Medsider: Learn from Medtech and Healthtech Founders and CEOs - Resiliency and Relentlessness are Crucial for Raising Medtech Capital: Interview with Beverly Huss, President and CEO of Qool Therapeutics

Episode Date: April 24, 2020

Joining Medsider Radio for this episode is Beverly Huss, President and CEO of Qool Therapeutics, a development-stage company working on a novel, non-invasive therapeutic hypothermia device for the preservation of tissue following catastrophic events like a heart attack, stroke, or traumatic brain injury.Previously, Beverly was the CEO of Vibrynt, a start-up medical device company dedicated to creating minimally invasive therapies for patients suffering from morbid obesity. Prior to that, Beverly was the President of Guidant Endovascular Solutions (acquired by Abbott), a medical device company focused on the treatment of cardiovascular and peripheral vascular disease.She holds an M.S. in technology management from Pepperdine University, as well as a B.S. in metallurgical engineering from the University of Illinois. Beverly also has a few patents to her credit in the cardiovascular and obesity medical device arenas.With me on this episode is guest host, Norbert Juist, one of the most honest, genuine, and personable people I know. Norbert runs Sales Performance Resources, where he specializes in recruiting for medtech marketing and sales positions. Prior to this, he was a sales rep at Cordis Endovascular, a spine consultant at Synthes, and a sales rep at Ethicon. Interview Highlights with Beverly HussThe origin story of Qool Therapeutics and how Beverly got involved with the company.The clinical trial strategy that Qool Therapeutics is following and the reasoning for it.Beverly’s strategic approach to making a medical device a reality, including the regulatory, clinical, and reimbursement paths that should be considered.Key learnings from Beverly’s time at Vibrynt. The “other R&R”: the importance of resilience and relentlessness when you are raising money for a company.How to get the attention of medical device venture capitalists.Critical lessons Beverly throughout her career at ACS and Guidant.Beverly’s favorite books and how they inspire resiliency.The business leaders and mentors that Beverly most admires.Advice Beverly would give to her 30-year old self.See more...

If you talk to a neurologist, they will tell you that athletes are overheated. And the one thing neurologists agree on is that heat is not good for the brain or for concussion. So we want it to be standard of care that it's in every school, on every soccer field, for every cheerleading squad, every gymnast that it's right there and you start it immediately in the field. Welcome to Medsider Radio. where you can learn from proven medtech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. On today's program, we've got Beverly Huss who joined Cool Therapeutics as president and CEO in September of 2013. Previously, Beverly was president and CEO of Vibrant, a company that developed a novel,

minimally invasive therapeutic device for the treatment of morbid obesity. Prior to that, Beverly was with guidance since 1986, actually, fulfilling a variety of executive roles within the company's various medical device divisions. She managed the worldwide endovascular solutions business as president and quadrupled worldwide revenues to $150 million for the crowded and peripheral vascular business in just under four years. Prior to that, Beverly held several executive level of positions across a variety of strategic business units within guidance.

She holds a master's degree in technology management from Pepperdine University and a BS in engineering from the University of Illinois. Beverly also has several patents to her credit in the cardiovascular and obesity medical device arenas and serves on the board of certify biomedical and skilled medical. In this wide-ranging interview with Beverly, here are some of the things we cover. The origin story of cool therapeutics, including the early product concept and how Beverly got involved with the company. Beverly's strategic approach towards making the product a reality, including the regulatory, clinical, and reimbursement paths that were considered, Beverly's key learnings from her time

vibrant and guidance, and Beverly's favorite business book, the leader she most admires and the advice she'd give to her 30-year-old self. There's a lot more we cover in this wide-ranging discussion, but I wanted to call out a few things before we get started. First, joining me on this episode as a special guest host is Norbert Juiced. Norbert and I go way back. In fact, we used to sell vascular devices into the same cath labs. Now he runs sales, performance resources, and specializes in recruiting for medical device sales and marketing positions. And he's quite good at it.

