Brian Hess, RevBio - Bone Adhesive Biomaterials Using Tetranite | LSI USA '24

Brian Hess  0:03  
Good morning. My name is Brian Hess, CEO and founder. I'm excited to talk about an exciting revolutionary biomaterial that we're developing at RevBio. It's a super glue for bone. Take a look at these images, surgeons treat millions of bone defects per year. Look at the type of hardware fixation devices. It's very complex. And often the patient is left with a delayed healing. The devices can fail, usually due to poor quality bone. And so we feel at Rev bio, we can solve the these problems because hardware innovation, while it has incrementally improved over the years, really hasn't found a new material that can help the surgeons. clinicians want a material that has all the requisite needs our biomaterial, our glue does that. As you can see here, our materials mix in it's injected, which allows for less invasive procedures. Our material is tacky, it sticks to bone, it sticks to metal, and it sets up within minutes in a wet field environment, forming load bearing bonds. These are significant bonds that can actually allow the patient to bear weight early. What's remarkable about our glue, though, is that it's osteo conductive, which means it fits facilitates resorption and new bone regeneration over the course of months. There are many orthopedic biomaterials out in the market as you can see here, but none of them has the combination of properties that surgeons desire. None of them have adhesive load bearing properties, and only a few have regenerative properties that allows the material to be resorbed and replaced with bone. Tetra night solves for that Tetra Nate has, has material properties that fulfills all the surgeon's needs. And as I said, we'll be the first glue that provides adhesive load bearing and regenerative capacity to the patient. The material is made from synthetic biocompatible components. These are small molecules comprising calcium, which forms our bone and an amino acid. These are products that are synthetic, and they're engineered for each clinical indication. Each kit is developed by the surgeons with the Special Delivery utensils that allow the surgeon to use the adhesive in a clinically meaningful manner. Tetra night is protected by several patents. We have over eight patents that are issued that protect the life of the patent portfolio through 2037 and beyond. In addition, rev bio has filed over 12 patent applications that will extend the life and the protection on compositions on methods of use, as well as on packaging and kits. We've taken a look at our top five indications and have tried to identify where we feel there's the most compelling clinical utility of our bone adhesive. We've come up with the five that have a total estimated addressable global market size of over $10 billion. Our lead indications which are on the clinical stage are above the head and shoulders. We're working on indications in dental and cranial in the animal testing that we've completed to date is going to allow us to market these products in the next year to veterinarians. In addition, we have expansion opportunities in the lower extremities in the spine. We're going to talk about our two lead indications The first one is dental implant stabilization. Over 50% of the global population has at least one missing tooth. But only 1% of those individuals go on and get an implant that supports a new crown. The reason for that is the time, the cost and the pain of going through a stage surgical procedure to get a dental implant restored crown yet, even so, it commands a $5 billion global market size for dental implants. The way we're looking to approach this is as follows In today's standard of care when you lose when you lose a tooth, the dentist extracts it, you have a large hole in the mouth and they have to go through a bone grafting procedure because the dental implant is not sized to accept into the bone. After that bone grafting procedure the patient will come back after several months and the implant dentist will uncover the bone drill into it and place a dental implant and then it'll be another three to five months before that implant. OSU integrates This is a stage procedure with Tetra night the bone adhesive allows the implant dentist at the time of the tooth extraction no matter what the bone condition to accept that dental implant going on for a crown and this eliminates a stage surgical procedure which has huge value of course to the patient. We are now in clinical trials. And we have clinical evidence showing that the material not only stabilizes the material initially with clinically meaningful levels of implant stabilization, but it maintains over time while the material is being replaced with new bone. Here's a clinical example of the molar that's extracted, leaving a very large hole in the back of someone's mouth. And with Tetra night, we're able to fill that hole and place the dental implant in lock it into bone, and then that implant in the mouth, the gums, they go on to heal, and they get a restored crown. This is actually quite revolutionary, because we're able to place that implant at the time of tooth extraction. Whereas I've indicated typically, you have to go through a stage bone grafting procedure first, to the implant dentist, we're solving quite a bit of problems on material cost and time, we're saving nearly half the time a few hours to go through the implant surgical procedures. And to the material costs, we reduce those by half as well, while the implant dentist can still maintain the same sale price to the patient. So that's a large I guess you could say driver on the net profit margin to the implant dentists with all those savings for cranial flap fixation, which is our second clinical indication, we think there's a very obvious and compelling value proposition. Today, neurosurgeons when they're performing brain surgery, to access the brain, they create a cranial flap, at the end of a long procedure, they strap that bone flap back with plates and screws, the patient can feel that the bone does not fuse over time. With the glue, we're going to be able to fix the bone flap directly to the bone and replace metal hardware. That's a tremendous value to the patient. It eliminates that foreign artifact for life. But also it improves fixation, we have stronger fixation, and also you get biological fusion. And you can see that in the histology slide on the right over time or materials replaced with new bone. When we talk to the neurosurgeon neurosurgeons across the United States based on our market research, 70% of them predisposed to the idea of Tetra night would adopt our solution, and it will become a standard of care pending the clinical results from our studies. Our pipeline is vast and diverse. You can see here our current and our future state. We are working with the FDA and we have FDA approved studies in dental and cranial later this year, we'll get FDA approval we hoped for treating fractures in the in the arms and legs. And then in the spine next year, we have a vision of bringing these products to market through de novo in some indications as class two, but also class three where we're looking at replacing metal for load bearing applications. We're looking to raise $15 million now in our series A and that will fuel these clinical studies. Our team is poised for growth and scale. myself. I'm the co inventor of the technology. My breakdown background is product development and bringing these types of products to market. I worked at Stryker, I founded the company with Grayson Allen after we went to business school, I wanted to become an entrepreneur. His background is financial and operating. And so we're bringing the money the bringing the capital to the company, and we're developing this technology and bringing it through the FDA process. We've set up our company with several surgeons, obviously engineers and scientists, we have two large clinical advisory boards kind of broken down into our dental programs, as well as our orthopedic programs. We've raised over $45 million to date, of which 20 million of that is through non dilutive grant funding. And these non dilutive grants have actually fueled over indications providing the leveraging effect nearly $1 for dollar to every investment dollar that we've raised from, from investors. We're looking to raise as I said, $15 million. And that'll help us drive our clinical studies over the next two years to drive true value inflection points for the various indications that I've talked about. We have a compelling exit proposition. This is based on several biomaterials that have been launched in in these companies have sold over the last five years, on average, they've exited for $400 million. And they've averaged an exit based on their total addressable market size. But these are all one product companies. what's compelling with Rev bio, is that with our technology, we have several indications and products that we're developing. So we believe this provides a nice floor for how we could exit. Finally, come join revival. We believe we're going to transform bone repair. We're making quite a bit of noise both on raising these grants, as well as the awards that we've received in quite a bit of publication. Thank you very much.