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[upbeat music] I think it is that being prepared enough which is really building out your financial model, being able to show what those assumptions are and what are the proof points that support those assumptions.
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I think that aspect is critical. Being able to show the here and the now of the company, of what you're producing, versus also what is the future of the organization? What will this company look like? How will it grow?
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Is there enough runway for that? So you have that runway, but for others where if you're, you know, second to market, being able to show the marathon version of it as well as the sprint.
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So your proof points in your sprint and your proof points in your marathon. So I think that's, like, down to the detailed level.
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[upbeat music] Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology.
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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 is your host, Scott Nelson. Hey, everyone.
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In this episode of MedSider, we sat down with Deanna Harshbarger, CEO of Cala Health. Cala Health developed the CalaKick system, a prescription wearable therapy for action hand tremor.
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A chemical engineer by training, Deanna brings more than 20 years of med tech experience to Cala.
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Before joining the company, she held senior leadership roles at Johnson & Johnson, Boston Scientific, and Medtronic, and helped develop and commercialize technologies across interventional cardiology, neuromodulation, and diabetes care.
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Here are a few topics we explored in this conversation. First, how to build a startup where good decisions don't depend on the CEO.
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Second, how should clinical evidence evolve from feasibility studies through commercialization? Third, creating opportunities to observe end users early in the development process for a first-of-its-kind at-home therapy.
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And last, the sprint and marathon framework for fundraising. Before we dive into the full episode, if you're a med tech founder or CEO preparing to raise capital, you should check out the MedSider Fundraising Cohort.
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This four-week live workshop combines small group sessions with real-time feedback to help you sharpen your investor story, build a targeted investor pipeline, and run a focused fundraising sprint instead of a never-ending slog.
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Over the month, you'll walk away with an investor-ready narrative and deck, outreach scripts that actually get responses, a refreshed LinkedIn profile, a simple content plan that keeps you on investors' radar, and a repeatable system for running your raise.
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You can join the wait list at medsider.com/fundraisingcohort. Again, that's medsider.com/fundraisingcohort. All right, let's get to the interview. [upbeat music] All right, Deanna, welcome to MedSider Radio.
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Appreciate you coming on. Oh, thank you for having me, Scott. Really excited to be here. Yeah, and this will be a, a fun conversation, right?
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So sort of catch up on all things Cala over the past handful of years since Renee was on the program, what seems like, uh, so it seems like ages ago now.
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But excited to have you, uh, have you, uh, on the, on the show, and very much looking forward to learning a little bit more about your background and then, you know, how you're, how you're building, you know, Cala and how, how you have been building and how you, uh, will continue to build, uh, the company over the next, uh, you know, maybe call it five to 10 years.
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But with that said, for those that aren't familiar with your background, uh, I recorded a, you know, a very brief bio at the outset of this episode, but let's start there.
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Give us, like, a one to two-minute kinda elevator pitch style overview of your journey, uh, leading up to taking on the, the CEO role at, at Cala. Sure. Absolutely.
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So I think what most people don't know is I was an actual practicing engineer for a little while- [laughs]... in a totally different space.
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I was a chemical engineer, and so I did research and develop and process engineering.
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And I think it was a great foundation and background in understanding financials because in that space, the margins are pennies on the dollar.
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And so from there, I went on to graduate school and got into the area that I absolutely love, which is healthcare. Mm. And so for the past 22 years, I've been working in medical device.
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And so I spent some time at Johnson & Johnson in interventional cardiology. That was a very exciting time. That was during the drug-eluting stent years. I think it was great training ground. Mm-hmm.
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And what I loved about that experience was the fact that they really valued diversity in thought and experience, so they rotated people through all of the different divisions pretty consistently, and it just gave such a rich place to learn from others.
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So it was a fantastic training.
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From there, I went to Boston Scientific, where I built the deep brain stimulation franchise, and that was exciting from the standpoint that that was, I believe, my first foray into really understanding startup. Hmm.
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So the division I was in was actually a startup that had been purchased by Boston Scientific, and it operated like a startup. Hmm.
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And so, uh, it was a lot of fun because I really got the opportunity to build something and really work with a fair amount of autonomy, and, uh, taking something from early clinical stage all the way through to commercialization, which took quite some time as a class III implantable.
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So going through the clinical studies, the different regulatory approvals, all the way through to commercialization, large pivotal, and, uh, taking that international as well.
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And then, uh, moved over into the diabetic space at Medtronic, and the impetus for that really was knowing that this is where healthcare is going- Mm...
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which is a consumer being part of their healthcare decisions, being able to have at-home health. And in the diabetic space, it was fantastic.
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I got experience in durable medical equipment and true DTC, and I think that was just perfect when I got a call from Cala to come join Cala. I thought- This is amazing.
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This is taking a space that I love, which is neurology.
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I had the opportunity to work with the customers, both physicians and patients in movement disorders for over a decade, and then I would get to go back to that at Cala in non-invasive wearable.
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True at-home healthcare and an opportunity to really have an impact on a large amount of patients. So that's what brought me to Cala, and I'm excited to be here.
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And I'm looking at your, your LinkedIn profile, which we'll provide in the, in the full write-up on MedSider. But you joined Cala, I think, in, uh... It was the mid, kinda mid '21, right?
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So you've been, you've been at the company, uh, for five years now. Is that, is that right? That's right. That's right. Okay. Very good.
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And for those that, um, maybe have heard of Cala but aren't overly familiar with what you're, you know, the, the products that you're, you know, developing and commercializing, give us a high level overview of, of what, what TAPS therapy is, your device specifically, and maybe frame it up as if I'm a, you know, a, a senior in high school and I wanna learn more about this, uh, this medical device space.
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Absolutely. So, you know, at Cala we're really focused on building innovative therapies so that we can profoundly affect the lives and patients with tremor.
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And today we have a wearable, non-invasive, it's a watch-like device that treats hand tremor, and we're indicated for two disease states, essential tremor and action tremor within Parkinson's disease.
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And the technology, I think, is absolutely amazing. What Cala is able to do is we are able to access the peripheral nervous system, which then subsequently affects the area within the brain that affects tremor.
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And so our current device uses TAPS therapy. It delivers what we call transcutaneous afferent pattern stimulation to treat the hand tremor. And what that really means is it's non-invasive.
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You can access the peripheral nervous system. We stimulate through the median and the radial nerve, and basically send signals to the brain which then interrupts the signals that cause tremor. Got it.
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I'm looking at the, the website now, calahealth.com. We'll also link to it in the full write-up as well. Beautiful design, which I think we'll get into here as, as, uh, as the conversation unfolds.
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Kinda reminds me a bit of like a, you know, a Garmin, uh, type of- Yeah... type of watch, right? Which is, uh- Yeah... I'm sure probably there was some inspiration there. But yeah, beaut- beautiful design.
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But in terms of the, the technology itself, is this like a full closed loop system where you're, you're sensing and then dosing, you know, to the patient? Or g- give us a sense for kind of like what, how this...
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It's a wearable, right? It's, it's literally a watch. But are, are you, you're, you're stimulating through the watch the, the peripheral nervous system then? Yeah.
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So what we're doing is we are actually sensing the tremor initially. So each patient will calibrate their system so that it is unique and personalized, the stimulation, to their actual tremor.
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So everybody's tremor is different, but also it's a neurodegenerative disease. It changes over time.
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And so what the device does is it looks at the frequency of the tremor that the patient has, utilizes that to set the stimulation parameters.
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What we do is we actually take a measurement of tremor prior to the stimulation and post to the stimulation session- Mm... so that we can help patients understand what therapy they're getting and what the outcome is.
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Okay. Very good. Very cool. Yeah, excited to learn a little bit more about kind of the, the lessons learned kinda getting to this stage.
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But we're recording this in mid 2026, so for those that are listening maybe three, six, nine months down the road, give us a sense for kinda where the company's at in the, in the, kind of the, the current time- timing.
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Yeah, absolutely. So we're really excited. We actually just announced the FDA clearance of our next generation system, which is called Cala Kick+. Mm.
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And what that will allow us to do is actually provide different waveforms or different stimulation options for patients.
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And what we believe we will see from that are patients really, it, their tremor is so unique to themselves, is really getting the best outcomes that they can.
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In addition, what we're doing is we are automating the calibration, anything and everything that makes it easier for the patient to use. And I'm gonna be really excited to talk about the design of- Yeah...
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the product, 'cause that is a, a key area for our organization is focused on being true patient-centric.
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I mean, even circling back around to your comment earlier about, this obviously ladders up, I, I'm sure, to the design.
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But the idea that, that consumers are, are, are ready and, and actually wanting, you know, to be more involved in their healthcare, I mean, that couldn't be more true today.
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I remember when, when I first started, uh, the company before Fastwave, Juve, it wasn't maybe as, I would call it, sophisticated technology as Cala per se, but it, like, it was tapping into this, this, what we saw or I saw was a very, uh, kind of this burgeoning trend of like, you know, in-home healthcare.
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And I, I think, I mean, that's like 10 years ago now. And so, um- Yeah. [laughs] It's very, it's, it's... If you haven't, if you're not seeing these, uh, these trends, it's like very, very clear, right?
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That even- Yeah... regardless of age, this is not just for like the biohackers anymore. Like any and all ages, they, you know, people want easy access to healthcare, you know?
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And so I couldn't agree more, and I'm excited to kinda talk about how that, how, how that has, uh, has, uh, has impacted kind of the design for, uh, the Kick+.
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But with that said, I think that's a good f- a good foundational kinda start for the, for the conversation. But let's, let's jump into the, uh, kind of the more substantive part of the, the discussion.
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And again, for everyone listening, it's calahealth.com is the website.
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So if you don't get to the full write-up and are able to read a lot of these, you know, key lessons that Deanna is gonna, gonna share with us over the next 20, 30 minutes, definitely check out the, the website.
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Really, really cool technology. And w- again, we'll link to it in the, in the write-up on MedSider. But it's calahealth.com, C-A-L-A health.com.
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So with that said, um, Deanna, let's, let's jump to, um, the first topic which I wanna cover, is kind of this overarching concept of, of, of building a med tech business, right?
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And you mentioned that you'd spent some time in, at, at a, at other large strategics, you know, Cordis J&J during kind of the heyday of the, of the drug-eluting stent [laughs] stent, uh, war, so to speak, and then kind of building a startup inside Boston Scientific.
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And so a- as you think about how you're trying to, to build the culture and push the company forward at Cala, are there a few, like, key things that you're e- uh, you're either you, you've taken with you, you know, from those experience at, at Boston Scientific and J&J Cordis and other strategics, or maybe even things that you're trying to avoid, right?
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Um, as you're, uh, as you're de- developing kind of the, the startup mentality at, at, at Cala Yeah, I mean, I do think there are a lot of parallels, and I think that surprises many people because when you think about working in a large strategic and then going to a startup and saying what's really different, I think it is decisions that are magnified because the stakes are high at the startup.
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There's no safety net. You miss your number at a startup, you know, it's one equation [laughs] X plus Y equals Z, and if you miss one of those, there's, there's nothing that can make up for it on the other end.
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Whereas at a large strategic you have multiple divisions, it's, it's a portfolio, right? You're ebbing and flowing with that.
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So I think at least having the opportunity to work, and I guess now it's funny to look back and say three large major [laughs] strategics, each has a different personality in how they operate.
