New Airway Device with Clay Nolan (11/12/21)

I'm very excited about today. I want to tell everyone a little story about how all this started. So I'm fortunate that people come up to me and call me and email me with their crazy ideas. And we were at Eagles in Dallas about four or five years ago and this guy named Clay comes up to me says, hey Doc, you mind coming over here? And he takes me over to one of the tables and he's like, I want to show you something. And of course I gave him some tough love and I said, I'm thinking to myself, this guy is, you know, he's got a big vision, but he's crazy because this is a space that many people have tried to innovate in and have not been successful. So we happened to connect a few weeks ago and I got a preview of what you're about to see and I was totally blown away. And obviously we're all data people. And what I think you're going to love here is the science, the physiology, the data, at least the early data. And the reason I have Dr. Scott Yonquist from Salt Lake City Fire is because he is of course, because he's always doing these types of things, collaborating with Clay on this product to get it into the first clinical trial. So Clay Nolan is a mechanical engineer who is just wicked smart and he is going to just change the world. And Clay, I'm going to turn it over to you. We're on record and take it away, my friend.

And you set expectations way too high. Yeah. So quick background. I am an engineer, but I also worked as a paramedic for 10 years when I was studying engineering. And so I have a practical field experience which inspired the Ventur and Collapse Medical.

So, quick background again. I am the CEO of Colabs Medical. We've been around now for about six plus years. We've been supported by Stryker Medical, previously Physio Control, and then the American Heart association as well as Phillips Medical. So we're a well funded company and we have been developing this product for the last several years. I'm going to highlight the kind of the problem that we're solving. I know you guys are all experts in this space, but I just kind of want to hit on a few key points. I'm sorry, if it's redundant, then I'll talk a little bit about our solution, the Ventur, and then our plan moving forward and open it for discussion. So I'm hoping the presentation will take about 15 minutes. Feel free. I'll kind of pause between each section and we can have I can fill in any questions as we go along. So this should be an interactive presentation and don't feel, you know, feel free to interrupt so, you know, quickly going into the problem. And we're looking at emergency airways and ventilation during CPR specifically. And so as we all know, you know, actually what inspired the ventur was the American Heart Association's reprioritization of like the ABCs, right? And we've seen over the last 10 years that there's been. The primary focus has been high quality chest compressions and. And the AHA has been de. Emphasizing airway and breathing. And the reasons behind this, right, is that without good circulation, airway and ventilation are in vain. And then that current ventilation techniques reduce blood flow by impeding venous return, right? So you have positive pressure induced hypotension, and in the low flow blood state of cpr, that can have an impact. And one of the, you know, the biggest reasons is airway management, particularly intubation, distracts from other vital care. So if you look at the research, right, both in hospital and out of hospital, there's been a trend to placing supraglottic airways during the initial cpr, right? So if you look at this study, so let me go back, this is a large. I don't want to. I'm gonna say it's like a 10,000, excuse me, 86,000 patient retrospective study. They look at survival rates at intubation in the ER within 15 minutes. And they're seeing that even in the controlled environment of the er, the, that the distraction of intubation is actually decreasing survival. And so you move over to supraglottic airways, right? And supraglottic airways, excuse me, in the emergency setting or in the EMS setting, have shown an increase in survival even though they themselves aren't perfect. So there's been a trend in EMS that you guys are all aware of, of placing supraglottic airways initially and then focusing on high quality CPR training, transporting the patient to the facility, right? And those supraglottic airways, excuse me, are easy to place. They're not without pitfalls, right? And so one of the concerns is that the balloons, or the positive pressure that current airways use to seal off the oropharyngeal blocks blood flow to the brain, right? So they could be pressing on the cerebral, excuse me, excuse me, carotid vessels, and therefore decreasing cpr, especially venous return from the brain. And then supraglottic airways don't have the best seal. They tend to leak at about 25 centimeters of water. And during CPR, you usually generate ventilation pressures much higher than that. And so you're going to inflate the stomach, which could lead to aspiration, regurgitation. But also the positive pressure in the stomach also reduces blood flow. And then even in the OR setting, supraglottic airways are only placed properly 70% of the time. And that's again in the OR. So in the emergency setting, it's probably a lot higher that supraglottic airways aren't perfectly placed, intending to leak or tending not to actually ventilate the lungs. But this is one of the most interesting things, and this is one of Siegel's studies in Dr. Yiannopoulos Animal Lab and what he's looking at here. And the reason why I'm showing this slide is this is how we do a lot of our animal studies, but it also shows the impact of cerebral blood flow during CPR using supraglottic airways. So I'm sure you guys are familiar with this, but what they're doing is they're looking at coronary, excuse me, cerebral blood flow through a Doppler probe placed over the carotid vessels. And they're doing CPR for a total of 20 minutes. And they're switching back between endotracheal intubation and common supraglottic airways. And what you'll see is each supraglottic airway has a profound impact on blood flow to the brain. And so here you go. You got your endotracheal intubation. They put in the combi tube, and as soon as they inflate the cuff, blood for the brain drops dramatically. Right. So your carotid flow drops to like, you know, 20% here. As soon as they pull it out and replace it with endotracheal tube, you get a return of perfusion. And same thing happens with the lma, though it's not as profound. And the same thing happens with the King tube. And this is important one because we'll show you what our blood flow with our device looks like. But also this animal model is really important. Any questions? Comments? Grabster observations so far. I know I'm moving quickly. Your screen is not very clear. Is there any way of clearing it?

