Transcription
Thank you very much. And good morning everyone. My name is Finbar Dolan and I am the CEO of Versono Medical. Versono Medical is minimally invasive vascular device technology company focused on transforming the endovascular treatment of the severest complex occlusions or blockages in arteries. And the patients who experienced the worst of these with critical limb threatening ischemia of the most advanced form of peripheral artery disease. There are over 200 million people worldwide who suffer from peripheral artery disease. And in the US in Europe alone, 8 million people who have critical limb threatening ischemia, it's hugely under treated. And despite this, there are over 2 million procedures done annually to treat critical and threatening ischemia, half of which are done endovascularly through the arteries, which accounts for the $10 billion market for peripheral vascular balloons and stents. And us atherectomy devices, and the other half receive open surgery in the form of endarterectomy graphs, and an increasing number of amputations. Patients who receive a diagnosis of critical limb threatening ischemia faced the same mortal prospects as patients who receive a diagnosis of an aggressive cancer. One year after diagnosis, 25% of patients will have died five years after diagnosis 60% of patients will have died. And worse, in many ways, these patients 30% of them will receive an amputation within the first year at huge expense to themselves personally, to their families, to the community, the healthcare system and the general economy as a whole. One of the patients that was treated in our first in human study recently had a toll just like this one. But the lady was just 35 years of age, had an extensive blockage in her thigh. So instead of receiving an amputation for a toe, she was about to receive an amputation of her entire leg. And you can imagine the cost of that emotionally as well as financially. But what it showed and what studies such as the prime studies, the Liberty 360 studies and many other studies is that successful endovascular treatment can prevent amputation. However, not all endovascular procedures are successful. And this is principally because of the composition of these complex blockages, or lesions, which are the consistency of cement and tar. They're calcified and fibrous, hard and tough, and the prevent guidewires the little wires that are introduced to your vasculature that crossed the blockage and delivered the therapy to reopen the vessel can't do their job. Some experienced physicians can attempt to cross using complex techniques, but these are time consuming and often fail. Unless experienced physicians attempt to do so less often and have greater and greater failure. And even the most experienced physicians are very cautious about treating below the knee tibial arteries because they're much finer and torturous for fear of damaging those vessels and opening up the risk of further surgical intervention. So Versono fast wire technology can cross these lesions and deliver the therapy quickly. It can cross all types of lesions of all composition, and all in all anatomies above the knee and below the knee and elsewhere. It's safe because it's supple, and it can conform to the shape of the arteries. And it's simple to use. So a single operator can use the vise push the button to turn it on, and push in order to turn it off. More importantly, an important from an investor point of view is that it is a truly transformational technology. And there is a series of products in the product pipeline for further therapeutic and diagnostic indications to follow. Compared to its competition fast wire can allow physicians to treat those patients today, above the knee and below the knee. And critically important from a physician's point of view. It's much more compact, it's easier for the purchase for the physician to purchase without involving all of the other departments within the hospital. And so it eases adoption. Versono has spent a lot of time working with physicians around the world and with over 30 physicians between the US and Europe. From interventional radiology, interventional cardiology and vascular surgery. All of the types of physicians who try and treat this disease. And throughout COVID We worked with the team of those types of doctors to put their eyes and hands on the device so that we are creating something meaningful. Now we're really blessed to be able to work with three of the foremost physicians in this field in the world. That to Jihad Mustapha, who convinced the Amputation Prevention conferences in the US and Europe each year. Dr. Thomas Salary is one of the most respected peripheral vascular interventionists in Europe. And Dr. Craig Walker who convenes the new Cardiovascular horizons and is one of the foremost and leading figures in the whole field. These physicians believe that fast work can revolutionize the market and can transform the treatment and drastically improve the treatment of their patients. Today's risotto has raised over 12 million euros and to bring the product beyond approval. We've built a highly capable and competent team to execute. We've received approval for ISO 1345 certification, and we've aligned with the FDA on our pivotal IDE study for later this year. We've advanced the technology, and we protected those advances through a broad series of patents, or the US and around the world. We have further demonstrated or proven the potential of the technology by receiving a disruptive technology innovation fund in order to commercialize that IP portfolio and productize those solutions and the pipeline of products that lead for Sona into the future. But most importantly, we've completed a successful first in human clinical study on patients who had the severest forms of calcification in their vessels. And we treated three times more below the knee disease than above the knee disease. It's been terribly exciting working with the team and Versono Medical over the last number of years, bringing the product from concept through benchtop and through to preclinical animal and fresh cadaver studies and a successful first in human study. And we're about to begin our pivotal work over the coming year. And we're currently seeking $13 million to bring the product to a very structured and controlled limited market release, leading to full market release over the next number of years. What Versono offers investors as an experienced management team that have commercialized a large number of medical devices, vascular medical devices in the past, and an experienced non executive board of directors composed of people like John Ashot and CEOs founder and chairman of Nurai Peter Walsh used to run all of mechatronics global operations manufacturing Marshall Claffey who's a Senior VP in Johnson and Johnson with clinical regulatory background, Nigel Jones, who is the founder of the Linklaters IP practice. This is on top of a really, truly world class clinical advisory board. Our investors are all domain investors, med tech and clinical professionals. We're in the highest growth segment in vascular with the highly effective device technology that can not only solve this tremendous global need, but also provide a progressive technology platform into the future. And just to clarify a little bit on that fast word cannot only migrate from peripheral anatomies into coronary and beyond. But we have a progressive technology disruption pipeline as well, that will allow us to go for vascular preparation, and also sensing over the next number of years funded through the innovation disruptive innovation technology fund. So thank you very much. Look forward to speaking to if you have any questions and would like to know more about Versono after the meeting. Thank you.