In this episode, Jennifer Ernst, CEO of Tivic Health Systems, Inc., discusses how their innovative bioelectronic medicine is transforming sinus and nasal inflammation treatment with their ClearUP device. Learn about the journey of this FDA-approved, consumer-acclaimed Healthtech product and its impact on wellness.
In this episode, Jennifer Ernst, CEO of Tivic Health Systems, Inc., discusses how their innovative bioelectronic medicine is transforming sinus and nasal inflammation treatment with their ClearUP device. Learn about the journey of this FDA-approved, consumer-acclaimed Healthtech product and its impact on wellness.
Afternoon and welcome to the podcast Startup to Stock Exchange. Today's guest, I think, is very interesting and we're going to hear some nuggets of data that I think are not commonly found when we're dealing with this particular segment of the industry. And I'm leaving it a little bit vague because I want to let our guest get into some of the details, but really it's around innovation. And very often when I have these interviews with different CEOs, executives, publicly traded companies, not all the time, but sometimes it's hard for the audience to relate because it's something that's biotech or pharma, or it's in development. That's not the case today in that, uh, you'll hear about a tangible physical way to help people, which I think everybody will find very interesting. So with that, I'd like to welcome Jennifer Ernst. She's the CEO of a company called Tivic Health Systems, and they are listed on the NASDAQ Exchange under the ticker symbol T I V C. Jennifer, welcome to the show.
Speaker 3:Thank you, Seth.
Speaker 2:So, you know, I'm dropping these, uh, these little hints about what the product is and the industry that you're in, but if you don't mind, give us a short overview about what Tivic is, and then we'll, we'll, we'll backtrack into other topics.
Speaker 3:Okay, absolutely. Um, so to make, as you indicated, we are commercial stage with health technology. Um, we're part of a segment called bio electronic medicine and it's a mouthful. But what it means is that we're, we are using the electrical signals of the body in the same way that drugs, pharmaceutical industry uses chemicals. Um, so think about the body, if we think about it. Writ large, um, it is an electrochemical system and pharmaceutical products to use chemical interventions in order to create benefits for the person, um, changes in the health system. So that's what we're doing with electrical signals. And, um, where we're particularly positioned is in a portion of non invasive. Um, so this,
Speaker:you
Speaker 3:know, if we go back and think electrical, electrical therapies. I think most everyone is familiar with a pacemaker at this point. Put inside the body, attach it to the heart, it fires off the hearts. Uh, the nerves that manage the muscles of the heart. Um, same thing, we have deep brain stimulators. So these are some of the early advance of using electrical stimulus in a medical application. As the industry has moved forward, uh, we're getting finer and finer tuned granularity about how do we fire specific fibers, specific signals, uh, and where TIVIC is particularly positioned has been in doing that without having to put anything inside the body. So this is a growing wave is the use of non invasive technology. Um, it's forecast to be one of the highest growth areas of neuromodulation is in using non invasive. technologies. So before we jump into talking about what we have in the market today, one of the reasons why this idea of taking, taking that kind of science that's behind the pacemaker or deep brain stimulator or those type of technology fields and being able to bring them into therapeutic areas where you really don't want to have to do surgery, to get the benefit.
Speaker:Okay.
Speaker 3:Bringing them into this non invasive means you're breaking wide open the application space that we have available to us to be able to deploy neuromodulation or bioelectronic solutions.
Speaker 2:Okay, you know, I'm not in that field. I'm with you so far. Very well, very well explained thus far, but you're still leaving us on the edge of our seats in terms of what it is that you are for me, you know, the product that's actually being offered.
Speaker 3:Okay, so, uh, the commercial product we have in market today is a treatment for sinus. And yes, I said sinus, like allergies, sinus congestion, sinus pain, sinus pressure. Um, think of allergies, chronic sinusitis, um, non invasive, non, non allergenic rhinosinusitis. Now we're starting to get into the deep medical terms, but all of these conditions that are associated basically with inflammation of the tissues inside of our sinus passages in our head.
