Upma Sharma, Arsenal Medical - Biomaterials for Neurovascular & Trauma Conditions | LSI USA '24

Upma Sharma  0:04  
Thank you everybody. It's great to be here this afternoon. I'm CEO and President of Arsenal medical upma Sharma arsenal is an innovative biomaterials company, and essentially what we're doing is we're making new materials as medical devices, and in doing so, that's allowing us to treat diseases that haven't previously been treatable, or reach areas of the body that have been previously inaccessible. We've demonstrated this concept in three clinical stage materials. We've created an embolic to treat brain tumors and brain bleeds that we'll spend the bulk of the time talking about today, a product to stabilize abdominal bleeding that We'll also touch on, and then a product that we spun out in lira therapeutics in to treat chronic rhinos sinusitis. The vision for Arsenal really came from our founders, who have created companies like moderna that we're all familiar with, and Genzyme and are really luminaries in the fields of material science and chemistry, and recognize that those tools were being used to create better vaccines, create better biologics, but were really underdeployed in medical technology and medical devices. And so they wanted to create a company recognizing the untapped potential. Historically, a lot of materials for medical devices are made by repurposing household materials. One of the examples they give is that the first artificial heart was really used created using a woman's girdle. And so rather than thinking about what are just the mechanical things we want a material to do, what about all the things a clinician would really want it to do? Hemocompatibility, biocompatibility, etc. This, this slide shows videos of our two clinical stage programs. On my right is our rescue foam product, and on the left is our Neo cast material, just briefly touching on rescue foam. So the the way I describe this is a is as a human fix a flat material. So you get in a car accident, your tire goes flat, you use fix a flat to get you to the gas station. If it's dead of your tire, it's your liver, and you're going to die before you reach a surgeon. Rescue foam could be administered and give you enough time to get to the surgeon alive. That product is FDA breakthrough designation. We have IDE approval and has been funded predominantly with non dilutive funding. On my on your right, our Neo cast product is a liquid embolic that's treating brain tumors and brain bleeds or chronic subdural hematomas. We'll talk about we've had some scientific validation on both of these programs through non dilutive funding, and on that product, we've completed our first in human study in brain tumors. So just a little bit about embolization and embolics. The idea of embolization is to cut off blood supply anywhere you don't want blood to reach. So imagine you have a tumor, and you want to cut off the supply of blood to that tumor to make it easier to remove to starve the tumor, you would do an embolization procedure. Embolization is a very large market, large addressable market, currently estimated to be $4 billion and to grow to $6 billion over the next decade. We actually think this is an underestimation, because there are a number of indications that continue to be explored for embolization, and that's because there's a lot of interest in moving away from surgical procedures to more minimally invasive procedures as disease burden increases, as the population gets older, and we see physicians continuing to seek new areas. Recent publications on use of embolization for chronic headaches and osteoarthritis will continue to grow this market one of the most common conditions, and expected to be the most common neurosurgical condition by 2030 is chronic subdural hematoma, or csdh. Csdh is essentially a bruise that forms on your brain. So a patient, typically an elderly patient, has some sort of head trauma. It can be as little sort of hitting their head and a bleed forms. The patient is likely anticoagulated, so that bleed that would naturally heal on its own continues to be persistent. A bruise forms, and that bruise grows. And symptoms can start with something like a headache, dizziness, but progress to almost looking like dementia and in fact, chronic subdural hematoma is the largest cause of reversible dementia, typically and Historically, it's been treated surgically. Literally, you take this elderly, frail patient and you drill a hole in their skull and evacuate the bleeding, but it doesn't. To the underlying underlying bleeding. So the underlying bleeding is really a leakiness of the capillaries that is still persistent, and so you can have a very high recurrence rate from those procedures. And so physicians have started to look at the use of legacy embolic agents to treat this. There's a first class of agents that contain a toxic solvent That's right, cytotoxic solvents that have been on the market for over two decades. And I think it just shows what a strong need there is for this patient population that these are the materials that are available that physicians are seeking. A second class of materials are glue based materials, essentially using the same materials that are in super glue. And these are the tools that physicians have to treat with to treat these condition as a liquid embolic you can see that despite these limitations, the multinational strategics are literally enrolling more than 1000 patients in randomized, controlled studies to test or to look at this condition, just showing what a strong need it actually is. Some of these studies have started to read out. In fact, the first data we saw last month from two of the studies from Medtronic and vaults, and the data in terms of embolization looks great. It's being described as a new era of treatment to use these liquid embolics. The liquid embolics, the embolization was demonstrated to be very safe and to have a significant benefit over standard management today, whether that's surgery or medical management, but it also highlighted some opportunities for a next generation agent. 80% of the cases with the solvent based agents require these elderly, frail patients to undergo general anesthesia to manage the pain that is associated with that solvent. 50% of the cases were only were not able to get very distal into the vessels. So again, if you think about what the root of the issue is, it's this bleeding deep within the vessels. An ideal material would obviously not have a solvent, would not be super glue, and would be able to get very deep into the vessel bed. And that's what we've created with our Neo cast material. It's a solvent free, non adhesive, embolic material that is used as sheer thinning science and is able to penetrate very deep into a distal vasculature. And you can see that comparison here with the market leading material shown on the top, this is six pig kidneys that have been treated with the market leading material, and on the bottom, with our Neo cast material. And again, you can imagine, think about this as like a brain tumor or a tumor structure. Our material is getting much deeper. It's much easier to use, and it's there's some studies now showing that deeper penetration will actually is expected to lead to faster patient relief. We've translated the first in human results into we've translated these results in our first in human study, where we've treated patients with brain tumors, and you can see the MRI of a rather large tumor that a patient had here that we embolized with the Neo cast material. And again, you can see the deep distal penetration we're achieving, very similar to what we saw in our preclinical animals. The physicians who got to use this in the first in human had a great user experience. They really appreciated not just the solvent free nature, the non adhesive nature, but the fact that the material was very responsive, easy to control, did what they expected it to do. So we're starting with brain tumors and brain bleeds. We think there's a number of other indications throughout the body. You can imagine tumors throughout the body that and bleeds throughout the body that could benefit from this. And we're currently raising $15 million to advance the Neo cast product to the next step in clinical development, with the rescue phone product continuing to be funded. Non dilutively, we have a great leadership team behind this, folks who have experience in startups and also multinational strategics, and our board has led companies such as chifon and Terry McGuire at Polaris as our lead investor. So hopefully today showing you some of the differentiated materials. Thinking back to chronic subdural hematoma, if you were a patient, would you want a material that was developed with a toxic solvent or super glue, or would you want a material that was really custom built for that right indication? Thank you. Applause.