Righting The Gut-Brain Connection With Mahana Therapeutics’ Steven Basta

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Charles Rhyee:
Hello, my name is Charles Rhyee, Cowen's Healthcare Technology Analyst, and welcome to the Cowen Future Health Podcast. Today's podcast is part of our monthly series that continues Cowen's efforts to bring together thought leaders, innovators, and investors, to discuss how the convergence of healthcare technology and consumerism is changing the way we look at health, healthcare, and the healthcare system. And in this episode, we'll be discussing the connection between your gut and your brain.
We all know that your mental state can affect your body, for example, from stress and anxiety. And this is particularly true for those suffering from IBS. While there are many treatments on the market for IBS, they're not always effective and come with many potential side effects. But now it's possible to treat IBS digitally. And to discuss the topic with me is Steven Basta, CEO of Mahana Therapeutics. Mahana IBS is the first FDA approved prescription digital therapeutic for the treatment of IBS, and it uses cognitive behavioral therapy, or CBT to help people build a healthier brain and gut relationship, decrease symptom severity, and improve overall wellbeing. Steve, thanks for joining us today.
Steven Basta:
Thank you very much, Charles. Appreciate the invitation to join you.
Charles Rhyee:
Great. Hey, so to start, let's talk about the connection between the gut and the brain. We all know how certain situations can make you quote, feel nauseous, or we can get butterflies in our stomach, or we might have what we call a gut wrenching experience. We know these things intuitively, but can you tell us maybe more about our understanding of the science now behind a connection between our brain and our GI system?
Steven Basta:
There's really a profound innervation of the nervous system into the GI tract. It's both picking up sensory signals from the GI tract, and also delivering sensory signals. So exactly as you described. The metaphors that we use in common speech, things like having butterflies in your stomach, like you feel it in your gut, you've got a tightness in your gut around a condition whenever you're feeling anxiety. That's just standard fair in our common speech, but really that metaphor reflects the natural gut-brain connection that's happening on a regular basis. And people really do feel their emotions in their gut.
In IBS patients, it may simply be exaggerated to some degree. It might be a slightly enhanced connection that causes that sensation of tightness in the gut, that sensation of visceral symptoms when someone is experiencing stress or anxiety, to be even more profound. And then the other thing that happens in IBS patients that we've been learning about is there's really a feedback loop. That the symptoms actually cause the neurological reaction that induces worsening of the symptoms. And so you create a feedback loop where a person feels their symptoms, becomes anxious about the fact that the symptoms might get worse, that anxiety actually causes the symptoms to get worse. And that feedback loop can become a vicious cycle that self-perpetuates.
Charles Rhyee:
Yeah. And when we think about IBS, it's really not one thing, right? But it's a group of symptoms, really. And there's more than really one type of IBS. Maybe you can expand on that a little bit. I know there's differences in types and severity.
Steven Basta:
The manifestations of IBS are different. Much of the underlying cause really is this gut-brain connection. Now, often there's a triggering event. So some patients will experience their first bout of IBS after they have an episode of some GI distress. Maybe they had food poisoning, they had some infection that caused the initial insult and caused the initial hypersensitivity to start in their GI tract, but often that lingers longer than it should. So most people get over food poisoning in two or three days. And so in many patients though, the symptoms might linger. And what that lingering is, is really the start of that hyposensitization and enhanced reflex phenomenon.
And then they just become sensitive to a whole bunch of irritants. They might be food irritants. They might be stress-induced irritants. The manifestation of those can be different symptoms. So some patients will experience significant abdominal pain. Some patients will experience significant bloating. Some experience constipation. Some experience diarrhea. Some alternate between constipation and diarrhea. You don't have to experience all of these symptoms. Patients will often experience one or two at a time. And so people talk about IBS-C or IBS-D meaning IBS with constipation or IBS with diarrhea. But the bowel dysregulation is really secondary to this neurological response in the GI tract that is worsening their condition.
Charles Rhyee:
And today though, I mean, there are treatments available for IBS. How is IBS currently treated for, for most patients?
