Nikhil Shah, Nephrodite - Spotlight Interview | LSI USA '23

Transcription

Nick Talamantes  

Nikhil, thank you for joining me at LSI studio. Tell me a little bit about what you're doing at Nephrodite.

Nikhil Shah  

We are creating a, I guess what could be called an artificial kidney of sorts. It really isn't an artificial kidney. But it is a continuous functioning filtering device that would work like an artificial kidney.

Nick Talamantes  

Tell me a little bit about how you guys came up with this idea for an artificial, not artificial kidney?

Nikhil Shah  

Absolutely. It happened sort of by accident, myself and my co founder, professor, Dr. Hiep Nguyen he was at Harvard at the time, we were both visiting professors at the German Aerospace labs and outside of Munich. And we had seen some incredible technology, which was heart failure pump, a heart pump technology. And we asked ourselves, that's great for the heart. But could we adapt that to work like a kidney? And as we engage those very brilliant scientists and engineers, who said, we could probably do that, we started on our journey of of making this device.

Nick Talamantes  

So tell me then a little bit more about what this device is. What's it called?

Nikhil Shah  

Well, it's, it's called the Holly Device. And our company's Nephrodite, which kind of is a cheeky play on Aphrodite. But we named it Holly, really, after one of our patients who was was a beautiful young lady who had been plagued by renal failure and ultimately had to go on dialysis. And she was battle hardened. If you can imagine a child that has to get needles and in and out of hospitals and all that stuff. And what she told us was she was scared. She told us that she was always in pain. And what she said to us most profoundly, was that she wanted to be normal. And we asked her what that meant. She said she wanted to be able to go play with her friends and not miss playdates. And so we named it the Holly.

Nick Talamantes  

That's a wonderful story. So how does your device compared to maybe hemodialysis and peritoneal dialysis today?

Nikhil Shah  

It's unique in the sense that we tried to take the best of what patients liked about peritoneal dialysis, sometimes called that PD. And what they liked about it was that they could be at home that they could manage their care of themselves. What they didn't like about it was that there, they have to fill their abdomens with fluid, it frequently became bloated, it was uncomfortable, and they would get infections. And that was terrible for them. But they liked the mobility part of being at home and independence on the haemodialysis side, that was more efficient. It allowed patients to work like a kidney, but they were only doing it three days a week. And so we said let's take the best of haemodialysis and the best of peritoneal dialysis based on what the patient's like. And let's make that into a device.

Nick Talamantes  

That's brilliant. So it's my understanding that you have 2.6 million patients today with hemo dialysis needs and 90% of them are using hemo dialysis versus peritoneal dialysis, peritoneal dialysis PD. It's more convenient for them. But it sounds like there's also a lot of education and upkeep and requirements for them. That is difficult. How do you guys how are you guys kind of threading that.

Nikhil Shah  

So you're absolutely correct, by the way, and those numbers are spot on. And the problem is, is that those numbers are only getting more magnified. You're absolutely correct. Also that it takes a village to help a patient manage their peritoneal dialysis because they have to have fluids delivered to the house, they have to have resources to the house, they have to be willing to do it themselves. Remember, these patients are feel sick, they don't feel well, a lot of times they need resources at home. And a lot of patients don't have that. Interestingly enough, PD is more accepted in Europe than it is in the United States. So we do profoundly more haemodialysis the United States than we do in Europe, our device would be surgically implanted. It's about the size of a small child's fist, and it would be surgically implanted. So it doesn't come out it's going to be inside it's going to continuously filter blood. But then there'll be a portion where a tube comes out of the device and it connects to a wearable where fluid would be going in and out of the device. What patients would have to do with our device is just change that bag out like they would in peritoneal dialysis. And I believe that that patients can do that they can be taught to do that. I don't think our device early on and it's first generation will be for everyone. But But my hope is that generationally as we get betterit will be a

Nick Talamantes  

And you're going to see then a market shift hopefully of people switching from hemo dialysis to this more accessible fusion of both of these technologies with yours.

Nikhil Shah  

Not only would hope for that, I mean, it sort of makes sense. It would reduce costs, it would reduce the burden of patients going to a center but it would also reduce the amount of work even with home haemodialysis, there's a lot of work to do and a lot of teaching. And we found that we found that patients, they don't like being confined to a chair for hours at a time. And that happens whether you're at a center or at home. So our solution would give patients the ability to move around.

Nick Talamantes  

That's incredible. Why don't you tell me a little bit about where you guys are at right now in terms of the clinical development? Are you in human yet? Are you preparing? Give me Give me a sense for that.

