Good evening and welcome to the Jefferies Global Healthcare Conference. My name is Camden Sisler with the Jefferies Healthcare Team. It is my pleasure to introduce Sheri Dodd, CEO of Tactile Systems.
Thank you. Excited to have the next 30 minutes with all of you, talk to you about Tactile Medical, talking to you on behalf of tens of thousands of patients, thousands of providers and clinicians, and over 1,000 employees. Our disclosure statement. Revealing and treating patients with underserved and chronic conditions in the home is our mission. This is what our company is all about. Our company includes two types of portfolios, one in lymphedema and one in bronchiectasis. As you see from the data below here, we participate in a very large underpenetrated, underserved market. Up to 2024, we mentioned that we had served over 79,000 patients in a market that is actually comprised of over 20 million patients that have yet to be diagnosed, 2 million patients just in lymphedema alone that have been diagnosed, and then a large number of patients that have not been treated.
I'm excited to go through the data with you, and you'll see not just what we're doing from a market standpoint, you'll also see our product innovation, and you'll see the ways that we anticipate being able to grow profitably in this space. Let's talk about some of the key highlights. Why I'm often asked in terms of what gets you most excited about this business, and I always start with the business fundamentals and the market fundamentals. Are they strong? And indeed, that's very true for Tactile. The end markets are growing, and again, they are with an underserved population. This is not a commoditized market. This is not a market where even the disease state is well understood. There is much to be done in the market development side. There is very broad payer adoption.
Unlike other technologies where you're looking for coding, coverage, and payment, we have coding, coverage, and payment, and that payment model has been very stable over the years. While there's been some differences in coverage, we have been able to weather through some difficult storms in that area and are definitely in a place where that reimbursement environment is more of a tailwind for us now. We also have market leadership. Both in terms of our lymphedema business, where we have both a basic pump as well as an advanced pump, we are the market leader in that area. In our airway clearance business with bronchiectasis, we're in a very strong number two position, coming up on number one. Unique assets for this business. We have a wealth of clinical evidence that supports the value proposition for the patient.
This is both value for the patient as well as economic value that supports value in the healthcare system. We have large distribution reach. We are a direct sales force in our lymphedema business as well as being the DME. We not only call on the providers, help educate on the technology and the disease state, but we process all of those claims ourselves, ultimately through collection and getting paid and have fine-tuned this model over time and have a very scalable revenue cycle management process in place. We have a variety of products that are in development on both sides of our business, looking to advance the patient experience as well as the therapy benefits.
Our tech digital strategy, both in terms of how we operationalize our back office as well as tech development and making that process simpler for a patient, has been on our roadmap significantly this year and continues to bring value. I know a lot of leverage as we go into 2026 and beyond. From a value creation standpoint, we are profitable. As a small-cap company that is growing, profitable, and has a cash balance, it puts us in a unique position. Our gross margins are above 70%, and we committed this year for them to be at 74% and are holding to that commitment. Again, a very strong cash position over the past several years has moved from a long AR balance to a place where we are very strong in collections and have a growing cash balance.
Despite the fact that we have also done a stock repurchase program, we continue to see that cash balance grow. An extremely attractive company and one that I am always eager to share. When we think about the size of the market, and this is not necessarily a new story for companies of our size, but it is a story that we have evidence to help support, which is both that population that is yet to be diagnosed, the population that is diagnosed, and the population that is currently treated with therapies.
What's interesting about this, both on the lymphedema side as well as on the bronchiectasis side, they're both similar in terms of that watermark on below the line kind of iceberg, a huge proportion of patients that have yet to even be diagnosed, and then a proportion of patients that have been diagnosed, and then a smaller proportion of patients that actually are on appropriate therapy. This creates a huge opportunity for us to penetrate and serve patients as well as the reality of significant gaps in the access to solutions and us being in the position where we have technology and solutions, again, that have very strong reimbursement coverage. The other point I want to make about these patients is that they have very long and complicated patient treatment journeys. It's for a lot of reasons, and I'll talk about that.
By the time someone finally gets to the point of being diagnosed, it can take months and up to years. When they get to a place of being diagnosed, to have a therapy that's available for them that is reimbursed and has the appropriate therapy benefits is a very satisfying and rewarding position to be in as an employee of Tactile Medical. Here are some of the market fundamentals. I talked before about that 20 million of undiagnosed patients. From a long-term strategy, we are very focused on trying to go after this. How do you bring more awareness to getting the patients to a diagnosis? This is a clinical diagnosis. It's what a clinician sees. There's not a blood test for it.
