Video Transcription
Finbar Dolan 00:02
Finn, good afternoon. My name is Finbar Dolan. I'm the CEO of Versono Medical, and as we just started initiating our first site for our pivotal study on Tuesday, I should say that we are transforming the endovascular treatment of patients with severe, complex total occlusions, patients who need the minimally invasive procedures most. There are almost 250 million people around the world suffering from peripheral artery disease, and those who receive a diagnosis of the most advanced form of that, critical limb-threatening ischemia, face a prognosis equivalent to aggressive cancer. Twenty-five percent will have died within the first year of diagnosis, but 30% of that population will receive an amputation, at enormous cost to them, but also to the healthcare system in the US. Well over 10 billion is spent performing those amputations, and the amputees for the remaining portion of their lives incur an additional $1 million over the normal cost to see for their care. There are over 2 million procedures done to treat patients with critical limb-threatening ischemia between the US and the top five countries in Europe. About 1.2 million cases are treated in the US by minimally invasive techniques and by surgical techniques, half of which are done minimally invasively using endovascular technologies above the knee and below the knee, and the other half receive traditional endarterectomies, bypass grafts, and still today, approximately 200,000 people in the US receive a major or minor amputation. And the awful thing is, it need not be that way. The very first angioplasty was performed by Charles Dotter as a limb salvage procedure. But not every endovascular procedure is successful, and the principal reason for that is because in over 50%, the blockage is so severe and so complex with the consistency of sausage and cement that guide wires, which are used to transfer and guide the therapy to restore blood flow, can't make their way through the blockage. Some physicians can attempt complex techniques by going subintimal and trying to use additional devices to cross eventually, but those techniques take time to practice, are slow to perform, and often fail. Fast Wire is a solution that will allow physicians to cross, first time, all types of lesions of all consistency and length, in all anatomies above the knee and importantly, below the knee. It's simple to use, and more than that, it's a transformational technology, and it was designed for market adoption, in contrast to existing technologies, which are large systems that require the services of the engineering and maintenance departments in hospitals to operate. Fast Wire can be taken from a shelf and used as needed in whichever operating theater the doctor wishes to work in. And more than that, it is also a new platform technology with a progressive series of indications in its product pipeline over the next few years, in vessel preparation and in vascular sensing. The potential of Fast Wire was demonstrated in the first-in-human study that was performed and completed in January last year by Dr. Mustafa and presented at the NCVH last September by Dr. Walker. And it just worked on severely calcified CTOs with an average length of about nine inches or 23 centimeters. All of those CTOs, even though they were considered to be impossible in some cases to cross, even using those advanced techniques, were crossed. They were all crossed intraluminally without any dissection or perforation, and they weren't very challenging. This slide just gives you a sense of how challenging. The shortest was just 60 millimeters, but the longest was 500 millimeters, running from the femoral artery all the way down to the tibials. But more than that, we considered three times more tibial disease vessels than fem-pop, in contrast to other devices and other technologies. The most notable thing, though, is the crossing times. So the crossing times were akin to a non-CTO, so the physician was able to cross those very long lesions in roughly about five minutes, which might not have crossed at all or would have had severe difficulty with. And because of the length of that very long one, you can see there's quite a variance there. But even with the long one, it's still only just about 10 minutes, and doctors can spend 45 minutes to an hour just crossing. The most notable thing, commented on by many of the physicians, is just how outstanding the results were below the knee. Not only were these severely challenging lesions crossed, but they also allowed for the therapy to be inserted and the vessel revascularized in below-the-knee disease without any observed dissections. So it seems to not only allow you to cross and create a sufficient aperture to introduce your therapy, but also will soften the plaque and allow you to inflate the balloon and achieve sizing at about nominal bar pressure. We've just started our free flow pivotal study. We hope to complete it over the next number of months, and we're at a new stage for the company, where we're now focused on developing our marketing and sales strategy. Our strategy is to go narrow and to go deeper into more below-the-knee disease, speed up cases, and allow more physicians to treat more below-the-knee disease, replace difficult-to-open procedures, and prevent these awful amputations by focusing on the unique selling points of Fast Wire, allowing first-time crossing, crossing all anatomies safely, and then saving time and allowing physicians to restore the reimbursements that they would get for performing these procedures. More than that, there's a pipeline to follow into more valuable market areas. We've raised 19 million to date, and we're looking to raise next year a 25 million Series B to bring the product through commercialization and to develop the product pipeline. We have a very experienced management team, a significant non-executive board, and we're working with the top physicians in the world. As I said, we've closed 19 million, we're at 1345, stage two company, and we've done everything along the way according to and in conjunction with communications with the FDA. We've advanced the Fast Wire technology's capability, and we have a strong patent portfolio of six patent families, multiple awards in the US and across the world. We have been awarded a disruptive technology innovation fund that allows us to work on these additional pipeline opportunities. We also were a receiver of a European Innovation Council grant for disruption that allows us access to blended finance of an additional 13 million. We've built a really extensive supply chain, and we've also done a competitive RFQ, so we've got a profitable product, and we've built with tier one suppliers, so we're working with the companies that are already on the approved suppliers list for any of the multinationals. We've completed a successful first-in-human study, and we're just in the process of starting our pivotal study. Thank you very much.