Speaker:Um,
Speaker 3:these are conditions that affect one out of five U. S. Adults. Um, it's growing in prevalence as allergy seasons are getting worse and worse. The chronic conditions are becoming more and more prevalent associated with the allergic response inside the passages. So what we developed is a small handheld device in which you place the tip on the skin that goes. I'm trying to think of how to, how to describe this, uh, without, without an image, but it looks like a little pear shaped device about the size of a business card. You use it for treating the outside of the sinus passages. So for typical sinus treatments are you take a drug, you flush your nose with salt water, uh, you spray something up your nose. We don't do any of that. There's no drugs involved, and it is an FDA approved product, so we have an FDA approval for relief of congestion. regardless of what causes the congestion. Um, and we also have, uh, gone through a five, 10 K process with the FDA for treatment of sinus pain. Uh, the product does also have a CE mark, although we're not currently available internationally, we're currently selling only in the U S. Um, this is a, completely drug free solution for delivering relief of chronic sinus conditions.
Speaker 2:And so just for our listeners, um, you know, if I could paint the picture of what, what I'm looking at is that, you know, it, it looks like it's the size of a traditional, like you said, it's the size of a business card. It fits in the palm of your hand. Um, I, to be completely honest, Jennifer, the first time you and I spoke and I saw it, I thought it was some sort of nasal spray. That's how small it is. Um, And you know, just drop it in your pocket. And so if you would, how, because it's non invasive, so how does one use it?
Speaker 3:So the instructions to use are to take it and apply the tip of the device to the cheek. As I said, like think of, think of it looks a little like a spray, but instead of a spray, you put the tip on your cheek and then you glide it along the cheekbone, along the nose area and up under the brow around the sinus passages. Um, We're activating a process that's associated with, it's associated with the fight or flight type responses. Um, two things that are going on. One is, if there's swelling in the tissue and there's pain present, there's a nerve that carries the pain signals to the brain, but there's also a set of nerves that control the contraction. These are called the sympathetic nerves, and they control the contraction of the blood vessels. The frequencies we use in our device have been showing to create the production of norepinephrine. Um, this is a, this is a vasoconstrictor. It's a, causes blood vessels to constrict. And when you can constrict blood vessels, then you get a reduction in tissue size. You start to get, uh, over time, you can reduce the substances that come out of the blood and go into the tissue and actually cause the inflammation to begin with. Um, so our clinical studies, we've shown that three out of four people will get relief with the first time they use it. Um, for about a fourth of our users, it's like, uh, pow up front. It's a, it's a pronounced difference within 10 minutes of use. Um, for 75%, they get at least a noticeable difference, a meaningful, clinically meaningful benefit within the first 10 minutes after they use it. Um, the really exciting part for me was when we ran the longitudinal studies and we saw that this benefit continued to improve with time because the, the drug solutions when we take a drug, you can use a nasal spray, and those you really shouldn't use if you're thinking, you know, something like an afferent. Um, you really shouldn't use that.
Speaker 2:That's exactly what I'm thinking about, by the way. And I won't say which of my kids, but like sometimes, I don't want to say they're addicting, but like there was one time I took her and the doctor was like, How long have you been using this? And she's like, wow, like five weeks. I was like, no, you cannot use it.
Speaker 3:Oh, I mean,
Speaker 2:one day, two days, three
Speaker 3:days, you're supposed to be off of it because it causes rebound. It makes the effects worse.
Speaker 2:That's what he said. Yeah, exactly. Um, so yeah, so that's
Speaker 3:a vicious cycle with that, with, uh, that particular drug compound and then the longer term use. You know, in terms of longer term use cases, most of these drugs are only approved for use for seven days, then if, you know, then you should be off of them.
