Finbar Dolan, Versono Medical - Intravascular Ultrasonic Platform | LSI USA '24

Finbar Dolan  0:04  
Thank you for your attention. My name is Finbar Dolan I'm the CEO of Versono Medical and Versono Medical is a goalie based medical technology startup company focused on an enormous global need to transform the endovascular treatment of complex total occlusions. There are over 250 million people globally suffering from peripheral artery disease in patients who received the most advanced diagnosis of that, of critical limb threatening ischemia face a prognosis equivalent to an aggressive cancer. 25% of patients will have died after the first year, and 30% of patients will have an add an amputation at enormous personal expense to them, their families and their health care systems. And over 2 million people receive a procedure a surgical procedure for critical limb threatening ischemia. Half of those receive a minimally invasive endovascular procedure and the other half receive open form of surgery either an endarterectomy or bypass procedure. And still today in the state about 170,000 patients receiving a major and minor amputation. enormous costs to the healthcare system. The CMS spends about $10 billion a year performing those amputations and the surviving amputees incur an additional almost 1 million additional dollars in health care costs over the remainder of their lives. Each year, there's 170,000 million added to the cost of health care in the States as a result of the amputations. And the terrible thing is it need not be that way. Successful endovascular procedures. Indeed, the very first endovascular procedure performed by Charles daughter was a limb salvage case. And it demonstrated that successful endovascular procedures can prevent amputations. However, not every endovascular procedure is successful. And the reason for that is that in over 50% of cases, the blockage is so severe with the consistency of cement or tar, it prevents guidewires delivering the revascularize in therapy. So six years after the first angioplasty this enormous need to be able to cross through these blockages in both the peripheral anatomy as well as in the coronary anatomy and beyond exists. Some doctors can perform complex techniques to get around these cases, but they're very time consuming take a lot of practice to perfect and often fail. But fast Why does is it allows physicians first time every time to cross any type of blockage, whatever its composition, calcified, or thrombus or fibers of whatever length of two millimeters 20 millimeters 500 millimeters in any location, above the knee and below the knee and beyond. And it does so safely because it's simple, and it's very simple to use. So physicians don't need to learn very advanced techniques. But more than this fast wire is a new platform technology. And the engineers and versona are currently working on a pipeline of products to meet further therapeutic and diagnostic indications. This video will just demonstrate how the product operates. Crossing complex title occlusions CTOs have been an enduring and the most challenging need in endovascular surgery. Many innovative products and surgical procedures have evolved to compensate but are difficult to execute and time consuming to use. versona is crossing wire arterial Access Technology simplifies and speeds up treatment complex lesions in peripheral anatomies are challenging due to their length and heterogeneous composition. calcified segments in CTOs make crossing them with guidewires time consuming it best verse Sonos crossing wire system is a compact off the shelf product which includes an actuator a driver and a specialist. Proprietary endovascular wire that can be easily stored in the cath lab via Sonos crossing wire is used like a conventional guide wire, and when in position at a CTO it is threaded into the actuator, the proximal button is pressed down, allowing the wire to pass through the actuator, the actuator is fed over the wire to the desired location for activation. The actuator is then locked into position by turning the distal car which when pressed in and rotated clockwise will tighten the actuator to the wire with the desired level of tool so gripping the wire with sufficient force to allow ultrasonic energy be coupled into the wire. The physician can then energize the activator with ultrasound whilst advancing the wire carefully through the lesion the progress of the advancing wire through the lesion and the diameter of the new lumen that has been excavated by the vessel no crossing wire system can be viewed under fluoroscopy distinct features at the distal end of the crossing wire provide optimum visit ability to the physician, allowing them to understand precisely the wire location while considering the suitability of the excavated lumen for follow on therapy. Verso knows technology platform can navigate throughout the vasculature and treat CTOs in femoral popliteal tibial, arterial anatomies. When activated, the crossing wire transforms into a device that can rapidly excavate and cross through any type of clock calcified or fibrous. This is optimized by controlling the distal end of the wire and the ultrasonic energy applied to a faster was demonstrated in first in human studies that were performed last year by Dr. Mustapha and presented last September by Dr. Walker. Only severely diseased arteries were considered in the study, and three times more tibial arteries that are considered than femoral popliteal arteries. They're all long, the average length was nine inches or so in length. And fast, far across all of these blockages successfully, without any preparations, any dissections or any failure of the device. And it did so in crossing times that are equivalent to non CTOs. In other words, the physicians will be able to treat more vessels or more patients more successfully using the technology. This slide just gives you an idea of the challenging lesions that were across, they're all calcified, and ranged in length from 60 millimeters, or about six centimeters to half a meter in length. The Crossing times antegrade were about five minutes, typical wiring time would be about six minutes, and going from the dorsal and dorsal people anatomy up was a matter of only seconds. But more than this, this is the results of one of the cases where you can see on the left the case, the arteries beforehand, and on the right, the rear vascularized artery, which was better and size that nominal pressure. This indicated a secondary effect that's been noticed with the technology, then both the tibial and the femoral anatomy where the device has gone down through the center of the vessel. But also because of the way in which the physics is controlled in the wire allows a lateral oscillation at 20 kilohertz to disrupt the plaque. The intramural plaque the medial plaque in the vessel wall and allows safe expansion of the angioplasty balloon under that pressure. So it not only crosses but it also softens the vessel and allows for a successful angioplasty without any dissection. The potential of fast wire has also been recognized as a platform technology by the disruptive innovation technology fund in Ireland. And our engineers are working in further indications of vessel preparation, and also vascular sensing. We're currently raising 7 million as an extension to our existing round and looking to raise 25 million euros next year to commercialize the technology. We've rearranged our boards, and we have our Chairman Jim Green, who's an ex Senior VP of Sales and Marketing for Medtronic, but also his years of experience in commercializing new technologies and startups. And with Peter Walsh, who used to run all of Medtronic operations, global manufacturing operations, and an exceptional team of physicians, Dr. Walker, Dr. Mustapha, Dr. Zeller and Dr. Chris Lazar, I'll leave you with this slide and thank you for paying attention. And the list of our achievements is there if there's any questions, please?