Norbert not only brings a ton of industry experience to the table, but he's one of the most honest, genuine, and personable people I know. So if you're looking for a new gig or need help recruiting for some open positions, Norbert is definitely your guy. In the show notes for this episode, you'll find a link to learn more about Norbert and his background. and no, he did not pay me to run this message. All right, second, if you're new to these Medsider interviews and I want to be updated when the next interview goes live, head on over to Medsider.com and enter your email address. That's M-E-D-S-I-D-R, Medsider.com.

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It really helps us a ton. All right. Without further ado, let's get to the interview. Beverly, Beverly, welcome to Medsider Radio. Appreciate you coming on. It's wonderful to be here. Thanks for having me. All right. And Norbert, you're with us here this afternoon. Absolutely. Looking forward to talking to Beverly. I say as always, but have enjoyed you joining the show. And these conversations are becoming a lot more informal and conversational, which I think, I think leads to some better, some better entertainment. There's a little bit better entertainment value with these interviews. So without further ado, Beverly, you have a incredible background in MedTech, and you're doing what appears to be some pretty interesting things with cool therapeutics. So really looking forward

to this conversation and seeing where it may take us. But before we talk a little bit more about your background, which I think we'll get to in the kind of the latter half of this discussion, And let's first start with cool therapeutics because I think that might help set the stage for people to get a better feel for like where you're at in your career and what you're really trying to do with running the company you're at. So maybe if you could speak to your technology right now, maybe even using a patient, a hypothetical patient as an example. Okay, thank you. It's great to be here and thank you for the very kind words. So I would start by saying that we have been cooling with a C, not a Q, like our name. patients since before the time of Hippocrates. So cooling the body down a few degrees, two to five

degrees centigrade to preserve the heart in the brain in a trauma situation before a vascular surgery when a vessel gets clamped or post-cardiac arrest to minimize damage to the heart in the brain. And so if you've ever put ice on an injury, you understand the power of cooling to reduce inflammation and the oxygen requirements of the cells. So what happens today is that a patient gets cooled with a cooling pad, which is placed on the outer portion of their body, upper torso, and legs, and cold saline gets circulated through that, and you cool from the outside in. And if you grew up in Chicago like I did, you know that, that shunts all the blood from your extremities to your core, and the core, the heart and the brain is what you want to cool. So that's very slow. And it

it has the benefit of being non-invasive. If you want to cool a little bit faster, then you have to take the patient to the cath lab under fluoroscopy or x-ray, put a large 12, 14-French central venus catheter in and circulate cold saline through that. And you get faster cooling because now you're cooling the core, but the problem is you've taken the patient out of the flow of care

and you have to delay the primary procedure and potentially have bleeding complications because you have to anacogulate the patient. So what we do is we deliver frozen saline particles. We call it snow internally to the large surface area of the lungs. The lungs have the surface area about half the size of a tennis court, 70 square meters. Any physician you talk to about that will finish the sentence and say 70 square meters. So must be one of the first things they learned in anatomy class.

So we cool the lungs, the large surface area of the lungs. The blood that goes there to get oxygenated gets cooled. and then that cool blood travels to the heart and the brain and cools the heart in the brain very quickly. So you might imagine a patient that has a heart attack and is coming in or a patient that is in the operating room about to undergo a neurovascular or vascular surgery or a patient post-arrest. Those patients, many of them, in the last two cases, all of them would be intubated. We have a special intubation tube that delivers frozen saline and ventilation, And then we have a machine with hardware and software that delivers that frozen saline to the lungs,

cools incredibly quickly, two to six times faster than the competition easily fits into the flow of care because intubating a patient is something you would normally do. It's just you have to do it with our tube and cool with our machine. And so we're really excited to have finished our first in human design. We're about to enter a first in human study in Eastern Europe or Australia, whatever site gets approval first. And we have cooled almost 100 large swine, 80 to 100 kilo swine, so human size. We've done our electrical testing, our verification and validation testing. So we're really excited now to put this in a human.

