Stephen Cox Presents InVera Medical at LSI USA ‘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 and it destroys lives. So unfortunately, it has a proven impact on quality of life as heart failure. It's a very prevalent disease that affects one in four of every adult in this room, and it's one in three over the age of 65. And Lee is the fourth most common chronic disease in the world, which leads to an amazing healthcare spend of up to 3% of Western Health Care budgets, and it gets worse for 4% of patients per year if you don't treat symptoms. Those symptoms start when blood flows in the wrong directions valves and your leg veins which are responsible for stopping blood flowing backwards. They fail over time due to weakening vein walls and valve leaflets, which then allows blood to flow backwards and then you then get this viral Cassidy and pooling of blood. The goal of current treatment is to close this disease vein and allow blood to circulate and healthy veins. The symptoms start with varicose veins and leads to aching pain and swelling, then you get this inverted champagne bottle of edema. And as blood begins to leak into the surrounding tissue, the skin changes and discolors that leads to these chronic open wounds which are known as venous leg ulcers, which causes 80% of all leg ulcers, which have a venous origin. This leads to 12 million sufferers in the US and EU who have this vicious cycle of recurrence between active and temporarily healed ulcers and they cost $10,000 Each per year to manage. Current treatments are unacceptable. They burn out the vein, which is very invasive. And in order to start this minimally invasive procedure, they have to inject the patient with 10 to 20 Stab injections to inject a liter of anesthetic fluids to prevent skin and nerve injury. So patients are either in tears are they present when it's until it's too late? These current terminal treatments they are effective, but this invasiveness is even worse when you get into the higher spectrum of venous leg ulceration which occurs below the knee and poses a higher risk of skin and nerve injury. So non inferior efficacy and a less invasive option is where we're headed. Unfortunately, venous ulcers are conservatively managed, which is even worse because they're not treating the problem. They wrapped the leg with compression bandaging which needs to be changed twice every two weeks. And it leads to this 50% recurrence rate at four years and it's a vicious cycle for patients. Healing takes about three to six months as well. The early venous reflux ablation study at the NHS is a randomized controlled study conducted in 2019, which proved by vascular surgeons that treating chronic venous disease not only reduces recurrence time and it reduces healing rates of these venous ulcer patients. So the idea and treatments would not only treat but it would prevent the advanced ulceration symptoms and restores quality of life for millions of patients worldwide. And that's why we've developed our device. It's the world's first medical device to treat varicose veins and venous ulcers without harmful side effects. This short animation video shows how the device works. It's an end venous system which has a simple five French catheter which is entered into the vein and deployed with a single handed technique. The business end of the device is a purely mechanical abrasive helical coil, which has a textured surface. It this is an outpatient based procedure with over 90% of cases in the US treated in an outpatient setting. So we use ultrasound guidance the same as the standard of care. With the five frame system, the physician enters just distally of the refluxing section and navigates without a guide where up the truncal vein towards just shy of the deep system with the junction of the safarinow femoral vein. Then the coil is deployed on furling. withdrawing the outer sheath and unfurling the heel of the coil, which expresses an outward radial force on the vein, and then the coil is simply withdrawn, which triggers intense venous spasm of the response to injury but also causes the cellular damage in the vein wall necessary to promote long term healing with an inflammatory response. Everything is removed from the patient at this stage we don't leave anything behind. The response creates thrombo stasis which is then absorbed by the body and a fibrotic cords which fills the vein lumen and simply push this stops blood flowing backwards in the wrong direction to or force and allows blood to circulate back to the heart with through the deep, healthy veins. The value proposition is clear, it's non inferior to market leading thermal ablation, it's safe, it's pain free, it doesn't have harmful side effects or competitors. It's faster physician for physicians because they don't need injections to prepare for the technique. And it's intuitive with no capital requirements. We have key opinion leader support for this from Dr. Lowell carbonic who sees great potential for this class to single use device we're targeting a premium of $1,500 in line with current non terminal treatments and a cost of goods sold of $150 for a high markup of 90%. There's no predicate here. So it's a de novo regulatory pathway which provides for differentiation when we go to seek a new reimbursement codes, and it has no capital requirements. The market size conservatively is over $3 billion worldwide, with only with view in the US EU and Japan alone, serving up to 1.8 billion and we believe 20% This market is achievable in the medium term. To date, we've raised $5 million in seed private equity funding, plus the same and public non diluted funding, which we've used to progress to the clinic in 2021, where we treated our first 11 patients, which proved that the platform is safe, it's pain free, and it provides for clinical and quality of life improvements for all patients. Since then, we've improved the device with the gen two update using that clinical experience. The new design builds on what we know it relies more on the venous spasm we're accurately triggering now and has a more abrasive surface. But we've also developed the clinical technique required to get the best from this purely mechanical, novel approach. And our preclinical results from last year are better than anything we've seen and up there with the best current technologies. We're bringing that back into the clinic in the next month. For a pilot trial in Budapest, we're retreated up to 40 patients, and this year we're raising a 20 million Series A round. That rounds will fund regulatory IDs studies here in the US have up to 50 patients for our de novo submission and CE marking in Europe and Japan. We're also found a pivotal comparison study versus radiofrequency ablation to prove non inferior efficacy and less side effects and start off that peer engagement and clinical data marketing studies. This shows the timeline of our plans. Execution for those studies with the ID study running in sequence to the pivotal trial for payers. Then we would plan to raise a further Series B round for full scale commercial entry. We built a strong team of experienced technical, scientific, clinical and commercial backgrounds. And we have a board member from KneePro Corporation, one of the top for health care companies who led our seed round as well. We met following the biodesign process of bio innovate Ireland, which is the only only Stanford affiliated Biodesign program internationally. Current market leader is Medtronic with they have radiofrequency but the future is non terminal which hasn't been secured because current non terminals are either less efficacious or they have increased side effects. recent acquisitions from Boston Scientific and BD proved that this is an area of interest for existing periphery intervention companies, including our own seed round backer Nipro. This shows the exit values in the area. But what it proves is that early trade sales are possible here at the regular tree stage. It's an early stage commercial traction in between the A and the series B rounds. So it's a growing epidemic of high, high associated health care costs. Scientific evidence for earlier intervention, we feel now is the time for a less invasive solution for this purely office based procedure. We're interested in talking to new investors who can join us in our journey to restore quality of life 2 million patients across the world. Thank you very much.