SD: Shailja Dixit | JA: Jerry Antimano
SD: So, I am Shailja Dixit. I am a physician by training, CEO and founder of Curio Digital Therapeutics. I stand here today, highlighting a really important issue, which is women’s mental health. We have talked a lot about other areas around women’s health yesterday, a great panel. We have talked about various things around digital health. Our company focuses on women’s mental health across their life cycle. So, a little bit more about us. All of our solutions are evidence-based and clinically validated. I’ll talk about it. We are taking an approach of software as a medical device. The circle that you see on your left side as you are looking at it, this is our goal to go across women’s life cycle. Unfortunately, about 80 million women suffer with mental health condition. And the area that we are focusing on as our first product is perinatal mood disorders and postpartum depression. About 25% of the women suffer from postpartum depression in the U.S. alone. And around 40 to 50% of the women, if you look at the spectrum of perinatal mood disorder, suffer with perinatal mood disorders. And it has not just an impact on women’s life, it has impact on family, it has impact on vaccination of newborn and many more things. In fact, very recently, mental health has been called out as third leading cause of death in United States within one year of pregnancy, third leading cause. It has surpassed many other causes that lead to bad maternal mortality. So a little bit more about the numbers, if it caught your attention. Unfortunately, March of Dimes has given a D+ to United States when it comes to maternal mortality. That’s a pretty bad number. And many states are actually, there’s a variable spectrum. And when you add a layer of women of color, underserved population, actually these numbers are even worse. So something has to be done about these numbers, and that’s what we focus on. Another very important aspect is that last year, for the first time, there was a bill that was passed, which talked about how big a financial impact, direct and indirect, mental health is. This is the first time there was a bill that focused on maternal mental health. We talk about maternal health in general, which we should, but this was the first time the bill that was passed and talked about maternal mental health and its impact on society, on mom’s health, and on a child’s health and family. So what is the problem? Let’s just uncouple it. We all understand American College of OB-GYN talks about screening for mental health as mandatory in third trimester and postpartum. Unfortunately, this screening doesn’t happen in a consistent fashion, because there are not many resources available in OB office. And a very important point, that oftentimes, by the time postpartum depression screening happens, which is postpartum, now called fourth trimester, it’s too late. That woman comes for one visit in the office at fourth or sixth week after delivery, and then she’s out. She’s thinking about other aspects of new child vaccination, pediatric visits, and whatnot. So we lose that opportunity. So that’s a big problem. The second is, those who are diagnosed or screened at time, we don’t have. 75% of those don’t seek any help. We don’t have enough mental health professionals in the United States. So there’s a huge gap. Another very glaring stat is that 65% of the counties in the United States don’t have a trained mental health professional. So that’s the impact, profound unmet need that I’m talking about here. Only 45% get treatment, right? So the women fall through crack. And that’s where we come. Our solution is a digital first solution. We have a patent pending predictive tool, where we are able to identify a woman very early on, at the end of second trimester, or third trimester, beginning of third trimester. 85% of the women we are able to identify who will end up having postpartum depression. That gives us a unique opportunity to get them on a digital first platform. Since we don’t have enough therapists, we don’t have enough mental health professional. That’s where the role of digital is. And they simply download the app or the digital platform. We augment it with coaches. So we call it like empathy intertwined with technology. So we are not taking out the human element altogether, because there is a role of making sure that there is human encouragement. So that’s what coaches do. These are highly trained coaches who understand mental health aspect really well. So we pair them with a coach, which are our own coaches. And then we have developed a curated network of therapists all across United States, and we escalate them to therapist as and when needed. The goal is that one therapist now can look at more female population and can manage them more efficiently. A woman is not waiting for 60 to 90 days for a therapist appointment. They are able to get to a digital platform which has digitalized cognitive behavioral therapy day by day and go through their curriculum in our platform itself. Our therapist, we have been able to get therapists to take multiple insurance. So the good thing is the therapist component is actually covered by the insurance. The platform is something that we are working with insurance company to get reimbursement and so on. We also took approach of Class I and Class II device. So we have a Class I category for our platform. We also have for higher severity patient a Class II device, software as a medical device, which is under review by FDA. And we are hoping to get approval towards end of this year. So there is a continuum. You identify early. You get them on the platform. Give them a Class I general wellness device augmented by a coach. And then you get to a Class II device if they are higher severity because those women do need a prescription or a cure of MD. So that’s the whole idea. So just moving on a little bit, one of the very big thing is that we are focused on women’s mental health. We have about seven clinical trials. I think Jerry was talking about some of our studies. We have done three studies so far, third one which is going on with HITLAB. This one is actually we started with took a journey. Our first study was human factor study. So, looking at the acceptability of our platform itself. The second one was a single arm proof of concept. And then now we are doing a double arm study with HITLAB. We also have international studies. So in total, we have done about seven studies, clinical studies. 