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And I think one of the great things I loved when I was at J&J, at the time the focus really was, you know, you don't call it a division. Everything is an operating unit.
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You should be able to operate on your own standalone to find your way to profitability or that growth level, or you should be number one or number two within the market space that you're in, and that drive.
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And that every person in the organization understood the financials, whether or not you were an operator on the line or whether or not you were running the sales team, and I think that was impressive.
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So I think that's one thing that I love taking to the startup phase is everybody should understand our high level financials because it's how we make decisions, and how we make decisions down to the individual level.
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We all make better decisions when we're well-informed.
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The other piece is I think at all the large strategics there was definitely the focus for patient centricity, and I don't see that as any different, why Kala should be any different in that manner. That is who we serve.
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Our customers are also physicians as well, but that is their mantra also. So it really should be easy for the patient, all the way from the product you design to the services and how they interact with the organization.
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So I think that's another key learning.
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And then the last one I think is typically what you see more when you think of the differentiation between a large organization and a startup, and it is the speed at which you need to make decisions.
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Again, at a startup you've got a finite amount of time. You have no safety net. You have to make those decisions fast, and you have to make them with the best information you have.
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It still means that you are scientifically driven. It still means that you are data-driven. It's just that you don't have time to wait to run down every single number to act. By then it's too late.
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Yeah, no, no doubt, and I think that there's a lot of similarities between that, that latter point and the first point you made around, uh, just the, um... Uh, how to best describe this?
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I think you, I think you put it better than, than the way I'm gonna describe it, but just the intensity, right, at, at a startup, right? 'Cause there, there are not a lot of secondary or tertiary options, right?
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It's like if you're marching towards a, a 510[k] or a PMA or maybe even an advance of that, an IDE approval for a pivotal trial, if you don't miss those or if something goes wrong, there's not a, a parachute there, right- No.
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[laughs]... to, to fall back on. And so, so I, I think that that's probably speaks to the importance of, you know, as you think about even team building, right?
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Ideally, you're, you're building a team that has, has some of that experience, right? A- as well as...
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Or at, at least has been, is used to operating in that sort of, that sort of environment where, you know, uh, achieving those milestones and they understand kind of the, the importance of those. So really good stuff.
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A- and before we kind of get to the next topic, which is really around kind of this, this, um, kind of developing a platform technology like, uh, like the CIG system, as you think about even your tenure at, at Kala specifically, right?
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Moving from a chief product officer to now, to a CEO role, have there been any, like, noticeable changes as you've kind of like, you know, mo- moved, uh, moved sort of up the ladder, so to speak, right?
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And, and maybe frame that up for, you know, for someone else that's listening to this or reading the, the highlights of this, this discussion that has maybe the same opportunity as you, right?
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They're being tapped on the shoulder to take on the CEO role. Like, what should maybe they think about as they, as they consider that, that increase in, in responsibility? I think that the difference there is...
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You know, my philosophy also is regardless of what level you are in the organization, you should look holistically and ensure that everything that you're doing is meeting the goals of the company as, as a whole, and that piece is, I think I said it earlier before, it's like it's something that's magnified when you step into the next position, right?
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So I think that is a key aspect of it, which is really making sure that you are now ruthlessly prioritizing to the key things that need to be done to make the organization successful.
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Whereas it's not that you wouldn't do that- Mm-hmm... in your prior role, but, but your responsibility is smaller, so you have a little more play in, in there.
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I think I would also say the other aspect is certainly from a people standpoint. That is really important, and I think at Kala a couple, you know, a couple key tenets that we have.
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One is our focus on innovation, and, and I love that has been in the tapestry of Kala since its very beginning, since the original founder who's still at Kala.
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She's absolutely amazing, and keeping that focus on the innovation. And then the other two, I call them the two Ps, which are people and patients. Mm-hmm. And people means the people that we have within the organization.
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And so I think stepping into the leadership role, it's having this responsibility of ensuring that, one, you have the right people with the right skill set, the right motivation, and, and that you are treating your people in a manner that will keep them going and keep them motivated.
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So I think that's a different level that you take to it.
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And I think the last piece is in whatever role you're in, if you're having this opportunity to step to a higher level, just keep that concept of the buck stops here- Mm... mentality.
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I think that is really important because when you have that, then you know what are the areas I need to dive into? Because if I'm gonna be asked at the end of the day, "Why did this happen?" or, "Why did you do this?"
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then you know when to dive into details and when to stay high because you have things that you know that are trust- that are, that are running. Mm-hmm. Yep.
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Like hearing you kind of riff on, on this, uh, on that, on that question, it kind of reminds me if I'm, if I'm... if I own a certain function, right?
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A- and a- whether it's a strate- strategic or, or like maybe more, more specifically a, a startup, ideally that function is operating as if they need to kind of report into the board on a quarterly basis as well.
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Maybe they're involved in those board meetings, maybe they're not, but regardless, how would I effectively communicate our progress to the board level, and what kind of critique- Yeah... would they, would they have?
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I mean, I think just as, like it's just a healthy framework for anyone that's maybe in a senior, kind of senior functional role that maybe is, is kind of considering, you know, or being asked maybe to potentially s- you know, step into a CEO role at some point.
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So all good stuff. And one of the thing that I kind of want to double click into, uh, that you made ear- a comment that you made earlier is about around, around communication, right?
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And, um, I think some founders and, and CEOs in my, in my network, um, kind of operate or they choose to operate kind of almost with, um, the attempt for, like transparency, but only at a certain level, right?
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And then, you know, there's sort of a, a, a gating by a minute, a gating kind of, um, aspect to that. And I tend to be a little bit the opposite, right? I want to try to be as, as transparent as possible. Yeah.
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And so where, where do you, where do you, where do you stand? I mean, do, do you try to communicate, I mean, almost, almost everything within reason, right, to the, to the entire company?
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Or do you, do you tend to prefer, you know, a little bit more of a filter? No, we definitely try to lean towards transparency. Mm-hmm.
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I, I think it's really important, and especially, I think we'll talk about this too, is the, the stage that, that we are at. We are growing at a fast pace. We are scaling, and communication is critical. Mm.
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And again, I think that also goes to the last question you asked, what's the difference when you step into the higher role? You can't be in the details of everything. Mm-hmm. Right?
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If you are, [laughs] then you're probably not doing your, your- So true... your higher level, level job.
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And so you have to trust and empower the organization and people within the organization to make the right decisions. Mm-hmm. And how can they make the right decisions if they don't have full information? Yeah, 100%.
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So I think that goes to the transparency aspect. So we wanna communicate, we wanna communicate fast, and with the information that, that is relevant. So- Yeah...
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and this is actually, you had mentioned earlier before, Renee, this is left over from years and years and years ago. We do a, a, a company meeting called All Hands- Mm-hmm... every week. Oh, it's every week? Okay, great.
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It's every- Yeah... it's, it's every week. It's short. And that's where we ensure that people are up to date on how the business is doing, what's going on within the business. That's where we celebrate.
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That's where we say, "Hey, these are things that we're gonna work on." But that way everybody has that same information- Mm-hmm... because then no one's gonna be down into that level of detail.
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But the people that are doing it, and they should be making the right decisions, and they need the, the right information to do that. Yeah.
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Yeah, I love the fact that you still do that on a weekly basis, especially considering your team's probably pretty, pretty large at this point. It's grown, yeah.
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Yeah, and so, 'cause I think, I think at a certain scale a lot of CEOs would say, "Well, hey, that doesn't work for us anymore.
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Let's just shut it down, or maybe go to once a month or once every quarter," and you're still doing it on a weekly basis. I think that's, like, that's a really important... That's really cool.
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And I, and I, I, I don't know about you, but I, I, I would imagine you probably agree with this, that when, when, when there's more transparency, right?
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And I'm, I'm not gonna pretend that I'm perfect at this, but when there's more transparency, the rest of the team feels empowered, right?
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Because they feel like they're, they're that much more bought in when they're, when they're getting the same information as everyone else, right? Regardless of kinda the, the level, the responsibility.
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So, um, I think there's, there's, um, I've, I've certainly seen that as well, so I'm on the same camp as you, right?
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[laughs] Try to, I try to be as, as trans- you know, you know, almo- almost kind of operate from the standpoint that any critiques I'm getting from investors or the board, right?
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Really for the most part, the, the rest of the team understands that as well, you know? And, and, um, and so anyway, good stuff. Let's segue into, um, into kind of development and kinda this platform plan.
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Let may- maybe this is a good opportunity to kind of talk about the, the design features that you built into the, the, the new KiC Plus.
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But how have you kind of balanced this overarching theme of developing a, a product, right, that, where a physician is still very much involved, right, in the kinda the patient care, but it's very much a, a, a, a patient consumer-centric sort of device, right?
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I mean, it's, it's worn on the wrist. It's, it's, it's l- therapy's delivered at, at, at home.
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So how have you kind of balanced that, and kinda give us a, a sense for, um, for some of the design decisions that kind of led up to this, this latest, uh, the KiC Plus.
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And first I wanna say that it really was the whole organization in the development. So we launched CalaKiC back in... Now I'm actually, this is like 23. [laughs] Okay. [laughs] '21.
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And that was a big change from the generation that had been commercially started with, and that was the one where it was kind of tear it down to the studs and really think about from the design standpoint and the patient centricity.
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And I also wanna say that, you know, we're providing tremor reduction and relief for, for patients that have hand tremors, so things are hard to do. And you have to make it as easy as possible for them.
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And so it really was the whole organization that put this effort and mindset into building a patient-centric device. Mm-hmm. I think that was really important.
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Our engineering team, everybody met patients, and that was a key aspect of the design was how do we look at this? And we're not the end user, so how is it that someone with tremor would use this? Mm.
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How would they put it on? We have a band that has to be changed every 90 days. Would they be able to change the band?
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We even did unboxing interviews where we would ship a box to the patient, and we would then do a video call with them and watch them.
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In one of our first generation boxes, the patient had such difficulty opening it, he had to use his teeth to tear- Oh. [laughs]... off the, [laughs] the, the initial opening, and that was eye-opening for us. Yeah. Right?
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And so it really was that type of thought process that went into the design so that every step of the way we thought about, can someone put it on? Can they change it? H- what is their interaction with the buttons on it?
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What is their interaction with the screen on it? And our philosophy also is if we can make it easier for the patient, that should also make it easier for the physician. Because we also don't want- Yeah...
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a patient ending up in the physician's office saying, "I can't use this. I'm having trouble use this. How do I use this?" Hmm.
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Or, "I'm not getting an effective therapy from it," because they weren't able to properly get it set up. Yeah.
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So it was a significant amount of patient research ensuring that we also broke it down to each step that the patient was going to use. Got it. Uh, I think that's a, that's a really good framework.
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You know, if we can, if we can deliver a, a really easy patient experience, that oftentimes is going to, uh... You're gonna see some of those efficiencies kind of carry, carry through to the, to the physician as well.
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Your comment about seeing someone open, open a box with their teeth, that never ceases to amaze me how the unexpected feedback, right, that you get when you start shipping some of the, you know, in this case, you know- Yeah...
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probably a, you know, some, some version of a, of a, of a, of a prototype, at least the, the boxing experience maybe. Yeah.
