Good afternoon, everyone. I'm Robbie Marcus, the MedTech analyst at JP Morgan. Happy to bring up CEO of Kestra, Brian Webster. He's going to do a presentation, then we'll do some Q&A after.
Sounds good. Thanks, Robbie. OK, thanks, Robbie. Hello, everyone. Good afternoon. You guys are coming up on midpoint of the conference, I guess, at this point. So congratulations. Well, I'm happy to talk a little bit about Kestra today. We've got a really fun story. The opportunity is really based on a few key fundamentals. We're in a very underserved market, we believe, that has an urgent need for the clinical benefit that our product brings. We believe we have a differentiated, now really well clinically proven solution.
The market, the TAM in our business, is about $10 billion in the U.S., a little bit larger outside the U.S. And in that TAM, we think there's about $1 billion of current market penetration that's low-hanging fruit for us as the second entrant to the market. We are entering what was, until we entered the market, what was a monopoly market. Our business is scalable.
I'll talk a little bit about that as we get into it. It has a really attractive unit economic profile. And then we have a proven leadership team that's been there and done this before. And we're excited to be doing that again today. We're a wearable medical device company and digital health care company. The first product that we brought to market is the Cardiac Recovery Platform. And that features the Assure wearable cardioverter-defibrillator. If you're not familiar with a WCD, the use model for that is typically about 35% or 40% of the patients are post-MI patients, so post-heart attack patients. Many of those patients are going to go on to get an implantable device. And another big chunk, maybe another 40% to 45% of the patient population are heart failure patients, so early stage, newly diagnosed heart failure.
Many of those will be diagnosed with heart failure, put on guidelines-directed medical treatment, which are the pharmaceuticals, and our job in both instances with both of those patient populations is to protect the patient when they're at an elevated risk of cardiac arrest, so cardiac arrest, as you know, is a serious issue in our country, and that's really the role of the WCD. Our leadership team has a well-grounded MedTech background. We have folks who are in the external defibrillation space, like myself. We have implantable experience. We've recently added a few new executives to the team to round out our executive team. Neil Bhalodkar, who's our IR leader, comes from Inari and Axonics, so recent public company experience. At the time of our IPO back in March, we brought in a new Chief Commercial Officer, which is Al Ford. He came out of the Axonics experience.
Most recently, we brought in Tim Moran, who came out of the Covidien ecosystem and most recently was the CEO of Avertix, which is in the heart failure space. So rounding out the executive team with some good commercial operators and public company operators. We've got a really well-experienced team when it comes to the medical device space. Our milestones along the path have been many. We've had some exciting milestones since our inception in 2014. We were originally financially sponsored by Bain Capital, private equity side of Bain Capital, by the way, which is a little bit different. Along the way, the life sciences side of Bain Capital came in as well alongside the PE company. We executed a long and challenging R&D program, which is. This is a difficult category because you have lifesaving therapy being delivered in an ambulatory patient environment.
And the patient's wearing this externally. And there's a lot of technical challenges to solve there. So we executed that R&D project, did a couple of clinical trials, got our PMA approved in late 2021, started our full commercial launch in about August of 2022. So we're three and one-half years into that launch. As I mentioned, we did take the company public in March at a successful IPO. Recently did a follow-on offering on the heels of some strong clinical results. So we're excited about that. And we published those results. That's our post-approval study, which was a large 21,000-patient study that we did as part of our FDA post-approval, which we recently got accepted and approved by the FDA as well. So a lot of exciting milestones along the way. We have some new exciting milestones coming up as well.
The problem we're trying to solve is cardiac arrest, and the problem with cardiac arrest in the U.S. is over 400,000 people suffer from cardiac arrest every year in the U.S. The issue you have with that is it's time-based. Every minute that goes by from the onset of cardiac arrest, your chance of survival goes down by about 10%, so start your clock right now and pretend for a minute that you just had an event and you're down on the ground and start thinking about how quickly that you can get EMS to you, and even in the best EMS systems in the world, if you can get them there within seven minutes, then you've really accomplished something, so that means 70% of your chance of survival has already gone by.
