immunotherapy and chemotherapy. She has these medications infused through her intelligent port and like every other cancer patient she goes home. And while she's at home, she starts to develop common side effects of this treatment of nausea, vomiting and diarrhea. She feels bad. So she's eating and drinking less. And so by day 3, she's starting to show signs of dehydration. And by day 7, these are really starting to trigger changes in her physiology, meaning that her heart rate is increasing. She's moving around less, but her temperature is normal. It doesn't look like she's developing an infection. This is all consistent with dehydration and our platform will detect these changes and center some targeted questions to answer about her symptoms, while also alerting the oncology team, who can very quickly interpret this data, schedule a video telehealth visit with Rebecca, and understand that she's showing early signs of dehydration. But because we've detected this in a timely way, we don't have to admit her to the hospital. We can just bring her into the clinic, provide an infusion of fluids and other medications to treat her symptoms. And most importantly, we can send her home to be with our family, and we don't have to interrupt her cancer treatment in any way. Now this is clear why this is appealing to patients, but there are many reasons why our platform is going to appeal to oncologists. So we talked about that remote patient monitoring revenue. Today, oncologists are not able to tap into that reimbursement by providing a means of billing for remote patient monitoring. An average oncologist, as an individual practitioner, can start to build upwards of $100,000 per year in additional revenue. And for those oncologists, who have their productivity tracked through work RVUs, those are also credited with these remote patient monitoring codes. Of course, every oncologist wants the best outcomes for their patients, and we will be providing the means to improve quality of life and improve survival outcomes in their cancer patients, reducing emergency department utilization, which is going to be more and more important as those oncologists move towards value-based care models. And of course, any patient who has improved health-related quality of life, is going to have better patient satisfaction scores for the people that are taking care of them, that's their oncology care team. So really, there are many, many reasons why oncologists are going to adopt this technology. And so that's why they will be our target customers as we move into commercialization. And so to summarize, our mission at Veris Health is to use technology, to use data to help patients and oncologists manage all of the risks associated with outpatient cancer treatment, start to bring more and more of that cancer treatment out of the hospital and into the home and smooth that transition through every step of the cancer journey, which will ultimately benefit patients as well as every stakeholder in cancer care. And so with that, I'll turn the presentation over to Sunny Webb. We're extremely excited to have Sunny join the team officially starting this week. She brings a very rich background in tech as a Silicon Valley veteran. So Sunny, I'll let you take it from here.

Thank you, Jimmy. I'm just so thrilled to join this really talented team. When I first read about Veris Health, I was impressed by their big vision to make a measurable impact on cancer care. And after speaking with them, I learned that they've really thought through how to empower oncologists to do what they already do better, support providers and payors to offer the best care possible at a lower cost, to help cancer patients gain deeper visibility into their own health and to support their families in gaining an understanding of how their loved one is doing. So who am I? I cut my teeth as INTECH, as a data scientist at the Department of Defense. And since I've had a 15-year career in Silicon Valley, leading software and engineering and product teams with some of the largest firms out there, including Accenture, Apple, Philips Healthcare, Disney, among others. I've been responsible for shipping over 50 products, building and leading global engineering product teams. And I've built technical strategies and led operations and I'm also the author on over 30 patents. So why Veris. Well, for one, like many of you, I've had people close to me that have battled cancer. And treatment has come a long way in recent years, but we can do better. I'm certain that Veris has the right approach and is developed by seasoned oncologists, to build an integrated digital health care platform that will help millions of cancer patients and their oncologists. And as Jimmy just outlined, oncology is really just the beginning here. Second, I became a mom for the first time this past year. And every day since my daughter arrived, I think about how -- what I'm going to do today is going to impact the world that she inherits from us. So data science and cutting-edge technology is something that I'm quite comfortable with, and I've worked with and lead for multiple enterprises, but applying data science to cancer care is a world changer for future generations. And Veris is the right team to make a reality. I'm thrilled to join the Veris team as a CTO and work on building that vision together. So I'm excited to get going with Jimmy, Lishan, Tim and the rest of the team here to make an important impact on the care, and together, we have a really exciting road ahead. So now I'll just cover a few use cases. We have a really slick app that Jimmy just covered, that's under development. We've got a really interesting and compelling platform that's going to bring it all together. But there's way more to it than just that. This is where value really comes into play and what's perhaps the most important thing that we're here to discuss with you today. There's a few things that we highlighted already, but things like improving the individual patient outcomes and the quality of life is really the focus of what Veris is working on. We can think about things like lowering the health system cost and reducing hospitalization. So if we can look at a data lake and understand what potential possibilities exist in a population set of cancer patients, we can identify new risks and prevent future hospitalizations for those patients. We can look at utilizing real-time data and real-world data to even inform things like healthcare policy. And then down the road thinking about the data-driven clinical trial design and real-time support is something that is quite important to us too. So just a few use cases to think about. Machine learning is always the buzzword here in Silicon Valley that everybody is talking about. But we can apply machine learning capabilities and image processing to things in cancer care like determining if a photo submitted by a patient was a rash caused by something simple like poison ivy or if it's a reaction to their prescribed treatment that a doctor needs to review immediately. Infectious rash is something that doctor really has to dig into and deal with immediately because if that is the case, then their immune system has likely been compromised. So we can use image processing to detect those types of scenarios. And then I've recently learned as well that weight loss is a common problem in cancer patients. So we can think about things like comparing photos of a face over time to detect major changes that could signify significant weight loss and other potential issues that they could work on with their physician. If we think about big data and analytics, the big headline here for families and physicians is Veris' capability to provide continuity of data. This allows physicians to quickly assess the probability of a major risk and then enable them to quickly respond to improve the overall quality of life for a patient. This is groundbreaking and quite revolutionary. So here's a few different examples that we shared with you here today. We have more to come, but just wanted to give you a sample. And we hope that you see as much potential here about the real impact as we do. Thanks for your time.

Great. Thank you, Jimmy. Thank you, Sunny. I believe we're going to move on next to the clinician's corner, which is a video discussion between Dr. Mitchell and Dr. Shah.

Good to speak with Dr. Sumit Shah. Dr. Shah is an oncologist at Stanford. And it's been a real pleasure to get to know Dr. Shah recently as a colleague, as a fellow oncologist here in the Bay Area, but also as a technologist through our work at Veris Health. So Dr. Shah welcome. And I'll give you a minute to introduce yourself before we jump into some questions.

Thanks so much, Jimmy. So my name is Sumit Shah. I'm a medical oncologist at Stanford, and I do specialize in neurologic cancers, such as bladder cancer, prostate, kidney cancer and testicular cancer. I focus on clinical trials within those cancers and also focus on digital health at Stanford. I'm a medical director for digital health for the hospital. So I've been involved in video visits as well as virtual second opinions and other remote technologies. So very excited to be here today and speak with you, Jimmy.

Great. And that expertise is certainly very relevant for what we're talking about today and what we're developing at Veris Health. And so I wanted to start out with a topic I know you've been talking a lot about, all been talking a lot about, and that is the experience of caring for patients during COVID. We all know that this has revolutionized a lot of our patient interactions. But I'm wondering if you can speak specifically about the cancer patients that you've been seeing and how that care experience has shifted during COVID, maybe how patients' expectations have changed? And then in a minute, we'll talk about some of your exciting research that you've been doing in COVID.

