Zach Berwick Presents TrueCath at LSI USA '23

Transcription

Well, last session last day, when they told me I was gonna be the closer I thought it was considered a compliment. So before we jump in, how many here have ever received an IV catheter? Don't be shy. Okay, a couple, how many times did they have to stick you? Four times? Wow, that's painful. Unfortunately, you're not alone. In fact, of the 33 million hospitalizations in the US each year, about 90% of them receive an IV catheter, of that 90%, about 50% or 168 million actually fail. Now, the consequences of this failure is extended hospital stays and the loss of vain for future use, in some cases, the inability to even treat the patient and overall culminating into an increase in treatment cost. So why the high rate? Why the reasons for such a high rate of failure? Well, there's actually three primary failure modes, infiltration, phlebitis, and occlusion. All of these failure modes are attributable to operator error. In fact, as the operator goes to insert the needle into the vein, because of the delay in the blood indication to the operator, they continue to advance the needle and perforate through the back wall of the vein. Now, what this means is now you have blood or infuse aids into the perivascular space, creating an inflammatory cascade that eventually leads to clotting and inclusion of the catheter. So really, the unmet need that we're talking about here is the requirement to provide single wall first attempt venous access independent of the operator skill level. And that's our mission at TrueCath, we want to create a safe and reliable venous access device that simplifies the IV insertion process to reduce complications and improve overall patient satisfaction. So how do we get there? Well, our solution is an automated IV catheter that reduces the burden on technique and replaces instead with technology. In order to accomplish this, we've got three buckets of performance. As mentioned, we have to reduce the reliance on operator skill, the need for assist devices, such as vein view, or ultrasound, which are cost prohibitive, and have not really gained much market adoption, and decrease the need for visualization of the vein. All that has to occur while maintaining current standard workflow, right? We've seen numerous technologies where they're a great solution, but they're disruptive to workflow and they they don't get adopted. And we're confident if we can achieve these four pillars, we'll be able to decrease nursing time, reduce complications, and improve patient care to collectively lower patient cost. So here's a short video on how it works. Before inserting the before inserting the catheter, you press a button with actually which activates a vacuum in the back of the housing, you release that once you're under the skin and the skin creates a vacuum seal around the tip of the needle, you then advance the needle according to standard clinical technique. And what's the tip enters the vein and senses the positive pressure in the vein, a little bit of blood is withdrawn into the needle, which breaks the vacuum in the back of the chamber as shown there. When that vacuum breaks, it pushes forward a spring, which advances the soft gel catheter into the vein. Now there's all curl occurs really quick and about 1/60 of a second, which is much faster than your normal human operator response time. The beauty of this is actually in the simplicity of that core mechanism, which is protected by several US and world issued patents. And another nice feature that simple core mechanism and we've already done this is that we can integrate it into current PVCs or peripheral IV catheters. One of the big steps and based on where we are in the early feasibility phase was to robustly challenge the performance of the device. So shown here is a couple of our preclinical animal studies. On the left graph, we're comparing the first attempt second attempt and overall success rate versus current market leading devices. And when we're showing significant improvement, and all in all of those parameters, averaging about a 70% improvement. And then when we dichotomize the data between the expert and the novice operators, we see actually that that improvement is largely driven by the novice operators. And this is a really important finding because the majority of people who use or placed IV catheters fall into that novice operator category and falls in line with one of our value propositions, which is we're making good nurses even better, right. So if we look at the improvement and that 75% improvement and success rate, we're talking about a reduction in the number of catheters needed, and an overall increase of about 79 million IV catheter successfully placed each year. And being a good steward of a startup company actually rolled up my own sleeve, as you can see here in this video, and as you advance the catheter, you can see it hits the vein. And once it senses that vein, it automatic glean inserts it providing that very important single wall first attempt stick. Really important, especially in the early stage with any product development is you have to look at your points of differentiation against market predicates and compare them to what's important to the payer and the provider, right. And so that's what we're showing here on the left figure, this is a radar graph, where our value proposition is really increased in the first attempt success rate that's driven by that core mechanism. That's rapid responding faster than you can with a normal operator time. And then also, because you're reducing the number of catheters, in fact, on average, it's 1.7, we're taking it down to 1.2. You need less catheters, and less catheters mean less nursing time as well. And that reduces overall procedural costs. So when we surveyed some of these performance features across both providers, and payers, all of these differentiating factors fell within the top three list of what it would take for them to convert over to our device. So this gives us at least early on in the program, a high degree of confidence for adoption. So the peripheral IV market can be broken down into several segments. The first is the acute care that represents your largest this is your inpatient outpatient settings. Unfortunately, within the setting, a lot of this specialized in house IV access teams are being reduced for cost reduction measures. And then we have the alternate care, which is your infusion clinics, home care and nursing homes. This segment doesn't even have access to advanced training or equipment was really unique to as a specialized care. In fact, this is probably the most underserved segment because you only get one shot on goal, right. And that one shot on goal if you miss it, that could be the difference between life or death. And what's alarming to even within the pediatric population, that 50% failure rate that I mentioned earlier, is increased to 70%. So think about that. You take your kid and to get any he has to get an IV catheter for whatever reason, there's a one in three chance that that might actually be successful. And that's painful. I mean, in my mind, that's unacceptable, and we got to do something about it. So those are the three segments. Our initial target market is within acute care that represents about 80% of the overall US market generating foreign 40 million in revenues. But we do expect to be able to expand into these other tabs, including the global market, which is projected to increase from the current 5.4 billion to 18. Point 8 billion by 2032. Our current business model is pretty standard one I'm sure you all have seen it before. The market is really mature and rather concentrated with a couple big players at the top. But because of those points of differentiation, and what we think we can achieve with a 7.3% market share, and your five revenues of 355 million, we're expecting probably an early licensing or acquisition following FDA clearance, which is our current roadmap right now. So early on, we've focused on really demonstrating the feasibility of the device and de risking it as well as protecting that core mechanism. Following that process optimization that some of its been supported by different SBIR awards, so we've been largely bootstrapped and non dilutive to date. But we're at that point now we're designed for ease and we're moving into verification and validation. Which brings us to why we're here today. We're trying to raise two and a half million in capital, early stage capital support those product development activities. Our team is pretty broad and background from clinical to engineering to product development. So definitely have the right skill sets to push this forward but also looking for the right partner to help with it. And I'll be happy to chat with anybody after this. Thank you.