Video Transcription
Yair Ramot 00:02
Hey, my name is Yair Ramot. I'm the CEO of Dimoveo. In the last 12 years, I've done some three asset deals, and Dimoveo is next in line. Okay, so let's jump in. Basically, what we're doing at Dimoveo is developing a technology for cleaning inside body cavities from infection. Basically, what we're doing is we're transforming the infection treatment. As you are all probably familiar with, 80% of infections are manifested as biofilm. Once biofilm gets into the picture, we basically lose the battle. Okay? This layer protects the bad guys and doesn't allow us to kill those bad guys with antibiotics or any other solution that we can use. What we're doing is we're using nanoparticles and ultrasound energy to mechanically dismantle this biofilm layer. And once we do that, the bad guys lose their protection, and we can treat them, either wash away the bacteria or use any other application, like antibiotics, chlorhexidine, iodine, or whatever you would use to kill those bad guys.
Our application is a platform; basically, we can clean any cavity within the body, as long as the infection is there or manifested as some kind of biofilm. We're now focusing on the first indication, which is total knee replacement. This is because this is a very simple and well-known procedure, and something that we can really see our efficacy and safety and present that and demonstrate that fairly well. So basically, the need is obvious. Infection is all over the place. It's one of the main issues in surgery and in orthopedic surgery as such. Dimoveo is using, as I said, nano cleaning on a nano scale. Basically, the nanoparticles act as thousands of brushes running within this cavity and just dismantle whatever biofilm they can find in the cavity. So we can clean very inaccessible areas within that cavity that you cannot clean with the standard of care that is used today.
As I said, this is the first indication. About 2% of the population is getting infected with such an infection that cannot be treated with antibiotics. There's about a 50% failure rate in the standard of care that we can see today, and we want to reduce that by 50% again and lower that to about 20%. The standard of care today is just washing the cavity with nine liters of saline, just pulse lavage, and the failure rate is over 50%, as I said.
So what is our technology? We take ultrasound, we apply the ultrasound onto the solution with the nanoparticles inside, creating a cavitation effect. The cavitation effect excites the nanoparticles to move within the cavity and just hit whatever targets they have there statistically and dismantle all the biofilm. Okay, as I said, thousands of brushes running within that cavity. This is our product. We have manufactured the first batch of that. It's composed of three elements. One is a capital element, the generator of the ultrasound, and two others are the knee element, which sits on the knee and holds the solution onto the knee, and the other one is the mixing device, which creates the solution with the nanoparticles.
The idea is to not do a revolution, but to do an evolution within the system. We don't want to fight the system, so we want to add our process onto the standard of care and intervene within the procedure, which is the first time they're trying to clean the cavity from the infection. Okay, and on top of that, reduce the risk by 50%. We can also intervene within this revision surgery, which is the next stage and a much more complicated and expensive one. The average cost is about $160,000. Okay, so that's a lot of money. The market opportunity is huge. We're talking about $1.5 billion worldwide. These are numbers from the literature; basically, in real life, it's almost double these numbers, okay?
And we decided to start with TKA, which is not the biggest portion of that market, but it's the easiest one to penetrate into the market. Okay, we've completed testing of all the BMV that we need for FDA submission and clinical trials, meaning animal study efficacy and safety, implant integrity, cleaning of tissue, and usability, done with cadavers. Okay? So we're ready for FDA submission. We'll submit the first claim to the FDA, which is a 510(k), within the coming months, and trials will start in parallel to that. The second claim, which is cleaning of biofilm, is something that no company has in the market right now—a claim like that from the FDA. We will probably be the first ones to receive that kind of claim.
As for intellectual property, we have a good portfolio: one granted patent in the US for the ultrasound cleaning method and the irrigation device for surgical cleaning, which is granted now in the EU and is under review in the US. We will probably receive that as well within the next few months. Okay, the business model is a value split model. Basically, as you can see, the COGS is very low for the product. The product is a simple product; it is a very low-cost product, so the margins are very high, and it's a good way. I mean, we can do a lot of profit with this product.
As for the competitors in the market, the ones that are now in the market and FDA approved are using different solutions for taking care of biofilm. They do not have a claim, and they cannot really take care of biofilm, but they do take care of infection and such. We will be the first ones to have, as I said, a claim for biofilm—really cleaning biofilm and doing it mechanically and not with antibiotics and other elements.
As for the company status, as I said, we've done a POC bench test and animal study, completed BMV, and we're preparing for submission for the FDA. In parallel to that, we want to do a three-center clinical study—one in Michigan, in the US, one in Israel, and one in Finland. For the CE mark, what we're looking at up to now, I mean, we've invested $1.5 million in the company until now, and we're looking for the next trial. Round A will be $5.5 million in three tranches. The first tranche will take us all the way through FDA approval and pilot clinical trials so we can move for a soft launch into the market. The second and third tranches will take us to extensive clinical trials, which we have to do for marketing and developing the next generation of prevention products, preventing infection instead of treating the PJI, the post-infection, and will take us into the market, into selling the product already.
All of this couldn't have been done without our excellent team, which I'm proud of: Roy as an R&D manager, Gal as CTO, Noa as our CFO, and Iran as our VP of business development. We have an excellent advisory board as well, which includes Shai, sitting here, who is the CEO of MEDX, which is the accelerator that we are part of. With our portfolio company of that accelerator, we have Professor Ranch Voskoboynik, who is the head of orthopedic surgery at NYU in New York. We have Omid Roubsky, who is the head of the Department of Orthopedic Surgery in Israel, at Beilinson Hospital. And we have Nathan Keller, who is an MD and a biology consultant as well.
Thank you so much for attending. If you have any questions or need any additional information, please don't hesitate to call me and get in touch. Thank you so much. Applause.