Yes, absolutely, Jimmy. So it's been an extraordinary year, obviously, because of COVID, it's completely transformed. It's not only the way that we deliver care, but also the type of care that we're actually giving patients. I remember at the early days of the pandemic, we actually canceled surgery for many patients. I even thought about not giving my patients curative intent chemotherapy, because we're worried about the dampening of the immune system that could take place that may put them a higher risk for COVID infection and subsequent sequelae of the disease. And so it's been extraordinary in terms of the ability to actually give care is not only impacted but also in terms of the type of care that we're actually keeping patients. But in terms of health care delivery, we've seen just a complete transformation in the way that we deliver care and that's obviously changed expectation. So most tangibly, what we've seen is we've seen the meteoric rise in the use of telemedicine or video visits. So as a digital health medical director, I've actually been waving the flag for video visits for the last 5 years. And I got about 2% utilization rate of video visits amongst my faculty. And then March 17, when shelter-in-place went into effect in 2020, we went from 2% to 80% overnight in terms of utilization of video visits. So it's been a meteoric rise. And I think it's here to stay as well. I don't think we'll be going back to the old system that we did before. And that's largely because I think of the 3Ps. Patients actually want it, providers definitely want it, and now the most important thing is payors. Payors actually are -- have kind of laid out the new landscape for how to reimburse for video visits. And so now we have parity of reimbursement between video visits and in-person visits, because of CMS restrictions that were lifted during this past pandemic. So I think it's here to stay. I think the patients now expect to see their physician, at least some percentage of the time via video, and they find it very convenient. And a lot of patients wonder why weren't we doing this 10, 15 years ago, because we've had the technology for such a long time.

Right, right. Yes, I think that's a great summary. And certainly, I've seen the same changes in my own practice experience, more in the community setting than the academic setting. So I do think that this has really permeated all aspects of health care delivery. Now I know you've been involved in some major research in cancer care during COVID, some national coalitions, working at these research projects and published some groundbreaking papers in journals like the Lancet. So tell us a little bit about what you've learned from that research.

Yes. Thanks, Jimmy. So I've been leading Stanford's efforts in collaborating with an international consortium. It's actually an idea that took off of the Twitter, I believe it or not, of one oncologist saying, hey, we should get all our data together to create a database of COVID-positive patients who have cancer. And because of that, now we have several hundred institutions from all across the world, contributing about over 15,000 patients, who are COVID-positive and have cancer. And we can see different outcomes amongst those patients and then look at different risk factors to see which patients are our highest risk for severe COVID or increased risk of mortality. And the results of these types of studies are unfortunately are quite humbling. What we know is that COVID has a very high association with mortality amongst cancer patients. We also know that, that risk is not on par with all cancers. There's -- it's not an equal playing field unfortunately. What we see is that certain cancers are associated with higher risk mortality than others. So for instance, in general, I would say that a cancer diagnosis with COVID positivity would lead to a 10x higher risk of mortality compared to the general population, which is quite humbling. In addition to that, we know that certain cancers such as lung cancer or blood cancer, such as leukemia or lymphoma are also a very high risk, up to a 30% risk of mortality with COVID. So those types of numbers are quite staggering and has obviously led us to change the way that we practice medicine and deliver care for these patients.

Yes. So I'm fascinated by the fact that some of this ideation came from using Twitter. And so I'm curious, if you've learned in your research or just kind of in your own, kind of thinking about that in your own practice, did you learn about challenges that new technology could address?

Yes, absolutely, Jimmy. I think for 1 is that, as we discussed before, patients were very afraid to come into the hospital setting or in the clinic setting. So they are weighing their options about whether to take the risk with their cancer or to weigh the risk of potentially impairing their immune system and potentially contracting COVID. So that risk benefit was very difficult for patients to take on by themselves. So it was really important that we made patients feel very safe in the health care environment. And so things like video visits were very important to allow patients to be in their home. We also did virtual second opinions. So if a patient was in Nebraska and has a rare tumor, they don't have to have come out all the way to San Francisco or Boston to see a specialist in that field. They can actually get an expert second opinion from their living room. We also enabled the virtual rounding, so that physicians, a lot of elderly physicians actually were very hesitant to even come into the hospital to see patients given the risk that was a little bit unknown in the early days of the pandemic. So we actually were able to employ virtual rounding. You actually have physicians go into the hospital virtually to see their patients as opposed to actually physically enter the premises. So I think those things were all very important and things that we learned. But we also know that there is a huge push towards remote patient monitoring because of COVID. Are there better ways that we can actually see how patients are doing outside the health care system if they're only going to be inside the health care system for a few minutes per year essentially, compared to the number of hours that they are going to be outside the health care system. And so there was a huge emphasis on remote patient monitoring because of COVID and I think it has really accelerated that.

Yes. Well, that's a perfect move into the next topic that I was going to bring up, which is that question of remote patient monitoring in cancer patients. We have seen reimbursements come out to support remote patient monitoring. There are a lot of technologies out there. So I'd like to hear your thoughts on what is the role for remote patient monitoring in cancer patients? What do you see as the desire or the need from the healthcare systems? And then what limitations do you see in some of the existing technologies that are out there?

Yes, absolutely, Jimmy. So one thing I'll say, just to comment on the current system that we have right now. So we know that care currently in 2021, for the most part, is very episodic. When a patient comes to see me, they see me in clinic or they see you in clinic, probably every 3 to 4 weeks, if not, some patients with prostate cancer, for instance, I'll see every 3 months. And when you see that patient with prostate cancer in front of you and you ask him, how you've been since the last time I saw you, most likely that patient would be like I'm fine and then their spouse would look at them with angry eyes and say, no, you haven't been fine, like you've been having nausea, you've had weight loss, you're not eating anything anymore. You've had diarrhea. All these symptoms. But what we found, Jimmy, and a lot of our research shows that physicians actually only get about half the symptoms that patients actually have during a clinic visit. That could be 1 because of limited time that we have with the patient or 2 that the patient just forgets the recall bias. They may be so focused on their scan or whether they're responding to treatment, they may not tell you about all those complications that may have arisen over the last several weeks or months. So that's the current system that we have. But obviously, we would like to do much better than that. So what we know is that if we have remote patient monitoring systems in place, we can have a more proactive and personalized solution to actually monitor patients in real time. So we're very excited about this technology. And I would say that it is, I think, very intriguing in oncology because we actually had some evidence for it. Right now, I think it's still in the very, very early days of RPM, remote patient monitoring. And the use cases are kind of few and far between and largely because there's not a whole lot of data yet for RPM. And I think that's what everyone is looking for our outcome differences. Because we can do a lot of fancy things these days. We can measure someone's heart rate and their temperature and their O2 sat. But does that actually translate into meaningful change for that patient. In a lot of fields like primary care, that would be very difficult to prove that. But oncology, we actually have proven that already, which makes oncology, I think, a terrific use case for RPM. So what we know right now is the biggest study that has been done in this field was back in 2017 with Ethan Bosch's Group in Memorial Sloan Kettering. And what they did is they randomized about 700 patients with Stage IV cancer to either the usual care, the episodic care that I just discussed or a separate platform where patients every week had the opportunity to engage in a web-based portal where they can just report their symptoms. And if there are any abnormalities in those symptoms, a nurse would reach out to them and offer potentially intervention. So nothing overshadowing by any means, and this is 2017, the technology wasn't even that great. There's probably some Netscape browser that they're using, and it's just new typing in their symptoms essentially. And but the results of that study were quite startling, even though the technology was actually pretty low tech intervention. What we know from that study is that for the patients, who were randomized to these web-based platform, not only did they have improved quality of life, which kind of makes sense if you're able to improve their symptoms, but we also saw decreased healthcare utilization. So we saw that patients on who were randomized to that arm actually had decreased emergency room visits, which is a huge win for the health care system in general. And the third most interesting thing, Jimmy, that I think which shocked a lot of folks is that actually improved overall survival. So by patients having access to this web-based portal, you actually improved overall survival by 5 months, which is -- at least in my world, in your world, it's pretty extraordinary. If you had a pill that would prolong prostate cancer survival by 5 months, maybe on the cover of the New England Journal, it'd a $1 billion blockbuster drug. So the 5 months, but just having this just changing the way that we deliver care is incredibly meaningful. So that was really exciting. It's kind of pushed us into thinking how do we actually institutionalize RPM now in the oncology space. So I think that's where things are going now. So yes, quite excited by this area, though.

