Heart Repair Technologies | Valavanur "Mani" Subramanian, Founder

(Transcription)

Mani Subramanian  0:02  

Thank you very much. I am Mani Subramanian, the inventor and the founder of HRT, heart repair technology. I am an octogenarian, I don't need Uplyft yet, prop probably soon in, maybe I'll invest in it. So I've been a cardiac surgeon for 40 years and started at the University of Minnesota with the wall Aloha, you heard about that in the previous address. And I've been a inventor for at least a little over four technologies, which has already made a tremendous impact and a good exits. I'm in the fifth curve. I think I'll do a six curve also. This might disclosure and disclaimer. We are about a transcatheter. mitral bridge and tricuspid Bridge, which is basically offering a central solution for a central problem is for the treatment of heart failure in mitral and tricuspid regurgitation, otherwise called the leaky valves. What is the problem? In this there's a tremendous amount of leakage back into the upper chambers in both sides of the heart, which causes heart failure, which basically is terrible quality of life. That means you're huffing and puffing every time you walk. You have fatigue, blown up legs, blown a belly, most importantly, 50% I repeat 50% die in three years, three years from the diagnosis that looks very ominous. Even with maximum medical therapy, even with lesser grades of moderate leaks. So you need to really get those leaks down to zero or mild. Is a big problem. It's tough out there. Or 5 million years patients suffer from symptomatic, mitral and tragus, tricuspid. regurgitation, they need therapy. Medication has been mostly ineffective. Surgery helps but it's very invasive, limited to few patients 10,000 in the US. Current transcatheter therapy like a mitral clip, Pascal, the VA good. The only limited for severe disease. Many patients are excluded from therapy. In the randomised trial and clinical trials they will show that 90% success rate. But in the real practical world, over two thirds refused because of challenges in the procedure and the anatomical restrictions. less than 2% of patients are treated by this therapy does the adverse presentation JPMorgan conference 2021. Bottom line, there's a tremendous, large unmet clinical gap. It's about a three or a $5 billion in the US alone, the market opportunity by 2028 A good growth rate of 15%. What is the real problem? You see in the bottom mitral and tricuspid is a wire and agree. It's like a girdle, right? There's a girdle and there's a curtain, which is the central part of the curtain. As the girdle becomes bigger and bigger, the skirt and smooth out, you have a huge gap. So you really need to decrease that gap, decrease the central and lower DEROTATION, which is a central issue. So to do that, in most instances, you got to have a need aggressive, little over 35 to 45%, sometimes 50% of that diameter, you really had to close the gap ventricle contract so it doesn't leak. But the remaining part of the girdle is fine. It's functioning well it's important to keep the left ventricular function and the leaflet in proper position. Bottom line, you got to achieve none or mild leaks, if you want to affect the Natural History survival rate for these patients. There are current Repair Solutions but they do not address well. The enlarged Central and modalities which I mentioned is a central issue. So we have the rings and replastered eggs. What does it do? It's a circumferential cinching to get the point A to point B looks like it's going too far around the circle for someone to cross from Manhattan to Staten Island. I take Arizona bridge. I don't go around the jersey to get to that point. Isn't that right? Yes, I t is too complex, too many acres too many sutures in the surgical so it doesn't produce in a good reduction is insufficient reduction also jailing the endless like you're tightening your sphincter in the bottom of your orifice. So it doesn't work. They have the leaf repair, I think is a good solution. You basically clip the leaflet, but don't do anything to the endless is still enlarge. So you can only use that in a limited patient population. So high in ineligibility rate technical procedure complexity, suboptimal procedural patient outcome, so there is an opportunity for better solutions. This is where we come. This is a very disruptive solution. rather simple. You simply bridge the gap with the bridge. So we have a mitral bridge, whoever tricuspid bridge, very simple and intuitive, because it directly reduce the diameter. It doesn't jail in the endless. There's no leaflet clipping. Because it's simple. It's very quick. Procedure time is less at least in the surgical. And it taught us a broader population. It doesn't restrict this to only a two thirds 1/3 of the patient population, we can put it in war 90 to 95% of the patients. Does it work? Concept escape? Yes, it works. It's safe. We did the surgical studies, European CE mark is approved mild leak or trace in 96% of the patient at four years nobody had moderate or severe leak nor device related events, adverse events, the device is durable, has not been explanted so far. So the same thing was tried in the tricuspid. Later on, same results, that 18 months 100% of the patient had a mild tricuspid leak. None of them has been taken out no device related adverse events. So we leverage this. Now currently to do the transcatheter percutaneous bridge. Again, our objective is very clearly outlined. To do this for all the proceduralist not just for the artist just like the clipping or the Angela bland, you know only a few people do that, when he go to the mainstream, then are able to do the mitral bridge catheter system is similar to the surgical bridge in form and function. But we made it fully retrievable repositionable, anchors and implant at all stages. Even after we put the implant we can pick it up. I think that's great. Also, if it fails, for some reason, in the years to come, we can put a mitral clip through that we can put a Pascal through that, we can blow it up and put a new valve so it doesn't cancel out any further options. Catheter systems very easy. So the procedures can use that very comfortably in a less time. Procedural imaging system is extremely simple. It's a single device for both wealth, it is not a niche device. That means it can be put on or 90% of the patients all the more it is so simple. And the time it takes to put one of them in the mitral position is one hour Tricopter one hour so there is a potential to do this as a same day procedure that is huge. That is huge. So here's a little video the video has to be queued in the can you actuate the video we tried it before there any way we can start the video or not? Yeah, here's the camera system go it's a little puncture in the way and it goes through the septum. Here's the mitral valve and we make sure that it's positioned well and then the now the steering catheter which is sort of like a snake comes down into a post back part of the endless and the anchors are driven and it flexes again like a snake going into the front part. And the heavy anchors has to tell us you see so we can send you and find out what the size bridge we want. So that optimizes the outcome here is the bridge coming in. Lucky then because it's coaxial pulls the post tree port to the interior one as you lock that port. So simple scan. The leak is gone. So now we can unscrew that and take it out for you. So the same thing is done the Tricaster

