Carl Genberg, N8 Medical - Incorporating Ceragenins into Medical Devices | LSI USA '24

Carl Genburg  0:04  
Good afternoon. It's a pleasure to be here with you. My name is Carl Genberg. I'm the Founder and Chief Scientific Officer of N8 Medical with me here today is Bob    Mitchell, our CEO, industry veteran for many years and spent 16 years I cook medical largest privately held medical device company in the United States. Typical disclaimer N8 Medical is a privately held company headquartered in Park City, Utah. Our technology is based on an exclusive license from Brigham Young University on technology developed by Dr. Paul Savage, who is well known as a medicinal chemist. This technology is a synthetic is a synthetic version of our body's own innate immune system. It has consequently very broad spectrum activity. It's active against all escape pathogens against Candida Oris, Aspergillus, including lipid enveloped viruses such as COVID-19. It is a platform technology and has applications both in medical devices and in drugs were funded in part by the Cystic Fibrosis Foundation because we're developing an inhaled drug. Over the years we've raised $45 million, of which 37 million has been from non dilutive financing sources, including the governments of Canada, Australia, the Cystic Fibrosis Foundation, as well as SBIR grants from the NIH. We're grateful for the support that we've received from the various institutions over the years. Today I'm going to speak about our lead medical device product, which is the service shield biofilm resistant endotracheal tube that addresses the issue of ventilator associated pneumonia, which is very well covered in a prior presentation on oral care and the importance of bacteria there. So we have now over 100 patents issued around the world, over 300 peer reviewed journal articles. Our SAP is chaired by Professor Michael Needleman of Weill Cornell, who is the leading expert in the world on ventilator associated pneumonia. We also have Dr. David Perlin from Hackensack meridian, who's a leading expert in fungal pathogens because our compound is highly effective against Candida Oris, which is of importance to me. I live in Las Vegas, and we are the Epi Center for Candida Oris outbreaks. So the problem here is antimicrobial resistance. We take antibiotics for granted because throughout our lifetimes, we've always been able to turn to an antibiotic to treat or cure an infection. This is not always the case, we are now entering what is called the post antibiotic era, in which common surgeries modern medicine will dramatically change you won't be able to perform things like C sections, hip surgeries, knee implants and the rest of it because they are all dependent upon administering antibiotics. And one interesting example of this is a historical one. In 1922, Howard Carter, the famed archaeologist was in Egypt and where he discovered the discovery of a lifetime, the intact Tomb of King tooten Come on. His sponsor was Lord Carnarvon, the one of the wealthiest man in the world, who hastily made the retreat down to Egypt, to see the tube and see these wonderful things that he saw. Unfortunately, he developed he got a severe a mosquito bite, subsequently shaved and developed bacterial sepsis as a result of the cut. There were no antibiotics. He died a few months thereafter. penicillin was not invented until 1928. Fast forward to back then, in the 1920s, the average life expectancy was 47 years for an American white male. Infectious disease were the leading cause of death, cancer was near the bottom. Why? Because cancer is disease of the elderly. If you don't live long enough, you're unlikely to get cancer today. Cancer is the leading cause of death and infectious disease that thanks to modern antibiotics is relatively contained. However, we are in a very dangerous situation. There's a tsunami coming you can't see it. You look out the window, you won't see it coming. It's a silent, invisible tsunami of bacterial, fungal and viral infections that is headed our way and unless we take urgent action now, we're gonna see 10 million deaths a year in the next two decades, which will surpass the leading cause of death from cancer. This is from a report from the O'Neill report which was commissioned by the UK Government. There's not been a new class of antibiotics in 30 years, large pharma has fled the field in favor of lifestyle. Drugs which people take on a daily basis, of course of antibiotics lasts about a week. Small companies developing antibiotics have gone bankrupt. Even if they get FDA approval once they get out of the regulatory process. There's no reimbursement for this. People would prefer generic low cost antibiotics in the hospital formulary. Our focus is on preventing the disease and prevention as Ben Franklin taught us, is an ounce of prevention is worth a pound of cure. And this is what the CDC says invest in prevention. And in fact, we met with the CDC about a year ago, we explained our technology to them to the second commander of the CDC in charge of hospital acquired infection. And he told us two important things he was himself as a microbiologist, and he said first, I have no doubt that your approach will work. Second, he said once you get FDA approval with convincing clinical data, we will recommend that every hospital in the United States use your product that's 2,000,002 tracheal tubes a year. FDA approval we expect in 2025 as a de novo 510 K clinical data we're gonna release in the next 30 days a result of a major study funded by the Canadian government in Kingston, Ontario, which we believe will show that we in fact prevent ventilator associated pneumonia there's no need for antibiotics, no need for drugs, use our tube you do not get ventilator associated pneumonia. This is recognizable fellow Scott Gottlieb, who basically said the best way to prevent a resistant microbe from becoming resistant is to prevent patients from coming infected in the first place. The root cause as described earlier, is biofilm. Your teeth plaque on your teeth as a fungal biofilm. It's nearly impossible to resolve with a mouthwash or other oral treatments so you need to chisel away in the in the dentist office. But you can prevent biofilm from going on medical devices, the CDC tells us that of all the hospital acquired infections. 65% of them are related to the use of indwelling medical devices and the growth of biofilm on those devices prevent the biofilm and you will prevent the infection. Our class of compounds mimics the body's own innate immune system. We have regulatory approvals in Canada, Brazil, Colombia, and as I mentioned next year, we expect it in the United States as well. About two months ago, I was in Istanbul at an international conference and I met with the second commander of the World Health Organization. We explained our technology to him. And he basically said once you get your data from Canada, we're interested in adding your device to the essential list of medical devices, which gives us access to 90 countries around the world. And unlike many advances discussed here and elsewhere, there is a huge market for us in the developing world. Even poor countries can afford to save money. Right now they're wasting money on trying to cure a disease that is in fact preventable.

Speaker 1  8:36  
So we have three SBIR grants, we have funding to develop pet coated pedicle screws, haemodialysis catheters, pacemaker envelopes, Allah what Medtronic has done with Tigrex however, we work on Canada Oris. And we also work on coagulase negative staph was which is a weak point for the direct product. These compounds work very similarly to the way the body's own innate immune system does. God has so divided the world that bacteria have na eonic negatively charged membranes, whereas normal human cells are zoonotic who are competent as poly cat Ionic. And it attaches to the bacterial membrane depolarizes and leads to rapid cell death. This is from a preliminary study that we did in Canada prior to our large study, and we basically showed a 97% reduction in bacterial colonization looking at endotracheal tube passwords. As discussed by an earlier presenter, which I found a very fascinating presentation. VAP is a huge issue. It's estimated that it causes about $20 billion in added cost, if you could present prevent that this is a major advance. Our approach is Use value based and outcome based pricing so that this will not cost you one dime more, we'll just share the savings that we accomplish by preventing VAP. We have a broad spectrum of technology applications. We have almost too many applications and we have to focus on the ones that make the most sense early on and can generate revenue which we are doing. We have strong intellectual property. We have a seasoned team led by Bob    Mitchell We have a stellar Scientific Advisory Board led by Professor Mike Needleman, and we have impressive clinical data and the platform technology. Here is our team. And I appreciate your attention this late in the day. Thank you very much