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And so, and I, and I think s- sometimes I, you know, I, I hear folks in our space kind of push back on this idea of, like, shipping an MVP, and I, I get we're in the device space. You can't sh- I mean- [laughs] Yeah.
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[laughs] It's, it's different than shipping software, right? It's different. Yeah. Yes.
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I get that, but my, my counter to that is, but look for, look for ways that you can ship prototypes or ship something, get it in the hands of, of, of end users as fast as possible, and look to- Yes...
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iterate on those feedback loops. Yes. So you can, you can just, you know, make changes faster, right?
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Because so often it's easy to get stuck in, in kind of the world of engineering, especially with your background in engineering, where it's like you develop something and y- your head's down for, for six months, and no one has actually touched and felt it, right, yet.
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Uh- Yeah. [laughs] You know?
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And, and then you, you kind of, you know, you get up from the bench and it's like, "Ah, here, here we are," and it's like, well, has anyone that actually is going to use this product, have they seen it yet?
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Have they, [laughs] have they touched it? Yeah. Like, have they provided feedback? And so, so yeah, I, I, I, I, [laughs] I think that's so, so important- Yeah... right, to, to, to find...
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look for ways to kind of ship versions of the developing product as, as soon as possible. [upbeat music] Hey, everyone, let's take a quick break to catch you up on MedSider Courses.
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Okay, let's get back to the conversation. And I really want to give kudos to our engineering team. They were all in, right? They...
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Like I said, every single person that worked on the product met with patients at one point or another. Mm-hmm. And, and you mentioned it there too.
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That was our, our philosophy too, is it should be in the hands of the end user prior to it going to a full launch. Mm-hmm.
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And so that, that's our philosophy as well too, is we will always do a small, you know, steps along the way where there's interaction with it. If it can't be fully functional at that point, then we do that.
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Clinical studies as well too are very critical to us. I, I think you had mentioned that before too, as we go through this evolution, creating the clinical data with it.
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But clinical studies are also really important to understand how the system will be used and how can we improve upon that. Yeah, no doubt.
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And I think, I, I, I think just kind of, like, kind of du- doubling down on this point, it's so easy, I think, um, as you're trying to look for feedback, right, of let's just walk, whether it's patients or in, in a lot of cases it's, it's physicians in our world, let's just walk them through a, a, a slide deck, right, with bullet points on a deck or maybe in some cases some, some static images.
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And I mean, that, that can work, but they, in most cases, you're not gonna get the best type of feedback until you actually... they can touch and feel something. You know what I mean? Yes.
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And I think the natural inclination is, like, "Well, it's, it's not ready for feedback yet."
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Well, it's like, well, most of the, the physicians or patients that we work with at, at those types of stages, they're okay with something looking rough. Yeah. You know?
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And they'd much prefer feeling and touching a rough, a rough- Mm-hmm... prototype and providing feedback versus, you know, versus seeing an image on a, on a slide deck. So- Yeah. Yeah.
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[laughs] Let's segue into kind of clinical, uh, and regulatory, and I wanna, I wanna, um, kind of get your take on how, how your approach to clinical evidence has, has evolved and how you're kind of continuing to build clinical evidence for the, for the device.
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And I'm sure obviously early on a lot of the clinical work was, was specific to the kind of the regulatory path.
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But give us a sense for kind of how that, how that e- what that evolution looks like, especially developing a device that could be used for a lot of different applications, right?
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So obviously you're focused on tremors for patients that suffer from Parkinson's right now, but I'm sure probably there's other, a wide variety of other, other use cases for technology, um, like this.
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So how are you kind of thinking about balancing, right, and, and prioritizing the evidence generation for kind of the, the core indications now versus what maybe what you could work on, uh, and develop in the future?
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Yeah. And that always is the challenge within a startup, right? There are definitely finite resources. I do believe that our philosophy to clinical data i- mi- might be a little unique.
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We strongly believe in clinical data. Mm-hmm. Uh, and I think there are a couple key reasons for that. So one is we created a new therapy that just didn't exist before in the non-invasive neurostimulation space.
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For tremor, everything was either pharmacological or it was, uh, more invasive, like an implant and, and now exciting, um, you know, there's focused ultrasound as well.
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So the clinical data was really important, not just from a mechanism of action standpoint. One is proof point that we're doing what we think we're doing, right?
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But the other really is what is that outcome and that, and that efficacy?
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And for those that have worked in healthcare for a long time, and in particular medical device, you know a feasibility study is just that- Mm-hmm... a feasibility study.
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It's something small that gives you a trend, but it doesn't tell you over time, does a patient still see a benefit in therapy? What type of outcomes do they get?
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And there's a difference between a, you know, an RCT and real world evidence too. Mm-hmm. An RCT is controlled. There's a protocol that's set. And so then how does it actually act out in the real world? [laughs] Mm-hmm.
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Which is really important for us because of the fact that we are at home use. And so our philosophy has been to build in all of those areas. Hmm.
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And I think, one, the first key is, and this is standard, you know, w- with any development, is you do your feasibility to say, like, does this even-... work, right? Mm-hmm.
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But then you get to, okay, now that we understand that, let's confirm our mechanism action. You confirm the mechanism action, and now you say, "All right, let's prove this in an RCT-" Mm...
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where you have a truly controlled environment and you can break it down to is what we're doing actually providing that outcome? Mm.
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And then you take it to the real world evidence to basically say, "Okay, now we're gonna be out in the world commercially. How is this really working? Does, you know, getting this many prescriptions, is that justified?
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Because are the patients in the real world seeing the benefit?" And so we've done all of those things. We have more than 2,000 patients in- Mm...
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that, that have been in clinical studies, which I think is, is, is pretty unique in, in our space. And our philosophy is to keep going with that- Mm... because we think it's really important.
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If a physician is gonna make a decision to prescribe our system for their patient, we want them to know what their patient is going to get out of it, and that can only be done through, through the clinical data. Mm.
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And also, as we advance, so again, moving to our next generation, what we want to be able to show is that there's a benefit from this next generation. Mm-hmm.
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So now I'm taking it back all the way [laughs] to how do you make that trade-off within, within the organization?
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I think that, you know, there's a lot more studies that we would love to do, but what we want to do are places where we can push the envelope and show the unique aspects of the therapy that we're providing in the, uh, indications that we're in today.
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And then you have to be able to save that room and time to say, you know, there's a place for a future because we've created something unique where we can access the peripheral nervous system noninvasively. Mm.
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There are other places that we should be able to treat if we do that, too, so let's save some of those dollars for, for those studies, too. But you do it in that stage. You start with the, the feasibility.
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You don't go big RCT. You should know the answer [laughs] to- [laughs]... what outcome you're gonna get into the RCT before- Yeah... you do it. Yeah, no doubt.
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I couldn't agree more with sort of the, the resource allocation around evidence generation, even though you're commercial, right?
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So I, I think, you know, it's fair to say that probably a lot of folks in your, in your position would say, "Well, we maybe don't need to do enough.
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We don- we, we can maybe kind of stop there or maybe slow roll the evidence generation." And obviously you're taking a, taking a different approach.
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But I very much agree, especially with the new category, that the evidence sort of compounds, right?
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I mean, your, your moat continues to get deeper and wider with every single study that you're running, uh, even if it's a, a post, a post-market study.
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So kudos to you and your team for kind of, you know, continuing to kind of build the real world evidence for the device.
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Let's segue into, into commercialization because I think, I think, um, the next question I have for you, which is largely around reimbursement, kind of s- you know, feed- feeds into this, you know, this evidence generation.
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And so- Yeah...
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uh, when, when you think back around kind of how reimbursement has impacted some of the decisions you've made towards either clinical trial design or commercial planning, give us a sense for kind of how you've approached that, right?
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Because I think it's, it's, um, from my perspective, reimbursement's probably even a, a larger hurdle, uh, these days, right, than even regulatory [laughs] approval.
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And so you've obviously accomplished a lot in this category.
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So for, for other CEOs maybe that are staring down, you know, generating a new, a new CPT code as an example, what words of wisdom would you offer up to, up to them? Yeah.
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And I want to start with saying here, too, that, uh, Cala's journey has been long. Certainly before I took on this role and before I joined Cala, I think that's also where the philosophy of clinical evidence started. Mm.
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And it is because of that planning and that clinical evidence early on that we were able to get the reimbursement. I think that piece is very critical.
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So I think i- you know, if you are just starting out, you need to build your clinical evidence robustly into your portfolio from the very beginning- Mm... because reimbursement doesn't get easier. [laughs] Mm-hmm.
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It continues to get harder, right? Mm. And that bar keeps, keeps going up.
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And the piece that drives that is the clinical evidence that proves that you can actually get that outcome, and then typically also, uh, patient and physician advocacy as well. And what are they convinced by?
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Clinical evidence. So, so I think those pieces are very critical for, for the reimbursement strategy. I think for us at Cala, you know, Cala's been leading the way every, every step [laughs] of- Mm... the way.
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So there were no unique codes for what Cala was doing, and so Cala had to create those unique codes and convince that we were different than what was already out there.
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So, you know, Cala's been told no [laughs] every- Mm... every time. [laughs] And then we go back and we gather the clinical evidence, the technical data to support that. So that was the creation of the new codes.
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And then on the payment determination side as well, too, you know, for, for companies that are, that are at the, the stage prior to we are, where, where you don't have that payment determination or that reimbursement yet- Mm...
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this is the hardest step, right? Mm-hmm. You're basically fighting every case by case. [laughs] Mm-hmm.
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One, to actually get some form of coverage for one single patient, and then trying to ensure that that coverage is the proper coverage for the therapy that you're providing.
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And so I, I see that one as almost like single battle- Yeah... [laughs] timeframe. That's the most difficult. But then moving to what Cala was able to do was move to a coverage determination- Mm-hmm...
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which was very fast, and I think also very unique, but it was based on the clinical evidence. We had the long-term data to say, not only does this help in acute standpoint, you see it over a long-term timeframe.
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You see it being used in places. There, there's, there's advocacy here for this, and that's what was able to, to get us to that, that coverage. Got it.
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And how much did health sort of at the, the, the economics, right, of your therapy impact, you know, that, that coverage determination? Was that pretty crucial as well? It's, yes. And it's, and, and it's always crucial.
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Mm-hmm. I think for us in particular, patients with essential tremor have a fair amount of comorbidities. They also have a history of trying pharmacological therapy and it not working. Mm-hmm.
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And then you end up with a patient that either is not going to the physician and therefore suffering, and then has issues later on. Mm-hmm. So I think that was an aspect as well too.
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I think it's a little harder for startups when it's a new therapy because you're never gonna have that super, super long-term data that you typically have when you're, you know, when you're coming into the market and you're second or third- Mm-hmm...
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it's been around a while and you can do that proof point. I think for the new therapy, you can only show what's available in that, in that certain timeframe. Got it.
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And when you think about commercializing the Kik device, the kind of the first generation device, versus all of the kind of the planning that went into to launch and now you're obviously, you know, getting ready to or maybe on the, on the, on the cusp of launching this, this, uh, the second generation device.
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Any kind of key lessons learned, right? Kind of going from planning to effectively, you know, commercializing.
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Were there any surprises or anything that, any sort of assumptions that you made that you, that you, that you really, you, you got right and were, you know, pleasantly, uh, surprised that you, that you plan- [laughs] you planned in the right fashion?
