Nikhil Shah Presents Nephrodite at LSI USA ‘23

Transcription

Nikhil Shah  0:05  

Thank you. Good morning, the average patient on dialysis will spend over 600 hours a year in a chair, tethered to a machine with the goal of cleansing their blood of fluid and toxins in order for them to survive. My name is Nikhil Shah and I'm the co founder and CEO of Nephrodite. And we're developing an implantable, continuous functioning implantable and wearable device that would allow patients to experience some of the things that they greatest, greatest, most greatest search for which is mobility, portability, improved health outcomes and quality of life. This matters to us, because myself and my co founder Hip Wynn, have deep bench experience in the transplant space. And as surgeons, we took care of these patients for many years. And we understood the needs that patients had in terms of the risk factors associated with their disease, the complications, the side effects, and it was very impactful for us both, given that plus our experience in medical device. Throughout the years, we were able to put a team together that we really think is pretty fantastic, in terms of the r&d, IP, regulatory, and the entire effort that it takes in order to push something like this forward. Our inspiration came from a young lady who was actually one of our patients who was suffering from kidney disease and ultimately went on dialysis. And it was many years in and out of the hospital with complications, failure to thrive, depression, really, really emotionally battered, and battle hardened. And she waited years for kidney transplant, and ultimately got them but but continued to reject them because of the issues of all the years on dialysis. But what she expressed to us was the fact that she was always sick, always tired, she was scared. And you can imagine big needles coming at a young patient, and all of the things of going in and out of a hospital. She just wanted to be normal. She wanted to be on the playground wanted to have playdates. And this impacted us. And as we continue to look at the industry, we know that that the impact is tremendous. Overall, this is a huge, huge burden to Medicare. There's a number of patients that are continuing to live longer. And this continues to impact not only every patient provider, but also the health system alone. And so we believe that with the changes coming with the federal mandate in 2019, to push forward kidney health, we believe that these are all forwarding new innovations such as ours. When we polled patients and asked them about what their biggest issues were with, with their condition, they really identified three main areas that they had problems with. One was the intermittency of treatment three times per week, going to the dialysis center complications in and out constantly worried whether their graft or their official was going to fail and have to go back to the hospital and get a central venous catheter, all the mental health issues that almost always don't get addressed. These were issues for patients. The second issue that they identified was the access. And we've heard a lot about that today, the access in their arms or the PD catheter is appearing to catheters in their abdomens are frequently blocked, obstructed or subjected to infection, which then causes a whole series of complications. And then the third thing that they identified, which was perhaps most impactful was the fact that they had a lack of mobility, they were constantly tied to a chair, whether they were at home or in a center, and they would trade they actually said this, they would trade 10 years of living dialysis as they currently do for just one year of being able to live more free and independent. So our inspiration really came initially from a heart device and LVAD, a left ventricular assist device. And as we saw this device, we started to ask the question, could we be the LVAD for kidney? Could we develop a continuous functioning device that could at a minimum be a bridge to transplant perhaps at most also be a standalone device. And so what we wanted to do was meld what we knew was working for patients on the peritoneal dialysis side, the fact that they could be at home and that they could be more independent, but less efficient right on on the PD side, but take hemo dialysis, which we know was very efficient functions like our kidney, and can we blend those two concepts together. And what we came up with was this depiction of our device. So what you can see here is our device is about the size of a small child's fist. It's a three chamber device with membranes inside. Those are proprietary to our company. The device would be sewn directly to the vascular space, we want to stay out of the abdomen, so the extra peritoneal space of the pelvis, we would go directly to that and the central chamber is the blood chamber. This would allow and facilitate flow through the body's own physiology through The heart rate and cardiac output with blood flowing continuously through our device. connected on either side are two chambers that are the dialysate chambers. And their tubing that exits the dialysis chambers and exits the body to connect to a wearable. And here you see a vest, there could also be a backpack, and that fast would be powered will have a power source, it would also have a reservoir. And that reservoir through a micro pump on the wearable would pump the dialysate into the device and allow for the exchange of not only toxins like urea, but also for water exchange. So what have we done so far? Our URL in our early stages of non delusional funding where we are in our discovery phase, we took our efforts to say Could we compress a large dialyzer into a small device that size of a small child's fist? Could we surgically implant that? Would we be able to have the efficiency of dialysis over time, and we were able to show that through our early studies and proof of concept, we then took that and did more advanced testing with blood on the bench, both human and animal blood to see if we were also meeting the same criteria. And ultimately, we went into sedated animals acutely, and put our device in those animals to see if we could efficiently work our device have resilience as well as function filtering and water exchange. We have three phases of development Currently, our implantable device, the hemofiltration device is where our IP mostly sits, we have a second phase that we're working on the wearable, whether in case of this case of vest or a backpack, that would also include the reservoir or micropump. And then we have a third effort that goes on in our r&d that's dedicated solely to the electronics, the sensors, all the data acquisition, as well as remote patient monitoring. We absolutely feel that that there are other there are other innovations in this space. But there really has been a paucity of innovation in the Renal Care space. And all of us in this space agree upon that. And so we really feel that since the 2019, push forward from the federal mandate, that this is really an opportunity for us to not only get together but to collaborate, we wanted to address a continuous functioning a device, one that eliminates access problems, specifically in the arm of the abdomen, that allowed for ambulatory issues and portability for patients. As we've done that, we have a patent estate that we that we have that currently involves three core families. But what we've really done with outside of the six issued patents and one on the way is that we really started to address our future in generational IP filings, and have been really excited about that as well. In terms of our regulatory approach, we have a full regulatory consideration that we put forward, we are really using the LVAD experiences to mimic ours as it is a vascular device and it's an implantable one. So we've looked at both of adspace as well, there are other areas to really map out our direction in terms of regulatory approval. While we understand that this is a class three device, and obviously it would be a de novo application as we don't feel there's a predicate device out there. We do feel that there's enough out there in terms of the pathway that we've described, as well as the push federally to get us through in terms of CMS and the FDA. We have validated some key assumptions by looking at the space not only from the cardiac, implantable side, but also home haemodialysis, and other PMA devices that have been out there. And we feel that we've really taken that into consideration as we estimate our funding needs, with our milestones and all captured with our relative timelines. In terms of where we're headed next, we have last year raised a seed round we're currently raising a Series A and that would be to get us to MVP and we look forward to talking to people about our journey along creating a fully implantable and continuous functioning renal replacement device. Thank you