Barry Allen Presents Sonic Incytes at LSI Europe '23

Transcription

Barry Allen  0:05  
Thanks very much, and thanks for staying till the end of the day. I'm here to talk to you about our AI guided ultrasound for fatty liver disease. So fatty liver disease is a metabolic disorder. About 70% of type two diabetics have it, its tied to obesity, and it's truly a global epidemic. There's no question that untreated as the disease progresses from healthy liver to NAFL, which is non alcoholic fatty liver, to NAS, non alcoholic steatohepatitis through to cirrhosis and cancer, that there's a need for a better diagnosis. Fully 69% of patients who show up in the ER and are with cirrhosis, don't know they have the condition. And we're very excited to be here. And this is an exciting time for the disease. In fact, in that we finally have a therapeutic. So this has gone from a lifestyle management to a disease that we can treat. And we know from past experiences, diseases go from being a specialist market into primary care, we need better tools, we need better treatments, we need guidance. The American Association of study liver diseases just released its guidance for how you diagnose Nash and apple. And specifically what they call for is a fib for blood test followed up by liver ultrasound, which is what we do. In fact, what we measure is the elasticity of the liver, which correlates to fibrosis and attenuation, which correlates to fat. Madrigal, as I said, there are drugs coming in madrigal recently filed and had their NDA accepted for a drug that's designed to reduce fat and fibrosis. And there's 26 companies with drugs in the pipeline right now. So we're very excited. And we think this is the time for better tools. Tools today, our range of historically that was always pathology, which required a biopsy, which is invasive, and of course, nobody likes biopsies. The gold standard or emerging is the gold standard is MRI. So MRI can measure fat through something called MRI PDFF. And MRI can measure elasticity is something called MRE. They're hospital based are expensive. The only point of care solution right now until we came along is fiber scan, a device that has limited accuracy and poor economics. It is a very expensive device with low reimbursement. Our solution, we believe addresses all of those, we have a 510K cleared device with a very strong correlation MRI, we can actually correlate and provide readings that that correlate to MRI and MRE, we've taken some of the best of Emory, which I'll show you, we developed an AI guided tool to increase ease of use workflow and adoption rates. And one of the key things of our device is that it's a lower cost piece of capital. In fact, for about one half to 1/3 of the price of our competitor fiber scan, and we have reimbursement of almost 4x in the US. The device is three parts. So one of the patient lies on this shear wave generator that creates a steady state multifrequency waves coil going up through the body that are able to be collected by the ultrasound probe a traditional abdominal probe, the scanner places the probe in the ribs space, and goes through a controlled motion where they're collecting a large volume of data, dozens of 2d images that are then built into a 3d image. And then real time assessment. As a result, we get 30 times volume of assessment twice as deep penetration. This disease is not only in high BMI patients, but historically, we have to deal with higher BMI patients. And I'm talking 45 50 and above, which is a very heavy patient with a large fat cap. So we're very happy with the results. This is what we built. This is our AI tool. We're very excited about this. What I know from past experience is launching new technology is all about ease of use, workflow and accuracy. And this device this software is specifically designed to do that. On the left side here we have our display with the traditional B mode ultrasound. If you're a sonographer, it's actually quite easy to tell what you're looking at. Our device is designed to be used by any any medical assistant or lower skilled user. In the middle, the vertical bar shows the quality of the waves and number of signals that are being emitted and received by the device. If you have good waves, you have good measurements. And on the right this sort of flashlight looking thing is a software tool that controls the mechanism as the scanner rotates through these 3d motions. But the right is the exciting part where we created a machine learning tool where we analyzed about 30,000 sonography images and trained our device to automatically distinguish and differentiate between tissue so that you can get on the liver. So a less skilled user knows they're looking at the liver and not different organs. In fact, it measures it tells you what organ is looking at. It knows where the waves are and it automatically moves the region Demetris the analysis box goes directly to where the liver is and where the waves are, we believe and we've just launched this literally this week, it will reduce scan time, it will improve accuracy, and it will reduce the learning curve. Here's some some data for you just a subset of some of our data. This data collected in a multicenter clinical trial of 160 patients over a couple of years in the US and Canada through six sites. And what we looked at was the correlation between our technology and MRI PDFF at measuring fat and attenuation. And we showed that we had very good correlation to them, and very good sensitivity specificity. In that same study, we compared our device to fiber scan the incumbent, and showed that we had significantly better sensitivity and specificity for measuring fat at all levels, in particular, the higher BMI patients. The data that same study looked at the correlation between our device and MEE, MR elastography. And we were able to show attenuation numbers with very adequate sensitivity and specificity and basically very similar results to to Fibroscan. The summary of that study was that we showed that we could measure fat better in heavier patients, which is exactly what we need to treat this drug. And what we see is a drug coming out with Metronome in particular, that's looking at a reduction in fat with no worsening of fibrosis. So they will need to screen patients on look at efficacy and monitor them through time. Overall, our summary is that we're significantly lower costs we are the lowest capital costs, the lowest operating cost of all the equipment, we have an office space scan. So the workflow, it's portable, easy to use, good accuracy, good fat numbers. And we have our AI guided tool, as I said designed to improve performance, ease of use and adoption of the CPT code is a real winner here in the US our device because how it works actually has almost 4x the reimbursement to physician that we would see that you would see with an equivalent FibroScan In fact, the physician doing only five patients a day with our device would generate in excess of $100,000 per year of net new revenue. But we're good for the payers were cheaper than MRI and biopsies. The patient's like it because it's non invasive and done in real time in the physician's office. The patients like it because of the workflow they don't lose control the patient, they get the new revenue. And again pharma needs this tool. Founded in 2017, with technology coming out of the University of British Columbia, some 22 patents launched in COVID. I joined in 2022, we doubled our install base. So we now have about 40 installations right now, looking for 60 by the end of the year, three times year over year sales, a small company of roughly 24 People with a strong management team and a great bunch of KOLs I just highlight Steve Harrison, as one of them. He is the PI for Madrigal for their phase three study. And in fact, Madrigal is our second largest shareholder. We are currently raising around in the range of about $15 million to accelerate US sales and launch into key markets. We are in a large growing market that is going to explode. We know that the drugs coming out next year or even if it's a little longer, will will dramatically impact and explode. We know that it's going to move it from a specialist market into a primary care market. We know that we have to do this now the FDA and the payers are looking at how they're going to manage these patients how they're going to work through and we think we've got the superior technology for that. I'm here happy to talk to you afterwards or you can hit me up on the LSI app. Thank you very much for your time.