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Give us a sense for kind of what that looked like going from planning to, to commercialization. Yeah.
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So I think, you know, because I've lived many lives before in, in commercializing, I think the one thing you can always guarantee is that your plan is never right, right?
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There are parts of your plan that are correct, but you will always find something that is new or that you hadn't thought about.
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And I think this goes back to even what we were talking about before, which is why you want to get a device or system into the hands of the end user before, 'cause you're gonna find something you had never even thought about.
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And so I think for, for us, we very consciously started slow just for that reason, because we knew we were, we were learning as we, as we went. So everything that we've done has been new.
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It's a totally new therapy. It's a new thought process.
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It's, you know, if you go and ask a physician today, they likely will have heard about either TAPS or non-invasive neurostimulation for tremor, and therefore it's a lot easier conversation to have today versus five years ago when people said, "Is this real?
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Are you sure? This sounds hokey." Right? [laughs] And so going through that commercialization, that's what you're up against. It's a totally new, new therapy.
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And so that's the criticality of making your plan, starting small, learning from those pieces, and then expanding and going bigger. And I think for us it's hard to hold back. Mm-hmm.
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But it's really important to hold back because you, you know, you never wanna alienate your customer at the first go around. [laughs] Yeah, yeah.
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If you go kind of scor- scorch earth at the very beginning, there's, there's gonna be probably lots of learnings, to your point earlier, that, uh, that you didn't expect.
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And maybe you planned for some of them, but some areas there were, there were gaps. And so was that tough to get? 'Cause that, that is a, that a, a hard challenge, right?
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I mean, there's years of build up, right, to commercial launch, and then you're, you're finally here and it's, it's easy to kind of wanna, you know, rip the, uh, rip the Band-Aid off.
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But, um, was it tough getting sort of buy-in, right, to kind of, you know, launch sort of in a, in a, a bit more of a, a, a methodical fashion versus, uh, you know, going, going, uh, you know, getting more aggressive?
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I think, again, this might be where Cal is unique. I think we have, I think we have a great board- Mm-hmm... a great set of investors. They're in it for the marathon.
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And I think their, uh, experience from the standpoint that, that they also know the value of, of being methodical about it. Mm-hmm.
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It's really knowing when to go slow and, but then also when to, to put on the gas, right? Mm-hmm. So you don't wanna be too conservative and, uh, never, never get big enough.
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But I think, again, I think that we have a, a group of experienced people, experienced with commercialization as well too, that, that are familiar with that, that this is what you typically, you typically do. Yeah.
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It goes back to even the conversation we were having earlier around the stakes are higher as a startup, right? Mm-hmm. You feel this rush to go full out because- Mm-hmm... [laughs] it's your only source of income, right?
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[laughs] Yeah. But at the same time, if you make a mistake, that's hard to come back from, and it's easier to make that mistake on a smaller scale when you've even set it up to say, "Hey, this is new.
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This is our first-" Mm-hmm... generation. We really want your input and feedback," and if you find something, then you have time to go fix it. Yeah, yeah. No doubt.
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And, uh, and I think this segues into kind of the, maybe the next topic, which is around fundraising and kind of, like, interaction at the, you know, with, with, with investors.
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But you made a, a comment earlier that I think is really, really important around, it sounds like you're, you're in a position with, with Cal where you've got investors and, and a board that understands the need, right, to whe- whether you wanna describe this as going slow or m- or, like, kind of a more of a, a methodical kind of targeted approach to your launch so you can learn as much as possible before you, before you scale.
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Not a, a lot of startups maybe don't have that, that luxury. Maybe they're stuck with kind of a, you know, some folks on their... Some investors understand the importance of that.
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Others, you know, wanna be more aggressive.
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And I think that's, i- if you're, if you're in that situation, sort of proactively addressing that as soon as possible, you know, so you're not a couple months out of launch and you've got a split sort of board around, like, how aggressive- Yeah...
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you should be.
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I mean, it just speaks to, like, you know, beginning to kind of prep your, your board and your investors for what your launch is going to look like or what it should look like, and the rationale, you know, that, that supports that.
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Yeah. I think that's really, really important. So on the, on the topic of- And- Yeah, go ahead. Go ahead. Yeah. Oh, no, I was just gonna say, I think to that it's also- You know, having a clear laid out plan. Mm-hmm.
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Like these are the items that we'll say, "Okay, now we're gonna put the gas on or now we're gonna put the brake on."
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And we can handle being slow because we've set up ourselves financially, infrastructure-wise, to be able to handle that. Mm-hmm.
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Versus, you know, you don't wanna build up a whole commercial team and say, "Okay, we're gonna limited launch now." [laughs] Right.
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While all those people sit on your payroll or you're spending massive, like, DTC money out there. Mm-hmm. Right?
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So I think it's having that holistic picture together and saying, "Here's the plan, and if this looks good, yeah- Mm-hmm... then we're gonna put the gas on." Mm-hmm. "But we're gonna make sure we can handle that."
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Yeah, really, really smart a- approach. I wanna leave enough time for the rapid-fire portion of this interview, but let's get to fundraising, right?
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Because, um, Cala has not only an impressive list of investors on the cap table, but has raised a, you know, a, um, a, a sizeable amount of, uh, of capital over the years.
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And so when you think about kind of stepping into this role as CEO and having to raise these rounds of capital, any lessons that you, you, you can share, right, for other CEOs that are in the, in the throes of maybe a series B or a series C round, right?
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What do you think they really, really need to get right versus, uh, versus, you know, what could possibly go, go wrong if they're not prepared enough?
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I mean, I think it is that being prepared enough which is really building out your financial model, being able to show what those assumptions are and what are the proof points that, that- Mm... support those assumptions.
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I think that aspect is critical. Being able to show the here and the now of the company of what you're producing versus also what is the future of the organization? What will this company look like? How will it grow?
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Is there enough runway for that? Like, again, I think the benefit of startups is a lot of time you're creating a new therapy, so you, you, you have this large unmet need, so you have that runway.
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But for others, where if you're, you're, you know, second to market, being able to show the marathon version of it as well as the sprint. Mm.
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So your proof points in your sprint and your proof points in, in your marathon.
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So I think that's, like, down to the detailed level, and then I think at the higher level of on the fundraise side, understanding what your objective is and therefore matching the investors to that objective. Mm.
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And that's also where you get alignment where you're thinking about commercialization and you're gonna, you know, go controlled commercialization.
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So if you have an investor that has invested, but they're a different type of investor which is looking for a short-term gain- [laughs] Mm-hmm... that incentive's not aligned. Mm.
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So you need to think about that strategy when you're, you're setting out for fundraising. Yeah, so, so crucial to, uh, [laughs] to find, find that alignment, especially if it's new money into a, into a, a, a round.
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If, if you're, uh... Sometimes it's, it's, it's really easy to wanna just take, take the capital that's, that's available, but that is often, um... It's often gonna bite you, right, if there's not that alignment. Mm.
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In fact, it... I would make the argument that it's gonna bite you most of the time, uh, if [laughs]... if the alignment's, if the alignment's not, not there. Um- Yes...
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but even, even just kind of, um, y- your point around ensuring that you under- Like, you can, you can thoughtfully talk through the inputs that drive those assumptions. I think that's so important, right?
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And it kind of just reminds me of, of, of getting your, getting your story, getting your deck in front of as a trusted group of people early enough that can, that can kind of provide pushback, right, on some of your assumptions, right?
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'Cause some of, some of the...
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You know, you've been maybe developing or, you know, in the weeds on a, on a few sli- a f- a few really important slides to your deck, and, you know, a- a- some- someone that's seeing it for the f- for the first time would be like, "Oh, did you think about this?"
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Or, "Did you think about Y?" Yeah. You know? And I think that's, um, that's u- usually a pretty easy step to, to kind of accomplish before you, you go too, too broad with, uh, kind of your, your investor pitches. Yeah.
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And for me too, I think that's where the benefit of having worked at all of those strategics before is I've sat on the other side of the table. Mm-hmm. I've judged. [laughs] I've judged me. [laughs] Yeah.
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And, and I know what are the things that we would typically look for. Mm-hmm. And I think it's, again, you're always looking for value creation.
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So whether that is in an acquisition or, or whether that is an investor looking for a company to go IPO, it always goes back to why did you make that assumption? Mm-hmm. Yeah.
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And can you prove, or what supporting data do you have that says that assumption's real? Yeah. What Yeah. Really cool. So, so important.
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Yeah, and if you don't have that type of experience where you've sat on the other side of the table, yeah, get... just getting at, getting your deck in front of, like, new kind of...
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and new audiences, right, that, that sort of safe audiences, if you will, that are, that are willing to kind of provide, uh, some skeptical feedback, I think that's really, really important.
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So with that said, um, Deanna, let's get to the rapid-fire portion of this interview. But again, before we get there, it's calahealth.com is the website. C-A-L-A health.com.
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We'll link to it in the full write-up on MedSider, but definitely encourage, uh, everyone to, to check out the, the company.
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We'll also link to, uh, Deanna's LinkedIn profile in the full write-up as well, but calahealth.com. Really, really cool technology. So first rapid-fire question on the docket. Take us out to, to mid '27.
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What are you most excited about at, at Cala? I am excited about the number of patients that Cala gets to treat. Mm.
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I think, a- again, to me, the unique aspect of being in a startup and being at Cala, where it's a totally new treatment option, there's so many patients that deserve treatment- Mm. Yeah... that don't get it.
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Keeps me going every day. Oh, yeah, especially with, with some- as big of a need, right, as you're, as you're solving for, right? So it's really fun to have a device that's so close to the patient too.
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If you've never worked on a device like, like, or, like, or been, you know, been afforded kind of the opportunity to, to work in or with a device like this, it's, uh, it's pretty cool.
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So, all right, second question on the, on the, on the, uh, rapid-fire list is let's say we're in, uh, in Silicon Valley, right?
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Maybe, uh, Cala's neck of the woods here, and, uh, it's a small group of, of, uh, med tech entrepreneurs, and you wanna leave them with kind of one billboard message, right?
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One message that they really need to get right. What, what would that be? Oh, that's a good one. [laughs]So many things. Know your business. That will get it every day, is make sure you understand it in and out.
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What are the levers that you pull that, that will make it successful? Yeah. Simple, but, uh, covers a lot of sins in the world of startups, right? If you know your business really well.
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[laughs] All right, last, last question.
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Um, if you, if you could rewind the clock, you know, take us back to earlier in your career, maybe kind of mid, mid to late 20s in your career, really started- starting to take off.
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Anything that you'd tell your, the younger version of your- yourself from a professional standpoint?
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There are many ways to get to the end and enjoy every experience along the way, because no decision is ever the wrong decision in a career. It's always something you learn. Mm. So trust in that.
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Yeah, really good feedback. Um, well, this has been fun, Deanna. Thanks again for, for carving out some time to, to do this interview. Uh, really, really appreciate it. Thanks for having me. It's been a great time.
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Yeah, definitely be fun to kind of see Cala's continued success, and I'll have you hold on the line, but for everyone listening, you made it this far, appreciate your attention as always.
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Definitely check out CalaHealth.com, and, um, until the next episode of MedSider Goes Live, everyone, take care. [outro music] Hey, it's Scott again. One quick thing before you go.
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You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups.
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But here's the thing, I'd be super grateful if you could help me reach even more ambitious doers who share our passion.
