Medsider: Learn from Medtech and Healthtech Founders and CEOs - Building the Market Before the Product: Interview with Inmedix CEO Andrew Holman, MD

Episode Date: December 10, 2025

In this episode of Medsider Radio, we sat down with Andrew Holman, MD, CEO of Inmedix. Inmedix is commercializing CloudHRV, an FDA-cleared diagnostic that quantifies biological stress with cl...inical precision to guide treatment decisions in autoimmune disease and beyond.Andrew is a practicing rheumatologist in Seattle with 25 years of clinical and research experience. His discoveries linking autonomic dysfunction to autoimmune disease outcomes led to a $10 million patent sale to Boehringer Ingelheim. After a decade in retirement, he returned to found Inmedix and pioneer the field of immuno-autonomics — preparing the market for his technology years before launch.In this interview, Andrew shares how to build a category before commercializing a product, why clinical evidence creates competitive moats that money can't replicate, and how to raise capital from angel investors by understanding what they actually care about.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 Andrew Holman.

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Starting point is 00:00:00 My advantage has been I have skin in the game. I have credibility. It's very unusual to have clinical trials before you raise money. That's just unusual. And the one thing the angels always look at, when's the exit? Because a lot of times they're waiting 15 years. And some of these angels are 70 years old. They're not going to wait 15 years.
Starting point is 00:00:22 So you've got to remember to speak to that concern that they have. And they're not like VCs where, you know, half of their companies can fail. can fail and that they have a bunch that are astronomically successful. They don't think that way. So just remember they're regular people. And sometimes they're motivated by their heart a little bit too. Welcome to Medsider, where you can learn from the brightest founders and CEOs in medical devices and health technology.
Starting point is 00:00:50 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, in this episode of MedSiter, I sat down with Dr. Andrew Holman, CEO and co-founder of Medics, a company commercializing Cloud H.R.V. An FDA-clear diagnostic that measures the autonomic nervous system with clinical precision.
Starting point is 00:01:15 A practicing rheumatologist and founding physician at Pacific Rheumatology Associates in Seattle, his 25-year clinical and research career includes 16 lead author published papers and 15 clinical studies involving me. nearly 1,500 patients. Andrew's discoveries in autonomic dysfunction and fibromyalgia led to a $10 million patent sale to Bowringer in 2007 and pioneered the field of immunoautonomics. Here are few the key things that we discussed in this conversation. First, give the specialty a reason to care
Starting point is 00:01:41 and a way to act immediately. By naming the field immunoautonomics and pounding the message for years, Andrew made autonomic measurements something rheumatologists could talk about. Cloud HRV was then designed to fit existing reimbursement and workflow, creating both demand, any clear path to adoption, a combination few startups managed to align. Second, evidence is the through line from FDA to fundraising to adoption. Before commercializing cloud HRB, Andrew mapped out an 18 study clinical plan spanning outcomes, indications, and health economics. It wasn't just about checking regulatory boxes. It built credibility with physicians, informed payers, and created a body of proof. Competitors would need years to replicate. Third, know who you're pitching. Angels aren't
Starting point is 00:02:21 many VCs. Andrew raised $17 million because he didn't pitch Angel like institutions. He showed skin in the game, delivered steady progress through small rolling rounds, and kept investors informed along the way. The result, a 65% reinvestment rate in a community of backers who stayed with him. 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 Canary Medical, Brian Lord, CEO of Pristine Surgical, Don Crawford, co-founder of Safian and current CEO of Corvista Health and other proven MedTech founders and CEOs.
Starting point is 00:02:58 Look, we get it. Keeping up with every Medsider interview isn't easy. That's why we created Medsider mentors. These ebook 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 medsider radio.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,
Starting point is 00:03:36 curated guides packed 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 VCs, 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 slash mentors. All right, without further ado, let's dive in in the interview. All right, Dr. Andrew Holman, welcome to Medsider Radio. Appreciate you coming on. Thank you very much. I know for the sake of formalities. I'll maybe refer to you as Andrew, but just for everyone knows, I recorded a short bio and they
Starting point is 00:04:17 they should understand that you're an MD, but we'll treat it like an informal discussion here today. But yeah, I appreciate you coming on. And with that said, I recorded a very short bio at the outset of this episode. But let's start there. I mean, if you can give us like a one or two minute, you know, high level overview of your journey up until now, that'd be great. Yes, thanks very much. I really appreciate the opportunity to be with you as well. So I'm a in the trenches rheumatologist in Seattle from here locally trained all around the country. Really, I started my entrepreneurial journey as a clinician trying to sort out fibromyalgia, which a very challenging problem.
Starting point is 00:04:55 Listening to patients were otherwise dismissed, we discovered a number of breakthroughs in terms of how the brain affects sleep and the autonomic nervous system which we can go into. And that led us to discoveries on how to solve some very important problems and failures that we had in our specialty of rheumatology. where the folks who take care of autoimmune disease, rheumatoid arthritis, lupus, ankyl spondylase, and so forth. They like to call us the consult of last resort. We are the last doctor, you'll see,
Starting point is 00:05:24 and hopefully your audience doesn't have to see us. I had an exit after selling patents, after discovering some answers in fibromyalgia, and then came out of retirement after 10 years when the world was ready for the other things we had discovered, because sometimes what you have isn't the right time. So that's the Edmetics journey over 25 years. And the last 10 is the Edmetics part.
Starting point is 00:05:47 Got it. Very good. Well, I'm certainly anxious to kind of dig into that in a little bit more detail, but you made a few points about your practice specifically that we might touch on as the conversation unfolds. But with that said, tell us a little bit about in medics and the cloud HRV system, right? And maybe frame that up as if no one has ever heard of this. And I'm a sophomore in high school learning about this maybe for the first time.
