Motasim Sirhan, Elixir Medical - Coronary Bioadaptor System | LSI USA '24

Motasim Sirhan  0:02  
Ladies and gentlemen, it is my privilege on behalf of my colleagues at Elixir Medical to share with you a story of persistence, commitment, and passion to transform coronary artery disease to the next standard of care. As you all will know, by the year 2030, there will be over 23 million deaths globally from heart attacks, there are about 220 million patients that die that is diagnosed with coronary artery disease. And there is in the United States 805,000 mi, per year, of which 25% is really a recurring heart attack cases. And I've thought that it causes about 14 billion in direct cost to our healthcare system, and over $200 billion dollars in indirect cost. When we see over the years from the year 2000 into 2018. We see a plateauing effect over the years and that's really primarily driven by statin use. So statin have been very effective in reducing heart attack incidents, but it plateaued over the years despite aggressive use of statins. And despite use of PCK PCs K nine inhibitors on the device front. For the past 25 years, drug eluting stents have been able to make improvements in the first year, but it plateaued again and over the years. You have a two to 3%, persistent, non plateauing annual event rates every year cardiac death, MI and revascularisation. And when you look at over five years, you have 20% major adverse cardiac events and over 10 years, one in two patients suffer either a heart attack death or revascularisation. And when you look what's behind that it's plaque accumulation, statins are able to reduce plaque getting into the vessel. But once the vessel is dysfunctional by putting a stent in there, there is an acceleration of that inflammatory process. And then secondary heart attacks cardiovascular death and revascularisation. Not to mention 20 to 50% of patients continue to suffer angina despite going through PCI. What we've done at elixir is we started many years ago with a commitment to transform coronary artery disease treatment. We have a significant IP portfolio, over 77 issued patents and 50. pending an experienced team. We come from backgrounds under one roof we have the know how to develop API, drugs transcatheter expertise drug delivery and polymer science. And what we've done is we've developed three major platforms dynamics coronary bio adaptor, it is designed to establish superior and sustain clinical outcomes over time, we've developed lithics intravascular lithotripsy, optimized for calcium fragmentation, and we've developed to eliminate the compromise between bleeding and thrombotic risk the TRX, which is a dual anticoagulation platform, it is really looking at it from holistically what would it take for us to elevate the standard of care in coronary artery disease treatment. The dynamics bio adapter is a three helical strands that are formed temporarily in circumferential fashion, it restores blood flow, and it unlocks and by unlocking uncaging, the vessel restoring the vessel motion and function, and by doing so, while continuing to support the disease vessel, you're able to reestablish the ability and mechanism of the vessels to clear accumulated plaque synergistically with statins. This is a disease patients and for the first time in history, you see a disease patient artery pulsating like a normal vessel, despite the disease because of the ability of the dynamics to carry the burden of the disease while on caging the vessel allowing for total restoration of the vessel function for this patient at rest. They're able to get At 30% more blood flow volume as a result of that positivity. And when you look at it, we've done several clinical trials. And in the first randomized trial ever in history, we're able to show favorable numbers versus the standard of care at the first year 1.8 versus 2.8, with significant statistical superiority in restoration, or pulsatility restoration of improvement in blood flow, significantly maintaining the effectiveness of the procedure at baseline, and for the first time showing a plaque volume regression minus 9%, over the standard of care of accumulation of 10% over one year, so you have an absolute absolute number of 20% difference between the new standard of care dynamics to be an under current standard of care. And so when you look at it, we're talking about patients today there are 6 million primarily patients who suffer heart attack. And that is the market that we're looking to establish a new standard of care. And with the ability to regress the plaque progression, we're looking at 30 million patients in being able to be uniquely addressed with a differentiated dynamics and then chronic angina patients an additional 15. So we're going from 6 million patients to over 30 million patients being able to be addressable with our platform. What I want to share with you is that we are seeing marked we are established a premium pricing we have three times year over year growth. We are sharing the Bioaro adapter second year results. If you remember, in PCI year, over year, you have a two to 3% Persistent non plateau in events, please come to PCR in Paris, we're going to share for the first time, second year results. And that is where history will begin. We have 2400 patients. Randomized trials, the results will be coming out in q3 and R Us ID approval in q4. We have established procedure coverage, we have pathways for reimbursement, and incremental reimbursement. And we are ongoing consultations with global players as to the lithics. It's the first user friendly non energy based calcium fragmentation platform. It is really designed to have multiple fragmentation in order to truly allow the expansion of the implant after you prep the vessel. We're excited about this opportunity and we have an expanded potential applications in peripheral and structural heart. And finally, the anti thrombotic. issue where physicians with oral anti platelets and anti thrombotic always are having to juggle between thrombosis and bleeding. What we have disrupted and figured out is by combining a factor 10 A inhibitor in its well which is rivaroxaban as well a factor to a inhibitor argatroban you can actually site specifically inhibit thrombosis without having any additional risk of bleeding as a result of that. So we can combine that with mTOR inhibitor sirolimus for a site specific PCR treatment, or we can apply it to any other implant, whether it is orthopedic Lea valves, and that should be able to address at a site specific potential thrombosis inhibition without having any risk of bleeding. In summary, there are over 220 million patients around the world that are suffering from high mortality, morbidity, and a big burden on our healthcare system. What elixir has developed over the years in unchartered waters where we could not see land for many years. We see today the opportunity of $30 billion have addressable market and significant expansion because we we really elevated our goal and that is to make sure that we address the patient need and if we address the patient needs, the market expansion and market reward will come and we have an overall portfolio of very solid and exceptional r&d team productivity and very strong intellectual property. Thank you so much for your attention.