Michael Whitman Presents Micro Interventional Devices at LSI USA ‘23

Transcription

Michael Whitman  0:05  

Nice to see a bunch of friendly faces out there. You know, occasionally a technology comes along that changes everything. Think angioplasty think stenting think Tavi, Micro Interventional Devices is one of those companies. We have a platform that we've been working on since 2010. The very seasoned management team, very seasoned board of directors. We have a proprietary technology, treating regurgitation and tricuspid and mitral disease, validated safety and performance. Data from the European trial, we have a pending CE mark, and we have a breakthrough designation from the FDA that we're working on our ID clinicals. The team's board has over $2 billion and exits over the last 20 years. You can see the curriculum vitae is here. Everyone's either been a public company CEO, or an angel or second third round investor in major exits across the spectrum and cardiovascular general surgery and thoracic surgery. The management team has been together for over 15 years, our last company power medical intervention, we built from scratch on her own IP, took it public on NASDAQ and sold it eventually to Covidien now Medtronic, that technology is doing a little over 700 million in sales today. We also developed the Andover stapling technology for the the Vinci robot, and that's doing about another category of about $200 million. So we're in a really good position to evaluate technology haven't done so over the course of the last 40 years. And we're working with world class physicians at Columbia, Penn mayo and around the world and developing this next platform technology. Our first application of the technology is for tricuspid regurgitation, or I should say the elimination of tricuspid. regurgitation, that is a disease that occurs when you have a mal coaptation of the tricuspid valve and the flow of blood is gone reverses its direction, its normal direction, regurgitating back in the atrium, the right atrium, so repairing that is a first line therapy that is well known in surgery, it is been done for over 50 years. And it's very effective. You can see in this chart from Harvard, the freedom from moderate TR extends in the later years, six, seven years post repair. But the problem was surgical repair is that it's incredibly invasive. It's a sternal cracking procedure, you've replaced on carbon bypass and the mortality rates associated with this access to the procedure. It's not the procedure itself that is debilitating. It is the access itself that is debilitating 14 to 32% mortality mortality rate depending upon whose study you look at. So, what would happen if we took that repair which is effective, and move that into a percutaneous approach, eliminating the need for the sternal cracking and the associated complications with that, we would expect that the current 25,000 procedures done would expand to the 4 million procedures that are available to this market. If you had a way of approaching this percutaneously. We've seen the effects of stenting that had on cabbage. And what Tabby had on aortic valve surgery, we expect our technology meity minimally invasive tricuspid to have the same effect on tricuspid valve. So what is meity It's a simple, safe, secure, 12 French system. It's designed to be very easy to use and easily trained and adaptable across the spectrum of caregivers. What it does, the system delivers a series of micro stance, the stance as a football, micro anchors that are polymetric poly core anchors poly meaning polymeric core meaning of the heart, the poly core anchors are placed on the annulus. I'll show you in a moment, using the delivery system in the middle panel here. That delivery system delivers an accurate for 1000s of a second, because as you probably already can ascertain, this is done on a beating heart. So that delivery has to be very precise and very accurate. To further facilitate the accuracy of the device. We have a what we call stabilization pins, you see that at the distal end of the right panel, there's two little arrows pointing to the stabilizing pins. They actually go into the annulus of the heart and maintain accuracy during placement. We then take a series of the anchors you can see in your left panel. There are placed circumferentially from the AP the PS CommInsure of the of the heart. We're looking at the left of the right ventricle, I'm sorry, from the right atrium down into the right ventricle and you see little white dots in the left picture. Those are the anchors being placed well connects those anchors is a two Oh prolene suture, which is the common suture used in cardiovascular medicine, we placate or pull those anchors together, eliminating the MAL coaptation. And thus the regurgitation, then we lock that in place is a relatively simple procedure. In our clinical trial in Europe, we were able to do this in 45 minutes, which in a first new human feasibility study is an incredible speed with which to do this open surgery would take three to four hours with seven to 10 days of follow up in ICU and hospital care stay, these patients going home and one or two days post op. You see in the top, right, that's a thorough images of the 12 Friends system in sight to delivering the anchors you can see the little dots that represent the anchors in the picture. And below the fluoro images is Echo. And so this is a combination of fluoro echo guided therapy very similar to Tabby and other advanced procedures like mitral clip and try clip. These cysts the study itself was a safety and performance study. There were no deaths, no myocardial infarctions and no strokes in any of the patients. There was a no serious adverse events that led to transition to surgery. And the performance was 97% technical success rate. And that was in the first clinical study. So this was done at universities that have, you know, moderate skills at these procedures. And so we got a very good result in that first, that first clinical trial, the patients did extremely well, you can see on the right there, the quality of life improved dramatically, the lower the score, the higher the quality of life. Patients, six minute walk tests were enhanced dramatically. And measurements of the reduction of the orifice area, which is the mount where the milk Mau co optation takes place was, on average 23, we had from 45 to 20%. Reductions in effective orifice area, you know, by all means, exceeded our expectations in the first trial. So what did that lead to, that led to a designation from the FDA as a breakthrough technology, we have access to rapid more rapid access to the agency itself and responsiveness from the agency. We also have access to CMS and other, you know, potential, you know, future, you know, government agencies that we will need to finally commercialize it in the US. And you see that above the blue line and the FDA boxes there. But below that the CE mark, we've already compiled the data that I just shared with you in summary, that's been submitted to the notified body in Europe. And it's pending a CE mark approval with our notified body Decorah as we speak. So what's the opportunity for investors? As I said, this was founded in 2010. It was interesting to hear in the previous discussions that these procedures and technologies they take time, they have to be done carefully. This has been in development for a lot of years, we've consumed $38 million to date, which is very effective for cardiovascular development program, we're looking for 40 million to complete the clinical trial and to begin our commercialization in Europe. There is one other important note for any family offices or high net worth individuals. We are right now looking for a participation in a bridge round, that bridge round is being matched by a large multinational and fortune 50 company. So if people are looking for a bridge to a, you know, hugely successful, you know, transformative platform in the cardiovascular space, please come see us after this. We'd be happy to talk to you about this further. Thank you very much for your time.