Medsider: Learn from Medtech and Healthtech Founders and CEOs - Two Stakeholders You Can’t Ignore: Interview with Tioga CEO Mike Dineen

Episode Date: February 19, 2025

In this episode of Medsider Radio, we sat down with Mike Dineen, co-founder and CEO of Tioga Cardiovascular, a Shifamed portfolio company. Tioga is developing a minimally invasive transcatheter mitral valve replacement (TMVR) device to address mitral regurgitation (MR) - a condition where blood flows backward into the heart, often causing heart failure.Mike has 30 years of experience in leading and scaling innovative medical device startups, and is co-inventor on more than 65 patents. His track record encompasses leadership roles at Kalila Medical (acquired by Abbott and later divested to Terumo), Maya Medical (acquired by Covidien), and Aspire Medical (acquired by Philips/Respironics). In this interview, Mike discusses why engaging with physicians early is essential and what he prioritizes in those conversations, the importance of pushing for early pre-clinical testing and how to best approach it, and his strategy for raising capital by targeting early-stage investors with a clear, exit-focused plan.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 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and 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 latest Medsider Mentors Volume VII. 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 Mike Dineen.

The amount of pressure and the ups and downs are so dramatic that it's extremely difficult on a day-to-day basis to kind of maintain your sanity sometimes. You know, I think this is true for any CEO, right? Because you have financing woes, you have patient woes, patient enrollment woes. You have a lot of different things that you're trying to manage. And I think what you start to realize or what I've really start to realize is that you've got to focus on a process. And more than anything else, sometimes when you get overly consumed about the outcome, whatever two years, three years from now. It becomes overwhelming. You've got to divide your year into months and then months into weeks and the days and really just focus on what you're

going to do that's right in front of you. Sitting down the night before and really deciding what you're going to do the following day, and don't even do anything at the time. Just really try to focus and try to get into a little bit of a Zen mode and think about what are the most impactful things you can do in the next day. That's how you're going to eventually move the needle forward. 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 Mike

Danine, who has over 30 years of experience in leading and scaling innovative medical device startups and his co-inventor on more than 65 patents. His track record encompasses leadership roles at Kalila Medical, which was acquired by Abbott and later divested to Tarummo, Maya Medical, which was acquired by Cavidian and Aspire Medical, acquired by Phillips Respironics. Today, Mike is the co-founder and CEO of Tioga Cardiovascular, a chief of med portfolio company. Here, a few of the key things that we discussed in this conversation. First, start with identifying real clinical needs by talking directly to physicians. Understand their pain points, the number of patients impacted and the clinical significance of the issue. Work

closely with key opinion leaders in your field who can provide deep insights into care gaps and guide you toward viable solutions. While doing this, ensure your device aligns with what strategics are looking for or prepare to take your startup further on your own. Second, get a functional prototype into pre-clinical testing as soon as possible. Don't over refine as early testing reveals critical insights you won't get from theory alone. Choose clinical sites that are credible, accepted by physicians, and see a high volume of relevant patients. Back your team with strong CRO support for navigating site-specific requirements. And third, for capital, seek out firms in your field that are interested in early-stage deals, especially Series A.

Present a clear, compelling story that outlines a feasible path to an exit within their typical timeline, which is six to ten years. On a similar note, engage with strategics early and treat them as customers. Take the time to understand their pain points and key initiatives, even as those priorities evolve over time. All right, before we dive into this episode, I'm pumped to share that volume 7 of MedSider mentors is now live. This latest edition highlights key takeaways from recent MedSider interviews with incredible entrepreneurs like Bill Hunter, CEO of Canada, medical, Brian Lord, CEO of Pristine Surgical, Don Crawford, co-founder of Safion and current CEO of Corvista Health, and other proven MedTech founders and CEOs. Look, we get it. Keeping up with every MedSider interview isn't easy. That's why we created Medsider mentors. These e-book volumes

distill the best practices and insider secrets from top founders and CEOs, all in a downloadable, easy-to-digest format. To check the latest volume out, head over to medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes, plus a treasure trove of other resources. If you're not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with swanky new features, especially for our premium members. In addition to every volume of MedSider mentors, you'll get full access to our entire interview library dating back to 2010. You'll also get Medsider playbooks, curated guides, path with actionable insights and topics like fundraising, regulatory challenges, reimbursement strategies, and more.