Starting point is 00:06:10 Okay. Okay. Well, we address what you already know matters. Everyone knows that stress matters. It's not a warm and fuzzy concept. It's actually biology in your brain. And it's not behavior. It's the epinephrine adrenaline response that you're wired to respond to the world around you. So in cloud HRV is a very advanced, a precision FDA cleared version of heart rate variability or HRV. So if your audience, who's using whoop or or a ring, Fitbit, Garmin, and so forth, that's a consumer fitness tracker version. What we have is a very much more specific hardware and proprietary software to measure the autonomic nervous system. That autonomic nervous system needs a little explanation. There's two parts in your brain, the sympathetic, fight or flight response. We all know what that feels like. You ride roller coaster or whatever. Lion chases you. And then there's an inverse component called the parasympathetic, which is predominant sleep that helps you recover. It's very important
Starting point is 00:07:13 for athletes and healing and so forth. And they're constantly on at the same time. Think of the sympathetic as the accelerator on your car and the parasympathetic is the brake. So these, some folks aren't really wired in an optimal way. It's not their fault. But if you walk into my office and you have more of the accelerator going on, you're in trouble and I can't control your problem. So this is not news to anybody that stress drives disease to excess. It's the missing link in clinical care, but it's the elephant in the examination room. We all know about it. The problem is we never had a way to measure it with individual precision. And that's what we've taken through the FDA to bring to rheumatology first, then the rest of medicine as they see fit.
Starting point is 00:08:01 started with fibromyalgia, how stress fragments sleep. If you block the fragmentation, the arousal, kind of the alarm in your brain, you will then facilitate sleep. So you don't make people sleep, you let them sleep. And they get recovery there. Some of those people also had rheumatoid arthritis. And as we solved the fibromyalgia half of their concern, their rheumatoid arthritis was getting better as we were getting the autonomic nervous system better.
Starting point is 00:08:26 And overall, we were able to increase in one study the remission rate. control rate of rheumatoid arthritis, we'll see young people, from 25%, which is the current problem, to 79%. So a very exciting science, very much a solution for a rheumatologist in the trenches like me, going from 75% failure from patient to patient to 80% success. Got it. So I'm on the website now, which is inmedics.com. So if you're listening to this and don't get to the full write-up on med site, or it's I-N, as a Nancy, M-E-D-I-X. So inmedics.com. We'll link to it in that full write-up, by the way. Give me a better sense for, like, cloud HRV.
Starting point is 00:09:04 So if I'm a, let's say my patient of yours, and you think this may be a good, a good tool to potentially, you know, diagnose an issue. Is it something that I use in your clinic? And is it purely a diagnostic tool at this point? Yes, it's a very precise diagnostic tool. It's kind of a difference between an x-ray moving to an MRI. So the patient experience is very simple. We all know that when you go to the doctor, they check you in.
Starting point is 00:09:28 they say, the doctor will be right in. Well, we know what that means. Scroll your phone, check your email. So during that dead time for us, and we try it to be too late, is we have you lie down, put pads, EKG pads on your wrists and ankles. No chestbands like you see in the sports folks in the park. It's wrists and ankles, very patient friendly. You lie down, don't talk, don't say anything, don't move. And a five-minute EKG tracing that's more sophisticated than any cardiac care unit goes to the cloud and in 10 seconds, here's your report of your sympathetic and parasympathetic numbers at rest. And I walk in and I incorporate that into your treatment plan. Got it. Got it. That's super helpful. And since you touched on some of the consumer
Starting point is 00:10:11 great versions of HRV, right? Because if, you know, there's some folks that are listening to this that are, you know, maybe more involved in the longevity or biohacking space, you know, track through HRV on their aura or their whoop, maybe they have an eight sleep even. I think eight sleep maybe tracks HRV. I'm not entirely sure. I don't have one myself. But anyway, give us a sense for kind of the differences, right? Because you're in the weeds. You obviously know HRV probably better than most, right? And so are there, you know, quite significant sort of underappreciated differences between a consumer, you know, kind of HRV data point and something like cloud HRV? Yes, it's a very important distinction. So I have whoop on my wrist right now. I like
Starting point is 00:10:50 have followed that company. I think they're very innovative. But Garmin, or a ring, Fitbit, which is owned by Google and Apple, of course, are players in that market. And what they do is they use something, the green light. So everybody look under their watch. They see the green light. That's called photoplysmography. There's your word for the week. And it's basically a way of looking at the pulse wave. So you can get a pulse. You can check a fib. You can check Brady, a cardiac, a cardio. Whoop just got FDA cleared for that. Apple's had a way. it for a while. But you can't identify exactly where the beat is. It's just kind of a wave. You need an EKG spike. People know what the EKG looks like with that QRS spike, right? You need that level
Starting point is 00:11:33 of hardware precision to know what the beat is because you're measuring millisecond differences between the beats. Turns out that your heart's not a metronome. When you have a beat of 60 mil beats per minute, it doesn't go every second. It goes 1.1 for a 0.9.1. That's variable with breathing. Normal people do that. When you're under stress, that variability disappears. And then you get more of a metronome, which is a bad sign for your health. So it's very important to measure where the heartbeat is with precision. All of these companies are teaching folks about HRV. We're very thankful. People realize that their autonomic nervous system is a big deal. You don't think about it unless it's not working and then it's a disaster. So basically,
Starting point is 00:12:17 we appreciate all the education, but this is FDA grade precision and paid for by insurance. I need that kind of precision to make a decision about your health care. Okay, got it. Got it. That's helpful. And you answer my follow-up question, right? How does that precision really matter in terms of like the outcome, right, for the patient? But it sounds like it's pretty important. And so it's interesting, too, because I've, you know, before Fastway, which is the company I'm working on now I was I started a it was a class two we designed a class two devices but it was much more in the consumer wellness space so I got familiar with all these devices and some of the founders actually whoop and aura etc I had never heard of HRV before and that was that was a new that was
Starting point is 00:12:54 new that was new to me and it continues to amaze me some of the the wild HRV data that you see in athletes I mean it is like off off the charts which we obviously get into the end of the weeds here but it goes to show you that that's sort of that's important right I mean if a high performance athlete has that type of an HRV, like that has to be a really important biomarker that is likely, you know, pretty impactful when it comes to when it comes to overall health. Can I add a little piece there since you mentioned it? So the technology we have exclusive license to medical applications worldwide actually comes from professional sports.