I don't think so.

I'm actually seeing it. Just try to make your screen as wide as possible and click on his name and say fit to screen. That's the recommendation.

That works. All right, so go ahead, Clay, right there.

And I'm happy to Share all these slides afterwards. So I'll send them to Dr. Antevi and he can forward it on if you want to look at the exact details.

Thanks.

Great. Then there's just the problem with current ventilation, right?

Positive pressure ventilation reduces venous return because you have this positive pressure in your chest that's impeding blood return during cpr. And then in the emergency setting specifically, EMS care providers are prone to sporadic or hyperventilation. Hyperventilation blows off too much CO2 and causes cerebral vasoconstriction, therefore decreasing blood flow. So even once you get an airway, the current ventilations could be decreasing blood flow. And it's done sporadically. So that's why the American Heart association has started de emphasizing it. Right. And we all know that the current survival rates of CPR are pretty dismal. They range between 10 and 20% depending on the setting and how the facilities that they're being transport to. But does it have to be that way? And actually Dr. Youngquist shared with me a really interesting article looking at arterial oxygenation during CPR in the hospital. What I like about this is actually shows the importance of ventilation during cpr. So it's not one of these things where we can just neglect ventilation during CPR. It's important to oxygenate these patients and balance their CO2. I realized that oxygenation is based on both. Arterial oxygenation is based both on ventilation and blood flow. Right. So you just can't over ventilate someone and increase their oxygenation because you have to have the blood flow with CPR to go along with it. But this article is still interesting and it ties directly into our data. So what they did is they took about 167 patients who had arterial lines or arterial ABGs taken during the first 15 minutes of CPR in hospital. And they categorized it into five groups based on the levels below 60 and then 60 to 92, 93 to 159, 160 to 300 and then 300 above. And then they looked at survival of these patients. So I'm going to have to zoom in on this real quick. First they looked at ROSC on these patients and sorry, I'm going to go back to that last slide and it shows the number of patients in each group. So in the above 300 you have about 18 patients, 24 patients in the next group down, and then it's in the 40s for the rest. So it's a reasonable number of patients in each group. Then you look at the survival and ROSC of all these patients and what you see here is that the patients with the arterial O2 above 300, 100% of them got ROSC and then 55% of those patients walked out of the hospital.

Within 30 days. And then you can see a dramatic drop as the arterial oxygen decreases. So this goes to show you the importance of obviously both blood flow and oxygenation during CPR on their rates of survival and the return of rosc.

Any questions about the problem or the importance of ventilation and oxygenation during cpr? Before I kind of go into the.

Solution, I'll just make one comment that is great to hear a mechanical engineer talk about CPR and the effects of ventilation on blood flow the right way. So thank you. Continue.

I'm glad I'm not making it up. It's only taking me five years to figure it out. But.

All right, so I'll talk about the Ventur.

And.

The Ventur. It's a multi tier approach to airway management and ventilation during cpr. And it literally is. Our approach has always been human factor or user centric. It's so easy to do that my daughter, when she was five year old, could have effectively place our airway and operate the system without problems with very limited training. And you'll see that in some of the videos I'll show you. We've gone out and showed both ER physicians, paramedics and EMTs, trained them on our device for a couple minutes and let them use it and they're all able to use the product very simply. So even though what I discuss is kind of complex in its physiology and how it's working, the user is, is simplified and I think that's one of the important things.

