William Hendren, Qura - Continuous Collection of Blood-Pressure Data | LSI USA '24

William Hendren  0:09  
Hi, I'm Dr Will Hendren. I'm the CEO of Qura. You know, it's really interesting. If you look at the history of medicine, at least in the last 300 years or so, it's been defined by these eras, very definable eras of transformational innovation or advances that literally impact the lives of not hundreds but millions and millions of people. And examples of that include going back to Jenner and and vaccination discovery or demonstration of anesthesia at the MGH X rays. More recently, we've all experienced the pandemic and MRA vaccines, and so I don't think it's lost on any of you in the audience that today we're just at the cusp of one of those similar transformational eras, and you've heard about this in the last few days, and that's the era of biosensors and digital data, and that's exactly what cura is all about. So in this era of sensors, we have developed a proprietary, cutting edge technology platform for disease management that uses implanted biosensors, wireless capability, software and data and with a platform. Our initial application is a very highly differentiated technology that automatically measures and transmits blood pressure data continuously using a very small implanted sensor device, our solution provides very important clinical and economic value for patients, providers and payers by affording unparalleled understanding of the True Blood pressure load and the risk of that load under a wide range of normal life physiologic conditions and a better understanding of blood pressure, so called TTR, or time and therapeutic range, is going to drive adoption and growth and propel what we think is a very substantial commercial opportunity. Finally, we are raising a series B funding that's going to fund our first upcoming human feasibility studies, regulatory clearance and early commercialization. So I always start with you know who we are from a leadership standpoint, because you can have the best technology in the world, but if you don't have the horsepower and the people around the table to commercial to get this to a commercialist state. It's a it's a struggle, and we're very fortunate to have assembled an outstanding group of individuals who are playing major hands on roles in this at every facet and at the same time, we're supported by world class engineering, regulatory, reimbursement, et cetera, capabilities, and as a highly cohesive functional team. So I'm a heart surgeon in my former life, so I spent my entire career in cardiovascular disease, and I'm absolutely stunned by the world's misunderstanding of blood pressure and what an enormous problem it actually is. It is the single leading healthcare threat, not only in the US, but globally. And the numbers that they're all there for you to read are absolutely staggering. So nearly half the adult populations in almost every developed economies have hypertension, yet only one in five who carry that diagnosis are actually controlled. The primary goal needs to change. It needs to be a seismic improvement in control and better understanding of what blood pressure load is all about. And continuous monitoring is the key to that. It's the way to unlock this problem, the biggest problem or challenge in clinical cardiology today is not a new pacemaker or a new way of mapping the heart or, you know, some of the things that you're hearing about here in this conference, the biggest challenge is the simple, reliable and What I like to call actionable blood pressure measurement, and the current standards that exist today for ambulatory blood pressure monitoring are simply inadequate, and you cannot argue with that. And cura is a move from this passive, reactive management philosophy based on incidental, ambulatory or clinic blood pressures to really a proactive and preventive focus. Using real time data and our path is going to improve our understanding of blood pressure, load and patient risk, and we think much in the same way that the measurement of hemoglobin, A, 1c and using continuous monitoring has has revolution. The treatment of diabetes. So our solution automatically delivers actionable data, not only to the patient and care team, and by being an implant, provides and drives unprecedented patient compliance, which is a huge issue in patient care in general and especially in hypertension. So why does this matter? Why is it important? Well, the reality is that we provide tremendous value across the entire healthcare chain. So for the patients, I already mentioned that patient noncompliance is a huge problem and plays a major result in the terrible results that are currently had in the treatment of this disease, and we eliminate that viable, that problem entirely through our technology, our approach and having an implant that measures this automatically. Patients really don't need to do anything. And the patients are also just like with the continuous glucose story, empowered through understanding their own blood pressure, load, knowing their numbers, and this leads, obviously, to a path with better adherence and results for the providers the patient, the physicians and caregivers will have a much better understanding of what is happening with the patient over time, and the true effects of blood pressure and its load, you know, more data, better estimation of the TTR and the area under the curve of blood pressure is going to result in much better outcomes and better decision making and outcomes. And finally, for the payers, of course, they