Marc Curial Presents MACH32 at LSI USA '23

Transcription

Marc Curial  0:04  

This is my first LSI. And this is pretty fantastic to be up here. So, Amanda, I'm gonna start off saying thank you, I may not be female, but I'm happy to report that 50% of our team is and they produce far more work product than I ever could. I I'm also gonna butter you up a little bit. I use Sonosite every single day at work because I am an emergency physician. So I'm coming to you as a physician founder here trying to solve a problem, and that problem is bleeding to death. So at Mach32. We are revolutionising pre hospital hemorrhage management. And the simple way of saying that is I want to stop people from bleeding to death before they get to the emergency room, not after, and that's what we're doing with our product. I am safe. You can consider this in Epipen for trauma. Now why do I care about bleeding? Well, personal story in my residency, the very first trauma case I managed independently without my staff looking over my shoulder, young guy crashed the ATV up in a remote northern community. Couple hours extrication from the bush and then another hour ambulance to get to the place where they could land a helicopter. By the time he got to me he had a horrible outcome absolutely awful neurologic injury. And I kept wondering, was there something that we could do to prevent that, and I knew that there was so that's where the idea for REM safe came from. Now massive hemorrhage is a massive problem. 9% of all worldwide deaths are due to trauma. Most people don't realize that more than HIV, tuberculosis and malaria combined, and almost half of those are directly related to bleeding to death. And there's some very important demographics that trauma and hemorrhage disproportionately affects soldiers. Bleeding is the main cause of death of preventable battlefield injuries. And this is a huge area of interest for your Armed Forces worldwide. junctional injuries, torso injuries, non compressible hemorrhage, we have a solution for those accident victims men were stupid, and we hurt ourselves on a regular basis. traumatic injury is the main cause of death for men under the age of 45. In North America, that's over 9 million EMS calls per year. And then women over 200 Women bleed to death every single day after childbirth. And that's unacceptable. To me. This is a simple problem, we should have a solution to it. Well, that solution is I Am Safe. We are a novel high volume intramuscular autoinjector. We take a proven safe standard of care, generic medicine that's traditionally delivered through IV. We're just delivering it faster and easier with a new route of administration. And why does faster and easier matter? Well, in trauma we know time saves lives. This is where the concept of the golden hour comes from. The quicker you treat someone the better they do. And this is more important for the medication to say that we deliver. There's a meta analysis in the Lancet 40,000 bleeding patients, as many as 70% of these patients could have been saved. If they'd got this medication immediately after injury. Why does easier matter? It's not easy, it's not going to get done. less than 5% of eligible patients receive this medication pre hospital because as one EMS medical director told us it's a pain in the ass. This is a pain point that we are actively solving. And I bet you didn't know but 1/3 of EMS in the United States are unable to deliver IV medication based on their scope of work and their level of training. They're only allowed to use autoinjectors. So not only are we saving lives, but pre hospital administration of this drug has been shown to decrease blood transfusions, decrease rates and hospital stays and save money all comers eligible for a blood transfusion or with low blood pressure due to injury. We would save $6,000 per patient in an urban setting and $13,000 in a rural setting. This is third party data looking at our device. Now where are we? We're still in the r&d stage. We have a beta prototype has been hands on tested by our end users, EMS, tactical police officers, military medics and firefighters. We've successfully completed our own internal live tissue testing five mils deep intramuscular less than two seconds, and then a military partner sponsored a large pharmacokinetic trial. Their conclusion with that trial is our device is it least as effective to IV, the current route of administration so non inferior, that's great. Our intellectual property is based around the device itself, but we're actively crafting claims on the drug formulation for IRM as well as the pharmacokinetics. And we have a massive market the market that we're looking at. This is a small proportion of it. This is looking at our first entry only trained medical professionals and it's over $4 billion to the USA alone. So what what am I thinking about with auto injectors that will auto injectors aren't for trained medical professionals auto injectors are for you and me. Auto injectors are to save a life if there's a horrible catastrophe on the side of the road or a mass shooting. This is the civilian market orders of magnitude larger than what I'm showing. Now our go to market approach. We're going to start with People who are actively calling for this, and that's the military, we're going to work into EMS and then civilians. Why do I know the military is actively calling for this? Because I talk to them regularly. I have connections in multiple armed forces who are saying, if you had a TSA auto injector, we would field it, can you please get this developed, but don't take my word for it. My aspiration is to have every deployed soldier, sailor and airman carry a TSA injector, for them to be rolled out across the ambulance service. This is one of our friendly UK Ministry of Defence colonels. It's not just the United States, it's not just Canada, there's many NATO countries looking for this device, and we just need to finish building it. Regulatory, this is a drug device combination, it will be regulated as a drug, the mechanism of action as a drug, it will require a new drug application, which scares a lot of people. But guess what? The largest double blind placebo controlled trial in trauma history has been done on this medication. It's in all of the protocols a TLS T Triple C major EMS protocols. And this is standard of care. And because of that we're pursuing a 505 b two pathway, which is analogous to a 510 K on the device side. And what opportunities does this give us? Well, with a new drug application, there's regulatory exclusivity once we're there. But on top of that, there's exemptions for military use before full FDA approval. And we're looking at three different jurisdictions that we're going to go for our regulatory approval in some significantly easier than the FDA, we're actually being provided with full time equivalent support on a regulatory strategy by an interested military partner to that's how interested they are competition standard of care. Starting an intravenous takes time, hard to do near impossible in the field. Sometimes, our device is quick, easy, effective, with no medical training needed. There's no commercialized platforms that can deliver the dose of medication and the time required, and there's no competitive hemorrhage injector is on the markets, and we're pursuing the quickest path to market so we have a plan to fully commercialize independently, leveraging contract manufacturing and out of house resources. But we're very open to a strategic partnership to there's multiple exit opportunities on our pathway. As a clinician founder, my main goal is to save lives. My secondary goal is to make someone else in this audience money along with myself, so I can retire early. They're probably going to do it again. But Financial Assumptions if we do this on our own, we plan to be cashflow positive in 2026. With first sales in 2025 leadership team you met myself, Kelly motet, she's the reason that we're here today, she has past experience and success in med tech, she's actually commercialized a device that is actively being used by the US armed forces for hemorrhage management. My co founder, Chris is a mechanical engineer, and he brings a lot of project management experience with a major industrial construction to the company. Aside from this, we have five FTEs, we have a great external team that we're leveraging, we're extremely lean, and we've come a long way for a small amount of capital expenditure. And our advisors are fantastic. We have, I just want to point out the very first advisor, this is the author of the largest trial and trauma ever completed, he is offering all of his data sets to our company for our regulatory pathway. So that's huge. Now, what are we doing, like I said, I'm here to raise money because I want to get this device to market I want to save some lives, I want to stop seeing people bleed to death in front of my eyes. This is a price round, we're taking two and a half million dollars for equity in the company. And we're going to move to be ready for first inhuman use with this capital raise. That's not a lot of cash to be ready for first in humans, and then pushing forward to phase ones. So for a small amount of money, like I said, we've been very lean and we've pushed forward to this point with minimal cash expenditure. I have no doubt that we're going to be ready for inhuman use in the next year once we finished raising this capital, so help us revolutionize pre hospital hemorrhage management and stop someone from bleeding to death before they get to the hospital. Thanks