So this is it, this is the ventor. And what it is, it's an airway and ventilator combination specifically to be used in the emergency setting during cpr. And it's got a disposable blind insertion airway here, which you can kind of see. It's obviously the airway and it's a dual lumen airway without any balloons. And it can actually, and I'll show you in a bit, it can figure out where it is, you blindly insert it, it can go in the esophagus, it can, it can figure out where it is, it can go in the trachea, it can figure out where it is and it ventilates accordingly. So works in the esophagus, works in the trachea, doesn't use any balloons to isolate the lungs from the stomach and then it has a novel ventilation technique for increasing blood flow during cpr, and I'll discuss that now. So the way the airway works is once you place the airway, you turn the ventilator on, and you press start or you put it in the CPR mode. And what it does, as I mentioned, it's a dual lumen airway. So you have one lumen that comes down and ends at the distal end, and then one lumen that ends halfway up the tube facing anteriorly, kind of like what the old combi tube used to be, but doesn't have balloons. And when you turn the device on, it starts applying suction to the distal end. And that's the first thing it does. If it's in the esophagus, the esophagus obviously collapses because it's a soft membrane, and the device detects that it's formed a perfect vacuum. It keeps suction applied around the esophagus, keeping it collapsed, and then begins ventilating out of the lumens that face anteriorly to the opening of the trachea, right at the larynx. And then it constantly monitors that suction seal to make sure the esophagus is sealed. So that happens about 95% of the blind insertions. The other five out of 100 times, it'll end up in the trachea. It does the same thing. It applies suction to the distal end. If it doesn't create a perfect vacuum. So the trachea, being cartilage supported, doesn't collapse? No perfect vacuum is created. It stops suctioning and ventilates directly out of the distal end. We have an algorithm that can detect clogs. So let's say the patient had regurgitated before EMS arrived. EMS placed the airway. It went into the trachea, but it sucked up a bunch of chicken noodle soup beforehand. It can actually determine the difference between the esophagus and a clog. And it can clear the clog out and then continue to ventilate with our algorithm. And then if it's in the trachea, it periodically reapplies vacuum pressure to make sure that it hasn't been repositioned. Let's say the patient's neck got hyper extended while moving. It can tell, so it's always monitoring its position. Any questions about how our airway figures out where it is and how it's operating?

If that's chicken noodle soup, is it suck it out and get it out of the way? Yeah, absolutely. So let me go back to this. So if you look here, we have a suction canister that holds about 550cc's of fluid that's separate from the ventilation lines. So it would suction up all of your contents and collect it in this canister and it has enough to clear an airway out two and a half times. Thank you. How long does it take to determine where it is? Yeah, and so it's initially. Initially figures out where it is in about three seconds. And then it takes a total of seven seconds to get a seal pressure good enough on the esophagus to prevent the ventilations from going into the stomach. So it's about a seven second evaluation period total initially. And then it would. Then it doesn't reevaluate when it's in the esophagus because it's constantly monitoring that pressure and it doesn't do anything unless that that seal's broken. And in the trachea it'll suction for seven seconds on its initial evaluation and then it'll reevaluate for about 1 1/2 seconds after ventilation. And so it doesn't interrupt ventilations when it quickly reevaluates. Does that make sense?

Sorry, Is there a certain amount of that? It puts a limit on as far as the, on the tissue of the esophagus so that there's no necrosis or any kind of damage done to the tissue? Absolutely. So right now what it does is it goes up to about 600 millimeters of mercury, which is a pretty strong vacuum. We've been working with Dr. YoungQuest and Dr. Yiannopoulos and doing histologies on the esophagus. And what we've noticed is that the esophagus doesn't show any signs of trauma. With our tip Design and about 600 millimeters of mercury vacuum, as long as we periodically break that seal. And so about every three to four minutes we'll release the pressure, then reapply it. And we haven't seen any trauma associated with it in the trachea. It obviously limits the pressure to below 200 millimeters of mercury. And if it goes above that at any point, it'll notify the user. So you don't have to worry about like decompressing the lung or anything like that.

If it is, in fact, I guess if the distal tip is in the esophagus and you're therefore ventilating through the proximal holes. If there's secretions in addition in the trachea, there's no way this Thing can additionally suction that out. Is that correct? That is correct. It performs, it has the same performance as a king tube or eye gel at that point where you cannot suction out, you know, supraglottically once it's in the esophagus. So it has the same limitations of a current supraglottic airway when it's in that position. That being said, there is an additional suction mode. So let's say you walked up to a patient and they had regurgitated before you arrived. You can actually put it into a suction mode before you insert the airway and then you can manually control the suction and clear out the airway and then insert this right afterwards. So you could. This would actually perform as your portable suction unit and you don't have to switch between suctioning and intubation or placing the airway.

Clay, I see that there's a mask there. Does that mask have to form a perfect seal for this to work?