And if you're fundraising, don't miss our exclusive investor database featuring over 750 life science BCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider Mentors and our premium memberships by visiting MedsiderRadio.com forward to mentors. All right, without further ado, let's dive in the interview. All right, Mike, welcome to Medsider Radio. I'm really looking forward to this discussion. It's been a while coming, so yeah, this should be a fun one. Yeah, looking forward. Great to be here. Yeah. So I reported a very short bio at the outset of this

episode, but let's start there. You've got a laundry list of experiences, right, that are quite impressive from earlier in your career at Strategics, then in just a number of different startups that you've been with over the past 15 to 20 years now, I think. With that said, give us like a two-minute elevator pitch on your background leaning up to Tioga. Yeah. If I go back way, way back to college, I was actually pre-med in college and I thought I was going to go to medical school. I've always really been interested in medicine. And then about a halfway, through college, I decided that medical school wasn't for me. I didn't feel like going through years and years of a residency in medical schools. I had this semi-brilliant idea of somehow

mixing business with medicine and that I figured that there was a lot of people with business backgrounds who wouldn't understand medicine and our science. So I decided, I didn't know what that meant at the time. But fast forward to when I graduated, I actually took a job in pharmaceutical sales. So that was my first job out of college. And that was at a very large pharmaceutical company, which was a great training background, et cetera. not only from a sales standpoint, but also just understanding medicine and different specialties and everything. My first job in MedTech really came in my late 20s, actually, when I was, I went to work for a company called DVI, which is one of John Simpson's companies.

John Simpson formed ACS, as you probably know, then he went on to form a DVI, which is an antherectomy company. And that's really where I got really interested in interventional cardiology. And that actually set my career off more than anything else in the world because it was working with just really fantastic. people. And it's really one of the most important things for when you're starting a career, it's making sure that you're working with really good people. And then from there, and I was in the marketing role. So I went from the sales role to the marketing role. And then from there, I went to a company called Target Therapeutics, which was one of the early neurointerventional companies right before the time it was acquired by Boston Scientific. So I got to live through the BSC

acquisition. And right after that, one of our, I was introduced to a venture capitalist at Three Arch partners, which at the time was one of the big venture, bed tech venture groups in the, really in the country. And we started a company called Radiant Medical. That was one of the cooling companies, one of the therapeutic hypothermia company. So what, and this was philosophically, which also very much shaped my career. The VC at the time said that what they like to do is put together somebody with a business or marketing background, together with somebody with a technical background and have them come up with a business. And it actually worked out really well because I worked with an engineer very closely, and we tried to figure out market needs and clinical needs,

and we came up with a bunch of really interesting things, which unfortunately, which got funded, but then the trials didn't necessarily pan out. And so that lasted a few years. And I came back to the venture firm a few years later, also as an EIR, this time, as an entrepreneur in residence, and started another company in Sleep Apnea. And we sold that to Phillips. Unfortunately, that was right around the time of the global financial crisis. So we actually ran out of funds and we actually had some technical problems.

And then I spent some time in an interventional stroke company, a marketing side. And then I met Ammer back in 2011. And this is really where things I think get interesting because Amher was prolific entrepreneurs, started a number of different companies. And he was starting Mya Medical, which was a renal denervation company. Again, as I mentioned to you earlier, was out of his house. And so he needed help with just lots of odds and ends. And in an early stage company, you're just

have to be willing to do whatever. And so my job was a little bit of clinical, a little bit of marketing. I served as a subject matter expert on some of the design reviews, et cetera, and just getting stuff done. And that company was acquired by COVIDian, back before COVIDian was part of Medtronic. And so I was at COVIDian for a while for only about six months.

And then Amur asked me to come back and run Kalila Medical, which was one of the other early chief of med companies. And that was a hysteria. Sheaf that competed with the St. Jude Agilis, which is now Abbott Agilis, of course. And so we sold that to Abbott Labs in 2016. And then right after the acquisition closed, about literally a month and a half later, Abbott acquired St. Jude Medical. It was a really big acquisition at the time.

