Medsider: Learn from Medtech and Healthtech Founders and CEOs - Seizing Unexpected Medtech Opportunities: Interview with Ablative Solutions CEO Kate Rumrill

Episode Date: August 2, 2023

In this episode of Medsider Radio, we sat down with Kate Rumrill, CEO of Ablative Solutions, a clinical-stage medical device startup specializing in transcatheter perivascular alcohol denervation for hypertension.Kate is an accomplished leader with over three decades of comprehensive experience within the medtech and pharmaceutical industries. She brings a unique blend of expertise to the table, spanning roles from clinical affairs to executive management, with pivotal stints at prominent companies such as Eli Lilly and Covidien.Her journey from being an aspiring neurosurgeon to leading a life sciences startup underscores the power of seizing unexpected opportunities. In this interview, Kate dives into her three-decade-long career and provides valuable lessons on the importance of thorough research, strategic clinical trial design, and effective reimbursement strategies.Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's a link to the full interview with Kate if you prefer reading.

Never to assume that things are going to go as planned and always to be thinking about contingencies and, as I like to say, looking around the corner. What's the next challenge going to be and what can we do to make sure that we have a plan B just in case things don't go as planned? 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 evening. 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 Kate Rummerle, CEO of Oblative Solutions.

Kate is an accomplished leader with over three decades of comprehensive experience within the medical device and pharmaceutical industries. She brings a unique blend of expertise to the table, spanning roles from clinical affairs to executive management with pivotal stints at prominent companies such as Eli Lilly and Kividian. Here are few of the key things that we discussed in this conversation. First, sustained success in MedTech requires three ingredients. Thorough research, a deep conviction in your technology,

and a complete understanding of its potential impact on patients' lives. Second, when designing clinical trials, you must take into account the required capital, regulatory compliance, and end-user experience. This involves engaging with the right stakeholders, investors, regulators, and practitioners early on to preempt potential issues and future-proof the trial design. Third, a comprehensive understanding.

of your technology's unique landscape is crucial to devising a successful reimbursement strategy. Your plan must be comprehensive and articulate as investors are interested not just in the technology, but in how it will actually get paid for. Before we jump into this episode, I wanted to let you know that we just released the latest edition of Medsider Mentors, Volume 3, which summarizes the key learnings from the most popular Medsider interviews over the last several months, with folks like Jim Persley, CEO of Hinge Health, Carol Burns, CEO of Cajent Vascular, and other leaders of some of the hottest startups of 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 MedsiderRadio.com. forward slash mentors. Premium members get free access to all past and future volumes. 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.

This includes conversations with experts like Nadine Yared, CEO of CVRX, Renee Ryan, CEO of Cala Health, and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors. All right, Kate, welcome to Medsider Radio. Thanks for having me. Yeah, this should be a fun conversation, right? We get to relive some old times together at Cavidian and Medtronic and learn a little bit more about, you know, what you're up to at an ablative solution.

So it'd be a fun conversation. So let's start there, though. If you can, you know, I recorded a brief bio at the outset of this interview, but let's go back in time a little bit, maybe not through every single career move. But if you can kind of give us your sort of the quasi-expanded, elevator pitch for, you know, Kate Rumroll's, you know, professional journey in med tech. Yeah, absolutely happy to. You know, I think for me, I'm a little bit unique in how I came to the C-suite, how I came to be a CEO. I actually, you know, started off with my undergrad thinking

that I was going to be a neurosurgeon. So I did, I was pre-med undergrad and took a gap year and and fell into a summer job working in research for a pharmaceutical company. And here I am 30 plus years later, never quite made it to medical school, but have had an interesting career with lots of twists and turns. I actually came up through the research side of things. So unlike a lot of my peers, I started off doing toxicology research, and then I crossed over into clinical affairs with, you know, my role. expanding into medical affairs, reimbursement, all those sorts of things, and then being part of

executive leadership teams where I had visibility across strategy and tactical plans, not just within the clinical world, but across the business. And I think those experiences really prepared me for CEO position, especially for early stage product development companies. So it's been a fun ride. Yeah, and we had the chance to kind of loosely work with each other at Cividy and in the chronic during my time. And I was remember you were almost involved in almost every single sort of functional, you know, larger functional initiative.

I was like, why is Kate always like everyone's like, you know, is Kate coming in this meeting or is Kate involved? But I think that speaks to that, right? Of like you were involved in so many different aspects of the business. You saw so much, right? What worked, what didn't, how to, you know, build synergy across different groups, et cetera. I got to think that's probably been pretty instrumental as you as you kind of built your own companies and I'm not leading them as CEO.

