Osman Khawar, Diality - Home Hemodialysis Machine | LSI Europe '22

Transcription

Osman Khawar  0:03  

So Diality is a med tech company based in Irvine with a mission to develop solutions to help patients with kidney disease. We need to understand the market a little bit and understand the the opportunity here the United States 90% of patients are getting dialysis and haemodialysis Center. This is a brick and mortar center where patients go three times a week to get dialysis. Dialysis is done normally within four hours. So high blood flow rates and dialysate flow rates a very powerful machine that does this. The brick and mortar is of a large space 10 15,000 square feet and probably you know a large proportion that is taken up by a water room which is developing dialysate in real time. The growth in that space is something in the order of 5%. And that's what the vast majority of her dialysis done. The other extreme is home haemodialysis, which is a space where a patient is getting dialysis at home. And they don't have a water room industrial scale. So they have a tap. They're getting dialysis either three to five times because of the lack of power of machines this device in this space. It's only really 1% however of of the market. So very few out of the 600,000 patients we only have about 10,000 patients getting home haemodialysis the growth in the incentive space is three to 5%. And the growth in home haemodialysis is 385%. So that's where the market is going. And it's going there. Because as we know, and as we've heard here, everywhere is moving outside of institutional spaces and and moving towards the home. So we have developed something that is able to, to play in the stage of of change that is happening in dialysis, and machine that is user centric. That is simple to use by any layperson, but it's powerful enough to play in the incentive space in every stage in between. We're on track for a 510 K submission of the device that I'll show you here. Next year. We've had to pre subs This is a predicate submission. And we see it as a low risk regulatory strategy. And we did a series B two in February. My team is made up of people who have either been in production of dialysis devices in the past to commercializing devices and our CFO was kind of Amgen, we have an experienced team. And I think we're really excited to bring this to the market. dialysis machines I think of in med tech is one of most complicated devices, you can go. And I wouldn't suggest for anyone to do this as your first device. But that's where we are. There is water coming in at the back here. So tap water goes into the machine, the gray area that you see is a water system like that water room that I talked about. We're taking tap water and we filter it, we purify it, we heat it up, we get pure water, we add concentrates to it to make a very specific chemical fluid called dialysate. We do this in real time. Water's coming in real time. And it's outputting at about 600 CC's per minute to have that peak performance. The front of the machine is where the blood and the dowel sit interface. So you've got needles in the patient blood is coming out it's going to the front of the machine. And the blood and Dowsett are touching there in the blood is going around 500 CC's a minute. To make this usable, a couple of things industrial designed to make sure it's not as intimidating as other machines that you may have seen. There's a cartridge that the patient pushes on and use a handle to connect. And then most of the interface then is with a GUI that we see in the front here. And as we continue to develop this connectivity is very important. So you can get that data, take it up to the cloud and start to improve dialysis, which right now has mortality rates of 12 to 13%. United States. With that usability and the power of the most traditional device that we're using center, we now open up the market to play in all the transitional spaces that occur. So we can see both hospitals, nursing facilities, dialysis units. These are all places we can be as far as eventually in the home. And on the modality of Dallas we use it's there's more than just haemodialysis probably about 12 Different kinds of therapy. We have compacted all of that in one device so it can play in any space with any user. Our first 510 K submission is allowing us to use when when approved will allow us to use the device in all places but home. We're expecting to place that submission in next year. We then take the device through a clinical trial, which is about 50 patients taking the device in the home, being trained on it to use at home and then using it at home. And then we take that same device back to the agency and get clearance for the home space. The dialysis market is really a very very dynamic space. It hasn't been for 25 years but the last three years have been extremely dynamic. There are lots of things going on. It started in 2019, there was an executive order by the Trump administration to increase the amount of patients who were getting a transplant or getting home dialysis to 80%, which is very lofty and probably unachievable. But since then there have been some concrete things that have happened on the payer side, there is movements called Tiffanys, which is extra reimbursement for innovative machines in the dialysis space, there is enrollment in Medicare Advantage. So in CMS, you're an uncontrolled expense space. But when patient Medicare Advantage means that people now care about cost and when they care about cost to either try and decrease hospitalizations, or get patients home. And they're new models like C KCC, etc, ICC all of these acronyms that are really getting patients and driving patients to be in the home environment and helping her pay for that. We spent four years developing this product, we are now in our final verification validation space. We will be completing that over the next quarter or two, and then take the device to the agency next year. We have a contract manufacturing partner for the disposable and a separate one for the device, which we recently announced. And her has started some of our verification validation on the external side. So we're excited to complete this product and bring it to the market. We did do our v2 in February of 24 million, and we're doing a C series next year. And for those that are interested, we'd appreciate the conversation. Thank you