Closing the Treatment Gap for Patients Living with Tremor with Deanna Harshbarger, CEO of Cala Health

[00:00:02] Hello, everyone, and welcome back to the Outcomes Rocket podcast. I'm really excited that you're joining us again for an episode today. I've got Deanna Harshbarger with us today. She is the CEO of Cala Health. They're doing some incredible things in the space, and I want to start digging into those with her. So, Deanna, thanks so much for being with us. Deanna Harshbarger Thank you much, Saul, for having me. I'm really excited to be here.

[00:00:29] Yeah. So, look, why don't we just kick things off just to help our audience get to know you a little bit better, as well as Cala Health. Fantastic. So, I've been with Cala for the past five years, and I've actually been in the medical device space for over 20 years. It's crazy to believe. Time flies. Time flies when you're having a lot of fun. Definitely. And I actually started my career as an engineer, a chemical engineer.

[00:00:59] Really? Chemical engineering? Yes, I think I was the few people that actually practiced chemical engineering before moving on to the commercial side of the business. Wow. And it was a great experience, a lot of fun, but I worked in a ton of chemical plants. Hmm. And one of the key things that I noticed was the criticality of safety. So, your day-to-day decisions had an impact on people's lives.

[00:01:28] And I loved what I was doing, but when I got a chance to really understand all of the different industries that were out there, I thought, I don't want to put people at risk on a day-to-day. I would love to, at the end of the day, know that I'm having that positive impact on people's lives. And I had a great opportunity to do an internship in the healthcare space, and I never looked back. Really?

[00:01:57] Yes. And so, I was really thrilled to have an opportunity to have such a large impact. When you get into healthcare, there are so many different things that you can do. But at the end of the day, that's touching somebody's life in a way that with most things you do, you don't get a chance to do that.

[00:02:20] Yeah. So, as chemical engineers go, do you find that the ones that end up in healthcare are more like pharma? You ended up in med device. So, tell me about that. That is a great question, because most chemical engineers end up in pharma. Right? Okay. So, my mind wasn't off track. No. No. That is very true.

[00:02:45] So, I had a chance to take a look at pharma, and what I saw there was a very long cycle time. And what I saw in medical device was you have an opportunity to move quickly, build quickly. And you see more mechanical engineers in the device space. But I loved having something that was tangible, visible, and physically impacting a patient.

[00:03:14] And as you know, within the healthcare space, at least I guess this is dating back to a while, you started to see the combination of chemical, pharmaceutical with device. And so, it's a great option, too. And you see how complex the world has become, and this opportunity to mix all of these different areas together. So, I think device was a great start. I think the tangible piece is really important.

[00:03:39] But I also see, like I said, the combination of pharmaceutical, and now you have big data, you have truly connected devices. And so, that's all extremely exciting. So, with a chemical engineering background, I still love the opportunity to pull all of those things together. Oh, yeah. Listen, I love it. I think it's a big opportunity. And I was just curious. One last question that I just have to ask you. I always found chemistry really hard.

[00:04:06] And I always wondered, all the people that did great in chemistry, like, do they have photographic memories? Do you have a photographic memory? I'm probably the least person that has a photographic memory. No, it's not a photographic memory. It's that engineering background of loving problem solving. So, it really is just thinking about it in atoms. I love it. Well, that's so great. Okay. So, talk to us about Cala Health. What are you guys up to?

[00:04:35] How are you adding value to the ecosystem? Yes. So, Cala Health, what we have today is bioelectronic medicine. We are being able to non-invasively treat tremor patients. And I think that is, first of all, a massive step forward as we think about the evolution of healthcare.

[00:04:56] And so, what we're able to do is have an opportunity to provide a treatment pathway for patients that just really didn't exist before. So, patients with tremor, currently, if you see the treatment options they have, they start out with pharmaceutical. And that is fantastic initially. But what you also see is this huge unmet need as they evolve with their disease state.

[00:05:23] So, tremor is neurodegenerative. So, over time, it gets worse and worse. And with the medications that are available today, when you continue to treat patients with those, you need to keep titrating them up, dosing them up as the tremor gets worse and worse. And almost half the patients will be unable to handle that leveling up of that titration.

[00:05:48] They'll begin to have side effects with those medications or with the age groups that they're in. They could end up being contraindicated to them. And the only other options that are available are more invasive options like ablative surgery or deep brain stimulation, which are highly efficacious as well. But you really don't see many patients going to that invasive type of procedure.

[00:06:15] And it just leaves this huge treatment gap for patients. And so, we're really excited to have an opportunity to fill that gap that just didn't exist before. And I think one of the exciting things is that we're really leading this space. This was not an area, non-invasive neurostimulation for tremor did not exist before.

[00:06:39] And we've taken the time focusing on the scientific foundation, ensuring that we have the clinical data to be able to support that. And then continuing to advance as well, too. So, we're really excited about where we sit today. And most importantly, we're extremely excited that we have the option to treat patients that really didn't have great options before. That's great, Deanna.

[00:07:05] I mean, I would love to dig into the technology, if that's fine with you, to better understand how it works. I'm very curious. Yes. And so, when you look at what calotherapy does, what we're really able to do is address the tremor non-invasively through the peripheral nervous system. So, on the wrist. Okay. So, what we do is we actually personalize the treatment to each patient.

[00:07:33] So, each patient, what we're able to do is measure their tremor, utilize that to set stimulation parameters. And what we're doing is actually interrupting the signals in the brain, which have been studied and known to address tremor through deep brain stimulation, for example.

[00:07:54] So, actually being able to access the area within the brain called the VIM non-invasively to be able to interrupt those signals and therefore treat the patient's tremor. So, the foundation really goes back to truly understanding how the tremor is created and then to be able to address that non-invasively through the peripheral nervous system. Very cool.