There are ways that the patient can present in terms of symptoms and then a way that the physician actually can measure the patient and make an informed diagnostic. That opportunity continues to be very large, and it's an opportunity that we have with our education and training assets to really help continue to uncover and move more diagnosed patients into diagnosed. That portion of the market fundamentals has been growing. Of the 2 million patients that have been diagnosed, again, there is a big opportunity here in terms of bringing them into treatment. A relief that they've been diagnosed, and now what are the treatment options? For these patients with lymphedema, the treatment options start with compression garments. You've seen patients wearing stockings, pantyhose, static compression garments that's trying to squeeze the lymphatic fluid.
From a trial in conservative therapy, patients then become eligible via reimbursement coverage to actually become eligible for a basic pump or an advanced pump depending on their condition. That market of patients that have tipped into medical device pumps, either pneumatic or non-pneumatic, that CAGR is at 10%. Lots of opportunity of going after more patients and getting them on the right therapy. Let me kind of back up to go forward. Lymphedema has many causes and effects of people of all backgrounds. We all have a lymphatic system. It enables this transportation of fluids that are heavily packed with proteins and waste to be removed from the body. The majority of patients with lymphedema have it as a secondary condition. They typically come in a cancer diagnosis or in a non-cancer diagnosis.
If you have cancer, even the presence of a tumor can cause lymphedema, but mostly it's in the surgical removal of the tumor or in radiation that can cause the patient to have a damaged lymph system. When that happens, you're going to have swelling. That lymphatic fluid is not able to move out of its original watershed area, but actually needs to be moved to a part of the body where the lymphatic system is working. When the system is damaged, lymphatics, it is chronic, it is progressive, and it is irreversible. There's no going back once it's been damaged. You have to find another place on the body to actually remove the fluid. Causes of lymphedema, as I mentioned, can come often from a secondary standpoint. It can be cancer or non-cancer. In the non-cancer area, often it's with chronic venous insufficiency or CVI.
The majority of patients that have late-stage CVI are going to have lymphedema. Your vascular system gets overloaded. It creates damage to your lymphatic system and, again, irreversible on the lymphatic side. Obesity can be a trigger also for lymphedema, as can trauma and surgery and overall infection. These are both cancer and non-cancer causes of the business, or sorry, of the patients. As you see in the circles here, about 40% of patients who have breast cancer are going to have lymphedema. Even more striking is that 90% of head and neck cancer patients are going to have lymphedema. It is nearly guaranteed you're going to have lymphedema if you have head and neck cancer. For the CVI patient, about 40% of lower leg lymphedema is going to be associated with CVI. As I mentioned, there's no cure, and a vast majority of patients are left untreated.
Here you see pictures of what lymphedema looks like. You can see some pictures of the two gentlemen in the top have head and neck cancer, so you see external swelling. This can also be internal swelling. Internal swelling in a head and neck cancer patient can prevent swallowing. It can prevent an ability to speak as well as significant limitations on range of motion. By being able to move that fluid away, we've seen in our clinical reports from our providers say that patients have been able to go from having a feeding tube to being removed from a feeding tube because now that they can swallow, they can go through speech therapy and actually get to a point of speaking. High prevalence as well as high impact from a cost perspective. It just isn't in head and neck cancer where those extreme conditions can happen.
In patients that have limb and/or trunk and/or chest lymphedema, they can have cellulitis, and cellulitis untreated can go into sepsis. You have swelling, hard-to-heal wounds. Imagine all that pressure on the skin starts to create a degradation actually in the skin, which can cause seepage of the fluid and basically break down skin integrity. You get hard-to-heal wounds. You do not want to do a pump around the wounds. Often patients that have wounds are being asked to stop conservative therapy so that their wound can heal, but then they still have lymphedema. Skin changes, pain and tightness, dysphagia, inability to swallow, as well as deep vein thrombosis. Very significant side effects are associated with lymphedema, high cost to the healthcare system, and very high cost to the patient, both in terms of their quality of life as well as their actual symptoms.