Starting point is 00:13:29 This is a company called Omega Wave. Half the NFL used it. U.S. Special Forces. Leonel Messi is trained with it for years, NBA, NHL. They made their name in professional sports. winning Super Bowls, World Cups, and Olympic medals. But they didn't know FDA, regulatory, and I got a chance to borrow it about 20 years ago when they were a little tiny nothing company, right?
Starting point is 00:13:52 Because otherwise they wouldn't let me borrow it. And I said, I think there's some medical application. If you measure the autonomic nervous system with this precision, and the answer was, yes, they do. So those of you on the podcast who are interested in professional sports, this is like Moneyball from coming to medicine. That's what this is all about. Yeah, that's interesting. And I love actually the overlap, but we don't get into this much on this particular podcast. But I think there are things that you can take in the world of medicine and apply them more to consumer wellness, right? And there's probably likely some good outcomes there. And then vice versa, right? Take a kind of a general concept that's not really medical grade and apply precision to that. And you could see like a really interesting use case, right, for, you know, for medical purposes. So I like kind of talking about that overlap every now again, because it's a good, it's a good reminder that sort of, It's a pendulum, right, that goes both ways.
Starting point is 00:14:43 So with that said, give us a sense for kind of where in medics is at with respect to kind of cloud HRV. It sounds like you're, you know, based on our researcher, you're in the process of commercializing the technology now. That's right. So research 25 years, a little hiatus there where nobody cared. That'll be part of the entrepreneur journey. Created the Delaware Sea Corporation in 2017, raised about $17 million from angel investors.
Starting point is 00:15:07 So no, no, no, no VCs yet. And we are FDA cleared in January, soft launch in June. The doctors are using it more than we expected. Insurance is paying for it more than we expected. And we just signed up Johns Hopkins. They are using it in their chronic Lyme disease study. They think there's an autonomic signal there. So all these are very exciting.
Starting point is 00:15:28 So we're now have a modest raise to go from six units to 600 as fast as we can. Because as you might imagine, stress, HRV, is precision grade is appealing to many, many doctors in both in rheumatology based on our clinical trials and other areas of medicine. Stress matters. It's a missing vital sign, essentially. Yeah, and you're quantifying it. So that's a good overview. So again, inmedics.com is the website I-N as a Nancy, M-E-D-I-X.com, willing to it in the full write-up on Medsider. And if you're new to Medsider, these write-ups accompany all of our podcasts that are meant to really highlight and emphasize a lot of the key learnings that our guest share like Dr. Holman. So with that said,
Starting point is 00:16:12 let's get into, let's spend maybe the next 30 minutes kind of going through not only your entrepreneurial journey, but kind of, you know, lessons learned, right? You know, building in medics specifically. And so with that said, first topic is I would say maybe the more obvious one, right, is your practicing physician made the jump, right, to sort of industry in the world of startups. There's a lot of, as you can imagine, there's a lot of docs that listen to this show and have an idea, right? They're close to the need, right, the clinical need and have an idea are hesitant to kind of like make make the jump you did so when you think about kind of how you went about that or maybe like a couple like really key things that you picked up along the way
Starting point is 00:16:46 what's your advice to other other physicians that are maybe thinking about thinking about taking a swing at their at their at their idea have you ever done a home remodel it costs three times as much takes three times as long so that's the first thing so so be ready you know be ready be determined try to work on something that you're a domain expert in and something that really something to you because they're going to be ups and downs you know play for the long game I'm a big believer in data we did our studies before we got the license for the tool that's not always possible I understand that it's also not always possible to have an exit that helps fund it I put four million in this
Starting point is 00:17:23 myself so that's hard also I became an entrepreneur at 55 you know my children are all kind of entrepreneurs because they said dad's doing it how hard can this be but but the key is you know a lot of people, so I kind of feel for the young entrepreneurs because they don't have all those assets and relationships yet. So the bottom line is, remember, you're the domain expert. Don't let people slow you down. You know more about it than they do. Just be persevering. Also, in the medical field, I mean, data is key. And I don't mean data like big data. I mean clinical data and evidence. So be rigorous in your evidence. Doctors like me who are going to use a medical product, which may be
Starting point is 00:18:06 different in other spaces, but they really don't care what the pharma company tells us in their marketing material. We want to see the paper. We want to see the evidence because my malpractice and my reputation and my success depends on really being right. So be rigorous with yourself. Don't fool yourself. The scientific rigor is not only more of a moat, but it actually opens up opportunities too. I want to get to that or I want to touch on that in a little bit more detail here. But a couple things that you mentioned that I think maybe are worth are worth highlighting a little bit is, is that that analogy you started out with, right? Like startups are like a home remodel project. They're going to be more expensive. They're going to be, they're going to take longer
Starting point is 00:18:47 than you expect and they're messy, right? So that that idea of operating in that kind of mess, I think sometimes can be, can be difficult, right? I mean, for most people that aren't used to it. So are there a few things that, I mean, did you feel like you just had the personality to kind of jump in? Or is it something that you just kind of learned to operate? You learn to operate kind of within that environment. Maybe you are well suited for this particular approach in rheumatology, you know, this consults of last resort. Fibromyalgia started with listening to the patients, believing them when other people didn't. I was kind of an outsider.