Yes. That's great. Thanks for that great summary. And enlightening discussion about the Bosch study, which I've always been amazed by the outcomes that they showed there. What really kind of touched me about that study was that they used technology to really enhance the physician patient relationship and the physician nurse relationship. And that enhancement of that relationship had a bigger impact than a lot of the drugs that we use. So really, really promising for the future. And so we talked about that study and some of the systems out there that focus really on symptom reporting, which is obviously critical in cancer patients. But you also touched on monitoring some physiologic parameters. And there's a lot less data out there looking at those specific parameters, but I think that there's a lot of promise in technology that enables tracking of physiology. So I'm just curious what your thoughts are on what additional value that can bring if you can detect early fevers and early rapid heart rates, and if there's any technology out there today that does this in a reliable way that patients can adhere to for many, many months of cancer treatment.

Yes, absolutely. It's a great question, Jimmy. What I'll say is that the technology out there, I would say, largely is focused on questionnaires. So we're sending out these what we call PROs or patient reported outcomes to patients on a cadence every 1, 2, 3 weeks. And I would say the best largely subjective data, which obviously is very important, credit to that Bosch study that I just mentioned, and that's exactly what they did. But you would imagine that you can get so much more granular data if you're able to get add-on objective data on top of that. A patient may not understand or realize that they're dehydrated. That's a very -- patients don't know how to describe what the hydration feels like. But does your heart rate change? Yes, it does. Does your -- just even like your physiologic parameters within your body change. And then that is data that we can objectively say in the hospital setting, for instance, I can tell you if the patient's dehydrated or not. But whether they would be able to do that in the clinic, or on a questionnaire is probably much more unclear. So when you're able to couple that information about subjective data from the patient about how they're feeling, but also with objective data from actual vital signs, I think that you have a very powerful platform at that point. For instance, one of the most dreaded complications that we have in oncology is neutropenic fever. So when I offer chemotherapy to a patient, it dampens their immune system, and now they're at increased risk for susceptibility to infection. And if they were to spike a fever when they had low blood counts or a lower immune system, we know the mortality rate for that type of infection is very high, unfortunately. So all of these patients have to go to the emergency room and they have to have their labs checked and we have to administer antibiotics right away. In each one of those hospitalizations for neutropenic fever, by the way, cost on average, $50,000, that's around the country. I can only imagine here in the Bay area how much it costs. But if we were able to prevent that, that is such a huge win for that patient and a huge win for the health care system in general. None of our patients actually want to go to the emergency room, especially in this era of COVID. If you had neutropenic fever, and if you're immunosuppressed, the last thing you want to do is stand in line next to a patient who's being ruled out for COVID, right, or a parent with their 2-year-old kid, who's sneezing all over. And so if we could use this type of technology to help prevent those visits, ED visits in particular and readmissions, I think that's a huge win for our health care system. So I think the physiologic data needs to be combined with subjective data to make it more powerful.

Yes. So I want to shift gears a little bit and touch on a new topic, which is the possibility of bringing cancer care into the home. Today, patients go to typically an outpatient center where they can undergo infusions of chemotherapy, undergo radiation therapy. And so I'm curious if you see a future where some of that treatment can come into the home and what technology would be required to enable that?

Yes, it's a great question, Jimmy. And I personally see this as a future of oncology right here. I think that over the next decade, we're going to see that hospital capacity is going to be going down considerably as all care, not just oncology, but it's really moving outside of the hospital into the home. And that's largely because, 1, patients want that. It's much more convenient for patients. Two, is that our therapeutics are kind of going in that direction as well. Before, we used to have the 6-hour infusions that you'd have to sit in a chair for 6 hours a day to get your chemotherapy. For one, we're seeing less and less chemotherapy being used in more of these shorter immunotherapies and targeted based therapies that are very different. But not only our IV infusion is getting shorter, but we're also transitioning from just IV therapies to really oral med therapies. And now we're starting to see subcutaneous therapy where a patient can actually inject a -- what used to be a 2-hour rituximab infusion for instance for a lymphoma, can now just inject within their skin within 15 minutes, which is really remarkable. So the types of therapies that we're giving patients are changing dramatically. And then the last thing I'll say about why this change probably will happen is I think that insurance will eventually be driving this, even more so than what oncologists themselves want. And the reason is, Jimmy, it takes a tremendous amount of resources and money to actually hang one of these IV therapies in like a tertiary care cancer center, infusion center that's attached to a hospital. I mean, the markup on that is extraordinary. There's so much overhead cost on top of that. So an IV infusion, for instance, for a single immunotherapy may be a $50,000 infusion. And ultimately, a patient may not mind that as well as long as their insurance is paying for it. But what we're already starting to see is that insurance companies now are unwilling to pay for this. They said, why are we spending $50,000 on an IV infusion at a tertiary care center when we can just do a home infusion with a home nurse and deliver for potentially hundreds of dollars through a subspecialty pharmacy, that they're contracted with. So I think because of all those reasons that we'll see a shift largely coming from payors that we'll have to see it going to the home. But the technology that we ought to have is, again, obviously, video visits to be able to monitor patients. But then 2 is, again, the whole remote patient monitoring, though, not only with objective symptoms, but this is really where the vital signs and the physiologic data come into hand, because that's the data that I would have if the patient were right in front of me in the clinic. And then you have other things like -- so in theory, you have a video visit with your physician. The physician says that you're doing well. They can actually see your data for the last 3 months about how you've been feeling. I can see your physiologic data in terms of your heart rate, your blood pressure, your other vital signs to make sure that you're feeling well. And then I can give you the okay to give you except for the injection, and you can even imagine things like digital safety blocks, where I press a green button and say, okay, now you can deliver yourself through subcutaneous injection. And I think all those things are probably in the works as well. So I think it's a very bright future ahead, but I certainly agree with you that this is where oncology care is going.

Yes. Great. Well, Sumit, it's always a pleasure to talk. Congratulations on all of your amazing work and for keeping Stanford really at the forefront, not just during COVID, but as we come out of this time of COVID and take what we've learned and use that to make cancer care better for the long term. So thank you again for joining us today. It's been a great conversation.

Thanks so much, Jimmy. It's really been a pleasure.

So I just wanted to say that was great, and it was really great to hear 2 accomplished compassionate clinicians talk about the status of their -- of the specialty, the support specialty of oncology and where it's heading in the future. I was also pointing out that we're hoping that Dr. Shah will actually be able to join us live for the Q&A session. He is doing what he's supposed to do right now, which is taking care of patients in clinic. So we're going to move on to the panel discussion, a bit of a roundtable. And I'm going to basically pepper my colleagues here with some questions for some deep insights into some of the -- deeper insights into some of the things we've been talking about. So I'm going to start with Tim Baxter. Tim, you spent your entire career as a technology executive at major international companies such as AT&T and Sony and most recently as CEO of Samsung, North America. And you've witnessed firsthand how technology has revolutionized that industry. What are some of the most important lessons that you think you bring from that experience to Veris and the area of digital health?

Well, first of all, Lishan, thank you for having me. I'm really excited to be able to participate here. And yes, I think there's -- as I think about it, in my 30-some years in the tech space, it's really been about establishing formats, and I think it's relevant for what we're talking about here, formats like high-definition TV or smart TV, streaming and 5G as examples of that. Building out ecosystems and a lot of what I heard in that prior session was doing some of that, right, in the health care space, both payors as well as patients and the practitioners. I think help navigate the shift from analog to digital. We're moving from these products that we would call discrete, some might say, dumb products, to now smart devices and smart solutions. And what's interesting, most of that 35 years in doing that, I used to use in coin a phrase called convergence. Now it's a much more sexier term calling it connected intelligence or smart devices. But the interesting thing about it is the growth that we have seen over the last 5 or 10 years has been remarkable, and that growth has been driven by a host of new technologies. We've talked about some of those, right? It's AI, it's big data, it's cloud, it's 5G, IoT, VR/AR, are all new enablers that are creating these exciting experiences. And when you combine that new technology with relevant data, with a simple UI, you're now creating new applications, new platforms. We're creating new possibilities and in some cases, disrupting old. So I think it's the combination of those that is one of the key lessons that I take away from this, number one. Number two, I'm really excited about where battery technology is beginning to go. And I think that's relevant for Veris and what the types of products that we're bringing to market. But we see on the horizon, solutions that will provide new form factors, longer battery life, right, quicker charging, greater capabilities. And I think that's another big opportunity as we look at technologies coming down the road. And I say that, Lishan, because if you think about Veris, it's fundamentally a health care-oriented tech platform that uses smart devices, right? And most of my career has been around platform and smart devices. And we're already using cloud, software and hardware, smart devices and a slick UI, right? So the key building blocks of that are already in place. And I think if we look down where things like smart cities are moving, IoT, the smart home, I think all of those technologies and solutions will only be tools that will help us enable us to move quicker, because it is smaller processors. It is sensors and everything, built in with 5G that are going to create new experiences that I think Veris is in a position to take advantage of.