If you're lucky enough to have been diagnosed with cardiac risk and prescribed a wearable defibrillator like the Assure system, we're going to diagnose that cardiac arrest and treat it within about 45 seconds. Your chance of survival in that instance is extremely high. In fact, in our clinical readout of our post-approval study, we had a 100% conversion rate of those lethal ventricular arrhythmias. Chance of survival goes up really dramatically. One of the other really important parts of the clinical trial readout that we had in November was the assessment of patient risk in this population. One of the underappreciated parts of the WCD space is the fact that there is a patient population. They are at risk, unacceptable risk in our view.
You see on the left here in the gold. That's the rate of arrhythmia for those patients, the annualized rate of arrhythmia for those patients in our study. The one just to the left of that was another recent study from one of our competitors in a German registry where they measured roughly the same amount of risk. And so we always say that there's really three things about the WCD space that you have to really think through. One is, is there a risky patient population? Are there patients who have measurable risk? And we think that the studies like these have answered that question unequivocally. The second question you have to ask is, is there a therapy that is effective at treating that condition? That's a definitive yes from our data, from any external defibrillator.
Then the third question, and the most difficult one in the WCD space, is, can you get the patients to wear the device? Because this is a device that you can put on, you can take off. Patient compliance has always been the biggest challenge for this category. We answered that also definitively in our data with median wear time over 23 hours a day. We feel like we've really set the stage with some great clinical data for growing this category. The overall market, we believe, is about 850,000 patients a year are diagnosed with low cardiac output. That typically is measured by ejection fraction. If you have an ejection fraction of 35% or below, you are typically eligible for a WCD. Today, that amounts to about a $10 billion market in the U.S.
Of that 850,000 patients, we believe right now there's about 120,000 a year that are being served. So it's underpenetrated. Only about 1 in 7 who are eligible for a WCD are getting a WCD. And we think that has to change. And there's a lot of market development activity that needs to happen. There's some guideline changes that need to happen. And we believe all those are within reach as we look to expand our footprint. The cardiac recovery system platform that we've developed, it starts with a wearable. Patients wear this 24 by 7. They take it off only to bathe. And the device was designed for both a male and female version because it turns out that females have cardiac arrest as well. They're about 40% of the patient population for cardiac patients.
Once we put a wearable on a patient, we download our application on the patient's phone, so now we are connected to that patient. We're transmitting that data from the wearable to the smartphone. That then gets pushed up to the cloud where we present that to the physician via the physician portal. We also set up the physicians for notifications when there's significant events going on with their patients. We have the benefit because we are connected to our patients, we have the benefit of being able to monitor our patients. This is not like the stick-on-patch business where you're doing a post-wear time evaluation with an IDTF and you're trying to find rhythms. This is real time. We see when something is happening with our patients, and we can take action on that. We can contact the patient. We can contact the provider.
And we can help to advance the care for that patient. So that's an important part. We call that our Heart Alert services. The other real differentiating part of our solution is in the event that a patient actually has to be treated with therapy, then within about three seconds of that shock being delivered, a notification is automatically sent to a 911 call center. They pick up the phone. They call the patient. And if they can't reach the patient or the patient's caregiver, then they automatically dispatch local EMS to the patient's location. And that's a recognition of the fact that if you've been delivered a defibrillation shock to treat your VF or VT, you're kind of in a world of hurt right now. And even if you've converted that rhythm, you're disoriented, you may have fallen, you may have other issues going on.
We're trying to get you emergency care, which is what you need. That whole system makes up the Assure Cardiac Recovery System. The post-approval study results that I talked about covered a lot of ground. When you're talking about 21,000 patients, that's an enormous amount of patient data. We certainly met our primary endpoints around safety and efficacy. That's a big deal in a study that large and in an environment like we're in, in an ambulatory at-home environment. We also had secondary endpoints like around the false alarm rate. One of the, I think, most important outputs of that was our extremely low false alarm rate. False alarms are an issue in a wearable platform because if the alarms are frequent enough, then what patients will do is they'll take it off. If they take the system off, then guess what?
It can't treat them when they do have their very serious event. So we believe that we've essentially solved the false alarm issue in these patients with our design. And it's a really multi-layered design approach for how we did that. The other thing about the clinical results that are really important is we also saw additional clinical utility for the platform. And that was in the form of diagnosis of AF and other arrhythmias. It was also in understanding some of the other comorbidities that happen with this patient population, things like coronary artery disease, hypertension. These are some of the other comorbidities that we saw in that patient population.