Steven Basta:
So most of the patients are receiving treatments associated with symptoms. If you have diarrhea, an antidiarrheal agent might help to relieve the diarrhea. So you can manage symptoms, to some extent, with a number of the therapies that are available today. But most of those therapies don't get at this core underlying phenomenon of the enhanced sensitization and the enhanced gut-brain connection and feedback loop that's happening, that's actually causing much of the bowel dysregulation. So managing the symptoms is great and that can help patients feel better. Our therapy can be used alongside any therapy that the patient is using today that's helpful to them.
But what we are able to do with cognitive behavioral therapy is start to get at the root cause of the condition. Meaning what is causing this hyposensitization and this feedback loop that is causing the bowel irritation and the bowel dysregulation? And if that's your nervous system that is turning on reactions in your bowel, let's just dampen the neurological system by teaching relaxation techniques, lack of catastrophization. How do you change the feedback loop when someone starts to catastrophize about their condition? Can we give them mindfulness techniques or other therapy techniques that alter their thought reference? So we're really trying to get at that core initiating process.
Charles Rhyee:
Yeah. And I want to jump into more of that in a second here. But when you think about the current treatments in the market, how effective are they? And I'm guessing the answer is, maybe not good enough, which gives rise to need for something like Mahana.
Steven Basta:
Well, so I think it varies by patients. So something on the order of a third of patients who take many of the treatments for a specific symptom, find that those treatments provide significant relief. So a meaningful number of patients might experience benefit, but there are many patients, and often more than half of the patients don't experience significant benefit or adequate benefit by virtue of the current existing therapies. They might find that their constipation is lessened, or they might find that their diarrhea is lessened, but they're still experiencing abdominal pain. They're still experiencing bloating. It's not really adequately resolving their core IBS symptoms.
And that's where a treatment that gets at the entire process of the disease, that gets at the root cause of what's exacerbating the disease can have a more broad based response. So what we found, in contrast to many of the therapies that treat just a single symptom, when we look at a whole constellation of IBS symptoms on what's known as the IBS Symptom Severity Scale, two out of three patients using our products ... more than 60% of the patients who used our product in our clinical trial. Got a clinically significant improvement on the entire constellation of their symptoms. That's a meaningful clinical improvement. And it's a very high responder rate, relative to many therapies.
Charles Rhyee:
Yeah. And I'm sure we're going to dive into that as well, but before we do that, maybe let's talk about CBT in general. How does CBT fit in with IBS? We touched on it a little bit already when we talk about this gut-brain connection, but maybe talk about the core of what CBT ... how it functions in this case.
Because I think for maybe some of the listeners ... maybe from some of our prior podcasts. We've looked at CBT in the treatment for addiction and for insomnia. And so CBT does seem to have a very broad range of conditions it can train. Maybe talk about its role here when we think about IBS.
Steven Basta:
Certainly. I think that is an important context for your listeners, because you're right. CBT has often been associated with mental health disorders. Anxiety, depression, et cetera, or other mental health conditions. Here, we're talking about treating physical symptoms with cognitive behavioral therapy, which may not be intuitively obvious. But if in fact the physical symptoms are caused by this cognitive and gut-brain feedback loop, then CBT is an excellent treatment for it.
And it's not something that we've conjectured. It actually comes out of 30 randomized clinical trials over decades of work where for the past 30, 40 years therapists have been using CBT techniques to treat patients with IBS with significant success, to such a degree that this is actually a recommended therapy. So traditional CBT is a recommended therapy intervention for IBS by the American Gastroenterology Association and the American College of Gastroenterology. So the two leading physician networks in this specialty recommend gut-directed psychotherapy. And CBT is the predominant gut directed psychotherapy for patients with IBS as a core intervention in that treatment. And again, it's supported over the decades by 30 randomized clinical trials that consistently show that this works.
So the CBT program that we use actually comes out of about two decades of work at Kings College in London with a group of therapists who were using this program and then ultimately, drafted an educational tool for the program for other therapists. They started delivering that education program to patients, found that the patients could learn it on their own. And that ultimately led to the creation of our therapy, because you can deliver this program in an automated fashion. But it comes out of that history of work.
Charles Rhyee:
So if CBT is so effective, why do you think we don't hear more about its use? And instead, I see commercials over the time for Trulance or Linzess?