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Stay tuned for another informative episode coming at you soon. [outro music]
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[upbeat music] I think it is that being prepared enough which is really building out your financial model, being able to show what those assumptions are and what are the proof points that support those assumptions.
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I think that aspect is critical. Being able to show the here and the now of the company, of what you're producing, versus also what is the future of the organization? What will this company look like? How will it grow?
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Is there enough runway for that? So you have that runway, but for others where if you're, you know, second to market, being able to show the marathon version of it as well as the sprint.
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So your proof points in your sprint and your proof points in your marathon. So I think that's, like, down to the detailed level.
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[upbeat music] Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology.
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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 is your host, Scott Nelson. Hey, everyone.
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In this episode of MedSider, we sat down with Deanna Harshbarger, CEO of Cala Health. Cala Health developed the CalaKick system, a prescription wearable therapy for action hand tremor.
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A chemical engineer by training, Deanna brings more than 20 years of med tech experience to Cala.
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Before joining the company, she held senior leadership roles at Johnson & Johnson, Boston Scientific, and Medtronic, and helped develop and commercialize technologies across interventional cardiology, neuromodulation, and diabetes care.
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Here are a few topics we explored in this conversation. First, how to build a startup where good decisions don't depend on the CEO.
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Second, how should clinical evidence evolve from feasibility studies through commercialization? Third, creating opportunities to observe end users early in the development process for a first-of-its-kind at-home therapy.
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And last, the sprint and marathon framework for fundraising. Before we dive into the full episode, if you're a med tech founder or CEO preparing to raise capital, you should check out the MedSider Fundraising Cohort.
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This four-week live workshop combines small group sessions with real-time feedback to help you sharpen your investor story, build a targeted investor pipeline, and run a focused fundraising sprint instead of a never-ending slog.
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Over the month, you'll walk away with an investor-ready narrative and deck, outreach scripts that actually get responses, a refreshed LinkedIn profile, a simple content plan that keeps you on investors' radar, and a repeatable system for running your raise.
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You can join the wait list at medsider.com/fundraisingcohort. Again, that's medsider.com/fundraisingcohort. All right, let's get to the interview. [upbeat music] All right, Deanna, welcome to MedSider Radio.
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Appreciate you coming on. Oh, thank you for having me, Scott. Really excited to be here. Yeah, and this will be a, a fun conversation, right?
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So sort of catch up on all things Cala over the past handful of years since Renee was on the program, what seems like, uh, so it seems like ages ago now.
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But excited to have you, uh, have you, uh, on the, on the show, and very much looking forward to learning a little bit more about your background and then, you know, how you're, how you're building, you know, Cala and how, how you have been building and how you, uh, will continue to build, uh, the company over the next, uh, you know, maybe call it five to 10 years.
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But with that said, for those that aren't familiar with your background, uh, I recorded a, you know, a very brief bio at the outset of this episode, but let's start there.
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Give us, like, a one to two-minute kinda elevator pitch style overview of your journey, uh, leading up to taking on the, the CEO role at, at Cala. Sure. Absolutely.
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So I think what most people don't know is I was an actual practicing engineer for a little while- [laughs]... in a totally different space.
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I was a chemical engineer, and so I did research and develop and process engineering.
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And I think it was a great foundation and background in understanding financials because in that space, the margins are pennies on the dollar.
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And so from there, I went on to graduate school and got into the area that I absolutely love, which is healthcare. Mm. And so for the past 22 years, I've been working in medical device.
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And so I spent some time at Johnson & Johnson in interventional cardiology. That was a very exciting time. That was during the drug-eluting stent years. I think it was great training ground. Mm-hmm.
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And what I loved about that experience was the fact that they really valued diversity in thought and experience, so they rotated people through all of the different divisions pretty consistently, and it just gave such a rich place to learn from others.
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So it was a fantastic training.
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From there, I went to Boston Scientific, where I built the deep brain stimulation franchise, and that was exciting from the standpoint that that was, I believe, my first foray into really understanding startup. Hmm.
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So the division I was in was actually a startup that had been purchased by Boston Scientific, and it operated like a startup. Hmm.
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And so, uh, it was a lot of fun because I really got the opportunity to build something and really work with a fair amount of autonomy, and, uh, taking something from early clinical stage all the way through to commercialization, which took quite some time as a class III implantable.
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So going through the clinical studies, the different regulatory approvals, all the way through to commercialization, large pivotal, and, uh, taking that international as well.
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And then, uh, moved over into the diabetic space at Medtronic, and the impetus for that really was knowing that this is where healthcare is going- Mm...
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which is a consumer being part of their healthcare decisions, being able to have at-home health. And in the diabetic space, it was fantastic.
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I got experience in durable medical equipment and true DTC, and I think that was just perfect when I got a call from Cala to come join Cala. I thought- This is amazing.
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This is taking a space that I love, which is neurology.
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I had the opportunity to work with the customers, both physicians and patients in movement disorders for over a decade, and then I would get to go back to that at Cala in non-invasive wearable.
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True at-home healthcare and an opportunity to really have an impact on a large amount of patients. So that's what brought me to Cala, and I'm excited to be here.
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And I'm looking at your, your LinkedIn profile, which we'll provide in the, in the full write-up on MedSider. But you joined Cala, I think, in, uh... It was the mid, kinda mid '21, right?
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So you've been, you've been at the company, uh, for five years now. Is that, is that right? That's right. That's right. Okay. Very good.
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And for those that, um, maybe have heard of Cala but aren't overly familiar with what you're, you know, the, the products that you're, you know, developing and commercializing, give us a high level overview of, of what, what TAPS therapy is, your device specifically, and maybe frame it up as if I'm a, you know, a, a senior in high school and I wanna learn more about this, uh, this medical device space.
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Absolutely. So, you know, at Cala we're really focused on building innovative therapies so that we can profoundly affect the lives and patients with tremor.
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And today we have a wearable, non-invasive, it's a watch-like device that treats hand tremor, and we're indicated for two disease states, essential tremor and action tremor within Parkinson's disease.
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And the technology, I think, is absolutely amazing. What Cala is able to do is we are able to access the peripheral nervous system, which then subsequently affects the area within the brain that affects tremor.
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And so our current device uses TAPS therapy. It delivers what we call transcutaneous afferent pattern stimulation to treat the hand tremor. And what that really means is it's non-invasive.
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You can access the peripheral nervous system. We stimulate through the median and the radial nerve, and basically send signals to the brain which then interrupts the signals that cause tremor. Got it.
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I'm looking at the, the website now, calahealth.com. We'll also link to it in the full write-up as well. Beautiful design, which I think we'll get into here as, as, uh, as the conversation unfolds.
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Kinda reminds me a bit of like a, you know, a Garmin, uh, type of- Yeah... type of watch, right? Which is, uh- Yeah... I'm sure probably there was some inspiration there. But yeah, beaut- beautiful design.
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But in terms of the, the technology itself, is this like a full closed loop system where you're, you're sensing and then dosing, you know, to the patient? Or g- give us a sense for kind of like what, how this...
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It's a wearable, right? It's, it's literally a watch. But are, are you, you're, you're stimulating through the watch the, the peripheral nervous system then? Yeah.
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So what we're doing is we are actually sensing the tremor initially. So each patient will calibrate their system so that it is unique and personalized, the stimulation, to their actual tremor.
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So everybody's tremor is different, but also it's a neurodegenerative disease. It changes over time.
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And so what the device does is it looks at the frequency of the tremor that the patient has, utilizes that to set the stimulation parameters.
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What we do is we actually take a measurement of tremor prior to the stimulation and post to the stimulation session- Mm... so that we can help patients understand what therapy they're getting and what the outcome is.
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Okay. Very good. Very cool. Yeah, excited to learn a little bit more about kind of the, the lessons learned kinda getting to this stage.
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But we're recording this in mid 2026, so for those that are listening maybe three, six, nine months down the road, give us a sense for kinda where the company's at in the, in the, kind of the, the current time- timing.
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Yeah, absolutely. So we're really excited. We actually just announced the FDA clearance of our next generation system, which is called Cala Kick+. Mm.
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And what that will allow us to do is actually provide different waveforms or different stimulation options for patients.
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And what we believe we will see from that are patients really, it, their tremor is so unique to themselves, is really getting the best outcomes that they can.
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In addition, what we're doing is we are automating the calibration, anything and everything that makes it easier for the patient to use. And I'm gonna be really excited to talk about the design of- Yeah...
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the product, 'cause that is a, a key area for our organization is focused on being true patient-centric.
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I mean, even circling back around to your comment earlier about, this obviously ladders up, I, I'm sure, to the design.
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But the idea that, that consumers are, are, are ready and, and actually wanting, you know, to be more involved in their healthcare, I mean, that couldn't be more true today.
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I remember when, when I first started, uh, the company before Fastwave, Juve, it wasn't maybe as, I would call it, sophisticated technology as Cala per se, but it, like, it was tapping into this, this, what we saw or I saw was a very, uh, kind of this burgeoning trend of like, you know, in-home healthcare.
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And I, I think, I mean, that's like 10 years ago now. And so, um- Yeah. [laughs] It's very, it's, it's... If you haven't, if you're not seeing these, uh, these trends, it's like very, very clear, right?
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That even- Yeah... regardless of age, this is not just for like the biohackers anymore. Like any and all ages, they, you know, people want easy access to healthcare, you know?
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And so I couldn't agree more, and I'm excited to kinda talk about how that, how, how that has, uh, has, uh, has impacted kind of the design for, uh, the Kick+.
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But with that said, I think that's a good f- a good foundational kinda start for the, for the conversation. But let's, let's jump into the, uh, kind of the more substantive part of the, the discussion.
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And again, for everyone listening, it's calahealth.com is the website.
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So if you don't get to the full write-up and are able to read a lot of these, you know, key lessons that Deanna is gonna, gonna share with us over the next 20, 30 minutes, definitely check out the, the website.
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Really, really cool technology. And w- again, we'll link to it in the, in the write-up on MedSider. But it's calahealth.com, C-A-L-A health.com.
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So with that said, um, Deanna, let's, let's jump to, um, the first topic which I wanna cover, is kind of this overarching concept of, of, of building a med tech business, right?
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And you mentioned that you'd spent some time in, at, at a, at other large strategics, you know, Cordis J&J during kind of the heyday of the, of the drug-eluting stent [laughs] stent, uh, war, so to speak, and then kind of building a startup inside Boston Scientific.
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And so a- as you think about how you're trying to, to build the culture and push the company forward at Cala, are there a few, like, key things that you're e- uh, you're either you, you've taken with you, you know, from those experience at, at Boston Scientific and J&J Cordis and other strategics, or maybe even things that you're trying to avoid, right?
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Um, as you're, uh, as you're de- developing kind of the, the startup mentality at, at, at Cala Yeah, I mean, I do think there are a lot of parallels, and I think that surprises many people because when you think about working in a large strategic and then going to a startup and saying what's really different, I think it is decisions that are magnified because the stakes are high at the startup.
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There's no safety net. You miss your number at a startup, you know, it's one equation [laughs] X plus Y equals Z, and if you miss one of those, there's, there's nothing that can make up for it on the other end.
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Whereas at a large strategic you have multiple divisions, it's, it's a portfolio, right? You're ebbing and flowing with that.
