Biorez | Kevin Rocco, CEO

(Transcription)

Kevin Rocco  0:00  

Good morning, everybody. My name is Kevin Rocco. I'm the founder and CEO of bio res where we are developing the future of tendon and ligament healing. So this may be a surprise to people in the audience, but about 20% of adults have rotator cuff disease. Unfortunately, as we age, our tendons become thin and weak, leaving them prone to tearing or injury. And this sends about four and a half million people to visit their physician each year. Symptoms are typically pain. And in more extreme cases, loss of function, the most extreme large and massive rotator cuff tears result in loss of function of the arm. And so in those cases, those are repaired surgically. And there's about 500,000 of those procedures each year. You can see here on the right, what a rotator cuff tear looks like. So we're actually looking at the shoulder, the tendon actually pulls off of the bone. So standard of care in this market today is for a surgeon to go in arthroscopically, grab that tendon and tie it back down to the bone Using sutures and suture anchors. So it's a it's a mechanical construct. The problem for the market is that about half of these repairs, surgical repairs fail within the first six months 50% it's shockingly bad, admittedly. And why is this happening? Well, you have to remember the reason why it tore in the first place is that it's thin and it's weak. And so putting it all back down to bone. Why would that guarantee a good outcome, it doesn't actually heal back to the bone. And because that tendon is weak, that mechanical construct can fall apart, sutures can pull through, etc. This is actually the largest unmet need in all of sports medicine. So Biorez has developed a very interesting novel implant technology called the Bio Brace. And it's the first biologic scaffold to improve the healing process that also has strength. So this device is intended to mechanically reinforced tendon ligament repair, as well as improve the healing process. And I'm going to show you a little bit about how that works. But the implant itself, where all of our intellectual property lies is this novel biocomposite architecture. So we actually take a highly porous collagen sponge, and we've embedded it with PLLA micro filaments, they're 15 micron in diameter. So you see the cross section there and look at it under a microscope, you have highly porous collagen sponge, resorbable fiber. And what that allows is, cells can go right into that use it as a scaffold to actually heal and regenerate new tissue. And the fibers provide strength and durability to the implant. And why that is such a big deal in this market is that it's the first product that can actually do both of these two things. The reason why these things fail, lack of healing, and mechanical kind of integrity loss. The bio brace can achieve reinforcement mechanically and improve the healing process. And this is a new paradigm it's a new approach to rotator cuff and what we're suggesting here is, in addition to completing the construct the mechanical repair, you add a bio brace at the time no special instruments or hardware are needed, it plugs into existing workflow. And once the bio brace is in the body, cells rapidly infiltrate into the scaffold regenerating new, thicker, stronger tissue. The bio brace protects the repair as the patient does physical therapy, and then it's naturally resorbed. We've demonstrated this extensively in robust preclinical studies in sheep, what we're showing is that we get a rapid biologic integration into the implant, you've seen all that pink is new tissue in the implant and on the surface, we measure this through MRI showing that the tendon gets thicker. And in the sheath model, we're able to actually mechanically test that repair, showing that by 12 weeks, the bio brace repair group was as strong as native tendon. So this is a there's a big meaningful finding the the value here for a surgeon user is readily apparent. And this was actually presented at a number of major conferences in 2020, and one of the best overall science paper so robust preclinical data. excitingly, we have our FDA clearance as of last May, so we're actually doing this now revenue generating procedures. And this is what it actually looks like. There's the bio brace. There's the suture, you pass the bio brace right down into the shoulder, you look up on the arthroscopic monitor. Now the bio brace is in the shoulder, it's under the suture, you tie down the suture in your lateral row and you complete the repair. So it's very easy to do with existing instruments workflow in the operating room. And this is what it does for a patient it's a game changer for the patient and the surgeon 58 year old lady has a massive rotator cuff tear treatment options could be superior capsule reconstruction very bad long, slow rehab six months basically immobilized 50% failure rate or replacing the whole shoulder which at 58. You're really too young to do to do that. So instead the surgeon called us added the bio brace into a repair and this is her at two months

Video playing  5:00  

A left shoulder rotator cuff repair for eight to 10. 