No. Great question. So let me get into the ventilation technique real quick. And that will help determine the purpose of the mask. So the mask is there just for orientation. So you know, you can insert the tube so the interior or the interior facing holes are facing the right direction. And then also you can slide the mask to adjust for sizing. And I'll show you a picture of how you use the mask to size it to the patient and then place it properly. So we kind of discussed the airway. That's one of the novelties. The other novelty of our device is its ventilation technique. And what this is kind of how the whole project started. What if you could actually use the positive pressure of a ventilation to enhance the chest and compression instead of impede it? And so the idea was synchronize these small volume rapid ventilations with each chest compression on the downstroke. And so you're literally compressing, as the user or care provider's compressing the chest. We give a ventilation to enhance the chest compression, push the blood out of the thoracic cavity and then when the chest is recoiling, we actually stop the ventilation. The air would get sucked into the alveoli and then venous blood can return unimpeded. And so it's this rapid synchronization of ventilations, all done automatically and hands free. And the pressure would we try to achieve a peak pressure with each patient so it automatically changes the flow to achieve the same peak pressure in every patient. We're ok. Does that actually, can you actually get gas exchange with that and increase blood flow. What we found out is that we can. What's amazing is we actually this ventilation technique increases blood flow to the brain and heart. We greatly increase oxygenation of the blood. I think the idea is that when we're ventilation during the chest compression, it's almost like peep at the right time, increasing alveoli recruitment. But then we're not blowing off too much CO2 because the real gas exchange is happening during the recoil of the chest, and we're not hyperventilating these patients. And again, this is done all automatically. So, Dr. Anteby, to your point, the mask doesn't have to be sealed at this point. It's an open system. It's almost like a jet ventilation that we're using the entrapment of the air with the ventilation to increase blood flow. So during all of our studies, we. And we never have a seal on the mask. It's just there for orientation and to help with sizing.

Does that answer your question?

Yeah. Thank you.

So during cpr, the mask doesn't do anything once they get rosc. So you get return of pulses. Right. This ventilation technique of synchronizing with chest compressions doesn't really do a lot of good when you're not doing chest compressions. And so going back to this picture, what you can do is switch to the second ventilation mode, which is the only other ventilation mode where you manually control the ventilation pressure by pressing that black button that's just above the mask. And what that does is once you press it, it starts the ventilation. Once you release it, it stops the ventilation and allows exhalation. At that point, you do need to have a decent seal on the mask to inflate the lungs completely. But it's not as nearly as difficult as ventilating someone with just a mask. Right. Because the pressure is being generated down here at one lumens, and the resistance of the upper airway is actually helping you seal instead of hindering your seal. Did I say that clearly?

Yep. Okay.

So we've done a lot of animal studies in several different labs. We're working really closely with Dr. Youngquist, who I'm so thankful is on the call. And then we're also working at Dr. Knopoulos lab. We've done cadaver studies. I think we're up to like 20 cadavers now, working at placement, ease of placement algorithm for determining its location and ability to inflate the lungs. And then we've been working with fire departments on our mannequins and in cadavers just for human factors to making sure this device is easy to use.

You know, so going back to the ventilation technique. Give me one second, let me do this.

Our idea is, can we increase the aortic pressure? Can we basically widen these gaps? We can increase both organ perfusion and during the diastolic, can we increase perfusion to the heart while getting gas exchange? This is one of our animal data. We did the same study setup as I showed you early with the cerebral, or excuse me, cerebral blood flow on the pigs, where we switch out between our ventilation technique and the gold standard of care every five minutes during cpr and we're looking at aortic blood flow, and then we're also calculating coronary perfusion pressure and we look at icp and then we take blood gases at the end of each ventilation technique. So we'll do our device for five minutes, we'll look at blood flow, and then right before we switch to endotracheal intubation with controlled ventilations, per the AHA guidelines, we take an arterial blood gas, we do that for five minutes, we switch back and forth. And what you can see here is that we have a profound effect on aortic pressure, both systolic and diastolic. And what that means is we have, you know, we're increasing organ perfusion during the systolic and then we're increasing coronary perfusion during the diastolic. As long as the right atrial pressure doesn't increase as well, we switch to intubation and everything drops. We switch back to ours and it goes up, we send back the intubation and it drops. So pretty impressive for an all fully automated ventilation technique. Then we look at the calculated coronary perfusion pressure. This is the same animal. This mirrors the diastolic pressure of our animal. So we almost double the coronary perfusion pressure in this animal by just using our airway in our ventilation technique.