Speaker:Um,
Speaker 3:in the case of our FDA approvals, our FDA clearances, these, there's no limitation on the number of times per day to use it. You can use it on an ongoing basis for as long as you need, um, and this is one of the things that's true of a lot of the neurotech, a lot of these neural solutions, because you're, you're stimulating just for very brief periods of time to activate a response that then continues to deliver benefit after it's been activated, you don't have these kind of profound side effects that you get with systemic pharmaceuticals. If I take something that's a vasoconstrictor, it's constricting every, every blood vessel in your body. We're just doing something very locally in the sinus passages to help relieve that localized symptom issue. Um, so great safety profiles, very strong safety profiles. Um, in the, in the clinical trials, 82 percent of the participants in the trials preferred it to their current treatment and the efficacy and the longitudinal and the longer term use is very very much on par with the the best of best of breed in the over the counter products.
Speaker 2:Can I just interrupt to ask before before we get into sort of like the background how you got here or how the company approached the the place that it's at so for all the listeners with the FDA approval in place um this is not in development this is not a will be this is out On the market, where do people, are you selling it direct to consumer through, through, you know, allergists, what's the, um, the mode of getting it out to the masses,
Speaker 3:right? So you can go today, search for clear up sinus and you will see it on our website. and clear up, like clear up your sinuses. So clear up sinus. You will find it on Amazon. You'll find it on our, on our website. Um, more recently we've signed agreements. We've signed distribution agreements with McKesson with Amerisource Bergen or now Sankora. Um, and we have been regularly available on the, um, FSA and HSA stores. So the product is also approved for FSA and HSA usage. So if you prefer to use that. Use your HSA funds. Um, the FSA and HSA store both carry clear up as a available today. Yes, you can. You can absolutely go online and order today.
Speaker 2:Now let me let me ask you this Jennifer, just in terms of the way that you have spoken for the first few minutes. Um, I'd be convinced your, your past life is either. You know, a doctor, a PhD in, uh, in health, where, where, what's your background? How did, how did you come to, um, the seat of CEO that you're in right now?
Speaker 3:Yeah, I fake it. Well, I've often been mistaken for a lawyer, an engineer, a doctor. Um, no, um, my actual background is in. My original part of my career was at Xerox PARC, which is a very advanced research laboratory. Most of the world knows it for having invented, been the, been the home of a lot of our modern computing, home of the graphical user interface, laser printing, mouse, et cetera. Um, I was in roles where we were taking the advanced research and translating it into either trying to communicate it to the mere mortals of the world, um, outside of the scientific field and by and trying to, um, Spent eight years in communication, then I then spent my career with Park on developing strategic partnerships. So go to market strategies, working with partners outside of our research ecosystem to be able to take the technologies, not necessarily into Xerox, but into other applications through spin outs, strategic alliances, licensing programs, um, that gave me a lot of versatility. It's a very unique background actually to bring to this seat because it gave me a lot of versatility across industries. Um, my first company that I did as a full scale commit, we're going to give this a give, um, at PARC I could do a lot of things like build departments, build functions, build partnerships, but I couldn't build a company inside PARC. So, um, in 2011 I joined a social a company that was a Norwegian company that was involved with Park and taking some technology out of the lab. Um, we were eight people on the public market in Norway. So that was my first experience with,
Speaker:um,
Speaker 3:doing a startup on the public market. Um, took that one from Oslo access uplisted to Bush, um, uplisted in the U S to get a dollar denominated share, took it from eight people to a half billion market cap in about five years time.
Speaker 2:Incredible.