That's great. I actually want to dive into one of the points you made, which is establishing formats, building ecosystems and sort of setting standards, right? So Jimmy and I know as physicians that there's always been just an incredible frustration that health care has been so far behind. I mean if you think about electronic medical records, I left practice just as they were coming on about 10 years ago and just basic keeping track of just the flow of information about what's happening to a patient as they move through the system, 15 years ago was predominantly done through notes, which is mind boggling considering how long all other major sectors have moved there. And we represent 20%, as I mentioned earlier, of the entire economy. So it's exciting that things are now starting to change and the -- obviously, on the information technology side that's moving forward and electronic medical records have established a foothold. But one of the things that the whole notion of standards and sort of an advantage of being first to market and establishing yourself as -- in a sense as a default or one of a handful of defaults is really important. I think if you look at the electronic medical records, they eventually coalesced into 2 or 3 companies that dominate the space. You might argue, are they the best or are they not the best. It's -- I think like you said, the VHS versus Betamax argument on format. So perhaps maybe you have some additional insights on that narrower point of being -- entering the space now of smart devices and physiologic -- collection of physiologic data with wireless communications and advantages that Veris might have about being early entering that and being pretty early entry into that market.

Yes, sure. No, I think there's a couple of ways we go with that. I think first, on the ecosystem piece of it and building that. It is heavy lifting. And there are so many different players in the value chain and all have different things that they're trying to accomplish or in some cases, protect, right? And I think health care can be looked at in the same way that content, hardware, operating systems and others. I'd like to use the analogy of tech industry is sort of a reflection of the world is getting more and more complex. It's not getting simpler, right? And if I think about the mobile phone industry as a small example of that. A decade ago, it was very neatly understood in terms of the value chain participants. Hardware people made phones right, operating systems connected those phones to the carriers, who are the other third part of the wheel of that. And everybody sort of stayed within its knitting, if you will, in that space. Well, the world has changed. Now you have the operating system guys developing hardware. You've got hardware developing services and solution. You've got carriers getting into other services. So it's much more complex than ever before. And while that could be daunting on one level, I think it's quite exciting on the other, because while those lines get blurred a little bit, there's opportunities for new partnerships in strange ways, right. The term frenemies is more and more common and I live with it. I actually had -- at Samsung, I was running a $30 billion business in the U.S. but my biggest competitor in North America was Apple. Samsung's biggest customer globally was Apple, right? How do you navigate that complexity or Google who ran the operating systems for it, but also sold -- but they were also selling their own product. So I think it underscores the complexity of managing that, but it really presents the opportunity to, first of all, embrace that complexity, embrace the frenemies, embrace the new opportunities that come about that, number one. The other point I'd mention on that is if you look at every single big tech company right now, they have all announced or are executing or have aspirations in healthcare, every single one of them, right? You've got the hardware folks that are leveraging their billions of devices and their apps to introduce consumers to wellness and other solutions. You've got infrastructure folks like IBM and Microsoft doing really good work associated with cloud and digital data. Google and Facebook, leveraging data for outcomes, even Amazon in that space. And so you can look at that and say, wow, they're all threats to what we're trying to do. But in reality, a lot of them are focused on, what I'll call, infrastructure plumbing for digital health care or general health care solutions whereas PAVmed, Veris, Lucid, we're very focused on discrete applications that can live within that area. And if you combine then big tech and the exciting things that are going in the start-up wellness space, the opportunities for partnerships, I think, are pretty limitless for us. And it's an exciting time.

I'm glad you transition to that because that was going to be the next thing I was going to push on. Because people wonder a smaller company like us and Veris, obviously, as a start-up within a smaller company, what is the competition going to be from these larger companies. And I think you and Jimmy and Sunny, please chime in as well, which is that health care is hard. And it's not -- it is -- there are specific and unique aspects of medical tech devices and actual the therapeutic and diagnostic side of health care. And we learned that it's not as easy as sometimes sounds to in order to do blood tests on them too, right? So the fact is that these larger companies, as Jimmy had said, are building sort of the highway. But I'm not -- and certainly, they're looking to do consumer-oriented products with wearables and others that can facilitate in sort of the digital therapeutic side of things. But we feel like there is a lot of room to work with them as enablers, but not necessarily as competition. I don't know maybe, Jimmy and Sunny, if you guys have some additional insights on that from -- as our 2 representatives from the Bay Area.

Yes. I'll go first. I absolutely agree with that. I think that the Microsofts of the world are building the highways, but the federal government is actually a big driving force behind a lot of this change as well. The 21st century CARES Act opened the door to interoperability and data sharing and broke down a lot of the barriers that were there. And so I think when you look at what the infrastructure Microsoft and the similar companies are building, the push from the federal government to keep data flowing and really prevent these walled-off gardens that we saw in the past. It's very exciting for the opportunities that come up for companies like Veris.

Yes. Just adding to that, just really putting the kind of the finer point on building the highways. In the past, technology companies, like the ones we've been talking about here today have been thinking about things like how do we digitize records, how do we take what we're doing today and just move it into the digital, right? And how do we consolidate data? And how do we standardize processes, a lot of what Jimmy was talking about. Currently, there's a big effort and a lot of energy being put into things like how do we take multiple devices and make them mobile? How do we take them out into the field, like a mobile ultrasound device. I've spent some time in my career actually working on solving some of the problems that are going on with mobile medical devices and how do we allow physicians to work with those in the hands-free context. But some of the really interesting technologies going forward that we're thinking about, it's groundbreaking even for us here at Veris are. They're not that groundbreaking. To be honest, in some ways, Bluetooth has a brand-new protocol that is out. It's already being used, Bluetooth 5.2. I was geeking out recently with Jimmy about it. But it offers a lot of -- a lot more advanced communication. You can sync with multiple devices. It's a lot faster than what we have today. It's just -- it's not in every device that we have today, because a lot of the big players we've been talking about like Apple and Samsung are building it into their devices today. And so there's a lot on the horizon that we can start building and thinking about even where we stand at this point.

Maybe it is an advantage that we're entering a little bit later in the life cycle of these technologies, because we have better Bluetooth. We have better batteries. We have other things that allow us to create these products and make them small and manageable and easily implantable and so forth. So I think that's great. I just why I think I'll just use this opportunity again to emphasize to make that distinction that I made at the beginning about we are taking existing paradigms of clinical care. We're not creating an app that someone can sort of use to help them feel better about -- manage their own diabetes, but I'm not saying there's anything wrong with that, but that's a very different business model. It's not building upon existing paradigms with facilities, which is where the money is, where all the money is flowing in health care. The 20% of the economy is going towards that to paying hospitals, providers, to care for patients within certain paradigms and modernizing those and using these exciting tools we think is -- carries a more predictable and more, we think, in the long run, more valuable business model than trying to see how many hours a day you can have your patients sort of interacting with your nutritional system or your other care. Let's move on to that. That was great. Let's move on to -- maybe if I can ask you, Jimmy. Tim had talked about platform technologies and the importance of platform technologies. And we absolutely, although we're starting and focusing initially on cancer care. We do see this as a platform technology that has other applications. And you sort of mentioned them, but I thought maybe this would be a good opportunity to do a bit more in-depth on some of the things we're working on and the plans we have in heart failure and kidney failure and then potentially other applications as well.