spec has been bridge similar so what have you done so far we've created the system we built the prototypes, we did a lot of bench testing. We've done serial acute animal studies completed with successful mitral bridge implants. The delivery system is via groin effective endpoints are already achieved. So we'll be starting in q2 this year chronic animal safety studies and the durability of this device has been already testing initiated will complete in the next three to four months. We're very broad intellectual property. Eight patents patent families 14 U.S. and six foreign issued patents six pending non provisional covering all phases might or tricuspid, surgical transcatheter you name it. Very experienced leadership team around here say anything about it. You already know. Rich Ferrari was in the boat, serial med tech entrepreneur 35 years CEO, co founder of multiple teams. multiple exits are a billion dollar and Tim McNeil is here. Our chief operating officer 30 years of experience in the space executive leadership position recently got an exit team in the harpoon medical acquired by Edwards for 250 million. Prior to that has been an ATS and other technologies. We're also got an exits. We have a fantastic engineer Jean Reese is the principal product development engineer 25 years in this med tech product development Hanson robotics PQ bypass a great catheter experience visit to produce catheters, great consultants Carlos Ruiz, my former colleague from Lenox Hill and New Jersey and Hackensack University. Vivek ready in the Sinai Hospital Maurice Buchbinder scripts all of them are very good and mitral space have used mitral clips other mitral technology. roadmap is very simple. We starting the DVM we face in q3, we go to the first and then later part of q1 and early part of q2 2023. Eight to 10 patients six to 12 months follow up. And we are now raising Series B financing. Exit Strategy, obviously potential acquisition by strategics. The historical acquisition transaction has been 225 to $750 million pretty good exits. So the investment opportunity in our technology, significant unmet clinical needs huge market billion $5 billion market, a new approach, very disruptive, differentiated technology like taking off in space, or coming limitation, first generation device and validated concept experienced leadership and winning strategy. To conclude your time is limited. Don't waste it living in someone else's life. Don't be trapped by dogma, which is living with the results of other people thinking. Steve Jobs say thanks. If you have any questions call me. By the way. This is not iPhone. This is our bridge