Dr. Margaret Kalmeta, Rapid Nexus - Nanotechnology Wound Dressing | LSI USA '24

Margaret Kalmeta  0:07  
I'd like to introduce to you the world's first nerve damage healing product for peripheral neuropathy. There are no products right now made to address the big elephant in the room, which is the nerve damage of this tissue. The products all consist of plugging up that hole. So the industry is filled with a ladder wound care products and yet no neuropathy healing products. And just a side note in the wound industry, the neuropathic tissue is called the peri wound and it's basically the interface between the healthy tissue and the wound itself and this is a major cause of amputations. This patient has been diagnosed for an amputation, for example. This is a very high unmet medical need. 20 million patients are suffering from neuropathy, 6 million patients from non healing wounds due to peripheral neuropathy. And just to give you an example of the number of amputations, 500 pre pandemic amputations in the US alone daily, and now we're up to 1500 amputations daily. This is largely consisting of diabetic and infected patients. Healthcare spends $360 billion a year to take care of this population and diabetes is on the rise. Aging is on the rise. So it's a massive burden to the healthcare industry and growing. Humans still is a product that is able to treat the neuropathic tissue in order to increase its volume and increase its density. And once we treat the neuropathic tissue, we are able to get blood flow and nerves are able to work again our patients have reported that they feel their toes or their feet after treatment or that they feel their legs after treatment. And so this is a real patient. He was diagnosed for an amputation. And after treatment with him is still you can see that his neuropathic tissue has been healed. And so we are very excited to bring this to the market for other patients. We completed feasibility studies of 39 patients. And those were all patients who suffered from non healing wounds who have neuropathy. As I mentioned, the patients reported that they feel their limb, you can tell here that there's necrosis even in this picture. The nerves are just very badly damaged. And after treatment, this gentleman was able to feel warmth in his leg and to feel his like, again. We completed biocompatibility and animal studies. We're preparing to file our first FDA application this April, we anticipate the first 510 K in q3 2024. And concurrently, we are beginning our clinical trials, which include biopsies. Now what we'd like to do is count the nerve fibers before and after treatment. This is unprecedented and we are very, very excited to be bringing this product to the market soon. Our feasibility studies consisted of patients that were 100% of the patients were diabetic and infected cases. And some of the other subgroups in this high risk risk category included aging, peripheral vascular disease for nutrition, Alzheimer's and dementia. All of the patients in our feasibility study had been getting standard of care for at least three months prior to treatment with our product. The market size is 13 billion and who we are actually overlapping two markets. One is the diabetic foot ulcer market consisting of the advanced wound space and the others the peripheral neuropathy market. It is an in our future plans to provide Peripheral Neuropathy Treatment before a window opens up. Since there are no healing neuropathy products we are showing competitors in the wound care industry. And Rapid Nexus is the only one that is bringing an highly antimicrobial solution. So as you saw in the picture previously, one of the high needs is to treat the infection of the patient. This product is very highly antimicrobial and it's lavatory easy handling, we treat the peri wound which is damaged neuropathy of severe chronic wounds. So we're gearing up for getting traction. So I'm excited to let you know that as I mentioned, we're planning to submit the first 510 K application. We partnered with pharmacy innovations to distribute us pharmacy Innovations has 160 pharmacies and their network and growing each of these pharmacy owners presents to hospitals and wound care centers with this so they have deep knowledge we're excited to partner with them as we begin our journey of commercialization right around the corner. partnered with J Maas Research Foundation, which is the number one burnin wound center in the country. We are doing our clinical trials on a Wagner type two and three cases. We are the only company doing clinical trials on Wagner, two and three cases. Other one companies if we compare ourselves to one companies, they typically do clinical trials and Waggoner, one type cases, maybe two, not two and three. So we are in the advanced wound space with the patients that have very badly degenerated tissue. So our financial summary, we anticipate by year number three to reach $32 million. We'll be growing a team commercializing, and we have very many potential exits. There's an uptick in the interest in the wound care industry, especially after the $1.3 billion acquisition for terraces that just occurred that really signaled heightened investor interest in this industry.

Right now we're raising $2 million at 8% interest $15 million cap and 20% is discount to the next raise. The next valuation inflection points will be just in another couple of quarters when we receive the FDA 510 K. Next inflection point is when we file after we do the nerve counter with our biopsy, clinical trials with JMS research starting next week, the next valuation inflection point will be once we receive that data of the actual nerve count and submit for the de novo application which will be our second FDA application. The use of funds for this raise is for that second FDA application so that we can complete more preclinical testing for it and add another large clinical trial in order to pave the way for a preventive neuropathy product. Patients with diabetes, that their nerves degenerate in their in their lens, especially in their toes and feet. And as the nerves regenerate, the muscles do not because they do not receive the innovation, the muscles degenerate, so the patient ends up getting small miniature holes underneath their epithelium, which when one of those gets big enough ends up as a wound, but at any point in the pathway that the patient with diabetes suffers from this condition. If we get to them early, we can prevent the wounds from opening and the degeneration. Thank you very much.