Kial Gramley, BackStop Neural - Spinal Cord Stimulation System | LSI USA '24

Kial Gramley  0:03  
I'm going to start off today with a personal story from our co founder that will share with you what a deeply mission driven organization we are. I'm going to go over a summary of the company. I'm going to talk about our products, and I'm going to talk about the platform technology that gives us a competitive advantage in the marketplace. After that, I'm going to go through the problems that exist in spinal cord stimulation and the solutions that Backstop Neural is uniquely capable of offering. So this is Jason Carmel. He is the chief medical officer and a co founder of Backstop Neural, and next to him is his twin brother David. Prior to graduate school, a diving accident left David paralyzed from the chest down. This deeply jarring experience changed the trajectory of both of their lives. But it catalyzed a mission within Jason to spend his life's work researching chronic pain relief and motor recovery through neuromodulation and spinal cord stimulation. Backstop Neural has a charter to take Jason's discoveries from Cornell and now Columbia University and share them with the world. With our mission to relieve pain and restore movement. We're gearing up to manufacture and commercialize the world's most advanced spinal cord stimulation leads for chronic pain relief and motor recovery. So the company is a C Corp. We went through a seed a round in 2020 to a $1 million round. We play in a $7 billion market opportunity. The technology has about 10 years worth of academic research that has gone into developing it and getting it to where it is now, along with about $10 million worth of research funding from the NIH and DARPA. Backstop Neural has exclusive worldwide licenses to 12 patents from Cornell and UT Dallas with six more that are pending prosecution. There are existing CPT codes in place and the regulatory pathway is a 510 K clearance from the FDA. The products include a thin film based paddle lead for spinal cord stimulation, as well as a percutaneously delivered paddle lead. The we have been through small animal studies, we have had devices in rats for up to six months, we have completed an early preliminary cadaver study, we have proven biocompatibility. And we're now optimizing the human prototypes. So the technology platform that Jason and his co inventor at UT Dallas had been working on is the ability to use semiconductor manufacturing processes to photo lithographically pattern metal electrodes onto a proprietary softening polymer. And because we use this novel polymer, we have the ability to revolutionize the property paradigm that should be expected from spinal cord stimulation leads, every incumbent lead today is some simple derivation of hand assembled electrodes on to a molded silicone. And what that means is that they all have the exact same limitations. Chief among these limitations is thickness and size, with these devices being two millimeters thick or more. And this gets to one of the key problems within spinal cord stimulation, which is the amount of space that is available in the epidural region where these devices get implanted onto the spinal cord. There are two primary placement points and spinal cord stimulation. One is in the thoracic region which delivers pain relief to the lower back and the legs and the other one is in the cervical region which delivers pain relief to the neck and the arms. In the thoracic region, there's five millimeters of space to place these devices. If there's no scar tissue or other complicating factors. In the cervical region, there's one and a half millimeters of space. So again, we're talking about implanting a two millimeter thick device into one and a half millimeters of space in someone's neck. So the challenges and the risks that are inherent in such a procedure are reflected in the numbers that we see for cervical placement, which comprises only 10% of all SCS procedures, despite the fact that chronic neck and arm pain is 40% of all chronic pain. So Backstop Neural is a solution to this problem. And the unlock that we offer to the industry are devices that are 10 times thinner than existing products and fit well within the space constraints up and down the spinal cord. Another key problem in spinal cord stimulation is battery life. So right now, a battery is put into an implantable post generator called an IPG and that gets implanted in the flank. That IPG delivers a current using the battery to the spinal cord stimulation lead which passes it on to the spinal cord. These batteries currently only lasts three to eight years, at which time the patient has to return for another surgery, further exposing that patient to risk and dramatically increasing the patient burden. backstopped, neuros solution to this problem is the ability to increase battery life by 2x, we're able to double that battery life in two different ways. Number one is the softening nature of our polymer, which at body temperature becomes very soft and supple, and now conforms to the shape of the spinal cord, which delivers the current more efficiently. The other way is the type of metal that we use, which has 10 times the charge injection capacity of the platinum iridium that's used today, again, delivering a current more efficiently, which creates less of a draw on the battery and doubles that battery life. So we've spent the past year interfacing with dozens of physicians across a range of specialties, including neurosurgery, orthopedic surgery, and pain intervention, all with the intention of validating that these are indeed problems that they face on a day to day basis, and that they're looking for valuable solutions to that product to those problems. But if I can leave you with one slide to remember it would be this that we are 10 times thinner, which increases the patient population and eligibility by up to 50%. We have 10 times more charge injection capacity, which doubles the battery life of the IPG and we are softer and smaller which reduces scarring and also contributes to the increase in battery life. It's important to note that we compete very favorably with existing products that are in the market, but also with other technologies that are currently in development to address the same problems. Our product, currently working on the thin film paddle lead and percutaneous paddle II that I showed you earlier. But we have a robust product roadmap that includes a miniaturised, fully integrated SCS system along with the IPG as well as devices that are optimized for motor recovery. As I said earlier, we play in a $7 billion market opportunity that includes both chronic pain relief, as well as an early but high growth motor recovery market. The key players in this space today include Abbott, Boston, Scientific, Medtronic, and nevro. With many other players trying to enter in, we view each one of these as a potential strategic partner in our go to market plan. Our leadership team has educational backgrounds from prestigious institutions like Georgia Tech, Columbia and MIT. Collectively, we have over 10 rounds of capital raise for past startups. We've launched more than 20 new products into the market and we have four successful exits between us. We have engaged with highly regarded service organizations to develop our regulatory and reimbursement framework. We've also recruited leading physicians in this space to offer us guidance in our product plan, as well as to increase our reach and our network into this space. So we are working on a $6 million seed be round right now which would get us to a finished and commercially ready product by 2027. We have several family offices and physicians in this space that have subscribed, we're looking for a lead investor to finish it up. Thank you very much.