And it's all about extending the golden hour, preserving tissue, and doing that in a way that. It's rapid because as one of our clinical investigators, Graham Nichols, says, if you don't cool quickly, cooling doesn't matter. So that's what we want to do. Cool the patient quickly, preserve heart and brain, and not get in the way of the flow of care, enable the flow of care to happen easily and quickly. Thanks, Beverly, for that background. This is super interesting.

So if I, I mean, without going too far into the weeds, if I understand this correctly, this is a first of the kind type of therapy. No one else is doing this. So I would presume, at least here in the U.S., this is a PMA type of product? We think it's an IDE-510K, a de novo 510K. Okay. And so based on some early interactions, that's what we think. Obviously, that'll be borne out as we get further in the process with FDA.

But that's kind of how we position ourselves. You know, we delivered through the lungs. Saline's already used in the lungs. And, you know, we've proven major things like we can cool quickly. We don't affect oxygen or gas exchange in the lungs. And we don't cause trauma to the tissues of the lungs. So we've done a lot of work to de-risk those major points. You know, the only time I've heard of this type of technology, and it's relatively new,

even in like spinal cord injuries, you see them doing that. I mean, you can answer that question, I suppose. How long have they been doing that? But it's not very long, right? that they have been doing that for the spinal cord injuries? Spinal cord injuries is an emergent area for this. So that's something we'll be looking at in the future. This is most used post-cardiac arrest.

So someone's heart stops and they shock their heart and bring them back. They will cool the patient 12 to 36 hours to minimize any tissue damage to the heart and the brain. And in fact, there's three studies that support that. Bernard is the name of one. Haca is the second, and the third is a French study called Hyperion that has shown a benefit post-cardiac arrest. And the really hard part about this is that because the technologies we have today on the market are not optimal, really the biggest proof of cooling has come in bypass surgery and

post-cardiac arrest treatment. And so we think that we will expand cooling to more areas because we have. cool quickly, rapidly, easily fitting into the flow of patient care. And you get really good control in terms of holding temperature with our method as well. Certainly interesting technology, Beverly. And with your background in the vascular space, can you tell us a little bit more about where, you know, where this product concept came from and how you got involved with the company, you know, back in what appears to be, you know, 2013 time frame? This concept came from Dr. Amir Belson. Amir is.

Amir was an Israeli flight surgeon. He's a pediatric nephrologist. And looking at the technologies that were out there, especially when someone has a major heart attack, FT segment elevation, myocardial infarction, and opening the vessel is the most important thing. He said, you know, no one's going to wait to cool the patient and then open the vessel. They're going to open the vessel first. We need something faster, quicker, easily fits into the flow of patient care. So I think in 2004, 2005, he had this concept for the technology. He raised a few hundred thousand dollars and started to build a patent portfolio. Amir likes to build a patent portfolio first and then start a company and find somebody like me to run it because he's more of a technology

clinical person and a very prolific inventor. So I actually met Amir and his wife Tamar with my husband Charlie at a Wilson-Sensini Phoenix CEO event, and Amir started talking to me about the technology in early 2013, and I told him, okay, I'll look at this, I'll look at the patents, the market, and if I think it's, I'll do the work a venture capitalist would do to understand this, and if I like it, I'll come and be your CEO, and if I pass, I'll give you whatever work I've done because we're friends.

And so, obviously, I'm here, and you see we're doing our best to get this into the clinic, and then eventually FDA and CE Mark approved into market. It got it. And you make that probably sound a lot more easy than it probably was to make that decision and that transition. But was there something particular that attracted to you about the technology? Was it the technology in and of itself? Was it the IP? Was there a few things that stood out that really drew you to cool therapeutics?

