Melanie Santos Presents Cern at LSI USA ‘23

Transcription

Melanie Santos  0:05  

Hello. So my name is Melanie Santos and I am the Chief Medical Officer of CERN Corporation. I'm also a practicing Euro gynecologist, and I'm head of women's health for the Providence healthcare system, which one is is one of the top five largest health care systems here in this country. And I'm really excited to be here and discuss this novel tech treatment we have. So we're really going to talk about a new game changer in the world of infections, we have a therapy that provides a new option for treatment for infections and for some, a new opportunity for effective therapy that they may not have even had in the first place. Currently, therapies for these infections are antifungals, anti bacterial antibiotics, drugs, drugs that can cause problems, they can cause adverse effects significant adverse effects, they can cause resistance, and they can even cause other problems such as not being available for certain patients when they're immunocompromised or pregnant. And so what we are providing is a new treatment that's effective and safe. So the problem is vaginal infections. So if you have a vagina more likely than not, you've experienced an infection, some point in your life because 75% of women have reported at least one infection in their lifetime. Most commonly, these are yeast infections, or bacterial vaginosis infections, especially when they're recurrent. Now the CDC reported over 9 million women suffer from recurrent vaginal yeast infections, and this is really underreported the true prevalence because they only considered women who sought care from a doctor at least four or more times. Now other surveys have shown that this is probably two to three fold higher. And then you have to consider the women who don't want to take medications or don't have access to a doctor who are using home remedies or over the counter therapies and treatment alternatives. So, clearly, there is a huge unmet need for this and we are going to provide that with a non drug treatment. This is the solution the CERN device. The CERN device is an international light therapy that treats vaginal infections is a non drug therapy. However, you could incorporate this with some medical therapy for antimicrobials to enhance treatment. It's very easy for the patient to use and the provider for treatment and retreatment. And it allows for easy home telemedicine management and adjustments. So we can do consultations and adjust dosage because the device itself can provide the prescribing doctor information such as basal temperature and pH levels. This will also be an ecosystem for education and marketing as well as epidemiology. And in my practice, I ran a busy Euro GYN practicing about 100 patients a day, constantly writing prescriptions and repeat prescriptions for these very infections, these specific infections I'm talking about, but this extrapolates to all other segments of medicine. People interested in this will be OBGYNs, pediatricians, infectious disease physicians, oncologist, even primary care physicians who treat veg and itis. So a little bit about the science. This small tampon size vaginal device uses low level microbicidal light in a mechanism called reactive oxygen species to render the pathogen and note now we're not using UV light here we are operating in the safer visible light spectrum, which is still in microbicidal. Think of us as UV adjacent. So when you get an infection, there is an increase or overgrowth of bacteria or yeast so that there is an imbalance of the vaginal flora or a dysbiosis. What we are doing is disrupting the pathogen cell's ability to replicate at a DNA DNA level, but not compromising the good vaginal bacteria bacteria which produces the desired vaginal flora. So then we get a rebalance of the flora going from dysbiosis to symbiosis. And not only can we make these changes in the pathogens and make sure that the vaginal bacteria that we desire is maintained. We also have lab studies that show that there is no compromise of the adjacent mucosal tissue meaning the vaginal skin and this helps us avoid collateral damage. So a little bit about infections when you take an oral antibiotic only about 2% of that drug actually gets to the origin of choice. So this is why we get a lot of side effects with antibiotics. This is because A, this medicine when you take it orally, goes throughout your whole system and can cause untoward desired effects and other areas and be because so little gets to the actual organ, you need a pretty high dose of that medication to actually cause a difference and improve the treatment. This is showing how we can help make help with the lateral with the collateral damage here. With our therapeutic window. You know, any medical therapy wants to minimize collateral damage, meaning treat the problem, but minimize or avoid other damage and injury. And with this therapeutic window, we can provide an effective but safe treatment. We have found different levels of doses that will cause a log reduction in our desired treatment of Gardnerella veg Gnosis which is bacteria vaginosis as well as Canada for yeast, but it does not compromise the good bacteria otherwise known as lactobacillus. So with this window again, effectiveness, but safe. So a little bit about our business development and our current status. We have intellectual property, including full utility and design patents, as well as international patent protection by the PCT. Freedom to operate agreement has been clarified has been confirmed for CERN by third parties, trademarks are registered. And we even have additional intellectual property through patents being developed as we are extrapolating this technology to help treat other infections. In regards to the FDA, we have completed pre submission applications with great feedback, we plan for a class two medical device with a 510K, application de novo. And all of that what we have currently, we have been completing our lab studies, which are all confirming both dose dependences for our pathogens, as well as cytotoxicity studies for safety. And we plan to have first in human studies in just a few months by our early feasibility study. So clearly, there is a huge opportunity here to help millions of women in light of this unmet need. If we look conservatively at that 9 million women who suffer from vaginitis and recurrent vaginitis. If we just get one in 10 of those women using the CRN device, we could anticipate 180 million gross revenue at a greater than 80% gross profit. They ask us for 5 million for series a funding. And this would allow for our full device development, national clinical trials and FDA clearance and we're going for clinical alignment and sales with major women's clinics throughout the country with possible exit by 2026. Thank you so much.