Galit Frydman, Coagulo Medical Technologies - Anticoagulants Portable Testing System | LSI USA '24

Galit Frydman  0:04  
I'm here to introduce you to coagula medical technologies. So who are we we are a coagulation diagnostics company that is run by world leaders in coagulation sciences and physiology. And what I want to point out in this is that we are not engineers that developed a solution looking for a problem. But instead, we are a group of physicians and scientists that identified a problem. And then we developed a solution for it. So we needed it, we wanted it and we built it, right. So let's talk about coagulation testing for a second because I know this may be a little foreign to some coagulation testing traditionally, was developed back in the 50s and 70s. Most of the common tests that you may recognize PT, PTT, AC T, and even viscoelastic testing was developed decades ago. But what those tests do is they essentially look at your coagulation pathway, and say, there's a problem here, and they'll red flag the clinician to it. But what it cannot do is say, we're in the code, that problem is, it's not a precision medicine approach. So what we have done is we created a completely new set of coagulation assays for the first time in decades. And we combined it with a new point of care diagnostic test, which I have here, you're all welcome to come and play with it, as well as a single use disposable to be able to use with it. And what we can do is actually pinpoint the exact coagulation factor inactive or active, that is not working appropriately. So either deficiency or inhibited. That enables to us for the first time to enable a rapid decision making precision medicine approach to coagulation testing. Now, in addition to inhibiting the coagulation factor, that's aberrant, we can also quantify the effect of end stage coagulation. So this is not a mass spec or a Chromogenic assay, but it's actually a clot based test, we can customize it and expand it. So we have many clients where we do bespoke custom assay development for them, including preclinical and clinical assets. And we can develop complete screenings for various coagulopathies. Now, just to give you an idea of the current competitive landscape, which are products that are already in the clinic for point of care, you have our device there that's on your left side. And then you have the two current viscoelastic tests, which are the human attics tech success and the stucco, hemo Sonics machine. And you can see they're basically they are point of care, but they're printer size machines, it takes about anywhere from 10 to 45 minutes to get results. And again, they don't actually give you the precise information that you need. In terms of the competition landscape for currently in development, most of these diagnostics are still performing the same old test. So you're going to have Yes, new technology and new sensors, they're smaller, they may be faster, potentially more accurate, but they're not giving new information to the clinician. And that's what we need right now, to move the needle in coagulation testing, we need to enable the doctors and enable pharmaceutical companies to have more specific information. Now our diagnostic adds value to both the patient, the provider, the payers and the pharma. And you can use this system in the entire developmental process of new pharmaceutical agents as well. So all the way from a preclinical testing were very small volume 50 to 100 microliters depending on the panel so you can do preclinical testing on it and in vitro diagnostics all the way through clinical and post clinical. Now the platform can be expanded across multiple indications, anticoagulation therapy and neonatal pediatric care haemophilia or other genetic anomalies and also lupus and autoimmunity. And also just anything inflammation based, right that will all affect your coagulation status. Our primary clinical focuses at this time are anticoagulation management specifically in complex patients. And I'll go into that a little bit. And then we also are starting to work on hemorrhage management is for things like trauma induced coagulopathy. postpartum hemorrhage is post operative, and also things like burn and radiation induced injury. In terms of our initial clinical application, looking at anticoagulation management is a giant total opportunity in the US and globally. So right now just looking at what's available PT INR, PTT, AC T and central COAG tests, it's already over a 5 billion a year market in the US alone. Now what we're focused on is complex calculation management. What does that mean? That means you're really complex six sick patients in the hospital, where they made in there for a number of reasons, they're very sick, they have a lot of inflammation and they're going through either surgeries or other complex treatments. Now, up to 30% of these critically ill patients will develop anticoagulation resistance, usually some kind of heparin resistance. And there's no way to currently rapidly diagnose this. Right now, what happens is the clinicians essentially anticoagulated their patients, and then they say, Oh, wow, this patient had a thrombotic event like a PE or a stroke, or they're clotting off their ECMO line. And then they order all their specialized tests to the central lab and say, We need to change anticoagulants. So we actually have multiple studies now, where we've published that we can not only specifically and very sensitively identify heparin resistance, but the detection of heparin resistance actually correlated with the patients that developed a major thrombotic event. Now, these studies were specifically in pediatric medicine. So we have multiple studies in pediatric ECMO and LVAD. Now this patient population, specifically, up to 50% of all the patients in the NICU are currently anticoagulated. blood volume is a huge issue, but also the availability of central lab testing for these patients. It just takes a very long time and is cumbersome to run. So this would be the first point of care tests available for anticoagulation resistance. Like I said, we have many publications and abstracts our current cartridge covers all two A and 10 A inhibitors. So that includes all the currently available injectable inhibitors, so heparin and low molecular weight on a pair new Argo Trubend bivalirudin, and also covers all the oral anticoagulants, not only can we tell if there's two a or 10 A inhibition, but we can differentiate them as well. And we have studies with that. So this exact same cartridge that you can use for heparin monitoring, you can also use it for by Val and argatroban monitoring in the same patient as well. We've been supported with many grants, including the DOD and the NSF, with very strong group, and very strong leadership, including directors that have been formerly the CEO of Roche diagnostics, ortho clinical Quan Terex, our CTO, Franklin dukkha, he was the CSO of Korea and ITC, and it was also a buyer diagnostics. And Dr. Berger, our CMO was formerly the CMO of exact sciences. So we have a very, very strong team of people that are very creative in the regulatory route, very strong and have many decades of experience in the diagnostic space. In terms of our milestones, so we spun out of MIT MGH in 2018, based on IP and assays that I created during my postdoc time. And since then, we've essentially completed our alpha beta. And now our final verification and validation unit, which we're completing. So we are ready to start our first FDA pivotal trial sometime this summer or early fall, and what we intend to do is do an initial pivotal trial and then do multiple FDA trials for add on indications for this first cartridge. So with the opportunity round is where we have historically raised a Series A so we have raised 11 million of dilutive and 4 million of undiluted capital, and we're currently raising a 20 million Series B to work to support our FDA trials, being able to transfer to manufacturing and expand our r&d facilities. And we will also plan to continue our work with DOD and multiple pharmaceutical partners which we have been working with for many years now. And with that, I believe I ended 30 seconds short so that you can all go to lunch.