Video Transcription
Yi-Kai Lo 00:02
All right, good afternoon, everyone. I'm the CEO and the co-founder of Aneuvo. So Aneuvo is a company that we are developing bioelectronic medicine, focusing on treating diseases and injuries or conditions that cannot be cured by conventional medical approaches. At Aneuvo, we develop platform technology that comprises different components, for example, microelectronics, electro algorithms, cloud, and digestive bio technologies. We synergize these different components into products or devices that can be used to stimulate the neural system or even tissues and organs. Our first target indication is spinal cord injuries. As you might know already, there's currently no cure for spinal cord injuries, and the current gold standard is still physical therapy. For patients with spinal cord injuries, they might lose their motor function, sensory function, and even autonomic functions. For many activities that we think are easy for us to do every day, actually, that's very challenging for those patients living with paralysis. One of the viable solutions to treat spinal cord injury is through transcutaneous spinal cord stimulation. The electrodes can be placed on the neck or the lumbar sacral spinal cord to help the patient recover upper or lower limb functions. The potential mechanism behind this is that for healthy individuals, the descending brain commands can easily exceed the threshold. For patients with spinal cord injuries, the level of signal is just not strong enough to always exceed that threshold. But with spinal cord modulation, or transcutaneous spinal cord neuromodulation, we are able to boost the signal strength to elevate it above that threshold, so that the patient can regain voluntary control. During the pilot case, the researchers either placed two electrodes on the neck or one electrode on the neck, or one or two electrodes on the lumbar sacral spinal cord. For transcutaneous spinal stimulation, or all kinds of different types of transcutaneous stimulation, there are always concerns. Leveraging our knowledge and expertise in neuroengineering and neuroscience, and also developing based on our platform technology, we have created an advanced neuromodulation system. We looked into realistic human models and built a model that incorporates the spinal cord, bone, vertebrae, skin, tissue, muscle, and fat. We deployed hundreds of electrodes to develop our algorithm that allows us to do targeted and selective, non-invasive spinal cord stimulation. In these two examples, one targets C5 and the other targets C2 spinal nerves, non-invasively. This effort led us to develop our flagship product, which we call AccessStim. It's a non-invasive multi-channel neuromodulation system that is also connected to the cloud. We have developed a very unique electrode that we can place on the spinal cord, non-invasively, to deliver stimulation. Each electrode can be personalized; each electrode can be individually configured to deliver personalized treatment for patients with spinal cord injury. We also received FDA Breakthrough Designation in 2019. I also want to show some of our pilot data. We finished our pilot study in 2021-2022. In our pilot study, the patients first went through two months of physical therapy as a sham control, followed by another two months of stimulation treatment. You can see that the patient improved significantly in terms of hand functions. This is another patient who finished our pilot study. He recorded videos while he was cooking at home, showing the huge difference between before and after the active treatment. He was able to manipulate objects much better after the active treatment. Currently, we are conducting our pivotal trial. It is the first of its kind, randomized, multi-center, sham-controlled trial focusing on treating spinal cord injury using transcutaneous spinal cord stimulation. We are targeting to recruit up to 140 patients, specifically those with severe and the most severe spinal cord injuries. Luckily, we spent quite a few months last year discussing with the US FDA, and we were able to reach a clinical study protocol agreement with them. It took nine months of back-and-forth discussions, and we are currently conducting our study at 14 centers across the US. We not only work with leading spinal cord injury centers, but we also closely collaborate with local community rehab centers. We are currently at 60 to 70 percent patient enrollment. Since 2019, we have made significant progress with very limited resources. I want to point out that 2024 will be a critical year for the company. We expect to finish our last patient enrollment for the pivotal trial by the end of December, and we also expect to receive our CE certificate by the end of this year. We just finished our clinical technical review, and the auditor completed their stage two audit in August. We are preparing for our commercial launch in Europe next year, followed by the US product launch. We will also work on indication expansion and expand our market to different geographies. I also want to do a deep dive into the competitive landscape. As you can see from this slide, there are other companies working on developing technology using spinal cord stimulation as an indication. There are also some established companies like NeuroWorks and NeuroRestorative, but Aneuvo is in a unique position as we are offering a non-invasive solution at a very affordable cost. If you look at this table, many of the companies have raised hundreds of millions of dollars, but there are still no approved products in the market. As of now, we have raised around $30 million and we are very close to getting our first product approved by the CE mark, allowing us to enter the market as a first mover. Here’s our business model: we will not only sell the product for clinical rehab, but we will also sell our product for patients to use our device at home. A significant portion of our revenue will come from selling the consumable electrodes. The electrode design is disposable, so we expect patients will use electrodes at home in their daily routines. Spinal cord injury is just our first indication; our platform technology can also be applicable to cerebral palsy, stroke, movement disorders, and pain management. We are running another small study, and we have already seen some treatment efficacy from our pediatric cerebral palsy study that we are conducting in Texas. Currently, we have raised $30 million since 2019 and we are preparing to raise our Series C for product launch, market entry, and to generate more clinical evidence. We also have a few products in the pipeline that are under development right now, and we are conducting some animal studies to explore the potential of our next one or two products currently in the US. To share about our team, we do not have a big team. I built a small team from scratch a few years ago. We have regulatory, quality, marketing, and clinical expertise, and we also leverage the expertise of our external advisors to guide us and ensure that we are doing the right things at the right times. Here is my contact information. If you are interested in learning more about Aneuvo, our plans, or anything regarding the company or clinical study, please feel free to reach out to me. I want to mention that now is a good time to work with us, as we have the first mover advantage to enter the market. We are a group of innovative leaders in bioelectronic medicine, and we significantly reduce the risk for regulatory approval and reimbursement. We recently had a conversation with the US CMS, and they provided feedback that they are looking for at least two clinical studies, with each study including at least 30 patients. After our pivotal trial concludes, we plan to run another home study to include indications for our patients to use our product at home in the US. We also have a very secure and robust reimbursement plan. Thank you, everyone.
