Stephen Cox, InVera Medical - Catheter-Based Therapy for Chronic Venus Disease | LSI USA '24

Stephen Cox  0:04  
Every year, there's 12 million people in the US and EU who suffer from venous leg ulcers as a result of ineffective circulation which is known as chronic venous disease, and it destroys lives. And venous leg ulcers are proven to have an equivalent impact on quality of life as heart failure. My name is Stephen Cox. I'm CEO and co founder of invera medical, 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 in healthcare. Chronic venous disease is very prevalent. It affects one in four of every adult in this room, unfortunately and across the world as the fourth most common chronic disease, and it gets worse for 4% of patients per year, which leads to a huge healthcare burden on Western healthcare budgets of up to 3% per government. And it's caused by valves in your leg veins, which are meant to stop blood flowing backwards, those valve leaflets don't meet properly, and they become incompetent due to weakening vein walls, and that allows bloods to flow backwards or reflux and pool in the limb, and you get these sneaking varicosities. The goal of current treatment is to close off this superficial disease vein and allow your blood to return to your heart through your deep system of venous return. It's a spectrum of disease that starts off with varicose veins. Leads to swelling as blood starts to pool and the limb and edema, and then the skin starts to transform and discolor, and that breaks down the skin, unfortunately into chronic open wounds that don't heal, which are known as venous leg ulcers. Venous disease causes 80% of all leg ulcers across the world, and unfortunately, it leads to a huge cohort of people of 12 million who are stuck in a vicious cycle of active and recurring ulceration, and they cost about $10,000 each per year to manage. Current treatment is unacceptably invasive. The market leading thermal ablation burns the vein in your thigh, but before it does that, it has to insulate the surrounding tissue from skin and nerve injury, which involves the injection of about 10 to 20 needle sticks to infuse and instill a leisure of fluid to protect that surrounding tissue, and that's before the minimally invasive surgery commences. This leads to patients being in tears or they present too late. These thermal burning procedures are effective, but they pose higher risks, especially below the knee, due to the adjacency of some nerve bundles, which make them even higher risk, again, for venous leg ulcers. So unfortunately, leg ulcer patients are conservatively managed, and the treatment doesn't really work that well. It can take six and nine months to heal a recurring ulcer, and then these patients have a 50% chance of recurrence at four years. Vascular surgeons who treat venous disease know that if they intervene earlier in the disease, it'll not only reduce healing time, it'll also reduce recurrence rates. So the ideal treatment here would not only treat the advanced stages of ulceration, but it'll prevent its occurs with earlier treatment as well. It removes remove costs from the healthcare system, and more importantly, it did restore quality of life for the millions of sufferers around the world. And that's why we've developed the invira device, which is a less invasive and the first pain free, effective treatment for the full spectrum of the disease. It's a mechanical ablation and infusion catheter. It has a 90 centimeter working length and is designed to treat the full leg if the patient presents with such disease. It's an office based procedure, and at the end of our catheter we have an abrasive helical coil. It fits in with the current standard of care. Vascular surgeons use ultrasound guidance to visualize where they want to treat in the leg. It's normally the great saphenous vein. They normally enter just distally at the knee, and they use a standard minimally invasive kit through our five French system, they navigate our device without a wire up through the truncal vein, and they stop just short of the saphen ephemeral junction. At that point, they deploy our abrasive coil, which stays attached to the catheter at all times. That coil expresses an outward radial force on the vein wall, and the physician then simply withdraws it, which causes an intense venous spasm in the response to the acute injury. But meanwhile, the abrasive surface makes cellular damage into the vein wall to the required level to trigger an inflammatory response. The catheter then allows the physician to infuse sclerosin medicine to deepen the venous ablation effect. At that point, everything is removed from the system. We don't leave anything behind. The acute response is acute thrombostasis, attached interluminal clot, which is very collagen, risk rich, which is absorbed by the body and then fills the vein lumen through a fibrous cord. So pretreatment, you get blood flowing in the wrong direction, pooling in the limb. Post treatment, the deep system takes over full venous return, curing symptoms. Our value proposition is quite clear. It's non inferior efficacy, target versus market leading radio frequency. It's safe. We know that from two pilot clinical trials, and it has been tolerated very well by all patients. And it allows vascular surgeons intervention radiologists and cardiologists who treat veins to treat up to twice as many patients per day. And it has no capital expenditure. We have key opinion leader support from Dr Lowell cabinet, past president of the American genius forum, who sees great potential for this class two, Single use, disposable we're targeting a 510, K submission this year for the mechanical ablation and fusion cats are intended use and can utilize an existing mechano chemical reimbursement code for fast market entry. The market opportunity, conservatively, is over $3 billion with our main markets. We're focusing on the US, EU and Japan, just as shy of $2 billion and 20% of this market is obtainable with the right device that we believe we have. To date, we've been very capital efficient. We raised $5 million in 2020 just 10 months later, we were in our first in human trial, treated 11 patients, proved the device at platform of safe, pain free and improved clinical and quality of life improvements. We've used non dilutional grant supports from Irish and the European Council governments to progress through gen two development of the trial, which is currently on enrollment. Enrolling. We treated 10 patients so far with unbelievably superior results compared to under non terminal treatments. 90% of our patients are seeing an 80% improvement in quality of life symptoms. We're raising a Series A towards the end of this round, which we're going to use for our regulatory submissions and to gather post market clinical evidence through registry studies and post market pivotal comparison studies versus market leading radio frequency and to allow us to initially target clinicians with this new reimbursement code, this shows the sequence of our trials run in sequence with the 50 patients treated in 2025 a pivotal of 200 patients, dual arm study in 2026 before raising a further Series B round for full commercialization and scale up in 2027 we built an experienced team of clinical advisors, technical people and commercial executives who've done previous exits in Successful Venus medtech companies were backed by a Japanese healthcare firm, nepro Corporation, one of the top four public healthcare firms in Japan. The current market is dominated by Medtronic but they pose higher risks. Recent evolution in the market is towards a less invasive, non thermal option, which we offer. BD entered the market recently, and Boston Scientific showing that there is an opportunity here for existing peripheral intervention companies to enter this new opportunity. This shows the exits in the area of the last 15 years. But the point is, really that an exit is possible here at the series, a traction or growth stage into our B round. So in summary, this is a big problem. It costs a lot of money. It's not solved. Patients and clinicians are looking for a less invasive solution, and we have it. I'd love to talk to investors and strategics who would like to join us on this journey to restore quality of life to millions of patients through solving this very painful and devastating disease. Thank you very much. Thank.