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So I think at least having the opportunity to work, and I guess now it's funny to look back and say three large major [laughs] strategics, each has a different personality in how they operate.
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And I think one of the great things I loved when I was at J&J, at the time the focus really was, you know, you don't call it a division. Everything is an operating unit.
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You should be able to operate on your own standalone to find your way to profitability or that growth level, or you should be number one or number two within the market space that you're in, and that drive.
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And that every person in the organization understood the financials, whether or not you were an operator on the line or whether or not you were running the sales team, and I think that was impressive.
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So I think that's one thing that I love taking to the startup phase is everybody should understand our high level financials because it's how we make decisions, and how we make decisions down to the individual level.
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We all make better decisions when we're well-informed.
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The other piece is I think at all the large strategics there was definitely the focus for patient centricity, and I don't see that as any different, why Kala should be any different in that manner. That is who we serve.
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Our customers are also physicians as well, but that is their mantra also. So it really should be easy for the patient, all the way from the product you design to the services and how they interact with the organization.
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So I think that's another key learning.
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And then the last one I think is typically what you see more when you think of the differentiation between a large organization and a startup, and it is the speed at which you need to make decisions.
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Again, at a startup you've got a finite amount of time. You have no safety net. You have to make those decisions fast, and you have to make them with the best information you have.
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It still means that you are scientifically driven. It still means that you are data-driven. It's just that you don't have time to wait to run down every single number to act. By then it's too late.
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Yeah, no, no doubt, and I think that there's a lot of similarities between that, that latter point and the first point you made around, uh, just the, um... Uh, how to best describe this?
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I think you, I think you put it better than, than the way I'm gonna describe it, but just the intensity, right, at, at a startup, right? 'Cause there, there are not a lot of secondary or tertiary options, right?
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It's like if you're marching towards a, a 510[k] or a PMA or maybe even an advance of that, an IDE approval for a pivotal trial, if you don't miss those or if something goes wrong, there's not a, a parachute there, right- No.
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[laughs]... to, to fall back on. And so, so I, I think that that's probably speaks to the importance of, you know, as you think about even team building, right?
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Ideally, you're, you're building a team that has, has some of that experience, right? A- as well as...
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Or at, at least has been, is used to operating in that sort of, that sort of environment where, you know, uh, achieving those milestones and they understand kind of the, the importance of those. So really good stuff.
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A- and before we kind of get to the next topic, which is really around kind of this, this, um, kind of developing a platform technology like, uh, like the CIG system, as you think about even your tenure at, at Kala specifically, right?
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Moving from a chief product officer to now, to a CEO role, have there been any, like, noticeable changes as you've kind of like, you know, mo- moved, uh, moved sort of up the ladder, so to speak, right?
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And, and maybe frame that up for, you know, for someone else that's listening to this or reading the, the highlights of this, this discussion that has maybe the same opportunity as you, right?
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They're being tapped on the shoulder to take on the CEO role. Like, what should maybe they think about as they, as they consider that, that increase in, in responsibility? I think that the difference there is...
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You know, my philosophy also is regardless of what level you are in the organization, you should look holistically and ensure that everything that you're doing is meeting the goals of the company as, as a whole, and that piece is, I think I said it earlier before, it's like it's something that's magnified when you step into the next position, right?
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So I think that is a key aspect of it, which is really making sure that you are now ruthlessly prioritizing to the key things that need to be done to make the organization successful.
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Whereas it's not that you wouldn't do that- Mm-hmm... in your prior role, but, but your responsibility is smaller, so you have a little more play in, in there.
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I think I would also say the other aspect is certainly from a people standpoint. That is really important, and I think at Kala a couple, you know, a couple key tenets that we have.
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One is our focus on innovation, and, and I love that has been in the tapestry of Kala since its very beginning, since the original founder who's still at Kala.
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She's absolutely amazing, and keeping that focus on the innovation. And then the other two, I call them the two Ps, which are people and patients. Mm-hmm. And people means the people that we have within the organization.
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And so I think stepping into the leadership role, it's having this responsibility of ensuring that, one, you have the right people with the right skill set, the right motivation, and, and that you are treating your people in a manner that will keep them going and keep them motivated.
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So I think that's a different level that you take to it.
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And I think the last piece is in whatever role you're in, if you're having this opportunity to step to a higher level, just keep that concept of the buck stops here- Mm... mentality.
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I think that is really important because when you have that, then you know what are the areas I need to dive into? Because if I'm gonna be asked at the end of the day, "Why did this happen?" or, "Why did you do this?"
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then you know when to dive into details and when to stay high because you have things that you know that are trust- that are, that are running. Mm-hmm. Yep.
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Like hearing you kind of riff on, on this, uh, on that, on that question, it kind of reminds me if I'm, if I'm... if I own a certain function, right?
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A- and a- whether it's a strate- strategic or, or like maybe more, more specifically a, a startup, ideally that function is operating as if they need to kind of report into the board on a quarterly basis as well.
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Maybe they're involved in those board meetings, maybe they're not, but regardless, how would I effectively communicate our progress to the board level, and what kind of critique- Yeah... would they, would they have?
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I mean, I think just as, like it's just a healthy framework for anyone that's maybe in a senior, kind of senior functional role that maybe is, is kind of considering, you know, or being asked maybe to potentially s- you know, step into a CEO role at some point.
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So all good stuff. And one of the thing that I kind of want to double click into, uh, that you made ear- a comment that you made earlier is about around, around communication, right?
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And, um, I think some founders and, and CEOs in my, in my network, um, kind of operate or they choose to operate kind of almost with, um, the attempt for, like transparency, but only at a certain level, right?
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And then, you know, there's sort of a, a, a gating by a minute, a gating kind of, um, aspect to that. And I tend to be a little bit the opposite, right? I want to try to be as, as transparent as possible. Yeah.
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And so where, where do you, where do you, where do you stand? I mean, do, do you try to communicate, I mean, almost, almost everything within reason, right, to the, to the entire company?
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Or do you, do you tend to prefer, you know, a little bit more of a filter? No, we definitely try to lean towards transparency. Mm-hmm.
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I, I think it's really important, and especially, I think we'll talk about this too, is the, the stage that, that we are at. We are growing at a fast pace. We are scaling, and communication is critical. Mm.
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And again, I think that also goes to the last question you asked, what's the difference when you step into the higher role? You can't be in the details of everything. Mm-hmm. Right?
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If you are, [laughs] then you're probably not doing your, your- So true... your higher level, level job.
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And so you have to trust and empower the organization and people within the organization to make the right decisions. Mm-hmm. And how can they make the right decisions if they don't have full information? Yeah, 100%.
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So I think that goes to the transparency aspect. So we wanna communicate, we wanna communicate fast, and with the information that, that is relevant. So- Yeah...
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and this is actually, you had mentioned earlier before, Renee, this is left over from years and years and years ago. We do a, a, a company meeting called All Hands- Mm-hmm... every week. Oh, it's every week? Okay, great.
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It's every- Yeah... it's, it's every week. It's short. And that's where we ensure that people are up to date on how the business is doing, what's going on within the business. That's where we celebrate.
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That's where we say, "Hey, these are things that we're gonna work on." But that way everybody has that same information- Mm-hmm... because then no one's gonna be down into that level of detail.
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But the people that are doing it, and they should be making the right decisions, and they need the, the right information to do that. Yeah.
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Yeah, I love the fact that you still do that on a weekly basis, especially considering your team's probably pretty, pretty large at this point. It's grown, yeah.
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Yeah, and so, 'cause I think, I think at a certain scale a lot of CEOs would say, "Well, hey, that doesn't work for us anymore.
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Let's just shut it down, or maybe go to once a month or once every quarter," and you're still doing it on a weekly basis. I think that's, like, that's a really important... That's really cool.
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And I, and I, I, I don't know about you, but I, I, I would imagine you probably agree with this, that when, when, when there's more transparency, right?
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And I'm, I'm not gonna pretend that I'm perfect at this, but when there's more transparency, the rest of the team feels empowered, right?
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Because they feel like they're, they're that much more bought in when they're, when they're getting the same information as everyone else, right? Regardless of kinda the, the level, the responsibility.
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So, um, I think there's, there's, um, I've, I've certainly seen that as well, so I'm on the same camp as you, right?
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[laughs] Try to, I try to be as, as trans- you know, you know, almo- almost kind of operate from the standpoint that any critiques I'm getting from investors or the board, right?
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Really for the most part, the, the rest of the team understands that as well, you know? And, and, um, and so anyway, good stuff. Let's segue into, um, into kind of development and kinda this platform plan.
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Let may- maybe this is a good opportunity to kind of talk about the, the design features that you built into the, the, the new KiC Plus.
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But how have you kind of balanced this overarching theme of developing a, a product, right, that, where a physician is still very much involved, right, in the kinda the patient care, but it's very much a, a, a, a patient consumer-centric sort of device, right?
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I mean, it's, it's worn on the wrist. It's, it's, it's l- therapy's delivered at, at, at home.
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So how have you kind of balanced that, and kinda give us a, a sense for, um, for some of the design decisions that kind of led up to this, this latest, uh, the KiC Plus.
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And first I wanna say that it really was the whole organization in the development. So we launched CalaKiC back in... Now I'm actually, this is like 23. [laughs] Okay. [laughs] '21.
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And that was a big change from the generation that had been commercially started with, and that was the one where it was kind of tear it down to the studs and really think about from the design standpoint and the patient centricity.
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And I also wanna say that, you know, we're providing tremor reduction and relief for, for patients that have hand tremors, so things are hard to do. And you have to make it as easy as possible for them.
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And so it really was the whole organization that put this effort and mindset into building a patient-centric device. Mm-hmm. I think that was really important.
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Our engineering team, everybody met patients, and that was a key aspect of the design was how do we look at this? And we're not the end user, so how is it that someone with tremor would use this? Mm.
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How would they put it on? We have a band that has to be changed every 90 days. Would they be able to change the band?
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We even did unboxing interviews where we would ship a box to the patient, and we would then do a video call with them and watch them.
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In one of our first generation boxes, the patient had such difficulty opening it, he had to use his teeth to tear- Oh. [laughs]... off the, [laughs] the, the initial opening, and that was eye-opening for us. Yeah. Right?
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And so it really was that type of thought process that went into the design so that every step of the way we thought about, can someone put it on? Can they change it? H- what is their interaction with the buttons on it?
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What is their interaction with the screen on it? And our philosophy also is if we can make it easier for the patient, that should also make it easier for the physician. Because we also don't want- Yeah...
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a patient ending up in the physician's office saying, "I can't use this. I'm having trouble use this. How do I use this?" Hmm.
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Or, "I'm not getting an effective therapy from it," because they weren't able to properly get it set up. Yeah.
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So it was a significant amount of patient research ensuring that we also broke it down to each step that the patient was going to use. Got it. Uh, I think that's a, that's a really good framework.
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You know, if we can, if we can deliver a, a really easy patient experience, that oftentimes is going to, uh... You're gonna see some of those efficiencies kind of carry, carry through to the, to the physician as well.
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Your comment about seeing someone open, open a box with their teeth, that never ceases to amaze me how the unexpected feedback, right, that you get when you start shipping some of the, you know, in this case, you know- Yeah...
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probably a, you know, some, some version of a, of a, of a, of a prototype, at least the, the boxing experience maybe. Yeah.