2,000 women have gone through our platform in IRB approved studies. This is our evidence package. And I believe maybe one, I don’t know, like could be one of the largest evidence package when it comes to maternal mental health using a software as a medical device. We are embarking after this on actually fertility. So we are launching fertility. Just a little bit about that. Fertility, again, the couple or the woman who’s going through assisted reproductive therapy, which is an increasing trend these days. They have emotional burden similar to somebody who’s going through cancer treatment. So the cortisol level or the quantitative effect of that is similar to somebody who’s going through cancer treatment, as high as that. And number one reason after financial for a couple or a woman to drop off from reproductive therapy treatment is actually emotional burden after financial, like the number one or number two reason. And that’s what we are trying to manage with our digital first approach. Again, our digital first approach integrated within EMR or the clinics where a woman can actually be an extension of their – she gets assisted reproductive therapy, IVF, let’s say, and then she can get on a platform and manage her emotional aspect of the care through our digital app. And then we have any menopause and menopause in R&D, which we plan to bring our proof of concept to market by end of this year. We work with institutes like for example we are working with HITLAB, we are also working with Mount Sinai. We went through the elemental lab, and they are also are – they also appear on our cap structure. We are also working with some other leading Institute across the globe, not just in U.S. This is a little bit of our pathway I already talked about MamaLift, it is general wellness, MamaLift Plus, then we have FertiLift, which is also going to follow the same path, and then FertiLift Plus for Class II device, so Class I, Class II. No name right now given to the menopause one, that’s still in R&D. Our journey a little bit, what we have done so far we launched with XCR which is about 750 OB-GYN group last early. We also are working with maternal child health, this is Medicaid and exchange population in New Jersey. We won a grant with New Jersey government to do specifically curate our content and our offering for underserved population so we are doing that, capturing lot of data there and learning little bit more. We also have working with Mount Sinai, as I said, and then we are launching with employers so we have partnered with some large employee benefit consulting company, you see Gallagher, AON, Lokton, Epic, Alian, they are all our partners at this point of time and we are launching with big employers through B2B approach that we have taken. So this is our journey and little bit of – sometimes the problem is so big that you start getting traction all across. We did not intend to launch internationally, yet, but we are launching actually in India right now as I speak. In July, our launch is getting prepared with some very large employers. We are also in discussions with Kingdom of Saudi Arabia. We will be launching sometime next year with Scottish healthcare system as well. And we are preparing for our CE mark because we have a lot of European data through Germany and France as well. Our program is available in English, Portuguese, Spanish, very soon German, and French maybe next year. So that’s our journey. Happy to – I don’t know if there’s no Q&A but if there’s anything I can, you can talk to me backstage, or when I’m back there so thank you so much for this opportunity and looking forward to connect with all of you. Thanks.
JA: Wonderful presentation, Shailja. Thank you so much. Any questions from the in-person crowd? Yeah. Gentleman over here.
UP (Unknown person): Regarding your coaches, and you’re training them per your protocols, are you able to bill for their time and activity directly, or how is that working into your model?
SD: So as coaches still don’t have a reimbursement model, or it’s varied, at best, if I may say. There are some places where you can do one-on-one negotiation and talk about coaches, so we do have that, but it’s very, very limited. We bake in the coach in our platform, so they are baked into our platform fee. And the beauty of coaches is it’s a very scalable model because you don’t have to look at state-by-state, friendly PC creation and licensing. They are very trained. They all have gone through Mayo Clinic, mental health training certification, and so on. So yeah, to answer your question, the billing is inconsistent as it comes to coaches. There is good and bad in that. The good thing with that is that you can scale, because as soon as you have reimbursement, the problem is that you have to go through the state-by-state licensing. So right now it’s a very scalable model. But we have to see. There is a big trend in coaching getting reimbursed in the near future, so we are keeping an eye towards that.
JA: Wonderful. Any last – very quick questions from the crowd? That’s it, Shailja. Thanks so much. Another round of applause for Shailja Dixit from Curio.
SD: Thank you.