Dan Rose Presents LimFlow at LSI USA ‘23

Transcription

Dan Rose  0:05  

Good morning everyone. My name is Dan Rose. I'm the CEO of LimFlow, which is a late stage cardiovascular startup based in Paris, but also with offices in San Jose, California. And the reason I'm here today is because we're in the third decade of the 21st century, and there are still hundreds of 1000s of major lower limb amputations going on in the US, EU and Japan due to ischemia, and late stage perforartery disease. So winflo aims to become the global leader in limb salvage for patients with CLT AI. We're going to do this by transforming the standard of care introducing a new therapy and technology into the space, growing the treatable market treating patients who can't be treated today with any surgical or endovascular option and establishing a unique durable, competitive position for the future. So the New England Journal medicine tells us that a major lower limb amputation is in the top five most dangerous surgical procedures in terms of morbidity and mortality, terrible outcomes for patients happening too often driven by an explosion in CL TI, which comes from too much diabetes, and too many obese patients combined with a lot of atherosclerosis and people surviving their coronary artery disease because we basically send everyone well, if you have atherosclerosis in your coronary, you're very likely to have it everywhere else in your body as well. current therapies today are essentially adapted coronary technology. So you think about wire stents, balloons, catheters, etc. But revascularisation only works if you have a target vessel to revascularize and many patients does in many patients, their diseases gross too far to be re vascularized leaving them essentially as non responders, people who either cannot be rasterized or don't respond to revascularisation. So independent research shows us that this is a couple billion dollar market 100,000 patients alone for LimFlow, were the only people focused on this target group. No option C LTI patients what does that mean? It's patients who have a chronic wound in their foot and this is believed me the nicest picture I could find you. And they have no acceptable vessels for revascularization. And in our pivotal trials. We have all the NGOs and pictures sent to an external committee to vascular surgeons that determined yes, no further endovascular therapy can be delivered, and no surgical option exists. So these patients are essentially consigned consigned to major lower limb amputation. What are we doing something called transcatheter arterialization of the deep veins. The easiest way to understand the concept is you're driving to the airport trying to catch your flight, you get stuck in traffic, your app tells you you're gonna get there tomorrow, you look over around you look across the media and you say wait a minute, that road on the other side of the highway, it goes to the airport, it just runs in the wrong direction. Veins come from everywhere arteries go. And in our patients, the arteries are unreconstructed. So why not try to deliver oxygen blood through the venous system might not be as perfect as an artery, but we're certainly going to get blood flow down to the foot. LimFlow is a breakthrough technology, it is a system of tools. We have an arterial catheter and a venous catheter for creating the connection between artery and vein. We have a unique push valve atone for a traumatically knocking out the valves in the veins that otherwise keep blood flow from flowing in the wrong direction. And then we have our own covered stent grafts, basically for channeling blood from artery into the veins and vocalizing it down into the foot. So we just completed a landmark pivotal trial called the Pomis II trial it was 105 patients and 20 sites focused on extremely hard primary endpoint, amputation free survival. Are you alive and do you have the limb we treated? This is the sickest population ever enrolled into a peripheral artery disease trial including stable dialysis patients which are basically always excluded from from the, from this these types of studies. We had extraordinary results and this this, these results will be published in one of the world's great journals next week. So we look forward to you seeing that publication when it comes out 76% limb salvage meaning 76% of the patients kept their limbs 76% of patients went from no healing to healing or completely healed and 99% technical success meaning that we were able to train patient a train sites across 20 sites across many more investigators to do this procedure successfully. We really deliver what patients want which is wound healing and pain reduction wound healing you can see went up over time from zero effectively to 76% and pain drop up by half in six months and continues to drop after that. You ask yourself, well, what is standard of care look like what happens to these patients if you we don't do anything with them. We ran another study at the same time a pharmaceutical clarity and that looked at 180 patients getting what you would get if you didn't have LimFlow and we saw 38% amputation free survival at six months. What does that mean? That means 62% of these patients were dead or amputated within six months. Pancreatic cancer diagnosis looks like a blessing. Compared to a CLTI had no option diagnosis. 47% of patients were amputated at six months. What is when flow deliver 70% improvement based on a pre specified propensity stratification that will be published soon and is pre agreed by the FDA showing high statistical significance 50% reduction in amputation. 2000 sites in the US are doing these types of procedures in terms of basic CLTA endovascular and surgical work. procedure can be performed by interventional cardiologists, vascular surgeons or interventional radiologists were completely agnostic. And there is certainly more pull than push and marketing terms here. We're seeing that I mean, these patients are in the cath lab, the patient, the physicians see the patients the unmet need is clear to everyone involved. This will be a cornerstone therapy and a key differentiator for providers. Our commercial strategy is based off of what Edwards did with TAVR focus on great outcomes, great outcomes, great outcomes go after the first 100 sites, train them up that will drive advocates and referrals increased volume and become a cornerstone practice. We submitted to the to the FDA about six months ago. We expect approval within the next two months. Our go to market team is in place now. We will launch in July latest we think unless there's a surprise which we don't anticipate. First 100 sites have already been targeted and this flywheel will begin. We have a few key enablers for commercial adoption, we've done a tremendous amount of external market research through an independent group, robust clinical data, clear mortality and quality of life benefits at what we've seen in the promise II trial 90% intent to adopt among KOLs. In terms of AR is this going to be impactful for these sites in terms of them being able to build up themselves a center of excellence 85% of KOL say yes 90% of CFOs and buyers are interested to buy at the suggested case contribution margins. We have clear reimbursement very attractive physician payment for the procedure. We have interesting DRGs are and APCs already already identified and in use today, we are selling into the pivotal trial I mean into our Promise III trial for $25,000 per procedure today. And we do have access to N tap and T TPT. In fact, we expect to end approval for and tap next month. So we have several key milestones upcoming key regulatory approvals FDA CE mark later this year are shown and approval in Japan will go into q4. We're going to demonstrate commercial traction, expand the team continue to invest in r&d and clinical and we will raise capital we will raise what is targeted to be a $75 million growth round this summer, every investor invested in LimFlowoday we'll follow on strongly into that round. So what will we see in the coming days 80% of patients will continue to be treated with the conventional options that are out there some of them on label some of them off label, I hope they get relief with those products 20% will have limb flow and option today they have nothing and they will have us and we believe that over time, the right side of this graft will be as valuable or more valuable than everything on the left side of the graph based off of our pricing power and the value we bring to patients in our procedures. So we are on track to become the global leader in limb salvage. Solving a major unmet need unique solution orange accessible patient population and amazing clinical program best in class clinical team and great dynamics for a successful global launch with strong pricing reimbursement and therapy therapy adoption in place. So thank you very much