Almog Aley-Raz, CorNeat Vision - Biomimetic Implants & Technology | LSI Europe '22

Transcription

Almog Aley-Raz  0:09  

What if I told you that this material could permanently integrate with your tissue? Look how strong and flexible it is? What if I told you that it can displace the use of donor unprocessed tissue in surgery? What if I provide you with clinical evidence that we can use it to permanently integrate implants with surrounding tissue, reinforced soft tissue for life, and use it for guided tissue and bone regeneration. It is also supposed to enable sensors to remain in contact with their surrounding tissue, imagining the possibilities. We call it the cognate ever matrix, it holds a future for a new era of implants. The matrix is the first nondegradable completely synthetic biomimetic extrasolar matrix, which is essentially the skeleton of our tissue. We discovered the ever matrix as we were developing our artificial cornea, researching ways to integrate artificial optics with resident ocular tissue. The other matrix addresses the main issue with implants and inflatables, which is a foreign body response a trigger, our immune system will work to degrade and eventually absorbed by materials, or alternatively and capsulatum with a granuloma. What makes the ever matrix work its its similarity to the extracellular matrix in terms of fiber diameter and porosity. It is made from polyurethane so that's not the great, so not a scaffold by definition. When implanted it practically goes under the radar of the immune system. Its special structure triggers complex biological processes, stimulating cellular proliferation that leads to full integration. The fact that remains in the tissue makes the integrated tissue even stronger than the original, kind of like a metal mesh within a concrete wall. The RE matrix disruptive tissue integrated capabilities were proven in over 12 Different studies, in vitro, in vivo, and are also in humans, who you can see histological evidence from a Subconjunctival space, demonstrating full parabolas colonization and abundant collagen deposition within our matrix. There is no capsule formation and even capillaries coursing the way through the material, rendering it an integral part of the tissue. I can't emphasize enough the significance of this discovery to human health. I will briefly touch upon the products we currently have under development. No not no the role of ever matrix in each. Every product has a full plan story, time to market business potential and strategy. They're all novel and expect to disrupt the market dynamics for the relevant indications. We also have a very strong and broad IP. The concrete ever patch is a permanent tissue integrating of Tomic surgical metrics. It is poised to displace the use of donor and process tissue in ocular surface surgery. Indications include scleral reinforcement, glaucoma tube shunt, implantations, trauma to resume and more. The main advantage of the ever patch is permanency. All existing tissue shunt tissue patches are absorbed over time, some leading to complications. All surgeons that experience working with the crenate ever pet just loved it. It's flexible it durable, doesn't rip when sutured. It is only 100 microns in thickness and it doesn't degrade. So perfect solution for the eyewall. The first inhuman implementation of the credit every patch took place in Canada in December 2020. The credit every patch was used here to cover and conceal our glaucoma drainage device. Our first patient underwent tube shunt implantation in both eyes. And as you can see here, the eye with the cornea every patch is quiet, while the other eye with donor tissue is congested and inflamed. Besides the huge aesthetic difference, our key advantage here again is permanency. The cognate ation is a unique glaucoma device that extends minimally invasive surgery to severe and refractory glaucoma patients. It's designed will provide long term predetermined pressure regulation halting the progression of this devastating blinding disease. The conditions innovative design addresses all shortcomings of existing chanson trabeculectomy. The quantitation is efficacious and stable immediately post up as resistance to flow is dictated by its inlet and tube design, and not by a valve or scurrying around the outlet. The device seamlessly integrates with the surrounding tissue shortening the procedure. It also won't clog over time as its outlet is uniquely positioned deep in the orbit in an area that has only fat and blood vessels and is less likely to fibrous the positive pressure in the orbit significantly reduces the risk of hypotony. We have successfully completed a bench test and several animal implementations proving the device drainage mechanism The integration concept and perfecting the implantation procedure. We are entering a GLP animal study and are on a path to initiate first in human study early in 2024 toward 510 K and CE marking the community patches are first device outside of terminology. This 1% synthetic reinforcement patch is expected to live to last a lifetime and provide the infrastructure for gingival tissue to grow on. It is also poised to displace the use of autographs Aloe grafts in xenograft as well as degradable collagen based membranes used to control gingival bone regeneration. The initial results of implanting this ever matrix product adjacent to the gingival bone done at the ADESA dentistry Hospital in Israel were very promising. We are currently following a 510 K path for approving this device as a gingival patch and expect it to be cleared for marketing at the end of next year. We recently won a 2.3 million Navy US grant for clinically evaluating game changing application for the use of the G patch in maxillofacial reconstruction surgery. The Collete Kaypro, our flagship device will enable corneal nearby and patients around the world to fully rehabilitate their vision following a simple and straightforward procedure without reliance on donor tissue. Globally, there are 2 million new cases of corneal blindness each year, but only a small fraction. 150,000 are treated with donor tissue 20 to 30% of these are repeated grafts. For every patient that receives donor tissue there are over 70 needed. But even if you're lucky to receive donor tissue, the chances that you will see well again, are a mere 50%. Unlike previous attempts, and corneal transplantation, which tried to integrate with the native cornea, a tissue that heals very poorly, we leverage an ever matrix skirt to permanently and biomechanically integrate optimal wide aperture lens under the conjunctiva the white part of the eye. That's an area that is rich with blood vessels and fiberglass that it heals vigorously. While we start with blind patients that are not suitable or failed transplantations, we design a product that is superior to donor tissue in many aspects, and is aimed to displace it in the future. In many indications, the global need and the potential impact are extraordinary. In January 2020, we hit a major milestone with our first inhuman implantation. Jamal, a terminally blind 78 year old men who are previously failed for transplantation and didn't see for a decade, regained his sight and independence following a one hour surgery. Jamal is now 20 months months post op, and his vision is stable with no complaints on pain or discomfort. We are currently working on clinically validating our first two products the chronic Kaypro and the chronic every patch teaming up with leading clinical sites in four continents. The Collegiate patch and the quantitation will enter the clinical phase next year. I'm excited to share that our first product the candidate ever patch will be submitted for FDA 510 clearance as early as next week. In the next three years, all four products will enter the market. We already signed up over a dozen distributors and are engaged with a couple of dozens of US reps, all our ibanking veterans, which will assist us in soft launching of products to the US market. So far, we've raised close to $20 million, including $4 million for setting our JV in China. With our over 5 million call nearly blind patients and only 5000 transplantations a year. We also won a 2.5 million euro ESC grant for advancing our artificial cornea to market. We recently teamed up with a reputable Boston based investment bank, and we'll be launching our a round in a couple of months, aiming to raise $20 million. We have an amazing team, which includes experienced engineers, clinical regulatory and business experts. We also have a physician, my co founder and close friend Dr. Gilad Litwin on staff. From a scientific perspective, we are supported by the world's top physicians. These include current and past presidents of leading scientific societies. I invite you to meet me and partner with us for success. Thank you