Tim Jacobsen 0:01
Tim. I'm Tim Jacobson. I'm CEO of noxy health products. So noxie health products is a US based pharmaceutical company probably saying, What in the heck at a med tech conference? Well, it's because most of the products in the chronic wound market are medical devices, and so it makes sense for us to be here. Our treatment is based on a molecule that occurs naturally in the human body, nitric oxide. So we all produce it naturally. All mammals do. Nitric oxide has three modes of action. It's a vasodilator, which is how it's currently used in the clinics. It's a broad spectrum antimicrobial with no known resistance. And it's also the cell signaling molecule responsible for the wound healing sequence. Most importantly, nitric oxide governs the inflammatory phase, which prompts inflammation, but more importantly, brings resolution to inflammation. It's also essential in angiogenesis, cell proliferation, collagen deposition and ultimately, ultimately in scar remodeling. The current wound care market is sparse. Well, it's ironic. It's loaded with products, but sparse in its addressing of needs when it comes to the things that wounds need need to heal. Across the top, you'll see the different types of wound care products that are on the market. Down the y axis, you'll see all the things that the wound needs to accomplish in order to heal. The asterisk on the biofilm disruptor represents primary research that we've completed. As you can see, nitric oxide literally ticks all the boxes. Most of the products on the market today really are just about addressing various symptoms of mark of of chronic wounds, exudate, maintaining a moist wound environment, debridement. All of these things are designed to engage the body in its own healing process, but none of them address the core pathology of chronic wounds, which is nitric oxide deficiency. We didn't just check all the boxes to make us look good. It's actually backed by research, which is the final slide of the presentation. It's all done and documented by other scientists. The key problem is that as we age, we produce less and less nitric oxide more so if we suffer from a comorbidity, such as diabetes or vascular disease. And so by the time a person reaches 60 years old and they're a diabetic, they're really producing no nitric oxide in a meaningful amount. So you really have a supply side issue when it comes to the patient population that suffers from chronic wounds. Also because of these comorbidities, many of them suffer from a compromised circulatory system. And so you also have a delivery side issue, meaning that the only viable path to help these patients obtain the needed nitric oxide that they have is to apply it topically. So what we have is a very simple solution, simple, simple, but complicated in its simplicity. It's two liquid solutions. And let me back up and say this, nitric oxide is a gas molecule, and when it touches ambient air, it breaks apart in two seconds. So you can't just create nitric oxide, put it in a can and put it on a shelf. You have to be a little more creative. And so what we have are two liquid solutions, an A and a B, when they're both are housed within foaming bottles. When each solution is expressed as a foam, those two foams are then mixed together in that mixing nitric oxide is created and now is filled within the micro bubbles of the foam that combined foam is then laid onto the tissue and with and the layer of bubbles closest to the skin ruptures and bursts, exposing its payload of nitric oxide, and Then as each successive layer of bubbles touches the skin, the same thing happens, and within five minutes, the therapeutically meaningful dose of nitric oxide has been delivered. And so as I said, it's a five minute treatment. So we're in, we're out, we're out of the way the nurses and clinicians that are currently using our over the counter product, which I'll get to in a second, say that it's non disruptive to their flow of care and very easy to use. It's backed by 12 patents. We also have an additional 20 patents that are either in provisional or application phase, and we're about ready to file another patent, which is a we believe is a game changer and not something I'm going to talk about publicly. So publicly. So I mentioned advenox is our prescription, so we do have clearance from the FDA to proceed with studies in the United States. So we're going to be getting our phase one trial in two to four weeks on diabetic foot ulcers. Noxidermas are over the counter product, which is now launched and in the clinics live so Advent, the advenox is actually inside noxiderm. The creative thing that we did was that there's a list of pre approved products that are approved for over the counter use. We found one that was compatible with our formulation. We basically. Took our drug, ported it inside of noxyderm. While we won't be able to make any medical claims about it, we are able to say that nitric oxide is an inactive ingredient in the product. Follow the QR code if you're an interested consumer. Shameless plug for noxiderm, one of the creative things that we did was we strategically raised capital from owners and operators of skilled nursing facilities, and so we are green lighted to go into 60 of those facilities that are owned by our investors, and we're on target to exceed that. That projection for the second quarter all told our investors own probably close to 600 facilities. And so if we were to achieve 100% penetration with noxidurm in those facilities, we'll be able to achieve about 5.8 million in net revenue. So if we achieve a third of those facilities, if we gain access into a third of those facilities, we'll be able to successfully fund our