Alan Lucas 0:00
Thank you very much, Kevin. Well, I'm very happy to be back here for the third year at LSI. And a lot has happened over this last year and very exciting things to report which you'll hear about in my presentation. But most importantly, to highlight we received a IDE and IRB approval, and started our 25 patient clinical study, we've actually completed 21 patients so far, and that will soon be completed. In addition, we received three patents. So we got three national phase patents issued, specifically related to our technology, had a received a $400,000 grant from the NCI National Cancer Institute to support development on one of our technologies. And that's the technology that we also received the NCI grant on. So those are exciting things that have happened over this last year. Now, let me tell you a little bit about what we're doing. Many of you are probably well aware that early stage diagnosis of cancer, particularly lung cancer actually can lead to cures and there's been a significant increase the amount of individuals who have been screened who are at risk for lung cancer. Well, the standard therapy for this is a surgical resection. And oftentimes, it's very difficult to identify or locate that lesions inter operatively. The standard of care typically is a lobectomy are a segmentectomy. But we want to drive those early stage cancers to a wedge resection, preserving as much lung tissue as we can, but also providing a clear margin. We do this through GPS navigation, be able to guide the surgeon to the location where the lesion is resected out having that clear margin. And that's exactly what we're doing in our clinical study now. And that's what the data has been showing, we place an electromagnetic sensor, close to where the lesion is. And we also have sensors on the cutting instruments, that gives us the real time distance from the lesion to the our sensor. And it's been very, very exciting. We're very happy at the progress that we've been able to make so far and show clinically. We have three different ways where we can really place that sensor. One is just by palpation and feel of the lesion itself within the lung, or through guidance, either interoperative CT imaging, and the electromagnetic sensor that's located per container within our percutaneous needle to actually place it close to the lesion. And the third that we're most excited about is the bronchoscopic delivery of our electromagnetic sensor. And that's exactly what we received our NCI grant done and the development of the bronchoscopic approach to that delivery. This is a video of our one of our patients from the clinical study itself. It's being done at the Brigham and Women's Hospital. It's a feasibility study 25 patients as I mentioned earlier, we've done 21 So far, we placed the electromagnetic sensor in this instance, under direct guidance, bring the stapler in, the surgeon sees on the monitor what the distance readings are from the surgical stapler to the actual cut line itself. So we're just getting real time, information and data on what those distances are. Makes the cuts in the pathology lab. When we've compared our measurements to the the digital measurements to the pathologist measurements, we're always showing that we have not less than what the pathology is measuring, which is what's most important. So the tissue sample comes out with our digital measurement, as well as the pathologist measurements showing a clear margin. The market sizes are really quite large, not just in the the resection of lung tumors. But we see a number of other soft tissue cancers that we can apply our technology to including liver, thyroid, head and neck, brain cancers, as well as potentially breast cancers in the future as well. So the markets are significant, both globally in the US and globally. For what the work we're doing. We do have a clear product gets for a class two device and a 510 K. So we anticipate that we'll take our data from our feasibility study and do our pre sub meeting with the FDA. And we'll be doing that sometime in the second quarter of this year. Our patents as I mentioned earlier, we have three patents that have issued we have a number of other patent patents now that were are currently filing both internationally as well as in the US. The competitive environment, primarily most of the navigation systems that are there for third scopic approaches are really used by the pulmonologist for lung biopsy. So we really see our technology as a bridge from the pulmonologist doing the biopsies using systems like from Medtronic or ion from Intuitive, but as a way to then bridge to directly to the first third thoracic Copic surgeon for the actual removal of the lesion after biopsy. So these are very, very good partners for the technology that we're doing. And also very good partners for our bronchoscopic approach to delivering our electromagnetic sensor. Today, we run very capital efficient, from the standpoint that we're a virtual company. So we've raised to date $4.5 million. That's gotten us to the clinic and will get us through our clinical study. We're now currently raising our B round, which in total will be proximately $7 million. And that'll take us through in the virtual mode as we are now through our 510 K application. Strategic Partners can be variety, both from a endoscopic minimally invasive company, a robotic company, as well as the imaging companies like Philips or Siemens. This is the team here. founders are from the Brigham and Women's Hospital. We have also a scientific advisory board that covers both neurosurgery head and neck pulmonology in thoracic surgery. So, in summary, we've raised a total of $4.5 million. We're in the midst of doing our B round, which we're forecasting at $7 million in total. That brings us to through 510 K application. So with that I'm finished a little bit early, but I didn't know we may bring take a question or two if that's all right. In my last two minutes, if there's any questions from the audience. I know that that may be a little bit out of out of character here, but I thank you very much. And I appreciate the opportunity to be able to tell you a little bit about Navigation Sciences.
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