Medsider: Learn from Medtech and Healthtech Founders and CEOs - A Self-Starter’s Guide to Medtech: Interview with Liberate Medical CEO Angus McLachlan

Episode Date: November 15, 2023

In this episode of Medsider Radio, we sat down with Angus McLachlan, CEO of Liberate Medical, a company pioneering a non-invasive neuromuscular electrical stimulator to prevent muscle weakening in patients who rely on a ventilator to breathe.Angus has a rich academic and professional history that intersects engineering and healthcare. Originating from Scotland, Angus began his academic journey in mechanical engineering at the University of Glasgow. This laid the foundation for his PhD research focused on electrical muscle stimulation for spinal cord injuries. His innovative work gained the attention of Apellis Pharma, leading to a collaboration that propelled the launch of his own company, Liberate Medical.  In this interview, we talk about Angus’s do-it-yourself philosophy, how a deep understanding of the technology you’re developing gives you leverage across multiple functions, and the nuances of pitching to investors. Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and a curated investor database to help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the recently launched Medsider Mentors Volume IV. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Angus McLachlan.

A lot of things don't always go your way the first time, but I think definitely the key to a lot of these things is just to keep on trying and try to keep yourself afloat and work out way to make things possible. Sometimes it takes longer than you expect, but that's kind of work for us. Just keep at it, be persistent and stay determined. Welcome to Medsider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now here's your host, Scott Nelson. Hey everyone, it's Scott. In this episode of Medsider, I sat down with Dr. Angus McLaughlin, co-founder and CEO of Liberate Medical.

He has a rich academic and professional history that intersects engineering and healthcare. Originating from Scotland, Angus began his academic journey in mechanical engineering at the University of Glasgow. This laid the foundation for his PhD research focused on electrical muscle stimulation for spinal cord injuries. His innovative work in this area eventually led to the launch of his own company, Liberate Medical, which is pioneering non-invasive neuromuscular electrical stimulation to prevent muscle weakening in patients who rely on a ventilator to breathe. Here are few of the key things that we discussed in this conversation. First, during the early stages of development, there's not an endless budget to play around with. Narrow your focus to only the core functionality that is needed,

leverage existing resources creatively and cultivate the internal passion of your team to drive innovation forward. Second, rely on your in-house expertise for specialized work. A deep understanding of your product makes you the best person to oversee development or handle niche conversations with regulatory bodies. Third, effective communication is vital in finding good capital partners. Learn to read the room for each pitch and adjust your narrative accordingly to best convey your message. Once you secure favorable investors, keep them in the loop and maintain a constructive relationship for long-term support. Before we jump into this episode, I wanted to let you know that the latest edition of

Medsider Mentors is now live. Volume 4 summarizes the key learnings from the most popular Medsider interviews over the last several months with folks like Rob Ball, CEO of Shoulder Innovations, Kate Rumrell, CEO of Ablated Solutions, Dr. Christian Ramdo, CEO of Tempe Health, and other leaders of some of the hottest startups in the space. Look, it's tough to listen or read every Medsider interview that comes out, even the best ones. But there are so many valuable. lessons you can glean from the founders and CEOs that join our program. So that's why we decided

to create Medsider mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to Medsider Radio.com forward slash mentors. Premium members get free access to all past and future volumes. And if you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. You'll also be able to see all of our playbooks, which are handpicked collections of the most insightful interviews with the brightest founders and CEOs. Whether you're looking to master capital fundraising, navigate early stage development,

tackle regulatory challenges, understand reimbursement, or position your venture for a meaningful exit, Medsider Playbooks have you covered. And last, considering that fundraising can be one of the most daunting tasks for any startup, we created a meticulous database of investors right at your fingertips. Explore a wealth of VC funds, private equity firms, angel groups, and more, all eager to invest in medical device and health technology startups. Access to this database is a premium member exclusive, so don't miss out. Learn more about MedSider Mentors and our premium memberships by visiting Medsider Radio.com forward slash mentors. Again, that's Medsider Radio.com forward slash mentors. All right, without further ado, let's jump right into the interview.

