Video Transcription
Jenny Hoffman 00:02
Jen. My name is Jenny Hoffman, and I'm the CEO of Biorithm, and I'm really excited to tell you about what we're doing today. I want to start by talking about something that every single one of us has in common. An amazing woman gave birth to each and every one of us, and hopefully she was lucky enough to receive prenatal care, but for many of us who even received prenatal care, there can be complications, and many of those complications, like my own experience, are preventable. So maternity care overall needs improvement. The rates of maternal mortality have been increasing at significant double-digit rates. If anyone has ever experienced a stillbirth, or is familiar with a loved one who has experienced a stillbirth, it's something you'll never forget, and it impacts you the rest of your life, and this is what we're trying to address. And the cost of these complications is very high for our healthcare system; in the US alone, pregnancy care costs over $71 billion, and those complications are over $32 billion. So we at Biorithm are reimagining pregnancy care right now. It is a very high cost of care, like we just talked about, and it's very labor-intensive, both for the clinicians as well as the patients. The patients are having to go in person very frequently, and it's outdated equipment, and it uses a lot of staff and resources in the clinics to be supporting these patients. So we view it differently. We have FEMA, which is virtual maternity care, and we offer a comprehensive care solution in a digital format that can be done from any location, including the home, and that enables high-quality, accessible, and personalized care for both mother and baby. And this is a really significant market opportunity because I believe that in the future, this is something that every expecting mother could benefit from. So this is the device that you can see that we have. So when you're expecting, the US is now recommending that every mother have their blood pressure monitored. So we have a blood pressure cuff that is easy to use with a single press of a button. So any patient of any education level, any language that she speaks, can upload this automatically to her electronic medical record for the physician to monitor. Second, the women are screened for gestational diabetes around 20 weeks. So at that point, if it's relevant for her, we also have a blood glucose monitor, and it's the same for anyone; it can be used, and it automatically connects to the electronic medical record. And then in the third trimester, we've designed this device, and this device is designed to have your finger put through the hole here, and you put it over your belly button. And I've seen patients be able to pick this up and easily be able to put it on with little to no instruction. And the orientation is less critical than some other options, so it's really easy for her to use. And what this enables is adding fetal heart rate, maternal heart rate, and uterine activity or contractions to all of the data. So overall, the clinician is identifying patients that they want to add to this monitoring program, and then the patient is using an app on a cell phone as well as placing this device when it's relevant. And the clinician benefits from having one platform where they can see all of the relevant data and information for their patients. And we've heard from physicians how helpful this is to have a single platform with all the data they need to make informed treatment decisions, and then this enables us to have both the hardware as well as a monthly subscription fee and utilize existing CPT codes. What this means overall is that in terms of value, everyone in the system has a strong value proposition. Let's start with the patient. For the patient, it's much more accessible care. The number one thing I hear from patients is it addresses the peace of mind, especially for new mothers or mothers who have experienced a complication before. I was one of those mothers. That's why I do this; that peace of mind is critical. It's also much easier to access. I was just at a hospital two weeks ago where 50% of their patients were not showing up for these visits because they're having to travel an hour or two to get to them, and it's just too burdensome when they're trying to take care of other children or do their job. So it was much more accessible for the patient; for the clinician, it's a much simplified workflow, as well as they have the information to monitor the health of both baby and mother and make earlier and more informed treatment decisions. Because the real problem is that the day that you want to be the best day of your life ends up becoming very rapidly the worst day of your life. And that's what we want to prevent. In terms of the payer as well as the hospital, this is much more efficient utilization of resources because you can more efficiently use the staff and clinicians as well as the space in either the doctor's office or the hospital. And the whole idea is to lead to better outcomes. We've had a really exciting last couple of months, so I want to share some of those key results that we've had. The first is, we have used this device in over 600 patients worldwide, and we have seen a very strong signal in a very high percentage of them. So now we've brought that technology to the United States, and we have started the clinical studies in the United States. Ohio State University is actively enrolling patients, as well as New York University, and this is a place where we're actually seeing physicians come to us and are asking us to work with them to conduct their research. We also have research going on with St George's in London, and what that's enabled is us to validate our novel fetal biomarker. So not only do you get the maternal heart rate and the fetal heart rate, but we can use a proprietary algorithm to create an overall assessment of fetal health. And again, the idea here is to give a signal of any fetal distress so that an intervention can happen before it's too late. We then are on track to receive FDA clearance in Q1 of next year. As we look toward the competitive landscape, the first all the way on the right, right here, this is what a patient would have to use today, so she either has to go into the hospital or into the doctor's office to use this big piece of capital equipment. It has its own room. It has its own staff member to run it all the time, and it has to be adjusted all the time. So this is not an efficient use of resources, nor is it easy to do so. We do have some in-kind type of competition in the middle. And what those have been designed for is, like us, we're looking to be able to take this technology home. So now it could be done in a doctor's office, a hospital, or at home. But the unique value we've added is that enhancement. So it's not just a non-stress test like a woman could get today. It's the peace of mind that it's enhanced for potentially better outcomes and earlier signals of distress so that interventions can happen. Furthermore, we've really designed this for high-risk pregnancies because these high-risk pregnancies are often the ones that have obese patients with a high BMI or of different backgrounds, and this device works equally as well, if not even better, with those patient populations. We have a really experienced team to execute, and so I'm excited about the medical device experience, the clinician experience, and the scientific experience that we've been able to combine. We are currently then, we've closed our Series A; we're raising a bridge right now that will get us the FDA clearance, HSA approval, which is Singapore approval, where our technology has originated from. That also unlocks some other Asian markets for us, and then we'll have that early commercial revenue, and our goal is to start with our clinical sites where we've got the experience and expand from there. We have a very international ecosystem of amazing partners. And so I welcome anyone to help us work to end preventable pregnancy complications. Thank you. Applause.
