Mara McFadden Presents Endolumik at LSI USA '23

Transcription

Mara McFadden  0:05  

Thank you so much. Thank you all for being here. And I am so excited to have the opportunity today to tell you about endo lumic and how we plan to illuminate the future of surgical devices. My name is Mara McFadden, I am the co founder and CEO of Endolumik. I'm a mechanical engineer and MBA and I have over 20 years in the medical device industry. I've had the privilege for working for amazing companies like Johnson & Johnson and Philips healthcare, where I launched dozens of products, and several startups as well. My co founder and our chief medical officer is actually the inventor of this technology. Dr. Nova Zoca. She's an assistant professor of surgery at WVU. And the head of our Scientific Advisory Board is Dr. Dan Asigrey, and he's the chief of minimally invasive surgery at Stanford University. All right, so what's the problem we're solving today? Minimally invasive surgery, such as laparoscopic robotic surgery has been a revolution in reducing hospital costs, increasing recovery time and speeding up recovery for patients. But it still presents a key challenge for surgeons. Because their only visualization is through a keyhole with a laparoscopic camera, there can oftentimes be poor visibility of key surgical devices. A prime example of this is in gastric surgeries. For example, in bariatric surgeries, one key tool called a calibration tube, sometimes known as the Bougie is inserted through the stomach and is down placed down inside the stomach through the mouth into the stomach. However, the laparoscopic camera is in the abdominal cavity outside of the stomach. So surgeon has no direct line of sight into this key tool. This has two consequences. First, it can drive adverse events. This can be things like very frequently stapling over the calibration tube and specially firing a staple into that tube, which can be very complicated to repair, or, more rarely actually puncturing the stomach or esophagus with the calibration to because the team couldn't visualize its precise location. The second outcome is poor consistency in finished anatomical size. When a surgeon is performing the surgery, it's hard to get very consistent on exactly how close to the calibration tube you're firing a stapler. If you can't see where that tube is. These costs don't just lead to bad outcomes for patients, but they're very expensive for us hospitals. In the US alone, adverse events from poor visualization of bariatric tools cost over half a billion dollars every year. It also increases wasted or time and reduces the applicability of new yarn for robotic surgical systems. Because when you don't have great visualization, you can't use those as well because you can't rely on palpation or other cues to help when you have poor visibility. So our solution is to light the stomach from within using near infrared light for safer and more consistent procedures. In this top image, you'll see the standard of care. This is what a surgeon sees inside the stomach under those gray arrows, there is a gastric calibration tube, you can see where it is exactly and the surgeon can't either our device and the lower picture shows up as fluorescent green for the surgeon they can see exactly the position and location of the device at all times. As you'll see in this video, our device is coming down through the esophagus into the stomach and we have perfect visualization of its position and location. The reason this works is because we design design the device to emit light in the exact same wavelength as ICG or incandescent green dye. So all the laparoscopic camera systems and robotic surgical systems are trained to look for that wavelength and display it as fluorescent green. The fluorescent green is extra important because it gives surgeons an exceptionally high signal to background ratio in their vision improves signal to background ratio has been demonstrated to improve accuracy for surgeries and reduce task time. So our device lights is coming from within to get more consistent results procedure to procedure, reduce risk of adverse events and speed up surgical time as well as making it more effective and possible to use robotic surgical tools in these procedures. So I often get the question. This looks like a fairly obvious thing to do. If you can't see a tool, why not just put a light on it and make it a little bit more visible? That's actually because the innovation that's happening in the laparoscopic camera space In the last five years company like Stryker Olympus stores have been working diligently to all add these near infrared or ICG modes to their cameras. So it's virtually table stakes feature that every new camera coming out has this ability to see near infrared light. We've taken advantage of this installed infrastructure and are now emitting a signal a new signal that those cameras are already designed to see. So we can take advantage in existing installed infrastructure, no new capital expenditure for hospitals, existing established reimbursement codes, but a dramatic innovation and improvement for surgeons. Our IP is secure, we have one issued utility patent and more in the works, the one we have issued already is focused on the ability for inter operative measuring using our device, and also use of the near infrared light spectrum in this application. And this is a slide I'm incredibly proud of and it's news that is fresh off the presses. Just a few weeks ago, our first product, the end of lumic gastric calibration tube received FDA approval, and we got our 510 K premarket clearance. But moreover, I'm very excited to share that we are the first product ever to get approved through the FDA new safer technology program. This step program is for devices exclusively reasonably expected to significantly improve the safety of currently available treatments. And we are so honored and privileged to be the first device to meet that high threshold of additional safety to justify getting this step authorization. So what have we been up to the last 18 months since our first round of fundraising. In addition to getting that FDA clearance, we have initiated a clinical trial, we've served over 20 patients so far, and surgeons are thrilled with our performance in their cases. We've also been recognized by sages, the American Society of gastrointestinal and esophageal surgeons as first place in their Shark Tank competition. So we have a lot of validation from the surgeons who will actually be using our device. So what's next for us, and the lumic is just getting started. In the next couple of months, we're going to be launching our first product into the field, we're going to launch and learn we're collecting a tremendous amount of clinical data, and validating our technology, product market fit all of those things. Perhaps more importantly, though, we're expanding our IP portfolio, we have been working diligently to think about other opportunities, where there's this same pain point of a device that has poorly visualized, and what can we do to apply the expertise and knowledge we've developed to at near infrared light to solve that problem, and I'm very excited to share, we just filed a patent application for our second product that I think serves an even more critical pain point than our first. Finally, we're building out our sales team to prove proof of concept of our commercialization. And we're eagerly looking for opportunities and partners for distribution and potential exit. To that end, we are also raising funds, we have a round that is largely closed, we only have room for one final investor. It's actually a little more full than this slide represents we had to submit our slides a few weeks ago. And I think this is the deal of a century. What happened was we were raising this round and the FDA approval came in the middle of the race. So we've what we've decided to do since we have room for one more is extend that pre FDA approval valuation of $12 million with the post FDA approval risk profile we have now but that's only for an additional 30 days. So we're moving quickly. We're laser focused on launch. If you're interested in learning more and potentially partnering soon as that last final investor, please reach out to me and follow up. Thank you so much for your time and attention. It's been a joy to share with you about Endolumik