All right, Angus, welcome to Medsider Radio. Appreciate it coming on. Thanks Scott. Pleasure to be here. Yeah, likewise. Really looking forward to the discussion and especially with a lot happening, right, with the company. So with that said, let's start with a high-level overview of your background. I recorded a very brief bio kind of at the outside of this interview, but I'd like to start there. Give us a kind of an elevator-style pitch kind of for your professional journey leading up to co-founding, Liberate. Okay. Yeah, sure. It's definitely all very connected.

So, you know, originally from Scotland and started in mechanical engineering, did my undergraduate in mechanical engineering at the University of Glasgow in Scotland. And that was a combined bachelor's and master's program. So in the final year of that, had the opportunity to do a research project for my final year project, which was using a brain computer interface to trigger a stimulation system in patients with spinal cord injury so they can control the system. So that's really where I got introduced to research. and also to stimulation, actually.

And that led me to pursue a PhD in biomedical engineering, which I also did at the University of Glasgow. And in my PhD, it was focused on developing different systems and methods of using stimulation applied to the breathing muscles to help patients with tetraplegic or quadriplegic spinal cord injury with their breathing. So lots of different applications we're looking at, including improving coughing, as well as just improving respiratory muscle strength in those patients.

but toward the end of my research we did we had an interesting situation where the engineering group they called it rehabilitation engineering at the time now it's probably called biomedical engineering but anyway at the time it's rehabilitation engineering they had their research space within the hospital the spinal cord injury hospital so it was a cool work environment research environment and we did have doctors and other clinicians come up with ideas now and again and so one of them came up with an idea or a patient really that was stuck on mechanics mechanical ventilation. Young guy, they tried to wean him from the ventilator and got to about 12 hours a day of breathing by himself, but then it had become stuck for about four or five weeks using the conventional techniques. So knowing what we were doing with coughing and other breathing indications suggested we might want to try a case study with him, which we did. And it was a case study, so you can't take too much for it. But this patient did come off the ventilator about four weeks later after starting with the stimulation. And so if nothing else, I was a really cool story and just, was kind of the start of the idea of using stimulation for ventilator we're doing, which is what we're doing and liberate. The end, again, of my PhD, I was approached by a company that was based here in Louisville, Kentucky, called a Pellis Pharma. We at the time, we're very small. They were a startup. There were only five or six people.

Now they're a public company. They're based in Boston. So they've left Louisville at this point. But also at the time, they were looking at respiratory indications, TBD in particular for their drug that they were developing. and just by nature of learning about COPD had an idea for a medical device. Their idea was essentially using the same technology we were developing in spinal cord injury, but they wanted to apply it in patients with chronic obstructive pulmonary disease. And so found some research papers that our research group in Scotland had written.

And that's how we got connected and asked me if I wanted to come to work for them to explore the idea, which I did. So that's how I made the move from Glasgow, Scotland, to, almost to Glasgow, Kentucky. There was a glass. It wasn't quite an Louisville, Kentucky. But, uh,

so it wasn't, so it wasn't that Kentucky Derby as maybe some people, or the whiskey. Or the bourbon, yeah. Yeah. Yeah. I guess because of kindred spirits, the Kentuckians and the Scots from as far as whiskey's concerned.

That's right. That's right. Although funny enough, do you honest, the only think people really think about in Kentucky about Kentucky is KFC. I mean, for a long time after I moved here. that's what my friends would ask me.

