Stephen Cox Presents InVera Medical at LSI Europe '23

Transcription

Stephen Cox  0:05  
Every year 12 million US and EU citizens suffer from venous leg ulcers as a result of ineffective circulation, which is known as chronic venous disease which destroys lives and has an impact on quality of life similar to heart failure. My name is Stephen Cox and I'm here to talk to you about how we're set to transform the treatment of one of the most costly and neglected patients and healthcare. Chronic venous disease affects one in four of every adults in this room, and one in three over the age of 65, and is increasingly prevalent due to rise in risk factors such as obesity and an aging population. And it places a huge burden on healthcare spends up to two and a half percent of Western healthcare budgets, and it gets worse for 4% of patients each year if left untreated. The cause of venous diseases valves in your leg veins which are responsible for stopping blood flowing backwards, they fail over time due to weakening of vein walls, which allows blood to flow backwards and reflux towards the foot. The goal of current treatment is to close this disease vein allowing blood to circulate back to the heart to help the veins. Symptoms for suffer starts with bulging varicosities. Legs start to swell as blood pools and the limb and starts to stain the surrounding skin. And unfortunately for the unlucky people, chronic open wounds that don't heal known as venous leg ulcers started as an advanced stages of the disease, which is very progressive and devastates quality of life causing 80% of all leg ulcers. And unfortunately, this affects the 12 million people in the US and EU who are stuck in a cycle of recurrence between active and healed operation and they cost $10,000 Each per year to manage current treatments are unacceptable. Burning radiofrequency and laser modality requires an injection of a liter of anesthetic fluid in the limb which requires 10 to 20 Stab injections, which are quite painful for patients to tolerate these terminal injections. These terminal modalities are quite effective, but they pose higher risks in top on top of the pain below the knee for leg ulcers for advanced stages of the disease. Current non terminals are either introduced toxic chemicals are permanently implants or are ineffective, so the market is looking for a less invasive effective solution. Unfortunately for the venous leg ulcer patients who are at higher risk for the radiofrequency effective treatments, they're conservatively managed. And that's even worse to be honest because it can take up to six to nine months to heal a venous leg ulcer and has a very poor 50% recurrence rate at four years. Vascular surgeons know that earlier intervention and treatment of the disease cause not only reduces healing time, but also reduces recurrence. So the ideal of treatments would not only treat venous leg ulceration, but it prevents it causes in the first place earlier in the disease. But also it would restore a quality of life to the millions of patients worldwide. And that's why we've developed our InVera device. It's the world's first pain free medical treatment that utilizes the body's natural healing to treat the full spectrum of the disease from varicosities to venous leg ulcers without using harmful side effects. It is an endovenous ablation catheter with a single handed operation and a 90 centimeter working lens. At the end of our catheter we have an ablation helical coil made of shape memory material, which has an abrasive surface which we use to scar the inside of the vessel to promote long term healing. It fits in with the current flow of vascular surgeons who treat these patients currently, they map out the vein and the disease segment onto ultrasound guidance. Then they use standard minimally invasive techniques. navigating our catheter without a guide wire up through the disease a vein which is usually the great saphenous trunk navigation continues until just shy of the deep system with the suffering of femoral junction. At that point they use our intuitive handle to unfurl the helical coil which expresses an outward radial force on the inside of the vessel. The physician then simply uses a clinical technique to withdraw and treat at the same time. This triggers acute venous spasm in the response to the injury we call it in the inside of the vessel. But it also makes cellular damage to the required level for a chronic biological reaction. And this chronic biological reaction, then forces treatments closure everything is removed from the body at that stage we leave nothing behind Trumbo stasis is the acute response that's absorbed by the body into a fibrous cords filling the vein lumen which It prevents blood from pooling in the wrong direction towards the force. And then you get on the other side of the screen here, a completely absorbed invisible vein, and everything returning to the heart through the deep system. Our value proposition is clear, it's non inferior, obviously versus market leading radiofrequency. But it's also safer, less side effects. We don't burn, we don't use chemicals. We don't leave anything behind such as sinagra like glue as other competitors. It's pain free. It's been tolerated by the 21 patients that we've treated so far. And it's fasters for physicians as well. So vascular surgeons make more money per hour with our system, treating up to twice as many patients in their clinics. It's intuitive, use the standard techniques and has no capital requirements. We have key opinion leader support from Dr. long Cabinet who the past presidents of the American venous forum who sees great disruption for this class II medical device. There's nothing out there like this at the moment. So this is a novel de novo pathway, which provides for a new reimbursement called differentiation. We're targeting a premium price of $1,500 in line with current non terminal new treatments, and can make the device for $150 Cost of Goods with no capital requirements. The total market opportunity at a conservative estimate is over $3 billion worldwide. And the addressable market in the US and EU and Japan has almost $2 billion, of which we believe 20% of the market is obtainable in the medium term. We raised the seed round to four and a half million euro in 2020, led by Japanese healthcare company Nipro Corporation. 10 months later, we entered our first in human trial where we treated 11 patients proved out the safety of the platform. Last year we built our gen two device which used that first in human clinical experience to improve our design to work with the venous spasm we incorporate, but also to optimize our clinical technique. And we saw outstanding preclinical results, which we're now bringing back into the clinic this year. With our generation two trial at the same clinic in Budapest, Hungary Western Eastern Europe, we've treated 11 patients so far, displaying excellent performance of the device with no patient pain, excellent safety results, no adverse events and class leading performance with over 80% of treatments are showing a quality of life improvements of almost 70%. For patients. We're continuing to enroll this patient study, and we'll improve our clinical technique for our next cohorts. We're raising an A Round next year, which we'll use for our regulatory ID study, which we'll use for de novo, FDA and CE mark submissions and a pivotal comparison head to head study and gather peer data for new reimbursement codes. We'll run these clinical studies sequentially with the ID first and then that pivotal versus radiofrequency showing non inferior RSC and less invasive outcomes. We then plan a market entry Series B to enter the markets. We built a strong team over the last number of years with clinical commercial and technical background and experience in venous disease. Our three co founders match on the BioInnovate process following the Stanford Biodesign process for unmet clinical needs. The current market is dominated by Medtronic with their terminal radio frequency but the market is shifting towards a non terminal less invasive evolution. Current non terminals either don't work as effective or they introduced toxic chemicals or glue. Recent entrants into the marketplace such as BD showed that there is potential for new peripheral intervention companies to enter this very lucrative market. This shows the exit values and superficial venous ablation. But the point is that there is a potential for an exit here at the approval or traction stages at the A & B rounds. So with the growing prevalence of the disease, high associated healthcare costs, increasing evidence for earlier intervention, now is the time for our less invasive solution which will disrupt this chronic venous disease market, restoring quality of life to millions of sufferers across the globe. We're interested in talking to investors who can share in that vision. I'd like to thank you for your time. Best of luck.