Brian Hess Presents RevBio at LSI USA '23

Transcription

Brian Hess  0:05  

Good morning. My name is Brian has some excited to talk to you all today about a revolutionary biomaterial. RevBio started with one goal in mind to end medicines 50 years search for Regenerative bone adhesive biomaterial. There are over 15 million surgeries treating bone every year in the United States. And of these, most of them are reimbursed by insurance with over $8 billion of insurance claims. But these are complex procedures in over 30% of the time they lead to complications, failed implants delayed healing infections. These surgeries often require revision surgeries in the payers and often the providers eat that cost. Researchers have been at this for decades trying to come up with a bone adhesive essentially a new tool for the surgeons, but they've never been able to develop such a material with all the requisite properties. Rev bio has developed Tetra night, a regenerative bone adhesive that we believe has all the rapid, requisite, and desired properties. The material is injectable that makes the material applicable for less invasive surgical procedures. It's applied as a liquid, but it's highly tacky, it's viscous, that means it doesn't run all over the place. Once it's applied, it sets up within minutes forming robust bonds to to both bone and to metallic surfaces. These bonds are load bearing. As you can see, we generated significant load bearing and separation force just minutes after gluing a fractured bone together here. What's remarkable about the bio materia is that it's vascular. It allows and facilitates bone regeneration over time, the material is dissolved and replaced with bone without losing volume or without losing strength. To really map out this space, the space of orthopedic biomaterials one way to do that is to look at materials based upon on one access the strength or the structure of the material, and on the other access its regenerative capacity. And when you do that, you can map out all of the materials that are on the market. None of these materials has the combination of both structure and and regenerative potential. For example, you have bone cements that have been on the markets for years. These have some level of structural strength, but they're essentially bioinert. On the other hand, you have BMP, these are bone morphogenic proteins like infuse, these are highly regenerative, but they have significant safety concerns because they lack structure or cohesion and migrate from the site causing ectopic bone formation. Tetranite is uniquely positioned as a differentiated product. It's the only product that has load bearing adhesive strength. So first in class on structure, but also regenerative properties. This puts itself well positioned in this vast ocean of materials. The material is comprised of simple technology. It's comprised of Tetra calcium phosphate, and phospho serine phospho. serine, is an amino acid, which is the discovery that led to the adhesive properties. The material is made of small molecules, and we produce it through synthetic manufacturing properties. That allows us to command a very high gross profit margin, we formulate the product for each indication that we go after using the same platform. However, we can tune the technology, maybe it's the particle size, maybe we add in additives to enhance the porosity of the material are resorbable fibers that increase the toughness of the material. In any case, we've been working with surgeons for each indication to develop each surgical kit, a packaging a kit to deliver the adhesive for the surgeon for that indication. Our technology is patented. We have over eight patents that have been issued six of them through a technology license from Stryker. In addition, revile has gone on and has managed the portfolio. We now have two additional patents that extend the patent life to 2037. And we've gone on and we've got over 10 patents that are pending. These patents are now going through prosecution to extend the life to 2040 and beyond. RevBio has identified five key markets commanding over a 10 billion global addressable market size. Our first indications are in the dental space for dental implant stabilization. We have gone through the pre preclinical trials and have already initiated clinical studies. The data that we amassed during our preclinical studies was conducted in dogs Therefore, we've identified a market next year to launch a product to vet surgeons to treat dogs that have periodontal disease. We are now working with the FDA to initiate an ID approved human study for cranial flap fixation, which is expected to start next quarter. We also have two products that are under developed development that are grant funded from SBIR grant mechanisms to develop a product for trauma, fracture fixation, and vertebral compression compression fractures. The same portfolio transpose now gives you an idea of our rollout and timeline to market. In all cases, we've been working with the FDA to define the regulatory processes. These are either de novo or PMA applications, we expect to hit the market in three to five years for all of these indications. The one exception is the animal health product where we look to launch that product next year. We keep an eye on our biomaterial competitors or peers in the group. These are materials that are biomaterials in the orthopedic market that have been launched over the last five years. However, none of these biomaterials as I said before, has a unique combination of both structure and regenerative potential. Tetranite is the only material that is asked to conductive and adhesive to bone. Our first lead indication is very interesting. We went after dental implant stabilization because of the very compelling value proposition with today's standard of care. Patients that have a failing tooth and kneaded extracted go through a complicated stage surgical procedure. In the first procedure, they extract the tooth and over 70% of the time, they fill that with a bone graft because it's deficient bone to be able to accept a dental implant, the patient comes back often three to six months later after the bone has taken place. And the surgeon can drill and place the dental implant followed by the attachment of the crown. With Tetranite no matter what the situation when the patient has to have their tooth extracted, the dental implant can go in and the same procedure because the bone adhesive bonds it to bone. This is now evident through our published preclinical animal studies. Here you can see a dental implant placed in bone with deficient bone what surrounds it is Tetranite binding it to bone. And then over time the material goes through a dissolution and bone substitution process until it's fully replaced with bone. But the implant doesn't lose its position or its structural strength. This is a clinical series where we've extracted a molar and placed the dental implant in the same procedure with soft tissue healing and crown attachment. Our team is well poised for growth. I co invented the material when I was at Stryker. I wanted to be an entrepreneur, I went back to business school where I met a co founder Grayson Allen. His background is in finance and operations. So we make a great team. We built the team with engineers and scientists as well as surgeons, we have over 35 advisors that help lead our different verticals. We have raised over $27 million to date of which 35% percent of that has been through non dilutive SBIR grants nearly $10 million. This has enabled us to turn on each additional indication and build value and potential to maximize the portfolio and the IP. We are now looking for $25 million to fuel our growth through the clinical studies to launch our products over the next three to five years. Where we end up is looking at exits. And what we do is we look at companies in our field. These are companies that have exited over the last five years with biomaterial products based on novel PMMA claims. On average, they've exited for $400 million. We think this sets the floor for RevBio. However, what's interesting, these materials only had one indication. So truly our platform technology could command a multiple and so we're very excited to move forward. I appreciate your time today. Thank you very much