That's a great question. And you're right. So what I'm, you know, I'm sort of a technology geek. And I thought this was such a sophisticated, elegant and yet sophisticated way to do this. It sounds simple in concept. It's sophisticated in execution. And I felt like if we could do this, we could apply it in many areas of medicine. And in addition to that, so post-cardiac arrest, neurosurgery, vascular surgery,

sepsis, burns, trauma. And so I felt like if we can do this, and also exercise recovery, so if you lower an athlete's temperature back to normal, there's an exercise performance enhancement, and that could potentially be an early treatment for concussion if we can cool the brain quickly on a football field, a soccer field, a baseball diamond. I heard the other day that cheerleaders have the second highest level of concussions from getting thrown and flipped and fall. on their necks and heads. So I felt like if we can do this, we can really expand it across a range of areas and make a big impact in reducing trauma and reducing neurologic damage, damage to the heart. So that's what I thought was really unique about it and why I wanted to be a part of doing that. That's really cool.

I can speak to the cheerleading part. My daughter is a junior in high school and she's had three concussions. the first one she got from the soccer ball drilling her in the head. The second one she got, a girl was doing a round off back handspring and elbowed her right to the nose. And then the third one she got doing the pole vault. She went over, knocked off the bar, fell on the mat, the bar came down and hit her white on the bridge of her nose. So the sooner you can get that technology for my child would be great. Thank you for saying that.

Yeah, and the thing of it is is that if you talk to a neurologist, they will tell you that athletes are overheated. And the one thing neurologists agree on is that heat is not good for the brain or for concussion. So we want it to be standard of care that it's in every school, on every soccer field, for every cheerleading squad, every gymnast, that it's right there and you start it immediately in the field. And so that's the vision of where we want to be. We'll start in the hospital and move out from that area. And it's all about, you know, in animal models, cooling quickly when there's an injury makes a difference. And so we need to make the equipment fit the human model to be able to cool anywhere and very quickly.

And so for your kids and everybody's kids, we need that. It seems like the market is huge, but how do you actually determine? And, you know, for example, a lot of times when Scott and I do these, we talk to somebody who's treating a particular thing and they know that there are 88,000 of these particular, you know, whatever, heart attacks or events, shall we say. How do you put a market on something like this other than huge? You kind of have to break it down by indication, where we'll start first, what will be the most straightforward indication to get, and then expand. it from there. So we would like to start because it's a controlled setting in the operating room and then expand from there. So the way we look at it is we go and we look at how many cardiac arrests are there a year throughout the world. How many strokes? How many brain injuries? You know, and what's the

breakdown of where those occur and how they get treated? And then what is the first path forward for us to get an FDA indication. And that part is we're still in discussions with FDA about. So that part I can't talk a lot about. So you figure out what's a straightforward path to get an indication, how can we get this product on the market? And then how do we expand from there and go and get other indications? So our first focus is in the hospital. When we go and look at market research, independent market research for cooling devices, the biggest market is in the hospital. Surgeons, centers and then finally ambulatory centers. So we'll concentrate on that first and build a beach head there and then expand our indications from the hospital and those other markets. And then

secondly, leverage our technology to exercise recovery to a more mobile unit that can be field deployable. And as we did research with the military, that's what the military is interested in, having a field deployable unit for trauma and other injuries that can occur in the battlefield. So we want to have this core business in the hospital and expand from there. And we look at that market data. We go to the clinical literature and say, how many cases are like this around the world? What do we think we can penetrate sort of at a macro and a micro level? Then we build a business plan from the bottom up saying we're going to start in the hospital,

you know, where would we go? How long will it take us to establish a beachhead with this technology? You know, one of my follow-up questions was going to be around, you know, focus, right? Because you could expand into so many different areas with this type of technology, Beverly. How do you focus? But you, in essence, sort of answered that question. But in the back in my head, I'm thinking, man, it would be hard to turn down some of the opportunities or market opportunities, I should say, that would come about, right, with this type of technology. So, On that end, is it just an intense focus on sort of the challenge at hand being the one you just mentioned versus, you know, in essence, saying no to the other areas that, you know, seem like nice opportunities, but would be resource constraining?