Steven Basta:
Well, we're solving the core problem. So the core problem is there're 35 million IBS patients, and there's something on the order of 150, 200 therapists that are specifically trained in gut-directed psychotherapy. So there just aren't enough therapists with expertise in the gut-brain connection. Now, obviously many therapists who may not have that specific training could also do the treatment. But even if there's a larger number of therapists, there is by no means the opportunity to treat 35 million patients. 15 to 18 million patients with moderate to severe IBS out of that population, there's just no way for them to get access to a therapist.
And so, in fact, when we talk to physicians, the reason that they haven't historically prescribed CBT is if they ever prescribed it, their patients could never get time with a therapist. There would be a yearlong waiting list and a patient would just be frustrated that they'd be sent to a therapist who might be able to help them, but they couldn't get an appointment for six or 12 months. What we're solving is that access problem. CBT works really well for a very large number of IBS patients. They can't get access to therapy, we have an infinitely scalable solution. So we've created a therapy program that can run autonomously for a patient. As many patients as we're able to get started, will be able to get benefit. So we literally can make this available to every IBS patient now. [inaudible 00:12:36].
Charles Rhyee:
So maybe that's a good segue. Maybe talk about ... tell us more about Mahana IBS, and how does it work?
Steven Basta:
So the Mahana IBS program, again, it's derived from a very traditional CBT methodology that has then been adapted specifically to IBS patients. So if you think about the term cognitive behavioral therapy, well, what are we trying to do? We're trying to change the way you think about a condition, we're trying to change the way you behave, so that changing your thoughts and changing your behaviors ... changing your cognition and changing your behaviors. Can actually produce the therapeutic outcome. So how do we do that? We do that by taking you through a series of lessons where you understand your symptoms and how your symptoms are associated with stress. How does stress make your symptoms worse? Once you get that understanding, we start to introduce techniques for managing your symptoms. When certain symptoms happen, what are things you can do that would lessen those symptoms?
We teach patients what eating patterns make their IBS conditions worse, what eating patterns make their IBS conditions less bad. So that if you start to feel certain symptoms, that's one of the behaviors that you can adopt that would lessen your symptoms. We teach them about exercise patterns. Something as simple as walking can be a very effective intervention for constipation, but if you're constipated and anxious and catastrophizing about your constipation, you don't think to go out and walk. So something as simple as creating an activity pattern for the patient, which is, let's go out and walk three times today, can dramatically lessen their constipation, improve that element of their IBS and improve outcomes. So we take patients through all of those.
We understand unhelpful thoughts, things like catastrophization. The last time my belly hurt this badly, I ended up going to the emergency room. So, oh my God, I must be going to the emergency room tomorrow. It's going to get worse. That's a catastrophization pattern that makes your IBS worse. If instead, you can think about the techniques that you might be able to use that would lessen it, and feel like you've got a degree of control and alter that thought pattern, we can dramatically lessen the likelihood that you are going to have an exacerbation of symptoms. So it's really around changing your cognition, changing your behavior, to deliver a therapeutic benefit. It's cognitive behavioral therapy, all in a digital app.
Charles Rhyee:
And does this include ... I know there's FODMAP for people for sensitivity to foods. Does the program also include nutrition guides and things like that?
Steven Basta:
So we don't provide a nutrition guide around what foods to eat. We do provide guidance on what eating patterns will make your symptoms worse, or will lessen your symptoms. Because often IBS patients will actually adversely impact their eating patterns and that exacerbates their symptoms so we teach them how not to do that. It's a different therapeutic regimen to do the FODMAP diet, and that's not a core part of the CBT program. It actually has been helpful. That's one of the other techniques that can be very helpful for IBS patients, but it's really a different therapeutic strategy.
Charles Rhyee:
So when we think about a lot of ... And I've asked this to others before, right? When we think about CBT for treatment of other conditions and you look at, let's say, Noom. Noom uses CBT. What makes it different being a prescription digital therapeutic versus just being maybe a digital app that provides CBT in some fashion?
