David Giarracco Presents Noninvasix at LSI USA '23

Transcription

David Giarracco  0:04  

Good afternoon. So David Giarracco, I'm CEO of Noninvasix, and I'm here today, thank you, I appreciate the time for you to hear our focus our story and why now is the right time to invest in our mission. And our mission is to be the first company to deliver non invasive and continuous vital signs from the right side of the heart or the venous side of the circulation. That approach is applicable to so many problems in healthcare. And we're actually starting it with sepsis. So why sepsis? This is the US impact of sepsis on healthcare. And this is despite 20 years of intense focus, driven by the Society of Critical Care medicines guidelines on the surviving sepsis campaign, as well as the Centers for Medicare, Medicaid, making sepsis care, a quality measure. And you can see despite this, that the problem still remains. And it's really not just the faces. But what these people have in common is that they were admitted for other things, but ultimately died from sepsis. And why is that? It's because sepsis is difficult to recognize earlier, and even harder to personalize the treatment. And so we think this has a lot to do with the current approach for monitoring for sepsis. And it's that approach for monitoring for sepsis today, that creates the morbidity, mortality and cost of care you just saw, and ultimately results in delayed identification and treatment. And if you look at the equity, which is a Patient Safety Institute, they're one of their top 10 patient safety concerns for this year is exactly that. And so non invasive to breaks this paradigm by recognizing that there were no options in terms of invasive and non invasively, measuring a vital sign from the right side of the heart from the venous circulation. So we took this approach where by measuring earlier and detecting patients at risk, we can provide sooner information, by not being invasive, we can be safer, and open up the monitoring to a broader population, and detecting those that you wouldn't suspect for sepsis. And ultimately, by providing real time and continuous feedback to clinicians, you allow them to optimize treatment in real time, and provide that care at the right acuity setting at the right time. And that's really the only way to improve outcomes and cost simultaneously. And we're going to do this by being the first non invasive continuous monitor of venous circulation. So this is where we come in live ox is a system to monitor oxygen, the veins or central venous saturation by the acronym. And this is what drew me to the organization that promise of being able to deliver this to the market. And we're not the only ones that think that's a big deal. Obviously, the FDA does as well, because last February, we received a breakthrough device designation for Spacek and continuous monitoring of patients at risk for septic shock. And our go to market form factors typical of high acuity monitoring, which is a hardware system on the right and reusable probe on the left, that then connects to a patient patient interface or disposable in the middle. And so how do we work? We are our patented optoacoustic technology allows us to sense deeper tissue, deeper veins than you would with traditional pulse oximetry. So effectively, we take laser light, we illuminate the hemoglobin and red blood cells, that hemoglobin expands that thermal expansion creates a shockwave and we listen for that sound coming back. And what that does, that tells us two things. It tells us not only what oxygen exists in the blood, but it also gives us positional information to know where that signal came from. So simply put, when you think about things like pulse oximetry that you may wear on your wrist or getting used in the hospital, that's a light in light out solution. We're a light in sound out solution. And what that further does is really gives us the ability to take out risks associated with melanin. So we know that we're an independent measure when it gets things like skin tone. So our performance equals the gold standard of invasive co oximetry. I'm going to start on the right by telling you hey, no matter what you think of me this, this science won an award at the Society for Technology and anesthesia just this past January, and I lovingly call them the nerds of anesthesia. And what you see in our slide is you see the blue dots, which are venous co oximetry that are gathered by taking an invasive line a central line and flooding it down and pulling a blood sample and bringing that to a benchtop tester. Those are the blue dots. Our black line is a continuous non invasive measure from the skin surface. And you can see how we track the invasive measure over time. And really what we can show is the detection of deterioration of the onset, and then the recovery that you see from treatment as we turn the oxygen back up. So this is a breathe down study where you deliberately reduce the amount of oxygen that a patient is breathing. And so this approach is the same protocol that will be required for a regulatory cleanse. So we've already done the study once that will repeat to actually get onto market. And so comparison to alternatives. I would submit to you that it's really no comparison to the alternatives, because as you can see from what are the standard of care approaches that I'd have significant limitations. One of the questions I get is, what about serum biomarkers? Well, they're kind of interesting. But again, they have the same limitation that you really can't do this in real time to guide the therapy. So ultimately, we think we have the value proposition that lightbox is sooner safer and personalized treatment for sepsis. And so our initial market is the annual us sepsis market. And we do this as a bottoms up build, and what we look at as our potential revenue per patient taken by the patient population, and we just create that market size. And we're going to focus in on our beachhead market, which is the intersection between the 193 level one trauma centers, and those institutions that have more than 50 ICUs. And then what we can do with our business intelligence tools, is ranked those institutions based on their sepsis patient load, so it can really be focused there. The nice part about narrowing it down is a reduces our commercial exposure, but also sets us up for as our technology evolves, we can do a share of account play as we bring new technologies to market. So beyond sepsis, and central venous saturation, we have other US market opportunities that we can play in. And the way we'll get to those markets is expansion through clinical claims and r&d. And you see in the top line, where we take our current live ox configuration, supported by clinical studies, and we can march from a septic shock clean to a hypovolemic claim to a cardiogenic shock claim. And then as we advance r&d, we can look at bringing other parameters to market as well as looking at different patient cohorts. So vital signs monitoring is an acquisitive market. And you can see this happens over time, usually what these do are strategic coming in and buying additions to their portfolio really based on what their revenue is. But if you look at cheetah medical in there, they actually broke the mold by getting acquired when they actually had a parameter that guided care, as well as a study that supported it. So we think we can take a similar approach but enhance that value, because we have a de novo approach that will really create the barriers to fast followers coming in on our technology. So that's slows competitive entrance, we have a very clear indication for us, which are two kids a clinical language. And then lastly, we'll be launching with evidence which will accelerate our commercial adoption. And what that does is provides us the opportunity to have multiple exit opportunities. I always say that companies are bought and not sold. So you really have to build a business that creates value throughout the continuum, and look for the right buyer at the right time. And so the team, it's a little bit of been there done that. I want to highlight Don Prue, who is a chief of anesthesia at the University of Texas Medical Branch and the founder. I actually come from Covidien Medtronic, and I was part of the team that put together the business plan, the integration, the scaling of the aspect acquisition, the so magnetics acquisition, the already an acquisition, were supported and complemented by a great board of directors that represents a serial entrepreneur in healthcare, as well as the largest medical complex in the world, and the preeminent patient monitoring company across the globe. We have our compelling vision is tracking the best and brightest to our clinical advisory board, where these are the key leaders in the societies that set the standard of care, as well as study sites for us. I do want to highlight Dr. Greg Martin, who is actually in addition to his responsibilities, Emery was one of the co authors of the most recent surviving sepsis guideline. So we have the right people on board supporting us. We continue to increase business value and create momentum. As we look towards our Series A arrays we've de risked the company where it completing our 13 Human that won the the abstract, we understand our regulatory pathway. We're a de novo, we've agreed with the agency on that. And we continue to be supported by our our shareholders. And so this is our use of funds is really to scale the organization to get through regulatory clearance in support of a study and then get a commercially ready product on the market by one two of 25. And so in closing, we think we're an excellent investment opportunity with a differentiated technology that can make a difference in not only sepsis, but other big problem statements by providing the first real time continuous measure of the right side of the circulation. So with that I thank you