Speaker 3:So that was, that was quite an experience. Unfortunately, I didn't realize it was unusual at the time. I thought they just all work that way. So we'd like to
Speaker 2:think that, but,
Speaker 3:um, so my, in 2016 was when 2015, 2016 was when I was introduced to the field of bioelectronic medicine. Um, and I'd come across, this unusual technology. I mean, it's kind of a friend of a friend situation. And it wasn't just the first, it wasn't just the fact of, okay, this is an interesting application of a neurotech. And I began really educating myself on the field. Um, but also, also the fact that this was just the burgeoning, you could see that this was just the tiniest tip of the iceberg of what is possible to do once you can harness. The usability of a device and the electrical signaling of the body, um, growing field of area right now is the vagus nerve stimulation in which we'll get into talking about later. But it's one of the deeper areas in the medical field where these, you know, these systems. Penetrate every major organ in the body clear up very localized solution. We were able to get the We were able to get the tech very efficiently to market Took me about three years from starting the company to having a medical product in market And then I think
Speaker 2:that's important. I think that's important to hone in on in other words everybody often sees the celebrations. They see the FDA approval. They see the ringing of the stock exchange bell, which we'll talk about in a minute. And, and we just assume that it's like an overnight success, but here it sounds like it was a multi year overnight success until you got it to where it needed to be.
Speaker 3:Um, I still won't claim we've gotten it where it needs to be, never where you really want to be. Um, but yes, you're right. There, there's a lot of hard work. Um, this wasn't an unusual case where we actually delivered in three years from founding to a commercial medical product or an FDA approved medical product. And then we launched a few months after that. So I think it actually did get it. Now, if I remember correctly, I do September 16th. It was three years to the date from the date we founded the company to the date we launched.
Speaker 2:Really?
Speaker 3:Literally.
Speaker 2:And what's, what's also fascinating is that, you know, so often when, when I speak to CEOs, they, they start these companies to Meet a need that they had. So, you know, in in your case, it's not like you had a horrible allergies as a kid and you vowed to someday find the solution. And here it is. Um, you you saw this product. Um, you and your team recognize the application capability. Is it, how far, how far of a, um, vast difference was it from the initial idea slash prototype to what it looks like today?
Speaker 3:Oh my God. Uh, the thing that we, the thing I first saw, it looked like a rectal thermometer for a cow. I mean,
Speaker 2:Oh, that's, that's a great image. Okay. It was
Speaker 3:horrible. It was ugly. Uh, in fact, my family thought I was crazy. Cause that is one of these questions of like, as an entrepreneur, you really have to be able to see beyond. Okay. All it is, is it's electronics and plastic. Those can be turned into any kind of shape. We can manage those. We can do the programming to make it more effective, to make it a little bit more elegant to use. But yeah, it was a, that was an ugly SOB. And so when, you know, going through usability design, um, I did have some background I was able to bring into that from my past experience to going through the usability, the design renderings, um, and turning it into something, um, You know, at this point feels very Appalachian, very, very sleek, right? Also created a lot of intellectual property in doing so. And, um, we You know, sometimes you don't know exactly that you have something totally unique. Um, we developed a way to locate the nerve fibers under the, nerve fibers and blood vessel, under the skin in order to guide a user. So the user would be able to locate where they need for treatment points. And then I started showing this around inside of the neurotech community and nobody had ever seen or heard of anything that helped you like actually through the skin, get that right. Non
Speaker 2:invasive is incredible. Sure.
Speaker 3:So, so that was, um, yeah, so we were able to develop intellectual property around everything that makes this particular device easy to use, comfortable, uh, effective. You know, patent the treatment protocols, the pathways. Um, so this space is a nice open space, even though there are technologies out there.
Speaker:Right.
Speaker 3:There's so much white space out around the bioelectronic field right now. It was one of the things that got me very excited. It's considering that great. We've got a first product that looked like a pretty straightforward path to market. We were able to do it in three years, which is extremely unusual in normal time for devices, about seven. Um, When
Speaker 2:you talk about that three year. Um, window at what point did you decide then that you wanted to, um, list on, on an exchange at some point after that three year period, or was it during after it was a public in, in 2021.
Speaker 3:So, if you remember in 2020, there was this minor thing that happened in the world. Um, I
Speaker 2:do recall vaguely. Yes.
