Video Transcription
Brian Hess 00:02
Brian, good morning. My name is Brian Hess again, CEO and founder of REVBIO. We are developing a revolutionary biomaterial in the field of orthopedics that we believe will transform bone repair. There are millions of surgeries every year, and often these injuries are very complex, as you can see by the array of images on the screen. Predominantly, these treatments and these patients are fixated with hardware fixation technology. The problem with hardware is it has a hard time adapting and connecting to bone. It's very invasive, and often you have large voids in the bone that need a regenerative biomaterial to help regenerate the bone. We believe this technology, because it's been around so long, really could be revolutionized by a bone adhesive biomaterial. And that's what we've invented at REVBIO and I want to talk about today. We believe this will transform bone repair for pairs, for clinicians, of course, for patients. Our material is what clinicians desire. They are looking for a load-bearing, fast-setting, wet-field adhesive. And you can see that in the image here; the material is injectable. It can be applied through less invasive approaches. It sets up fast, within minutes, forming robust bonds to both bone and metal hardware. Moreover, the material is regenerative. As you can see here, the material transforms into bone over the period of months without losing the requisite strength of the construct. There are many materials in the field of orthopedics and dental for dealing with regenerative bone tech solutions. And as you can see here, none of these materials possesses the qualities that clinicians desire. None of them have the adhesive characteristics that our material has. Some of them have regenerative capacity, but they lack the structure like Infuse, a very powerful bone morphogenic protein that Medtronic sells. This product went to meteoric sales years ago and then fell because they had a hard time controlling the protein, and it led to ectopic bone formation. Our product, Tetranite, solves for all these needs. It's injectable, it's adhesive. It stays where you want. It forms robust, load-bearing strength, as I talked about, and it is bone regenerative. Our technology is both revolutionary and patented. It's comprised of calcium phosphate and phosphine, which is an amino acid. These are synthetic molecules, which we can produce at scale for a low cost of goods. This technology is patented through eight issued patents in the US, and we have several that are pending. This will extend the patent life through 2043 and beyond. We are approaching five key markets, as you can see here. And in total, these five markets command over ten billion in global addressable market size. We are in the clinic for three of these product indications: one of them for dental implant stabilization, one of them for cranial flap fixation, and the other we plan to launch next year, finishing clinical trials for Animal Health to treat an indication in dental. In addition, we have indications finishing preclinical large animal studies this year so that we can start clinical trials next year for long bone fractures and then into spine. I want to talk briefly about our top two indications that are in the clinic now, dental implants. This is a huge and largely untapped market for two reasons. Number one, nearly half of the world's population loses at least one tooth in their lifetime, and so they are in need of a dental implant, restored crown, which is a standard of care. However, these procedures are very long, complex, and costly, and so the adoption rate has been only about one to two percent. Yet it's a huge market, commanding a $4.6 billion market. We believe with Tetranite, we can remove a surgical phase in the procedure to accelerate the overall treatment and actually reduce the cost in our clinical studies that we're conducting. Here's a case example where we removed a molar that was failing in a patient. There was a large hole. The clinician could not place the dental implant. Had to stage that procedure if they didn't have our material. But rather, because of the glue, we were able to bond that implant directly into the patient's mouth, and they went on to healing. We've tapped many different clinicians through surveys to understand the pricing and the adoption. And what we found is that our procedure, our material, allows procedures to be cut in half, which will reduce the cost as well in half, which will drive revenue growth for the practice because of chair time that will open up for new patients. So, for our second indication, where we're in the clinic, I'll talk about cranial flap fixation. This is a procedure with neurosurgeons where they often go into the brain through a craniotomy, and at the end of a long procedure, they close the bone back up with plates and screws. We're going to obviate the need for plates and screws because they're going to essentially glue that flap back into place. We've completed all of our animal studies and published on this. The actual adhesive is over five times stronger than the plates and the screws, and it fills up that curved line, which is a space allowing for bone effusion, which you can see in the slide on the right, which is histological evidence of bone in our first case that we've now implanted over five patients. You can see here the large bone flap that was removed, and after about three months, the brain went down and swelling following a stroke, the surgeon was able to put this flap back with the glue, and you can see how conformal the flap is to the bone. There's no metal, no artifact, and this will lead to a very nice cosmetic outcome, as you talked about in your previous discussion. We also just won a $2.4 million grant from the NIH to fund this clinical trial. So we're very excited about that. Taking a step back and looking at our pipeline, we actually have several indications I talked about, and all of them are in the process. And so we are poised now to raise our Series A round of capital of $15 million, and that money will be used to fuel these clinical studies. As I mentioned, several of these studies are ongoing in the pilot phase, and so we will work over the next two to three years to go through the pilot into the pivotal phase as we approach market and look to get regulatory approval, not only in the US, but also in Europe. In terms of our clinical data, we now have over 100 patients that have been treated with Tetranite across three indications: the dental implant stabilization, cranial flap fixation, and in our animal health. We've now got three FDA-approved clinical studies that are underway. We've also got four studies over in Europe that are running, including one that's a pivotal study for our dental implant product. So we're well on our way into the clinical stage, and this is where we'll be for the next couple of years. Our team is stacked and poised for growth. Myself, the inventor of the technology, and sort of my background is product development, bringing these products to market. We've also got a team of executives in management that has experience in the industry, but we've also got some surgeons on board, and that's very important because we are now in the clinical stage, and translating from animals to the market is very important. We also have advisory boards. We've got a dental advisory board. We also have an orthopedic advisory board comprising neurosurgeons, spine surgeons, as well as orthopedic surgeons. In terms of our capital raise to date, we've raised $47 million, which is comprised of $27 million of equity in addition to $20 million of non-dilutive grant funding, of that $10 million we've won in the last year from several different grants, including the grant I just talked about for cranial flap fixation. So we've got a very nice compound effect for our investors, which has been validated by the NIH to sort of help drive our different indications into the clinical studies. Right now, we're closing a convertible note round of $8 million. We've raised $7 million, so we have one more million to raise yet, and that'll convert into a $15 million Series A round. And that money will help us fuel the clinical studies, as I talked about, to key inflection points for data across four of our indications. In terms of the company, we've made quite a bit of noise and progress over the last couple of years because of our translation into the clinic. We've published animal studies. We've actually just completed a study up on the International Space Station where we've actually surgerized rodents, flew them up to the space station, and have proven that we can regenerate bone in space, which is an environment which is very difficult; astronauts lose bone. So this is evidence that not only is our material innovative because of its adhesive properties, but also for its regenerative potential. Thank you very much.