Steven Basta:
There're several distinctions around being a prescription digital therapeutic. One is the rigor of clinical testing that's required to go through the FDA review process imparts a degree of confidence to patients who use the program. It imparts a degree of confidence to physicians or prescribing the program or psychologists who are recommending the program that A, they know that this is backed by a substantial clinical study. B, they know that the FDA has reviewed this, and the medical claims that we're making are substantiated by the clinical data. That level of confidence becomes really important for the patient level of engagement at the time that they're starting the program, and important for the physician who is prescribing it.
The other element of it is that also enables us to be able to work with payers to seek pharmacy benefit coverage for patients, which may make the program much more accessible to patients. So as we get insurance coverage, the patient copay might be much less than they would otherwise have to pay out-of-pocket. And so it works to improve access for patients. It works to improve confidence of patients. And it works to improve confidence of healthcare providers, by virtue of knowing that this has been well tested clinically, and it's being reviewed by regulators.
Charles Rhyee:
So I wanted to then touch on payers, then. One of the challenges I think for prescription digital therapeutics, and I think one that investors are trying to understand better is, figure out how best to commercialize them, given that this is a novel class of products without an existing pathway for coverage and reimbursement like that of drugs. So maybe can you talk about your strategy to commercialize Mahana IBS?
Steven Basta:
Perfect. Well, so there are several elements of the commercial strategy. Let's start with the payer topic that you raised, and then we'll actually go to, how are we introducing this product to patients and physicians? So one of the key elements of thinking about commercializing prescription digital therapeutics is obviously getting payer coverage. We're well into those conversations and we just started those a few months ago. So we're at the early stages of the discussions. One of the things that we're clearly finding every time we meet with payers is the clinical data is very compelling, regarding this therapy.
It's clear it produces a really terrific outcome. It's clear this is a cost effective therapy that, I believe in most cases ... and I believe this resonates with the payers, from our conversations. That this therapy will ultimately reduce costs. Because there are a number of published studies around cost effectiveness of different therapeutic interventions. One of the recent published studies described the fact that traditional CBT with a therapist, which could cost $2,000 or more because it'll take eight to 12 sessions with a therapist to work through a CBT program, that's already the most cost effective therapy for IBS. Because the benefits are so far ranging, the amount of improvement that an IBS patient gets, that's already the most cost effective therapy.
We're at a third of that cost, with the same clinical benefit. And in fact, we showed in a clinical trial, we can get comparable clinical benefit. So it's clear this is cost effective. That's going to win the day ultimately with payers, but it's a gradual process of payers learning how to adopt digital therapeutics, and the coverage decisions are going to come over time. So that's moving forward really nicely.
The other conversations or the other elements for commercialization strategy are outreach to patients and outreach to physicians. One of the approaches we've taken is an all digital commercialization approach. We think that's a very cost effective, efficient way of launching the therapy into this space. So we're doing direct marketing to patients, bringing patients into our website or directly into the app. From the initial app experience, they can actually do the first few days unlocked before they hit the prescription therapy portion of the program. And then they can seek a telemedicine prescription from within the app. So that it becomes a very efficient process for a patient to be able to learn about our program online, download the app, get started, seek telemedicine prescription and unlock the program. So that program runs very efficiently.
We're also driving marketing automation communications, where we're sending emails, eBooks to physicians. Inviting them into webinars, where they learn about the program, creating resources for them through medical affairs that allow us very efficient digital interactions with physicians. It becomes both a very effective and a very cost effective commercialization launch.
Charles Rhyee:
So that's really helpful. Maybe delving into the provider side of it, with the fully digital approach. Obviously we've seen a shift away ... and probably more so with the pandemic. Less sales people from pharma companies going into physicians' offices, the rise of e-detailing, as an example. Maybe talk about your approach here a little bit more and the reception that you're getting from the physician community.
Steven Basta:
Well, so I think that's exactly right, is our approach is tailored both to the fact that we have a digital product, and tailored to a post COVID-19 environment among physicians. That physicians over the last three years have gotten comfortable with the idea that they can learn about a therapy through a webinar, and they don't have to have a sales rep walk into the office. And in fact, it feels less comfortable for them now to have a sales rep walk into the office perhaps than it did pre-pandemic, because they've just become so accustomed to digital interactions.