Starting point is 00:19:20 I was thought to be that crazy guy in town. And then I discovered how dopamine drove the thing and eventually sold patents to bearing a land for $10 million. And three other farmer companies, UCB and GSK started programs in fibromyalgia. So I got, you know, some validation there. and some resources. So that's unusual. And then basically I came out of a nice retirement because we had the ability to tell the world how to improve outcomes in autoimmune disease and having patents and so forth. If you don't do it, you feel guilty about it, you know, to withhold some a breakthrough that you know because you have the patent, nobody else can do it. So, you know,
Starting point is 00:19:58 I came, I'm driven to do this because if we don't do it, who's going to do it? And we have the data. So, you know, I'm a little bit sort of wired that way. So I'm on a mission. Not all the investors, they love the passion, as they say, but they'd like to me to be, you know, down sort of feet on the ground at the same time. So I surround myself with people like that. Yeah. But I make sure I drive the vision forward. Yeah, that's great. And I love the fact that you brought up, you know, you became an entrepreneur in your mid-50s, right? Because like so many, so many listening to this. And honestly, really myself sometimes, I think, gosh, I mean, I, I, my two old now to, like, do this stuff. It's, like, hard. It's like really hard. You know what I mean? And if you've
Starting point is 00:20:41 been doing it for a while, it's really hard. But the reality is, you know, there's so many great entrepreneurs, right, that started later in their, in their careers. And, and things did end up working well. And, you know, you can make a strong argument that you just have way, way, way more life experience and wisdom, right? To be making, you know, really crucial decisions later in life than maybe, maybe that far outweighs sort of the youthful sort of ambition of a 20-something-year-old. I think you're right. I think you're right. It's an advantage and a disadvantage. It's both. It's both. So that's both. That's both ways for sure. Yeah. With that said, let's talk a little bit about clinical data and maybe you're engaging with FDA, right? Because if I hear about cloud HRV, I think, I don't know. I mean, like to get an FDA clearance, probably don't even need clinical. I don't know for sure, but maybe not even need clinical data, right? And you've had the balance probably that of this idea of, you know, what do you really need to like effectively sell this, right, and get to market versus what do you
Starting point is 00:21:35 truly need to convince, you know, other physicians to adopt therapy? So talk to us a little about your approach, you know, considering you just mentioned the importance of clinical data and how that, you know, how that's factored into even your, you know, mapping out your, your clean reg kind roadmap. Yeah. We are 510K with a predicate. So there are other FDA cleared HRV devices. Now, they're used for more like brain damage. And they have a lot of bells and whistles with provocative tests. They may take an hour or two to do all the bells and whistles. They may cost 10 times what ours costs.
Starting point is 00:22:10 But we used a predicate with a, and that was a process where it does not require clinical data. Now, that said, we had the clinical data ahead of time because I didn't want to launch into a business without having it for the sales and marketing people. I didn't really know what I was solving. You want to make sure you're solving a problem. The FDA process, though, we have added indices, which add extra value, which could have been a de novo. So we had five presubs. Encourage the entrepreneurs, whenever I see deal pitch to me, I always say, have you had a pre-sad with the FDA? And if you haven't, it's automatically, no, I'm not investing.
Starting point is 00:22:46 It's free. It's an hour. Please take advantage. We did it five times. And listen to the FDA. Don't argue with them. You can see some of the stuff going on with. publicly. They're taking a different approach. I'd love to talk to Will Amit, by the way, if you want
Starting point is 00:23:01 to introduce me. But I think we have synergies. But the idea is, listen to the FDA. They tell you, they will not tell you what to do. You propose what you want and you say, FDA, is this okay? That's true. But if you're respectful and an entrepreneur, I think they have a soft spot for someone out there trying to make a difference and they're not funded like some, you know, massive and collaborate. So be respectful, use them as a resource and realize that they're there on a mission too. And they want you to succeed. That's good advice. Yeah. And that topic comes up quite a bit is like the importance of Q subs, right, and taking advantage of those. Circling back around to your comment about clinical data being a moat, right? How is that, how is that sort of
Starting point is 00:23:43 impacted how you've built in medics, right? Because it sounds like that's been something that you've sort of, you know, double down on. Not just in terms of it being able to sort of drive adoption, the technology, but again, kind of further deepening and widening your footprint, so to speak. Yes, we have an 18 study clinical development plan, which we have budgeted in the $10 million series A. We're doing a little bridge round right now, a convertible note. But all of that is paid for to understand your different stakeholders. So some of it is for the patients to see, okay, can we apply this a certain way? Some is for FDA to say, can we add our indications for use? We already have our basic one as an HRV machine that are diagnostic that any doctor can use at their discretion.
Starting point is 00:24:28 That's extremely broad across medicine. But we like to have some specific ones as well. Also, payers. We've done health economics studies. Understand your stakeholders and try to speak to that. The moat issue is that no matter how big you are, and sometimes the bigger you are, the slower you are with your clinical trial work. I mean, look how long it took Apple to get AFib, you know, compared to. what, whooped it. I mean, it's a lot quicker. Basically, no matter how much money you have,
Starting point is 00:24:56 you can't do a one-year prospective double-blind study in less than one year. So by the time you try to catch up within medics, we published already, we're already three, four years ahead of you. And then from a strategic exit point of view, it puts us in a position where it's a lot easier to buy us than to compete with us. So that's something for the entrepreneurs to think about as well. Got it. Yeah. So it's not just about the sheer amount of data.
Starting point is 00:25:20 In your perspective, it's more about can we stay ahead, right, of others that are trying to catch us, right? And are you so far ahead of others that it just prevents, you know, other folks, other potential competitors from even getting into the game because it's, you know, the money, time to even remotely try to attempt to catch up is just not worth the swing. Right. And the proprietary algorithms are trade secrets. And so a lot of people in the software area don't want to put that in a pattern.