So the foundation that we built with our platform, right now, it's a really inclusive platform in terms of our ability to collect patient data, act on that data, treat the patient when we need to, and overall provide the care that the patient needs. We've also designed the platform to be extensible. And the idea being that we built all the framework to put this product on a patient, get patients to be willing to wear it for extended periods of time. And now we want to be able to add additional capability to that device so we can provide more value to the clinicians. We have around 380 pending and currently published patent assets, actually more patent assets than we have people in the company. And we intend to act on that intellectual property as we extend the platform. We had an announcement this morning.
Maybe some of you saw that around an example of what we're going to do with this platform. We announced this morning a strategic partnership with a company called Biobeat Technologies, which is the first FDA-approved, clinically proven blood pressure monitoring that's in a cuffless wireless format. And this particular one is in a stick-on format. And you might ask, well, why is that important? Why would you want that in a WCD? Well, I'll go back to the clinical results. 72% of our patients were hypertensive. And so when we saw that, we said, we've got to help provide better tools for those types of patients. And so we entered into a partnership, exclusive agreement with Biobeat. We are intending to integrate that technology into our platform.
And that's a key technology, especially for monitoring the guidelines-directed medical treatment, the drug treatment that a lot of these patients are put on. Clinicians need to know how aggressively to move with how they titrate these drugs. And there's really the single most important thing they want to know as they're learning that is, what's the blood pressure for my patient? And how is that trending over time? And so our intention is to be able to integrate that into our system and present that to them so they can better care for those patients and ultimately make the GDMT treatment even more effective. We're really excited about the Biobeat relationship. We did an investment into that equity round. They just did a financing round with some top-tier VCs that we know well. And so we're happy to come in.
And as part of that syndicate, we are in the early stages of a co-development agreement with them to do that integration that I talked about. And there'll be more to come on this topic. It's one that we're pretty excited about. So with those clinical results, with that product that's pretty clearly differentiated, we also have to solve the insurance issues. And so we've been working really hard on insurance contracting. We're now over 290 million covered lives, 90% coverage in the U.S. Anybody who's been in this space knows that it's a big challenge to do that. And it's where companies go to die during that phase. So we're happy to be on the other side of that and have a really good framework. It really unlocks the business model in our business model.
The reimbursement rate for this WCD category has been very stable over time, continues to be stable. We expect that to continue. And so we've been building out our commercial footprint. And now it's about getting the commercial team out there and taking advantage of all the attributes that we have as a company. And so we've more than doubled our sales force. We're up around 100 sales territories now. We intend to continue to build that out over the next year. And once you get to 100 sales territories, at least in my experience, then you're talking about a legitimate, real med tech sales force. And we're putting one right on the cardiology space. And we've got a really great team. And we're excited about the build-out of that commercial team. We do operate a rental model. That's the business model that we operate.
So the device goes out to the patient. We fit the patient, train them. They wear it on average for around three months. Although in our clinical data, about 30% of our patients actually wore the system longer than three months. Once the device is done, that comes back to us, we recondition it and send it back out for the next patient. And this goes on for a number of years. And that really leads to very attractive unit economics as you leverage the build cost and the operating cost of that device over many years and many patients. That's led to, as we've gotten some volume, that's led to the gross margin expansion that you see here. We've had about eight quarters in a row of gross margin expansion. We believe we'll continue to see that into the future.
We think that the business model at scale is very clearly a north of 70% type of a gross margin. And we're seeing that in action as we move along the volume curve right now. On the revenue side, we're in the growth trajectory right now as we build out the commercial team, as we improve the insurance in-network coverage. And so you can see year over year on the left-hand side of the chart, really nice growth. We're experiencing again in the quarterly growth on the right-hand side of the chart, north of 50% growth quarters, the last couple of quarters. And we believe that we'll see that through the balance of this fiscal year. So we're starting to see all the levers that we've put into place are delivering pretty exciting growth when it comes to the MedTech environment.
So all of that has really set the foundation for what we believe will be long-term, durable, exciting growth. And we have a large market, a big TAM to go chase. We have a lot of really good clinical results that we believe have a reasonable shot at impacting the guidelines for use of WCDs in a positive way. And I think when we see that happen, I think you're going to see this market growth expand even more rapidly. The market growth right now, we believe, is in the low double digits, somewhere around 11% or 12%. So on a $1 billion current market, growing that every year, that continues to be a very, very attractive market. We have that clinical data that I talked about that's really compelling. The commercial scale that I talked about, we're going to continue to build that capability out.