Absolutely, yes. I think that the application in cancer care is very clear. And it makes sense for that to be the first market that we enter. But there are a lot of other diseases out there, a lot of sick patients that have a similar paradigm where they're getting outpatient care. They're at high risk of complications that you end up in the hospital all the time. But there are a handful of very specific parameters that if we had real-time information on, we could actively manage and prevent a lot of those complications. So we touched on cardiovascular diseases. I think CHF is a great paradigm to look at, because there's a long history of research in congestive heart failure. And there are devices that have been developed over the years to help provide some of that early warning system, but these are severely limited in their application. There are some implanted devices that require a lot of labor on the patient's side to get even still small snapshots in time of what is like the pulmonary artery pressure, which is a marker of severity of someone's CHF. So again, leveraging all this technology that we've been talking about building in this platform into a combined kind of data gathering device and software and analytics solution, that can capture a suite of physiologic parameters in real time, have uninterrupted data and really show the nuances of physiology change over time. That would revolutionize the way cardiologists take care of CHF patients. End-stage renal disease, similarly, patients that are getting outpatient care, that have a high risk of complications end up in the hospital all the time, and have devices in place for vascular access for the exchange of blood that's required for hemodialysis. And so again, leveraging the platform technology that we're building to look at those parameters that are specific to those hemodialysis patients can save the overall health system a lot in terms of money and resources. There's a huge push on the government side, on Medicare side, to move dialysis into the home, and you're never going to do that if you can't monitor patients while you're doing the dialysis.

You wanted to pinpoint one of them you mentioned because it's sort of true to my heart as a former heart surgeon. I just to flesh that a little bit, which are monitoring of pulmonary artery pressures, which is an important -- a very useful indicator. And this is a good example of why maybe we're coming in at the right time, because the CardioMEMS device, which was leveraging microelectronics and mechanical systems, I believe the CardioMEMS device launched 10 years ago, maybe not quite by St. Jude's now it's within Abbott. But because of the limitations of battery technology, it was a passive device that had to be interrogated. So you were not getting continuous data. And so you have to go in and actually the patient had to put the device on and measure a spot measurement. Spot measurements are never as good as continuous data, because you don't follow trends. And anytime you're asking the patient to contribute to the collection of the data it's going to be -- you're going to have difficulty with compliance and so forth. So what's really exciting that we've sort of entered this period of time where the technology is such that we will be able to provide continuous data. So anywhere -- anywhere we go, whether it's measuring temperature or the central venous pressure eventually will we end up in the cardiac space, all of that data will be continuous data. Now what may be transmitting -- but again, as Sunny said, Bluetooth is getting lower and lower power, it may be transmitting intermittently, but it's collecting it continuously so the physician will have all that data. And Tim, you've talked about how platforms expand opportunities and sort of embody and empower. I thought maybe you might just chime in about the whole notion of using platform technologies to expand and empower.

Yes. Well, I think the piece that I think is so interesting about this, and I think what's obviously clear is I'm not a medical expert. I've come from the business and technology space. But what I'm really excited about is not only where PAVmed is going and moving more and more towards, what I call, smart med tech solutions, but what Jimmy and the team are building out in terms of this digital health platform. And he touched upon where the extensions are that exist in other clinical uses. The way I tend to think about it is we can take this platform, and that's why it's important to establish it first in cancer care, into a host of different other areas. And the lens that I tend to think about associated with evaluating these are, where can we empower patients, right? Where can we identify early detection opportunities? How do we leverage real time information, not just for the patient, but for the patient care team, real-time quickly? How do you reduce those ER visits? How do you improve the quality of life? And thereby, how do we drive cost out of the system? And I think -- by applying that type of lens to this, I think that we will find significant amount of opportunities to take advantage of this platform and use it. And so the notion of rinse and repeat is a common notion, and I think it's very relevant here. As we build that platform, I think we can use this in a number of different exciting ways that, as you said earlier, we're not creating new applications. We are fixing and improving and enhancing existing care solutions, and I think that's pretty exciting.

Yes, that's great. Thanks, Tim. I'm going to actually move on to Sunny. So there's a lot of hype around AI and machine learning, and it seems like everybody just sort of slaps that ML, AI, anytime you have an acronym like that on anything. And we see it in health care. Every day we get the newsletters as sort of what's going on in the medtech industry, and it seems like every company, no matter what they're doing, is trying to sort of use that. So how are -- how should investors cut through some of the hype around AI, machine learning, even terms like big data and understand the real value of these tools and data analytics in general and sort of with regard to some of the things we're looking forward to working on.

That's such a great question, yes. AI, here in Silicon Valley, you see it on everything. It's like you've got an AI salad almost if you just want to find it. But artificial intelligence is a really, really powerful tool, but it's not a magic box. And I think as an investor, you can avoid the buzz and the fluff of AI by finding a company that's really hyper-focused on solving a really important problem. So those are the 2 keys, right, hyper-focused and important problem. You start by asking the question, really, what does this solve? Who are the -- who is the audience that this is going to impact? And how important is this problem? There's a lot of chatbots out there, and I don't mean to diminish them by any stretch. I've a lot of friends here, who are working on those things. But one example is, we, as a society, have been hearing and reading a lot about autonomous vehicles for years and years. We keep hearing that it's around the corner, reading it's around the corner. Here in the Bay area, there's a lot of fleets driving around almost on every corner where you see an autonomous driving vehicle, but we're still not there. We still have a long ways to go. So the important part is really focusing on those questions that I mentioned. What is the problem? How important is it? Who is it impacting? And here at Veris, what we're working on is quite hyper focused. We've walked through a lot of that material, we talked about it here today. And it's using advanced but not impossible technologies. They already exist. There's nothing here that's highly experimental and it's solving a quite important problem. So I think those are some good ways to think about cutting through the buzz in AI stuff that is out there.

Because it's mature, right? I mean, AI and ML algorithms are quite mature. And if you feed it good data, obviously, c***-in, c*** out. But if you feed it good data and one of the things that we're going to be generating is gobs and cups of data. And if you feed it high-quality data and you can correlate it with certain real clinical -- outcomes in clinical events and clinical symptom reporting and so forth. That, to me, seems like, in many ways, the ideal way to be able to sort of the data structures that you can use to feed these well-established mature algorithms that allow you to identify patterns and learn from them and basically be able to provide better care.

Yes, absolutely.

Great. So let's move on to the business model. I know Jimmy had that slide that showed the fact that this is -- again, this is one of the things, as you know, when we were talking before we acquired Oncodisc, the sort of the light bulb went off when I saw that a previous version of that slide as to how there's an opportunity here to create a business model that's not based on sort of traditional slogging it out on the reimbursement realm with Medicare and private payors, and so forth. And it's quite -- we've added that, as you know, quite extensively before making the acquisition. And one of the things that I thought was quite creative and struck me and the thing that you avoid with this is devices that are common, that been around for a while, such as ports have become commoditized, right? So which port, and particularly I'm sure you would concur in your experience, which port you happen to use is almost not -- is no longer in the decision tree of the physician. It's what's bundled with when some particular package, either at your hospital or more increasingly at your IDN or your group purchasing organization and so forth, and it's all commoditized. And so when you look at this initially, without the business model that you developed and say, well, okay, we have clearly a better port, right, that does all sorts of cool things and adds value to the care of the patient. We should be entitled to get paid more for that. That's a very heavy lift. And then we've seen that in other less invasive technologies, other new technologies. It's not that you can't get it done. It's a lot of -- so it can be a slog both on the reimbursement side and also just making the case to the facilities that they should be paying more for something that has modern new technologies. And what's great about this model is we bypass all that, that we were not going to the care center, and we're not asking them to pay us more for their port. We're actually giving them the port or selling them the port at the same cost as they would have done a dumb port as Tim had called, right? So maybe if you could just talk a bit more about how that looks from an oncology practice point of view or a cancer care center. And then some of the other aspects of this beyond the remote care and the revenue from the implantation with the care models and never events and value-based care, things like that.

