Partik Schmidle, CARI Health - Next-Gen Wearable Remote Medication Monitoring | LSI USA ‘24

Patrik Schmidle  0:04  
I'm Patrik Schmidle, I'm the founder and CEO of CARI Health. The problem that we're solving is medication adherence. The way that we're solving it is by developing a small wearable medication monitor that informs personalized dosing and medication adherence in real time, okay, we're getting ready to conduct our first in human trials were med tech backed company from a group of experienced angel funds, and we're getting ready to raise a $3 million seed round. Okay. Prior to this venture, I was part of multiple exits. And I founded this company because I had a personal experience that had a profound impact on me. I'll tell you that and tell me more about that in a few moments. Essentially, you can think about our solution as a continuous glucose monitor. But instead of monitoring glucose, you're monitoring medication levels, and even though our sensor can detect multiple medications, we're going to prove our platform capability first with methadone, which is used to treat opioid addiction. Why opioid addiction? Two reasons. One, because I had a personal, we had a close family member that struggled with opioids. And that's the personal experience that gives me the passion to want to do something in this space. First, too. There's a very urgent need for solutions that keeps patients from dropping out of methadone treatment. Why is it so urgent because of illicit fentanyl is that fentanyl is 50 times more potent than heroin, which means that those patients that are addicted to illicit fentanyl have very, very high tolerance rates, tolerance levels. So what that means is that when when patients get to that place, the last remaining options as methadone treatment, but unfortunately, there are two major drawbacks to this otherwise safe and efficacious medication. One, it takes too long to get to a therapeutic dose because of the high tolerance levels and to once patients have to once patients get to the therapy does they then have to physically go to a clinic every day, in order to prove compliance? Yes, every day. Those two factors combined cause very high dropout rates, patients relapsing going back to using fentanyl, overdosing landing in the ER. Okay, mind you, these are all patients, they've decided to leave the cycle of addiction and lead a better life, but they keep getting pulled back. Because it's so hard to stay in treatment. So here's the elegant solution that we've designed to break this vicious cycle. It's a small wearable monitor that uses a proprietary electrochemical sensor to help clinicians titrate patients to a therapeutic dose quickly and safely. Once they get to the therapeutic dose, they can then use our monitor to demonstrate compliance remotely without the the the daily clinic visits. It would be it's truly life changing for methadone patients, it would increase the chances they'll stay in treatment and escape this vicious cycle of fentanyl addiction. One of the compelling things about this market is that it's large and it's growing. Just the SAM alone is $5 billion annually. And we expect it to continue to grow due to the presence and the rise of illicit fentanyl based on the patient and the clinician feedback we've received. We expect adoption rates to be 50%. Eventually, that's five zero. Similar to continuous glucose monitoring, our business model is based on reimbursement at $5,000 per patient per year. And because it's so expensive, and patients drop out of treatment, the business case is very, very compelling. From a go to market perspective, it's very straightforward. There are only 2000 methadone clinics in the entire country that are authorized to administer methadone. Of those 600 are operated by the seven companies that you see here listed. The reason that you see community medical services highlighted is because we already have multiple programs in progress with them, their Chief Scientific officers on our advisory board, there'll be our clinical trial partner and expect them to be first in line for early adoption. Put this into context for us to reach $100 million in annual revenues. It takes 20,000 patients, which is a little bit more than 10% of the 200,000 patients that you see here. Now clearly, methadone monitoring is the right place for us to start. But you want probably wondering, does it also work for other medications? And the answer is yes. And let me show you how. There's a an electrochemical assay that's gets cold That's our secret sauce gets coated on these tiny little micro needles that are pain free. That assay, be oxidation detects certain analytes, including methadone, as well as other analytes. The sensor then transmits that information via low power Bluetooth to an app patient app goes to the cloud out and then it gets distributed to clinicians. We identified this need to monitor methadone late 2021. Since then, we've migrated our chemistry from screenprint electrodes to wire sensors to micro needles, which is where we are today. Later this year, we're going to conduct conduct our first in human studies, we've conducted a series of n and one studies before. And as you can see that over here, the sensor how small it is, when it's applied to a human being, I can attest personally that it's, it's pain free. And then we will, we will then convert our clinical prototype to the wearable version, which will go to market with subsequently. In 2022, we conducted a groundbreaking study with methadone patients. And in that study, it's never it was the first of its kind. In that study, we confirmed that methadone is actually in human interstitial fluid. It's it's in the levels are higher after patients have taken a dose than before they took the dose. Okay, we also established that there's a direct correlation between the methadone levels, in ISF and in blood. And what you see on the on the right hand side on the left hand side there right for you is that the our in vitro sensor performance covers the range of what we expect to see in vivo based on the clinical study that we've that we've performed. So far, we've been incredibly capital efficient, thanks to non dilutive funding. We raised a seed round in late 2020, to form a series of med tech savvy funds, including Cove new fund medical device of tomorrow and chemical angels, we use the proceeds of those of that raise for a very, very productive 2023, which has gotten us ready for our first in human study later this year. Once we complete that first in human study that will see us through our Series A, which will get us to our next value creating milestone, which is regulatory clearance. Many of you know that most of you know that device companies are usually acquired post regulatory clearance, we'll have that opportunity as well. But we certainly as you get further to the right, the potential exit becomes much, much more lucrative. There are already companies in the market with solutions that monitor methadone, but none of them well, some of them monitor methadone adherence, but none of them monitor adherence and informed personalized dosing. In real time, our solution is unique. Because it does both. It's also pain free and convenient. If anyone would try to enter our space, they would have to try to do it in a different way. We filed several patent applications to protect our methods to prepare the device as well as our assay. And the company owns all the IP outright. There are no licensing fees or royalties. We're well on our way. From a quality management perspective, we this is going to be a de novo clearance process based on our FDA pre sub meeting. And we've already talked about the compelling business case for reimbursement. Because it's just so expensive when patients drop out of treatment. To make this happen, we've assembled a team of experts in med tech chemistry and engineering as well as clinical expertise. From the logos on this slide, you can tell that we're leaning heavily on people that have done this before, primarily in the glucose space. Personally, I've already talked about having been part of multiple exits together, we have the right team to make monitoring and medication levels in real time a reality. We've assembled a heavyweight Board Advisory Board, we they'll provide us clinical regulatory, legislative and commercial guidance. I especially want to highlight Brenda Davis, over here. Brenda has been a methadone patient for 27 years. And she is a patient advocate our company DNA is is embodied by patient Centricity and certainly having her on our board and body reflects that. In closing, we're fulfilling and addressing a very high unmet need with a very elegant and highly scalable solution. We have a fantastic team that knows how to execute. And what is even more compelling for you as investors is that you're making an investment in a life changing solution for methadone patients that has a positive impact and the opioid crisis, and which is a national epidemic. So with that, I'm going to conclude Thank you