It's like, do you mean to KFC? That's funny. Not the whiskey or the worst raising, but anyway, so that's I ended up in Kentucky and, you know, worked on, I was really the only one within a palace that was looking at the stimulation for COPD patients. And so after about 12 to 18 months, they decided they were focusing on drug development and wanted to kind of spin out the idea. They'd already file or we'd already filed some patents.

on an idea. So they asked me if I wanted to continue with the project, which obviously I said yes. And so we spun out Liberate Medical from a Pellas Farmer. And that's how we got started. Oh, got it. Super interesting. And you've been at it for quite some time, right? I mean, we're almost 10 years in the making, right? 10 plus years with Liberate. And I think you're coming off a Series B fundraise, which we're going to do a little bit more detail on later on in the conversation. But give us just a high level sense for kind of what the product is. And maybe pretend I'm a freshman in high school and you're explaining kind of what the technology does and how patients get access to it. Yeah, absolutely. So, you know, the core technology is based on non-invasive neuromuscular

electrical stimulation. And so for a basic standpoint, stimulation works by applying electrical pulses over the motor nerves to cause those muscles to contract. Stimulation technology has been around for a while. What we've done that's unique is combine the stimulator with a breathing sensor so that we can synchronize the output of the stimulation with a patient's breathing pattern. And we can use that for lots of different indications. Like I said, my PhD was using it in patients with spinal cord injury. When we start to liberate, we're actually primarily focused on patients with COPD patient, with COPD that are at home.

But as of today, we're using it for patients that are on invasive mechanical ventilation as a way of helping those patients come off the ventilator. and the basic problem that we're trying to solve is that when a patient goes on to the ventilator, the ventilator is breathing for them, and so their own breathing muscles aren't being used, and just like any muscle in your body, if you're not using the muscle, then it starts to waste away. As it happens in these patients, the muscle wasting happens almost immediately after being placed on the ventilator and progresses really rapidly, particularly over the first five or six days of ventilator support. and this puts patients into a situation where the initial disease or insult that put the patient onto the ventilator can be treated.

That might be pneumonia or sepsis or anything else. But now the patients are too weak to breathe for themselves. And so they go through this process that's called weaning from the ventilator, which is gradually reducing the ventilator support so they can breathe by themselves. And as of today, there's really nothing that can be done to prevent or lessen that atrophy of those breathing muscles. while the patient's on the ventilator. So that's essentially the problem that we're trying to solve with our device.

And by using the stimulation, we apply it to the muscles while the patients on the ventilator because it's synchronized with the ventilator. It's applying during the ventilator breathing cycle or the patient's spontaneous breathing cycle. So it's not interfering with the ventilator in any way. And it's sort of like a way of strength training or exercising the muscles while the patients

on the ventilator and in the ICU. is two 30 minute sessions per day and is a way of preventing that atrophy or muscle weakening from happening essentially so that when the patient's ready, they're able to come off the ventilator more successfully and in less time than they would have been able to do otherwise. Got it, got it. I imagine, you know, back in, you know, 10 years ago when you first kind of, you know, we're getting the company out of the, out of the blocks, you didn't expect a worldwide pandemic and ventilators to be, you know, such a huge focus. So curious to learn a little bit more about, your experiences, yeah, during, during COVID with the technology. But for those listening,

Liberate Medical is the website where you can go learn a little bit more about Bent Free, which is the device that Angus just described. Liberate Medical, just as it sounds, L-I-B-E-R-A-T-E-Med Medical.com, is the website. We'll link to it in the full write-up on Medsider for this particular conversation as well as Angus's LinkedIn profile, but that's where you can go learn a little bit more about the technology. So Angus, give us a sense for kind of where the company's at now. You know, we're recording this and September of 2023. Are you actively commercializing the technology yet? Or kind of where are you out in the life cycle with Liberate? Yeah. So the devices is designed, or at least the, you know,

the first generation of the device is designed. We do have the CE mark for the product, which was done under the MDD. And then we have the ISO 1345 qualification for our quality management system. And in the US, we do have breakthrough device designation from the FDA and it's currently still active. We have an emergency use authorization as well from the FDA. So, you know, we've made very good progress on the product development and the regulatory milestones. Actually, the focus right now is not on commercialization, but is to complete our pivotal clinical study of the technology. And that's needed, of course, to get the FDA clearance, which we think would be the de novo pathway for this device, but also to help gain clinical adoption.