Right, right. Absolutely. So you're absolutely right that by providing a platform and a service, we avoid that battle to the bottom that goes on in the device industry for pricing. And we're truly providing value, but the unique aspect of our platform is that we have those existing reimbursement codes to leverage out of the gates. And so we could start selling tomorrow. We can leverage these existing codes, the implantation codes, the remote patient monitoring codes, but still set up the vast majority of our revenue as a service recurring revenue model. And by selling directly to the oncologists, again, we're selling directly do the decision makers in a cancer program, not selling to the buyers or the GPOs like you mentioned. That alone -- even under the existing framework, that alone is a $2 billion to $3 billion market in the United States. And then, of course, the rest of the world is out there. But if we look a little bit more about what are the trends in health care and what are the trends in cancer care, and how can we leverage that value creation in the future? We are shifting more towards value-based care. Medicare has what they call the oncology care model, where risk is shared between Medicare and the practice delivering the treatment. There's a similar program among private payors called the oncology medical home. And Medicare is also rolling out their alternative payment models for cancer care, where there's almost like a capitated payment for an episode of care. And so within that framework, it's going to be critical that the deliverers of the health care, the doctors, the hospitals, that they are managing their own costs and their own expenses. If they do this well, then they stand to probably do better under those systems financially than they are in traditional fee-for-service. But if they're not doing well, patients are having a lot of hospitalizations; 1 hospital admission to the ICU can blow up the entire financial model for a practice that's in value-based care. And so we know that practices that are currently enrolled in the oncology care model are looking for technology and instituting programs that have an upfront cost but are ultimately saving big dollar value on the back end by preventing these hospitalizations and moving care into the home. And by doing that, they then ultimately reap the financial benefits of higher payments and bonuses that come from Medicare or from private payors and then ultimately, better contracts with those payors down the road. So as we move in that direction, this technology that we're building is going to become a must-have for all practices.

You mentioned that they start off with them that they're willing to pay a cost upfront. But what's again amazing about the math here is that their net cost is actually not positive, right? Because they're getting reimbursed for the device implantation, they're getting -- they're going to get reimbursed for the patient monitoring. So they're already being reimbursed. And yes, they're paying the subscription, but that subscription is already covered by their baseline reimbursement within the current -- within the baseline sort of fee-for-service structure. And then if you include the incentives and bonuses, those are really on top of that. So Tim, this kind of reminded again, another example of the tech industry has moved to subscription models for software and for other things for a long time. This just seems to be another example of us sort of coming around to things that have been well owned in the technology sector. I thought maybe you might comment on that. I assume you had some experience at least in the later years at Samsung for that.

Sure. Well, what's interesting about it and as Jimmy was describing, and I was thinking back, it actually goes back really a lot longer, decades ago. I mean think about -- and a doctor's office is great, everybody had a printer, right? You didn't buy necessarily the printer. It was a managed service, right? You basically paid a monthly fee for somebody. And when it was a problem, they took it out and they replaced it. And -- so that notion of managed services, right? And now it has a much sexier term in SaaS or other related capabilities. And truly, the mobile phone industry was built off of that for decades, right? People thought they actually paid $200 for this phone, but -- or they thought the phone cost $200, but it was lumped in with the service and hardware solution just the same way razor and razor blade concept emerged on that. So I think it surely has gotten more sophisticated in the IT space around seats. And I think that is a very common approach to it. And having multiple business model options is attractive, because you can really design it to the needs of the audience, whether it's a large-scale hospital or whether it's a doctor's office or something in between. So having that flexibility, and I think it's great to see the health care industry embracing that. Because I think, too, there are different ways to solve pain points in the industry, and this is just another one. And being creative on it is front and center.

Great. I want to leave enough time for questions. I thought maybe we would close out on a discussion around data. So maybe I'll start with you, Sunny. Companies like Livongo and others have garnered large valuations based on data monetization. And sometimes the notion of data monetization comes, I guess, maybe even -- more often than not, comes with a negative implication that you're selling the data, there's privacy issues and all that. So I guess, really 2 questions, maybe you could start with how do we actually value data? I mean, how do we think about, okay, we have this terabytes of data or more, we have the analytic tools that you're going to help us build to extract that. And then we're going to go to payors and pharmaceutical companies and others and claim that there's value in that. So I just -- maybe if you could talk a little bit about how you think about that.

Yes, happy to. When I think about data monetization, it's quite a popular term, but when I'm trying to maybe explain to my mom, it's something along the lines of -- if we have all of this data, we can then extract probability of good things happening and perhaps risks happening. And from that, we can take and figure out what are the services that we could offer to build around those types of calculations and that probability. So that's sort of mid-level and from a technical perspective, but we're not taking data, perhaps and selling it or trying to put a quantified number on how much each binary digit is worth, but really thinking about how we take data and then extrapolate it into something meaningful. And then how do we build services around it to be able to help the people, who are affected by it. So we're thinking about the stakeholders that are involved. Today, we've been talking a lot about the patients, the oncologists and providers and payors and thinking about how data that's collected can then be useful for them for trade in the right way. That's how I would describe and then...

We're not selling ads, right? We're not using data for all sorts of...

Not selling ads.

The various reasons that people are having to testify in front of Congress over. This is the identifiable data is going to the care provider, right? And the broader data is really population-based data that has -- that's not identifiable. That allows us to identify patterns and learn things about what works and what doesn't work with care. Jimmy, do you want to maybe elaborate on some of the privacy aspects of that as we wrap up here?

Sure, sure. So there are very clear standards put out by the federal government, by FDA, from other standards organizations on how you manage data privacy in health care. And so it's a very clear road map of how this is done and how that data can be exchanged between parties, between the care delivery system, their business partners and the federal government. And so fortunately, the Microsofts and Amazons of the world that are building that infrastructure that we've talked about, this is a critical component of those cloud computing platforms that they're building. And so there's a road map and an infrastructure in place. And so we have a very clear pathway ahead for how we manage that, how we comply. But most importantly, how do we live up to the spirit of that to protect patients while also moving medicine forward.

I think that's one area, perhaps where health care has been a little bit ahead of the curve in terms of standardizing processes for protecting privacy and not having to slog through a 20-page terms, privacy notes that you have to click to accept to use the technology. So that's really not where we're going to be. All right. We have 15 minutes left. So I think we definitely want to save enough time to answer questions. And I think from the count here, I think we may -- if our operators here can bring in Dr. Shah if he's here, and then we can move to questions in here. Yes, Dr. Shah, thanks for joining us. Actually, while we're waiting for the question, the Q&A to sort of fill up the pipeline. I did want to ask you one thing which didn't come up in your conversation with Dr. Mitchell, which is I know you've worked closely with the pharmaceutical industry on the use of digital technologies in their aspect of the business. And I was curious if you might have some insights from that and how that might inform some of the things that we're trying to do.

Yes, absolutely. I think one thing that pharmaceuticals are very interested in this space for, as I talked about in that prior trial -- further quality improvement outcomes comes into way of life, there is a decrease in health care utilization. The improved overall survival was thought to be 1 of 3 possibilities in terms of the conjectures why that -- why this intervention actually led to an overall survival and probably the one that is most intriguing for pharmaceuticals is that we were able to show that patients actually stayed on their drug longer. So there is better adherence to medication, because of better symptom monitoring. And so for pharmaceuticals, that's a big thing for them. If they can continue patients on their drugs for longer that obviously is to their benefit and also to the patient's benefit as been shown with overall survival. So they have a very vested interest in understanding how their patients take their medications, what leads to compliance issues. And so physiologic data like that we're providing through this platform will be very helpful for them.

