Amrish Nair, Biorithm - Obstetric Remote Monitoring Solution | LSI USA '24

Unknown Speaker  0:03  
My name is Amrish    Nair. I'm the co founder of Biorithm. And as you can see on the slide, we are addressing pregnancy health and women's side of the broader women's health category. So you've probably seen this image before. And it's, it's a rather stark one, the March of Dimes have actually, and the March of Dimes have actually notified the country that more than roughly half the counties in the US actually lack access to maternal care, and it's not lack access to some maternal care, it's like access to all maternal care. And this is a huge issue. And what we're doing is putting women at risk 32 women, 32 million women are vulnerable to poor outcomes because of a lack of access to care. And this is not just a statistic, you know, you speak to women, and everybody in this room knows someone who's been through a tough pregnancy. And the countless women who have mentioned, lack of access to care, lack of quality care available to them. And the ACO G addressed this during COVID, where they understood that, how do we define a quality visit? And understanding that an in person visit is not necessarily the only form of a quality visit? And how do we actually change that paradigm? And COVID actually sort of accelerated that by 20 or 30 years, understanding how we can use digital and remote care, and to complement in person care. And understanding what data do we need from the home to complement a video consult, or to be able to complement it in between care. And understanding this is understanding the problems that providers have in providing this care. It's about the lack of manpower currently available. It's about late diagnosis, which causes preventable poor outcomes. And how do we address these problems specifically in practice, and it's about getting high quality physiological data to the physicians, and to be able to train that information for early diagnosis, and to be able to substitute hospital care for home care. And so what we've done is we've introduced a remote monitoring platform for pregnancy, we want to be the one stop shop for obstetrics monitoring in pregnancy. And that includes maternal and fetal monitoring. And so the way it works is, the doctors able identify women at risk, either of maternal conditions like diabetes, hypertension, as well as fetal conditions, where babies are at risk of fetal distress. And they deliver a kit, it can be off the shelf devices like blood pressure, cuffs, glucometers. But more importantly, it is utilizing a novel sensor that we've developed to assess fetal vitals and well being. And the data is then transmitted to the cloud, where the doctor is able to trend and track babies who are being monitored remotely. And it works pretty simple. The device can be placed by women themselves at home. So we've redesigned the device for home use. Now, I'm not pregnant, so I've trained hard for this, but you're able to place it over the navel, and voila, you stick it on, and it's able to track fetal heart rate, maternal heart rate and contractions. And why this is important is these are the fetal vitals that assess dynamically how well the baby's doing. And what we're looking to do is not just bring the test home, it's improving the test. It's been widely acknowledged that this is an imperfect test. And but it's the only one they've got, and how do we improve the test? The false positive rate currently is no better than a coin toss. In the current interpretation scheme, what we've done is half that so that we reduce unnecessary readmissions, we reduce unnecessary follow on tests, and addressing the fact that cost doesn't care doesn't need to be that expensive. Delivering sort of the quadruple aims of health care is important here, understanding how we're not just looking at improving outcomes and costs but the patient and the clinician experience as well, which is vital when you look at women's health and their relationship with their OB GYN. It's a very unique space where women trust the OB GYN implicitly on treatments required over a long period of time in their lives, and being able to deliver a solution to women where they can monitor themselves anytime, anywhere. My wife commented that her care was no different than what her mother went through in terms of being having to visit the OB GYN frequently during care. And the clinician experience I mean, clinicians want to see complicated cases, they want to be able to deliver a proper care in office rather than deliver routine care which can be done at home or by a midwife or a nurse. And looking at reduced costs. As I've explained how do we reduce unnecessary visits in hospital? How do we reduce unnecessary follow up tests that they require improved outcomes in the sense we're able to capture fetal distress early reducing neonatal ICU, neonatal ICU admissions, but also understanding maternal disease better? Currently, it's reimbursed on two different levels and RPM as well as fetal monitoring. And the reason this is important is because the practice economics matters here. physicians often earn a little bit of money doing these tests in office. And how do we help them do that. And so we implement it a per patient per month monitoring, per patient per month business model, were the two tiers for maternal only and maternal and fetal monitoring. And the practice economics worked both ways for both value based care and fee for service care, in the sense that now clinicians are able to scale themselves, because where they have two machines in office, now they're able to monitor 10 women at the same time. But more importantly, in value based care where they're looking to save money, they're able to stretch a capitated dollar much further than they otherwise would. And these models have been simulated. And we're currently running some running pilots in Boston and Houston to be able to establish this. The devices themselves patented together with a trade secret on signal processing, which is where the IP came from. We were originally we were originally investigating arrhythmias. And some of the IP came from Qualcomm, which, who we worked for before. But we've redeveloped the signal processing to be able to have all the trade secrets in house. And further future development would include maternal cardiology, we're capturing maternal ECG, can we do early detection there, and it's a hot area currently with ARPA releasing significant funding related to maternal related cardiac disease. Our clinical trials have been worldwide, we have about 600 patients worldwide from proof of concept all the way to pivotal studies. We're currently meeting the FDA requirements for clinical performance 510 K. And we hope to submit in the next couple of months, we've worked with great doctors, Boston, Houston, Ohio, London, Singapore, Australia, to be able to establish this and understand that this is a global problem. It's not a uniquely us problem. We do have competitors. But like I mentioned, one of the key differences, we're thinking of this as a whole. And we're thinking of this as how do we improve the test, not just bring it home, we're understanding how we can use novel digital biomarkers to be able to track and trend fetal health, thus, being able to intervene early, and we're estimating it could be 40 to 72 hours early, where we're able to provide early early warning markets. We have raised we've raised across three routes, seed a bridge, and now series eight, where we've, where we've had a first close of three and a half million, and we're looking for another $2 million. And what this will bring us is FDA clearance, the first million to 2 million in revenue, as well as further clinical studies into novel into the novel digital biomarkers. And with that, I think one of the clinicians I really enjoy spending time with us said right at every conference, we often you'll hear tons of companies and millions of dollars being spent on how do we prevent death. But how do we actually invest more in the one we were born? I think that's the key takeaway and urge you all to look more into the space and Yeah, welcome any questions. Thank you.