Well, I think what we've tried to do is, you know, the thing about being in a startup is you only get so much time and so many people and so much money to prove something. So that causes you to get laser beam focused on what's important in the near term and the long term. And we feel like if we prove the technology in one area that it's safe, effective, better than the competition, then we can launch it in that area, generate revenue to get some of these other indications. And essentially, that's what our competitors have done. They're on the market. And the funny thing about this is that no one out there has any clinical outcomes. claim for cooling. Nobody has a claim, for example, that says, we preserve the heart or we preserve the brain

or we save these tissues. Nobody has it. They just have cooling for temperature management. And so not letting the patient's temperature get too high or too low. There's also a warming market. So what we want to do is establish that first beachhead. That's always been our strategy and then go after very specific indications and prioritize those. And it's also really hard to get some of those. The patient populations are hard. For example, brain injury, concussion, that's a very heterogeneous patient population. So if you're going to get a claim there, you want to really understand what patients are going to most benefit from your therapy before you embark on a big clinical study. How do you measure when you had mentioned the brain damage that you're preventing or the

the tissue damage that you're preventing. How would you quantify that? How would you measure it? Well, for brain damage, there are CPC rank and scores. There are standardized tests for measuring patient brain function for cardiac arrest. You use those same neurologic outcomes. And then it's essentially, you know, there's such a high mortality rate postcardiac arrest that you look at mortality and neurologic function. And then for stroke or traumatic brain injury, again, you would, you'd get classified by those various tests. So we initially want to say, you know, we can cool equal to or better. We think better than the competition and not create untoward effects, get our first indication, and then, you know, expand and do more studies after that. On that note, Beverly,

And you mentioned earlier in the conversation that you have your first inhuman clinical trials, I believe, OUS, I can't remember the countries you mentioned. But what's your take on, I guess, where are you doing these clinical studies? Because you mentioned the de novo pathway might be the most feasible option right now when it comes to the FDA. And that under the, you know, the regulatory guise of the FDA. But why not start your clinical trials in the U.S. versus outside the United States? Well, you know, we had actually looked at starting an early feasibility study in the U.S. And working through some of the meeting times with FDA, it just became clear to us that it was faster to go outside the U.S.

Now, that's not to say we haven't done all the same testing we have for the U.S. Indeed, we have bench, animal, biocompatibility, sterilization, validation, all those things, verification. and validation, all of those things. It's just that you can start the application process outside the U.S. while you're waiting for your final data, and then you don't start your trial until you have supplied that data. And so that's why we elected to go outside the U.S. And we know that what often happens and what is planned for us is that we'll go and do our first inhuman with what we believe is a safe product. And then there will be things that need to be changed and modified after we get that data to make the product better. And then that'll be the product that

we pursue under the regulations in a clinical study here in the U.S. On that note, you know, we recently had a conversation with Dan Rose. I'm not sure if you're familiar with him, but he's the, he's currently the CEO of Limflow, but was with direct flow medical prior to that. He mentioned that this concept of the valley of the valley of death, which is, you know, a regulatory approval from from FDA, or clearance or approval, depending, I guess, the device class. But then this period of time when you can't effectively commercialize because there's no insurance coverage or reimbursement. So how are you thinking about that latter topic in insurance coverage and reimbursement? Because it seems like that without a CPT code and without insurance coverage, whether it's,

you know, Medicare or private pay, that's even becoming a bigger obstacle with a lot of early, early stage med tech devices well the beauty of this technology is that there are iCD 10 and tpT codes for therapeutic hypothermia that we believe get reimbursed under the DRG based on our research so there are already codes there for payment so this for us as we see it is an execution play where we have to generate the clinical evidence we have to prove our claims and get this to market but there are codes there today, which support the use of these devices. So that's one of the nice parts. We believe there's a regulatory pathway. We have to firm that up with FDA. It's not guaranteed yet. It never is until you have approval, honestly. And then there's a regulatory pathway,

so it's really about execution on our part. Got it. That makes a lot of sense. Thanks for clarifying that. Do you have any other follow-up questions with respect to cool therapeutics? Or are you okay with kind of talking a little bit more about Beverly's prior experience in her kind of broader med tech career. I'd love to hear the previous company, you know, with the technology for obesity and stuff, it seems fascinating. I'd love to hear about that as well. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up.

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