Charles Allan, MY01 - Timely Sensing for Compartment Syndrome | LSI Europe '22

The MY01 device is a sterile, single-use device that quickly measures muscle pressure following orthopedic surgery for trauma.
Speakers
Charles Allan
Charles Allan
CEO, MY01

Transcription

Charles Allan  0:07  

So hi. So I've got an engineering background on kind of talk a little bit about where we come from. We're a physician founded company. And our goal is to help physicians make the right decision under pressure. We're doing that by providing objective data at the right time at the right place to help save limbs and lives. We're focused right now on a trauma related issue. And it's called compartment syndrome, and basically happens when you have a high energy event where swelling will start to build up within the muscles. The problem right now is that that's really diagnosed today using pain. So very subjective data point, usually pretty late, when it comes in, and you're able to actually know definitively what to do. And to give you an idea compartment syndrome, you really have only have a two hour window between whether when the patient's actually feeling it, and you need to react and losing full paralysis of that. So the nerves dying and not being able to walk out of the hospital. So what you want to do is be able to catch the problem as quickly as possible and provide a therapy, which is called the fasciotomy create an opening and reducing the pressure within the muscle. The problem is that that's a pretty invasive procedure. This is a picture of what it looks like. There is a large open wound quite a simple procedure to do. But obviously, high increases the length of stay cost. And an infection rate within the patient is a permanent permanent therapy. So doing that for no reason is not great. But missing. It's worse. And that's that's when we see a little article on the bottom. That's a patient not too long ago, a 19 year old soccer player that got fixed for his tibia fracture, but they missed the compartment syndrome. He sued the hospital and got $110 million payout. So it's a really big problem when it happens. And you really want to have something that's more objective to make that decision. Luckily, we're here we have an FDA breakthrough technology that's commercial stage, we're the only product is clinically proven to catch this problem early. And we're really excited about it. So we've got an FDA 510K clearance, Health Canada and CE mark, and we're really, we're working on that commercial traction. Our focus is primarily on the US market. It's a patented technology, deployable within seconds, and then it lasts for 24 hours. I know for firsthand how it feels as the surgeon that developed to help develop the technology. That's my leg. So if anyone wants to know what it looks like, what it feels like, I'm happy to talk about that afterwards. We tried to make it really easy to use, technology was developed in McGill University, took us about five years to build that out that MEMS sensing technology. And we've got patents around that to make it really reliable and easy to deploy. So happy to talk more in detail on that side. Because I was part of the founding team. We've taken it from an idea all the way to commercial stage, we're currently completing our pilot, commercial launch. And we're wrapping that up to move on to a full commercial launch in about two weeks time. So it's a very exciting moment. For us as a company, I hear some of the company hospitals that are using our technology today. They're all reordering and reordering at an increasing rate. So really excited about that. We're also really excited that we've been able to combine that with our clinical work. As you know, this could be a very big problem in the military. And they've helped fund a lot of the research that's going behind this technology. We've got 12 level one trauma centers that are currently running studies are across three physician LED. And what we found is that our technology is helping diagnose this problem. We've We've had great results. So over 99% accuracy. In diagnosis, I'm happy to talk in more detail on how we came up with those numbers. But what's also very exciting is that we're able to catch this early. So when I talked about that two hour window, we've been able to increase that that window to five hours, which is clinically significant because that means we're able to catch the problem. Well before there's ever any complications associated to to this disease. That also means we're able to do it at a lower cost. So we've we've done the economic analysis, and we've been able to show that our our technology saves significant cost within the hospital on a per use basis. So we're single use device and so being able to show that when we place the device in and we're able to save money that obviously is very important for the healthcare system. We're also really excited to announce that we've just received full reimbursement in the outpatient setting through the CMS transitional pass through process, effective October 1. So we're excited about how everything is moving towards us having a very strong successful launch into the into the US market. And we're looking forward to partnering up with people that can help us we've clinically validated the market size, both on the clinical side and cost And we're related. And it's a really large opportunity. So over over a billion dollars in opportunity based on our average selling price, and the market that we're seeing is over 500,000 At Risk trauma events in this category. We use a groundswell approach. So we're partnering right now we've done our pilot launch where we were commercial with those groups. And we've been doing an active evaluation program with a series of hospitals across the US. And we've had over 30 of them participating today, we're converting those into commercial partners in our in our launch event. So very healthy pipeline, really excited about where we're going. And we're looking for people that can help us join and make that happen. We've got a very strong team. As I talked about earlier, Dr. Harvey was the the physician who founded this technology, and really had that problem. He's got a large research background, and he's an orthopedic trauma surgeon at the Montreal General. From that point, when we were developing this technology and McGill, we then went and brought on some senior leadership. And one of those that I want to highlight is Nino, he's got 30 years experience. We used to work for Johnson Johnson. And then then he worked in he went into the startup space. And his last three startups we worked on, were all very successful, all exited at a high multiple. His last one was a sell. Once he sold the ones he helped sell that, he then joined our team, and he's been helping with our commercial strategy. So we've got a very good team, very strong, highly motivated, and we're excited about where we're going. The real goal is to help treat, manage and diagnose this problem of it's called compartment syndrome. So anyone who's interested in learning more about that, I'll be in the back and happy to discuss that further. Thanks.

 

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