Farrukh Usman and Rod Kenley Present Byonyks at LSI USA '23

Byonyks mission is to provide affordable dialysis care to millions of patients worldwide suffering from renal failure.
Speakers
Farrukh Usman
Farrukh Usman
Founder & CEO, Byonyks
Rod Kenley
Rod Kenley
Chief Innovation Officer, Byonyks

Transcription

Farrukh Usman  0:06  

Yeah, hello everyone my name is Farrukh Usman and I have Rod Kenley with me here. We are revolutionising that space of peritoneal dialysis, we are inventing new devices as well as we are inventing new therapies inside the peritoneal dialysis. The reason is, you will ask why we need a new form of dialysis or why we need new machines. Let me tell you a few interesting facts. Number one, people are dying all over America and abroad, your likelihood of survivability on dialysis is worse than cancers. And second thing I want to tell you is, in today's world in 2023, would you believe we are putting toxins and acids into human body and expecting a good outcome? Rod can we will explain it to you? What does it mean? I have personally lost four loved ones. That's why I started this company. And what do you what what makes us unique to solve this problem 62% of Dallas machines which are getting sold in America, in terms of peritoneal dialysis, have major contributions within our team members routine, me rod and other team members. So we are here to revolutionize this. And there are three major opportunities out there that we'll be covering. So let's see how treatment gets done. One is called hemodialysis where you put two tech needles into the arm and goes to the machine and comes back into the body and other ones called peritoneal dialysis or PD, in which you put salts, electrolytes and sugars into the peritoneal cavity and take it out. So these are the two forms of dialysis. In US there's a major paradigm shift. Let me cover that first. In US we it's a $44 billion industry with 7% growth rate 88% of those who will get dialysis in a data center. And we are investing $3.5 billion in a home hemo space, which is only 14% of the home market. And bionics is is placed at home peritoneal dialysis space. So why do we care about the small market because this 88% is about to shift, US government has decided to move 80% of its patients to home treatment, or auto transplant. That's why this market is about to explode. So it was doubled before that as well before this executive order, and that's where bionics is placed. Look at the global opportunity. It's $120 billion industry, with 35% of the world population still do not have access to peritoneal dialysis. and 120 countries do not have access to peritoneal dialysis. This is Chad Abdullah, he would have died without virus presence in that country. And we took our machine and saved his life. So our machine is portable, it works. And instead of being on human, we are on it. Instead of being on animals, you're on humans, so we have raised $9 million. So far, we have built a factory, we have treating patients 1000s of treatment has been done. We have an r&d center in Chicago and one overseas, we have built a phenomenal team of eight engineers, and doctors and nephrologist we have to you with 13 for it five certification and approval in the first country. And this is happy patient that may get me out of the bed every single morning. And that's what we're proud of. So in terms of roadmap, we have built not just the first machine which is serving patients which has been developed the second machine is getting submitted to FDA later this year. And then this is the most exciting part of the project where we are bringing in world's first asset free and toxin free dialysis over to you Rob Kenley.

 

Rod Kenley  3:55  

Thanks for well as the person who instigated the commercialization of peritoneal dialysis in 1977, while employed Baxter and then developed the first portable cycler in the late 80s. I find it fairly gratifying that the US government is finally seeing their way clear to provide some very significant incentives to grow this home peritoneal dialysis market because it's really good for the payers for the providers and for the suppliers. While they don't find so gratifying and actually fairly frustrating, though, is how little improvement we've seen in the life expectancy of this patient population. And that is the subject of our third major opportunity improving the life expectancy and increasing quality of life of these patients. As for mentioned, the life expectancy the five year survival of dialysis patients is worse than most forms of cancer. And even though peritoneal dialysis has a 10% advantage over who hemo dialysis, we know how to do much better. It really revolves around the solution that's being used to perform peritoneal dialysis. This solution and its manufacturing process hasn't changed in the intervening 45 years. Although our knowledge of the problems associated with it has. When this product is heat sterilized, the glucose component contained there in degrades into several degradation products known as glucose degradation products. When absorbed into the bloodstream, they're converted into advanced glycation end products, which are toxic and exacerbate diabetes, and all forms of cardiovascular disease, which are major contributors to the death of these patients. Now in order to slow this process down somewhat, the manufacturers add acid to lower the pH of the solution. And putting that solution that acidic solution in in connection with the peritoneal membrane 24/7 365, causes that membrane to sclerosis or thicken over time, which impedes the ability of water to be transmitted through it, which is of course, one of the great needs when your kidneys fail. So eventually, these patients lose the ability to remove enough water to avoid congestive heart failure, or death, and they must either transfer to in-center hemo, dialysis or die. Now another big problem with the way this is manufactured is it's made in a plant and 800 pounds of this solution is shipped to a patient's home every month, along with many boxes of tubing sets and ancillaries, which consume a huge amount of space in their homes, and cost a lot to ship and deliver to those patients homes wherever they may live. Well bionics has two advanced development programs will address all of these problems. The first of those programs is a new, radically different cycler, that's miniaturized, it will be smaller, lighter. It's quieter, easier to use faster to set up and most importantly, much cheaper to manufacture, which will allow us to be very aggressive in pricing to penetrate the US market, and to provide a very affordable peritoneal dialysis system for these developing countries. Now, the second major development project is one that will completely eliminate these bags of solution and the toxins contained there in that module, we'll be one that actually makes the dialysate at the patient's bedside, by combining their tap water with concentrates, and doing a version of cold filtration, sterilization. and by so doing, we will completely eliminate the acid and the toxins which will reduce the amount of malnutrition and muscle loss and also the atherosclerosis and other forms of cardiac disease that translate into 52% of the reasons of death in this patient population. All combined, this will significantly reduce the rate of dropout in these patients. And we will be eliminating 120 million PVC bags 75 million tubing sets that now go into landfills which is of course, good for the environment. So let me turn it back over to you.

 

Farrukh Usman  8:36  

So we have built a team who know how to build peritoneal dialysis machines that have done that and change the nephrology practice multiple times in past and we're going to do it one more time. And in addition to that, we are already serving patients in South Asia. USA is next than Middle East and Europe will be our target. And here we are to Jeep to change and revolutionize this industry. Once again. If Is there any capital partners want to join us? We can talk Definitely. Thank you

 

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