It was like a $25 billion acquisition. But the Federal Trade Commission made Abbott divest Kalila. So we were subsequently divested to Tarumo Medical. so I ended up at Tarumo and we're still working through milestones because the deal had about 50% in milestones. So we worked through all the milestones, got the milestones done. I left. I left Tarummo, took a bit of time off, actually bought a van, built out a van, traveled around with the kids, did a little bit of van life and then took came back and started looking at new companies, what that we were going to start, the next generation of chief of met companies. And this was like

early 2018 at this time. And so we looked at a number of different things before we got really excited about the mitrovallel space. And that's the project that ultimately led to Tioga and where we are today. Yeah. Tayaoga, isn't that like a van? Like I've seen like campers like with Tyoga. Is there any like backstory to that at all? Yeah. So Tioga, so we were named after Tyoga Pass in Yosemite. So it's the highest paved road in California. It closes down every year like in November because of snow. And so a couple of our early co-founders were climbers and doing some ice climbing up in Tioga Pass. And they came back and said, why don't we make a Tioga medical? And actually Tayauga is actually the name of, it's an Iroquois name from upstate New York. And it means

something about rivers or flows or something like that. So that's where it comes from. That's cool. And I'm looking forward to learning a little bit more about the journey over the past I guess a half decade now with Tioga, I think, right? Because you, I think maybe officially started it and in 19, maybe we're tinkering before then. But yeah, that's a fun background. But on that note, before we get into Luna, learning a little bit more about Luna, I'm hoping that at the very least you got paid twice on those milestones, right, through the integration of with- We didn't get paid twice. We just got paid completely. We got paid completely. Okay.

So that's more importantly, yeah. Yeah, two swings maybe at the plate there with those milestones. But joking aside, tell us a little bit about Luna. And maybe start with the big problem you trying to solve and then maybe how your system differentiates from others? Yeah. So mitral regurgitation is the largest heart valve problem. There's four valves in the heart. The most famous one now, of course, is the aerotic valve because Edwards has built its entire business around treating the aerotic stenosis, which is the valve right next to the mitral valve. Mitral regurgitation occurs when you have obviously a leak of the blood going backwards into the left atrium. And it presents with heart failure or shortness of breath. And again, it's the biggest heart valve problem that exists in the world today.

And right now, from an interventional standpoint, the only thing that's really out there is tier, trans catheter, edge to edge repair, which is mitroclip and Pascal by, matroclip by Abbott and Pascal by Edwards, which is a repair device. The problem with a lot of the repair device is that there's certain anatomies that they can't treat or that they treat suboptimally, meaning that they leave a lot of residual MR behind. Physicians really want a transcatheter mitral valve replacement option to be able to treat these patients and to treat the MR. So that's where a TMBR device comes in.

Now, where we're really differentiated is that all the other TMVR devices, and there's a bunch that are in clinical evaluation, they have a really high screen failure rate, meaning that when a patient is referred to the company to look at whether or not the valve will fit in that patient, they usually go through the process and very often they are denied treatment. And actually it happens ridiculously like a very, very high rate. So for some of the major competitors, 80 to 90 percent of the patients are excluded from treatment before, you know, at the screening level.

So a big part of what we're trying to treat is, or trying to address rather, is the screen failure rate and try to lower that screen failure rate. The way we've done that is by making a better delivery system, number one, and number two is a more compact. And there's some other things as well, but more than anything else, those are the two main design components that have led to where we are today as a company. And that high screening rate, which is like absurdly high. I had no idea that was that high. That's largely due to just like the sort of the technical constraints of existing therapies, existing devices. Yeah. If you look at one of the major competitive valves from say metronic. It's a very tall valve and it occupies the entire mitral annulus.

So it's so big that it actually blocks what's called the left ventricular outflow tract, which is where the blood leaves the heart. It's the area just below the aerotic valve. And really what the company and all the companies will do is they'll take a patient cat scan and then they'll put a virtual valve into that patient's anatomy and make sure that there's adequate room for it. And if there's not, they won't treat the patient. So you actually do a virtual implantation of the valve before you do the real one. And that's really where the screen failure rate occurs the most often. Got it, got it. I'm on the website right now, Tioga Cardiovascular.com, just as it sounds, right? T-I-O-G-A-Cardiovascular.com.

We'll link to it in the full write-up on MedSider as well as Mike's LinkedIn profile. But give us a sense for where the company is that. I know you recently announced some first in human cases. We're recording this in late 24, but I think that was maybe a couple months ago or something like that. But give us a sense where you're at right now in terms of stage. Yeah. So we did our first in human in September and we've done now three cases and we're screening more cases. All the cases have gone really well from an acute standpoint. So we just literally just entered the clinic and we're going to be doing more cases in 2025. Got it. Cool. Very good. I'm sure with some sites on some sort of IDE trial at some point in the

future, correct? Yeah. So we're starting like most companies, we're starting outside the U.S. So we have a number of sites outside the U.S. And then next year we're planning to submit an EFS ID to the FDA and then start starting treating patients in the U.S. after that. Got it. Very cool. It'll be fun to watch the progress. Exciting stage for Tioga, especially considering there's been lengthy development process to date.

