Robin Shandas Presents EnteroTrack at LSI USA '23

Transcription

Robin Shandas  0:05  

Thank you all, gut health is human health. We all know this. We also know that gut health can change. It can change as a function of who we are, what we do, and where we live. But gut health is, in fact really hard to evaluate, especially if you want to do it easily, routinely, and quantitatively. That's where we come in. So the NRO tracker, it's our device that allows simple quantitative direct sampling of the upper GI system, it's a small capsule, with a proprietary string wound inside, it allows minimally invasive location specific sampling throughout the upper GI system. The samples are protected from contamination, it can be used in the office, it can be used at home, and the samples are sent to a reference lab for analysis of disease markers. We have a variety of sizes of this device ranging from that large device that you see it's about the size of a Mike and Ikes to a smaller device that's a little bit larger than a tic tac. The procedure for administering the sample and collecting it's very simple. You secure the proximal end of the string to your finger, swallow the device, relax for a bit, retrieve it and send the sample out for collection. For reference lab analysis. The device collects protected localized samples from the esophagus all the way through the small intestine. We have data from human subjects that tracks the location of the string as it moves through the GI system. Will we show that it collects samples, as I say it from the esophagus within the stomach, and that sample or the bottom there is actually bio collection from the small intestine. The device also collects biomarkers of Gi health, we have data that shows it collects DNA, RNA, proteins, metabolites, and bacteria. In this, the device offers opportunities to comprehensively profile the GI phenotype, the metabolic phenotype. In fact, I've been following my microbiome using this device over the last few months. That's some data from my microbiome. I noticed one day that I had the device in me, I drank a cup of coffee, it wiped out myself and your microbiome. Fortunately, it came back a couple of days later. And so I still drink coffee. Our company what we're going to do, we're going to systematically build business opportunities in each relevant gi health area. And this This is this is a pretty large range of areas ranging from inflammatory conditions, such as eosinophilic, esophagitis, to get cancer to gastritis, nutrition, food allergy, and so forth. We'll do this by combining the simplicity of the sample collection. With lab developed tests to monitor different diseases. We can do it by collaborating with physicians and clinics, we can send the device there, we can also send the device to to the patient's home and have them collect the sample at home and send it for reference lab analysis. Our market entry point is the $1.5 billion eosinophilic esophagitis monitoring market. eo is an allergy type disease, it has no care. It impacts about half a million people in the United States. We need frequent monitoring of the esophagus to control the disease. And even though endoscopic biopsy is used to diagnose the disease. Because of its complexity, cost and other issues, it cannot be used for routine monitoring. This is where our strength test comes in. simple procedure you administer, you retrieve the sample, you ship it to a reference lab. And a couple of days later you get a report quantifying disease activity in that particular patient. We've completed validation studies on the device. We validated against biopsy and a multicenter five center phase two clinical trial 344 adults and children compared to biopsy on every single patient. The results from this have been published and continue to be published. But I want to point to one graph, which is the bar graph here that shows the area under the curve for our test versus biopsy, showing that we have this similar sensitivity and specificity to biopsy. We have excellent reimbursement for the assay. We have a PLA code, and we've we've generated CMS reimbursement of $772 for the test. We launched the test in November of 2022. And it's starting to be picked up in major EOB centers around the country. clinical utility studies are now underway. And the primary utility of this device is to do post diagnostic monitoring of this boutique disease that that changes from patient to patient So this is data that was presented at the last year's quad AI meeting that shows that our test monitors and follows inflammation in the esophagus throughout treatment. And I want to make two points. One is that it is as good as biopsy in following that treatment. And the second one is that it can be used in children and adults. private payers are beginning to pay for the test. We're working on a CPT cat one procedure code for the procedure itself. And what's interesting is that it's also changing some of the adoption dynamics allergists are beginning to adopt this. This test, we anticipate about $300,000 in revenue in 2023. And this is revenue with us doing absolutely no marketing. This is all word of mouth type of type of revenue. We have the usual cast of characters, outstanding team, I won't go into them, but they're very good. I'm happy to talk about any of them in great detail. So we have a substantial patent protected pipeline that provides multiple, multiple multiple shots on goal. So our first product is EOE in the US market. We've We've launched the product, we have revenue, and we're starting to say to scale, we have a research revenue stream as well, where we sell our device to pharmaceutical companies and CROs that use the device in place of endoscopic biopsy to save money on aadmi trials, and PK PK PD study. So we have revenue there as well. And again, this revenue is purely word of mouth revenue. So far, we've received a lot of interest from physicians in the EU to have this device just because of the value proposition that that generates. So we're planning a launch in the European Union, we just started a trial to do home based screening for Barrett's esophagus and esophageal cancer. We are, we have an ongoing trial to look at it for microbiome, we have an ongoing trial to look at it in the nutritional metabolome. And we're beginning a trial to look at it for Colegio carcinoma or deadly, biliary disease. Together, these monitoring markets comprise over $21 billion. We have strong IP protection and strategy both granted several pending patents, trade secrets about how to make the device SOPs for the assays and so forth, protected marks in the US and EU, unique materials, reagents, and so forth. And overall, we have a core strategy of using the string unique string based technique for monitoring, diagnosis, evaluation, and ultimately therapy in the GI system. So we're coming emerging from kind of a pseudo stealth mode right now. And we're looking for funding in two tranches about $7.2 million. And what we're looking for as a first tranche, where like I said, we've had not exist in marketing. So what I want to do is build the marketing and sales vertical for EOS in the US and the research trials. Launch the product and EU complete phase one trials in Barrett's esophageal cancer, longitudinal studies from microbiome and nutrition and begin the pilot for the Calandra carcinoma. In the meantime, what I want to do is move the lab test and in house right now we we licensed the test, you'll reference lab, we collect a royalty fee per test, but we want to move the test lab testing in house so we can collect the entire reimbursement revenue, and that's what the second tranche will set us up for. Our performers are pretty straightforward. The numbers in green are sales, we've already done, revenue we've already done. 2027 is when we start making money. So I appreciate your attention. I want to point to the product that meets patient provider and payer needs together. And I'd be happy to talk with you later about the opportunity. Thank you so much.