Rui Jing Jiang 0:04
Hi everyone. My name is Rui Jing Jiang, and I'm founder and CEO of Avisi technologies. Thank you so much for coming to this track, and I'm honored to kick it off. Out of easy we are developing a portfolio of solutions for eye care, and we're leveraging a patented metamaterial platform technology invented at the University of Pennsylvania. Our first device is to treat glaucoma, which I'll give you an update on today, as well as an insight into our emerging pipeline. We've raised over ten million to date. In our next round, which will be in the ballpark of 15 to $20 million will be to achieve 510 k clearance for our visit plate product, as well as complete the pivotal trial associated with that pathway. Let's talk about the technology. It's the world's thinnest freestanding material. And what I mean by this is, if you think of certain thin films, like Saran Wrap, you quickly realize that you can't pick it up. It crinkles, it sticks to itself. You can't use it for much, especially not minimally invasive surgery. But this technology is many times thinner than saran wrap. It's durable, it's flexible, it's robust, and it's biocompatible. And we have filed applications in the realm of multiple minimally invasive surgeries for eye care, drug release and cell delivery. Here on the slide, you see a sem of the surface of our glaucoma drainage device, vis aplate, how smooth that looks. And then you see that same device suspended on a droplet of water. Glaucoma is the world's leading cause of irreversible blindness. It is an under diagnosed disease affecting over 100 million patients. At a high level, our eyes are constantly producing and cycling a fluid called aqueous humor. But in eyes with glaucoma, the drainage system is blocked, and this leads to an excess buildup of fluid that ends up applying a lot of pressure on the optic nerve, and it is this pressure that leads to vision loss. Unfortunately, reducing intraocular pressure is the only known way to prevent progression of disease currently. However, when you take a look at the treatments out there, you realize that they fail at very high rates across multiple points from pharmaceutical treatments, including eye drops that have very high patient non compliance rate, to laser surgeries and manual surgeries that have a failure rate of close to 50% implants are really the last line of defense for these patients. Thankfully, we've had a new wave of innovation come into our space called microstins, or minimally invasive glaucoma surgeries. Today we'll talk about visit plate, a standalone Subconjunctival glaucoma treatment targeting moderate to severe glaucoma to start. And we're taking this pathway, because it's the 510, K pathway, enabling us to get to market as quickly as possible to serve our patients. This is a very rapidly growing space with over 15% growth rate year over year. Treatments for these patients today look like this. We have the trabeculectomy, which is a standard surgery that's been around for over 100 years. The physician makes a flap inside the eye, hoping that it drains the right amount of fluid. However, post op complications abound, like overly low pressure, scarring, bleeding and leaking microstents have grown in popularity over the last decade. These are thin tubes the length and thickness of an eyelash. Unfortunately, they can clog scar or migrate and tube shunts have been on the market for about two decades. These are thick drainage plates about the size and surface area of a nickel sitting in your eye connected to a large drainage tube. These are lengthy surgeries with complications like double vision or healthy tissue erosion. And with all this in mind, we designed this a plate. This is an ultra thin shunt designed to avoid occlusion. We do this by using non fibrotic materials, meaning they don't scar by having a multi channel design to create redundancy of flow, and by having a surface area to maintain that space over time. We're many times thinner than a human hair. You can see it balanced on the tip of the fingertip, or maybe you can and it's our technology that ensures handle ability despite this scale. We are implanted in the Subconjunctival space that's between the clear membrane of tissue in your eye and the thick white layer and the tip sits between the iris and cornea. Our device allows the pent up fluid to drain through a network of microchannels in a slow and controlled way, reducing pressure over time and that body, that surface area maintains the space we've been able to demonstrate competitive safety and effectiveness in clinical trials outside of the US. This is data from a multicenter safety and feasibility study. And what you see here is that vis aplate may be the first device to achieve what we call the 1010 10 goal, a 10 minute procedure leading to a 10 millimeter of mercury ending eye pressure over the course of 10 years. And you can see, compared to existing minimally