Embody | Jeff Conroy, Embody

(Transcription)

Jeff Conroy  0:01  

Good morning, everyone. I'm Jeff Conroy. I'm the CEO and founder of Embody. And we're a sports medicine company based in Norfolk, Virginia. Love to tell you our story. We've been at this for about seven years now founded the company back in 2015. And we're using the power of collagen and physical structure to create collagen based implants that stimulate new tendon tissue healing in sports medicine injuries, so rotator cuff patellar hamstring ACL. Traditionally, the answer had been put another suture in it. Let's add mechanical strength in these repairs. What we've done is we've really brought biology and healing to soft tissue repair. The company was founded really based on the needs of Navy Seals and Green Berets. We've started with a DARPA contract for over $12 million back in 2015. Specifically, because of the need to come up with a new solution return to sport returned to duty for high performance warfighters high performance athletes, what we've been able to do, we've now raised $23 million non diluted funding from DARPA, the United States Air Force, United States Army, and we raised $21 million from investors. So we have more non dilutive capital in the company than dilutive capital about $43 million in total 21 investor funds, we launched tapestry our first product last year in in our first commercial year during COVID. We did a 400 cases, really all over soft tissue injury. So shoulder hamstring, patella bicep. And what we did was we demonstrated and de risked our platform meaning 400 cases, no inflammatory issues, no adverse events, no unhappy surgeons, no revision surgeries. And so that was our first commercial year. This quarter, we're about to launch, tapestry rotator cuff, so fully instrumented rotator cuff repair. This is a next generation fast follower of Smith and nephew's regeneration, and we think we're going to change the rotator cuff repair market. And then I'll tell you a little bit about our collagen based sutures. So we'll launch a line of collagen enhanced sutures next year. There's a couple of things I'd love you to take away when you think of embody. One is the power of collagen and how we use college and to bring healing to many many different soft tissue injuries. Specifically, we focus on a range of big market opportunities, rotator cuff meniscal repair Foot and Ankle repair, fastest growing segment in orthopedics, ACL patellar. And so we really touch every growth driver in orthopedics. And we bring the power of biology to stimulate new tissue healing their second thing I'd like you to understand is that we've got a phenomenal team 42 People now in the company, including our sales and marketing organization, and really poised for growth. We've built this company with world class clinical partners who've been involved in the design, the development, the validation, of tapestry and of our instrumentation and our suture line. And really, what when we think about what we control, we use, we call it physio chemistry with tapestry we use physical structure and the collagen chemistry to be able to derive your own cells to form new tendon tissue and to form new collagen. In the healing process. Our implant is about 75% aligned tissue. That means it mimics the native micro architecture of your native tendon tissue, your own cells attach, infiltrate grow into new aligned tissue. Our regulatory filing gave us great breadth in the fact that we can size this anywhere from 20 by 30 to 50 by 70. So it means we don't need any new 510 k's to be able to use work in different parts of the body. Same for instruments will we'll take our instruments for rotator cuff and we're we've already started adapting them for hip. And the mechanism of action is really using the copolymer approach this collagen based polymer that we've developed, and we can stimulate cell attachment and infiltration as soon as four weeks and really drive the healing cascade and new tissue formation in the patient. Our implant is gone in 24 to 52 weeks, and we've got new tendon tissue and aligned collagen that's expressed in place. And if you think about the purpose built construction, so we really engineer this align fibers construction, as opposed to products that are based on collagen sponges, or products that may be a cellular dermal cadaver tissue based decellularized collagen patches, really to create a new standard to drive cell growth inside the patient. We had great success in subscapularis enhancement. So total shoulders don't fail because metal fails, total shoulders fail because soft tissue failure and in fact, nearly 50% fail to patients fail to recover full range of motion. In six, six month imaging of our first six patients, we've got independent musculoskeletal radiology confirmation, no sign that that tendon was severed and reattached, nothing but healthy tendon tissue, no scar formation and no implant. So this has been really exciting news and our first six patients with six month data. We have a multicenter study going on in a registry that we've just launched. So we're going to extend this and extend these images over the next couple of years. And really, what we've done this year is we've taken tapestry, and we've demonstrated in 20 Different soft indication soft tissue repair indications, it's an appropriate approach to stimulate new tissue healing for that patient. Now what we're doing is we're taking the power of collagen and the power of tapestry's healing, and bringing it to the biggest market opportunity for us in orthopedics. That's rotator cuff repair. We've developed our own instrumented solution that I'll tell you about in a second. But this is a huge market opportunity 800,000 cases a year in the US 640,000 cases in our sweet spot. That means partial tears, and grade one, two and three full tears. The market leader has 3% market share and 15 16,000 cases last year, there's $100 million business built on 3% market share. We're very confident that there's 3% market share for us in the next three or four years. And we think this is a huge opportunity to reset leadership in rotator cuff repair. How are we going to do that, not just with an implant that stimulates healing and has a differentiated mechanism of action. But we're going to do it with instrumentation specifically designed for both beach chair and lateral delivery, and multi shot anchoring and resorbable anchors for both bone and tendon. So we're innovating on fixation and delivery. And really launching in May we'll have our first cases micro braid is our suture. So we're now developing a line of collagen enhance sutures. And this is really a market breakthrough in the fact that something like Arthrex is fiber wire is a non resorbable material, we've now taken 50% Collagen 50% Dyneema, the ultra ultra high molecular weight polyethylene come up with a suture that demonstrates tissue infiltration and integration. And if you look here in this picture, a collagen coated fiber wire in 14 days shows a couple of spots of cells growing micro braid has cells infused and integrated and growing between those non resorbable fibers. This is going to become a standard in high strength orthopedic repair, not just for things like ACL, but also for meniscus. This is all about clinical data generation for us now. So we've got multiple patient registries launching three different clinical case series in process. And we've raised 21 million to date from investors we're about to kick off in the second quarter, another $10 million round really to drive our commercial exponentially parabolic and and and then get our sutures launched next year. So last year for us was de risking this 500 patients actually over 500 patients now done since we launched no inflammatory issues. Now we're launching into rotator cuff, taking the power of collagen into sutures, and really building a franchise here and a sustainable business going forward. appreciate the chance to tell our story. Nine minutes to talk about the last seven years is always fun. We'll be outside if you have any questions. Thank you