Video Transcription
Declan Soden 00:02
I thank you. It's great to be here in Portugal, and I guess first up, thanks to LSI for organizing another wonderful event at a lovely location. So Mirai Medical, we're an Irish company based out of Galway, and to play this forward, what we're doing, what our goal, our mission as a company, is to enable all endoscopists to be able to deliver a technology called Pulse Field Ablation, to be able to effectively and safely ablate tissue in the gastrointestinal tract. So you may be aware, you've probably possibly heard about Pulse Field Ablation. It's generated a lot of excitement in the cardiac ablation space for dealing with arrhythmias. I think there's possibly some other companies presenting on that clinical indication here. It's really kind of taken off in that space. And what really helps, I guess, is when you have the likes of Boston Scientific that earlier this year announced they had, I think, just over 40,000 patients treated within their registry using the Fire Pulse system. It certainly kind of helps around confidence in using this new ablation technology, which is a very different mechanism of action to older ablation technologies. And really the key clinical benefit is the fact that we're not destroying healthy tissue structures, vascular and nerve structures. So this is kind of just a brief animation showing you the kind of the Endovi system, the Endovi device that we use to deliver this endoscopically within the GI tract. So obviously, it all is around team, isn't it? You know, having a great team, a world-class team, is hugely important in terms of any medical device technology and kind of bringing things forward. My own background is actually in gene therapy. We were using pulsed electric fields for gene therapy, converting cold tumors to hot tumors, which was where we initially kind of started the development of this technology. And then developed the endoscopic system because there was nothing available to be able to allow us to deliver pulsed electric fields to gastrointestinal tissue. Colin Forde, Chief Operating Officer, is a Stanford BioDesign, BioInnovate fellow. Seán Kinsella, CTO, is here with us today as well and brings a lot of experience, kind of in both the startup and the commercial world as well. And then naturally, you want to be working with some of the leading clinicians in the endoscopy space in order to kind of facilitate adoption and give you good strategic advice in terms of the development of your technology. So the likes of Dr. Rajan at the Mayo Clinic, Dr. Long at Perlman, Mr. Amen Haji, one of the leading kind of pre-malignant colorectal cancer specialists in the NHS, is based out of King's College London. We're also working with the likes of Dr. Mark Chatner out of Memorial Sloan Kettering. So, yeah, what does this look like? So, you know, maybe to give you kind of an idea, this is the Endovi device. It's on the front of the endoscope. It's been maneuvered through the bowel. We use a vacuum to grip the tissue. You see the tissue kind of comes in. The clinician can see it's been captured. The pulses are delivered directly into the tissue. You get an effect, actually, on the physiology of the tissue as well, where the capillaries shrink, and you see a very nice vascular lock or blanching of the tissues, which is kind of quite visible here in the kind of rectangular shape of the Endovi device after it. So we're treating the mucosa, the submucosa, and the musculature underneath it as well. And we're doing so safely. Obviously, that's the critical element. And the proof here is in terms of the clinical studies that we've been doing. This is data from our pilot study done at AIG Hospital Hyderabad. This is a bleeding complex polyp. You can see here on the far left, after the pulses are delivered, the tissue blanches again because those capillaries shrink. And you can see the response to the follow-up here at four weeks, obviously healthy mucosa replacing adenoma tissue, and most importantly, the underlying healthy tissue isn't damaged or destroyed, as would be the case if we were delivering a thermal ablation modality. Another patient, this patient had a resected endoscopic resection originally, which you see on the far left, who was bleeding, a young patient in her 30s. So very difficult case, treated with Endovi and pulsed electric fields over a year ago now, at this stage, and the follow-up again, the kind of the key benefit we've seen in our clinical studies is that we can deliver this. We can ablate pre-malignant and malignant tissue. We can do so while not destroying the healthy lumen of the colorectal tract, which is crucial. So what's the standard of care? Endoscopic resection? And this is an example of what happens. The clinician goes in, has to be a highly trained, highly skilled endoscopist. They lift the tissue and they carefully cut it out. A procedure like this can take, well, it can take a lot of time. It can take an hour. It can take longer, depending on the procedures. I showed you on the previous two slides, took an average of about three and a half minutes to deliver the energy. So you're talking about minutes to significantly longer. So that's hugely beneficial for the patient who goes home the same day. In a case like this, there's about a 10% risk of bleeding post-procedure requiring a visit to the emergency room. It's time-consuming. There's a risk of perforation, and there's an approximately 20% recurrence rate, depending on where it gets done and the skill and the experience of the endoscopist. So it takes about 80 cases for an endoscopist to get good at doing an endoscopic resection. It really takes them one or two with the Endovi, with delivering Pulse Field Ablation. So our goal is to enable all endoscopists, really just to be able to simply treat their patients. It's kind of point and treat as the kind of goal, or the vision we have for the technology. The Pulsar study, which started earlier this year, was very much focused on that, capturing the data around Pulse Field Ablation for complex polyps, treating kind of NICE type 2A lesions in the colon. So we managed to treat patients across the entire colon. No safety issues, which was the primary endpoint, pain or discomfort post-procedure, histologically confirmed responses. So we're very excited about that. We're just about to start the pivotal study at King's College London in the next month or so. There's a broad range of indications within the GI tract. So why target complex polyps? Straight up? Really, it's because of the market size. There's about 12 million screening colonoscopies in the US annually, 6 million or so polypectomies, so about half of patients will have a simple polypectomy removed. There's about a million or so complex polyps, and about 140,000 of those cases that have actually failed endoscopic resection previously. So the kind of key thing is you don't need pathology to treat that group. So that's our kind of entry point into the market. There are other areas, like GI bleeding, which we've seen excellent clinical results with, which we're kind of targeting, and Barrett's esophagus, which is pre-malignant, and esophageal cancer, which is currently treated with RFA from Medtronic primarily. But again, that's another kind of lead indication that we think has tremendous value. Obviously, like other companies here, like the other presentations, you know, IP is everything. We have a very robust portfolio that's 12 granted patents at this stage, built around the E-port generating a high-frequency biphasic generator, which is now patent granted, very low COGS. We've other IP around new catheters. We got a seven and a half million R&D grant two and a half years ago, which is allowing us to develop the next-generation devices as well, which is very exciting. We've also just had IP granted in the last two weeks on kind of the pulse parameters we utilize to achieve PFA, which is a hugely strategic moment for us as well. So that's kind of it. We're doing a Series A around $20 million to support us in our US market launch next year. We're currently preparing an FDA 510(k). We'll have the kind of 50 patient readout from King's College, the kind of pivotal study there early next year. And then the plan will be to kind of do a limited market launch in the US, some of the key sites in the US market, and kind of build on that. And obviously, there is reimbursement available for colonoscopy and ablation. So, you know, that's obviously the critical business element to get right around the reimbursement and coding before we would do a full commercial launch. So we have a booth here at the end of the hallway down here. Very happy to follow up and take any questions offline. Please feel free to reach out to me. Thank you. Applause.