Nikhil Shah  

Absolutely. You can imagine maybe taking a big dialyzer that tries to dialyze someone's blood in three hours, and condensing that down to a small device that would be implanted. It was a, it was a massive task for us. And we spent a lot of time in in testing and prototyping. And so where we are right now is we have we have a full working prototype. We've tested it in animals. But what we need to get to now is making the human grade, the human grade prototype. And so our next journey is to start building that human grade device that we will ultimately test first and animals and then in in humans.

Nick Talamantes  

That's incredible. When do you think this is going to happen? What's the roadmap sort of look like that?

Nikhil Shah  

Absolutely. We were guessing and hoping 18 months, and that's with a little bit of padding. And so to get to that minimal viable product, we're believing that will be there in about 18 months. And then we'll start all of the necessary trials.

Nick Talamantes  

So I was doing a little bit of homework. And I'm not aware of any other companies developing a device that is implanted that combined hemodialysis and peritoneal dialysis. Are you guys to your knowledge? Is there anyone in this market that's doing similar technologies? Do you guys are you pioneer?

Nikhil Shah  

Well, I, I don't know that anyone's put it together the way we have. There are certainly some other great innovations that are farther along in this space, but but no one that's working on a continuous kidney replacement device like we are. And that makes me happy in the sense that we're not really competing with with others, I think there's a huge opportunity for us to collaborate with some of those other folks out there, and really bring a meaningful device to the market.

Nick Talamantes  

Are you finding a lot of excitement when you're collaborating or seeking partnerships with other figures in the industry or with key opinion leaders? Is there a lot of excitement to know more to join up? Or how's that going for you guys.

Nikhil Shah  

There is a huge amount of excitement. I think there's a lot of pause. When we look at the Renal Care space, there's been a paucity of investment over time, unlike the robotics market, the neuroscience markets, the cardiac markets. And so so we're really trying to impress upon people that the space is changing, there was of interest in in the summer of 2019, there was a federal mandate pushing forward, American Kidney Care Health, and we're really, we're really pushing that forward in terms of using that as a as a, as an instigator of of our collaborations.

Nick Talamantes  

Yeah, I completely agree with you. And I sympathize with the cause, you know, it's my understanding, this is a massive economic burden on our society in the US here, worldwide, there's hundreds of 1000s of patients in the US that are hoping to be on the receiving end of a transplant list with very few of them each year only receiving it. So what you guys are doing is really bringing a new hope to these patients that are struggling with a condition that there's really not a lot of great options out there for them today. And there's a lot of risks and morbidities associated with that. So it's impressive what you guys are doing.

Nikhil Shah  

I appreciate that.

Nick Talamantes  

So tell me what brings you to LSI this year.

Nikhil Shah  

Our first visit LSI was a few years ago, we kicked the meeting that year was in May, and it was I think, at the end of COVID are sort of aligned with COVID. And what a great opportunity. It is a it is an area where it's investors, it's bankers, it's other entrepreneurs and innovators. And, gosh, I couldn't imagine a better environment. And so when the opportunity came and the timing worked out, I wanted to take advantage of it.

Nick Talamantes  

That's fantastic. You're presenting you said today.

Nikhil Shah  

Today, that's right.

Nick Talamantes  

All right. You feeling warmed up now feeling warmed up, ready to go. That's good. I'm glad that I could help out a little bit. Is there anything else you want to maybe share with us in our audience about what you guys are doing?

Nikhil Shah  

Every time we meet a patient that's on dialysis or we meet a family member? They keep asking us you know, when are you going to be ready? I wish we could be ready tomorrow and as soon as possible. We love the support we've been getting with to your point earlier or I don't know that everyone knows that they know that dialysis is bad and the burden of kidney disease is bad. But we would love to get the word out more. And with your help. And today and everything else, we really want to get the word out that we're trying to make a difference here. And I think it's going to be a collaborative effort for us. We're going to come out there with our end product, that's going to be an amalgamation, if you will, of several of us getting together and really putting all our efforts into commercialized device. And I can't wait to see that and I can't wait to tell you about it next year.

Nick Talamantes  

I can't wait to hear more about it. You know, you guys are embarking on a noble mission helping all these patients, as I said, bringing them hope. And over here at LSI we are championing for you guys, we're rooting for you guys. So I wish you all the best of luck. Appreciate that. Nikhil, thank you so much for joining me here in the studio.

Nikhil Shah  

It was my pleasure.