Ted Bird Presents Dymicron at LSI USA ‘23

Transcription

Ted Bird  0:04  

Good afternoon. It's a pleasure to be here. I am an LSI alum. And it's great to be back here. This afternoon I'm going to tell you about our very unique and innovative product. The theme here is diamonds are forever. It's an exciting product. I want to tell you about the story of this development, this innovation and the opportunity. We're currently seeking $20 million as an investment to help us get through and fund FDA studies, PMA studies required to get this into the US market, and to extend our international commercialization where we have had the CE mark for eight years. The Dymicron story is fascinating. The founder, Bill Pope you see here in the picture, is a material scientist and a university professor at BYU, who invented the process of creating polycrystalline diamond and be able to manufacture it in a systematic way. He applied this and was very successful in several businesses for industrial applications, starting with deep earth mining drill bits, basically put tungsten carbide drill bits out of business and was very successful. The impetus for Dr. Pope to start Dymicron was when his neighbor told him, I've got to go back to the hospital for a total hip operation next week. And Dr. Pope said well, why is that I thought you just had that total hip about 10 years ago. And he said, Well, apparently my hip is worn out. And so the entrepreneurial light bulb went on. And Dr. Pope said You know, if I had made your hip out of my diamond, you would never have to go back for another operation. So that led to him developing starting Dymicron and in a nutshell his vision was to create musculoskeletal implants that lasts for a patient's lifetime. The leadership team at Dymicron is very impressive in the spine space where the first product that has been developed is being applied to the cervical spine. We have over 100 years of combined experience in spine. I've come from the big companies from Medtronic, J&J, the mid sized companies like Orthofix and the smaller companies like appy fix out of Israel and Titan Spine, Jeff Bennett, Merit medical Kimberly Clark Bellard medical BD Eric Lang in the bottom right with my neighbor in Memphis, Tennessee at Dannic soft organic, which we sold to Medtronic for $3.7 billion. And in 1999, one of the sharpest spine engineers that I know and got Dr. Peters with tremendous experience in Europe runs our commercial operations. So what is cervical disc degeneration? Well, it's a process where the discs outer ring or annulus breaks down, or the bone creates osteo fights and creates problems creating impingement on the nerves which just sends pain, numbness, tingling down your arm difficulty sleeping, makes it very difficult and painful problem. The prevalence is is quite large by age 50 85% of us will experience disc degeneration to some degree, and it's actually rivaled the common cold as the second most frequent reason for a visit to the doctor. There's over 6 million visits a year just in the United States alone for neck pain. What are the treatment options for cervical degenerative disc disease? Well, the Cascade is conservative care and insurance companies want to see that that's injections. That's physical therapy. That doesn't work. The next step and the most prevalent procedure today for cervical disc degeneration is a fusion where the spine is rigidly fixed, the disk is taken out titanium plates and screws are in cages are put in with biologic products to fuse that joint. The problem with that is it sends the forces into the adjacent segment of the spine and creates that breakdown which means that patient is going to have to go back for another operation down the road on the next level up. In recent years disc replacement, replacement or motion preservation has come aboard and provides tremendous benefits by maintaining the motion and eliminating that adjacent level disc degeneration. The problem with the first generation implants are they're made with plastic and metal materials just like total he's total knees and total hips, which break down over time, create implant failure and require a revision. So Dymicron has developed a cervical artificial disc with two unique factors one is the material which is Dr. Pope's polycrystalline diamond. The hardest substance no Then the universe, no detectable where debris we can't produce where debris with this hard, slick, like diamond material but man made the combination of the material with an engineering design that was invented by a PhD spine engineer that did all the lab testing on the other first generation products is this tri lobe design you see in the picture, the animation here. This trial was like a three legged stool versus a one legged stool versus a ball and socket. It's a more stable design. And it takes the stresses off of the joint the problem that the PhD engineer had his he couldn't find a material that was strong enough to hold the strong stresses that the tri lobe design creates. And he was introduced to the company in Salt Lake City just down the road, diamond crown which was making polycrystalline diamond for a hip and they the cervical disc was born. We have robust patent protection over 83 pens. Let's talk about natural diamond, you know it comes from carbon, and that's where our product starts. But it has exceptional properties strongest, hardest, stiffest, slickest most wear resistant product product out there is beautiful, it's a gem. It's used for you know, engagement rings and jewelry and other things like that. The problem with natural diamonds it's brittle, it creates a millennia to create the pressure to create a natural diamond. So you hit it with a hammer, it's gonna fracture polycrystal and diamond harnesses those exceptional properties of natural diamond while eliminating the weaknesses. So polycrystalline diamond it's man made in Orem, Utah engineer material randomly oriented diamond grains is what we start with are centered and fused together under geological pressure and temperature, but not geological time we make each unit in four minutes. bulk material, not a coating, retains diamond properties in a fracture resistant form and can be formed that a near net shape which is then cut to size and polished. That ring on top is actually made from our press we we leased the machine out to a jewelry company that makes polycrystalline diamond rings. You can see me afterwards if you want to place an order. So this is the most impressive manufacturing sheet machine you'll ever see. This is the diamond press. It's nine feet tall, nine feet wide, nine feet long. It creates a million psi at 2700 degrees Fahrenheit, and over four minutes, the grains of the diamond powder are fused together to form a solid polycrystalline diamond. The random orientation of the fused diamond grains eliminates any of the fracture planes making poly gristle and diamond much tougher than natural diamond. Why polycrystalline diamond on this tri lobe? Well it allows for were free complex high stress designs not otherwise possible with traditional materials. Here's an example of a existing product in the market a metal on metal disc after 40 400,000 cycles with the scratch and the wear scars versus ours, which we can't produce after 10 million cycles which is the equivalent of about 400 years of human life. The market opportunity is a fastest growing market and spine growing at 18 to 20% CAGR. It's about a billion dollars today in terms of anterior cervical procedures, but 800,000 a year, but 85% of those procedures are fused fusions. So there's a great upside potential. There are five current discs on the market. But all of them are the inferior materials and on the US market metal on plastic metal on metal viscoelastic plastic ceramic on plastic. Dymicron has already retired critical risks in product development, market, regulatory development and capital. Over 500 clinical cases over the last actually eight years in Europe have been successfully implanted currently active in Europe, over 80 patents, strong regulatory CE mark, strong capital funding. So the summary the investment opportunity and Dymicron it's a best in class motion preservation device, disruptive IP, over 500 devices implanted in Europe, CE mark, we're seeking $20 million dollars for FDA trials and OUs expansion. We're currently launching the Regulation A tier two equity crowdfunding campaign paid last month minimum investment of $1,000 Go to invest.dymicron.com to hear the rest of the story and partner with us as we move this thing forward. Thank you very much