Nyra Medical | Murali Padala, CEO & Founder

Nyra Medical is developing an image-guided, catheter-based intervention, called the cardiac leaflet enhancer (CARLEN), for the treatment of mitral and/or tricuspid regurgitation in heart failure patients.
Murali Padala
Murali Padala
CEO & Founder, Nyra Medical

Murali Padala  0:00  
Good afternoon. Thank you very much for the opportunity to be here. I'm Murali Padala. I'm presenting Nyra medical, which is developing a simplified transcatheter intervention for mitral and tricuspid regurgitation. So heart failure is a very large problem, and I don't need to really reinstate that. But it affects about 6.5 million Americans and 85 million worldwide. One of the hallmarks of heart failure is that the failing heart enlarges over time, meaning it increases in its size becomes quite popular. When that happens, it starts deforming some of the valves that are attached to it within the ventricle causing them to leak. Leaky valves are not good because leaky valves tend to reduce the efficiency of the pumping action of the heart, which increases the metabolic demand on the heart and further accelerates their failure. About 45% of the heart failure patients have a heart murmur or leakage of the valves, especially of the mitral valve on the left side of the tricuspid valve on the right side.

Why is it important to focus on these two conditions is that patients who have mitral or tricuspid regurgitation tend to have a mortality rate of about 70% within five years compared to those heart failure patients who do not have these valvular problems. Not only are they dying earlier, but during their time, the hospitalization rates are quite high from decompensated heart failure, which reduces the quality of life of these patients, but also increases the financial burden on the health care system. Traditionally, medical therapy various types of heart failure drugs have been used for managing these conditions, but they have not really shown any survival benefit. Open heart surgery for repairing or replacing these valves can be done. But these patients are often too sick to perform cardiac surgery in them. So emerged the field of transcatheter image guided mitral valve repair in the beating heart where you can deploy devices at the end of a catheter, so that you can repair the leakage of the valve. There are two technologies which have pioneered this field now developing a system where you can pretty much get the two leaflets together where the leakage of the valve is. One is the Abbott mitral clip system, and the other one is the Edwards Pascal system. These technologies have succeeded quite well with about 100,000 implants to date, and several US centers which are now very well adept at using these technologies to perform these repairs. And it is now a approximately a billion dollar market per year in revenues. Then why are we even creating another technology? Well, this is an echocardiographic image from the same patient. As that mentioned previously, the tissue bridge that is formed between the leaflet by these devices works in the systolic or the contraction phase of the cardiac cycle, but in the diastolic or the filling phase of the heart cycle, it actually creates an obstruction.

So, these technologies can be used in very favorable specific anatomies to get the most optimal result. They tend to create wild stenosis over time, and neither mitral clip or Pascal or forward compatible, meaning that if the valve regurgitation was to recur again, you typically cannot do anything in these patients. So what we have developed a simple device called the cardiac leaflet enhancer, what it does is it creates a bump on one of the native heart valve leaflets. It clips onto the leaflet and creates a bump. So why is it important to create a bump where the leakage of the valve is, what it does is when the bump comes into this coaptation are closure of the valve, it covers the gap and enables correction of the valve leakage. But since the device moves along with the native valve leaflet, it does not create any form of stenosis of the valve in any manner. And you can attach this to any part of the valve either that one anterior leaflet or the posterior leaflet in the mitral valve or even the septal leaflet in the tricuspid valve. What this allows is not only correction of the valve leakage, but it does not create any side effects and makes it highly forward compatible with any other future technology that you would want to use in this patient. So this is an animation and I'll walk you through it the device is mounted onto a delivery catheter and traditional imaging is used to assess where the leakage of the valve is following which we select an implant of the right size to deploy into the patient. The device is mounted at the end of a catheter that is inserted through a very small incision in the groin, through the femoral vein, and then once in the left atrium, we pretty much steer these different catheters to get the implant towards the valve. And with ultrasound guidance, we grasp one of the leaflets where the leakage of the valve is and then release the implant onto the valve. If the leakage is not corrected, we can readjust the position of the implant and the implant moves seamlessly with the valve leaflet once it is implanted. Over about a month, the multiple implants can be implanted if you have a very large wide gap in these valves without causing any blockage to blood flow. And over 30 days you have tissue growth that forms around the implant and completely encapsulated. And obviously since we have left the valve, orifice quite open and moving in diastole, in the future if needed, we can even deploy a transcatheter replacement valve or even a mitral clip and pass or Pascal around these devices.

This is a delivery system that we have developed which is definitely not as complicated as modern medical, something more still mechanical, but it gets the job done of getting this implant onto the mitral and tricuspid valve. We have done extensive preclinical validation studies per ISO 5910 standards, completing our bench studies and also approximately 55 pig implants thus far taken out to six months demonstrating the safety and technical feasibility of our technology. And our next step would be to try to get to first inhuman early feasibility trials in the near future. So this is an echocardiographic video. On the top you see a heart failure, pig with a lot of regurgitation, that is the red jet going through the valve on the bottom, you see the same jet corrected with a very bright implant, which is the cardiac leaflet enhancer.

We have two patterns one issue and one pending directly related to this technology. And we have performed the freedom to operate analysis that is quite favorable in support of our technology. And we continue to build upon this platform that we have in terms of intellectual property. So so far, we have done most of our work with $6 million of non dilutive grant funding that we have received from the National Institutes of Health. And we have completed with that funding, all the preclinical work that I have mentioned thus far end of last year, we signed a term sheet with a major strategic partner, the latest $15 million series A investment of which they are committed to half of it. And now I'm syndicating rest of the seven and a half million with 2.75 of that syndicated seven and have already committed to. So I'm seeking to close this round by the end of April 2022. So we are going to use this 15 million to get us from where we are today in the advanced preclinical stages through 30 patients in both outside the US and within the US and understand the technical feasibility, safety and effectiveness of our technology. So that we can actually position this as a potential competitor or a simpler alternative to mitral clip, and Pascal. And this is the team I have led the technology inception all the way through now. And I have a team that is both technical and also focused on clinical and regulatory, that is helping me with taking this technology forward. And together we have enough focused experience in the mitral and tricuspid space to make some of these plans actually come to fruition. So in summary, in this Series A investment we are addressing firstly, I think it's a large business opportunity because we are addressing a very large market size, which is valued at about greater than $5 billion per year in both FMR and FTR by 2025. There are two technologies today, but there are multiple more acquirers who would potentially be interested in a technology as ours. The product is a single use product with a pretty large gross margin. Considering the mitral clip and Pascal I've set the precedents for how we can actually price our device and our cost to make the devices rather small. The end users are going to be interventional cardiologists. And one of the reasons we want to simplify this even further is that potentially electrophysiologist who go in and do therapies in the left atrium could also potentially repair leaky valves down the road. And our hope is that with this technology by reducing the valve leakage, we can improve survival but also reduce hospitalization rates and delay the need for a lot more expensive advanced therapies such as robots and heart transplantation. With that, thank you very much for the opportunity to present here

LSI Europe ‘24 is filling fast. Secure your spot today to join Medtech and Healthtech leaders.

September 16-20, 2024 The Ritz-Carlton - Sintra, Portugal Register arrow