As you see from the very bottom, the fact that a lot of patients have these symptoms, they're often unaware that they have lymphatic disease. The understanding of lymphatic disease isn't something not only are patients educated on, it's because physicians aren't often educated on. You now know more a little bit about lymphedema disease than others might know about lymphedema disease. There's a huge opportunity for training and education, and it's a big part of how we've been able to see our growth to date is really coming from growing the market through training and awareness and having excellent technology. Let me switch now to the other side of our business, which is in bronchiectasis. This is airway clearance. It is one of the most common respiratory diseases. It's a complex disease where you have damage to the airways that creates this abnormal widening.
It gets inflamed, it gets scarred, and so it ends up permanently damaged. Very similar to lymphedema. Once you have bronchiectasis, you can't reverse that as a disease. Your airway is damaged. You cannot correct that. What happens with a damaged airway is you're going to have a pattern of increased mucus, which is going to create inflammation, which is going to create infection, and it goes in a circular format. The way out of this is by having some sort of therapy that allows you to move that mucus, so you reduce the infection and you reduce the inflammation. 42% of COPD patients are going to have bronchiectasis, and nearly one out of four smokers are also going to have bronchiectasis. It is actually fairly prevalent, just underdiagnosed and undertreated.
One of the frustrations that a lot of patients have is, why did it take so long to finally get to a diagnosis? Bronchiectasis is often misdiagnosed. One of the reasons it's misdiagnosed is the only definitive way of diagnosing it is actually through CT scan. Otherwise, these patients present with recurring pneumonia. They need non-invasive vents. They continue to have airway clearance problems, and it is not until the physician actually orders the CT scan sometimes that you can actually definitively diagnose bronchiectasis. The CT scan can get you to a definitive diagnosis. The problem is that the longer the patient goes with the lack of intervention, the more cycles they're going to have of this infection, which is going to make the condition overall worse.
Kind of a classic that they often do not get diagnosed till later into treatment. The degree of therapy that they need is pretty significant. Earlier treatment is going to help these patients significantly. When we think about both the lymphedema then and the bronchiectasis business, we are talking about a $10 billion total addressable market. The gaps in patient and clinician education and access to care, I spoke briefly about this, and I am going to show you some of the strategies that we are working on to make this better. The reality is that these patients require lifelong care, and they require lifelong care in their home for symptom management. They are not going to be cured, but they certainly do have an opportunity of seeing a reduction in symptoms and getting back to a higher quality of life.
The solutions that we have, let me start on the lymphedema side. We have what our existing systems are and where we have been innovating. We participate in both the basic pump and the advanced pump market. These products have been called our Entre Plus, which is our basic, and our Flexitouch Plus portfolio. They are for different patients. A basic pump basically covers the arms and the legs. You can have half leg, full leg, or your arms, but it does not cover the chest and the trunk. When you have limb edema, you can have bilateral or you can have unilateral. These have been our mainstays, and we have been able to meet patients' needs regardless of where their lymphedema has been triggered from, again, whether it is coming from a cancer diagnosis or non-cancer with these products.
The advantage on the Flexitouch Plus are two-fold. One is the Flexitouch Plus actually has the coverage of a head and neck, a chest, and a trunk. If that's where your edema is, that's where you should have coverage from the actual garment so that you can actually pull that lymphatic fluid away from you. Again, it is very much dependent on location of edema as well as often with skin. The nice thing about Flexitouch Plus is you can program the sequencing of the pump away from a wound. If you do have a wound, it doesn't prevent you from getting compression therapy. You just need to have a pump that allows for programming away from that. What we've been moving to is how do we advance our portfolio so we continue to meet the needs of the patient.
We were really pleased to launch Nimbl, which is our next-generation basic pump, which we launched for upper extremity in October of last year, and we launched that product for lower extremity in February. This is an entirely new platform for patients. The size of the controller is significantly less. The amount of tubing and hose that does the pneumatic compression air is vastly smaller as well as it's portable. It has a battery, so you do not have to be tethered to the wall, and it's Bluetooth-enabled, which allows the patient to actually have connectivity over to our Kylee engagement platform, which allows that patient to actually track their therapy sessions. This has been a wildly successful launch to us. Not only has there been very strong physician adoption, but very strong patient adoption.
Patients before may have looked at the Entre Plus and saw the hosing and the tubing and the weight, the tether to the wall, and said, "You know what? I'm not sure this is for me." With Nimbl, they can identify and say, "Yes, I can see myself. I can travel with this. I can move around. I have more mobility," which has been very, very encouraging. We have had a very successful launch. We are currently working on our next generation for our Flexitouch, taking those same considerations into play. How do we make sure that the technology is approachable from a patient standpoint? We do not change any of the therapy benefit, and we just make it a better patient experience overall. Also backing up our pump therapy is clinical evidence. Talked about that in terms of where we have differentiated assets.
