Rhaeos | Anna Lisa Somera, CEO

(Transcription)

Anna Lisa Somera  0:00  

Well, happy Friday, everyone. Hope you all had a great meeting so far, the last mile marker in this endurance event of LSI. That is LSI is well within sight. So I hope all of you had great meetings. I know I did. And now it's really nice to come out, you know, especially to the sunshine coming from the Midwest. So I welcome that. And I hope you all had a great events. I want to share something with you really quick. And that is, every morning I wake up, I'm motivated. I'm motivated to run this company. This company is called Rhaeos, and I'm the CEO and co founder of Rhaeos. And over the next several minutes, I'm gonna tell you a little bit about what we're doing and why I'm motivated. So Rhaeos is a VC backed clinical stage medical device company that's developing a wearable platform sensor that can assess bodily fluid floats subdermally throughout the body. So when I say things like bodily fluid, think of things like blood, Lynn. And in the case of our first indication, cerebrospinal fluid in shunted hydrocephalus patients, now, the technology has its origins out of the John Rogers lab at Northwestern. He's a prolific inventor and serial entrepreneur. And we're a thermal flow sense company. And we're kind of taking a bookended approach in assessing that flow that I was talking about, where we can assess really slow flow in CSF shunted hydrocephalus patients, and then really fast flow in patients undergoing dialysis who have AB fistulous. And it's a non invasive wearable sensor, we are designated class to do over 510 K. And we're also fortunate to have breakthrough designation as well. In terms of financing, we've brought in over $8 million to date. And a big chunk of that is non diluted funding by way of NIH and NSF SBIR, ours, we're currently raising a $10 million price round for capital for launch. Now, the indication that we're initially targeting is called hydrocephalus. Some of you might have not heard of it. And let me tell you what it is. It's characterized by excess CSF on the brain, and if left untreated, can lead to developmental delays, and cognitive impairment and sometimes even deaths. And the standard of care for these 1 million Americans who have Hydrocephalus is the placement of something called a shunt, which essentially drains the brain of this excess fluid that I was talking about. Now some technologies have been around for about 50 years or so. And even though it is the gold standard, the problem with these shots is that they fail. And they fail almost all the time, due to things like infection, obstruction and dislodgement, that sort of thing. And when that happens, another shunt needs to be placed in meaning in other invasive neurosurgery. So it's not uncommon for kids like Jack here, unfortunately, to have multiple brain surgeries over the course of their life. Not only that, things like headaches, dizziness, and nausea can bring you to the ER. And when you go to the ER, you're subject to imaging which can be inconclusive, expensive, and exposes patients to radiation. And after imaging, you either go home because you're actually having a bad day unrelated to your shunt, or you go into surgery for more invasive testing to see if the shunt is actually dripping. And this whole cycle and it is a cycle because it's chronic medical condition repeats itself. And there's no technology available today that can non invasively easily wirelessly assess what's going on within the shunt until now. So race is developing a technology called Flow sense. It's a non invasive, wearable technology that doesn't require any capital equipment that can detect flow beneath the surface of the skin in a matter of minutes. Now, here's one of the devices in one on one of our patients. And you know how it works in this bumpy looking Bandit is that we employ a little bit of heat that's imperceptible to the user. And if there is flow within the shunt that heat dissipates in the direction to flow. We have temperature sensors that pick up the activity, kicks it off via Bluetooth Bluetooth chip to mobile app that analyzes the data. And in a matter of minutes bedside, we can let the clinician know if there's flow or no flow along with flow rate information. Now, in terms of the products that we're looking to launch, we intend to launch our first product later this year, which is the hospital facing product. It's a single use disposable that can be used both in the inpatient and outpatient settings. We are also fortunate to receive over $4 million from the NIH for outcomes based studies for this hospital device. Our second device which received money from the National Science Foundation, is a reach reusable rechargeable device for home based product. Now in terms of our clinical work, we have published clinical work in science in nature family journals, we are currently conducting an eight center clinical trial at key academic centers across the country and have other upcoming outcomes based studies as well. In terms of intellectual property, we have two issued US patents, as well as international filings as well. We have our own, you know, filings, you know, through counsel that we've commissioned, and it's for the issued patents that we have. They were exclusively licensed from Northwestern University, as well as the University of Illinois. And it's an exclusive all fields. In terms of freedom to operate, we have had an FTM performed and that has become clear. And I've talked a bit about hydrocephalus. But think of hydrocephalus is chapter one in this novel of applications that we're actually going for. We're also looking at areas of flow within patients undergoing dialysis in skin flaps and plastic surgery and other areas as well. Now, in terms of the team that's leading the charge here, we've all have experienced significant experience in both the startup as well as the industry level for medical devices, we brought a number of products to the market and have multiple exits under our belt as well. Here's a snapshot of our current clinical investigators, which has some of the biggest name neurosurgeons across the country. In terms of business advisors, we're working with folks that have exited medical device companies within the past couple of years. Now, in terms of financing, we've brought in over $8 million to dates. And this includes an oversubscribed seed round as well as significant SBIR funding. So we're currently raising that series, a price equity round. And really, it's launched capital, it's not capital to get us through regulatory we have the funds to do that right now. As well as our eight center pivotal study, the money that we need is for launch. And that's really to generate sales within you know, the the sites that we're currently working with as well as other academic centers. And the capital will also be used for outcomes based studies and really to build up more accounts across the country. Now in terms of, you know, revenue and exits, we're initially targeting the partners that we're working with, and we'll take a regional and national approach to scalar devices. So in summary, Rhaeos is developing a platform technology that has the potential to assess bodily fluid flow throughout the body, initially targeting patients undergoing a condition called hydrocephalus. We're working with the biggest name neurosurgeons across the country. It's led by an experienced medical device team. We're launching our breakthrough designated product later this year. With our seed round closed and financing from the NIH and NSF. We have the momentum to complete our pivotal study and submit a regulatory application. And we're currently seeking a Series A round of $10 million for launch and growth. If you'd like to learn more, please scan this QR code. I'm Anna Lisa Samara, thank you so much for your time.