Okay. We are live. Good afternoon, everybody. My name is Mike Polark, medical device analyst at Wolfe Research. Welcome to day two of the Wolfe Research Healthcare Conference. Pleased in this session to be joined by Mobia Medical CEO Richard Foust. Richard, welcome to the conference. Thanks for being here.
Yeah. Thank you.
Mobia is new to the public markets. You've been on the journey for some years. I'd love to give you a chance to just introduce Mobia, Vivistim, and what you're building.
Yeah. Thank you. For those who don't know the company, Mobia Medical is really pioneering work for chronic stroke survivors. We're the first company in the U.S. for this huge unmet need, which is stroke recovery. Many of you know people who've had a stroke, and today, in a lot of places, that's where their care ends. We're trying to rewrite the narrative so that in the future, comprehensive stroke centers will really refer to themselves as comprehensive stroke centers, including stroke recovery. What our technology does, it's a vagus nerve stimulator, Class III implantable, and that device essentially rewires the brain and allows for people to have better hand and arm function within a six-week protocol. As I mentioned, it's a huge unmet need.
There has been incredible science that has led to the proliferation of stroke survivors, people surviving a stroke, and a proliferation of those people living in the U.S. today. It is one of the larger unmet needs of disability and cost. There are 9 million ischemic stroke survivors today living with impairments. Our goal is very simple. It is to bridge that gap and to give everyone that would like to have this technology the ability to get better and become the standard of care.
Good setting of the stage. As I look at the journey for Vivistim, it is early. There is a lot of runway. It is local. It is hospital by hospital. I see three major stakeholders, the stroke physicians, the neurologist, the neurosurgeon, the patient and their family, and then rehab specialist. I think you need to work to get engagement from all three to make the concept work. As you commercialize and invest in, engage with these folks to make Vivistim a reality, if you go by the three stakeholders, what is the most common question from all of them, the biggest tension, and what is your answer?
The most common question is, "Why didn't I know about this before?" Honestly, the stakeholders that we are going to and educating about this solution have all been looking for the solution. I will start with the physicians in the hospital. It is the uncomfortable conversation when a neurologist or a neurosurgeon is visiting the family after the stroke survivor has woken up, and it is, "Okay, you are going to be on a journey. You are going to do rehab. Things are going to get better." Then the question is, "Well, Doctor, if I don't get everything back, what is next?" I think for the hospitals that we work with, Vivistim can be that. I think that is changing the entire dynamic. I would say even more so, we will get to it a little bit later on how the guidelines are impacting that.
On the patient side, we did some early research. We have to realize this huge unmet need is really highlighted by symptomatic patients, meaning they had a stroke, they have impairments, they know they had a stroke, and they can see that impairment every day they wake up, all of their friends, all of their family members. What that means is they are actively engaged in finding solutions. We found about 75% of all stroke survivors are actively engaged in finding solutions. Then you have the therapists. Therapists in general, some of the most brilliant caregivers that I have worked with in my career in medical devices, highly educated, and really put the patient first.
And what's amazing is they actually can't believe the outcomes because these PTs and OTs have treated patients sometimes for 10 or 15 years, and it's more maintenance than improvement, but they're still providing a service for that patient because it's motivation, it's about hope isn't lost. But after they've used Vivistim, their entire perspective changes, and they become an advocate. When I think about the challenge that we're facing, honestly, it's awareness. It's that, as you said, we are using a very disciplined and methodical approach in terms of how we are engaging with the care system to make sure that we're creating something that is durable. That's the tension, is that we can't be everywhere at once in order to be a durable business, but our goal obviously is to be the standard of care.
Maybe economically with the provider, what happens? What do they say most commonly when you say, "Well, we have coding and we have payment, and you're going to make money putting in our product"?
Yeah.
Is that as equally surprising as the existence of-
No one believes it.
Yeah.
Right? You have to prove everything. Even if you are randomized, triple-blinded, sham-controlled study, everyone wants to see it for themselves, and they want to see the payments, and that is fine. We kind of had that playbook in the beginning, and it was just being very humble in the approach, which is getting that cross-functional group together. The surgery is quite straightforward and safe. The patients get better, and then the hospitals get paid. Then all of a sudden, that conversation happens, which we are not there yet, but you have seen this play out with other kind of elective procedures like knees and hips, is when you have all of that alignment moving in the same direction, which is it is good for the patient, it is good for the hospital, it is good for the company, things start moving pretty quickly. I think eventually we will get there.
Obviously some things to do
Yep
before then. But I think that is the hope and the focus.
Especially on the patient side, focused on the prevalence, not the incidence. That is a future opportunity.
Yeah.