We have a robust R&D engine with all that intellectual property that I mentioned. And we have a really nice pipeline of products in that pipeline that we're going to see consistently come out over the next two or three years to feed that commercial engine now that we're in there. And all those, we'll take advantage of that attractive unit economics to deliver really exciting results. So it's a really exciting time to be here at Kestra. We've done a lot of heavy lifting, and there's plenty more to go. But all the foundational pieces that are required for a fast-growing, high-margin, exciting MedTech company are all coming together in the form of Kestra Medical Technologies right now. So we're excited about the future and excited to answer some questions now. We'll go ahead and open it up to Q&A. So thank you very much.
Great. Maybe we could kick it off. Starting with commercial topics, maybe you could spend a minute on historical market growth, where we are today. And do you think Kestra's entry into the market has driven acceleration in the category growth?
Yeah, I think the market growth has been a little bit of a journey. In the, let's say, 2010 to 2016 or 2017, we saw really rapid growth in the WCD. There was only one player. It was Zoll. They were a monopoly. And they were really building the category out. They had a randomized trial in 2017 that missed by a little bit. And that slowed the growth down. And now we're seeing the growth pick up. I think our assumption last year was we thought unit growth was about 6%. And then on top of that, you have about 2% average price growth, so about 8% growth.
Now, as I mentioned, we think it's in the low double digits and continuing to expand. So we think certainly we've had an impact on that. I think we're revitalizing this category. We're changing the discussion around the category. And I think most recently, we've seen our largest competitor, they've really shifted their focus because they're losing a lot of market share. They're shifting their focus towards market development. And that only helps the whole category.
Maybe to follow up on that, thinking Kestra specifically, how much is coming from market expansion and how much is coming from market share capture?
I think it's hard to put a specific number on it. I think it's certainly something like 80/20. 80% is definitely market share capture and the balance being market share expansion. Clearly, if you put a new sales rep in a territory and you tell them, "Here's where the prescribers have been in the past," the first thing they're going to do is go try and convert those prescribers, and so that's where you get the market share shift, but then along the way, the prescriber down the hall who hasn't been prescribing WCDs then starts to do it, and so that's how we see really the market growth.
In the presentation, you noted you had 100 reps today. Where do you think we'll end up at the end of the fiscal year in April, and for each rep, how long does it take for them to become productive and fully ramped?
I think we've said that we're going to target for probably getting to somewhere around 130 reps by the end of April. So that's the end of our fiscal year. And we'll continue to expand that again in the following fiscal year. Typically, what we've seen is it's about a six-month timeframe for them to go from date of hire to what we would consider to be that first level of productivity where we know they've got the story, where we know that they're starting to deliver results. And so when we model that, that's the way we think about it.
You talked about Kestra's post-approval study that was published as a late breaker at AHA, with only one in seven patients who are eligible for a WCD actually being prescribed, in fact. How impactful can this clinical study be in influencing physician behavior and getting more patients on therapy?
Well, I think the study validated a couple of those things that I mentioned.
It validated that defibrillation shock is incredibly effective if you can get it delivered within a timely period of time. So it validated that. We already knew that. We answered the wearability question, as I mentioned. But I think the biggest part of the study that will impact market growth is this assessment of risk. And the fact that now as we're out talking about the study with physicians, that's the biggest aha that we're hearing is them saying, "I didn't fully appreciate that the risk level was that high for these patients. And so maybe I should rethink my risk spectrum that I'm using mentally about when I prescribe the device." And so ultimately, we hope that will influence guidelines. And if you influence guidelines, then this becomes more of a protocol, which will certainly lead to exciting market growth.
We've already seen you bring innovation to this market. Where are you focusing your R&D spend, and what product innovation should we look forward to?
We're focusing our R&D spend on solving the biggest clinical issues in this patient population. So if you look at the comorbidities of these patients, if you look at the other arrhythmia types that these patients have, then that leads you to where we want to innovate. And we think that there's opportunities to influence those. You will see us continue to build out the diagnostic monitoring capability of the device because patients are wearing this for a long period of time. And so you have an ability to collect an incredible amount of data about that patient, including trending that data, so that you know whether that patient's getting better or getting worse, and you can take some clinical action there.
