Ronit Goldberg, Liposphere - Effective Biolubricants for Medical Applications | LSI USA '24

Ronit Goldberg  0:05  
Hi, Hello, good afternoon. My name is Ronit Goldberg. I forgot that Mike is actually here and I am. I am a co founder of a company named liposphere. At liposphere, we developed a platform technology of new biolubric ads for various orthopedic application. The company was founded in 2019 by Sabrina and I. We were both scientific at the Weizmann Institute, and many years later, we became business partners. The company is located in Israel, near Tel Aviv, and we have 25 full time employees now, the first product we are now developing is aimed for an eoA indication. Neoa is a degenerative joint disease affecting hundreds of millions of people worldwide in eoA, it is the lubricious cartilage layer that progressively degrades, leading to pain and function disability. Current available treatments on the market are divided into divided by the disease severity. We can consider the first step patients go exercise and physical therapy, and then the most, the most invasive is the total knee surgery step however, there is a real need to postpone the surgery, and therefore there is a huge market which is step two, which is the local injections. Current Local injections on the market includes corticosteroids, drugs and visco supplements, also known as ha which is a multi billion dollar market. However, despite the available therapeutics on the market, there is a true need to bring new cure and to help the OA patients to improve their quality of life and functionality, and this is where we step in our knee. Injectable is called aqueous joint. So you can see that following an intra articular injection, injection into the synovial fluid, you can see that the material goes onto the cartilage and coat it, forming a robust, thin layer. The material is composed from a submicron spheres. These spheres are actually a closed lipid, synthetic lipid layers. The mode of action of our technology is very different from the existing materials, because they have no active ingredients. There are no drug and they are not acting inside the synovial fluid. Actually, the viscosity of our material is very close to water, so they are definitely not a viscosity enhancers. The technology behind our technology is called the hydration vacation mechanism. This technology was discovered few years ago and was was already published in various High Impact Factor scientific journals such as Nature and Science. The idea behind this technology is that in order to lubricate a surface, and especially surfaces that are in motion under high loads and pressure, very similar to the physiological condition as we have in our knee joints. The best way is not to use oil or polymer, simply because if you increase the loads on these material, they are gone. They cannot resist high load and pressure and the hydration lubrication mechanism they found. I mean, the scientists found that the best way to resist is by trapping a thin water layer onto the surface. And this is because water is the only material in nature that as you increase the load, it increases its resistance. And this is what is so beautiful with this technology. It's very simple and it is working. So during the last five years with we have accomplished various milestones. We our company has an ISO certification. We have built an in house, small manufacturing facility where we produce our clinical batches. We have finalized successfully, a first in human clinical trial, and we have currently an ongoing clinical trial where we compare our aqueous joint lubricant with a placebo, saline control. Other strategic and business milestones are so we have an exclusive worldwide license with the tto of the Weizmann we have filed our own patents. One of them is a composite composition of matter patent we have, we have raised a substantial amount of both private and governmental funds. We won the ATI O best early stage company award last last year, and. We have the AO foundation join us as a strategic partner. So what are the clinical benefits for an OA patient who use aqueous joint? So first, the safety profile of the aqueous joint has been demonstrated. We have injected so far into more than 70 patients, no serious adverse events were reported. Moreover, our first in human clinical trial showed that a single injection of the aqueous joint into the joint cavity without an immediate pain reduction and functionality improvement over the six months of the study period within our ongoing clinical trial, which is a double blind and randomized and multi center. So we see that from the from the preliminary results, the aqueous joint group outperforms placebo. This may not be surprising. If we look at this graph here, showing the well reduction between two surfaces, and we compare our aqueous joint composition to the commercial lubricant standard, you can see that having only few percentage of the aqueous joint immersed in the solution result in a two order of magnitude of magnitude reduction of the well, and this is what we do. We simply by having this thin layer trapped on the surface of the cartilage, we reduce the wear. We and the patient are actually restoring the whole lubrication on the surface itself. So what is next for the aqueous joint product? So we will initiate another clinical trial in Europe where we will compare our aqueous joint with one of the commercially available ha products. We will, we are, we are planning to complete the ongoing clinical study of the aqueous joint versus the placebo, and we were partnering with strategic for the product commercialization and distribution. We anticipate receiving CE mark approval toward the end of 2025 though we are focused on getting the joint injectable into the market using the aqueous joint, and the hydration technology could be very useful in other lucrative sectors as well, such as sport medicine, cosmetics, surface coatings and drug delivery, so that's it, and thank you for your attention. Thank.