Video Transcription
John Erbey 00:01
Good morning. Thank you. As you said, I'm John Erbey. I'm the founder and CEO of Roivios, and we're here to talk to you today about our renal assist device. So over the next nine minutes, I'd like to get across four things. One, we have a massive problem that we're trying to address. I don't think anyone will dispute that kidney disease is a big problem, both economically and clinically. The solution we have is a very elegant, simple solution, but what makes it unique is the fact that we thought contrary to conventional wisdom on how to actually approach the problem, and that's led to some wonderful opportunities for us. We're gaining traction. We've just received FDA breakthrough designation. We're negotiating our pivotal trial. We have clinical data from across two different populations in two different geographies. And because we thought of the world differently than everyone else, and we took advantage of that, we now have over 100 issued patents across 29 countries, including 20 in the US with multiple families. The investment potential here is enormous. There is a $105 billion TAM that we're going after. These are the CKD patients who are admitted to the hospital. We have a high-margin disposable, and because of our tax-efficient strategy, we have an opportunity to bring down significant earnings after tax in a relatively short period of time.
Let's talk about the problem. So we're talking about the 35 and a half million patients with CKD. These patients over-index to the emergency room, they over-index to the hospital, and they over-index to surgery, meaning they generate 14 million admissions every year. And not only do they generate more admissions, they generate more costs, and they have worse outcomes. That includes nearly three and a half million visits to the ICU, and those visits to the ICU create an opportunity because those patients generate 76,000 new dialysis starts every year. Once you start dialysis, it's generally not likely you're coming back from that. So we have a moment in time with a big opportunity, sort of shooting fish in a barrel, to be able to change that trajectory for, you know, literally millions of people.
Our approach was to go at the collecting system. So we deliver a mild controlled negative pressure into the collecting system. That negative pressure, through the fluid column, Pascal's law delivers a force to the backside of the filter, the glomerulus, which immediately reinstates filtration. And once filtration comes back online, all of the beautiful work that the kidney needs to do to re-establish and maintain the body's internal environment comes back online. The mechanism is simple. The filter requires a higher force above than below. Conventional wisdom has been focused on either pushing more blood into the kidney or pulling more blood out of the kidney. Both are limited because they are in circulatory contact. You have both thrombotic and infectious risk, but you're also subject to auto-regulation. The kidney will fight you on that one because of the way it's evolved. We approach the collecting system so there is no auto-regulation. And we've demonstrated in multiple species and in multiple indications that that effect is durable and sustainable.
The value proposition is simple. You allow the kidney to help with recovery. You get the patients out of the ICU faster. The doctor wins, the patient wins. The hospital turns the beds faster, and it's a win-win-win. The business model is direct. We're going razor and blade. Our goal is to sell as many of the disposable units as we can; they're single-use per patient, per admission, and there is a simple bedside pump that's required to enable that, but that's reusable. We've been ISO certified since 2020; we're in the breakthrough designation, as I said before, and we're leveraging existing CPT codes and the DRG, so we've got an opportunity to enhance those, but we're running at it from a running start. Rather than trying to boil the ocean, we're going after a very high-risk, well-identified population through cardiac surgery, so patients undergoing an art procedure on pump with CKD and an EGFR of 15 to 60 have horrible outcomes, and it's through no fault of the surgeon. So we're going to leverage that advocacy of helping the surgeon with his quality scores to get in the building, and then leverage the intensivist to spread throughout the ICUs as we move from indication to indication.
The initial indication we anticipate will be a de novo; subsequent will be 510(k) off the predicate. There's a lot of activity in AKI and Cardiorenal. Like I said before, we thought of the world very differently than everyone else. So we're going after the kidney rather than trying to push more blood into the kidney, pull more blood out of the kidney, or shift fluid around within the body. We think we have a distinct advantage over all of those. We've assembled a team that's been around the block and knows what they're doing. Brian was a renal physiologist before he went into industry. He's got a 15 and 0 record with the FDA. Jacob Pop just turned 30, and he has 100 issued patents under his belt. We've built the team and the advisors. As the data evolves, the interest among the academic community is growing.
The financial projections— all forecasts are wrong, but what we've laid out here is an understanding of how we're going to approach the market and what it means to be successful. So these numbers get pretty insane pretty quickly. As we move towards 2029 and 2030, we're seeking $20 million. That $20 million will carry us through our pivotal trial into the filing, and then we'll need a subsequent raise of $35 million to build the team if there hasn't been an exit by that point. Juxtaflow is just the first. We recognize we don't have the resources to do heavy lifting on PMAs, but we have plans for two additional products that will take us out into the community, including our renal assist device that is a pacemaker for the kidney. So imagine presenting to the hospital. The reason you're in the hospital is your kidneys aren't doing their job. You've got CKD, you've been in the hospital twice in the last year. Let's give you a technology like a pacemaker that can support your renal function 24/7, 365. Thank you. Applause.