On the top, you can see some of the clinical data that supports the patient satisfaction. It supports the reduction in limb volume. It reports the patient's ability to go back to activities across the board from a variety of published studies. In fact, Tactile has been the leader in published clinical evidence, particularly in the advanced pump area. One thing I'm particularly proud of is just yesterday we had a press release which detailed our two-month results from our randomized control study for head and neck. This is the largest prospective randomized control study ever in patients that are head and neck cancer survivors with lymphedema. Those results are based on a six-month study of which we are currently working on that analysis, but was pleased to have the two-month data presented at ASCO, one of the largest clinical oncology conferences.
As you see below here, already starting to see some differentiation of patients who were randomized to Flexitouch versus randomized to usual care. Usual care for this population is working with a therapist to do manual massage, actually moving the lymphatic fluid away from their head and neck and moving that fluid to an area on their body where they have an intact lymphatic area of the body that can process those fluids. We were able to show, even with this two-month study, that by imaging on internal swelling, we had a significant reduction in internal swelling versus usual care. We also saw benefits in quality of life. I should say all patients showed benefits in quality of life, but showed statistical significance in some of those subscales.
I also want to point out the fact that of the patients that were randomized to usual care or to our therapy, only 71% of patients that were randomized to usual care, again, seeing a therapist, a massage therapist, actually had an appointment and saw that person by two months. There is a huge time backlog of being able to get into a therapist for massage therapy. You have finally got diagnosed, you have the symptoms, you have significant disability, and yet only 71% of patients were actually even able to start their therapy by two months. We will see what that looks like at the six-month time point. You can see the value of actually being able to have a technology you are able to put on the patient earlier than having to wait for that opportunity of getting to a therapist.
I don't believe that's going to change over time. Not more therapists and lymphatic therapists are going to be joining the workforce to keep up with that 20 million patients that are going to move from being undiagnosed into diagnosed. Having a therapy option that a patient can start therapy early will be critical for overall outcomes. Patient engagement, very important piece because, again, this is a lifelong disease of where the patient is managed in their home. Several years ago, two and a half years ago, we launched what's called the Kylee app.
The Kylee app allows a patient not just to learn about lymphedema and the disease state, which is incredibly important, but it also allows them to track their symptoms as well as their therapy sessions and then allows them to share this data with their clinician, which includes an opportunity of sharing pictures of their swellings or potentially wound with their provider. This is an app that's available to anyone, anyone with lymphedema at all. What we're finding in some of the cancer centers, those physical therapists are asking the patients to download and get on Kylee to track their symptoms and their manual massage therapy sessions so that they can see how the patient is doing in between sessions and then using that then to continue the patient on with a referral on to Flexitouch and so that continuity of care can be tracked.
We recently reported on our Q1 earnings call that we will have 50,000 patients having set up a unique profile. It's going to happen in June. And we have one million interactions on this app. When a patient goes in and is recording symptoms or looking at education, those become an interaction as well as because of the Bluetooth enablement, both for Nimbl and for Flexitouch, the sessions with the pneumatic compression device are automatically recorded into the device. I will tell you, having one million interactions, when I heard about this, I was a bit surprised. I didn't know we had that many. I would say we're very early in understanding all that we can do with that data.
Imagine we will learn a lot about what is happening to the patient in their home, what type of symptoms they continue to have, or what type of treatment modalities they continue to have post getting a pump, but also for the patients that are using it prior to getting our therapy, also understanding their care pathway and some of the symptoms and the therapy exposure that they have that's driving them to our product. With $5 billion in total TAM in this space and having products that fit both in basic as well as advanced pump, we really see ourselves as being in a position to really own the space in lymphedema solutions. We have a clinically proven pneumatic compression brand that is well known in the market.
We have this expansion of clinical evidence, as I mentioned the press release yesterday, as well as we'll have the six-month data that's specifically on head and neck. I should mention that head and neck is not a new indication for us. Head and neck has been an area where we have the garments we've been able to treat patients. The challenge with the head and neck space and why we did this study was specifically to help with coverage mostly on the commercial side. Many commercial health plans still consider head and neck compression therapy with a pump as being experimental and investigational. With data, we will be able to show that it is neither experimental nor investigational and be able to help change that coverage into what is the coverage which should be providing accessible access for patients to get that product. We have very large sales reach.
