Rui Jing Jiang Presents Avisi Technologies at LSI USA ‘23

Transcription

Rui Jing Jiang  0:00  

Good afternoon, everyone. My name is Rui Jing Jiang with Beijing if that helps you remember, and I am founder and CEO of Avisi Technologies. For most of us in this room, we're blessed with good vision and this is how we see the world. But there are close to 4 million people living in the US today who can't see what you see because they have glaucoma. And when you have glaucoma, this is what your worlds becomes. At Avisi we are working on a novel device called visit plate and ultra thin multi channel aqueous shunt initially targeting 2.6 million moderate to severe glaucoma patients in the US. Today, I'll walk you through the market potential the 510K pathway. Tell you a little bit about the team, as well as overall where we're headed. We are commercializing the world's thinnest freestanding technology a metamaterial as it's known. So let me put that into context for you think of something ultra thin like Saran wrap. You can't pick saran wrap up very easily right? It crinkles and it sticks to itself. Well, our technology is many hundreds of times thinner, and yet it's robust, freestanding, and it can recover from Sharp deformations, making it highly suitable for minimally invasive surgeries. We have licensed this technology from the University of Pennsylvania and we have developed robust IP around treatments for various eye disorders including glaucoma. So what is glaucoma? Well, as our colleague here just spoke, it is the world's leading cause of irreversible blindness, affecting over 140 million patients worldwide. 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. This leads to intra ocular pressure building up and permanently damaging the optic nerve. Unfortunately, reducing intraocular pressure is the only way to prevent progression of disease. But when we take a look at current treatments, we noticed that they fail at very high rates from eyedrops with high patient non compliance to laser surgeries gold standard manual surgeries which both fail at close to 50%. Implants really are the best and last line of defense. This is where it is a play comes in. We're initially targeting moderate to severe glaucoma patients at over $1,000 average selling price per device. This is a multibillion dollar market opportunity. Coincidentally, in the market space which we are playing in this space is growing at over 90% year over year. Now treatments for these patients in particular failed due to two key reasons by occluding with scar tissue or being very large and invasive. Let's start with trabeculae dummies. These are manual surgeries that have been around for over 100 years. They're not standardized and they can have complications like overly low pressure, infections, bleeding, scarring and leaking minimally invasive glaucoma surgeries or makes have arisen in popularity. These are thin tubes, the length and thickness of an eyelash they can be easily injected into the eye. But unfortunately, they also clog scar and migrate. Now tube shunts have been around for at least two decades. These are large drainage devices about the size and surface area of a nickel sitting in your eye with complications like double vision or healthy tissue erosion. So with all this in mind, we developed visit plate an ultra thin shunt designed to avoid occlusion. And we do this by using non fibrotic materials, meaning they don't scar by having a multichannel designed to create outflow redundancy. And by having a surface area to maintain that drainage space over time, our device is five microns in thickness that's 20 times thinner than a human hair and up to 300 times smaller than some of the devices I just spoke about. Again, it's our patented technology that ensures handle ability at this scale. We like to save as a plate is bottle shaped and we implant it in the subcontract table space that's between the clear membrane of tissue and your eye and the thick white layer. pent up aqueous will drain through multiple channels through visit plates neck coming to restaurant visit plates body. From there, the fluid will be slowly reabsorbed into surrounding tissue, thereby reducing pressure within the globe and protecting the optic nerve. We designed as a plate to overcome the trade offs that we see continue to plague devices on the market and in the pipeline. today. We are the only device with redundant multiple outflow pathways, meaning that we don't rely on a single outflow pathway that can be easily obstructed over time. In fact, we have over 80 Outflow pathways in every which way. Secondly, we can maintain the drainage space over time. We have over 60 millimeters squared in surface area to keep that space open and ensure continual drainage. Last but not least, we use non fibrotic materials specifically alumina and Parylene C both of which have a long history of use in the human body preclinically we have demonstrated sustained biocompatibility as well as IOP, lowering potential in the standard New Zealand White Rabbit model. We have published this data in the peer reviewed journal of material science materials and medicine. At a high level we've demonstrated that we can meet the FDS performance thresholds and actually perform better than some paddock had devices for example, having 75% greater magnitude of reduction in intraocular pressure compared to the Zen Charleston, which was acquired by Allergan. Today, we have been able to treat over 20 patients in an early first in human clinical study, and I can tell you that the early data is looking really good. It shows that visibly is clearly differentiated across efficacy, safety and ease of use. Our device has high efficacy in standalone glaucoma surgery, meaning that you can treat patients who may not have a need who or who have already undergone cataract surgery. Secondly, we have a well differentiated safety profile with no adverse events during the surgery itself. As well as very easy to learn procedure, meaning that our device should be easily adopted by practicing physicians. This brings us to our timeline we're targeting the 510K pathway with a $15 million series A our prior financing includes over $7.5 million from investors and non dilutive grants like the National Science Foundation, SBIR program, and these funds will really go to support our US clinical trials pathway and the 510 K application process with a goal towards community commercialization sometime in 2026. Now, some of the green stars on the prior slide corresponded with these precedent transactions. Glaucoma is a super interesting space with a long history of external innovation. And we definitely see ourselves as potentially partnering with some of the larger companies on the slide here. That being said, today we've heard a lot of panelists talk about the importance of standalone commercialization, and we believe we can do that as well. There is a pre existing category one CPT code 661, a three that is very attractive, it will allow us to play to be priced at par to some of the more premium competitors out there on the market, while yielding positive net margins for facilities and physicians. A little bit about the team I started the company in 2017 out of the University of Pennsylvania, we have an outstanding team including Gary Pruden, who is our independent Board member, former worldwide chairman of medical devices at Johnson and Johnson, Dr. Katherine Moore, who was the president of the Intuitive Surgical Foundation, Paul Norris, former CFO of Sonic solutions. Barry Cheskin is a strategic advisor. He is the former founder and CEO of power vision, a company that was acquired by Alcon Jeff Emery leads our r&d and operations. He has over 25 years of successful medical device development experience. Georgia, Greg's comes to us with her background in nano fabrication and nanotechnology. And Kim Do it leads our clinical operations also from power vision. And the time that I have left would love to give some recognition to our clinical advisors without whom we would not be here. Dr. Ed Miller LS is director of glaucoma at the University of Pennsylvania Shea Eye Institute. Dr. Rick Lewis is the past president of the American glaucoma society. Dr. Ike Ahmed is known as the father of minimally invasive glaucoma surgery. Dr. Vance Thompson is director of refractory surgery and founder of Vance Thompson vision, and Dr. John Myers is chief of glaucoma at Wills Eye Hospital, Thomas Jefferson University. Thanks so much for your time today. Again, today we talked about visit plate and I look forward to connecting with you off the stage. Thank you