Randy Moore Presents ViTAA Medical Solutions at LSI USA ‘23

Transcription 

Welcome, and thank you for allowing me to talk about how we're radically transforming the care of patients with aortic disease. I'm vascular surgeon, serial entrepreneur, chief medical officer and co founder of ViTAA Medical Solutions, virtual touch aortic aneurysms. And our story really began many, many years ago, with the death of one of my young patients that I had been following with an aortic aneurysm. Two weeks after I told him he was going to be just fine. But as he was dying on my operating room table, I put my hand on his aorta inside his abdomen, and it was weak and degraded. It occurred to me that if I had been able to virtually assess his aortic wall, I would have made a different decision potentially saved his life. This is Our Story. Abdominal aortic aneurysms represent pathological dilatation of the largest blood vessel in your body, and still account for one of the 10 leading causes of death in the USA Today, there's over 200,000 new patients per year with a huge addressable market that continues to grow primarily because of the aging population. But because of a lack of intelligence around how to select patients, the decision to treat patients with aortic aneurysm is still based on a single diameter measure. And this is data that's over 50 years old. There's a critical need for improved metrics to help us with our decision making. In fact, the International Society for Vascular Surgery, has issued a plea to clinicians and industry to come up with a better metric, a better tool. And it's this flawed reliance on size data that the FDA is referring to. And they talk about the flawed care for aortic aneurysms, that leads to impaired decision making either treating patients too early, or too late, like my patient, that results in huge costs, both in terms of dollars to the healthcare system, but also patient outcomes. And the FDA has told us as clinicians, it's not good enough, you need to do better, you need a tool that provides intelligence for precision care. Vita medical solutions, after 15 years of very hard work has that tool. Our proprietary technology allows us to virtually assess the mechanical properties of the aortic wall, I put my hand inside the patient's abdomen and feel it in my office, not literally, these maps provide the clinician for the first time with aortic wall weakness score scale, the raw score regional aortic weakness maps that can be used by the clinician for decision making about when to intervene, and how to intervene. works. We were very careful when building this platform to insert this seamlessly into the workflow of every aortic clinician. So begins with a CT scan, and standard DICOM images are uploaded by the user on our web app on their browser. That goes up to our cloud. It's HIPAA compliant, we've had multiple security penetration tests and pass them all with flying colors. That's then processed on the cloud. And our proprietary raw biomarkers which include thrombus analysis, peak wall strain, and time average wall shear stress are then provided as a composite index back to the end user, and an user interface that's been again vetted by multiple user acceptability studies. And this is again done on their web app, there is zero footprint in the hospital, no capital expenditure required. This is all done on the cloud. What separates us from any other investigators that have tried this in the past is that we have unprecedented validation based on tissue. For 15 years, every single aortic aneurysm that I repaired, I removed the entire aorta. And based on a sampling grid, We subjected those pieces of the aorta to intense analysis that included mechanical testing, histologic, cellular, and genetic markers. And we were able to demonstrate without a doubt that our raw score analysis, links back to tissue analysis was statistically significant p values, looking at gene markers, tissue destruction, and weakness of the aortic wall. As a result, then we've already published a number of pivotal studies including this one that demonstrated for the first time in the world the ability to actually detect and predict not only where an aortic aneurysm is going to rupture, but the risk of that aortic wall failing. We've used it to measure and determine the strength at the landing zone at the aortic neck, which is now used as a target for all endovascular reconstructions, and post endovascular repair, which represents the primary modality for treatment nowadays, you can actually monitor peak wall strain using our technology and tell the clinician which patients endoleaks need to be intervened on. We actually use this technology for risk stratification in the office. These are images from two American partner centers. These patients have identical aorta is based on their size criteria, but you can see very clearly the patient on the left has a much Higher raw score identified in yellow compared to the one on the right. And despite these patients having the same size they ordered as the one on the left one on two urgent surgery, the one on the right was monitored. You can use this as a daily tool for precision based care. So when we talk to our clinicians, and partnered with us centers, our value proposition can provide care for every step along the care continuum, including diagnosis with complete tissue aortic mapping, planning the therapy, which type of stent or which procedure to use in these patients, optimizing stent placement in the surgery plan, and monitoring these patients longitudinally. In fact, when we discuss this with our KOLs, that represents some of the major aortic clinicians in North America and Europe, every single one of our clinicians at every single symposia has told us, they would use this technology 100% of the time in 100% of their patients. But not only can we map in real time, what's going on with your aorta, but because our entire platform was generated on an AI, proprietary AI platform, we can provide predictive components as well. And so this was data, I presented the New York V symposium. And there was a collective gasp in the audience, because on the left, you see the raw map showing weakness, but on the right, a 12 month glimpse into the future, the predictive map for growth, we know that growth is a marker for rupture risk. So now as a clinician, I can tell the patient where their aorta is now, but also where it's going. Our raw rock scores were point nine for 94% accuracy, we've built up an entire platform called ViTAA Iris, that allows us to take all of that data and roll it into our machine learning algorithms, including some of the most cutting edge deep learning technology to provide the clinician with a risk forward stratification product. We can look into the future. Our IP portfolio is strong, we have 10 patents that continue to grow that cover all of the foundational patient therapy and monitoring algorithms, including some of those deep learning modalities. And our regulatory roadmap was developed in partnership with the FDA we've had a number of very, very tight meetings with the FDA or de novo submission based on the novelty of our product will be completed in the next week or two. With a limited indication for use that includes aortic mapping with a subsequent predicate that will be will be submitted sometime early in the in next year. That will have an expanded indication for us that includes those predictive and clinical outcome elements, with expected pre approval at the end of next year. During that time, we've developed our go to market strategy based on discussion with a number of other players. This is a SaaS model at $1,000 per scan, which has been vetted by our reimbursement team. And we have two commercialization streams, one of which is active with the first peels crossing our desk this week from some of the major aortic centers in North America with another 16 targeted. This Research Use Only program has clinicians and research centers actually paying us to use our technology. While we're waiting for full approval. The post market approval market is massive, with a million scans per year being done in the USA alone. We've partnered with a reimbursement consultant and we've received approval from the Society for Vascular surgery to take forward recommendation at the June submission. Looking for a category three code with movement to category one as the data accumulates post approval. And again Society for Vascular Surgery. CPT coding committee has met with us and fully endorses our activity. This is not an updated because we had a pretty significant injection yesterday, which made us all very happy. But we know that the revenue projections include both the RUO program which again POS are crossing our desk this week, as well as the post market adoption. Even with limited penetration based on the million CT scans that are done a year in the US and the wide adoption by our KOLs. We expect significant revenue with an uptick in 2025 As some of those Pio contracts renew. We have on our cap table currently founders, angels, physicians and university venture fund we've raised a total of $5 million through seed three tranches as part of our seed round, and also have brought in $3 million of non delusional grant money, including the highly prestigious award from the Canadian government for novel AI technology. $2 million in grant, we're asking for 15 million and kicking off our Series A today welcome. And that will allow us to advance the support and processing capacity, we are ready to go. We've got contracts on the go, we need to ramp up to adopt and accept that Ru will capacity while we're waiting for our approval. So to summarize, the unmet need is staggering. We're the only company that can do this that has done this 100% bind with every surgeon. This is precision medicine for aorta care, and we can use this technology in every blood vessel that pulsates. Thank you.