I mean, this is really a first-in-class technology. It's not replacing something that's already been done. And so there is a certain level of evidence that's needed to convince clinicians the device really works and helps patients get off of the ventilator. And so this trial is going to help with both of those things, convincing clinicians and also getting the FDA clearance. So that's the current focus. A little bit about the trial, we call it the prevent study.

and to be honest, I've now forgotten the long name of the trial. It's easier just to say the prevent study, but it's going to be, it's roughly 270 patients, randomized, blinded, and controlled trial, and the primary outcomes time to extubation from mechanical ventilation. And then key secondary outcomes are looking at the physiological endpoints, cough peak flow, which is important in these patients, as well as expiratory muscle strength.

And then all of the other ones you would expect, like hospital length of stay, ICU length of stay, mortality, et cetera. Got it. Yeah. Joking aside, always amazes me, like the acronyms that are kind of used for these various studies,

but prevents a good one, right? I mean, it kind of encapsulates what you're, I guess what you're trying to do with the technology. Yeah, perfectly honest. I mean, I always find it kind of ridiculous when you see these things. You know, like people bold, a certain letter. I mean, to the point where it's not an acronym at all, right?

And so we just didn't bother with that. We just decided what we wanted the short name to be and called it prevent. And I think there is a way. you can force the long title to to become prevent people, like random letters in it. But we didn't go that route. We just chose the name that we liked. Yeah. It is funny.

Letters are taken out of words to come up with sort of the short form version of what you're calling the study. But yeah, no, totally, totally kind of fall. Totally lined with your thoughts on that. So, and sorry if I missed this, but you're, are you actively enrolling in the pivotal right now? or that's sort of the next major kind of inflection point or milestone for the company is to start enrollment? Maybe or hopefully by the time that this is the podcast is available, we will be actively enrolled. Okay.

You know, as of today, 6th of September, we're, you know, we just have completed the initiation visits for our first sites. Got it. Which are actually in Australia, but hopefully the U.S. sites will be, well, where we have some scheduled already later this month in the U.S. and enrollment should sort of start any week now. But as of today, we haven't enrolled in our space. You're on the cusp, on the cusp of commencing the pivot. Okay, cool. Well, exciting times, yeah, for the company, no doubt.

But that said, let's use the next maybe 20 to 30 minutes to kind of go back in time, right, and cover some of the key functions that, you know, and really kind of challenges. I kind of like to consider the sort of like act two of the interview, right, where we kind of cover the key hurdles that most med tech entrepreneurs kind of, encounter along the journey. And so let's start out with kind of early stage development. I think this is especially pertinent considering your engineering background, having received both the masters and a PhD.

I mean, it's so crucial. Everyone that listens to MedSiter, at least a high level, understands the fact that most startups need to be extremely capital efficient in the early days. You're not, you don't have access to, you know, typically endless budget, right, to kind play around. So you need to kind of get your your prototype, iterate on your prototype and get to kind of the next phase as quickly and efficient as possible. So with that said, what do you think, what are some of the key learnings, I guess, when you kind of think about the very first versions of vent-free

and kind of moving from alpha to beta to kind of where you're at now? What has been either some things that you did right or, you know, things that you kind of learned and wish you could maybe do over again? Yeah, sure. Definitely, definitely, plenty of those. And as you said, we were definitely very tight with cash in the early days trying to develop these things. So that was a big consideration. Yeah, I think a couple of things come to mind that we, I think we did right. You know, in the early versions of the prototype,

I do think it's very important to work out what's really the core functionality or the unique functionality with your technology. In our case, it was really about the synchronization of the stimulation with the patient's breathing pattern. And so that was where all of our initial development effort was focused on. So for the first prototypes, we weren't, you know, I do believe that user interface and usability is important, but for those first prototypes,

we really had those as secondary considerations, so we wanted to just make sure we could get the core functionality developed. And so that really helped focus us and focus the team on getting that really working very well. And then related to that is kind of then how we actually did the development. And I think you can be quite creative, and I think we were quite creative in how we put those first couple of prototypes together, even the ones that we used for our pilot clinical studies. So there's a couple of examples of things we did that just saved a lot of time and money, I think.

