Brian Hess Presents RevBio at LSI Europe '23

Transcription

Brian Hess  0:05  
My name is Brian Hess, I work for RevBio, and I'd like to talk to you about a revolutionary orthopedic biomaterial. There are over 15 million bone surgeries in the United States per year. Unfortunately, over 30% of them end up with complications. But take a look at the pictures here. These procedures are complex. Today's standard of care requires hardware fixation devices, but often there's deficient bone. Therefore, it's hard to get good integration. In therefore, bone grafting materials are required to be added to these procedures. This leaves these procedures with long suffering healing times that lead to these complications. So by and large, the field has remained largely unchanged for decades. RevBio is going to transform bone repair, we have invented and developed a regenerative bone adhesive biomaterial that will address these medecine problems. Our material is called Tetranite, and it's been engineered to address all the clinicians needs. As you can see here, the materials injectable for less invasive procedures, it sets up fast and wet field environment and forms load bearing adhesive bonds to both bone and metal. Moreover, once the material is in the body, it goes through a bone regeneration process over the course of weeks to months. If you take a look here, these are the existing materials that are out on the market today in the field of orthopedics. They're all clustered across two axes, those that are regenerative and those that have structural strength, but uniquely none of them have the combination of both. This is where our product Tetra night sits. The material will be first in class as a load bearing adhesive material, but it also has regenerative potential to the body. The leading orthopedic biomaterials are shown here, none of them as seen has the combination of all the features that conditions desire. Tonight though solves for this. Our material is fully synthetic. It's comprised of two core materials, a calcium phosphate, and a bio inspired amino acid. This material can be produced at a low cost. And we can engineer a kits for each indication with a cost of goods command and a gross profit margin of at least 90%. The technology is patented, we have over eight issued patents. Most of them issued to us through licensing exclusively from Stryker. RevBio has gone on has filed for over 10. 12 additional patents that are pending. This helps extend the patent runway to 2037 and beyond. We are approaching five key markets with a total addressable market size of over $10 billion. The top three indications are above the shoulders. We're approaching dental indications and indications in the cranium. We're using our animal study data from these to then field products in the animal health space for early revenue. After this, we're approaching spine and extremities for fracture repair, where we're running pivotal animal studies with FDA support leading to submissions for starting human studies next year. Want to talk about our dental implant indication. For those that don't know over 50% of adults have at least one missing tooth. But only 1% elect to get a dental implant supported crown and that's because of the time and cost for these procedures. But even so, the global market size for dental implants is nearly $5 billion. The reason for that hesitation for these procedures is because it goes through a stage procedure. When you have your tooth extracted, and over 70% of procedures you have to go through a complex bone grafting process before the bone is available to then come back later and have the implant dentist drill a hole in place an implant or Tetranite bone adhesive allows those two procedures to be claps into one at the time of extraction, the dental implant complete placed in our human studies we've shown that it not only immediately stabilizes the implant, but it maintains clinically acceptable stability throughout the healing process. In our animal studies, we've shown that the material which stabilizes the implant as shown in brown on the left, goes through a regenerative process and forms bone all while keeping the implant stable no motion or loss of stability. In our early human studies here you can see this is a molar case where molar was extracted. Now tip quickly that's too big of a hole to place a dental implant and they'd have to go through a bone grafting procedure before returning months later for the implant. With Tetranite we're able to place that implant in the same procedure. Thus taking out a surgical phase healing has gone on to the implant dentist, there's a well real winning strategy here. When comparing today's standard of care and the treatment cost and time to the new procedure with Tetra night, we remove over 50% of the cost and the time for the implant dentist. That means they can move patients through their chair and still charge the same amount of money but retain the savings. So there's a real driving mechanism for them to adopt the product. We're also expanding into other orthopedic markets. We have an FDA approved cranial flap study which we're about to start in the fourth quarter. This will replace replace metal plates and screws for procedures that involve neurosurgeons that involve going into the cranium to repair the brain and then come back out and replace the flap. We're also looking at fracture fixation. And as I said before, are looking to start human studies next year. Our pipeline is diverse. Here you can see we look to launch products for human use over the next three years, while also launching our first revenue generating product next year in the animal health space. Our team is well diversified. We have a group of engineers, clinicians, executives with significant experience at prior medical device companies. We have over 30 Clinical advisors, all organized into the different verticals that we're approaching markets. Our advisory board is comprised of key opinion leaders, and all of them have been utilized in our development process with hands on experience helping us define the user needs for each indication. Over half our investment has come from clinicians over $10 million, which helps validate the clinical utility of this product. We produce our product and develop it at an incubator and medical device incubator in Boston Metro called M2D2, we are producing clinical grade product and we are ISO 13845 certified. To date, we've raised over $40 million, of which 40% comes from non dilutive grant funding. This has helped us fuel are different indications. We are now looking to raise $25 million to essentially accelerate our clinical development process and help us run through these clinical studies to commercialize the product across the five indications I talked about in terms of an exit strategy. Here's a look at the last the last five to seven years of orthopedic biomaterials or biomaterials in general that have exited on average $400 million. What's interesting are most of these companies are all single product companies where their exit has been equivalent to their annual total addressable market size. We believe this provides a floor for how we could exit but also thinking about us having multiple products, we could go into multiple approaching or exceeding $1 billion. Thank you very much for today's presentation.