Again, we have a sales organization that is highly tenured. We are committed to being at 300 sales reps by the end of the year. Our sales reps call on all channels where we are apt to see the patients getting diagnosed. This is an oncology channel. It is a physical therapist, massage therapist. It is in vein centers. It is in vascular, and it is in the VA. Very large reach. Because we are our own DME, we have a scaled and very efficient back office where we are continuing to simplify that process with technology, multi-channel referrals, and we also have very supportive coverage. About 80% of all payers have both coverage as well as meaningful payment for patients in this area. Bronchiectasis as well, very strong position from a product and a market standpoint. We have the high-velocity chest wall oscillation.
It basically mimics what would happen if a therapist was going to be pounding on your chest trying to loosen up that mucus. It can be used with other treatments, including some drug therapy that's coming out. The drug therapy supports one aspect of bronchiectasis, but does not help with all. These will be adjacent therapies. The Tactile vest, this AffloVest, is the only fully mobile vest. It is not tethered into the wall. A patient can wear the vest and move about and complete their session as they wish. The evidence here is also very supportive of patients' compliance as well as the effectiveness and how it fits with their overall lifestyle. One important aspect of our growth is really by increasing market share. In the AffloVest side, I mentioned the portable design is incredibly important.
That's where patients want to be, is not tethered to the wall, which is also very similar to our Nimbl product on the lymphedema side. This broad DME channel. With the AffloVest business, we are indirect, and we have partnered with the top 10 respiratory DMEs. These respiratory DMEs carry a portfolio of products for the respiratory patient. They have oxygen, they have non-invasive vents, and they have AffloVest. It fits in very well, especially as these patients tend to be frequent flyers, potentially have been on oxygen, have been on non-invasive vents, and that DME rep respiratory focus is able to help identify patients. We also have very strong reimbursement in this area and it has been stable for a long time.
We have some recent milestones with our business that are reflective of both our technology development over time, how we continue to enhance both the product experience as well as building out our own evidence plan, as well as the simplicity that we're looking for for an entire process, both for our patients and our providers, and quite frankly, for our own business. We are end-to-end on the product from getting the sales and marketing out all the way into collections. It is in our interest to understand workflow-related tools from the front office as well as the back office. As we look to 2025, we continue to look at both technology innovation as well as our opportunity of simplifying the process and expanding market access. Over the past multiple years, you've seen for this business a 16% overall CAGR.
Our guidance right now is sitting at that $309 million-$315 million from an overall revenue standpoint. We specifically made the determination to invest in the business this year. We are holding our EBITDA and OpEx at a percentage where we are able to take those dollars and invest back in the business in both headcount by putting more reps into the field, as well as technology that, again, helps support the overall simplification of both the selling process as well as the order management process. Our strategic priorities are very clear. These are our growth drivers. We will be looking to improve access to care. This is a basic market access strategy. It is not anything that should be a surprise or feel overly complicated. It takes time, but it does involve training and educating physicians, providers, and patients on the disease state and the therapy options.
It is making sure that reimbursement environment stays healthy so that there remains appropriate coding, coverage, and payment for these patients. It is also around how we just streamline the entire process. How do you make it go faster, take the friction out from the patient being identified to the patient actually getting the therapy? We're also very interested, and we know that you have to be innovative in technology in this area. We continue to look at both with our organic opportunities of how do we enhance and look at technology to improve the patient experience, but also looking at our cash balance of what opportunities might we want to find from an M&A standpoint that helps build out the portfolio. Last, this lifetime value. These are patients, again, chronic progressive disease.
They have a long journey to get to getting a pump, and they have a journey after pump. How do we think about creating more lifetime value on an end-to-end care continuum for these patients? We have a number of pilots that are underway. Our near-term strategic investments are only double down in these strategic priorities. Everything we do and every investment we're making has to align to those three strategies. The market development activities are well underway. We have a number and are committed to a number of forums and engagements with clinicians. We recently did a rebalance and optimization of our Salesforce, making sure we had the right people in the right location doing the right job. We actually started with Salesforce, a new CRM tool. Now we have modern technology for our Salesforce.
We implemented that in February, and we will be putting the back office on that here in the last half of the year. Looking at the data that continues to support the value proposition of our therapies is going to be key to how we continue to drive overall growth in this area. I know we only have a few seconds, but I am happy to take any questions, or we could meet right after.