Kevin Rocco  5:04  

You turn the volume up a little.

Video playing  5:05  

And we also use the bio brace to help augment or repair. And let's see what your motion looks like right now. So go ahead and bring it all the way up. 

Kevin Rocco  5:14  

And this is a patient that two months ago couldn't move around.

Video playing  5:18  

And then show us the external rotation like you did earlier. Right reach behind your back.

Kevin Rocco  5:25  

And he goes through a range of motion exercise. But the takeaway here is that two months low paying full range of motion and robust tendon thickness as confirmed through ultrasound. The surgeon actually took this and posted it on his LinkedIn remarkable recovery. He's told us offline that he's actually had to accelerate the rehabilitation protocol for his patients to keep up they want to do things faster, they feel so much better. You can see I'm not even connected with him on LinkedIn, but we should fix that. Excitingly, too, in addition to the kind of that patient outcome, we're also collecting MRI data. And this is a patient here, this circle in red, that bright spot is actually a gap in the tendon, you can see there's anchors in the top of the humeral head. Those that means this surgeon, this patient already had a rotator cuff surgery failed by four months. Surgeon didn't know what to do. So he adds the bio brace three months later on the revision surgery adding the bio brace, this patient is fully healed. Thick robust tendon good range of motion surgeon patients super happy. So if you're a patient, you get surgery once it fails, what are you going to do you get the same procedure again, the bio brace can make an impact here. So I'm sharing some of the preclinical studies we have a number of peer reviewed publications, you know, over 4000 pages went to the FDA. We're now in this process of collecting real world clinical data case reports market surveillance. And excitingly this year, as we make our way up this quality of evidence pyramid. We're going to launch both a prospective registry to formalize that process and capture more data, as well as start prospective studies. I mentioned the FDA clearance it is the indications are for reinforcement of soft tissue where weakness exists. So it is a broad indication for use. And we offer it in two sizes. So two sizes covers most anatomies for tendon and ligament repair. There are existing favor and favorable reimbursement mechanisms, and were priced at 3000 and 2000. So takeaway here is broad indications, multiple sizes, platform technology. And we know that because in the first nine months of our clinical use, while I focused on rotator cuff, about 50% of our cases, our rotator cuff, this tendon and ligament, slow to heal and high failure rate is common in all of these other anatomies ACL, Achilles, elbow, et cetera. And so this is real world data from us of where surgeons are using the bio brace over 150 procedures in the first nine months 17 different anatomies 100% surgeon satisfaction zero device complications. Now we feel ready to build out a sales team around this really game changing technology, the sales expectations hiring the team now, first two reps are trained and hired hiring 10 more this year, we're expecting to do about 14 and a half million next year. And then really the big year for us will be 2024. There are attractive margins here. We've got a great management team, a lot of experience both small and large medical device companies with the expertise in sports medicine, a number of folks involved in rotation medical, which was a similar technology a few years ago, and put together an all star board of directors and advisory team some of the biggest names in sports medicine. I can't help but just brag a little bit, entertain me, please. Last year, we exhibited at our first conference, the EO SSM, which is the largest sports medicine society for medical doctors. And we actually won the Best Overall New Technology Award at that conference. So that was, you know, some independent validation from surgeons that this is an impactful technology. We were very excited. And for a tiny little company, it got us a lot of visibility. So it's really been a catalyst to what we've what we're doing, as well as some of that validation. So look, I shared this already. But in conclusion, this is a massive, you know, unmet need in really, that affects the fundamental well being of your life. We haven't developed a really novel technology with the bio brace, it's got great intellectual property around it. We've got early positive clinical traction, early positive commercial traction, and now we're ready to scale this company up. So if buyer is our financing and or our team are of interest to you, please come find us. Thank you for your time.