Video Transcription
Sharon Handelman-Gotlib 00:02
I am Sharon Handelman-Gotlib from Shela Health. I'm one of the co-founders and the CEO. And what is Shela? If I want one takeaway from here that you take home and join my journey and join the success of us, it is that we are about to redefine the maternal journey, redefine what we can do differently, and why we need to redefine. So here are some interesting facts. They're very sad. Unfortunately, we are just about to finish 2024, but still, the numbers are staggering. 25% of pregnancies entail a severe pregnancy complication. 25%—they impact not only the mother, but also the newborn. Not only that, it's also for the short-term pregnancy and pregnancy outcomes, but also for the long and mid-term. These are facts that not, not, oh, not, not necessarily are known to us women when we are pregnant, and to, I'd say, the general population. It's not only a health issue, of course, because the fact of the matter is, and you can see it up here, it's a huge market and a huge economic burden. These are numbers only from the US, and we're talking about a market share of $32 billion annually addressed to pregnancy complications, impacting again, mother and newborn. And these are numbers only for the short term. What are pregnancy complications? What are we talking about when we are addressing what is Shela? Looking at the major pregnancy complications are preeclampsia, preterm birth, gestational diabetes, and growth restrictions. They are all connected, impacting short and long term, but oftentimes are addressed very siloed, very narrow approach, if at all. I saw before in the previous presentation discussion of how important data is, how important proactive activity is. But when we're talking about pregnancy complications, oftentimes they're not addressed; oftentimes if they are addressed, they are too late and too little. So once detected, it's not an IT issue, and we're trying to kind of chase our tail. That's why we built Shela. We have the right chefs in the kitchen. Each one of my co-founders comes from a different domain, from the science, from the clinical side of things, from the data, providing a wealth of knowledge and experience and are considered to be global experts, each one in their domain, from the science, multi-omics, Professor Henry Cohen, from the clinical side of things, Avi Tool heading Women's Health Innovation in one of the top innovative hospitals in the world, and Jong Lee. So we gathered together, understood that there's a huge unmet need, there's a huge opportunity, and this is how we do things differently. We look at things in a more comprehensive approach, in a proactive approach. We identify and have an early risk management, and we add an interesting secret sauce layer, precision health for women's health. The first time it's obvious in other places, in other domains, like oncology and others, but for women's health, and specifically for prenatal, this is not something that we see today. They're all cookie-cutter solutions, very narrowed and very limited. How does it work? We have the ability, with our platform, with our models, to have the process in place as early as week 12 of gestation. Our algorithms, our models are able to identify the risk for a woman for currently we have three: for preeclampsia, preterm birth, and gestational diabetes. It's before those conditions happen. So we have the ability to flag it out, raise the flag. This is a risk. These would be also the additional precision layer; this should be the health pathway, medication, or other attributes that we consider and recommend. And we also have the ability to provide the digital intervention, whether it's reminders or other activities and actions that we can embed as part of our platform and part of our solution. So early prediction, we get women's engagement and the clinicians' engagement in a proactive, personalized, precision-based approach, and have the right intervention in place. The way we do that, we have digital screening. It's based on clinical data, and I'm running fast because I have time limitations. And then we add the secret sauce again, for the multi-omics approach, based on the condition and the complication that we are able to detect. We provide the layer of multi-omics; each one of the conditions takes a different route, but we are able to detect and provide a personalized profile for each one with a recommendation. We already have models for the three leading conditions that I mentioned before, and we are about to publish our first precision model for preeclampsia, which is going to be the first one in the world. We are data and science-backed. We have even now the numbers are higher, close to 500,000 data points of women on a global basis. That's the largest data set that is in the maternal space in the world. It comes from Europe, from Asia, and other specific countries. Of course, we have a large biobank. We have four prediction models, as I said, patents, clinical studies that are ongoing as we speak, patents, and strong partnerships coming out of Israel, which is where we're based, and also in the US with a design partnership with Mass General Brigham, a payvider, a company that we're working with, and additional ones that we're about to hopefully disclose in the next few months. So that's kind of our success and milestones up to now. In our approach, we work bottom-up and also top-down to get the KOLs, the leading and key opinion leaders, to embrace and endorse our technology, to say this works. We want this technology to be part of the solution, part of the way things are done. And from a roadmap perspective, we are now validating the models, getting our FDA in the right track. We already initiated the pre-sub meetings, and hopefully to have by the end of 2025 our first FDA approval for preeclampsia. From a competition landscape, you can see here the competition. I won't speak about that for long. We're in the middle of a round, so if there are investors in the crowd, we're looking for a $3 million round to get us done and clear with our clinical studies in the US, our readiness for the market access, for the regulation, to get things in place and make sure that we are ready to launch and then accelerate in a very speedy manner. And what next? So our focus is maternal health, and that's a huge market as a standalone, but we've identified, and that's the fact of the matter, that there's high connectivity between what happens in pregnancy to a woman's long life journey, and we are working on our way to provide support for pregnancy, then we'll expand to postpartum and ultimately provide ongoing support for a woman throughout her life long until menopause and beyond. Thank you very much. Thank you.
