Peeyush Shrivastava, Genetesis - Detecting Functionally Significant Ischemia | LSI USA '24

Peeyush Shrivastava  0:03  
It's my honor to present my life's work here at the conference. Big I'm legally allowed to say that because we started the company when I was 17. And I'm practically an old man now. So perfect. Great to follow up a presentation on on optical physics, I think we're going to share a different application of optical physics, taking it now to the world of cardiovascular disease. So our company is Genetesis, I'm the co founder and CEO, companies, Cincinnati based medical imaging. We are a 30 person organization. We've been around since 2013. And since 2016, as a venture backed company. And I think best way to start is to really illustrate the paradigm shift that's taken place in this world of cardiovascular medicine. You know, over the last 2025 years, we've really shifted our understanding away from being an anatomy focused view of the world in terms of anatomy drives cardiovascular outcomes to a physiology drives cardiovascular outcomes. In other words, simply having a blocked coronary artery doesn't imply good or bad outcomes. It's the physiologic flow, the presence or absence of ischemia, really, that we're after. And yet, despite knowing that, we still see that the standard of care has not shifted to evolve with this very, very profound academic understanding that we all now share as being the universal truth. And the consequences of that have never been clearer and the standard of care when we look at our standard of care today, we look at how the guidelines have changed in the last few years. We see that CT and CT angiography is at the front of the guidelines and for good reason. It's got excellent sensitivity and specificity to identify obstructed coronary arteries that could result in a heart attack or even death. But when you look at a paradigm, our current standard of care that focuses on anatomy and anatomy only, we see a massive Fallout and that Fallout disproportionately affects women, too. When we look at the standard of care that focuses on obstructive CAD, we look at patients who are told they don't have cardiovascular disease simply because they don't have obstructive coronary artery disease. And that is absolutely not the case. If you turn your attention to the right hand side of the slide, we look at now this new patient of population ischemia in the absence of coronary artery disease, or I know, ischemia with non obstructive coronary arteries. 50% of those patients end up seeing three or more cardiologists, they end up in the ER, they end up being told it's all in your head, they end up on anti-psychotic treatments, and not the cardiovascular diagnosis and treatment that they need. These patients have a four fold increase in major adverse cardiac events and a five fold increase in mortality within five years. This is not a benign condition, they have cardiovascular disease, and our current standard of care erroneously concludes that they do not. So the mission of our company and what we have attended to accomplish is to deliver a functional test that marries the ease of use and simplicity of an ECG. But with the spatial resolution, the efficacy that we have come to expect with nuclear medicine, like a PET scanner. And what that promises to deliver is a new paradigm where if you have chest pain, whether you're in the ER or you're going to your cardiologist, or even primary care physician, whether you have had a CT, whether you have persistent angina, acute chest pain, the idea is that a 92nd test and a five minute end to end process will be able to definitively tell us whether your chest pain is cardiovascular, non-cardiovascular and even what type of cardiovascular disease we're looking at. Is this epicardial disease a major obstruction in the coronary artery? Or is it microvascular dysfunction, which we know to disproportionately affect women, the very women who we have ignored in our current standard of care. And so I'm excited to introduce you to cardio flux. Cardio flux is our lead product, say 510 K cleared with reimbursement establish a 92nd imaging solution to diagnose the entire spectrum of ischemic heart disease with or without obstruction. So this is a 92nd test that does not involve any radiation contrast. It's actually performed at rest. That's performed by an EKG tech, not a radiology tech and it can be done as I mentioned in minutes and and plug and play. It's a 110 volt plug. So even though it looks like a MRI scanner really is quite seamless in terms of the workflow integration. As I started, you know, the idea of this test when we first started the company was to marry the ease of use and simplicity of something as simple as the ECG, but to have it rivaled the spatial efficacy and resolution of things like cardiac pet, we've delivered on that Promise and we've now published our findings with our leading collaborators. Our installed base at these fantastic institutions has helped us not only validate the use of our test in obstructive coronary disease in patients with acute and chronic chest pain, but also the pioneering application of being able to detect coronary microvascular dysfunction, ie the very physiologic processes that occur disproportionately in women and lead disproportionately to women being erroneously concluded as having non cardiac origin chest pain. So our Magneto trial here on the right hand side was a landmark trial for 100 patients just published in the American Heart Journal, showcasing the ability of our cardio flex McG test in 90 seconds to rival the capabilities of stress testing, to turn a 1314 24 hour long IDI length of stay into a sub eight hour, much closer to three or four hour length of stay, fraction of the cost fraction of the time spent no radiation exposure. On the other extreme, the idea of the micro trial, this is a landmark trial that's pending peer review now as well. This is the first study of its kind to showcase that cardio flux, our technology can not only identify ischemia in the epicardial disease population, but in patients with microvascular disease. And I want to emphasize these are patients who have clear anatomy, their CT scans are fine, they're being told it's noncardiac. And we pick up disease on a massive number of these patients is treatable. And so what this means in terms of how research leads to commercialization as we are intending to commercially launch this technology, at the beginning of 2025, our target customers women's heart centers, programs that are specially focused on being able to diagnose, treat and monitor these women who have been underserved under diagnosed under treated in our standard of care. This is a population that's very motivated and does not have diagnostic solutions today to be able to diagnose and treat women with chest pain, shortness of breath, fatigue, jaw pain, who have cardiovascular disease, and we just don't do anything about it. Long term as we launch and expand our use case in the IDI our use case and stable chest pain, stable angina, pre calf, all very very important segments and indication expansions that we are pipeline for the very near term future and 2025 and 2026. There's a team behind it, we've got a group of superstars. I've been working with most of these people for at least five years. My co founders are still with me, middle school best friends and we don't hate each other yet. So that's a good sign. Robert tackler chief medical officer executed our first pilots joined us full time about two and a half years ago was the former chair of the largest er and state of Michigan ascension system on mass and waste is a medical imaging director with us heads up cardiology at Mount Carmel, in Columbus and as a expert in all things cardiac imaging. In terms of the market opportunity, as I mentioned, our early adopter market is focused predominantly on women's heart centers where we see the most value in the short term to be able to drive revenue, drive new revenue value added service for patients that we are currently under diagnosing and under treating, and then we'll launch and expand from there and to emergency room care, as well as pre Cath imaging as well. I just highlight slide to close out in terms of where we are as a company. We've raised 42 million since 2016, the last of which was a Series C. I'm in the pleasured position to not be actively raising right now. Let's hope it continues to remain that way. But it's a great team 30 employees. We are ISO 1345 certified FDA cleared, we've established for reimbursement. And I'm here to tell you that there's a real gender gap in cardiovascular disease and we want to be the women's heart disease company. And we're hoping to keep you posted on our developments. And there's any strategic interest in working with us on commercializing this product please do reach out. Thank you