It is more rewiring workflows, but there is a lot of stroke survivors years post-stroke. Your average patient, what is the role or requirement of a family member here? I am just thinking, look, there is some impairment. Do these folks even drive the patients? Do the patients drive? Maybe not. It is the family. Just the steps required, how many visits. Talk to me about that as just a tension that you are navigating and what you see most frequently for your average patient, and what is a common misconception if patients and families are interested, ask the question, and then recoil?
It is hard. I think for people who have had friends or family that have had a stroke, you realize how traumatic and how dramatic of a change it is. If you are the primary caregiver, you are no longer the primary caregiver. If you were working, you may not be working, and there is a big adjustment. What is really clear, and it is not 100%, so I do not want to say more than it is, but most of the time, the family members and/or friends become caregivers, and they are there to support the stroke survivor. So, what we see is those people pitch in when there is a gap. There are lots of resources out there that people utilize, and we have a care team that helps point people in those directions.
But it really is, you get to see in the most amazing way, the community come together around people to help them get better and then celebrate their successes.
Last stakeholder, the OT/PT. When I first got to know the story, I had to ask all these kind of questions, and this one is, there is no incremental economic incentive, but these folks are working with the patients already, and now the patient just gets better faster on your. Is it that simple? Is that how your average OT/PT partner?
I think so.
is seeing Vivistim?
I mean, they see this. Well, first of all, they see it as a-
They have to be trained a little bit, but-
Yeah, technological breakthrough, so there's interest, right? There's been lots of, I would say, tools that are more orthotics for helping patients with lots of things, and those all have a place. This is really the first technological revolution that's happening in OT and PT, and they all see it as a way for them to be better, to bring more to their patients, and to lean into technology, which is really exciting for them. Then there's something we haven't proven yet, which I think is just a bullet point here, which is our patients, once they get our device, they show up for therapy. We don't market this as something that saves money for the therapy site, but one of the key attributes that they look at pretty carefully is call-off rate.
I can tell you that our call-off rate for patients is very low.
Meaning like no-show rate? Yeah. Okay.
Yeah. So, having a patient who's going to sign up for at least 18 sessions and show up is a really positive thing for a therapy site.
They don't get the bill if the patient doesn't show?
No. Correct. No.
Yeah. Okay.
That would be illegal.
What would you Just, I wanted to clarify for the record and dot the I there. Dumb analyst, please.
No, it is okay.
Okay. What is the data suggesting in terms of difference in no-show rate in the real world? Your real-world data.
Yeah. I would say it is really low. And typically-
Yours is low.
typically in the real world, it's 25%-30% of the time.
Okay.
It's a material difference and change. Again, I don't want to overstate it, but it is something that every director of therapy, which is kind of the person who governs usually a therapy department or a therapy center, is looking at and tracking.
Yeah.
Because ultimately, you reserve spaces for people to show up, and you're paying for the therapist to be there either way. If people don't show up, then they're paying for no service.
Yeah, that's a good tidbit, new to my ear. Guidelines, so remarkable, and you already said it, but I want to say it again. You have a randomized, prospective, sham-controlled, three-blinded trial that worked, you know? Respect to all of the medical device coverage, a lot of products can't say they have that. You have that. That was important to me. It's the foundation of anything medical device concept will do. And you've leveraged that great quality data, great outcomes from a quality trial. You're in the guidelines, a couple months ago. A major accomplishment for a young company in the commercial phase.
Yeah.
What will be the impact of this today, within the next year, in the next two to three years? What happens when you go from not even on the radar to-
Yeah
on a radar like this?
Yeah, I think it's something, first of all, that will play out over time. One of the anecdotes that I gave on the earnings call, which is something that we saw pretty immediately, which is a hospital system deciding to go from an individual hospital implementing to an entire system implementing. I think in a lot of ways, you have to step back and ask yourself, what do the guidelines mean? I would start with, AHA is kind of really high up in terms of rigorous and multidimensional, multi-specialty governance. It usually is one of the last guidelines to get in the cardiovascular world. You usually get specialty society guidelines first. So, it means a lot. I think the first thing is it's a validation of all of the data and the technology.
Anyone who is kind of on the fence, this gives them kind of that passive validation that, "I don't have to worry. The society has kind of put the bow on this for me." The second is that when you are in the guidelines, it's supposed to change practice. The way you change practice is you have quality measures, you have protocols, and you're able to be measured against those. That's what different organizations that come and audit hospitals and give them stroke designations on a biannual process, like JCAHO and others, will use the guidelines as a way to assess where people stand in terms of getting with the guidelines. I think that is something that'll take a little bit more time.
What is very clear today is that hospitals and physicians take it very seriously, and I think it's changing the way they see us. I think that is all very positive. In terms of how it changes payers, I think it's another part of the process. I think being in the guidelines helps. It doesn't flip things overnight. You still need more data. You still need to be able to have the number of paid claims. But it's incredibly important to have that at this point in time.