So it feels like a natural interaction for a physician to receive information by email, click on it and say, yes, I'm interested. And then be able to talk to a sales rep virtually through a Zoom connection for 10 minutes, get whatever information they need. And that's a very efficient interaction, and often more efficient than having a sales rep walk into your office and sit in your waiting room. That's something they all got used to during COVID. It's something that physicians have really embraced.
We find that it's very effective. That either bringing the physician into a webinar to learn about our program or creating a series of webinars that they can access whenever they've got questions. Creating a medical affairs resource team so that anytime they want to talk to an expert, they don't have to wait for an MSL to fly in to visit them that day. They can literally just ping us and 10 minutes later, be on the phone with an expert for five minutes, get the answer they need, and that's what they need in order to get comfortable with the program. That works really well for us. And it's been very well received by the medical community.
Charles Rhyee:
And maybe jumping back a little bit, when you're describing the program itself, you talk about research done and a program developed at ... Was it King's College in London?
Steven Basta:
Yeah.
Charles Rhyee:
Maybe talk about then, the competitive mode here, the IP protection. Because is it possible for someone to find similar CBT training online and follow it themselves? Maybe talk about the protection that you're able to build around your technology then.
Steven Basta:
Right. So I think that that's actually a really important point for investors to think about in this space. IP protection is not going to be the same for these products as it is for a traditional API in the drug world, where you can have patent protection on the drug, and you're going to have exclusivity until your composition or patent runs out. Exactly to your point, Charles. I think it is true that we fully expect that there will be multiple entrants in each disease category. I think first mover advantage is going to be really important, both in terms of creating market primacy, share of mind among physicians, share of mind and the patient community. And once you have the initial contracts with payers, you'll be able to accelerate uptake within both the patient community outreach and the physician outreach.
But I fully expect that we're going to be in a world where a few years from now, there will be several competitors. Because exactly to your point, somebody can go to another academic group and identify what their CBT program is, and then turn it into a digital app. They will still have to run through a clinical trial to show meaningful clinical improvement, so it's still a multi-year development program. But yeah, within the next four or five years, there will be multiple competitors that launch.
Charles Rhyee:
Jumping then back to insurance coverage. It seems to me, a no brainer For insurance companies to cover Mahana IBS, particularly if you think about relative outcomes cost. And I'd say this even in generally to PDTs, given the efficacy data we've seen from many of them. Also the fact that there's minimal to no side effects, and as I just mentioned, relative cost is very attractive. And yet though, we still see, or at least we're hearing a lot of payers are asking for longer health economic research, real world evidence trials, really to look at things like durability of effect.
Why do you think this is? And I mean, what changes for insurance companies to move on and say, hey, look, the FDA said this works. The data looks good. We'll just cover it.
Steven Basta:
So there are many parts to the question you asked. Let me take individual parts of them and respond to different contexts. First, in terms of durability of effect, different clinical trials have shown different durations of outcomes with different therapies. So each therapy in each therapeutic category will need to be evaluated on its own merits as to both how well that therapy works, but also in that patient population, how durable is the benefit?
Now, one of the advantages that we have is A, we've got the largest clinical trial ever done with CBT in a GI condition, with 558 patients. So a huge, robust data set for our pivotal study. With end points at three months, which is after our program's completed. It generally takes patient about six to eight weeks to finish our program. Sometimes eight weeks plus, but they're done well before three months. And an endpoint at 12 months, and many of the patients were actually followed out to 24 months. So what we see in our clinical trial is clear and dramatic difference at the three month time point, which was the basis of our approval. But also, clear and compelling difference at 12 months, and a sustained difference at 24 months.
So we actually have that durability of benefit that many payers do ask about. And in that context, we just generally don't get the question, hey, we want to see longer term results. What payers find compelling is, well, if you stop therapy at eight weeks and somebody's still showing benefit of 52 weeks, clearly they got it. Clearly, they got the benefit from this. And that's a long enough duration that the ROI works. So often, what's embedded in that question about duration is a return on investment kind of calculation. If I'm going to be spending the money on this, how long is the benefit going to accrue?