Starting point is 00:25:46 patent. So they understand that. Not all investors do, you have to explain that to them sometimes. It's the exclusive license for worldwide rights that is also very valuable. So if you try to do what we do, you can spend an awful lot of time spinning your wheels when you might just want to give us a call and make us an offer. Do a deal. I want to get to the patent topic, right? Because you obviously had you mentioned this earlier, right, the exit to Bowringer. But really just your thoughts in general. about IP, because you obviously have a fair amount of experience here. But before we get there, let's talk a little bit about fundraising, right? You're 17 million in. Sounds like mostly through
Starting point is 00:26:25 angels. All angels. All angels. That's, you know, obviously, in and of itself, pretty significant amount of capital coming from, you know, from individual investors. Two part question. One, like, how have you been able to effectively do that? If you can summarize maybe a couple of key learnings there. And then, you know, how are you approaching, you know, your discussions with institutional capital, right? And that kind of transition from early stage money. to, you know, more, I don't even, I hate to say it, but, like, maybe a fit more sophisticated money at this point. Sometimes.
Starting point is 00:26:53 Sometimes. We're laughing about it, but you get me, you understand my hesitation, right? I don't even want to use that label, but I think it's easy to understand for most people. Hey, everyone, let's take a quick break to talk about fast wave medical, the company I co-founded and lead as CEO. We're developing next generation intravascular lithotripsy system. or IVL for short, to tackle complex calcific disease. The IVL market is valued at over $10 billion, but there's currently only one major player.
Starting point is 00:27:25 In early 2023, we opened up an investment opportunity to our community, and within a month we secured close to $10 million. Then in early 24, we closed an oversubscribed $19 million round in just a few weeks, bringing the total investment into Fastwave to over $40 million. Corporate interest in the IVL space is growing too, the $900 million acquisition of Bolt Medical by Boston Scientific. And then J&J's $13 billion acquisition of Shockwave medical signals a lot of attention towards emerging IBL startups like FastWave.
Starting point is 00:27:54 And we're making some serious progress. FastWave recently received its seventh patent for our differentiated laser IVL platform for coronary applications. On the clinical side, last year we completed the first inhuman study of our advanced electric IVL system with some pretty compelling results. Next up in 2025, we have IDEE trials plan for both our peripheral and coronary IVL platforms. So if you're interested in investing in the fast-growing IVL market, sign up for our investor wait list at fastwavemedical.com forward slash invest. Again, that's fastwavemedical.com forward slash invest. Now let's get back to the conversation.
Starting point is 00:28:30 Yeah. So I'm not trying to give up a free plug to anybody necessarily, but I am very grateful to the angels. And I was a member of Karitsu Forum, which is one of the largest angel networks in the world. as a member and just sitting back learning about fintech and real estate and i was retired right and then they ask you what are you doing well i have this little startup so they got me started pitching with them and we have 10 different chapters they've got funds and four of them you know i just pitched yesterday uh in a big expo for them so uh basically i would be um encouraging entrepreneurs looking at angels to look at the various angel groups some are different than others contact me if you've got
Starting point is 00:29:11 questions I give you the scoop on really who are the most nurturing because you need that as well and supportive you don't want to just be said oh your pitch isn't any good kick you to the curb that's not helping anybody so anyway the angels will be very helpful I don't know if I have any friends left from college in high school or childhood that will take my phone call anymore because you know they're always asking oh you got another round yeah well that's going to happen this weekend so so there is that you know but and transition is very, very hard. So our strength is science, regulatory, product market fit. We know how to run this business. We're trying to executives from diagnostic companies.
Starting point is 00:29:54 But I lost my business partner to cancer, and he was my business half, which is always nice with the medicine with the business, right? The science with the business. He was actually the founder of Illuminate, his very famous guy, Larry Bach. He was my Bowdoin College roommate. So I had him like two years. And then I now have to do his job. And so that's hard. That's hard. So try to get the best advice you can because the VC world is very different. They have mandates. And I'm in the diagnostic field, which is very poorly thought of.
Starting point is 00:30:23 In fact, diagnostics are a terrible investment unless you've got a new repeated vital sign, like measuring stress, with SaaS margins. You know, we get paid for 10 seconds in the cloud while the doctor does all the work. Now, we had to do some work, or obviously. But that's very unusual. Most diagnostics are companion diagnostics, and they really go with a drug for one person, for one disease, and that's it. And maybe your genomics, you only check it once, right? Most of the time.
Starting point is 00:30:54 So anyway, I don't have a secret answer for VC. I'll tell you after we get funded. Right. Well, I'll follow up and go deep on that. But you brought up a couple good points. One is which, how you describe kind of diagnostics and the view that most VCs have around that category. I think that's really important to understand if you're, if you're pitching now, right?
Starting point is 00:31:15 Understand how, understand how you, how you fit within sort of these defined categories, right? But also go deep and understand how are, like, what's the track record of those categories, right? Has this VC ever, ever invested in lost big? Or have they maybe invested in maybe one, actually, surprisingly around this category? I think that's really, really important to understand because it's extremely helpful and will oftentimes signal to sophisticated investors that you, you know, know what you're talking about, right? You understand how they invest, how they look at the world, et cetera. So I think that's a really, really important point to mention. Kind of certainly back around to Angels, though, the name of the forum that you mentioned, what was it called?
Starting point is 00:31:51 Curitsu. Curitsu Forum is founded in San Francisco. The Pacific Northwest is one of the largest life science ones. I'm on the life science review committee as well, so I kind of help with the regulatory and things they may not know about. There's a process to get, and they don't charge it ticket to the end. Got it. Got it. And they include a due diligence as well. Ah, very good. We'll link to that in the full write-up on this. But I guess just specific to kind of angels, right? And getting as far as you have largely with angel money, I think this is like an ever-growing gap, right, for most life science, med tech startups is finding investors to come in at pre-seed seed, even quite honestly series A at this point, right? It's just there's not a lot of that type of capital around.