So a lot of the times when you increase aortic pressure, you actually increase ICP as well. So this is one of the big things with automatic cpr, especially like the auto pulse. What they see is that you really increase icp, which decreases or increases the resistance to cerebral blood flow, and we do not appear to have the effect. I've never seen our product increase ICP on any animals compared to the gold standard of care.

And this is what I think is the most exciting is the blood gases. So same animal, and these are the arterial blood gases after the five minutes of each therapy. So we start off with a Baseline. So this is before the animal is in rest. Just to get an idea of what their carotid. Excuse me. What their baseline blood gases look like. But also we have the Doppler carotid flow to look at what their cerebral perfusion looks like in a normal state. And then with our product. So you can see here, after five minutes of ours, we greatly increased the PAO2. We balanced the POCO2, which is important. And carotid flow, obviously is a lot less than the baseline. But then when you switch to intubation, the arterial oxygenation drops. They're actually hyperventilating the patient, and the cerebral blood flow decreases. We switch back to ours. We get almost double the blood flow to the brain. Arterial oxygenation goes up to 531. So remember on the research paper I showed you earlier, any patient with a PAO2 above 300 had 100% chance of Ross and a 55% chance of survival. Then we switched back to the gold standard of care, and everything drops again. So not only are we able to increase both perfusion, we're actually able to increase oxygenation, which appears to have a direct effect on survival.

I've mentioned a couple of these things, but it can function as a portable suction unit. So this is not an additional piece of equipment we have to carry on site. One airway fits all adults. It's adjustable. I'll show you a video of that. We have the second ventilation mode once they get rosc, so where you can manually control the ventilations. Capnography sampling lines integrated into our device. We also have a viral filter integrated into our device. And then we have some other technology where actually you can see the pressure detection of the heart. I'll show you guys that next, but I'll stop here for a quick discussion.

Yeah, yeah, Clay. So we only have two minutes, and we're going to jump over to the Eagles. You're more than welcome to stay for that, but I wanted some feedback or some people to kind of try to poke holes in this because you got a great group of people here. So let's open it up. First, let's hear from Scott. So, Scott, you're taking a leap of faith with Clay. What are your thoughts on this?

Well, I think we're still waiting for the FDA to give the thumbs up first for that. So it's not happening tomorrow or the next day, right? I mean, unless you have. Unless I lost your email. It's gonna take a little while to get this into the field. But this is a very Interesting device because you not only get ventilation that matches perfusion, you actually get augmentation of perfusion. And CPR is great in the first five minutes of the resuscitation, but by minute 20, usually the wheels have come off and you're getting backup of blood on the right side of the heart. You're getting a very low Pao 2, very high Paco 2. We know this because we bring patients to the hospital for ECMO and draw blood gas and go, wow. They're either not getting good blood flow or they haven't got good ventilation or some combination of the two. And this is a device that seems to match those very well. I don't know if Clay just got very lucky or he figured out some sort of quantum mechanical equation for this, but it works very well and much better than an endotracheal tube at keeping those two aligned. So I think it's very interesting. Novel device for sure.

Awesome. And, Scott, thank you so much, and we look forward to having you present your research on this webinar in the future. I'm going to hit you up for that. This FYI. Anybody else, I want to hear. Joe, Holly, you've done all the cadaver studies on Igel, and what are your thoughts on this? Joe?

So, thanks, Peter.

I agree that you have captured the physiology very accurately. I think conceptually, this thing ought to work.

I think it's going to come down to.

How well the.

Right word here, the process works. In other words.

Can we be certain that the.

Suction on the esophagus remains consistent so that we don't have an air leak there, we don't get aspiration, all that sort of stuff provided everything for functions as you have designed it. The enhancements to perfusion, et cetera, ought to be pretty impressive with this. So I think it's definitely on the. On the right track. I'm eager to see how this works in the clinical setting.

Awesome. Great comments from Scott and Joe. We're at the. We're at the bottom of the hour. I wish we could have more questions, but, Clay, great presentation. I'm going to give you the last word and take us away, and we'll head over to Eagles right after you're done. Thank you.

Thank you for your time. You know, as Scott mentioned, we are preparing for a clinical trial. I'd love to share the details of kind of what we're looking at and get your guys input on that as we go into study design. Scott's been fantastic, but the more eyes that we have on it. I greatly appreciate your input. So, Dr. Antebbie, I'll send you that information and hopefully have some offline discussions. But thank you guys for having us, and we will be in touch soon.

Awesome. And just to reiterate, I have no conflict of interest. I love this. And, Clay, you're amazing. Keep up the great work. Keep working hard, my friend. Vegas, let's do it. Thanks, everybody.

Drop off.