Well, if we can save interventions over the course of a one to two year period, the cost savings are much more than the cost of the product, so the ROI is very positive to the payer. So we don't get the question, typically, of asking for longer term data. Our data is really robust. Now, if we had done a three month trial, we might have been able to get FDA clearance, but not have the kind of duration of effect that a payer would want to see. We have the good fortune of having a clinical trial that was designed with long enough outcomes.
Charles Rhyee:
And it sounds like the way the Mahana IBS program ... it's really meant to be a single cycle of therapy. Do you see this being used more often by patients, or do you feel like going through the full course, patients should have the skillset to really help, to your point, have that long lasting effect?
Steven Basta:
So we don't yet know what percentage of patients are going to want to come back and do it again. So we don't have enough data in the real world of patients using this therapy and being out long enough to trigger a reuse kind of protocol. Now, what we showed in the clinical trial was that patients could continue to get benefit, but that's not every patient. And so would a quarter of the patients or a third of the patients or 10% of the patients want to use the program again? It's very hard to know that yet, until we have one or two years with large numbers of patients and have some real world commercial experience as to when patients will want to come back. And how will they want to come back and use it?
Do they want to come back and reuse the whole program, or do they want to come back specific modules? One of the things that we are doing is even though our program is intended as a 90 day course of treatment, we provide access to the program for a year. So as we get through the first year or 18 months of commercialization, we will start to have enough experience with that one year duration to understand more about patient habits around, when do they come back to the program? My own expectation is there will be some number of patients that stopped the program early, didn't finish it. But then later have a flare up and want to come back and finish the program.
There will be other patients that went through the whole program, but six or nine months later, they have a flare. And it's typically a flare in their IBS that will trigger their interest to then want to come and do something again. But they will find that the program was so helpful to them the first time, they want to go back and refresh it. And we will start to see those kinds of patterns and understand what triggers a patient to come back and want to use it again.
Charles Rhyee:
That's really interesting, and we'll be interested to see how that data plays out here. So then, you touched on a little bit about how you see this market playing out. Maybe broadly, what role do you see digital therapeutics playing in care delivery if we look out the next five to 10 years? I mean, do you see this class of treatments being a meaningful part of how patients are cared for?
Steven Basta:
I see this class of treatments being transformative for a whole range of chronic conditions. Just profoundly transformative. So take IBS, for example, the effect that we can have on IBS patients is a degree of magnitude change that basically is taking a moderate IBS patient to mild IBS. The life impact of that change is profound for that patient. All of a sudden, they're not missing days of work. They are not canceling social events. They are living much more normal lives, much more comfortably. That's a profound change. And that will get better over time as we refine the programming.
One of the things we were talking about earlier is the competitive dynamics, so in the next five years, there will be competitive products that launch. But we will have five years of experience making our program better. Understanding how patients are using it and interacting with it. Learning how to make it even more effective and more useful for a patient, which will produce better outcomes. So I realize that this may come off as a little bit of an aggressive comment, but right now our program is comparable to a therapist. Five years from now, I'm certain our program will be meaningfully better than any therapist, because we have so many embedded advantages.
A therapist gets to see a patient once a week. We get to touch a patient daily. We get to nudge them multiple times daily. We can capture data from a patient about what their condition is, what their symptoms are. We know if the patient's constipation score is rising on the IBS symptom severity scale that we're capturing, that we may need to tailor the treatment to help them with more of their constipation related techniques. That can actually help a patient even more than if they go to see a therapist once a week. So right now the program is structured to mimic what a therapist does over the course of treatment.
Over time, it's going to get better and better and better in terms of its level of interaction. And that's not just true of IBS. For a whole range of chronic conditions, actually getting a patient the tools to take action in ways that significantly improve their condition, is over time going to be how these therapies become much more effective. And you can imagine the natural evolution of this is you start to integrate these kinds of therapeutic programs with digital sensors. Whether it's the quantified self-movement of capturing data off of your Apple Watch or capturing data off your phone, that then feeds data back into the programs. There is going to be a natural evolution of these therapeutic interventions where digital therapeutics may be first line treatments for many, if not most medical conditions over time. And will be profoundly transformative in the healthcare space.
Charles Rhyee:
Yeah. No, I tend to agree with you. It's it seems like there's huge advantages, certainly across many conditions, and we'll see how it certainly plays out. So maybe just closing then, what would you say is next for Mahana? What should investors be focused on? And maybe give us some key milestones that we could look towards, let's say in the next year or so.