Starting point is 00:32:36 And so these angel groups are becoming more and more important. Or angels just in general are becoming more and more important. So like thinking about your journey raising that much capital, if you had to start again maybe, right, and do it from scratch, is there like a couple things that you do differently at all? Well, I never won any pitch competitions for having a nice, slick, great pitch. Even Larry, my buddy said, tell me what you do so my neighbor high school or would understand. He died before I figured out how to do that.
Starting point is 00:33:04 I mean, you know, it's very sad. Other people have beautiful pitch techniques, but maybe they don't have a great business. So part of my advantage has been I have skin in the game. I have credibility. It's very unusual to have clinical trials before you raise money, right? That's just unusual. And the one thing the angels always look at, when's the exit? Because a lot of times they're waiting 15 years.
Starting point is 00:33:30 And some of these angels are 70 years old. They're not going to wait 15 years. So you've got to remember to speak to that concern that they have. And they're not like VCs where, you know, half of their companies can fail. And that they have a bunch that are astronomically successful. They don't think that way. So just remember they're regular people. Some of which are wiser, right?
Starting point is 00:33:52 They're wiser angels, right? And sometimes they're motivated by their heart a little bit too. Yeah, yeah. There's people like certain issues. Like we're in women's health. We're not reproductive, but most people in autoimmune disease are women. So that starts the conversation. Yeah.
Starting point is 00:34:10 Those are really good points to remember. And kind of on that last statement that you made with respect to kind of the economics, keeping that front and center, I just think is always a good reminder because it sounds like you really leaned into your strengths, right, and really kind of double down on those, which I think also is important. But at the end of the day, like these people are investing, most of them are investing for not economic return. I mean, we just published an interview with Tracy McNeil recently with maternity medical. And she, they've raised a fair amount of capital too from, from Angels and
Starting point is 00:34:40 have gotten pretty far. And she, it's a point she really emphasized, right? Keep, make sure you're always circling back around to the potential economic return. Because the other things matter, right, for sure. But that matters most is the potential financial return. So, and keep them informed. Keep them informed. I send an update about every two months to my angels and I'm always available for a call. And some really like to give advice and most of the time it's pretty good. We're joking about that. But I'm always amazed at the number of CEOs that don't do that, that don't communicate with their investors. It's pretty astonishing. And I think that makes it so difficult to raise capital again from those same people. If you're taking money and
Starting point is 00:35:24 they haven't heard from you in six months a year in some cases, like that's probably not going to code well next time you come around and maybe ask for some some additional funds to keep going. With that said, I'm looking at the clock and I want to ask you a few more questions before we get to the IP topic. But let's talk about a little bit about commercialization, right? And maybe later in kind of, you know, the unfortunate death of your business partner, right, and how you're thinking about that. Because it sounds like very much he was the, he was the business guy, right? All things, business, raising capital, thinking about sales and marketing, et cetera. I'm sure you know a thing or two about that, right? Because it's literally, this is a device that
Starting point is 00:35:55 you've used in your practice, right? So you know this, you know this more than most. But give us a sense for kind of how that transition has been and talk to us a little bit about your approach to kind of scaling up commercially. Yeah, it starts with data. It started with inventing a term called immuno-autonomics, the immune system and the autonomic nervous system. coined that term 10 years ago. It's in the medical literature. We've written editorials with leading rheumatologist around the world. I co-chaired the immuno-autonomic study group for five years at the national meeting. We just pound, pound, pound the autonomic nervous system, even though it's neurology, it matters to you, rheumatologists. And also, we understand the pain of what it's
Starting point is 00:36:35 like to fail 75% of time. One of my proudest things in my career, I don't have to put me on my tombstone, is I never left a room with a patient crying. And I took care of a lot of frightened young people, and it would get you late sometimes. But, you know, you just got to hang in there. If you understand the pain and you feel the solution and get to feel that, it makes all the difference in your product market fit and you go to market strategy. Because I'm talking to people who felt the pain that I felt. And so you give them the reason why this is important, right? I mean, if it's a checkpoint inhibitor or if it's a crisp or something, what are you going to
Starting point is 00:37:12 do with it, right? How are you going to solve the problem? Make sure you set the stage for why the solution is really a solution and then have evidence that it actually is in the medical literature. And then I have a scientific advisor board and thought leaders that back you up and talk behind your back. The whole idea is you want people talking behind your back
Starting point is 00:37:30 and saying nice things. So that's kind of key. And then the other thing is very important reimbursement. Everyone in the audience who does MedTech knows if you launch, you usually have to fight for a new CPT billing code and then you have to fight for reimbursement. We didn't have to do that.
Starting point is 00:37:48 We give you the old HRV that's already paid for, so everybody gets paid, and then we give you the new indices for free on the same page. That's a huge advantage. But for everyone else, remember, you're going to have to run your business for 18 months before you get paid. And that's a challenge. So be ready for that. Yeah. Arguably, maybe the biggest anymore, right, is reimbursement or answering the question, who's going to pay for this, right? Right. Sounds like you had an existing code to work with, but when I see new pitches, especially with novel therapies, because sometimes it can be really hard, right? You can see the promise of something, but then you're staring down the way to get there, right,
Starting point is 00:38:24 the clinical data that's going to be required to justify a new CPT code. And then that's not the end of that journey, right? It's like you have the code, but now you've got to, you've got to solve for the, how is it going to be reimbursed, right? And getting all of the disparate kind of payers to kind of agree to that reimbursement or get them on board. So it's a big, big issue for sure. So it sounds like that wasn't, fortunately, something you had to, you had to solve for necessarily. I've never had anything in my practice where if I wrote a or made an order for something that I got paid to do it. This is a procedure rather than a test that you send to LabCore or request.
Starting point is 00:38:56 So this is a procedure. So the doctor's built for this and they get paid. And then we charge them up per click. So that's a massive advantage. So it's easier to give something to try if you're getting paid. Yeah, no doubt. Going back to that idea of branding, what would you call it, immuno? Imminoautonomics.