First of all, since, you know, I mentioned stimulators have been around for a while. And so we were able to find a commercially available stimulator that was used for physiotherapy that had a triggering port in it. And so what we did was just bought a bunch of these stimulators. And then we developed a separate device that essentially had the breathing sense. sensor and algorithm that worked out the timing of the stimulation and interface with that stimulator using that triggering port. So in Benda, we were able to avoid having to develop the whole stimulation circuit and get IEC, you know, 606 of 1 testing for that stimulation circuit, which is, you know, time consuming an expensive process.

We're able to avoid all that just to get our first prototypes and get our first clinical data. That was a huge time saver. And then, you know, that was the sort of general theme of how we put those prototypes together. Even the electrodes, we couldn't find the sides of the electrode we want. So instead of making custom electrodes, we bought two that were half the size that we wanted and then connected them together with bifurcation cables. So a lot of things that were used. And off the shelf enclosure and customized it,

bought a cheap 3D printer to make the user interface and the buttons ourselves rather than, you know, custom making a button pad for the device. So, you know, it wasn't maybe the prettiest thing. And it was definitely from a usability standpoint. It wasn't ideal because there was essentially two user interfaces. you have to control a simulator and the, you know, the timing and the triggering and the stimulation separately. But it worked and allowed us to test what we, you know, what was really the unique thing about

our technology and those early clinical studies. So I think that there was two things that we, I think we did right. Things we learned along the way is, and we did some of this, right, but we've sort of learned it over time that in terms of sort of building it yourself versus outsourcing, you know, our personal belief is it's most of the time is better. to do yourself, especially with some of the technology that's unique to what you're doing. I think outsourcing works quite well if you have a well-defined definition of what needs to be made. But even those early phases, as we call it, the discovery phase where there's a lot of iteration

and trying a lot of different things. And you never really know where the end is going to be. You just have to keep trying things as you get something that works. That can end up being really expensive, even if you find a great, you know, outside, contractor to do that can end up costing you a ton of money. But the other thing is it's just hard to find people that are going to, and it's not anyone's fault or anything at that, it's just hard to find people that are going to care as much as you do. And for that stuff that makes your device unique, no one's really going to care as much about getting that working as well as

you do and your team does. So, you know, we did have some mistakes over time where we did learn that. And that kind of filtered into how we built our team. So all of our initial team were, we're on the engineering side and we did all of that technology development ourselves on the triggering. And we ended up developing the stimulator ourselves as well when we got to that point as well as well as all of the software. So it and now today it's an advantage because we know how it all works. We built it. So it's easier to make improvements to it rather than having to go back every time you want to change something to a third party to get them to make those changes. Yeah. I always love hearing about kind of some of the scrappy stories, right, of early,

early stage, you know, companies where you're, you know, trying to leverage other, other, you know, cleared systems, et cetera, to sort of fast track that iterative, that, that very iterative process. But I, I 100% agree. Like, unless you're, unless you have a very unique relationship, right, with the CEMO where you can sort of, where you're going to get the attention, right, of their, you know, their best engineers, where that care, you can ensure their care factor is going to be high. If you're iterating very, very rapidly in their early stages, like, should be probably doing that yourself, right? it's hard to, hard to outsource that. And I think, I think generally speaking, I'm not sure if you

