Alan Lucas Presents Navigation Sciences at LSI USA '23

Transcription

Alan Lucas  0:04  

Well, it's exciting to be back here. This is our fourth year presenting at LSI. And I'm excited to tell you about some critical milestones we've achieved over this last year and hope to come back and get my five year pin next year. So first off, I just want to let you all know that we completed our 25 patient clinical study a single site feasibility study done in at the Brigham and Women's Hospital where the technology was originally developed. And coming up in May, we'll be presenting the data at the American Association of Thoracic Surgeons. So that's really one of the most exciting milestones we've had. About two and a half weeks ago, we had our first meeting, pre sub meeting with the FDA to really define our clinical pathway and review our clinical results from the clinical study, which was very favorable. We've also added to our patent portfolio in also had an additional patent in the US that was issued, so significant milestones. And then on top of that, we've received the NCI Grand National Cancer Institute grant to support the development of our product in was selected to their investor showcase. So significant milestones over this last year. Now, let me just tell you a little bit about the company. So I think a lot of people are very well aware that early diagnosis of lung cancer leads to better cure. And there's clear studies that show in lung cancer, if you're doing low dose CT studies, starting at age 50, you can pick up these cancer cancers while they're still surgically resectable. And we've looked at this very, very closely at the the growth in actual stage one disease and that's been very, very well documented. stage one, stage two are clearly an opportunity for doing surgical resection. These lesions are actually very difficult to locate they're between one and two centimeters in size, sometimes difficult to palpate. So the whole concept is how can we take these small lesions, instead of doing a lobectomy or segment that would be actually lead to a wedge resection, which provides a much better outlook for the patient, particularly individuals who are compromised with lung volume to begin with. So what we've done is we've developed a way to locate the lesion within the lung, place a sensor to it as well as a sensor on the cutting instruments, or the stapling instruments that gives real time information and data to the surgeon and be able to give them those measurements at the time in during the surgical procedure itself. We do this by placing the electromagnetic sensor using either an 18 gauge needle or through a bronchoscope and then have the cutting instrument that actually gives those distances and readouts here shows really the three ways of placing that electromagnetic sensor palpation or through image guidance, as you see in the short video there. And what's been sponsored by the National Cancer Institute is the ability to be able to place our sensor bronchoscopic CLI using using bronchoscopic navigation, leaving it bring it to the site and then bring the patient to the operating room to direct the surgeon actually to where to resect it. At a 25 patient clinical study done by Scott Swanson at the Brigham and Women's Hospital, we were able to collect a significant amount of data here you see the actual placement of the electromagnetic sensor through the chest wall. The sensor is built into the stapling device. And with that the real time guidance as to what the distances are from where that the electromagnetic sensor is to the actual cutting instrument. This is the first time that you can actually measure in real time, the actual margin distance from the tumor resected. Not only in lung cancer do we see this as an opportunity, but also other soft tissue tumors. We've already done cases in the thyroid and see opportunities for removal of brain lesions as well as other soft tissue cancers. The market opportunity is significant, both in the US and globally. Not only for the lung, as I mentioned earlier, but liver, thyroid head and neck and brain cancers. Those are our follow on target markets for our technology. We look very closely in the US as to the growing number of procedures for the stage one stage two diseases and the lookout over The next five to five years and see a significant opportunity for those minimally invasive resection as well as these are very, very profitable procedures for the hospital and significant opportunity for reimbursement and also additional reimbursement to the surgeon for the placement of the electro magnetic sensor preoperatively. We have a very good predicate for the 510 K similar type device that's used in breast cancer currently or breast cancer resection. In think that we'll be following down that pathway. An arc patents we have our three issued patent patents currently, a number of other additional new patents. The original technology was licensed from MGH Brigham. And we've been listening added significantly to that portfolio since we've taken that license on. The current technologies that are being used for bronchoscopic navigations are actually quite complementary to what we're doing. These are used primarily by the pulmonologist where our technology is really designed to be used by the thoracic surgeon. So we can use or place our electromagnetic sensor. As I mentioned earlier, Branca Scott Buckley, and then guide the thoracic surgeon for the actual resection itself. Give you a little background on our timeline a significant amount of work was done at the Brigham with non dilutive funding and grants initially, when we started the company, we first put in first precede round, we've raised a total of $4.5 million. Currently, we're doing a $7 million raise, of which 2 million has been closed by initial existing investors to date. The exit strategy are minimally invasive surgical companies, robotics, as well as some of the other surgical navigation companies that are already in market. My team includes the Chief of Cardiothoracic Surgery at the Brigham, who's the inventor, as well as radiologist who did all the writing of the initial core code for use in our software and the development of our hardware. And then we have advisors and board members, as you see in these images here. So, in summary, some of the key highlights, we're currently doing a $7 million raise, you have met at least one of the management team members here. We've completed our clinical studies, three issued patents and multiple exit strategies, as well as a clear regulatory pathway following our pre sub meeting that we just recently had. And with that, I'll complete my presentation just a minute or so early. So I thank you all for attending. I'll be in front of the coffee in the back. And I hope you'll join me with any questions that you may have. Thank you