Speaker 3:Yes. Um, so, uh, we have been largely funded by angels and doctors. Raised about 13 million in private finance and private financing through angels and doctors. Um, that wasn't going to give us the lift we needed, but pocketbooks in 2020, I started my a round in February, 2020. So pocketbooks were closed
Speaker:at that moment
Speaker 3:in time. If, you know, everybody was holding capital to see. not knowing whether this was going to be a six month, I mean, I remember the day that our office is closed and said, we'll be opening in three weeks.
Speaker 2:Right. Exactly.
Speaker 3:I think that, you know, that, so that timeframe, um, so it was a carefully considered decision. Did we think we had enough to be able to go onto the public market? Um, I'd had the experience with growing a company on the public market before. So we made the choice that, um, Yeah, we kind of were faced with a no financing in the private market situation, or the ability to finance a company and get us off the ground in the, in the commercial, in the public market. It's not for the faint of heart. It's not what I would recommend for everyone. That was
Speaker 2:one of my next questions that I, that I actually like to often ask the You know, CEOs are in your position, especially Nasdaq. Um, on the Nasdaq. How do you find that dual hat that you wear right? Because you still have to run the business element of it on on a full scale, if not with even more pressures, but also balancing that other full time job of being a public company, communicating with shareholders, dealing with regulation and compliance. How have you found that that that role?
Speaker 3:Um, I've been very fortunate. I knew when we were going to the public market what that was going to be like, because I'd had the experience before with it, so I've been very fortunate to be able to build a support structure inside the team that I'm not running. Right now I am, but in most days I'm not running the like day to day. How many chargers do we have kinds of conversations and how many production runs to put through in this week? Um, so having a, having a strong team in place was essential because then really my focus can be on, um, more strategic issues about. what beyond ClearUp can we be doing? Where, where can we put some anchors in that may have a stronger vector for value creation? Um, so I think ClearUp is a great product, but really some of the things we're putting in place now are going to be more important for building, building the longterm value of the company.
Speaker 2:And, and I'm curious, what was it like that day of the actual listing on NASDAQ? And I mean, I know you had, you had previous experience on the foreign markets, but, um, you know, NASDAQ is to itself. What was it like, you know, that first day? For any, for any that are aspiring to get there at one point, whether they know it's good for them or not, what was it
Speaker 3:like? I mean, the aspiration to get there is good. I, to do it when you've got a really nice, strong 50 million of revenue under your belt, that's a good time to go. Um, you know, there's, there's a place and time to take a company to a public market. And in the middle of an economic crisis, one month before the biotech crash might not have been our best timing. Having said all that. Your question was, what's it like that first moment? And there's, there's this word of liminal that somebody introduced me to. Um, it's just that moment of anticipation, that moment when a ring is spinning and you don't know if it's going to fall or where the wind is not yet started. I mean, it's just this, Moment where all things are possible and anticipation is just there like the share hasn't traded that moment before anything has happened and you know, you're going to see your first trade some point. And when is that going to happen? And is it going to happen in a split second? Um, Now I think back and go, oh my God, yeah, now we have, within our window of time on the public market, we not only have the moment where we started trading, but we also had two days where we were the highest traded stock on the New York NASDAQ. One day we did almost a half billion in trades.
Speaker 2:That's
Speaker:incredible.
Speaker 2:Jennifer, I've probably interviewed 75, you know, at least 75 CEOs of publicly traded companies. To your credit, I don't think I've ever heard anybody explain it in such a poetic type of way that would certainly motivate anybody that is looking forward to that to, uh, to experience it in that way that you just described. So I appreciate that. That's really
Speaker 3:There was this point where it was also a little bit anticlimactic because we weren't one of the companies that got to do the bell ringing. They were so backlogged. We never really got to do it. Yeah, I
Speaker 2:remember that. Hundreds of companies were behind on that schedule. Exactly.
