Peter Vranes Presents Nutromics at LSI USA '23

Transcription

Peter Vranes  0:00  

Good morning, everyone. Now holding my hand a medical wearable that is small, but has the potential to literally save millions of lives. It's comprised of micro needles with DNA based sensors on the tips of those micro needles. And those DNA based centers can monitor any diagnostic target continuously and in real time. Now, this is a platform technology, and we can solve many problems in healthcare. And we're going after the deadliest disease states. They include therapeutic drug monitoring, acute kidney injury, sepsis, and cardiovascular disease. Now, it's a platform, but we're acutely aware that all roads lead through that first indication. So that's where our focus is. Now, at its core, the problem that we're solving is that lab diagnostics today provide only a single data point of where a patient was several hours prior. So let me take you through how lab diagnostics today is the process that you're all going to be familiar with. So a test is ordered, a blood draw is taken, the sample is delivered to the lab, it's processed in the lab, and then the clinician gets a single data point of where their patient was several hours prior. Now, 60% of all clinical decisions are made using lab diagnostics like this. So this is a significant process. And for the most part, lab diagnostics are fine. Because not everything requires continuous monitoring. But there are hundreds of diagnostic targets that do. And they are targets that move rapidly, or patient conditions that change rapidly. So such as in the ICU. And in those situations, coalition's require trend information. So they've got to repeat this process over and over. And we all know in reality, that's simply just doesn't happen. And it cost lives and it costs billions of dollars in hospital inefficiency. So our solution is continuous real time diagnostic monitoring using this patch. And so this patch replaces the blood draw the sample delivery, the analysis in the lab, and the single data point from several hours ago. And so it's what we call a lab on a patch. Because when you think about all of that infrastructure and process that goes into producing that one single data point, we do on this small solid state device, which is quite remarkable, really, when you think about it. Now we put together a bit of an animation to put all this together. So visually, it makes it easy to understand. So we're in the ICU patients wearing a patch. And we're gonna go into the skin into the interstitial fluid, which is where we operate. And they're the micro needles, and on the end is the DNA center. That's what it actually looks like, very specific towards target. So you say other targets come along, it doesn't react, the target of interest comes along, and it recognizes that and there's a shape change and a signal change, it releases it, which is what allows it to be continuous, the signal gain goes up through that micro needle. And each micro needle is a different sensor, we can do multiplexing, that's an industry first, the signal then goes through Bluetooth gateway, out into the lab information system, and then into pre existing screens. So this is the visual way of putting all this together. And that's what we're developing. Now, this device is the world's first precision diagnostic platform. It's the world's first because it's a platform, it's real time, and it provides trend data. Now IBD, which dominates the industry is a $70 billion mainstay of our industry. That's revenue. And it is that because it's a platform technology can do many, many things. And it's accurate, but for the reasons that I just mentioned, it's not real time, and it doesn't provide trend data. Now see, GMs have come along and they resolve two of those three problems. They are real time and they do provide trend data. However, that's not a platform technology. I'm gonna explain that in a bit more detail in a sec. But that's carved out those three major players have carved out $116 billion enterprise value industry. Having resolved those two major issues. We resolve all three. And so we are the evolution of CGM. There's two reasons were the evolution of CGM. So this timeline tells a story. In the last 40 years, there's only ever been six enzymatic sensors. Now that's the technology that CGM is based on six enzymatic sensors that have been developed and trained to work in vivo that's in the last 40 years. Now compare that to DNA based sensors. In the last five years, we've developed more than a dozen and shown them to work in vivo Oh, that's the powerful platform. And secondly, those six informatics sensors are all metabolites. So that's the only class that that technology can do. Whereas we can do metabolites. We can do drugs, we can do proteins, we can do hormones, we can go into Blue Ocean Territory when no other technology can compete. Now, I don't want you to think this is all aspirational. We have 13 peer reviewed journal articles showing that this technology works in vivo. So if you can monitor any diagnostic target continuously, and in real time, what are the problems that we're going to solve in healthcare? Well, we're starting with therapeutic drug monitoring of the antibiotic vancomycin, there's a really good reason for that. This is commonly dosed one in six ICU patients received this drug in the US. But it has a very narrow therapeutic window, and high toxicity. And coalition's get very little data to dose this drug. The outcome is that up to 43% of patients receiving vancomycin induced acute kidney injury, with a mortality up to 33%. And half of all patients that get this drug, are dosed in the ineffective region, which means that the bacterial infection is not being treated. That's how problematic it is, there is a pull from the market to solve this problem. And we can do that with a vancomycin sensor on this patch. So instead of three data points over 36 hours, clinicians will receive 1000s of data points. So their ability to get a patient in that therapeutic zone, and keep them outside the toxic zone is greatly enhanced, that will save 1000s of lives. We do a lot of work with collaborations with hospitals, about 35 hospitals around the world that we work with. And we're very, very focused on looking at product market fit. We recently engaged Alira to do some independent work on product market fit. There's a lot of work around this, but essentially, of the clinicians involved in the dosing of the drug four and five indicated they would use the patch every time they of course and vancomycin was prescribed. So that goes to early adoption, high adoption and recurring usage, which is what we're after for the first product. Now, beyond therapeutic drug monitoring, we're gonna get further down that vertical. Remember, we can do multiplexing on the one device, we can add more needles, microneedles and more sensors, then we're going to move to acute kidney injury. That's one of the top 10 killers in hospital, then we're going to add sensors for sepsis, and then cardiovascular disease. So where are we are in terms of our roadmap? Accuracy, we have accuracy to plus or minus 10% of the true value that's well within clinical acceptance criteria. Specificity, this is one of the strengths of DNA based sensors, you can see the data there is very, very strong sensitivity, it's how low we can measure the concentration down to pick them all up. And longevity for seven days, I should mention the first indication is 24 hours in the ICU. So well beyond that. Our patch, we secured this technology in 2020. And since then, we've really rapidly advanced so we've gone from a DNA sensor on a wire to a fully integrated working prototype that's now in clinical trials. And this device that I'm showing you here, which is our commercialization device, we have manufacturing, with developing plans for manufacturing capability to scale up to 100 million devices per annum. And we have an r&d facility in Melbourne and in San Diego. In terms of regulatory, we've applied for breakthrough designation. We meet all the criteria. So we're confident we will achieve that pivotal trials and 26 and either 510 K or de novo in 27. funding we've achieved $20 million of funding today led by Dexcom. So they're a close partner of ours. We have clinical trials, as I mentioned ongoing now and off the back of that we will be going to a $50 million Series A round and middle of this year with an IPO later on. You can't revolutionize an industry based on technology alone. You need great people. And we have that so we have a Scientific Advisory Board of the world's leaders in DNA based sensing and a team of 50. And with deep experience in medtech diagnostics and manufacturing means that people die because clinicians lack continuous diagnostic monitoring data to make informed decisions. And our vision as a company why we exist is to create a world with zero preventable deaths due to a lack of continuous diagnostic monitoring. Thank you