Maybe staying on clinical data, from last week, I think there was a teaser, maybe out of the real-world registry, GRASP, something coming next year. Just talk to us generally about the data strategy. What can come out next year, the year after that, and maybe next year specifically out of GRASP? What's a reasonable expectation? What are endpoints? What's the purpose of it? Is it simply real-world data and kind of validating the trial setting, or illuminating new endpoints?
Yeah
Talk to us about that vision.
I think the vision starts with, as you mentioned before, the foundation of the VNS-REHAB trial, which really set the tone for validating clinically that this therapy protocol works for patients in a material way. Number two is generalizability. That was limited in scope in terms of patients covered. I think what you want to do with a real-world registry is show that no matter where you are across the U.S., what the demographics are, that you can get a similar aggregated endpoint and timeline associated with the pivotal study. I think with that's when things really start getting more serious. In terms of the strategy, GRASP is not just an endpoint for 2027. Our goal and our objective is to have a larger registry and have a publication and a readout on a regular basis. The first one will be in 2027.
I'm not prepared to say because we need to get the manuscript in first. It's going to have a substantial number of patients, and it'll be a step in the right direction. It won't be probably definitive. I think part of this is just having really large numbers at later time points so that it'll continue to build our understanding across, again, patient populations, but also cement us as a company with a technology that can become the standard of care.
Who in the broad cardiovascular field, thinking specialty, who is your focus specialty physician? When you're AHA, I always, and ACC, I consider kind of broad cardiovascular entities. Is it the general cardiologist, or is this really a product, it's stroke neurologist? Who do you expect to win over time? What does that focus look like?
What I would say is, and I keep having anecdotes of why this is true, but I think the first thing to notice is that AHA has governance over neurosurgeons, neurologists, PM&R physicians, OTs, PTs. They have guidelines that are for those societies. It's not the only thing that gets guidelines, but my point being is that is very holistic. When we think about changing the standard of care in stroke hospitals, what we need is an individual who's going to lead the charge and who's going to coordinate and work with other people. We find that team effort part of all stroke programs, right? It's hard to say there's one specialty or another because there's a group of people that are working on behalf of stroke survivors.
I will say, in general, stroke neurologists play a very central role because of tPA and their understanding and central role in driving stroke programs. There's also lots of things to do. At any individual hospital, you can have a multi-specialty approach. In terms of how we integrate with all of those specialties, again, we need a neurosurgeon to do the procedure. The stroke neurologist plays central to coordination of care, and PM&R physicians are managing these patients long term in the community. Yeah, I'm not prepared to say there's only one specialty.
Yep.
We do work pretty intimately with all of them, because ultimately the goal is, let's not leave any stroke patients behind. I think the anecdote that I'll give, and I've given this a couple times, but stroke patients are everywhere. We're starting with the people that see them more regularly. But the reality is, I was having this conversation with the CEO of a hospital, and he said, "At this moment that we're having this conversation, we're going to see 1,000 patients today in this hospital. How many are stroke survivors that are coming here for things besides stroke care?" We don't have anything on the intake form to designate stroke survivors. I think that's a little bit of the point, is that our goal ultimately is about awareness.
It's about carrying this message that there is something more for all of these people that meet their criteria. The more people that know about it, the more people that reinforce it allows more people to get access.
On the patient side, are you focused on these in-system folks, the folks that are still engaging in their care and using kind of the traditional physician channel to acquire a patient, if you will? Or is there some DTC that is happening or might happen? What's the direct-to-patient marketing vision?
Yeah. I would say we have a lot of ways that we're engaging with patients. For me, direct-to-consumer, it's a wide spectrum. We have a great web presence. We do webinars. We have patients that have gotten our technology, do webinars to really tell their story. We also do some social media advertising, because I think part of this is that patients are doing a lot more search on their own, and I think you need to have a lot of different sources. But that's part of, like, we're also educating a lot of different physician groups. I think when people are making decisions, they talk to a lot of different sources. I don't think they depend on one particular source to make a decision like this. But it's multifactorial. I mean, our goal, trying to get to 9 million people, you spread a wide net. And today, it's working.
A Vivistim patient today, case, heal from case, and then re-engage in-
Yeah
rehab. What is Mobia doing during that part of the process?
Sure.
That OT/PT is trained on pairing and is going to evangelize and support that patient, and they're excited because that patient's going to show up 100% of the time. Are the territory managers or the support still monitoring to ensure kind of quality real-world outcomes? Talk to me about-
Yeah
how you work that angle.
