Sujit Dike Presents Gyder Surgical at LSI Europe '23

Transcription

Sujit Dike  0:05  
Okay, I'm the CEO of Gyder Surgical, very excited to be here to share our story. We have developed a non invasive, easy to use, and cost effective product for improving surgical accuracy during total hip replacement. This is a big deal, as the vast majority of surgeons currently do not use any technology, when they are placing a prosthesis into the hip socket, often missing the target angles and leading to significant complications and poor patient outcomes. All right, the guided technology does not require any metallic paints or intraoperative imaging, and it's a computer assisted navigation system, it is TGA approved. We have also shown through cadaver studies, reproducible accuracy and clinical relevant accuracy comparable to other systems. We are in the process of a soft launch in Australia, with first inhuman anticipated next month. So very excited about that upcoming milestone. We are also targeting a US submission by the end of this year, with commercialization following approval next year, and then followed by EU submission and commercialization. The following year, we do have a strong protected portfolio of patents in most major countries, three patent families, including Europe. And while we have started with our first product indication, which is for anterior hip surgery, which is the fastest growing procedure in total hip arthroplasty, and it's when the patient is lying on their back and the surgeon comes from the front. We have also worked on a posterior application which will be the next product out of the gates. We are currently raising $3.7 million. We are already halfway there with 1.8 in and looking to close the gap. There was an interesting publication by the Cleveland Clinic last year which suggested that for a surgeon to minimize post surgery complications, they have to actually do at least 260 cases annually. And interestingly 93% of all hip arthroplasty is done by surgeons below that volume. In fact, the vast majority surgeons as I mentioned, do not use any technology on top of that, leading to significant target miss. And when you have mis-positioned or malposition cops, because of the wrong angles that are implanted with you can have significant consequences. For example, on the top left, you see an example of dislocation, where the prosthesis has come out completely out of the socket. There can be a series of other complications over a period of time, impingement, gait challenges, and so on so forth, leading to real, poor patient outcomes over a long time. And this can be costly. For example, in the US alone, 13% of all hips undergo revisions, 40% of which are directly tied to malposition cups, leading to $2 billion of impact on the healthcare system. This is also true in Europe and most of the countries. Now there are existing technologies like navigation robotics, which have clearly tried to address this problem, and they have their own place in the marketplace, but all of them use metallic paints which are inserted into the human pelvis for creating landmark registrations. This can often lead to patient complications like localizing flexion is definitely complex and takes a lot of time to actually use the procedure, which is one of the major reasons why most surgeons currently do not use any of these technologies. So the Gyder system uses a very different approach. It consists of three major parts handheld or palm size navigation unit, which can be attached to a tripod looking metallic brace using a plastic clamshell. Before surgery, the surgeon places the brace on the patient to size the pelvic region using standard landmarks. When that is done, the the surgeon is able to input the target angles they want. So we are providing that option to surgeons on what their preference is based on patient profiles. After inputting the angles the the navigation unit is attached to the brace and the whole setup is put on the side. The surgeon then proceeds to actually create access to the asset tabular site using the normal workflow. And when once that's done, the entire unit is placed again on the pelvis on the pelvis to to capture the registration. This is a very straightforward process super fast. with the press of a button they can capture the registration. Once that's done, the entire unit can be moved away from the patient And the navigation unit can be transferred to an impactor which will come in in a minute. But as you can see, it's a very simple process. So the navigation unit is then transferred to an impactor and the surgeon can then proceed to impact and use real time navigation to understand where they are, in comparison to the target angles. So that's the entire procedure, it's a large market $1.4 billion in hip alone, the technology itself has a potential to be applied for any bony anatomy like shoulder replacement and knee replacements. We have done cadaver studies over a wide range of specimens, a wide range of target angles, and successfully demonstrated implant accuracy comparable to predicate. Now, frankly, surgical accuracy or the ability of this technology or any technology to provide accuracy is table stakes. In my 12 years of orthopedic experience, what I've learned is, what drives adoption are three things. Is it easy to use, how fast it is, and is it cost effective. In all these three dimensions, our technology really stands out. So for example, compared to robotics, on the bottom left, you see Mako large footprint, long setup time, very complex to use requires a dedicated specialist. In our case, we don't need any of that. It's super fast and easy to use. And all of these systems that exist in the market, they all use pins, which lead to a lot of hassles. And as I mentioned, it is super fast, we barely take a minute or minute and a half to do the entire registration and followed by impaction. So this is a major step change compared to competitive systems. For example, in robotics, it takes about 25 to 30 minutes. Other navigation systems add 10 to 15 minutes to the procedure. So this is a material change. Additionally, we have a massive cost cost driven or design driven cost advantage, which allows us to place the entire system at no cost, no capital equipment required, please that entire system, and basically charge over a consumable model, so on using a razor razor blade system, this is very attractive, we have done a lot of interviews with hospital administrators and outpatient centers. And they find this model very attractive, for example, compared to robotics, where it can simply add $3,000 per procedure plus a major upfront equipment in capital investment. And just to close this out, as I mentioned, it's easy to use. In fact, we have been successful in training surgeons literally in an hour, and they are up and running. That is how fast is this great positive feedback, unanimous feedback on pinless use in various presentations at WS and other systems. We are in the process, as I mentioned of submitting for FDA anticipate commercialization following that next year. And then we are also looking at Japan submission pretty soon. Commercialization following that. While none of the regulatory bodies so far require any human data, we do have a strong clinical evidence donation plan to build upon the cadaver studies that we've already done, which will focus on the economic impact as well as the clinical impact of this product. We are looking at third party distributors anticipate our first distributor to sign next month, followed by commercialization in Australia. And then our business model is very simple. We will continue to use that model mostly in most markets. With the exception of us we'll we'll we'll look at building our own small sales team to cover the market. Strong leadership team in place I have 12 plus years in orthopedics experience at Johnson Johnson and Synthis Bill Hill who lead product development 15 years abroad development experience. And then she looked Thomson we just recently hired comes from Abbott muscular, and she's leading the sales and marketing in Australia. We also have our entire system to commercialize in place. All manufacturing is done in Australia, a strong roster of clinical advisors. And when we continue to build upon that, just to close it out, we have been very capital efficient. Historically we have raised $4 million in private rounds and $700,000 in grant funding. With that we have developed our first product gotten approval in our first major market and also advanced or secondary education. Currently we are raising 3.7, half of which has already been raised. This will fund commercialization in Australia complete the development of the second indication as well as allow us to get regulatory approvals and submission process in the US and Japan. And obviously we have aspiration to expand beyond that. So one final comment. Very strong team. highly differentiated product, strong unit economics, way close to commercialization and first inhuman and if you are interested in joining us in our journey would be happy to talk to you after this presentation. Thank you.