Alan Lucas, Navigation Sciences - Precise Surgical Resection for Lung Cancer | LSI USA '24

Alan Lucas  0:04  
This is our fifth year presenting Navigation Sciences to the group. And it was a good time for me to sort of reflect back on some of the things that we've done over these past five years. From really, when we first came here, we had an idea and to patent applications that were developed at the Brigham and Women's Hospital. And really since then, we've now have multiple patents that have been issued additional patents that are pending. We've done a clinical feasibility study of 25 patients that are single site at the Brigham. We've done a pre sub meeting with the FDA. And most importantly, we have still some capital in the bank of when we did this all on $5.5 million. So we've been extremely sensitive to our burn rate being a virtual company, but also with employees as well to manage the program. Our First go to market application is for lung cancer in the key that I want to bring out is it's been sort of discussed earlier in a couple of the sessions. Lung cancer is really at a tipping point of really starting to be diagnosed earlier. And then new methods of treatment or therapy are coming coming into place. We as was discussed earlier, the there's a real push to have early stage screening for lung cancer right now is there's just really a very, very small amount of patients that screen. But in very large clinical studies that showed a 20% reduction in mortality due to low dose screening. This creates a tremendous opportunity for patients to come in and have surgical procedures, which is really the area that we're focused on. And if you compare that with breast and prostate cancer, where roughly about 70% are screened at an early stage stage one stage two on lung cancer, it's somewhere between three to 5% depending upon where you are actually get screened for lung cancer. As a result of that, many patients are diagnosed at a stage four, which has about a 15% five year survival rate versus a stage one which has about an 85% survival rate if treated with surgical application. The standard of care for these patients are a surgical resection, lobectomy, segmentectomy, or preferably a wedge resection where you can preserve more lung tissue, particularly in individuals that have compromised lung volume. Sorry about that. But these, these lesions are actually very, very difficult to locate. They're typically two centimeters or smaller at diagnosis. There, they can be sometimes palpated if they're on the surface, but very often, they can't be really felt. One of the things I've been involved in many invasive surgical applications from the beginning of my career starting in sports medicine, and when you place an endoscope into a knee joint or into the belly, you can very often identified the structures very, very easily. But in lungs, the patients are being operated on with the one lung being collapsed. And actually identifying and locating the lesion becomes very, very, very difficult, particularly when they're in stage one in very small. So what we've done is we've developed a electromagnetic sensor that's placed in close to where the lesion is. And then we place also sensors on the instrumentation. And we're able to measure in real time in the operating room, the distance between where that sensor is placed, and where the cutting instruments are located. And I think this cartoon sort of demonstrates that we have a cart that's in the operating room. So it's capital equipment, in combination with a consumable instrumentation and a what we call the J bar, the electromagnetic sensor, which is much like a fishhook that is placed into where the lesion is in locks in place to then guide the surgeon. We can place that really by three different methods. One is through palpation. The second is with comb beam guidance for intraoperative CT scan. But a third one that we feel is very exciting, is being able to place it with the interventional bronchoscopy procedure, where in this program has actually been funded by the NCI National Cancer Institute. On a phase one study, we're just now submitting for our phase two application and that's where we place the sensor with the bronchoscope and then the thoracic Terjun retrieves the actual wedge, interpretively, and that can be placed through, you know, products like the ion for instance through their working channel. I mentioned earlier that we completed a 25 patient clinical study. In this video here, you see the actual placement of what we call the J bar through an 18 gauge needle into close where the lesion is, then we've had added sensors to the surgical stapler. And in real time, this is an earlier version on our software. In real time, they're able to see a readout of the distances from the stapler to where the sensor is placed. Rip surrounds not just the measurement distance, but also creating 3d models of the tumor and what the margin is around the tumor itself to then be able to guide in real time, the actual surgical resection, thereby ensuring a clear margin depending on what distance the surgeon chooses to want to make. When we look at the actual size of the market, I think this is likely underrepresented, particularly as we see an increased number of Stage one diagnosis. But it's really it's significant for lung worldwide as well as other soft tissue tumors or solid tumors in head and neck neuro and in thyroid. So significant opportunity for our device, not just in lung cancer, but all cancer type resections. This chart sort of really represents the increased number of minimally invasive lung cancer procedures in the US for our total addressable market. And even what we think in our early forecasts, what kind of market penetration we can have in when we launch our product in 2025. I also mentioned earlier really about our patently, our patents really go around a number of key items that were protected, not only in the distance, but a lot of the 3d modeling of the tumors and modeling of the margin around the tumor in the soft tissue deformation algorithms that we have developed around our intellectual property. So a little bit of on the on the timeline here. So initially, the technology was developed at the Brigham and Women's Hospital, there was a significant amount of our one grants that were devoted specifically to the technology and an early form of using a fiducial marker that was placed in the development of what's called the eye vats procedure. And there's been a significant amount published on that procedure from the Brigham institution, and I think recorded roughly about 125 patients in those studies. We then took the technology over and started working on using electromagnetic sensors. So that you can implement this technology not just in an operating room that has a cone beam CT, but you could implement it in the in the standard operating procedure to be able to have a more global application of the actual system itself. Today, we've raised $5.5 million. And we're in the midst of closing our B round, which we have by $2 million open on a B round, we plan on doing our 510 K application in the end of this year, early 2025 phase where class to device, and then we'll do a commercialization round of roughly between eight to $10 million. And that would be for our early commercialization. I think the you know, as you all may be aware that strategic interests in this really fall into three groups. It's a robotic, it's imaging companies, and also minimally invasive surgical companies that really have expressed interest. And we've had a number of discussions with a number of strategics about our technology, and how it could fit into both their distribution channel, but also in their product, product groups. The team are really the art my three co founders, two of which are at the Brigham and practicing. Then we're like everybody we have a board that represents neurosurgery represents transplant and liver surgery where we have good applications, interventional pulmonology.

So, in summary, I mean we really think about what are the three candidates So we have a strong influence in to Dr. Our product doctrine. For patients, it's really reduced local recurrence through minimally invasive surgery, shorter length of stay, and lung, lung function preservation. For the providers, it really has a real key application and be able to identify and more easily find the lesion in the surgical procedure itself. So with that, we've reviewed a couple of key things of what we've done over the last five years because when we first came here, as I mentioned earlier, we were really pretty much an idea in two patents. We've moved, I think, a significant amount of milestones along the way, for really a very, very minimal amount of capital today, and I think the team is very proud of what we're gonna be able to achieve and accomplish. So with that, I thank you very much. And again, I thank LSI for allowing us to present