Speaker 3:And so I bought for our teams a bunch of little bells and had us ring over literally over Zoom. We're ringing our bells. Um, I mean, it was just
Speaker 2:a
Speaker 3:crazy, crazy, crazy kind of experience at the same time, a little bit like. Oh, well, that was a little out of tech. Come back to cook and get back to work. But I think it's not unlike that for anyone who is coming onto the market. It's a lot of buildup. It's a lot of work to get there. You need to have your systems in place. You need to really be prepared. Um, there's that moment when you don't know what's going to happen and you sit that split second of the first day of trading that will never happen ever again. Um, and then you got to get back to running the business cause thanks. That was all fun, but. Now I've got the pressure. That's when the hard
Speaker 2:work begins. I know. Um, well, I definitely want to be cognizant of your time. But, but let me ask you as we, uh, as we wrap up. Um, you know, it sounds like the neurotech that you are working on and have successfully been able to roll out. Are there other applications that you're anticipating that you can share with us? Um, other, other products or, or, or broader direction that you expect to be able to, uh, to roll out in the near future?
Speaker 3:Absolutely. So we do have, um, we do have a clinical trial underway for the same product family for treatment of, uh, after reconstructive surgery for sinuses and for nasal or facial reconstructive surgery. So that is going with Mount Sinai right now, and it's an opportunity to expand the application space for the clear up technology as it stands. Um, the other one that is very exciting for the company is I mentioned earlier, the Vegas nerve. Um, the vagus nerve is a nerve that connects the brain, the brainstem to the gut, and it touches every single major organ in between. Um, it's a very high value target for the medical, for medical applications. And we have recently announced, um, some very important data. It's coming out of the Feinstein Institute, uh, the Feinstein Institute for Bioelectronic Medicine, which is considered among the world leaders, if not the world leader founded by the guy that pioneered the field. Um, Our data is showing results equivalent that we're getting with a VNS stimulation approach, um, better results than what we've ever been seeing with non invasive treatments, in terms of markers in the brain activity, markers in heart activity, and, um, markers in the autonomic nervous system, so the immunology functions. That particular approach is also quite novel. We were able to start developing intellectual property around a new way of hitting the vagus nerve, of targeting the vagus nerve, and the type of medical applications we are looking at there are things like cardiac disease, where there are, you know, arrhythmia, Decreasing morbidity and cardiovascular disease decreasing. Um, and also because of the brain markers, we've gotten very much a viable alternative for treatment of depression and for treatment of epilepsy. Um, alternatives to an implant. So there's a company leave another that's. 2. 9 billion market cap, making money on an implanted technology, uh, that they go and they hook it up to the vagus nerve. And we're showing signals from a non invasive technology that is very, that is very similar in terms of the performance parameters. And that's just with our first trial out of the gate. So before we've even done the optimization studies, we've been able to show that a non invasive technology can be as powerful in changing brain function and heart function as an implant can. Thank you. That's when things start to get very, very serious, uh, for a truly valuable company.
Speaker 2:Well, I would, I would say that what you're doing now is very valuable to, um, a lot of people, but some of the, um, verticals that you're touching on, cardiac and epilepsy and, and that's, that's next level stuff. So, um, I hope. That, uh, you will join us in however long that is six months from now, nine months from now, 12 months from now and give us an update on some of the exciting developments because I know everybody's going to want to hear about that. And in the interim. Um, where is the best place that people can learn more about the company? What's the company website?
Speaker 3:Um, the company website is TivicHealth. com. So think of the book, T I V I C, TivicHealth. com. You'll find it just searching for Tivic, T I V I C, um. And we do have our investor section of the website to be able to learn more there, as well as you'll be able to find the clear up the clear up product on our website, as well as, as I said, on Amazon and a few other major channels.
Speaker 2:Fantastic. Well, um, I'm excited that I shouldn't need it, but the next time I do, I'm not going to CVS to get the nasal spray anymore. I'm going to be getting the clear up. Um, and, uh, really thank you for your time. Thank you for sharing this knowledge, this experience, uh, where you're at, where the company is going and, uh, we appreciate it. And, uh, thanks again.
Speaker 3:Thanks for the opportunity.