[00:08:21] So, the detection and delivery of the therapy happens at the wrist? Yes. Super cool. Yes. I'm sure you have a video that we could probably put in our show notes. Yes, we do. Awesome. So, we'll definitely take you up on that. So, if you guys are wondering, huh, this is interesting. Well, guess what? There's a video in the show notes for you to see exactly what Deanna is walking us through in how this therapy both interprets and delivers care.

[00:08:51] So, as you've been building the company, I feel like, especially in Mend Device, it's a lot of setbacks, right? So, what's a setback that you can remember, whether it's near or a while ago, that gave you a key learning that has made you guys better? Yes, yes. So, I would say Cala's been through a long journey.

[00:09:12] That question, I think, is very funny because you feel as though every day is a setback in the workplace, right? But I would say it really would be around when Cala has been told no. Hmm. And that can be from a variety of different places.

[00:09:33] So, a lot of it is really when the company started back early in developing the very first device, being able to get that through the DeNovo pathway. That was, we say smooth, but there's a lot that goes along with that. But really, when you're creating a new treatment option, ensuring that you actually can create access for patients. And that's really a reimbursement pathway.

[00:09:59] And so, a couple key things that Cala was able to do was to actually create new codes for this new treatment option. And then be able to get a payment determination that really valued what was the effort, the clinical data, the research, the uniqueness of being able to sense the tremor, be able to personalize the medicine and get that.

[00:10:25] And then move on to being able to get a local coverage determination with Medicare. So, the setback is it was not a smooth path. And every step of the way, Cala was told no. But I think what was amazing was the team really came together to say, why are we hearing this no?

[00:10:48] And how can we help others understand the uniqueness of this new treatment, the uniqueness of how we can treat patients, and how we need to be able to get it to patients? So, I think there's a perseverance that has to go with it. If you truly believe that this is the right path forward, then it's keeping with that and also breaking it back down to what are the key reasons for the no?

[00:11:18] I love that, Deanna. And I heard this a few years ago, and it has stuck with me, actually, the no, right? I heard NO is missing the K and the W, the K-N-O-W. Have you heard that one? Yes, yes. Oh my gosh. It sounds like you guys have literally known, and it's taken a while to inch into where we are at now. So, congratulations on that reimbursement. Like, that is no joke.

[00:11:47] That is an uphill battle that a lot of companies don't get to see the end of. So, congratulations on that, and exciting to see where this goes. So, where are you guys now, and what's next? Is the therapy getting delivered? Talk to us about that and what the future looks like. Yes, yes. So, very exciting as we are commercial stage. We are serving Medicare patients. We are serving veterans in the VA.

[00:12:12] And we're really excited that in March, we actually announced that we'll be launching our next generation system, the CaliKick Plus. And this is really taking it to the next level, being able to provide new stimulation modes for patients. And what we plan to do with that is when you think about offering different modes, one is you want to make sure that everybody that gets your therapy gets the best possible therapy.

[00:12:42] And tremor is unique to every single patient. And tremor is different in each hand. And so, what we're really doing is being able to find what is the best treatment option for each patient. So, we're really excited about being able to bring that to market later this year.

[00:13:02] So, we're really happy that what we're really able to do is provide a simple treatment option for patients that really have few alternatives. Cala Health has a device called CaliKick, and it is a wearable. It is like a wristwatch that provides stimulation through the band, which then accesses the patient's peripheral nervous system to treat their tremor.

[00:13:31] So, it's as simple as wearing this device when you need treatment for tremor. Deanna, I love that. Form factor matters, right? Like, I mean, we're people and we're social. So, if this thing is literally like a watch that doesn't look any different or doesn't make me feel weird, that matters. And that was a key concept for Cali, which was how do we fit into the life of a patient?

[00:13:59] So, you'll see that our design is very patient-centric. It's meant to be discreet. Nobody wants to call out what's going on with their health. And that's why it looks like a simple watch. Wow, that's awesome. So, congratulations and really exciting place to be in. If you had a closing thought for us, Deanna, on just kind of how people should be thinking about this category that you've created, how should they think about it and where can they reach out to you and the team to learn more?

[00:14:28] Yes, absolutely. So, a couple key thoughts that I would like to leave everyone with. One is a quote, one of my favorite quotes from Nelson Mandela, which is, it always seems impossible until it's done. Because I think we can apply that to the world of startup and what we do every day. And also, think about that in the context of patients.

[00:14:52] It's our obligation to be able to get as many patients that deserve the therapy, the therapy. And there are so many things associated with that. So, I think that is really important. If there's one thing that we should take away from this conversation today is, we get up every morning to help more patients. That's what we say at Kala. I love that. And if people want to follow our journey, please, you can access our LinkedIn page, our Kala Health LinkedIn page.

[00:15:22] And I am also on LinkedIn at Deanna Harshbarger. Outstanding. Well, Deanna, thank you so much for being with us today. And really, for what you and your team at Kala Health do. Just making a difference, being brave enough, taking the risk, spending the time to make new treatments available for this particular area, that tremor, that doesn't have many good options.

[00:15:49] So, if this is new to you, your first time hearing about this, check out the video in the show notes. Maybe you have somebody in your family that's dealing with this. Share the episode. Post it on social. Get the word out. Because that's how we ultimately make a difference in this space, is we sort of leverage our networks and we spread the word on things that are good. So, yeah, just check that out. Reshare it. Deanna, thanks for being with us. Really have appreciated the message you shared today.

[00:16:19] Thank you so much. I really appreciate the time. I was thrilled to be here.