Starting point is 00:39:15 Immunoautonomics. Is there an acronym that I can say, I'm going to mess that up. It's kind of like immunoncology. It's just, you know, it is what it is. Okay. If people Google immunoautonomics, they'll say, oh, my, look at this. It's a new field kind of a rheumatology. How important was that to the success of the next?
Starting point is 00:39:32 Massive. Massive. We did a product market fit, independent impact study with a group called Core Evitas. They're very good. They do this for a farmer company, is 231 rheumatologists. And they looked at, well, have you even heard of this? Yeah. It's very interesting.
Starting point is 00:39:48 We're excited. the way, there's a diagnostic coming. What would you think about it? Ninety-six percent said they want to use it as soon as available. So it all came from branding the, why would you do this? Yeah, very, very interesting. When you think about, because it sounds like there's a fair amount of demand, right, for this. And that scale up, you know, going from, I think you said, six to six hundred minutes. Are you, are you, do you envision like hiring a direct sales force? How are you thinking about like actually? Yeah, okay. We're packed with, uh, I brought on team members from Exigen, it's a lupus company in San Diego, you know, retired people,
Starting point is 00:40:25 remounted retirement, have their head of marketing in BD, crescendo bioscience, South San Francisco, they had a diagnosis called Vectra. They were bought by Myriad genetics. So I have former executives from Myriad, from crescendo, from Exigen, yeah, and they all agree. This is a sticky relationship with rheumatologists. We don't trust anybody. We're always sold whatever. and if you're actually managing a revenue stream, our reps will get in the door. Because most docs don't see the reps anymore. It's very hard for Pfizer and J&J to get the attention of any doctor. Very hard.
Starting point is 00:41:00 Yeah, no doubt. No doubt. All right, let's touch on IP because I think this is especially interesting in your, this topic is especially interesting in your case considering your exit, right, to Boerringer. Maybe touch on that in general. Like, you know, because I think there's, again, a lot of not just physicians, but a lot of engineers, too, that listen to this podcast. So they've got, maybe they have some IP that they're sitting on that they think is worth it.
Starting point is 00:41:18 So how did that come about? Any like tips for success in getting a deal like that done? And then secondarily, if we've got time, I'd love to hear your thoughts on IP in general because it sounds like some of what you're doing in medics, though, is intentionally you're keeping it as a trade secret, right? You're not patenting it. And so I'd love to get your thoughts on that too. So the sad news is you can have the most marvelous idea that everybody loves and just you can't
Starting point is 00:41:43 get through to the company. So we had the utility patent for dopamine agonists to use for Parkinson's disease for Bering-Eleheim, GSKs, and UCB's product. And we showed that they actually had an effect in fibromyalgia. But it was so far afield that we had to do three studies, including a randomized prospective study on my own nickelide to buy the drug from the pharmacy and actually had compounded to make the thing. And we had to go to the FDA and negotiate to do the study, which took a lot of time because we were using 10 times the approved dose for Parkinson. So there's no safety data. So it's an interesting story if anybody wants to go into the weeds on that.
Starting point is 00:42:22 So finally, they would not listen to me. I was the number one prescriber of their drug in the world. But I wasn't a neurologist, right? So they go, who's this crazy, idiot, right? And they were worried I would find a side effect that might at 10 times the dose that would pull out the market. So that every reason to be concerned. So I could do a tutorial on this, but I won't hear.
Starting point is 00:42:40 So to get through to them, after we did the randomized control trial, the everything, you know, published in a major autonomic journal, nothing, nothing, nothing. To get through, you have to be innovative to your audience. So I had about 80 Christmas cards from my patients, very nice handwriting, say, don't write anything mean, this is going to the CEO of Bearingleheim in Germany, and just, you know, thank them for their drug, has made a difference, and then a week later I sent the guy a letter, I said, I hope you enjoyed the Christmas cards. I knew that they would get past the handlers. The secretaries are not going to open the CEO's Christmas cards, right? You can tell them, a Christmas card. And I got a personal letter back, and he said, oh, thank you for these Christmas cards. And he was delighted that, you know, there was this new opportunity.
Starting point is 00:43:23 And he says, how come nobody ever told me? I go, you know, you need a champion to get your patent considered by anybody. And I pretty much have learned, don't talk to anybody about the CEO. Just don't bother. Because people don't want to take a risk on that. And within three months, I had three PhDs from Germany and France talking to me in my office, and then two big due diligence is later, and I sold it for $10 million. Huh. Took Christmas cards to get through to the decision maker.
Starting point is 00:43:49 That's such a great story. Oh, man. And I couldn't agree with you more. Like, ultimately, so many deals never get done, right? Because the right people don't know about them. And so that's such a good lesson learned, right? That if you're on to something that you really have conviction around, next step is really to get to the person that. truly, truly has decision-making authority. So that's good stuff. Let touch on IP, though,
Starting point is 00:44:11 right? So this is like an ongoing trend, right? Like you talk to Elon, you know, he's like IPs for the week, you know. Joking aside, though, you know, more and more patents are being, you know, invalidated, right, by the PTAB, right? So oftentimes I wonder, right, how much of this is really worth it versus just keeping it as a trade secret, right? And it sounds like to a certain extent you maybe have some similar thoughts. And it's expensive. Let's remember it's expensive, right? Like $5,000 for me, it's about $35,000 per patent. There are certain things you want a patent. Basically, if you have a new compound or a method to do it,
Starting point is 00:44:45 if you have something specific with clinical data that you found a new treatment with somebody else's drug, that utility patent is valid, and it's your data. The people who owned it tried to scoop me at the patent office, and the patent office saw right through it because they were using the Parkinson's treatment, and mine was completely different, and I sent in a year's worth of data with a patent application, which you nobody does, right? It's usually novelty in a couple of examples. So, you know, stack your patent application with data so the office takes you seriously. Also remember, it's first to file now. It's not first to invent. So somebody, be careful that people don't scoop you on this. So don't
Starting point is 00:45:24 tell anybody. No public disclosure. You've just got to be super secretive about what you have. And then provisional patents are very valuable too. You get a year to get your data and then file it. So provisional is good, but we had a provisional where we could get the data in time, but we still decided to publish the provisional so that it was prior arts and nobody else could do it. So sometimes it's like the Yankees getting the outfielders so that the Dodgers can't get them. You know, it's one of those things. So patent strategy is tricky, but it's not impossible. Yeah, definitely it's tricky. And it reminds me of like oftentimes you need a really experienced team around you, right? Especially if things are getting serious.