With that said, let's for the next maybe 20, 30 minutes. So going through some, I like to call these just different cross-functional kind of topics, if you will, right, that every startup or ambitious founder that's listening to this is going to have to probably address at some point if they're going to expect their venture to see some light of day. First one on the docket is you went through kind of the lengthy list of various companies that you've been with, right, that are not just specific to cardiovascular, right? Sleep apnea, cooling or hypothermia, specific time in hypothermia space, which is quite interesting. And so you've seen a lot of ideas, right? And I think maybe even you mentioned when you

circle back around after taking some time off at circle background with Amar, you probably evaluated a number of different concepts. So when you think about like where to go, how to choose, right, how to determine whether or not an idea is even worth, even worth pursuing. Are there a few things that kind of come to mind that would help another founder, maybe that's never, doesn't have as many swings at the plate as you, really hone in on something that might actually work? Yeah, I always go back to fundamentals, which are clinical needs, right? And if there's a marketing clinical need, and the way to assess this, in my opinion,

is not necessarily to read a bunch of things or look at reports or anything like that. It's actually to go out and talk to physicians. where are the pain points that they're having? Do they see a lot of these patients? Are there, is there a lot of morbidity and or mortality associated with this? Do they need a better tool? So that's where it starts. So it's making sure that you actually have the right set of KOLs.

And again, like this is assuming, obviously, that you're already moving into a, you already have a vertical identified, like interventional cardiology. And then from there, I think you have to take a look at the strategic space and making sure that what you're working on is going to ultimately fit with a strategic. Now, there are more disruptive things that actually have a great clinical need, but they don't necessarily fit with a strategic. And that's okay. It's just you have to know about that because it may mean that you have to take it longer and really get into commercialization, more directly into commercialization, as opposed to certain areas of a lot of interventional cardiologists like this, for example,

are, there's a number of things in structural, whether they be mitral or anything outside of structural, where strategics are looking for better solutions that can treat more patients that are easier to use, that have better outcomes, et cetera. So you want to make sure I think that it fits both of those things. And then the final thing actually, and this actually may actually go first, is just picking the vertical. When you get outside of certain verticals, things get a little bit harder. I think, I think that I still think that interventional cardiology is a better vertical to operate in. And really all of cardiology is a better vertical just because of the physicians, whether they be an interventionalist or electrophysiologists, are all looking to adopt new technologies

and they're open to new technologies. Other spaces that I've worked in have really big clinical needs, but they're harder to access. I think sleep apathy is a really good example. That sleep apathy company I did 15 years ago, 15 plus years ago, is that there's the E&T surgeon who sees some of these patients, but then there's a pulmonologist that sees patients. And then there's really no one that really owns the patients that, that, you know, and so it becomes very difficult from a market development standpoint. And again, it doesn't mean that you, you don't pursue a project like that. It's just you have to really go into it with eyes wide open, I think. Yeah, that's a really interesting point. I want to circle back around to the first thing that you mentioned as well, but that that kind

of understanding sort of the workflow, if you will, how patients come into a certain kind of pathway and how referred. Do you think that like oftentimes that's the nature of that specialist or it's just like a sort of more of a symptom of this is how kind of patients have navigated the pathway for 20, 30 years and it just remains the same. Or do you think it's more like you mentioned intervention cardiology. Like a lot of cardiologists as we both know, they're just aggressive, right? Not only do they own the patient, but like they're aggressive about adopting adopting new therapies. So you get a mix of both or one or the other? So you're talking about whether or not it's patient driven versus physician-driven.

Yeah, correct. Yeah, yeah. I think in interventional cardiology is not necessarily patient-driven. I think these are all patients that, for one form or another, all already being seen by cardiology. I don't think there's a lot of patients that are trying to seek out a better left-atrial appendage closure device or something like that. Some of them may. They may get to the point where they're deciding, I don't want to take cummidin or anticoagulants anymore, and therefore I want to see what I can do around this. I think that's probably some of it. But it's probably more because the cardiologists are more likely to offer those

therapies. Now, if you're talking about something like sleep apnea, then it's going to be much more patient-driven, right? Because that's really an elective procedure. Most of these procedures are elected, but some procedures are more elective than other procedures. And I think that's where it gets a little bit stick here is when you're really having to reach into patient populations and get them to drive it. And we see this with a lot of less traditional therapeutic areas. not so much things that chief of med companies are working on, but non-Chief-a-med companies are working on. I can think of a few. I don't want to necessarily mention them. But they have tackier or stickier patient flow dynamics because there's not one specialty that is just seeing all these things.