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And so, and I, and I think s- sometimes I, you know, I, I hear folks in our space kind of push back on this idea of, like, shipping an MVP, and I, I get we're in the device space. You can't sh- I mean- [laughs] Yeah.
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[laughs] It's, it's different than shipping software, right? It's different. Yeah. Yes.
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I get that, but my, my counter to that is, but look for, look for ways that you can ship prototypes or ship something, get it in the hands of, of, of end users as fast as possible, and look to- Yes...
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iterate on those feedback loops. Yes. So you can, you can just, you know, make changes faster, right?
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Because so often it's easy to get stuck in, in kind of the world of engineering, especially with your background in engineering, where it's like you develop something and y- your head's down for, for six months, and no one has actually touched and felt it, right, yet.
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Uh- Yeah. [laughs] You know?
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And, and then you, you kind of, you know, you get up from the bench and it's like, "Ah, here, here we are," and it's like, well, has anyone that actually is going to use this product, have they seen it yet?
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Have they, [laughs] have they touched it? Yeah. Like, have they provided feedback? And so, so yeah, I, I, I, I, [laughs] I think that's so, so important- Yeah... right, to, to, to find...
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look for ways to kind of ship versions of the developing product as, as soon as possible. [upbeat music] Hey, everyone, let's take a quick break to catch you up on MedSider Courses.
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Okay, let's get back to the conversation. And I really want to give kudos to our engineering team. They were all in, right? They...
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Like I said, every single person that worked on the product met with patients at one point or another. Mm-hmm. And, and you mentioned it there too.
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That was our, our philosophy too, is it should be in the hands of the end user prior to it going to a full launch. Mm-hmm.
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And so that, that's our philosophy as well too, is we will always do a small, you know, steps along the way where there's interaction with it. If it can't be fully functional at that point, then we do that.
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Clinical studies as well too are very critical to us. I, I think you had mentioned that before too, as we go through this evolution, creating the clinical data with it.
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But clinical studies are also really important to understand how the system will be used and how can we improve upon that. Yeah, no doubt.
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And I think, I, I, I think just kind of, like, kind of du- doubling down on this point, it's so easy, I think, um, as you're trying to look for feedback, right, of let's just walk, whether it's patients or in, in a lot of cases it's, it's physicians in our world, let's just walk them through a, a, a slide deck, right, with bullet points on a deck or maybe in some cases some, some static images.
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And I mean, that, that can work, but they, in most cases, you're not gonna get the best type of feedback until you actually... they can touch and feel something. You know what I mean? Yes.
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And I think the natural inclination is, like, "Well, it's, it's not ready for feedback yet."
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Well, it's like, well, most of the, the physicians or patients that we work with at, at those types of stages, they're okay with something looking rough. Yeah. You know?
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And they'd much prefer feeling and touching a rough, a rough- Mm-hmm... prototype and providing feedback versus, you know, versus seeing an image on a, on a slide deck. So- Yeah. Yeah.
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[laughs] Let's segue into kind of clinical, uh, and regulatory, and I wanna, I wanna, um, kind of get your take on how, how your approach to clinical evidence has, has evolved and how you're kind of continuing to build clinical evidence for the, for the device.
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And I'm sure obviously early on a lot of the clinical work was, was specific to the kind of the regulatory path.
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But give us a sense for kind of how that, how that e- what that evolution looks like, especially developing a device that could be used for a lot of different applications, right?
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So obviously you're focused on tremors for patients that suffer from Parkinson's right now, but I'm sure probably there's other, a wide variety of other, other use cases for technology, um, like this.
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So how are you kind of thinking about balancing, right, and, and prioritizing the evidence generation for kind of the, the core indications now versus what maybe what you could work on, uh, and develop in the future?
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Yeah. And that always is the challenge within a startup, right? There are definitely finite resources. I do believe that our philosophy to clinical data i- mi- might be a little unique.
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We strongly believe in clinical data. Mm-hmm. Uh, and I think there are a couple key reasons for that. So one is we created a new therapy that just didn't exist before in the non-invasive neurostimulation space.
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For tremor, everything was either pharmacological or it was, uh, more invasive, like an implant and, and now exciting, um, you know, there's focused ultrasound as well.
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So the clinical data was really important, not just from a mechanism of action standpoint. One is proof point that we're doing what we think we're doing, right?
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But the other really is what is that outcome and that, and that efficacy?
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And for those that have worked in healthcare for a long time, and in particular medical device, you know a feasibility study is just that- Mm-hmm... a feasibility study.
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It's something small that gives you a trend, but it doesn't tell you over time, does a patient still see a benefit in therapy? What type of outcomes do they get?
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And there's a difference between a, you know, an RCT and real world evidence too. Mm-hmm. An RCT is controlled. There's a protocol that's set. And so then how does it actually act out in the real world? [laughs] Mm-hmm.
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Which is really important for us because of the fact that we are at home use. And so our philosophy has been to build in all of those areas. Hmm.
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And I think, one, the first key is, and this is standard, you know, w- with any development, is you do your feasibility to say, like, does this even-... work, right? Mm-hmm.
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But then you get to, okay, now that we understand that, let's confirm our mechanism action. You confirm the mechanism action, and now you say, "All right, let's prove this in an RCT-" Mm...
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where you have a truly controlled environment and you can break it down to is what we're doing actually providing that outcome? Mm.
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And then you take it to the real world evidence to basically say, "Okay, now we're gonna be out in the world commercially. How is this really working? Does, you know, getting this many prescriptions, is that justified?
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Because are the patients in the real world seeing the benefit?" And so we've done all of those things. We have more than 2,000 patients in- Mm...
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that, that have been in clinical studies, which I think is, is, is pretty unique in, in our space. And our philosophy is to keep going with that- Mm... because we think it's really important.
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If a physician is gonna make a decision to prescribe our system for their patient, we want them to know what their patient is going to get out of it, and that can only be done through, through the clinical data. Mm.
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And also, as we advance, so again, moving to our next generation, what we want to be able to show is that there's a benefit from this next generation. Mm-hmm.
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So now I'm taking it back all the way [laughs] to how do you make that trade-off within, within the organization?
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I think that, you know, there's a lot more studies that we would love to do, but what we want to do are places where we can push the envelope and show the unique aspects of the therapy that we're providing in the, uh, indications that we're in today.
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And then you have to be able to save that room and time to say, you know, there's a place for a future because we've created something unique where we can access the peripheral nervous system noninvasively. Mm.
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There are other places that we should be able to treat if we do that, too, so let's save some of those dollars for, for those studies, too. But you do it in that stage. You start with the, the feasibility.
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You don't go big RCT. You should know the answer [laughs] to- [laughs]... what outcome you're gonna get into the RCT before- Yeah... you do it. Yeah, no doubt.
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I couldn't agree more with sort of the, the resource allocation around evidence generation, even though you're commercial, right?
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So I, I think, you know, it's fair to say that probably a lot of folks in your, in your position would say, "Well, we maybe don't need to do enough.
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We don- we, we can maybe kind of stop there or maybe slow roll the evidence generation." And obviously you're taking a, taking a different approach.
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But I very much agree, especially with the new category, that the evidence sort of compounds, right?
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I mean, your, your moat continues to get deeper and wider with every single study that you're running, uh, even if it's a, a post, a post-market study.
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So kudos to you and your team for kind of, you know, continuing to kind of build the real world evidence for the device.
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Let's segue into, into commercialization because I think, I think, um, the next question I have for you, which is largely around reimbursement, kind of s- you know, feed- feeds into this, you know, this evidence generation.
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And so- Yeah...
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uh, when, when you think back around kind of how reimbursement has impacted some of the decisions you've made towards either clinical trial design or commercial planning, give us a sense for kind of how you've approached that, right?
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Because I think it's, it's, um, from my perspective, reimbursement's probably even a, a larger hurdle, uh, these days, right, than even regulatory [laughs] approval.
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And so you've obviously accomplished a lot in this category.
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So for, for other CEOs maybe that are staring down, you know, generating a new, a new CPT code as an example, what words of wisdom would you offer up to, up to them? Yeah.
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And I want to start with saying here, too, that, uh, Cala's journey has been long. Certainly before I took on this role and before I joined Cala, I think that's also where the philosophy of clinical evidence started. Mm.
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And it is because of that planning and that clinical evidence early on that we were able to get the reimbursement. I think that piece is very critical.
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So I think i- you know, if you are just starting out, you need to build your clinical evidence robustly into your portfolio from the very beginning- Mm... because reimbursement doesn't get easier. [laughs] Mm-hmm.
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It continues to get harder, right? Mm. And that bar keeps, keeps going up.
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And the piece that drives that is the clinical evidence that proves that you can actually get that outcome, and then typically also, uh, patient and physician advocacy as well. And what are they convinced by?
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Clinical evidence. So, so I think those pieces are very critical for, for the reimbursement strategy. I think for us at Cala, you know, Cala's been leading the way every, every step [laughs] of- Mm... the way.
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So there were no unique codes for what Cala was doing, and so Cala had to create those unique codes and convince that we were different than what was already out there.
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So, you know, Cala's been told no [laughs] every- Mm... every time. [laughs] And then we go back and we gather the clinical evidence, the technical data to support that. So that was the creation of the new codes.
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And then on the payment determination side as well, too, you know, for, for companies that are, that are at the, the stage prior to we are, where, where you don't have that payment determination or that reimbursement yet- Mm...
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this is the hardest step, right? Mm-hmm. You're basically fighting every case by case. [laughs] Mm-hmm.
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One, to actually get some form of coverage for one single patient, and then trying to ensure that that coverage is the proper coverage for the therapy that you're providing.
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And so I, I see that one as almost like single battle- Yeah... [laughs] timeframe. That's the most difficult. But then moving to what Cala was able to do was move to a coverage determination- Mm-hmm...
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which was very fast, and I think also very unique, but it was based on the clinical evidence. We had the long-term data to say, not only does this help in acute standpoint, you see it over a long-term timeframe.
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You see it being used in places. There, there's, there's advocacy here for this, and that's what was able to, to get us to that, that coverage. Got it.
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And how much did health sort of at the, the, the economics, right, of your therapy impact, you know, that, that coverage determination? Was that pretty crucial as well? It's, yes. And it's, and, and it's always crucial.
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Mm-hmm. I think for us in particular, patients with essential tremor have a fair amount of comorbidities. They also have a history of trying pharmacological therapy and it not working. Mm-hmm.
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And then you end up with a patient that either is not going to the physician and therefore suffering, and then has issues later on. Mm-hmm. So I think that was an aspect as well too.
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I think it's a little harder for startups when it's a new therapy because you're never gonna have that super, super long-term data that you typically have when you're, you know, when you're coming into the market and you're second or third- Mm-hmm...
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it's been around a while and you can do that proof point. I think for the new therapy, you can only show what's available in that, in that certain timeframe. Got it.
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And when you think about commercializing the Kik device, the kind of the first generation device, versus all of the kind of the planning that went into to launch and now you're obviously, you know, getting ready to or maybe on the, on the, on the cusp of launching this, this, uh, the second generation device.
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Any kind of key lessons learned, right? Kind of going from planning to effectively, you know, commercializing.
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Were there any surprises or anything that, any sort of assumptions that you made that you, that you, that you really, you, you got right and were, you know, pleasantly, uh, surprised that you, that you plan- [laughs] you planned in the right fashion?
