Andrew Iott, HAPPE Spine - Spinal Implants Using a Patented Material Platform | LSI USA '24

Andrew Iott  0:03  
Good afternoon, everybody. I realized I'm one of the last talks between you and happy hour. So I'll try to keep this interesting and on time. A little bit about me I'm formally before I joined the team and happy spine I was a co founder at Globus medical, where I ran all of product development, global product development, and launched over 200 products during my tenure there. One of my chief responsibilities was assessing new technology and seeing who we would want to partner with or potentially acquire. We're always looking out for technologies that could address core problems in orthopedic devices, and really have more of a platform type of application. And I believe happy is that in fits that bill, so. So a little bit about us. Our mission is to improve clinical outcomes and orthopedic implants with a proprietary biomaterial platform. And the secret sauce to happy is really in our name happy stands for hydroxy apatite, porous peak, our current status, we're commercially, we have a commercially clear product, I think, a clear, called integrate see, it's a ACDF device for the cervical spine in a great means to bring two components together, and we feel that's appropriate name for this device. We've ongoing commercialization, we've had positive early clinical outcomes, our production process is protected and scalable. And we have additional products in our pipeline. As I mentioned, a very strong patent portfolio protecting both design and manufacturing, I think it's critical. Our we have an extremely experienced management team and a large Tam, to go after. So speaking of that, the the market that we want to address is primarily in spine currently valued at 2.5 billion in the interbody fusion space. But there are applications in trauma and in Sports Med as well. So what is an interbody fusion and probably a little bit of our view for for many of you, but it's a procedure used to leave pain by fusing adjacent vertebrae together. It's really what the surgeon is trying to do. There's about 850,000 of these procedures done each year. But there are many problems associated with these procedures, multi level procedures can have a pseudarthrosis are non fusion rate of over 30%. And this can cause further complications, additional surgeries, breakdown of additional segments. So it's it is a big problem. So what is the clinical goal of orthopedic surgery, many times it's to facilitate healing with stable fixation between the bone and the implant. And we feel that there's four major components of the implant or characteristics that an implant needs to have. One we want biologic fixation by bone in growth really growing into the implant or osteo integration. Next is hydrophilic or ants and cell friendly surfaces. We want it to be radiolucent for post operative assessment of healing, and we want to have optimal biomechanical properties for load sharing. The problem is that current applic biomaterials are unable to meet all of these criteria. The two major alternatives for materials available today are peak and titanium peak is not a great material, it has more of a hydrophobic nature to it, so it repels liquids, and currently doesn't have the ability to have in growth, but it is radiolucent and has a modulus of elasticity closer to native bone. Titanium, conversely, is much more friendly to bone on growth and 3d printing designs enable in growth, but it's not radiolucent. So it's difficult to assess post operative fusion, and it is much different than native bone. This is you can see in these images examples of the shortfalls that they have on the left you have titanium, where it's showing some subsidence as well as poor image quality and on the right is peak where you can see some evidence of non bone interaction. And this also can lead says subsidence says there may be motive changes in the implant. Our solution is hydroxy apatite porous peak. So, we have interconnected cancellous porosity, for bone in growth. This is the proprietary part of our product, we have exposed hydroxyapatite for hydrophilic and cell friendly surfaces. It is radiolucent due to the nature and we've optimized the implant design by versatile placement of dense and porous material. So here's how it works. You can see here in the upper left, the porosity absorbs autogenous blood and proteins. This is the primary step of bone growth you need blood and you can see this picture from an intraoperative image that the implant is actually starting to soak up that blood. Down in the lower right you see a slide of our material our porous material versus native bone Are porosity mimics almost exactly the properties of human bone. It's 99% interconnected so there's not any voids or holes. It is 75% by volume and the pore size is exactly similar to native bone. to that we add Hydroxyapatite. hydroxyapatite is a critical component of bone growth, it makes up about 50% of native bone. Our hydroxyapatite particles are firmly embedded in the peek, this is not a spray, it's not a coating, it's not going to dissolve the Hydroxyapatite adsorbed, the acid osteogenic proteins, this material loves proteins and it guides support bone forming cells. We've done research that shows we have a four time greater adsorption rate with our material as opposed to to regular peak. So you combine these two things and you get bone in growth, which we've validated in an O vine preclinical model. The side that you see on the right is a histology slice, where the pink is the is the bone there's evidence of osteo class starting to integrate with the light brown section, which is the actually the poor section of our implant. So over a 12 week period, we show that there's up to an even greater than one millimeter portion of in growth into the porosity. So again, we're going to create a stable fixation with this implant. We did a first hitman. Late last year, we're already starting to see bone integration. Even over three months. Dr. Steven Smith was the surgeon who performed the surgery happiest both spine and surgeon friendly it is biologically compatible, strong and radiographically informative. Or commercialization highlights we've done about 50 patients so far over 100 implants, we are getting a premium price for this device, typically an ACDF spacers. Anywhere from 800 to $1,000. We're getting upwards of 1450. While having similar cogs to normal peak devices, we do deliver this sterile packs that doesn't make it easier from a logistic standpoint. In the AOR. We're doing multi level cases again, that's where some a lot of the problems occur with standard devices. We did win an award for best new technology and we have a national network of distributors. Again, this is a platform we have multiple products that we're going to be working on in the lumbar interbody space where we can command even even higher HSPs but there are designs for trauma and in sports medicine. We have an extremely experienced leadership team Dr. Ryan Reiter is the inventor and founder. No one knows more about peak than then Dr. Reiter. He's well published and has multiple experiences in manufacturing. Doug is our head of engineering. Jenna does operations and finance. Luke is our commercial commercialization lead and has an extensive network of both surgeons and distributors. To that we join our board of directors Steven Foster is the CEO of Tennant. Medical currently, although longtime Medtronic executive Brian McCollum, CEO of health concept partners in the CFO, wasn't CFO at orthofix. We have a really top rate clinical advisory team spans from coast to coast from academic to private practice. Many of these gentlemen have been on the podium many times and are well known in the industry. We have raised to date a little over $9 million. We did a seed funding from in 2018. Our series A was led by Genesis innovations in the Cultivate fund. We are currently opening another series A one $4 million dollars, this will go to product development, continued commercialization and scale up in more manufacturing capability. We will reach a well over a million dollars this year. And we expect to be at 10 million in 2026 with the addition of newly launched products. So why happy spine enabling platform technology I really feel that this is going to solve a lot of problems in the in the spine and ortho space. We've we've proven that we can get a product to market we have a proven 510 K regulatory path for future products. And we've got a great team. So we'd love to if you're interested to hear more. We'd love to hear from you. And see how you can get involved with with happy spine. So thank you very much