CoLabs Medical | Clay Nolan, CEO

Clay Nolan  0:00  

Hey, everyone, I'm Clay Nolan, founder and CEO of coLabs. Medical. I'm also a paramedic. And so it's no surprise, as a paramedic, I had frequent contact with cardiac arrest, right? There's over 500,000 cardiac arrest events each year in the US alone. What is sad and surprising is that only one out of 10 of those patients will actually walk out of the hospital neurologically intact. And so they've done a lot of research around kind of the components of how to increase the survival, and you have three components. One is circulation. You need to restore some sort of blood flow. During that time, we use CPR or chest compressions, right. The other component is making sure that blood flow has oxygen in it, and we've removed carbon dioxide, airway and ventilation. The third component is definitive care, right, you need to reverse the cause of cardiac arrest. And that's either defibrillation that's taking the patient to the cath lab, or that can be a simple you know, airway obstruction. And what they found in the research is one of those three, don't play nicely with the others. And that's airway and ventilation. And what they found out is that airway management in the emergency setting is fraught with complications, and it's distracting. The most highly trained medical professional on scene, a paramedic out of hospital, or an ER physician in hospital is responsible for establishing an airway. And even if you're good at it, you're distracted on what you're supposed to be doing best. And that's thinking and reversing the cause of cardiac arrest, so they can get some consumed with airway. Even when they do it right. Then they have to now ventilate the patient. And what they found out is that ventilations decreased blood flow during CPR, that decreases venous return, because you have this big positive pressure in your chest. And so the solution that the American Heart Association has offered is that we're going to de-emphasize airway management and ventilation or not do it at all. Right, we have chest compressions CPR, as a problem solver, not doing something as important as airway and ventilation seemed like there was need for improvement. So we came up with the Ventor. And what the Ventor is, it's a smart airway, that that can work both in the esophagus and the trachea. And it's a ventilation technique during CPR that actually enhances blood flow.

So what is a smart airway? It's like a step down from artificial intelligence, right? So it's an airway that has no wrong location, it can go in the esophagus, and it can ventilate the lungs, and it knows it's in the esophagus, it can go into the trachea, isolate the lungs and ventilate

the lungs as well. This is all automatic user, whether it be a doctor or nurse and EMT or maybe even a bystandard can place this airway and it manages itself throughout the duration of care.

Ventilation. So how do you you know if ventilations were reducing venous return? Simple solution, don't ventilate when the venous is where the venous blood is returning. So that's on the recoil the chest. So the idea was, let's ventilate when you're compressing the chest. And what would that do? It would enhance the chest compression force all the blood out of the out of the thoracic cavity, you stop the ventilation when the chest is recoiling, and blood can return unimpeded. It's no surprise that we increase blood flow to the brain in the heart. What is surprising is using the synchronized ventilations with chest compressions, that were able to increase the oxygenation and arterial blood stream. And that's because we recruit more alveoli kind of like a BiPAP machine. And then we also balance co2. A really another important fact is that we removed human variability in both airway management and ventilation. Right now, this is a synchronized system no matter what rate you're doing chest compressions, it automatically does it for you. And so the care providers are freed up to do other life saving procedures. But also, they don't screw it up.

So I've talked a bit about what our technology does for the patient, increasing blood flow and minimizing airway interruptions. But you have to make three people happy, right? This is like the kiss of death for a lot of companies. How do you have a device that not only improves patient outcomes that the users like to use, but also is in a cost productive package, and I feel like we've hit all three of these. Superior care in a simpler device, those two together is unheard of. And that's what the mentor does. And then again, we've kept that a price point both on the disposable airway and the reasonable ventilator that competes with current resident resuscitation products.

The market so who are we selling to initial markets pretty obvious. beachhead market is your pre hospital care provider. So EMS you have ambulances fire apparatus, military, right, this would be responded cardiac arrest highly trained medical professionals. Same thing in hospital you put these on every crash cart. So now when someone codes in a room, a nurse complacent airway, a doctor can arrive and start solving problems. From there you evolve similar from defibrillation to the AED. Your secondary markets would be outpatient surgery centers nurse

in homes, dental offices, right where you have medical professionals, less written contact with cardiac arrest, but still able to place our airway. And the ultimate vision is to have this co located with the AED. I'm sorry the AED.

There's no reason I mean, my five year old daughter can place this airway, there's no reason anyone in this room couldn't place it. It's that easy to use. Not only that, we have some patented technology that we actually work with the AED by placing when the defibrilation pads on our tube, and we can reduce the amount of energy it takes to cardiovert a heart. So there's some beautiful synergy moving forward between us and the AED market.

So how do we get there? How do we get to our beachhead market, and halfway first thing you need is money. We just closed our series B with strategic leading the round, that gets us all the way through our regulatory approval, we're a de novo 510 K. With clinical data, we have about three months left of device design, we begin our non clinical validation testing, we have a phenomenal animal model, because resuscitation is really hard to study out of hospital, we rely heavily on animal model. We complete all of that, and this year, and then we begin our clinical trial at the beginning of next year.

One important thing to see on this slide is where we see our superiority results. So we have about a year and a half long clinical trial. But within 10 patients, we actually see our devices superior. So my hope is next year when I'm at this conference will start getting those first patients in and I'll be able to talk to you about our next round as we're seeing the results come in on how much better we perform compared to the current standard of care in hospital or excuse me out of hospital in the clinical setting.

I have to talk about our clinical study design, because I love it. So traditionally, cardiac arrest studies are huge. Thousands of patients looking at outcomes such as neurologic survival, or survival in neurological outcomes through six months. For a small company for large company, this is an impossible feat both from a time and cost standpoint. So we worked with the experts in resuscitation and our timing was perfect, they're starting to do a new therapy in the hospital where they circulate the blood and ventilate the patient's blood on ECMO. And what's so exciting about this is an order increases their chances of survival by 10x. But you have to get the patients to the hospital in a viable state. So all these patients that are in cardiac arrest are getting funneled into a single hospital. And the last inclusion criteria for this current ECMO therapy is they look at their arterial blood gas. And if they have good arterial blood gases, which is which shows how well CPR was performed out of the hospital, they get put on ECMO and their chances of surviving or 10x. If they don't. They're pronounced dead on scene. Our product greatly increases arterial oxygenation in the pre hospital setting, because that that's reflective of ventilation and circulation. And so now we can show our chain and survival that, hey, within 25 patients, we had more enrollment in ECMO, which ultimately that patient survived. And we don't have to do a large study, the FDA agrees with the study design, the market understands the study design is "hey, how difficult it is to study cardiac arrest. And this will really show what your product is responsible". And then we can go out and do post market surveillance with these thousands of patients and see the real effect of that Ventor, you know, with sales.

As I mentioned before, we just closed our series B. I think we're fully committed on that round. But we're always looking for the conversations on our commercialization round next year. So if you're interested in this space, please come talk to us. We're just interested in technology. I'd love to show you the device. I have a demo. But ultimately,

we're CoLabs an airway and ventilation simplified. And thank you guys for being here. Thank you for your time.