Howard Hechler, Lumicell - Fluorescence-Guided Technologies | LSI USA '24

Howard Hechler  0:04  
I'm Howard Hechler the president and CEO of Lumicell. This is an exciting time for Lumicell. As we head towards approval in just four to six weeks. We are one step closer to fulfilling our mission to change the face of surgical oncology, and enable every patient to go home cancer free. The breast cancer care continuum is large its complex starts with mammography goes on to marking the cancer, the diagnosis, but it all comes to the lumpectomy 180,000 lumpectomies a year. The design of a lumpectomy is to be the minimally invasive solution right instead of getting a mastectomy. The goal of a lumpectomy is to remove as much tissue as possible while at the same time surrounding the tumor that you removed with a healthy rim of tissue. The idea is to create negative margins clean margins. Unfortunately, there is no invivo imaging approach that lets the surgeon understand the extent of tumor still in the cavity. There are ex vivo approaches. But none of them examine the tissue inside the cavity. Think about this for a minute. Or since we only have nine minutes. Think about it for a second, you have a very limited opportunity to understand the difference between what comes out of the body and how it places back in, you take this tissue out. And it's a good mesh of tissue. And suddenly you're trying to understand how it fits back inside the cavity, you look for a positive margin, and you say where in the cavity does that translate. And we know we know that cancer is left behind, right? We know that positive margins more than double the risk of recurrence. And we know that these recurrences will take one in four lives. pathology is the next line of defense. But it's doing the same thing. It looks at tissue that's been removed from the body and tries to infer what's going on inside that cavity. And when pathology declares a positive margin. That means the patient has to go back again, once, sometimes twice, sometimes three times for additional surgeries to try and get it all. Pathology has well known limitations. The first and most important being that this tissue deforms. It's not this easy to understand sphere, it's a good mesh of tissue with nooks and crannies and the moment it comes out it flattens it twist. And so the idea that a surgeon and a pathologist, even with inking even with stitching can understand where a positive margin translates back into the orientation within the cavity. Well, you can see why that's so challenging. Moreover, as pathology does the many many, many slices necessary to look at the tumor. Frequently, they will end up exposing cancer that was originally surrounded by healthy tissue, and they think that it's a positive margin. And so this creates this false positive margin and sends the patient again off to a surgery they don't need. And finally, because each of these slices requires its own slide requires its own analysis, it would take more than 3000 slices to fully look at the surface area of a tumor. Most surgeons don't even realize that the pathologist is looking at less than 1% of the surface area of the tumor. All of this leads to an alarming rate of false negatives and false positives. In 19% of the time when the pathologist says that there are clean margins that the patient is cancer free, there is still tumor remaining. In 65% of the time, when the pathologist says there's a positive margin and you have to go back for a second surgery. There's no actual tumor there. All of this leads to a recurrence rate of nine to 36%. This is our solution, the Luma system. It's a real time intra cavity fluorescence guided imaging system, and it is an adjunct to standard of care. It makes standard of care better. Let me tell you about the components. The first is Luma sight. It's our optical imaging agent. It's given a same day of surgery two to six hours prior to the surgery with a simple three minute IV push. It's inactive when administered and then it activates upon confronting the proteolytic enzymatic activity that occurs in and around tumor cells. Now, after the injection, after the standard of care lumpectomy is done, the surgeon then goes in with the Luma cell DVS handheld probe, they go into the cavity and they scan the cavity wall looking for that imaging agents fluorescence the fluorescence that will indicate that there's suspicious tissue, or real time cancer detection software will then analyze and throw up a picture real time on the screen that guides the surgeon where to remove that suspicious tissue. Let me tell you a little bit about our data. In our most recent pivotal trial of over 400 patients, we enabled the identification and removal of residual cancer in 8% of our patients. Moreover, we reduced 15% of positive margins to negative margins. That reduces the number of second surgeries. Our sensitivity was more than 20% Better than standard of care. Our specificity was 85%. And take it in its totality, the accuracy of our system was 84%. But the data never tells the whole story. When we first went down this pathway, we heard Well, shouldn't radiation take care of this? It's all microscopic stuff you're finding isn't it? So we said, let's take a closer look. And what we found is that the tumor we removed very much matters. First of all, more than 90% is either greater to grade two or grade three cancer. And in fact, 50% of the cancer we removed was grade three, the most aggressive form of cancer. None of the cancer we found was microscopic, it was all macroscopic, from one to 13 millimeters, go out and find any radiation oncologist. And they will tell you that the radiation treatment that they use is not meant to work on radii on tumor size of eight millimeters grade three cancer. The most common responses when we show this data to radiation oncologists, to surgeons to mCell oncologist is wow, is shocked that this much cancer is being left behind. No one's even thought about it this way. And finally, I draw your attention to the last number because in some respects, it's the most important 70% of the cancer we found was in patients who had all negative margins. That means the patient was told by pathology, we got it all, you're good to go home, and they would have had cancer remaining behind as a ticking time bomb. So first, I showed you the pivotal data Great, then I told you why it mattered. But now I want to tell you what it means for standard of care, right? How do you put the seatbelt together with the airbags and make something more than the sum of its parts. So during our trial, in 45, patients standard of care sent those patients for a second surgery, but in only 14 of them with cancer found so standard of care found 14 additional instances of cancer residual cancer that was removed. But by using Luma cell there were an additional 20 patients where cancer was found and removed. And then there were seven more patients where both of us contributed to the removal of additional cancer. It's easy to see here that by adding the Luma system in as an adjunct to standard of care, we are more than doubling what standard of care accomplished on its own. It's been a momentous year for us. We submitted our PMA for our device. We submitted our NDA for our drug. We presented our data at a SBRs a major breast cancer conference we published in New England Journal of Medicine evidence, we finished up the FDA review period, the pre approval inspection. All of this LED and culminated in the overwhelming vote of the advisory committee just two weeks ago, the FDA has confirmed that Luma sell is on track for approval by the end of April. But we do more than breast, there's so much more so many more solid tumors, so many more patients in need. The great thing about Luma cell is that once we gain approval, that imaging agent is the same imaging agent we will use in every indication, which means expansion opportunities are dependent upon our ability to either partner with modify or develop new imaging cameras, right? We're chasing that signal wherever the cancer is. You see as an example, in the upper left, that's a large leading scope company that we're working with. They modified their rigid and the scuff endoscope in order to pick up our signal. On the bottom right is one of my favorites. We developed our own flexible fiber camera that goes down the working channel of a therapeutic gastro scope, so that we can pick up signal in esophageal and those are just two examples. We are currently raising 40 to $60 million. It will support us as we move into the limited launch as we expand. It will support us as we go after new indications it will quarter says we pull in the many partners who are already expressing interest. I know I threw a lot at you today, but I hope you'll reach out. Happy to set up meetings happy to tell you more about our team that has taken a combination of an NDA and a PMA and gotten it this far. Thank you for your time.