Yeah, absolutely. Yeah, I mean, you can't be an expert in everything. You need to surround yourself with talented people who know what they're doing and empower them to get things done. But you need to at least know the basics. You know, I don't claim to be a marketing expert, but I know enough about what needs to be done so that, you know, my marketing team can can, can. have the support that they need in order to do things and do things well. Yeah, no doubt. I recently

had Carol Burns on the program. She's the CEO of Cajent. You're probably familiar with Carol. And she made a very similar comment. She's like, you know, one of the most important things that she's learned as CEO is like you just, you need to recognize and be sort of intellectually honest about your gaps, right? You're going to have, you know, you're going to have your wheelhouse. Certain areas that, you know, are in your wheelhouse or your core strengths. But you need to understand like some areas, you know, you know enough. You should know enough to kind of be dangerous. but that means you need to bring in the right people, right, to kind of, you know, really, really shore up some of those gaps. So, so I'm right, I'm right there with you. Let's,

let's talk a little bit about ablated at a high level. And then we'll certainly kind of go back in time to kind of learn a little bit more about the company's journey. And just things that, that you've learned as the company's kind of evolved and developed and grown up. But let's start high level. What is, tell us a little bit more about the technology, you know, what it is and then like how it came to be. Yeah, sure. So a, a blublish, Plative Solutions is a renal denorvation company. So we're developing a treatment. Our first indication will be hypertension or the treatment of hypertension for patients who are uncontrolled. In other words, they're taking antihypertensive meds and their blood pressure is still not

within the guidelines. And so for those that aren't aware of renal denervation, it's basically a catheter-based systems where you go into the renal artery and you, oblate the nerves in the space around the renal artery. And in doing so, basically what you're doing is you're cutting off an over signaling of the sympathetic nervous system, which is what causes high blood pressure in many patients. And so there are a few other therapies that are out there, energy-based devices that are in FDA review right now. We're about a year behind them with what we think is a novel mechanism or a novel way of achieving this denervation, we actually use our proprietary catheter that delivers a neurologic agent into the perivascular space as opposed to energy.

So our neurologic agent of choice is alcohol. And so we infuse 0.6 milliliters of ethanol into the perivascular space around the main renal arteries, and then we can treat up to assessaries, if need be, if they're large enough, not to ignore. And in so doing, we create this cloud or this cylinder around the artery where all of the nerves run, and we ablate the nerves. Interesting. That's really cool. And so still, even though you're delivering, you know, alcohol as sort of the agent to sort of ablate these nerves, it's still a device, right? It's not a device, drug. Well, technically it's a combination product. So we have 510K clearance and CE for the catheter as a device that infuses neurologic agents, you know, into the body. But what we're

working on right now is the approval of the device with our alcohol, which technically is considered a drug. And so it's a combination product, but it's actually an NDA approval process through the FDA. Got it. Got it. Okay, that's super helpful. You mentioned that you're about a year behind, right, some of these other startups in the de-uneration space, but can you give us a sense for kind of where the company is specifically in terms of, you know, Klin, reg, and, you know, maybe even eventual, you know, commercialization? Yeah. So we just press released a few weeks ago, that we've completed enrollment in our pivotal trial. It's called the Target BP-1 trial.

This is in, as I said, patients with uncontrolled hypertension, taking two to five medications. And so we completed enrollment in that. The primary endpoint is three months, but we keep the study blinded out to six months so that we can also monitor medication uses of these patients longer-term, and then, of course, longer-term safety.

And so we're in that follow-up phase now. We anticipate completing the six-month follow-up for the last patient. It was a 300-patient study by the end of the year, and then we'll be doing the data analysis. All going well, we should be submitting to FDA by Q2 of next year. Got it, got it. We're recording this in, you know, kind of mid-2023-ish to help kind of level set everyone that's listening.

after the fact. So that's really helpful. For those listening that don't get a chance to read the full summary article that on that I'll accompany this particular episode, and you want to learn a little bit more about the technology and the company. Website is Ablative Solutions, just as it sounds, ablative solutions.com. And you can go and check out the technology in a little bit, a little bit more detail. But let's, if it's okay, let's move on to the substance of the discussion, right? You mentioned Reno Denervation. I think for anyone that's listening to this, that's familiar with the cardiovascular space, they're aware of Ardian, right?

