Declan Soden Presents Mirai Medical at LSI USA '23

Transcription

Declan Soden  0:05  

Delighted to be here this morning on behalf of Mirai Medical, we're an Irish medical device company based out of Galway. And our mission is to transform how disease in the gastrointestinal tract is treated. And we're using a targeted precision ablation technology that uniquely can trigger tissue regeneration, and has huge potential for improving overall patient care. So when we talk about the gastrointestinal tract, or the gut, it's a hugely important organ to over nine meters in length. It contains trillions of microbes, in fact, more microbes than there are cells in the human body, there's more neurotransmitters released in the gut than there are by the brain, it releases hormones that control metabolism, the majority of our immune system resides in the gut. So it's a hugely important part of the body that's very delicate, very easy to perforate, or tear. And clearly, when things go wrong in our gut, it can have serious consequences for overall health. So with that, in mind, Mirai Medical has developed a platform technology, looking to improve treatment in the GI tract using a technology that's called pulsed electric fields, or electroporation. And what's unique about this technology is that allows us to treat without destroying the extracellular matrix. So we can treat deep and we can treat broad and we can do so quickly. And we don't have to worry about destroying nerve and healthy tissue structures. And as I mentioned earlier, we get this very nice tissue regeneration, then this opens the door to treating a very broad area of unmet clinical need of indications from pre malignant disease through to GI cancer bleeding, and potentially as well down the road in terms of type two diabetes treatment by treating within the duodenum. So we as a company have CE approved the ePORE generator, and in dove a device that's on the market. Now we've completed four clinical studies, we have over 200 patients treated in Europe primarily. And we were fortunate to get a 7.2 million r&d grant in 2021, which allowed us to develop a new family of devices that can be delivered through the working channel, essentially, to simplify and make it easier for the endoscopy to deliver the treatment. So what we're offering the value we're offering essentially, as for any endoscopist to deliver the treatment as a simple outpatient type solution that can be performed at any hospitals small or large. And that's really, really important. In terms of the overall value proposition that our technology is offering, it hits on the kind of, I guess, perfect trifecta of offering support and benefit to the patient, the payer and the provider by reducing the degree of hospitalization by reducing the cost to the reduce of complications. And the side effects. The patients benefit hugely from this sort of approach to helping to manage their disease. We also open the door for more in endoscopist, to be able to deliver the treatment reducing the barrier terms of the training and time required to become an expert in terms of delivering the technology and that obviously then ultimately benefits patients in terms of a broader cohort of patients potentially been able to benefit from the technology. Looking at the current treatment approaches, and specifically with a focus on pre malignant disease and looking in the bowl to colorectal cancer or pre malignant colorectal cancer. Essentially, these complex polyps are complex colorectal polyps These are large in size and difficult to remove, they're in hard to access areas of the body. There's about 600,000 patients a year in the US that we'll end up having surgery for pre malignant disease, the current solutions of endoscopic surgery, ESD and mortar, they're time consuming, they require a lot of hospital resources. And then you know, a lot of patients will end up undergoing surgery, which obviously comes with its own risks, particularly for patients with comorbidities. And essentially what we're offering is to be able to treat this group of patients rapidly, simply in a matter of minutes as a an endoscopic outpatient procedure. For the commercial opportunity around this, there's about a million cases a year of complex polyps identified in the US market alone. So patients over 50, about 50% of patients will be diagnosed with a polyp. Most are easily removed with a snare, but about 15% or so will be what's defined as a complex polyp difficult to remove and they put an awful lot of pressure on the hospital system in terms of their management. And there's more and more of these cases being identified every year with advances in screening and advances in imaging and AI and so forth. And we currently don't don't really have the solutions in terms of how to adequately manage that in an efficient manner. When we look at the market, there's about 56,000 patients a year in the US when have recurrent polyps and they were very difficult to remove and currently required typically they'll end up having surgery. So that's a particular area that we would see a tremendous value in our approach been able to demonstrate that we could help these patients to avoid surgery for their treatment. Looking at the upper GI space, it's actually very nicely neatly defined in terms of the tremendous work that barracks did, using radiofrequency ablation to treat pre malignant esophageal cancer or Barrett's, they were able to demonstrate reduced risk of going to develop progressive disease. Medtronic obviously acquired Barix, a number of years ago. And we would certainly like to follow that model of demonstrating ablation and reducing the risk of disease progression in the lower GI space, but also for berets as well. So we believe that our solution our technology can demonstrate superiority in terms of efficiency and cost savings for for hospitals, and also be able to treat a broader range of patients as a result of it's a better safety profile. For us, the market access roadmap are already on the market in Europe, we have CE approval for the poor, and the handover device. We are well down the path in terms of the development of this new family of devices. We're in large animal studies right now. We have four clinical studies completed and published. And we have a 510K roadmap and we plan to submit on this later this year, we'd anticipate a 12 month review process and hopefully then commencing clinically in the US at the start of 2025. We've had excellent engagement with some of the leading cancer hospitals here in the US with the Mayo Clinic with Memorial Sloan Kettering, Cleveland Clinic and so on, they're all keen to begin clinical work with us once we have that 510K in place, there are reimbursement codes where we intend to tap into and obviously then as part of our overall strategy and plan will be to build the health technology assessment demonstrating the full value proposition of our technology. Terms of the funding and exit for Mirai were funded through seed through high net worth individuals, enterprise Ireland, in Ireland, and we are now commencing a Series A round to 20 million to bring us through that FDA road map and through to initial clinical evidence building in the US market and that ties in nicely with potential value inflection points and exit for investors. So our team we have over 20 staff and as I mentioned the broad experience in the medical device space we've already brought to market and are in sales with and in dovie my own background is as a scientist with a PhD in genetics and molecular biology have a lot of experience with pulsed electric fields in cancer treatment over 20 years. Our chief operating officer comm forward is here today as well. Colin has a lot of experience in the medical device space and previously had an exit for an embolization catheter to see our part. Our board is led by Chairman Kieran Moynahan, and we do plan to broaden the board with US commercial and strategic experience over the coming months clinically, we've had huge support from Professor Izmail goldenear. At the University of Copenhagen Dr. Hammond Hajji kings hospital are now working with Dr. Reddy at the world renowned AIG Hospital in India. That's one of the largest industry hospitals in the world. So then, finally, in terms of Mirai Medical In summary, I think it's important to just emphasize how potentially disruptive this technology of pulse electric fields and the manner in which we deliver it as an outpatient solution can be, and how it can potentially impact tremendously for patients and address many unmet clinical needs within the GI space, we can offer a safer, more efficient solution for doctors to be able to treat their patients. And we're also democratizing access for an Tosca bus, we're lowering the barrier in terms of the amount of training required that we're removing the barriers to entry for industries, it doesn't matter what size hospital they're at, whether it's big or small, they will be able to deploy this technology to treat their patients. And that's ultimately what they want to do. They want to be able to treat their patients that don't want to refer them over to surgery. So offering them the tools to be able to treat their patients and to be able to treat a broader group of patients is really for marine medical is adding value. We've Duris the technology we have CEU approval, we're on the market in Australia and Singapore, as well. We have a growing patent portfolio. We have a lot of experience with this area of pulsed electric fields. We have patents filed on the devices and the pulse parameters being utilized for market access sales in Europe. There are codes here in the US that we would intend to utilize as well. And then finally, in terms of you know, an important point maybe in terms of decarbonisation, unable to reduce the carbon footprint for patients and for the hospital is obviously hugely important. And it's an area I think we can also add value to with this technology. So thank you Your time I'd be delighted to follow up with any investors as we begin our path to Series A round. Thank you very much