Steven Basta:
Well, so I think you're going to see us making real progress on the commercialization of the IBS product. That is, how do we reach out to patients? How do we reach out to healthcare providers? So when we think about healthcare providers, by the way, we're thinking not just about physicians, but how do we reach out to therapists? How do we reach out to dieticians? So you can imagine a world in which a CBT program is actually an augmentation tool for a therapist, so that a therapist sees a patient, recommends the program. Patient is using the program, comes in three or four times to the therapist to work on any specific issues that that patient has. And now that combination is a much more powerful treatment intervention. Same is true for dietician or treating IBS.
So when we think about commercialization and outreach to healthcare practitioners, it's to physicians, to therapists, to dieticians and nutritionists, and how do we educate the healthcare community to advise patients? How do we reach out directly to patients who are going to see us? Making real commercial traction in terms of the awareness level within the patient and the provider community. You'll see us making real commercial traction with payers.
And then the other thing you'll see us do is start to demonstrate clinical data on our next several programs. We have three additional products in development. One of them is already in the clinic today. Two more are in early development ... not early development. We're actually already well into content design on those programs. Those three programs are all internally developed. So our team of therapists works with subject matter experts in each specific discipline to create state-of-the-art programs that use the best therapy traditions from different psychotherapy techniques. And we integrate those into an app that's really customized to optimize outcomes for patients.
I think we're going to be creating very effective therapies for three new indications that would be ready for launch in 2024. So a year from now, people ought to look to us to start having clinical data in those indications that demonstrates the ability to create a whole pipeline of these treatments over the coming years.
Charles Rhyee:
And have you shared what those indications are yet? Or is that still [inaudible 00:36:29]?
Steven Basta:
So our second program is in vulva and vaginal pain. Our third and fourth programs, we haven't shared the specific indications. But as we take those into clinical trials, we'll let folks know what those indications are.
Charles Rhyee:
And maybe ... I know that was my last question. But maybe just to follow up. You talked about the ability to iterate the product and to have a feedback based on sensors or data coming in to modify the program over time. And certainly as patients, you track them after their first 90 day course, you can see how they come back to the program and being able to adapt.
Talk a little bit about your discussion with FDA. Because I think it's one of those things where FDA has given guidance around software as a medical device and the ability to iterate without having to resubmit. And it sounds like that's something that you will take advantage of there.
Steven Basta:
I think that's right. So the kinds of evolutions that we're talking about, some of them we can do within the program without requiring additional clinical trials and additional submissions. Some of them would require additional clinical trials if we wanted to actually integrate our product with digital sensors. Now that's a combination with a physical device that might require regulatory review, might require clinical testing. But a change in our program, for example, where we ask the patient key questions and then suggest to them that they go back to a particular session in the program that was already built into the core program in response to that, that probably doesn't require regulatory change because the core program is the same. We're simply recommending that a patient use an additional therapy.
So those kinds of changes might be possible without regulatory review. There's a whole gradation of changes as to what triggers the need for additional clinical trials and additional regulatory review and what modest changes can be made. Medical devices, for example, all the time, if you change the color of a medical device, you don't have to resubmit. You create a letter to file change that it was a modest change that has no meaningful clinical impact on the performance or on the safety of effectiveness of the device.
So that's one of the advantages of being in the medical device space versus the pharma space is you do get a little bit more degrees of freedom around how you slightly modify the device within the constraints and the framework of the initial regulatory approval. But then obviously there will be some changes that we want to make that are meaningful substantive changes, where we'll do additional clinical and trials prove that new program works. And hopefully in some cases, prove that new program works even better than our current program, which is already terrific.
Charles Rhyee:
Yeah. Okay. Well, that's great. And it sounds like three new indications in the pipe. It sounds like your second product is well on its way, and we'll definitely look for more details in the months to come. So I think we'll end it there. And Steve, great to have you as a guest here, and I appreciate you taking the time to speak with us. And thanks everyone for tuning in. And look forward to having you join us on a future podcast.
Steven Basta:
Charles, thanks so much for the invitation to be with you today.
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