And even if you don't have like an in-depth understanding of that story, it's super interesting at a high level. They were pretty early on. Medtronic came in, monster acquisition. And it really hasn't got anywhere, I think, for, you know, maybe that's the best way to describe it, or at least at a high level. And so looking at your career,

and we chatted about this a little bit before I hit the record button, you've been, you've had really unique experience in the sense that you've sort of had two different boomerang stories, right? with Cavidian and then Neosync. So I'd love to kind of get your take on that. But then if I'm in your shoes and I'm considering, you know, what's my next move after Neosync and, you know, you're looking at ablative, you know, a lot of people would be a little bit scared to make that move, right?

I mean, renal de-innovation and maybe comes with some negative, you know, context. But you obviously saw something different. You saw some promise here and you obviously have a really, really strong clinical background. So I love to learn just a little bit more about that thought process and, you know, maybe frame it up for other people that could be in a similar boat, it seems like a good career opportunity, but the space seems maybe a bit risky. So, yeah, I'm going to get your thoughts on that. Yeah.

Yeah, and I think it's a really good question. Certainly, as you're pondering your next move, whether it's a CEO role or any other position for that matter, you really need to do your homework. And at least for me, I've always, when I've been making those decisions, I always factor in, do I believe in the technology? Do I have a vested interest in the disorder or the disease that is being treated? In my case, both of my parents have struggled with hypertension and hate taking their medications and I have to yell at them all the time.

And, you know, what is it, what is the unmet medical need? And what are you trying to do there? And so I always try to think about that. And then, of course, I look at the company, the people, because you spend a lot of time together and, you know, are you going to enjoy that journey together and, and are you going to be able to come together and really work as a team, which is, you know, obviously critically important as well. You can get a job anywhere, but, you know, you have to really love what you're doing and believe in what you're doing. In the case specifically of renal de-arvation and oblative solutions,

you know, you nailed it. It has had, this space has had an interesting journey. I, myself, was there front row and center at COVIDian, we had our own renal denervation product called OneShot that was acquired by My Medical. And back in 2011, 2012, it was going to be the next big thing. Everybody had a product that they were developing. But as you mentioned, even Ardian, it was very early. People were doing first in man studies. And we really, I don't think, had a good grasp or understanding of renal denivation and the mechanism behind it, but also how complicated hypertensive patients are to study in a clinical trial. And so, you know, 2012 was, you know, April of 2012 was when hypertension three came out and all the companies really reevaluated and said, hmm, let's take a pause here.

and, you know, fast forward for me then to 2014, when COVIDium was acquired by Medtronic and I was approached to take on the CEO position at Neosync, I stepped out of the vascular space for a while for obvious reasons for a couple of years. And I was kind of keeping tabs on things that were going on in the space, but I wasn't, you know, living and breathing things that were going on in the cardiovascular space. So fast forward to 2019, when Abolative Solutions approached me to come and join them as CEO, of course, my first response was, wait, I thought we killed renal de-nervation back in 2012. And so then, you know, I started reading up on it and doing my homework. And what I found was that not only Medtronic and, you know, other companies,

but really the KOLs, the leading experts in this space that underwls, understand hypertension and understand the mechanism behind why renal de-inervation does work and should work, they took the time to really evaluate what is the appropriate expectations for an intervention such as this. Because back in 2011, 2012, there was this belief that renal deervation was going to cure hypertension. Well, hypertension is a lifelong illness. And it's very complex, right? Because it's not just what's going on with your sympathetic nervous system. It's diet. It's exercise. It's lifestyle. All of those sorts of things factor in. And then also it's a progressive disease. And so to think that you could treat somebody with a renal denervation

procedure and they never have to take a pill again in their life. They can take either taking seven pills and they're never going to have to take another pill. That was just unrealistic. at the time. The other thing I think that that was learned during that time was how to design these trials because clinical trials are difficult in and of themselves, but to do it in a hypertensive population where we know that more than 50% of patients are not compliant with taking their meds. And we need them to be stable and taking their medications consistently. Because if you don't, in a randomized control trial, you don't know how much of it is medication influence and how much of it is truly related to renal denervation. So through this, the KOLs came up with kind of a template of the

appropriate protocol that actually all the companies now follow. We measure ambulatory blood pressure for 24 hours to get a more consistent measure of blood pressure as opposed to just a single measurement in the physician's office. We track compliance that the patients are actually taking their medications. And so very methodical in, you know, thinking through what these protocols look like. I will tell you, they are not easy to run, having just completed our pivotal trial enrollment. But, you know, I think it's the scientific community has done their best to really, try to take the noise out of the data sets the best that we can under the circumstances in this difficult population. You got it. And I, that's such a great background. And I forget that