Great. Thank you. So let's go to some questions here. I'm just going to basically take them in order and sort of relevance to the topic at hand here. So maybe, Jimmy, you could start with this. What predicate devices are applicable to be used for the 510(k) pathway? So maybe just a bit of a summary on our initial regulatory assessment of the pathway moving forward for the Veris device.

Yes. So the predicate devices are the existing port devices. There are many out there that we can choose from. And that will be the main predicate with reference to other connected devices and standards for monitoring parameters such as temperature and heart rate. So the main predicate is the existing port technology with reference to the other monitoring technologies.

Great. I guess maybe I'll take a crack at this and why don't you chime in a few, if you have anything to add. The question is, can you comment on your view on the path and timing to receiving Medicare and private coverage reimbursement for Veris products i.e., the intelligent vascular access, assuming 510 (K) approval. So -- and then the second part, I think, answers the question or question which is, do you view Veris' future product has fallen within existing CPT codes? Or do you think it will require new codes? So again, just to reiterate, that's what's amazing about this model. So there are existing CPT codes, which Dr. Mitchell showed both for -- obviously, for the implantation of the device as well as for remote patient monitoring. And we are not dependent. The model is not dependent on receiving Medicare and private coverage reimbursement. This is a subscription-based model where we will be charging the oncology practice or the cancer care center directly, not Medicare, not private payors. On a subscription basis, so they will have the right to be on our platform to receive the remote patient monitoring, and that provides us with an immediate margin from our point of view, if you take the cost of the device. And from their point of view, because they will be reimbursed both for the implantation of the device, which is, again, an existing code and for the remote monitoring itself. So in terms of the time lines, as you -- I think you're suggesting towards revenue, it is not going to be dependent within the current business model on Medicare and private coverage. Dr. Shah, do you want to maybe comment on how that sort of fits in within your -- the practice models that you work with I realize you're at a large academic institution, but perhaps you might -- there might be some additional insights you can provide on it.

No, that's exactly right. I would just say that we are kind of going towards value-based care in general at Stanford as well, and that reimbursement will largely be tied to cost sharing with insurance companies. But in general, I completely agree with what you said.

So another interesting question, which again, we've touched on, but I think it's a good opportunity to drive it a little bit more. So the question is, is Veris competing with big tech companies like Apple? And if so, how would you compete with such large tech companies? So let me just start the conversation on that, maybe Tim and Jimmy and Sunny like to chime in and Dr. Shah as well. So it's our -- what Veris is doing is taking this existing paradigm between physicians, the facilities they work at and patients and applying digital tools to that and using modern technologies to facilitate those and to create value for all the stakeholders, as we've outlined before. That's very different than what the large tech companies have been doing, at least in terms of the device monitoring side where it's been very much consumer-oriented wearables, non-implantables. And as such, we don't really see that as competition, but we also, as we noted, the big tech companies are also working on the data side, and we're leveraging that with our relationship with Microsoft on the building of sort of the highway for the data to flow as opposed to the technologies themselves. Tim, do you want to maybe reiterate some of the points that we talked about earlier as sort of how -- what -- where the big tech companies are focused on the hardware side, perhaps?

Yes. Yes. Yes, I think as you mentioned and I mentioned earlier, I think they're much more focused on consumer wellness in general. Yes, they're getting more specific in certain areas. But I think as you think about the device, it's adding value to their watch and to their phone and to that ecosystem of solution -- solutions. And I also think I'm a big fan of the health product, right, which helps me track a host of things, mostly around sleep and recovery, but their general solutions, I think that exist here. And so I see it less around direct competition. I think as we build out our Veris ecosystem, I think, again, not trying to be the kitchen sink of all things associated with healthcare, but getting very specific and more narrow with an appropriate lens, I think, allows us to stay very clear in the areas that we think we can knit best in. And we can create more value to that. And I think that is a much different approach than I think most in the tech space have been taking so far.

Great. There's a question about customer privacy, I think we touched on that. Thanks, Hassan, for that question that the regulations with regard to HIPAA, high-tech and others around the transmittal of patient data in an identifiable way is highly regulated, will be subject to that. The FDA and other regulators will be -- will be -- will provide significant oversight on that. Dr. Shah, do you have any sort of points of concern? I know in telemedicine, there are some new issues around privacy that I'm sure you've dealt with and you've managed, but do you feel like the current infrastructure that's provided to us by the regulators has been sufficient to protect patient privacy.

Yes. It's been very patient-centric. And I would say that the regulations that we do have in place do ensure patient safety as well as patient privacy. I think that at times, there can be -- the innovators can feel that this could be so much stifling because it's difficult to move at the pace that you'd like. However, I think it's actually critical that we do have infrastructure in place to maintain patient safety and privacy. And I think those regulations are very well regarded right now.

Right. We have a question about Veris' intellectual -- thank you, Dr. Shah. We have a question about Veris' intellectual property portfolio. Obviously, prior to doing the acquisition, we spent a lot of time, both with internal and outside counsel on that diligence. Frankly, we're a bit surprised at how good a job Dr. Mitchell and his colleagues had done in what we thought would be a fairly crowded space. So perhaps Jimmy, you could talk a bit about the strength of the portfolio, both on the platform side as well as on the device side?

Sure. So it continues to grow. We have 1 issued patent and 7 patent applications pending with some of the pending applications being kind of an omnibus application that can -- we can draw upon for many, many claims in many different realms. But we really looked at this holistically in building the IP portfolio, looking at not just the device, but also the platform, the data and the clinical utility of what we're building and how can we provide broad intellectual property protection in all of those aspects. So for example, our initial granted patent is very targeted towards the use of this technology to monitor cancer patients for complications such as sepsis. There are very kind of traditional and specific device patent claims that we have filed to protect the device itself. But again, there's a lot of work being done on protecting the platform, the clinical utility of the platform and some of those higher level analytics that we'll be drawing upon to create value.

Great. I think I'll direct the next question to Dr. Shah, because as a practicing oncologist and Jimmy talked about the data with wearables, but the fact that patient adherence was an issue. And so the question is, why do we think that patient adherence will be better with an implantable device where this is incorporated into their chemoport versus the adherence issues that have come up when people have tried to use Fitbits and other types of technologies to improve care, where we know that adherence can be a problem?

Sure. Well, I can just tell you that from clinical trials that have been done in the past, even with wearables, where you think that it's a wrist band that you're wearing that you just can use data, 30% of patients were unable to sync their Fitbit with their phone or their computer. So there's still a technology piece that is very essential for engagement. In addition to that, I think the physiologic data that we have will always be continuous. So always -- there's no issue of adherence or compliance, because it's literally implanted within you. So I think it will take care of all the adherence issues. And we also know that the data that I need as a clinician, often is not just objective data that is coming from the patient, but really this objective physiologic data that I need to help make a decision about whether to give a patient chemotherapy or radiation or whatnot. So I think adherence will certainly improve with the implantable.

I think anytime you don't require a patient input and it's automatic, I think we know that deterrence is going to go. We're running a bit short of time, but I think I'll sort of take the prerogative to extend it for 5 or 7 minutes, because we have some great questions. So we'll keep going if everybody is okay with that. There is a question about the 2.0 device and its relation to the 1.0 device, which you highlighted in one of your slides, Jimmy. So just to be clear that the -- what we'll be submitting for clearance in the second half of next year will be the 1.0 device, which is tailored to oncology patients. So many of the things that you saw in the other -- the additional things that we're looking to do in our part of an R&D project that we believe we'll be able to incorporate in the second-generation device are targeted like cardiac rhythm and other types of arterial pressure and things like that will be for the broader application. So Jim, would you like to -- you did a survey, for example, of oncologists and asked them what parameters would be most useful in their practice, you maybe touch on that a little bit to provide some color?

