Nick Delmonico Presents Strados Labs at LSI USA '23

User-friendly sensors, unique collection methodologies, and data processing software that creates a more holistic view of a patient's respiratory health.
Speakers
Nick Delmonico
Nick Delmonico
President & CEO, Strados Labs

Transcription

Everyone, my name is Nick Delmonico. And I'm the CEO and co founder of Strados Labs. And at Strados Labs, we believe in making every breath count. And the reason we say that is really based on my own personal story. I had been diagnosed with asthma when I was four. And I've been to the hospital six times for acute exacerbation of my asthma. And I'll never forget being asked the same question every time I would leave is, when did this all start? When did you start wheezing, coughing and having shortness of breath and has it gotten better or worse. And that's a really difficult thing for most patients to understand. And in fact, that's really part of the standard of care for most pulmonary diseases that are chronic. Knowing when you're having symptoms is essential to getting the right treatment at the right time. And yet, for most patients, which there's over 30 million patients with COPD alone in this country, they have a hard time doing that. And so we spend in the US over $100 billion on the cost of care for COPD. And we have one of the highest readmission rates of any chronic condition and nearly 22% nationally. And I talk about, again, symptoms management and it's quite fascinating problem is, it's been well researched that patients under or over report their symptoms nearly 50% of the time, but that is what drives ultimately, the standard of care for COPD post exacerbation, knowing when the symptoms are occurring if treatments are working, and then ultimately trying to avoid hospitalization. So the cycle continues. Until now, we've now created a technology that can listen to patients lung sounds and assess them, whether it's from hospital to home, it's been clinically validated to be able to identify the early warning signs of an exacerbation of COPD. And it is FDA cleared. And really the key and essential component here is now you have an objective assessment of somebody's lung sounds over a period of time in conjunction with the treatment plan that they're on. And so now we can finally solve this really difficult, expensive and challenging problem. The proprietary components of this is our wheeze check platform. This is a algorithm that's been validated and studied. And now in six peer reviewed publications at the American Thoracic Society in Journal of Emergency Medicine to demonstrate not only can we track these lung sounds at high fidelity, but it's at the same accuracy level as a clinician as if they had their own stethoscope on you at all times. So it's really exciting, from a clinical and scientific perspective to have finally gotten to a place that we can do that. And it's really because of the team that we have here at Strados Labs our vision for the future and pulmonary, as well as the experience that my team has building medical technologies and solving extremely difficult problems. Three of my management team members were with cardio MEMS, which was ultimately a technology that helped reduce hospitalizations by nearly 50% for heart failure patients by getting data from the patient at home. So the doctors could treat patients earlier and provide better outcomes. So we're quite quite excited about what we've been able to do there. And again, talking about the differentiation of this solution. What's out there in the market today for pulmonary disease is predominantly patient reporting of self management through journals. But there are some technologies that are starting to creep up in the space. But we're the only one that really combines all those parameters that are clinically interesting to both the pulmonologist and primary care physicians in getting that extremely important clinical data point and we're FDA cleared. So some technologies are out there not FDA cleared, maybe CE marked or TGA, but do not have clearance, because they do not have the accuracy level that we have it Strados, talked a little bit about my management team here. But I also want to talk about our advisors, we've got an amazing panel of specialists in reimbursement and regulatory Clinical Strategy, including the Chief Medical Officer of the American Lung Association, who's an investor, and has been pivotal to making sure that this is a technology that can be well adopted into the pulmonary community. And this is again, pressure tested by a panel of a pulmonologist who are constantly reviewing the data constantly helping us establish the science and making sure that we're getting in front of the right clinical audience to be ultimately make this part of the standard of care. And where we're really focused for this technology. In its its first market space is post acute exacerbation. And as I mentioned, that's where you have a 22% national readmission rate, nearly $10,000 per admission about six day length of stay. And that's where really all the costs and challenges are and so what we want to do is be able to identify those early warning signs and treat patients earlier. This technology has been used by over 236 patients and six clinical trials. We are now active in four different countries, which we're very excited about as well. And people often ask us well, will patients wear something like this? A device that's worn on the chest for a period of time and well, what we know in the space is cardiac monitoring. This is already true, but we want had to prove it for ourselves. And we've had over 96% compliance to use over a 30 day period, we've only had one patient drop out. And that was really not based on the device itself at all. And what we've seen again, I want to get into that data, which is just so exciting for us. This was just peer reviewed. And it's going to be presented at the American Thoracic Society in more detail. But here's just a little bit of a glimpse of it. Going what are we doing, right? What What exactly is this technology, it's listening to breath sounds, we're using an algorithm to detect abnormalities much like a Holter monitor for for the lungs, as it's often described. And here's a patient from one of our studies, again, proving that we can not only measure an increase in coughing rate and wheezing rate. But how that interplays with that patient's care, you can see that the patient was actually discharged with a an increase from their baseline and wheezing and coughing, and that patient readmitted, and we saw three patients like that in a study of 15 patients. And then what we saw was well, readmission, they weren't treated. And ultimately, you can see they're discharged, they had way less long silence, they were treated properly got get on the right medication regimen, that patient continued to be stable for the next 90 days. And so what we've been able to prove is that we do have the early signal versus existing standard of care. And we're in the process of expanding this trial. This was done at Thomas Jefferson University Hospital in Philadelphia with this 15 patients I described, we're going to now do a outcome study interventional Lee to prove that we can do this beyond standard of care reducing readmissions by over 30%. And that study will be about 380 patients. And we expect to start doing that study in the next couple of months after we raise our Series A. So those of you who might be interested in funding and financing something like this, we'd love to have you join us patient experience I get I think it's just so crucial as a patient myself to make sure that this is something that's really real world friendly, and they're going to really use. And so we've had as again, over 250 users at this point on this device, great compliance rate. And really interesting insights, what we found is when we ask patients to report their symptoms, 30% of those patients don't actually report coughing or wheezing at all. And we see that they are in fact coughing and wheezing objectively. And so a lot of benefits to having this objective data, even beyond post acute management. So this is a platform solution, I think has really, really great legs. But again, I want to just focus on that target market, first 3 million patients who are hospitalized with acute exacerbation of COPD in the US, usually 100 $80 million revenue opportunity market. And then from there, we can establish this for beyond post acute management into chronic disease management for those with COPD. And that's a nearly $1.5 billion market opportunity. And so here's just a glimpse of what that study is that we want to start running. And again, this is a really an extension of the observational study that we conducted and said, Hey, we know that we've got the signal. Let's go after it. And let's try to drive down outcomes for patients. And so we want to start enrolling that study as soon as possible. sites are already lined up and ready to do it. And the beauty is they've already been trained on how this technology works, because they've already used it. So very excited about that application. And there are several other applications that we've been in as well, including pharmaceutical research. And that's continuing to help us establish the science of this technology we work with large pharmaceutical companies are gathering objective data for them in pulmonary diseases like IPF chronic refractory cough, and COPD, which again, helps them objectively assess what's happening and make sure that treatments are working for their patients. So multi modality for this solution. And so we're really excited about what we've done here. And so why invest and why now, I talked about that series, a financing, we've already raised $10 million for this business between pre seed and seed funding. We've established the science we've gotten regulatory clearance, the product is already in the pharmaceutical market and multiple countries got a great team of experienced investors here at Strados. And we're ready for the next big inflection point for our company to ultimately make every breath count. So I look forward to talking to all of you who are interested, you can find me on the app or I'll hang over here for a little bit too. So thank you all for your time.

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