will benefit from an overall lower cost of care, particularly with our first segmented group of those who are really high risk from hypertension and chronic patients, as well as better quality metrics in general. So this is how it works. So our system is called Q smart, and the device itself is the qsense, and it is a small, just a little under an inch in length, subcutaneous implant, which is placed on top of the easily accessed radial artery. It's actually a very sophisticated machine with highly miniaturized components at the core of which is a true capacitive MEMS pressure sensor. It will be placed very easily under local anesthesia and a little introducer that we are creating from there, this will automatically and on a continuous and program basis, accumulate blood pressure measurement, transmit it to the cloud, where data analytics reside, and from there, it can be distributed, literally, not only to the patient immediately, but to patient caregivers the medical record of whatever. So we have some really important differentiators in our story, the first of which is the technology. And we've really built this around five pillars of innovation. One, we've perfected the art of extreme miniaturization. We have a game changing encapsulation process, which is novel for hermetic sealing of the components and biocompatibility. We actually have a battery in this, and so it's at a so called active implant, and that's really key to key to freeing up the patient from having to do anything. And we have wireless transmission innovation. And finally, we're giving and generating waveform blood pressure data, which some of you will understand, has a lot of information, which is very different from just a blood pressure, mean pressure, etc, etc. All of this has been well tested and validated, and we have unequivocally proven that what we are doing and how we are doing this is absolutely equivalent to having an intra arterial catheter in place. And some of you will understand that that is the gold standard that every medical student learns is the gold standard for blood pressure measurement. We have a very substantial IP portfolio that is expanding 17 to date, with number 18 on my desk back home in Boston. So you know, I should retitle this robust commercial opportunity to you know why this is a great business and it's going to be a great business. We have a disruptive solution for, as I indicated, high risk hypertension, and we'll have immediate commercial value that will drive adoption and starting in value based care systems where payers and providers are focused on optimizing outcomes and care. And I think most of you are aware that CMS Medicare has actually set the goal of 100%. Medicare recipient beneficiaries being in Accountable Care relationships by the year 2030, so fast coming. We have early, planned, early pilots with risk bearing organizations. Organizations will then further demonstrate the clinical and economic value. And this, of course, is just part of the process of establishing and expanding current codes, getting more coverage and where value supports the economics in the value based delivery paradigms, we absolutely know that this will occur in the fee for service arena as well. And so we have lots of opportunity from revenue from a broad and expanding number of sources, one of which is, despite being a very sophisticated machine at scale, we can produce this very inexpensively. So you know, low cogs, high margins, data, revenue, recurrent monitoring for the collection monitoring analytics in the value based care paradigm, ppm, PMPM and risk sharing contracts, and then lots of other sources, including contracted David cert data services licensing, royalty softwares and medical advice The device. And finally, I want to mention strategic partnerships. Some of you have been listening to some of the talks here today. Well, we absolutely believe in that combination of support, financially and in other ways, from early strategic partnerships. And we have generated tremendous strategic interest thus far, and we think that's an important thing. And it was really refreshing to hear some of the strategics espousing that today. And finally, just base financial modeling that we have demonstrates remarkable strong operating income and revenue ramp, even without all of this targeted expanding of the coatings, etc. So here's where we are. We're raising $25 million to fund our first in human feasibility studies, our FDA submission and early commercialization process. We are into that and have done well thus far in that raise, and are continuing now and on the process, and just from a milestone, they are listed here. And I would just point out that either in q3 of this year or late q3 or early q4 we will be doing our first in human feasibility studies in Australia, under Dr Ian Meredith's auspices, who you might have noticed as part of our team and early design free submission. We strongly believe that this will be a de novo submission. And many of you have heard, or are you familiar with that process, and we think we can have early commercialization by the first quarter of 2026 so just a capsule summary is this is cutting edge technology platform, which we think is going to be an important contributor to the success of the sensor and data era, which we are now firmly in. We are addressing absolutely massive markets with one of the most important disease entities in the world, and we think this is going to be a very robust commercial and investment opportunity. And with that, thank you very much. Applause.