That's right. Back in the very early days of Oncodisc, we did a pretty comprehensive survey of oncologists trying to ascertain what are the most critical physiologic parameters that are important to the oncologist as they take care of patients. And then we did a comprehensive survey of the technology landscape to look at, okay, of these parameters, what can we realistically monitor today. And fortunately, those lists actually lined up very well, and that's what you see in our 1.0 feature set. But as we go forward, we know that there are additional parameters that can bring value to oncology care. And then also different parameters that would be beneficial in, say, cardiovascular or renal diseases. And so those are R&D projects, that will lead to 2.0 and beyond. Those features, like Lishan said, are not going to be part of that initial 510(k) application. But we've already initiated a discussion with potential R&D partners on developing these technologies, and we expect that they'll be incorporated into a commercial product probably 12 to 24 months after 1.0.

Great. Another great question for elderly patients or compromised patients who do not have or know how to use their cell phones, how will this product work for them. Again, I'll ask maybe you and if Dr. Shah, you'd like to chime in on that as well.

Sure. So the beauty of the implant is that it will operate in the background and communicate data even if the patient never signs on to the app, and isn't interfacing on a regular basis. So we will have access to the physiologic data even if there's no integration of interaction with the patients. That said, we want to drive that interaction and that usability. And so taking into account the typical cancer patient age and demographic, we are integrating all of those considerations into the user design. So having a simple design that's very intuitive, has very clear and kind of large text, large images, easy-to-use buttons and other features for navigation. So that really -- just about anybody can use it with very little instruction. And I'll just add that even with my experience, there's this idea out there that certain generations struggle with technology. But most of the patients that I've seen in the last 5 years, regardless of their age, they come in with their smartphone. And when we talk about their schedule, they open up their calendar and they start texting their contacts. And so I think that every generation is more tech savvy than we give credit for.

I think my 86-year-old mom would fall in that category. So just a real quick question. I'm trying to do some of these quickly, which is a question about the process of getting -- basically getting the device in the market. So as we said, we're targeting the second half of next year for that to be available for use in cancer patients. The process for that is completing the design verification validation process, submitting to FDA for the device. There's some fairly minor hurdles that we have to do for the actual software side of things. And it's -- we believe it's a 510(k) process with good predicates. So that's where we'll -- that's the process before we can actually see it on the market hopefully by the end of the second half of next year. There's a question here, which I'll summarize, Jimmy, about, I think it would be good to explain to people what's involved in the implantation of a port, how common it is, what percentage of cancer patients get it, how invasive is it, where is it done, what's the recovery and so forth compared to wearing a device, which, again, perhaps you could reemphasize the benefits of an implantable overall, since patients are going to get it anyway.

Sure. So again, these devices are implanted every day in cancer patients. Typically implanted by interventional radiologists or radiologists who do procedures in a minimally invasive outpatient procedure that requires conscious sedation. So there's typically no general anesthesia. The procedure takes about 30 to 60 minutes, and patients will typically go home after the procedure is done. But patients can actually go straight from interventional radiology to oncology and get an infusion of their anticancer medication right after the port is implanted. Today -- if we look at what percentage of cancer patients that are undergoing infusion therapy have ports. Today, it's about half in the U.S. So there's definitely room to expand that market by having a more compelling offering. There are also now multiple prospective randomized studies to show that ports are safer, more effective and more cost effective than other forms of medium- and long-term vascular access devices. So that would be things like PICC lines and tunnel catheters where there is some external component to the device. And so -- and then to touch on the comparison with a wearable. Again, a wearable doesn't serve any therapeutic purpose in cancer care today. You can't infuse drugs through a wearable, you can't deliver therapy. So we still need to have that vascular access for therapy. And then again, with a wearable patients can take it off, can leave it at home. And we're talking about 6 months of therapy even longer for a lot of patients. So to adhere on a regular basis to any kind of wearable tech for that duration, we just haven't ever seen that in medicine. Whereas in an implant, we know from the world of cardiovascular diseases that once there's an active implant in place that it's going to run in the background and we don't have to do much else to make sure we can capture the data.

I have a couple of questions to touch on the question of the sort of the spectrum of oncology practices between smaller practices and cancer centers and large networks, perhaps maybe Dr. Shah, you work in obviously at a large academic institution, perhaps you could give us a bit of insight on that.

Sure. So in the U.S. right now, there are, I believe, 13,000 medical oncologists and several other surgeons as well as radiation oncologists. But just in terms of medical oncology, which is largely around 13,000. In terms of the different health care systems, there's large tertiary care, academic medical systems, and then there's also a large community-based practices such as the Kaisers in those such systems as well. And I believe the question is about the number of cancer patients that are relevant to Veris technology. So I mean there's well over 1 million new cancer patients diagnosed every single year in the United States. And I would say that probably at least 30% to 40% of them will be undergoing some type of infusion-based therapy and may actually be eligible for a port in the future. For those patients with advanced disease, like Jimmy was saying earlier, it's probably at least 50% of patients will require port during their therapy. So quite a few patients, quite different few -- quite different health care systems, but all applicable to this type of technology.

Great. Okay. Thank you, Dr.Shah. That's great. And let me just try to sort of collate questions here. I have a couple of questions on what we hinted at, but maybe good to spend enough time on, which is the application in clinical research, clinical trials for pharmaceutical companies and how it could be useful for them to have access to this continuous data. And perhaps you could touch on that, Dr. Shah and then Jimmy talk about how that could be -- represent a substantive contribution to future revenues.

Yes, absolutely. I think the one that's actually most intriguing would be getting pharmacokinetic data from our patients for early phase clinical trials. So when a patient comes to us for like a Phase I clinical trial in early development, we'll have to keep that patient in the chair for about 8 hours even if their infusion was only 1 hour long, largely because we're just drawing blood from them and getting different time points to see how their drug is distributed in their body over time. If we had a better system of doing that, maybe the patient wouldn't have to come in as often. And so I think that will be one of the big advantage of this type of data is to get pharmacotherapy data. In addition to that, we can also see -- or physiologic changes in blood pressure, in heart rate with the introduction of these medications as well. So I think a very intriguing space for clinical trials research.

Jimmy, would you like to add to that maybe from a bit of a business perspective, and then I think we can wrap up.

Yes. So if we think about the process of getting a new drug through Phase I, Phase II, Phase III clinical trials. This is a very expensive undertaking for a pharmaceutical company, and there's a risk in every step of the way that whatever they're pursuing, whatever the product is, that it's going to fail. And if you have a failure in a big Phase III study at the end of that development, we're talking about billions of dollars of losses for the drug companies. And a lot of the times, we see a Phase III study fail, not because the drug doesn't provide a benefit, but because those benefits are washed out by either toxicities that couldn't be managed or toxicities that just were a bit of a surprise when the drug gets put into a bigger population. So we can provide data for patients on clinical study that can allow the pharmaceutical companies to maybe look at their Phase I and Phase II patients, look at nuances in the physiologic data and those patients' medical histories and use that to make smarter decisions about inclusion and exclusion criteria for the bigger studies, as well as study design, what are the appropriate endpoints that we're going to look for. And then once patients are on study, using the physiologic monitoring to actually track for adverse events and intervene quickly before those adverse events lead to a bad outcome that is then going to negate the good outcome that we might be seeing from the drug. This enhancing or enabling this process of drug discovery not only helps the pharmaceutical companies financially, but it also potentially gets therapeutics out there to patients earlier and sooner. And so to provide that clinical trial support can open up big sources of business for Veris Health.

Okay. Well, there's some more questions, I'd love to get to all of them, but we're 10 minutes over our time. So we're going to have to stop. But just wanted to first thank all the panelists. Obviously, my colleagues at PAVmed as well as particular thanks to Dr. Shah. And of course, for all the participants that we almost hit 300 participants. We're really, really grateful that you guys all spent 2 hours of your day to learn more about this technology, and it's been great to have the opportunity to do a bit more in depth than we're typically able to do. Any questions that were not asked can be sent to [email protected], and we look forward to hearing from you there. And we'd also encourage you to follow us on Twitter and on LinkedIn, where you'll see regular information posted about PAVmed as well as Veris and our other technologies and companies. So with that, I'd like to thank everyone again, and enjoy the rest of your day. Thank you very much.