Starting point is 00:46:04 yeah yeah the other thing i didn't tell you is i come from a family of lawyers and judges i'm the black sheep than the family going into medicine my dad said when i got to med school finally somebody's going to get a decent job around here um he was like a pro bono uh lawyer so so my brain thinks like a lawyer even though i'm a little bit of an odd duck yeah you've been around around too many lawyers right to not think not not not think a little bit like them so uh that's funny um we only have a few minutes left i want to get the rapid fire force in this interview but again And inmedics.com is the website, I-N-M-E-D-I-X.com. We'll again link to it in the full write-up on med-site.
Starting point is 00:46:41 Or highly encourage you to check that out. These articles always do a pretty good job, I think, anyway, I'm biased, but do a pretty good job of really emphasizing a lot of the key points that our guest shares. So highly encourage you to check that out. But if you don't get there, again, inmedics.com. So that said, first question on the rapid fire list, take us out to this time next year, right, called mid-226, Q-3-26. What are you most excited about at in medics?
Starting point is 00:47:03 Yeah, we're expanding through the United States, through rheumatology, other verticals, other, you know, stress is not just my problem. It's other people's problems as well. And really making clear that this is a missing link in clinical care that drives personalized treatment and improves outcomes. Since coming out of retirement to give this a go, right, given medics a go, what's maybe the most surprising or unexpected thing that you've learned? I've learned that you can have the best data in the world and still people don't understand it. You're right. It's not like you're giving grand rounds and you're a professor at the podium droning on with a captive audience who's taken notes because there's going to be a test after it, right? The other thing I learned that it's about messaging. You really have to message as well as you can.
Starting point is 00:47:50 And some people have more skills than other. I've tried to learn as best I can. But my strength is more the sausage than the sizzle. Yeah. I don't know. You've got a good way of kind of using some phrases. There's some stories to really highlight certain points. I think you're not too far away. Or maybe you're being too humble. Next last question here. Let's say we're in Seattle.
Starting point is 00:48:11 Maybe call it, you know, July, August, the best time to be in Seattle, maybe. You've got a room full of med tech entrepreneurs. What's the one lesson that you really, really want to drive home with that group? So the reason we're calling medics, because it's innovative medical discovery. That was in 2004, before everybody used to innovative. investors and the world out there prefer the safety of iteration something proven we can take some of the market share i'll invest in that innovation is really hard and innovation scares investors so just be prepared for that and stick to your guns have your data and understand why this innovation really is
Starting point is 00:48:48 going to change the world it's a good good way to kind of frame frame up the difference between the two all right last question let's rewind the clock maybe take us back to your late 20s early 30s maybe you're at the tail end of your training or like getting closer to that maybe potentially uh anything you you tell the younger version of yourself here's the most important thing i would tell them look you know more about this than anybody in the room right and you're not an imposter you know more surround yourself with people smarter than you but remember you know more than everybody else uh so have faith in yourself because you're doing this for good reasons because you know more about it than anybody else yeah that's a that's a good way to wrap it up i i got
Starting point is 00:49:28 kind of think that your, what's maybe helped, it's just a hunch, was maybe helped your entrepreneur careers, like I get a sense of optimism, right? And maybe that was, maybe that sort of shine through in your practice, right, because you're literally, you know, treating patients that are at, at their wits end, right? Everyone had said they're, they're making this pain up, right? And you were able to kind of give them a glimmer of, a glimmer of hope. I got to think that's helped you in your, in your journey thus far. It did. In fact, one of my professors said, you know, you really are a cheerleader for your patients. It's really wonderful that you're making such progress.
Starting point is 00:49:58 And I go, you know, it did work in a randomized prospect of trial, too. It's not just, you know, being a cheerleader. Right. But, but it all, you know, that doctors work very hard and especially, you know, the ones who have the tough problems, cancer, pediatric stuff, it beats us up something terrible. And to finally be lucky enough to have lightning hit to have a discovery that makes a difference, it gives you a smile in your face like I have. Yeah, yeah, I can see why.
Starting point is 00:50:26 And I, the more I think about, like, how you branded, I'm not even say it. Imminoautonomics. Immunoautonomics. I think if I said that enough, I'd get it. I'd get it. Just immune system. But this concept of quantifying stress, right? I really, really like that.
Starting point is 00:50:42 I think that's, like, so, such a good way to kind of like understand kind of exactly what you're doing, right? Because everyone, everyone under, to your point earlier, everyone understands stress is a big issue, a big problem. But, like, how do you actually quantify that? in some sort of a measurable way, it sounds like you're on to, you're on to something right there. So, and you're actually doing it. So kudos to your team. Can't thank you enough, Andrew, for coming on the program. This has been a fun, fun chat. My pleasure, too. Thanks so much. I'll have you
Starting point is 00:51:09 hold on the line. And for everyone listening, again, inmedics.com is the website. I highly encourage you to check out the company and learn a little bit more about this technology that is actively being commercialized. And again, if you want to check out the write-up, definitely as you do that as well. That's on Medsider.com. So with that said, thanks everyone for your listening attention. As always, until the next episode goes live, everyone, take care. Hey, it's Scott again. One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups. But here's the thing. I'd be super grateful if you could help me reach even more ambitious
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