invasive glaucoma surgeries, just how effective vis a plate is, we're having stable, lower pressures maintained over time, compared to these marketed devices with easy post operative management, we have no intraoperative or severe site threatening adverse events seen in other devices, and importantly, patient comfort and esthetics are preserved, while also reducing medication burden. Our patients started out with an average of over two medications to treat their disease, and by month nine, we're at an average of 0.7 I also want to highlight that visibly is uniquely effective across a wide range of baseline. Lines. Our first subject here is an 18 year old subject with an intraocular pressure of 40 millimeters of mercury. She was on three medications at baseline, sorry, four medications at baseline. But by month three, we are seeing a 76% reduction in her baseline IOP. Her medications have dropped from three, from four to zero, and we've had no postoperative management, no needling or any other interventions. Our second subject here is a different story, 60 year old patient with a starting baseline of around 1819, millimeters of mercury on three medications. By month nine, we're 52% lower in her intraocular pressure, no medications, and again, no needling or postoperative management. In the OCT below, you can see there's a plate placed inside the eye. It's highlighted with the blue arrows, and you can see just how thin the profile of our device is communicating fluid from the anterior chamber into the drainage space. On the reimbursement side, we're targeting a class one CPT code 66 183, which will enable physicians and facilities to rapidly adopt visibly into their practice. And this is just the beginning. We have a couple other programs in our pipeline, the second being a program for mild to moderate glaucoma surgery, and this is in the preclinical stage, as well as a third program which targets sustained drug delivery and which was recently funded by the National Science Foundation. A quick introduction into visoplight s this is our product for a combination of glaucoma cataract surgery targeting the mild to moderate patient. This device is meant to support a wave of interventional glaucoma as these milder patients are often caught at the time of their cataract surgery. It's applying vis aplate technology to the supercelli space using the same concepts of non fibrotic materials, multi channel design and surface area. Our device vis a plate s here will be placed at the same time as a cataract surgery through the same incisions, enabling physicians to treat patients earlier in the paradigm, and importantly, preserving real estate inside the globe, should their disease progress and should they need a visit plate device down the line in the time that I have left, I just want to touch upon our timeline again, we're raising 15 to $20 million to support our pivotal study, enabling us to achieve market clearance for visit play in 20 late 2026, some of these funds will also go on To support the programs that we have in our pipeline, which we spoke about today, vis a plate us as well as b1 our sustained drug delivery candidate. We've raised over ten million today. Some of our investors are in the room. Shout out to good growth capital, for example, for believing in us and supporting our journey. A little bit about the team. We are eight people in Redwood City supported by a very expert board. Gary Pruden is the former worldwide chairman of medical devices at Johnson and Johnson Dr Katherine Moore, who gave the keynote speech today, is the President of the intuitive foundation at Intuitive Surgical Paul Norris is from a canto partners. Barry Cheskin is a strategic advisor. He is a serial entrepreneur, with his most recent exit being a advanced intraocular lens that was sold to Alcon on the full side, full time side. Sorry, we have Jeff Emery, who is our senior VP of Operations and R D with over 25 years of medical device development experience. Georgia Griggs, who is a master in nanofabrication nanotechnology, and Kim du who led the clinical trials for power vision. Last slide here are clinical advisors without whom we would not be here. Dr Edie Miller Ellis, who is chief of glaucoma at the University of Pennsylvania. Dr Rick Lewis, who is the past president of the American glaucoma society. Dr John Myers, who is chief of glaucoma at Will's Eye Hospital, Thomas Jefferson University. Dr isan saudri, who owns a network of private clinics in California, visionary Eye Institute. Dr Ike Ahmed, who is known as the father of minimally invasive glaucoma surgery. Dr George Durr, professor at University of Montreal, and Dr Vance Thompson of Vance Thompson vision. So today, we covered a lot of updates on vis aplate and avisi. Thank you so much for your time, and I look forward to connecting with you all outside of the room. You.
© 2024 Life Science Intelligence, Inc., All Rights Reserved.
