Daniel Teo Presents SynCardia at LSI Europe ‘23

Transcription

Daniel Teo  0:05  
Hi, my name is Daniel Teo many on the medtech investments circuit today will recognize me as a founder and managing director, managing partner for Honeywell Lake ventures. We're a West Coast US West Coast VC firm focused on surgical innovations. But to vote today, I'm speaking as a board member at Picard medical one of our portfolio companies. And it's 100% subsidiary, SynCardia systems, that the manufacturer of the world's first and only FDA approved total artificial heart, or TAH that's now poised for significant growth over the next few years. Now, because we're on track for public listing, this presentation is provided for your information only, and is not a solicitation to issue or sell any securities. The customary safe harbor provisions, disclaimers and risk disclosures here can also be downloaded from our website and from the LSI summit website. Now the th er total artificial heart is a mechanical device that replaces the full functions of a failed or failing heart. In cases of N stage by ventricular failure, it addresses a $30 billion market share TAM of which we are the dominant if not only player in most markets in a potentially $5 billion. Sam is approved by the FDA under Class III PMA as a bridge to transplant and has a strong track record of clinical successes with over 2000 implants are ready. Now because we're in Europe, I need to stress that we're not currently available in Europe. This is not a marketing presentations for clinicians, and that we last year have withdrawn our long standing registration under CMDD. So that we could devote our full resources to secure the C MDR. Certification hopefully, by early next year. The company is poised for significant growth over the next few years on the back of one new product upgrades at the launch of next gen devices to a proposed expansion of its current labeling to long term therapy and three global expansion to China, India and elsewhere in Asia, quadrupling the current market reach. As mentioned earlier, financial audits have been completed and a proxy statement filed with the SEC for reverse merger with the NASDAQ listed SPAC so God willing, because medical will become a listed company by the year end, at a valuation of about $480 million, meanwhile, is currently raising a $10 million convertible note and a $43 million pre listing equity round. Cardiovascular diseases are the leading cause of death globally. We all know that and with 6.2 million cases of heart failure annually in the US growing to 8 million by 2030 or 86 million globally. long term effects of COVID is likely to add to these numbers of these five to 6% will still progress to end stage heart failure. And that's 4.2 million patients a year now, l vets can assist somewhat. When it's still the left ventricle that's in trouble. Very often we know that left ventricular failure leads to right ventricular failure or by ventricular failure as well, if they don't die first, and so at that point a heart transplant is needed. The problem though, is that there's currently a huge imbalance between the three to 400 cases of end stage heart failure in the US and the 4000 donor hearts that are available annually. discrepancy is even wider. Elsewhere in the world where donor hearts are even more difficult to come by. This is where the SynCardia th system comes in the system which sells at $180,000 in the US comprises of an implanted a chest cavity that replaces the native heart and it's powered by a external pneumatic driver connected by dr. Lyons and cannulas. Now for the implant, which you want to keep simple and limit the points of failure, it is only 13 movable or mechanical components with no complicated electronics or software that can fail or they need to be upgraded or replace. The ventricles are molded from a proprietary plastic called spars with proven biocompatibility and a unique geometry that minimizes hemolysis and a precisely tilt angle tilting this involves further ag to gently wash the connecting blood vessels as the blood passes through the valves. A diaphragm made from spars also separates the blood from the external air, providing true pulsatile flow which mimics the hemodynamics of the human heart. And it's much gentler on the blood and a continuous flow propeller, whipping your blood at about three to 6000 revolutions per minute. Now these implants are currently available in two sizes is 70 CC for the larger adult male, delivering up to 10.5 liters of flow and a 50 CC for smaller adults. to women and teenagers delivering up to 7.5 liters. All of this blood is driven from either a hospital driver called the C two or hub discharge driver to freedom. The C2 is mounted on a hospital card with adjustable pumping parameters to not only deliver the precise waveforms that are needed to drive the heart, but they also provide the means to monitor patient conditions without sensors or electrical connections. Now once a patient is stabilized and stabilizes post operatively, he is transferred to the home discharge driver, which is a six kg device that is carried around or pulled on the backpack. Today, the SynCardia TAH an enviable