Luca Ravagnan Presents WISE at LSI Europe '23

Transcription

Luca Ravagnan  0:05  
Okay, so good afternoon, everybody. It's a pleasure being here and we'll present you WISE and I want immediately to start sharing with you the vision of my company WISE is, indeed is a medical device being the first to produce Nero Lee's being soft, conformable, stretchable and minimally invasive, we have indeed already developed one product that is an intraoperative electrode used during brain surgery. This product has been approved in Europe, clearly in the USA, and now also approved for commercialization in Australia. And now we are developing a chronic connector for spinal cord stimulation. And today we will enter into the details of the second product. And we are now in animal phase with the second product. But in the long term, we think that our technology and our we're stronger belief will impact many different medical sectors. But why is it so important to make a conformable compliant electrons? Well, because especially in the Euro sector, there is a huge mechanical gap between the very soft mechanical properties of the brain of the spine, and the very hard current nature of neural actors, because they're made of half metal components where the two cables, this reduces the conformability. We solve this problem by introducing a software automatic conductor that allow us to close this gap making reducing reversibility, increasing conformability and also allowing new geometry geometries of delays. This is done thanks to our supersonic technology that allows it and unveil stretch ability of the electrodes, everything's biocompatible and the manufacturing is easy. We have developed the first product as I said, is the wise cortical strip used during brain surgery, a tumor or epilepsy surgery for monitoring and stimulating the brain. This is actually the medical proof of concept of our technology. You can see hopefully, yes, on the top our wise cortical trade compared with the conventional strip anything you can clearly appreciate the difference what does it mean conformability. So, these improves the quality of the signal and the monitoring of a during the surgical procedure. Okay, we have a concluded clinical study here we are now commercial. But now what is very important is the feedback we are getting from our clinical partners, because indeed the surgeons are able to use the strip's has never did before. And this proves indeed that supersonic technology makes the difference. So based on this foundation, we are now developing the head on lift the handle lid is an electrode for spinal cord stimulation for treating pain, you might be very familiar with chronic pain is a condition affecting a large proportion of the population 1.5 5 billion people. Well, opioids is the typical approach for using crank, for treating chronic pain, but they create addiction, spinal stimulation, spinal cord stimulation is an alternative way. Indeed, by stimulating the spine, it is possible to block pain signals before it reaches the brain. Indeed, this is a market that already exists is a 3 billion market. And there are already well established players in this market. There's motronic, Boston, Albert and nevro fighting for market share. And this is what we like, because indeed, at the end of the day, all of them have the same system. They have an implantable part simulate is a stimulator generator, and ever stimulating live. But over the past years, they focus completely only in the development of the stimulator side, there is a lot of development over there on in different waveforms for the stimulation, different approaches closed loop, or changing the battery Big or small, or even no battery. But there was nearly no innovation. If I'm able to show you on the electrical side, what goes in contact with neural tissue? Well, it's I can guess nobody is able to recognize which is which I put the logo. Now these are the electrodes that are currently on the market virtually identical. But there is a big need. Because if you look on the portfolio that this company have, they are either cylindrical lathe that can be inserted percutaneously or their paddles that can be inserted surgically. Why do they have to have them because most of the users are pain specialist and have to implant the electrodes percutaneously. But paddles that require high end invasive surgery are better in terms of performance because they are directional. So allow better energy stimulation so more efficient. They also allow better coverage and also better sensing. So there is no ideal solution. And this is what we're bringing. So we're solving this dilemma with the handle late this actually how our medic advisor say how SCS lives should have been done since the beginning. Indeed, this is the first percutaneous and directional multi column spinal cord stimulation lead. And this is indeed offering a new competitive leverage in response in the market in the fight for market share in the spinal cord stimulation market and Now, let me allow precision medicine is placed at the thoracic level of the spinal cord through a percutaneous implantation approach. A 14 G to A needle is inserted below L one level guidewires advanced into the epidural space through the tui needle. The needle is removed and an introducer which consists of a dilator and an outer sheath is inserted into the epidural space facilitated by the guide wire, the dilator is removed, the outer sheath remains in place and the delivery sheath containing the Heron lead in stowed configuration is fed into the outer sheath and navigates to the target location to procedure is guided with the aid of X ray fluoroscopy. By retracting the delivery sheet, the Heron leaders opening and the electrodes are face to the dura mater. So, actually, this is not just the detail, it's a reality. We have extensively tested our product now on cover model. And indeed We were demonstrate we were able to demonstrate that indeed, we can percutaneously implant a paddle. So a directional lead is highly sterile is your fuse. currently more than 25 a stratagem tested on cat lovers, we are now in the animal phase. So we have now initially we have already demonstrated no migration over three months now we are making longer anyone studies and as they say, and also that our length remains open after deployment after many months. So we are now in the process of validating this product, this product. So the strategy is to go through a 510 K clearance this was already validated. And also we already have contacts with FDA on that, then the plan is to go for first thing human study, eventually going to an exit of a project and a product selling to the big corporation to then allow them to have this new leverage for market a market fight. Well, our plan now so we have we have finalizing the product, we are entering the validation phase, clearly we will need additional money. And so today I'm here for me looking forward to have contact with you as we are raising a new round and clearly very happy to disclose the details in private. They we have invested they believed already investing over 25 million euro over the development of the company, they also committed already 70% of the next round. But again, we'll be more than happy having other investors joining with us we have a strong team we have almost 40 people developing fully developed in the development but also in the manufacturing of the product and we have a facility where we do the manufacturing of our products based in in Italy in Milan. So what are we doing so we are the first bring it to the market soft conformable stretchable and minimally invasive electrodes we have a product that fully validates our technology. Indeed we are approved the Europe USA and now also approved for commercialization in Australia and expanding now our our distribution network in Europe and head on lead that is the first directional percutaneous multicolor spinal cord stimulation lead has been validated now on cover extensively and now on animals. And we have now our pathway for approval and LP will join in this in this venture. So we are raising our financial round and it will be very happy to have discussion with you if you want. So thank you very much.