Or the specialty that is seeing all these patients is not the one that's going to do the implanting. And that's hard. That's a really good point. It's something that I think probably a lot of folks that haven't been around as long as you have or have done many startups is, yeah, aren't thinking about that friction, that kind of commercial friction early on. So that's a really good point. You mentioned the first answer in what I like to consider getting in the mix, whether you call it VOC or just engaging directly with the end users. Do you think that stems from like some of your commercial background early on just knowing how truly valuable that is

just to have real like conversations, conversations with interventionalists or name your specialty? Yeah. I think that's just where I've come from. I've come from more of a commercial background. and I've always turned to physicians. And again, you want to make sure you're turning to the right physicians because not every physician is going to give you deep insights. But one of the things that's great about cardiology is that it's really easy just to reach out to somebody that you don't even know. There's a whole group of people that know people that you know. But then there's other people that you don't have any connection to,

but you can find their email, reach out to them. And they'll like, oh, yeah, I'll meet you at TCT. And then you start a relationship. So it's really easy to see who's talking on the podium. and then start a relationship with them or at least a conversation with them afterwards. But yeah, I think it actually has to come from a clinical need and has to come based off of watching a procedure, watching a disease state, etc. It all comes down to when I was at Three Arch, which was Tom Fogany's venture capital firm,

he talked about, I always thought it was interesting. He said that he always said a number of things that really stuck with me. One of the things when I was in marketing that he used to say, And he said, people in marketing don't segment the market, physicians segment the market. And I thought that was a really interesting way of saying it, because if you really sit down with a physician and you can understand the buckets of patients that they're thinking about, that's ultimately how for early stage device technologies, especially how the market gets segmented by disease state and by anatomy and by this and everything.

So I think I've retained a mixture of the commercial and clinical. background if that makes any sense. And I think it's really hard because a lot of people that come from a marketing background don't necessarily like to get super technical when it comes to medical issues. They tend to be more promotional or they've worked on sales tools or something like that, which is all well and good. But if you're really going to be doing this upstream stuff and starting companies, you've got to really sit down and get into the brain of the users and find out where the pain points are. And the only way to do that is to really understand what they're doing. doing spend time in the lab, go to meetings, talk to people.

Yeah, no doubt. Like the best marketers that I've ever known can hold their own, right, in an R&D conversation, right? Because they just know, they know the space. They know the technical constraints of developing a certain product to meet a certain need. That's a really good point. Let's transition to whether you want to frame this up to the early days of Tioga or just give us an example. I'll let you take it from here. But let's say you've identified a need or an area to tackle.

You've got a concept that you think is worth pursuing. Some of the hardest work that, in my opinion, is like trying to iterate early on when There's not a lot of capital to play with, and resources are pretty lean. And so I'm sure, like Luna, as an example, right, looks a lot different now that is in patients than it did very early on. And what are, like, your best tips for other, whether it's a physician that wants to pursue an idea or another engineer that wants to do a startup, like, what are the kind of the keys to success to, like, quickly iterating with limited resources in those early days?

I think the most important thing is to try to get a prototype working in an animal model as soon as possible. And a lot of times, sometimes don't be some resistance. Oh, we're not ready. we need more time, et cetera, but like literally forcing yourself to reduce it to something that will work in a model, in a pre-clinical model, is really important. And it took us a lot to get to where we are today. We went through probably a good three years of back and forth to get to a function, a valve that we knew we could land in a pre-clinical model. It did not happen overnight at all.

And the complexity that we started out with versus where we are today, we have reduced the complexity dramatically over the last really two to three years. So I think you got to push it into a preclinical model as soon as possible. And then I think you have to really make sure you have an engineer in an engineering team that's willing to throw up complexity. There's a lot of engineers that again, I don't want to speak negatively about engineers, but it's really, really easy to make something really complicated in some ways because everyone gets excited about solid works and doing a bunch of iterations of things. It takes a real talent to make something, to take that complexity and reduce it into something that's simpler. And so I think it's really applied to both of those things. I would say preclinical models as well as reducing complexity.

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