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Give us a sense for kind of what that looked like going from planning to, to commercialization. Yeah.
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So I think, you know, because I've lived many lives before in, in commercializing, I think the one thing you can always guarantee is that your plan is never right, right?
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There are parts of your plan that are correct, but you will always find something that is new or that you hadn't thought about.
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And I think this goes back to even what we were talking about before, which is why you want to get a device or system into the hands of the end user before, 'cause you're gonna find something you had never even thought about.
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And so I think for, for us, we very consciously started slow just for that reason, because we knew we were, we were learning as we, as we went. So everything that we've done has been new.
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It's a totally new therapy. It's a new thought process.
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It's, you know, if you go and ask a physician today, they likely will have heard about either TAPS or non-invasive neurostimulation for tremor, and therefore it's a lot easier conversation to have today versus five years ago when people said, "Is this real?
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Are you sure? This sounds hokey." Right? [laughs] And so going through that commercialization, that's what you're up against. It's a totally new, new therapy.
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And so that's the criticality of making your plan, starting small, learning from those pieces, and then expanding and going bigger. And I think for us it's hard to hold back. Mm-hmm.
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But it's really important to hold back because you, you know, you never wanna alienate your customer at the first go around. [laughs] Yeah, yeah.
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If you go kind of scor- scorch earth at the very beginning, there's, there's gonna be probably lots of learnings, to your point earlier, that, uh, that you didn't expect.
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And maybe you planned for some of them, but some areas there were, there were gaps. And so was that tough to get? 'Cause that, that is a, that a, a hard challenge, right?
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I mean, there's years of build up, right, to commercial launch, and then you're, you're finally here and it's, it's easy to kind of wanna, you know, rip the, uh, rip the Band-Aid off.
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But, um, was it tough getting sort of buy-in, right, to kind of, you know, launch sort of in a, in a, a bit more of a, a, a methodical fashion versus, uh, you know, going, going, uh, you know, getting more aggressive?
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I think, again, this might be where Cal is unique. I think we have, I think we have a great board- Mm-hmm... a great set of investors. They're in it for the marathon.
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And I think their, uh, experience from the standpoint that, that they also know the value of, of being methodical about it. Mm-hmm.
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It's really knowing when to go slow and, but then also when to, to put on the gas, right? Mm-hmm. So you don't wanna be too conservative and, uh, never, never get big enough.
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But I think, again, I think that we have a, a group of experienced people, experienced with commercialization as well too, that, that are familiar with that, that this is what you typically, you typically do. Yeah.
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It goes back to even the conversation we were having earlier around the stakes are higher as a startup, right? Mm-hmm. You feel this rush to go full out because- Mm-hmm... [laughs] it's your only source of income, right?
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[laughs] Yeah. But at the same time, if you make a mistake, that's hard to come back from, and it's easier to make that mistake on a smaller scale when you've even set it up to say, "Hey, this is new.
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This is our first-" Mm-hmm... generation. We really want your input and feedback," and if you find something, then you have time to go fix it. Yeah, yeah. No doubt.
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And, uh, and I think this segues into kind of the, maybe the next topic, which is around fundraising and kind of, like, interaction at the, you know, with, with, with investors.
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But you made a, a comment earlier that I think is really, really important around, it sounds like you're, you're in a position with, with Cal where you've got investors and, and a board that understands the need, right, to whe- whether you wanna describe this as going slow or m- or, like, kind of a more of a, a methodical kind of targeted approach to your launch so you can learn as much as possible before you, before you scale.
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Not a, a lot of startups maybe don't have that, that luxury. Maybe they're stuck with kind of a, you know, some folks on their... Some investors understand the importance of that.
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Others, you know, wanna be more aggressive.
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And I think that's, i- if you're, if you're in that situation, sort of proactively addressing that as soon as possible, you know, so you're not a couple months out of launch and you've got a split sort of board around, like, how aggressive- Yeah...
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you should be.
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I mean, it just speaks to, like, you know, beginning to kind of prep your, your board and your investors for what your launch is going to look like or what it should look like, and the rationale, you know, that, that supports that.
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Yeah. I think that's really, really important. So on the, on the topic of- And- Yeah, go ahead. Go ahead. Yeah. Oh, no, I was just gonna say, I think to that it's also- You know, having a clear laid out plan. Mm-hmm.
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Like these are the items that we'll say, "Okay, now we're gonna put the gas on or now we're gonna put the brake on."
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And we can handle being slow because we've set up ourselves financially, infrastructure-wise, to be able to handle that. Mm-hmm.
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Versus, you know, you don't wanna build up a whole commercial team and say, "Okay, we're gonna limited launch now." [laughs] Right.
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While all those people sit on your payroll or you're spending massive, like, DTC money out there. Mm-hmm. Right?
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So I think it's having that holistic picture together and saying, "Here's the plan, and if this looks good, yeah- Mm-hmm... then we're gonna put the gas on." Mm-hmm. "But we're gonna make sure we can handle that."
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Yeah, really, really smart a- approach. I wanna leave enough time for the rapid-fire portion of this interview, but let's get to fundraising, right?
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Because, um, Cala has not only an impressive list of investors on the cap table, but has raised a, you know, a, um, a, a sizeable amount of, uh, of capital over the years.
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And so when you think about kind of stepping into this role as CEO and having to raise these rounds of capital, any lessons that you, you, you can share, right, for other CEOs that are in the, in the throes of maybe a series B or a series C round, right?
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What do you think they really, really need to get right versus, uh, versus, you know, what could possibly go, go wrong if they're not prepared enough?
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I mean, I think it is that being prepared enough which is really building out your financial model, being able to show what those assumptions are and what are the proof points that, that- Mm... support those assumptions.
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I think that aspect is critical. Being able to show the here and the now of the company of what you're producing versus also what is the future of the organization? What will this company look like? How will it grow?
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Is there enough runway for that? Like, again, I think the benefit of startups is a lot of time you're creating a new therapy, so you, you, you have this large unmet need, so you have that runway.
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But for others, where if you're, you're, you know, second to market, being able to show the marathon version of it as well as the sprint. Mm.
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So your proof points in your sprint and your proof points in, in your marathon.
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So I think that's, like, down to the detailed level, and then I think at the higher level of on the fundraise side, understanding what your objective is and therefore matching the investors to that objective. Mm.
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And that's also where you get alignment where you're thinking about commercialization and you're gonna, you know, go controlled commercialization.
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So if you have an investor that has invested, but they're a different type of investor which is looking for a short-term gain- [laughs] Mm-hmm... that incentive's not aligned. Mm.
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So you need to think about that strategy when you're, you're setting out for fundraising. Yeah, so, so crucial to, uh, [laughs] to find, find that alignment, especially if it's new money into a, into a, a, a round.
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If, if you're, uh... Sometimes it's, it's, it's really easy to wanna just take, take the capital that's, that's available, but that is often, um... It's often gonna bite you, right, if there's not that alignment. Mm.
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In fact, it... I would make the argument that it's gonna bite you most of the time, uh, if [laughs]... if the alignment's, if the alignment's not, not there. Um- Yes...
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but even, even just kind of, um, y- your point around ensuring that you under- Like, you can, you can thoughtfully talk through the inputs that drive those assumptions. I think that's so important, right?
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And it kind of just reminds me of, of, of getting your, getting your story, getting your deck in front of as a trusted group of people early enough that can, that can kind of provide pushback, right, on some of your assumptions, right?
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'Cause some of, some of the...
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You know, you've been maybe developing or, you know, in the weeds on a, on a few sli- a f- a few really important slides to your deck, and, you know, a- a- some- someone that's seeing it for the f- for the first time would be like, "Oh, did you think about this?"
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Or, "Did you think about Y?" Yeah. You know? And I think that's, um, that's u- usually a pretty easy step to, to kind of accomplish before you, you go too, too broad with, uh, kind of your, your investor pitches. Yeah.
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And for me too, I think that's where the benefit of having worked at all of those strategics before is I've sat on the other side of the table. Mm-hmm. I've judged. [laughs] I've judged me. [laughs] Yeah.
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And, and I know what are the things that we would typically look for. Mm-hmm. And I think it's, again, you're always looking for value creation.
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So whether that is in an acquisition or, or whether that is an investor looking for a company to go IPO, it always goes back to why did you make that assumption? Mm-hmm. Yeah.
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And can you prove, or what supporting data do you have that says that assumption's real? Yeah. What Yeah. Really cool. So, so important.
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Yeah, and if you don't have that type of experience where you've sat on the other side of the table, yeah, get... just getting at, getting your deck in front of, like, new kind of...
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and new audiences, right, that, that sort of safe audiences, if you will, that are, that are willing to kind of provide, uh, some skeptical feedback, I think that's really, really important.
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So with that said, um, Deanna, let's get to the rapid-fire portion of this interview. But again, before we get there, it's calahealth.com is the website. C-A-L-A health.com.
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We'll link to it in the full write-up on MedSider, but definitely encourage, uh, everyone to, to check out the, the company.
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We'll also link to, uh, Deanna's LinkedIn profile in the full write-up as well, but calahealth.com. Really, really cool technology. So first rapid-fire question on the docket. Take us out to, to mid '27.
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What are you most excited about at, at Cala? I am excited about the number of patients that Cala gets to treat. Mm.
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I think, a- again, to me, the unique aspect of being in a startup and being at Cala, where it's a totally new treatment option, there's so many patients that deserve treatment- Mm. Yeah... that don't get it.
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Keeps me going every day. Oh, yeah, especially with, with some- as big of a need, right, as you're, as you're solving for, right? So it's really fun to have a device that's so close to the patient too.
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If you've never worked on a device like, like, or, like, or been, you know, been afforded kind of the opportunity to, to work in or with a device like this, it's, uh, it's pretty cool.
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So, all right, second question on the, on the, on the, uh, rapid-fire list is let's say we're in, uh, in Silicon Valley, right?
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Maybe, uh, Cala's neck of the woods here, and, uh, it's a small group of, of, uh, med tech entrepreneurs, and you wanna leave them with kind of one billboard message, right?
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One message that they really need to get right. What, what would that be? Oh, that's a good one. [laughs]So many things. Know your business. That will get it every day, is make sure you understand it in and out.
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What are the levers that you pull that, that will make it successful? Yeah. Simple, but, uh, covers a lot of sins in the world of startups, right? If you know your business really well.
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[laughs] All right, last, last question.
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Um, if you, if you could rewind the clock, you know, take us back to earlier in your career, maybe kind of mid, mid to late 20s in your career, really started- starting to take off.
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Anything that you'd tell your, the younger version of your- yourself from a professional standpoint?
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There are many ways to get to the end and enjoy every experience along the way, because no decision is ever the wrong decision in a career. It's always something you learn. Mm. So trust in that.
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Yeah, really good feedback. Um, well, this has been fun, Deanna. Thanks again for, for carving out some time to, to do this interview. Uh, really, really appreciate it. Thanks for having me. It's been a great time.
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Yeah, definitely be fun to kind of see Cala's continued success, and I'll have you hold on the line, but for everyone listening, you made it this far, appreciate your attention as always.
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Definitely check out CalaHealth.com, and, um, until the next episode of MedSider Goes Live, everyone, take care. [outro music] Hey, it's Scott again. One quick thing before you go.
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You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups.
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