agree, generally speaking, this sort of applies to any sort of function, right? If you, I mean, it could make sense, right? If it, to your point, if something is very well defined and it makes sense to outsource, but you could almost always expect that, you know, the sort of that care factor aspect to be a challenge that you're going to have to overcome, right? Because it's, it's not someone else's baby. It's yours, right? And you're going to, you're going to get the most about about your baby and kind of pushing it to the next, the next sort of milestone that you need to achieve. So let's kind of transition to regulatory clinical function. And we touched on this a little bit earlier with that kind of the exciting, you know, pivotal trials that you'll, that you're close to

embarking on. Maybe by the time this is, this is released, you'll, you'll have actually kickstarted those efforts. But you guys, I mean, have accomplished a fair amount, right? Breakthrough device designation, I think in early, early 2019, I think which you referenced, TSE marking, emergency youth authorization during COVID. That's a lot. And that this regulatory function can be, you know, generally speaking, kind of complicated, right? Pretty challenging, pretty nuanced, especially with novel technology, right? Like Ventfree. So give us a sense for kind of how you've approached kind of this function and been able to kind of knock out, you know, really, really key regulatory wins for Liberate. Yeah. And, you know, we don't have anyone on our team full time that's a regulatory person.

And now we do have a clinical team, but in the early days, it was, it was me that was, you know, just, I did quite a lot of clinical work as part by PhD. But, you know, that was what we used to get through a lot of the early conversations with, with regulatory bodies. I think it's kind of along the same lines as what we were just talking about, about trying to do stuff yourself as much as possible. So, you know, we have worked with definitely you need to work with, and we have worked with experienced regulatory consultants to help us with, you know,

the actual preparation of packages and, you know, the meetings that we have with the FDA and other regulatory bodies. But, you know, I think you can learn a lot yourself. So even at first, when we're trying to work out, you know, F510K versus de novo, I mean, we never really thought our device was going to be a PMA. Like, doing that predicate analysis, you can pay a consultant to do it, but you can also, it's not that hard. You can also just work out yourself, find their product codes, find devices, and then you have a better understanding of, and you're probably doing more thorough search again, just because it's your, you know, your baby, as you said. So, and generally speaking, that's what we've tried to do with, with the regular. submission. So we tend to write as much as we can, at least again, on the technical side,

we know it better than any consultant is going to be able to catch up with. And we've been lucky to find some great regulatory consultants that helped us, you know, sort of format that and put it in the way that the FDA or someone else would like to see and helps us with, you know, with the meetings. There's definitely a certain way to talk to the FDA and other regulatory bodies, which that's really where that regulatory experience from a consultant can be valuable at least it has been on our side but we don't have an in-house regulatory person so here that's been our approach you know we have had several meetings with with the fda the pre-sup process i think is definitely really helpful we've had great interactions with the fta they've

definitely provided this uh you know a lot of good feedback along the way and you know we continue to to engage with them as we go through the process so so that's been helpful yeah i'm trying to I think what else I can see on that. But that's some of the main things I think we. I can see kind of a theme emerging here where it's like, you know, you prefer to kind of do things first, right? Take a swing yourself, understand kind of like helps you, but helps you to better better understand kind of like the direction and need clarity

on the direction before, you know, beginning to kind of really, you know, outsource a function or a key initiative. I got to ask you, though, I mean, considering you got emergency youth authorization, you know, during, during COVID, did that, like, thinking back, right? I mean, it's been, what, three, over three years ago now. Did that, do you feel like that was a boon for Liberate? Like, was, or did it create unnecessary challenges for the company? Give us a sense for kind of what that was like, you know, working on ventilator related technology, you know, when that was, you know, at the attention of a lot of people at that at that point in time.