operations, XR cost for R and D. We expect to do that by the end of the year. Going back to advenox, you can follow the QR code to my presentation on this in Barcelona, where I address various case studies. But needless to say, there is no uniform standard of care in the chronic wound market. There's only two drugs or biologics approved for use in the chronic wound space. Both are expensive and marginally effective. It represents a major unmet medical need. Nitric oxide deficiency is the main characteristic of this patient population, and so because of nitric oxides, triple mode of action, of vasodilitation, broad spectrum antimicrobial activity, and it being a cell signaling molecule, really addresses the core pathology of chronic wounds. Therefore, we believe and hope that avenox becomes the standard of care in the industry and really becomes the first line of defense. I mentioned our primary research on biofilms. We took six pathogens, both and all of them antibiotic resistant. We inoculated them with pig into pig tissue, incubated them until they formed a mature biofilm, and in 10 minutes of total exposure time, we were able to achieve a 99 to 99.99% reduction in those biofilms. This is groundbreaking research, and it's been published in the Journal of wound management, because of the modes of action that nitric oxide has, we really represent a platform of opportunities. Chronic wounds represent the largest unmet medical need. That's why we're going there first. But we really have acts or the ability to then pivot into burn wounds, surgical wounds. We're even working on an acne over the counter formulation as we speak. It's being tested right now, thanks to my nephew and my daughters, we can also go after eczema, telephonus, warts, medical esthetics, essentially, our platform represents 100 billion in Tam. The skilled nursing facilities represent a key more market for us, given our relationships, if we were to tackle all 16,000 skilled nursing facilities in the US. That represents 350 million in annual revenue at our price point, 2.6 billion, if we're able to touch all 10 and a half million moons in the United States with our price point. Terms of timeline of development, as I mentioned, we're a phase we're starting our phase one in diabetic foot ulcers. Currently, we expect to have the results of that by the end of the year, and then move into our Phase Two slash three pivotal trial at the beginning of next year. At the same time, we expect to reach break even through our over the counter sales and then, hence, raising a 15 to $20 million series A over the summer to fund our future R and D efforts. We're extremely excited about what we're doing. We have an amazing team, some of the most world class scientific advisors on our team, and we're excited for the future of noxy. Thanks for your time. You.
Tim Jacobsen 0:01
Tim. I'm Tim Jacobson. I'm CEO of noxy health products. So noxie health products is a US based pharmaceutical company probably saying, What in the heck at a med tech conference? Well, it's because most of the products in the chronic wound market are medical devices, and so it makes sense for us to be here. Our treatment is based on a molecule that occurs naturally in the human body, nitric oxide. So we all produce it naturally. All mammals do. Nitric oxide has three modes of action. It's a vasodilator, which is how it's currently used in the clinics. It's a broad spectrum antimicrobial with no known resistance. And it's also the cell signaling molecule responsible for the wound healing sequence. Most importantly, nitric oxide governs the inflammatory phase, which prompts inflammation, but more importantly, brings resolution to inflammation. It's also essential in angiogenesis, cell proliferation, collagen deposition and ultimately, ultimately in scar remodeling. The current wound care market is sparse. Well, it's ironic. It's loaded with products, but sparse in its addressing of needs when it comes to the things that wounds need need to heal. Across the top, you'll see the different types of wound care products that are on the market. Down the y axis, you'll see all the things that the wound needs to accomplish in order to heal. The asterisk on the biofilm disruptor represents primary research that we've completed. As you can see, nitric oxide literally ticks all the boxes. Most of the products on the market today really are just about addressing various symptoms of mark of of chronic wounds, exudate, maintaining a moist wound environment, debridement. All of these things are designed to engage the body in its own healing process, but none of them address the core pathology of chronic wounds, which is nitric oxide deficiency. We didn't just check all the boxes to make us look good. It's actually backed by research, which is the final slide of the presentation. It's all done and documented by other scientists. The key problem is that as we age, we produce less and less nitric oxide more so if we suffer from a comorbidity, such as diabetes or vascular disease. And so by the time a person reaches 60 years old and they're a diabetic, they're really producing no nitric oxide in a meaningful amount. So you really have a supply side issue when it comes to the patient population that suffers from chronic wounds. Also because of these comorbidities, many of them suffer from a compromised circulatory system. And so you also have a delivery side issue, meaning that the only viable path to help these patients obtain the needed nitric oxide that they have is to apply it topically. So what we have is a very simple solution, simple, simple, but complicated in its simplicity. It's two liquid solutions. And let me back up and say this, nitric oxide