I think those are going to be the themes that we chase in R&D. The Biobeat is a perfect example of that strategy in play.
Maybe since you bring it up, maybe expand on Biobeat and what motivated the deal and what value does it bring to Kestra?
The architecture for the Assure system by design was intended to allow us to extend the platform and take other monitoring devices, other sensors, and their data into our platform and be able to then present that to the physician. Because you have to remember, the WCD is an urgently clinical needed product. It's the anchor in that for our reps. Then once you have that patient, now you can help that patient in other ways. The Biobeat, it's the number of patients that are hypertensive.
It's the constant feedback from physicians, especially the heart failure physicians, that they have challenges with the GDMT titration. They have patient compliance challenges. Today, they send them home with a cuff, and they expect them to do the cuff measurements themselves and record those and send them in. That's a challenge in the living room in America. And so what we're going to do is we're going to take that challenge away and make that an inherent part of the system. And that's really the impetus behind that so we can provide better care for those patients, help them in the GDMT titration, which ultimately will lead to their hearts getting better quicker.
Let's talk about gross margin. You got up to 50% in the last quarter. You've guided to 70% over time. How do you get from point A to point B? What's the line of sight?
I think it's going to be steady, Eddie, along the way. It's going to be volume dependent. We will see on the revenue side of gross margin, we will see continuing revenue per fit growth as we see even higher percentage of our actual patients be in network. We'll get some benefit of the annual COLA for the reimbursement code that will help that revenue per fit, and then on the cost side, it's the continuing amortization and use of these devices in the rental model and turning them more rapidly and using them longer. One of the things that we did that we implemented about 18 months ago or so was a really robust preventative maintenance program for our devices. So every time they come back, so by definition, we see them every three or four months.
Every time they come back, we retest them, check them out, repair them if needed, and they go back out as new. And so that's going to allow us to really leverage those devices for a long time. And so the impacts of volume will be substantial in this business. And so we think we're going to ride that volume curve right up to that kind of gross margin range.
Volumes are important, and amortizing the depreciation is also important. So what do you think the capacity of your existing fleet is today, and will you need to invest in the near to midterm on more vests?
The fleet we have today gives us the capacity to certainly execute our revenue plan for this year. And we will continue to add to sort of top off the fleet, the CapEx fleet, every year as we continue to grow.
What we're striving to do is ensure that about 90% of the patient fittings that we do in any period are done with a device that's been reconditioned. It's a used device. It's already out in the fleet. So if we do that, that means we're turning these devices really effectively. We will always have some CapEx as we build out the fleet, but it's really to keep it topped off to be able to help us manage growth.
Coming up on a year as a public company, how do you feel today versus when you came public about the future of Kestra?
The journey to a public company is a long and arduous one. I'm happy that now the conversations we have with investors are thematic.
They're not trying to go eight levels deep into the due diligence that we experienced during the VC stages. But I do think that, look, I think the more we're out in the market with this product, the more we see it in action, the more we hear feedback from clinicians, the more excited we are about it. I think we have broader opportunities with the platform and the underlying technology than we ever fully appreciated before we got up to some scale. And that really is exciting for us because we're going to build a really strong commercial engine, and then we're going to couple that commercial engine with a whole bunch of really exciting innovation. And in my experience in MedTech, those two things coming together is what makes the magic. And so we're excited about the future of the company and where we're going.
Let me just check. Any questions in the room? All right. Maybe one final question here. Are there any parts of the Kestra story you feel that are underappreciated by investors?
Well, I think we've been talking about maybe what I consider to be the biggest one, which is that this market is growing at a rate that I don't think people fully appreciate it and that there's potential of a real pivotal change in the market growth with guidelines expansion. And I think if that happens, I think you have to change the whole view of this WCD market. So I don't think people have been too focused on that. They've been focused on, "Hey, go out and get that existing market," and that's a clear place to go at the start. But I think the market expansion is really exciting. And so we're doing market development activities.
I think we did more medical education events in the month of December than we did in the previous seven months combined. So we're really taking the clinical data and really trying to get into what I consider to be classic MedTech market development.
Well, great. We could end it there. Thanks for a great discussion. Thanks to all of you for joining today.
Okay.