Yeah, no, I mean, I think overall it was definitely good for the company. You know, it wasn't the be all to end all that was maybe tempting to think. I mean, I'll say we even thought that at times. beforehand like you know that's it's a huge huge take off here but um it was definitely very helpful you know we got it was quite a blur when we got the emergency we got it barely early on i think it was june or so i don't remember exactly um so you know pandemic was announced in march we got it in june um we actually hadn't got our manufacturing set up at the time we had the eua so it was definitely quite a scramble to get that put together and the sense that we use in our

device is actually not the transducer itself, but the mechanical part of the sensor. That's also used in ventilator circuits. We had some fun trying to source those sensors, even at the start getting everything set up. But we got everything taken care of. And then we had several hospitals that used the device. We never actually collected any data formally, which maybe in hindsight we could have done a better job at that, but it was, you know, it was sort of a bit of a crazy time. And we had some great stories from doctors that were using it. And some, you know, some personal stories as well. Actually, one of our employees, his mother ended up using our device to help come off the ventilator, which, you know, even though they're just individual stories, they obviously hit home a bit harder than, you know, than people you don't know.

there's also something local that we know here that was aware of our you know of our company just from following the local news and things of that and uh you know had a similar story there it was actually slightly different in that that case was a compassionate use case because he started the therapy when he was on non-invasive ventilation to try and see if it would help prevent going to invasive ventilation and you know in that case he was able to avoid the invasive ventilation so so that was a great story as well and then we heard you know other stories sort of second hand through the physicians. It was harder to meet patients directly. But it was helpful. We learned a lot about the device. I think some of the challenges during COVID were it was a crazy time.

Most ICs, I mean, all the ones we spoke to were either had the same number of staff, but double the number of patients or they'd lost maybe the same number of patients, but they'd lost half their staff. So people were, either way you looked at it, people were really thin on the ground as far as clinical team was concerned. So it was just a challenging time to try and introduce a new therapy into the workflow as an additional, you know, it's an augment to mechanical ventilation what we're doing. So it was a new thing people had to introduce. So it was challenging in some cases to get introduced under those circumstances.

But like I said, I think we had some nice, nice stories. We were happy to be able to help out in the way that we could during the pandemic. And we did get some good product feedback as well. and we're able to build that into the product development process as well. Yeah, it sounds like I would imagine there's probably some key learnings, even if it's not overly quantitative in nature, just to be able to get your device in the hands of physicians, use them on patients, et cetera.

There's bound to be some really, really important lessons coming out of that. But just to circle back around your comment. So it sounds like with respect to the emergency use, the authorization, so it sounds like you didn't have a line. up at that point, right? I'm curious, how fast were you able to kind of start building devices that could be used on patients, you know, from the time you got EUA to the time you actually were able to kind of handoff product to hospitals? Yeah, I think it was around September, if I remember correctly. It was, I mean, it was around, it was definitely around that time.

Maybe it was end of August, maybe it was beginning of October, but roughly September 2020. Yeah. So it's a, and it's not like we had, we'd already started the process. but it certainly wasn't finished and you know that was another challenge as well it was not possible to go to the we were working with a contract manufacturer and it was close to us in Ohio but just with you know the restrictions and things it was not possible to go there in person so you know we were having to get that all set up remotely over zoom you know they had their own thing people were getting sick you weren't be able to go into work and things of that so it was definitely an interesting time to try and

and get the manufacturing. But you're able to do it, though, right? I mean, the reason I'm asking about this is I, so many times, and I'm sure it probably relates, you can probably relate to this. And in MedTech, the answer is almost everyone kind of gravitates. So it's not possible. We can't do that or we can't do this. And not to say that's always the response,

but most of the time people, you know, kind of are biased towards, they find ways why it can't be done or why you can't move as fast. And then, you know, I think your story of, you know, look, you were already working with a CDA, you can actually go there in person to fast track this, you know, the development of manufacturing of the device. But yet you were able to kind of find workarounds, find ways to do it. And obviously that probably is testament to kind of you and your team.

But I love hearing those stories, right? Because I think we need more of them in MedTech, right? Stories of like why, yes, it is possible. You know, yes, you can move fast. Yes, we can do that, you know? So I think those stories are great to learn about. Hey there. It's Scott.

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