is a gas molecule, and when it touches ambient air, it breaks apart in two seconds. So you can't just create nitric oxide, put it in a can and put it on a shelf. You have to be a little more creative. And so what we have are two liquid solutions, an A and a B, when they're both are housed within foaming bottles. When each solution is expressed as a foam, those two foams are then mixed together in that mixing nitric oxide is created and now is filled within the micro bubbles of the foam that combined foam is then laid onto the tissue and with and the layer of bubbles closest to the skin ruptures and bursts, exposing its payload of nitric oxide, and Then as each successive layer of bubbles touches the skin, the same thing happens, and within five minutes, the therapeutically meaningful dose of nitric oxide has been delivered. And so as I said, it's a five minute treatment. So we're in, we're out, we're out of the way the nurses and clinicians that are currently using our over the counter product, which I'll get to in a second, say that it's non disruptive to their flow of care and very easy to use. It's backed by 12 patents. We also have an additional 20 patents that are either in provisional or application phase, and we're about ready to file another patent, which is a we believe is a game changer and not something I'm going to talk about publicly. So publicly. So I mentioned advenox is our prescription, so we do have clearance from the FDA to proceed with studies in the United States. So we're going to be getting our phase one trial in two to four weeks on diabetic foot ulcers. Noxidermas are over the counter product, which is now launched and in the clinics live so Advent, the advenox is actually inside noxiderm. The creative thing that we did was that there's a list of pre approved products that are approved for over the counter use. We found one that was compatible with our formulation. We basically. Took our drug, ported it inside of noxyderm. While we won't be able to make any medical claims about it, we are able to say that nitric oxide is an inactive ingredient in the product. Follow the QR code if you're an interested consumer. Shameless plug for noxiderm, one of the creative things that we did was we strategically raised capital from owners and operators of skilled nursing facilities, and so we are green lighted to go into 60 of those facilities that are owned by our investors, and we're on target to exceed that. That projection for the second quarter all told our investors own probably close to 600 facilities. And so if we were to achieve 100% penetration with noxidurm in those facilities, we'll be able to achieve about 5.8 million in net revenue. So if we achieve a third of those facilities, if we gain access into a third of those facilities, we'll be able to successfully fund our operations, XR cost for R and D. We expect to do that by the end of the year. Going back to advenox, you can follow the QR code to my presentation on this in Barcelona, where I address various case studies. But needless to say, there is no uniform standard of care in the chronic wound market. There's only two drugs or biologics approved for use in the chronic wound space. Both are expensive and marginally effective. It represents a major unmet medical need. Nitric oxide deficiency is the main characteristic of this patient population, and so because of nitric oxides, triple mode of action, of vasodilitation, broad spectrum antimicrobial activity, and it being a cell signaling molecule, really addresses the core pathology of chronic wounds. Therefore, we believe and hope that avenox becomes the standard of care in the industry and really becomes the first line of defense. I mentioned our primary research on biofilms. We took six pathogens, both and all of them antibiotic resistant. We inoculated them with pig into pig tissue, incubated them until they formed a mature biofilm, and in 10 minutes of total exposure time, we were able to achieve a 99 to 99.99% reduction in those biofilms. This is groundbreaking research, and it's been published in the Journal of wound management, because of the modes of action that nitric oxide has, we really represent a platform of opportunities. Chronic wounds represent the largest unmet medical need. That's why we're going there first. But we really have acts or the ability to then pivot into burn wounds, surgical wounds. We're even working on an acne over the counter formulation as we speak. It's being tested right now, thanks to my nephew and my daughters, we can also go after eczema, telephonus, warts, medical esthetics, essentially, our platform represents 100 billion in Tam. The skilled nursing facilities represent a key more market for us, given our relationships, if we were to tackle all 16,000 skilled nursing facilities in the US. That represents 350 million in annual revenue at our price point, 2.6 billion, if we're able to touch all 10 and a half million moons in the United States with our price point. Terms of timeline of development, as I mentioned, we're a phase we're starting our phase one in diabetic foot ulcers. Currently, we expect to have the results of that by the end of the year, and then move into our Phase Two slash three pivotal trial at the beginning of next year. At the same time, we expect to reach break even through our over the counter sales and then, hence, raising a 15 to $20 million series A over the summer to fund our future R and D efforts. We're extremely excited about what we're doing. We have an amazing team, some of the most world class scientific advisors on our team, and we're excited for the future of noxy. Thanks for your time. You.
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