you were that closely involved with the space back at Cividion. You mentioned Maya, meta, like, I almost forgot about that acquisition. So when you were, you know, sort of digging into ablative, you obviously had a certain level of familiarity, not a certain level, a pretty deep level of familiarity with the space. But my understanding of, you know, without kind of, you know, I guess getting too far into the weeds with reed on innovation, I sort of, you know, loosely understood that a lot of the challenges were related to clinical trial design and actually running an effective clinical trial. But it sounds like it was, it was dynamic, though, right? There's like these issues with how to, how do you effectively run a trial to demonstrate, you know, efficacy? Probably some of the

issues were related to the technology itself, right? You know, energy versus like what you're, what you're working on at ablative, you know, and then you've got like these maybe wild expectations, as you mentioned, that are probably not, not rooted in reality. And so those didn't scare you away. You were, you know, it sounds like, you know, you, there's enough of a sort of a personal sort of story. Plus, you're kind of your, your, your expertise in the space already that, you know, that you're like, you know, this maybe comes with a little, a little bit of risk, but I'm okay with the risk. You know, I'm a believer in the space. Yeah, absolutely. And, and I, I guess, I'll close that thought on, you know, so I kind of reeducated myself on what had transpired, you know, during that time frame.

Of course, Medtronic had done additional studies with their next generation catheter, saw some really good results. And Oblative Solutions also had done their first in man and some early open label work where the results were quite compelling. And so as I started talking more to the investors and the management team of Oblative. solutions and really started to understand the technology itself, that's where they really got me. Because, you know, I'm very familiar with RF energy. Obviously, during my time at COVIDian, we had closure fast for, you know, for venous disorders. And then, of course, you know, specifically in the renal denorvation space. But what we have at Oblative Solutions, in my humble opinion, is a pretty cool technology. So, you know, we,

are not imposing energy through the media. We're inserting microneedles through the media into the peribascular space and we are exposing the nerves exactly where they are located in that peribascular space to this neurologic agent. It's a simple catheter to use and it's one and done. So it's a single infusion per artery. So it takes the guesswork out for the physicians who, you know, they don't have to question, am I in the rate location? Did I get the ablation correct? It's a single infusion. It takes about a minute each. Yeah, yeah. So it's definitely distinct technology, right? So you're solving for that sort of that gap with other energy-based platforms. And just to clarify, is it largely interventional cardiologists that are performing the procedure then? Okay. Okay. Yeah,

that's what I, that's what I expected. Well, cool. No, it sounds like, and I don't think I was fully aware of sort of the underlying sort of mechanism, right, of your technology, at ablative, but it sounds, sounds super interesting, right? So with this micro-needling approach, right, being able to sort of better infuse, you know, this, this agent, right, alcohol to ablate the nerve. Sounds like, sounds like you're on to something. Yeah. Yeah. Oh, cool. That's awesome. And just to kind of close the loop on this kind of career topic that we started out with, you mentioned before we hit the record button about this boomerang, right? And I touched on it just briefly, this kind of this double boomerang in your career. But I'd love to get your, your thoughts,

because I think that they're super helpful for most people that are going to be listening to this. And you mentioned something about, you know, just, you know, being very cognizant of keeping relationships intact, not burning bridges. Maybe just touch on that before we kind of move to the next major topic, which is clinical affairs, which I want to make sure we leave enough time because that's obviously, you know, one of your, one of your, you know, key strengths. But yeah, just maybe touch on that because it is unique in the fact that you've been at two companies, you know, twice now.

So, yeah, I would love to get your take on that. Yeah, absolutely. So as you mentioned, we were chatting before you hit the record button. I was with a company that was acquired by COVIDian in one of their divisions and left the left, left, Cibidian after successfully making the transition with the acquisition and went to another company called Neo Sync that was in the neuromodulation space. I joined that company as their second employee helped them, you know, all of their SOPs written, protocol through FDA, hired a team and started the clinical trial.

And then it was at that point, COVIDian called me and said, would you be willing to come back? This is about 18 months later. Would you be willing to come back in the vascular space? And, you know, never would I have thought, you know, 10, 20 years ago that I would work for the same company twice. But, you know, they came to me with a really compelling offer that. with a portfolio, they had just acquired EV3. And it was really intriguing and interesting for all the reasons I mentioned earlier

of what I look at when I'm looking at making a move. And so I made the decision. I felt like I was leaving Neosync in good hands because I had done pretty much everything they needed me to do. And now it was just waiting for, as I like to say, the suplea to cook is to complete the clinical trial. And so I went back to Covidian and, you know, several years had passed. And then the Covidian Medtronic merger or acquisition occurred.

And that's when the chairman of Neosync called me and said, hey, we'd like you to come back. And we want you to come back as the CEO. 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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