Our sales unit is a territory manager and a therapy development specialist. The territory manager is mostly focusing on starting new programs in stroke hospitals and also working with them to develop kind of this early identification program. We also have therapy development specialists, which are OTs and PTs, and they work in the ecosystem around the stroke hospital. They're really the ones that are working with the therapy sites. I would say in general, they're usually there in the beginning and the end, because when a therapist has pretty much done one patient, it's pretty straightforward. They want to be a support to make sure that the patient feels supported in the beginning, and also to celebrate what happens after their in-clinic therapy finishes. The transition that we have is a way of engaging with patients over time.
giving them a way to make sure that they're continuing to utilize the benefit of our technology in the home setting. The fact that they can continue to turn the device on up to eight times a day and do activities of daily living. We've shown that already in our pivotal data out to two years that patients continue to improve. I think all of those are really healthy habits, and they're usually cemented while they're working with the OT or PT in clinic, and they come up with ideas of what are the things that they're going to do and how they're going to utilize it. I think part of this is obviously getting the benefit upfront and then developing all those healthy habits to continue utilizing this technology when you're walking your dog, preparing food, folding laundry, doing whatever you do.
We have five minutes. I want to hit on a couple growth financial topics, maybe reimbursement.
Yeah.
Your favorite topic. The good news, the New Technology APC payment level was affirmed for 2027. The idea is there's a level 6 for neurostimulation one day. Talk to us about the path, potential timing, and confidence that the provider reimbursement levels here in this New Technology APC are enduring.
Yeah. I think the first thing, just to level set for everyone, we have a Category I CPT code. This is something that we don't have to be concerned with. A lot of companies spend a lot of time going from category 3 to Category I. Number two, what Mike is referring to is our payment level. The most important thing is today, we don't experience any disruption, or the hospitals that are using our technology are getting paid, right? That's both for Medicare patients as well as private patients. There is a normal process that the companies go through when they have a technology that doesn't fit within the current structure, which ours doesn't. It's kind of somewhere above a level 5 code.
We had what is called transitional pass-through for three years, where CMS paid for the price of the product separate from the hospital payment, and that helped them generate some data to understand what was next. What was next was a New Technology APC 1580, which allows us to sit in a, I call it, a place, while enough claims are paid that validate all of the measures that they look at in order to create a new payment level. We're not the only company that could fit into that payment level, but we are one that has clarity. What is really important to recognize is that being in a New Technology APC, there is a lot of clarity for the company. We feel very comfortable about obviously being in the proposed rule.
It wasn't a surprise that we were part of the final rule.
Yep.
It's usually the way it works. We feel very comfortable that that will be the case until there's enough claims, at which time CMS can determine to do it. In the meantime, we'll probably be in New Technology APC 1580. The payment level is essentially the same. From a hospital perspective, they don't see any difference.
Last topic, a few minutes, hiring. You're in growth mode, four to five new territories each quarter. Just talk about your hiring process, your candidate flow now that you're public versus before then, and maybe your training process. What are you looking for?
Yeah.
How do you bring these folks in and get them set up for success?
You're absolutely right. Super growth mode, and the energy is palpable. We're definitely a destination employer. People do seek us. I would say that the culture that we have does also attract people. From a profile standpoint, we've stayed very clear on both the behaviors as well as the skill set that we're looking for. It is definitely a combination of successful salespeople that have run processes or built programs. There's no company that has all of these people. They just have had experiences in their career that have bridged both of those gaps. Conceptually, they have to lean into a growth mentality. So much of what we do is creating the future. Those are the people that we're hiring, and I have to say that the team is doing an amazing job.
In terms of training, we've gotten into a really nice rhythm of the cohort of people that we hire on a quarterly basis, and when that training happens and how that training happens. We feel really comfortable with our ability to continue to do that repeatedly. But it's exciting. Lots of talented people coming to the company, and they're all on the same mission, and we get to celebrate patient outcomes every day, and that's really special.
How does the company do that? Email?
We have this-
Weekly email, daily email?
we have this platform that everyone loves called Slack, and we've got a channel called Vivistim Victories, and people post all of the patient outcomes that they see in terms of videos and things like that. It's amazing, because everyone is gaining all of this incredible energy on patients getting better and seeing what they can do, and what things that they can do today that they couldn't do yesterday. It's amazing.
Is there a new Cathy on that Slack? I feel like Cathy gets a lot of airtime, but she might need a friend.
Cathy gets a lot of airtime. It's not surprising that one of the things that stroke survivors do put down as the thing that they want to get better at is writing their name and writing in general. We see it all the time. People are like, "Honestly, I don't even like to write checks anymore, but I want to write a check." So, yes, there's definitely a new Cathy, but Cathy's got a warm place in the heart being one of the first Vivistim patients treated.
Good. We're at time. Richard, thank you so much for being here.
Yeah. Thank you very much.
Appreciate the conversation.
Look forward to the future.
Yep.