Video Transcription
Stephen Cox 00:02
Every year, 12 million US and EU citizens suffer from venous leg ulcers as a result of chronic venous disease, which is venous leg ulcers are a devastating condition. They destroy quality of life and have a severe impact on quality of life, similar to heart failure. Chronic venous disease itself is very prevalent; it affects one in four adults in this building. It's the fourth most common chronic disease and the third most expensive chronic condition in the world, and it gets worse for about 4% of patients per year if you don't treat it. It's caused by valves in your leg veins, which are responsible for stopping blood from flowing backwards. When those valves don't function anymore, they become incompetent, and blood leaks towards your foot, which is known as reflux. The goal of treatment here is to close off this superficial vein to allow blood to return to the heart through your healthy deep veins. It's a spectrum of disease. It starts out with varicose veins, bulging, snaking varicosities, and then as blood starts to leak into the limb, you get swelling in the limb, discoloration, and unfortunately, that leads to chronic open wounds that don't heal, known as venous leg ulcers. Venous disease causes 80% of all leg ulcers across all modalities. This leads to a huge number of patients who suffer from the disease, specifically the 12 million I talk about, who are in a vicious cycle of active and recurring venous ulceration. They are very expensive, costing $10,000 each per year to manage. Current treatments for superficial chronic venous disease burn the vein to close it up using targeted vein delivery of radiofrequency or laser. But to do that, you have to insulate the surrounding tissue with a liter of anesthetic fluid through a 10 to 20 preparation injection. These thermal treatments are effective, but they pose higher risks, especially for venous leg ulcer patients, as the risks of nerve and skin injury below the knee increase. So instead, venous ulcers are conservatively managed with compression bandaging, which is even worse; it doesn't really work, is very slow, and has a high 50% recurrence rate at four years. Vascular surgeons want to intervene earlier and treat the source of the disease, and they've proven with NHS randomized control trials that this reduces recurrence and healing time. So our goal is not only to treat the ulceration but to prevent it from starting in the first place. That's why we've developed the InVera endovenous mechanical ablation and infusion catheter. It's an endovenous catheter with a 100-centimeter working length, and at the end of that catheter, we have a proprietary abrasive helical coil which we use to denude the endothelial lining in the vein. The coil has an abrasive surface with features that are twice the width of human hair. This fits in with the standard of care of current vascular surgeons who treat the disease in an office-based procedure. They use standard, minimally invasive techniques to enter the diseased vein just distally of the diseased section, usually at the knee or below, navigating up through that truncal vein, usually the great saphenous, stopping short of the deep system. When they are happy with their placement, they deploy our device, which unfurls a helical coil that exerts an outward force on the inside of the vein wall. Then the physician withdraws our catheter using a specific clinical technique, treating up to 10 centimeters at a time. This withdrawal mechanism debrides and denudes the inner vein lining, the first vein layer, the endothelium, and into the media layer. This triggers acute venous spasm, collapsing the vein down over our coil, but also causes cellular damage in a mechanical way to that vein wall. At that point, the physician injects one to two milliliters of a chemical sclerosing detergent known as polidocanol, which is infused into the vein wall, deepening the ablation. This sclerosing liquid is delivered deeper into the vein wall because we've etched away this outer surface, which is a protective layer. The actual sclerosing agent itself is a liquid surfactant that breaks down the lipid bilayer of the cell wall, leading to cell lysis and cell necrosis, deepening the vein ablation. The acute response to the treatment after they treat every section is acute thrombostasis. So we get an attached intraluminal clot. We don't leave anything behind; there are no implants left behind. Once this clot is formed, after about eight to 12 weeks, it's absorbed by the body into a fibrous cord which fills that vein lumen and prevents blood from pooling in the limb. So before, on the right-hand side, you have blood flowing in the wrong direction, pooling towards the foot. After treatment, you have all blood returning to the heart through the healthy deep system. Our value proposition is clear. We're targeting non-inferior efficacy compared to market-leading radiofrequency ablation. We know it's safe from our two pilot trials, and it's been pain-free and well tolerated. It's faster, allows vascular surgeons to treat more patients, and is very intuitive for those who treat the disease. We have key opinion leader support from Dr. Lokabnik, who sees great potential in this single-use disposable Class II device. We're targeting a 510(k) early next year for an infusion catheter and tend to use an existing mechano-chemical reimbursement pathway. The market opportunity is huge, over $3 billion conservatively, with the US, EU, and Japanese markets as our target for a 20% serviceable, operable, obtainable market in the medium term. On this journey, we've conducted a number of clinical and preclinical trials, prototype development, and two pilot clinical trials treating 26 patients, which have been successful in two US medical device accelerators. We've obtained $5 million in equity funding and $5 million in non-dilutive funding. Our most recent pilot trial shows superior results versus our closest non-thermal competitor, with a 90% improvement in quality of life. We're targeting a €20 million Series A early next year, which will be used for our regulatory submissions, our initial market studies, and a pivotal clinical study versus market-leading radiofrequency and initial user adoption to get this technology into doctors' hands as part of a limited market launch in the US. For full-scale commercialization, we'll be targeting a full $30 million Series B and $27 million for full market scale-up. We've assembled a very strong, experienced venous med tech team over the last number of years, with backing from a Japanese corporate, Nipro Corporation, which has a seat on our board, and also a number of other backers. The market future is clear; non-thermal technologies will take over this incumbent radiofrequency domination, and a less invasive option makes the most sense. We've seen recent entrants from corporates such as BD in the last number of years. What other peripheral intervention areas are companies interested in this high-growth area? This slide shows the exits in superficial venous reflux ablation in the last number of years. But what it proves is there is an exit very feasible here, at the end of a Series A, at early-stage traction, or after the B, into our growth phase. In summary, this is a big problem. It costs a lot of money. It's not solved. The market is looking for a less invasive solution, and we believe we have it. We're investing in the clinical data to prove that. My name is Stephen Cox, and I'd like to thank you all for your opportunity. I'm happy to take any questions after the event. Thank you very much. Applause.