clinical track record, with over 2000 implants in over 25 countries around the world with different genders, different ages, and ethnicities. Most of the patients present cells with some form of dilated or restrictive cardiomyopathy, but they also have niche users and congenital heart diseases. And in graph rejections, dozens of clinical studies have been published in medical journals have demonstrated its efficacy as a bridge to transplant to discuss here and the rest are available and can be viewed from our company website. This pivotal article from the New England Journal shows that patients bridge to transplant with a TAH have almost twice the survival rate versus a control group of equally ill patients who are waiting for a transplant without the th. Now in almost all of the cases where the TAH patients do not survive, they die not because of device failure or from heart failure, which can't be possible because they do not they do not have a heart, but most frequently from other organ failures. Similar study in 2020 by nons confirms a similar sort of survival profile with 75% of the TAH patients surviving up to 10 months or more. Remember, by the time these patients come on to the th, more than 80% of them intermax one and two. And for those familiar with that scale, they represent a sickness of the sick patients in cardiovascular and people who are facing imminent death. So some of our patients don't necessarily get a transplant right away. And some may never will, for various reasons may be medical, or for personal reasons. So about 8% or so far 180 of our patients were on the TAH for more than two years, and a record duration being six years or nine months. And right now as we speak we have a live to patients who are fast approaching the sixth anniversary. These patients are kept alive not in a vegetative state and hospital. But most especially the 1/3 of the 2000 who are discharged home on the freedom driver enjoy a high quality of life with a considerable mobility in and leading very normal lives. And here's Johnny playing golf just two months after his implant with an artificial heart. And you can see in this photo the driver next to him. Here are more of our x amazing ex patients who while on a th do crazy things like hiking 1000 kilometers in Alaska, box run play basketball, go on hunting trips, or spend precious time with the children or grandchildren. In the US, we have already had to pre set up meetings with the FDA to discuss expanding the labeling from bridge to transplant to long term therapy and expect to make a full submission by year N and we're very confident about our success rate there. In Europe, we expect to submit our MDR application by the year end as well and expect to return to Europe on an accelerated approval pathway. Because this is not a new device. And so approval will be based largely on all data that was submitted for MDD. Reimbursement by the US MCA CMS is under the DRG 001 with the highest of the DRG codes that pays up to $425,000 per implant. We're also covered by procedure. Rather, we're also covered by most private insurance in the US that pays somewhere between six to $700,000 for each procedure, compared with the $180,000 price tag for an implant. This works well for most hospitals. And if it happens that a discharged th patient returns for a donor heart, the hospital gets to be paid twice for two procedures instead of one. So in the pipeline is a series of new product upgrades that we have put in place that will make the device more user friendly softer with more features. The next the second generation freedom driver remember the first one is a 13 pound or six kg backpack. The second On generation freedom driver available by late by 2025 will be reduced to a two kg device that can be worn around the waist, and is even quieter at 45 decibels. We're working on the third generation driver that can fit into the chest cavity. And depending on where Ted's technology is, at the end of the at the time, where it's available in 2027, this could be the world's first fully implantable, total artificial heart. So I talked about long term therapy, we're quietly confident about application for that indication, compared to the LVAD successful application for long term are durable. As a durable product, durable device, we have a larger sample size with better clinical outcomes and extend the LVAD and compare it and expect approval in the next 12 months. Finally, in global expansion, we have a Chinese subsidiary that has already started the registration process with the nmpa. And in India, where we are getting the highest ASP $200,000 per implant, we are waiting for our first implant. And this chart just kind of shows, you know we believe that with loads of medication and the next gen drivers we can be the ubiquitous standard of care globally by the end of the decade now as we look forward to the fulfillment of our vision, where no one should ever have to die from chronic heart failure. Here are a couple more slides on the competition and on the management which can be accessible on our website. And if you have any questions here by QR codes, should anyone have a question or wish to reach out thank you very much