Kevin Hershberger Presents Lumicell at LSI USA '23

Transcription

Kevin Hershberger  0:05  

This is my first time here at LSI. And very happy to be here. So thank you. As as he mentioned,we're focused on surgical oncology, we're focused on improving outcomes in surgical cancer removal and the knee we're addressing is well known. I mean, in cancer surgery incomplete resections cancer left behind more than doubles the risk of recurrence. The Lumicell direct visualization system finds that cancer and guides removal of it. We have strong data and over 700 patients in breast cancer alone. Little bit of an update to this slide, we have now filed our NDA because we have an imaging agent and a device where we're filing an NDA and a PMA, the NDA went out last Friday to the FDA. So we're on track, looking for approval and by the end of the year, followed by a commercial launch in early next year. And again, we're focused on raising capital raising equity to drive commercialization. So let me start with cancer surgery. Okay, and our first indication is breast cancer. The entire care continuum in breast cancer treatment from imaging to pre surgery is all about complete resection, because as I mentioned before, incomplete resection has been shown to more than double the risk of recurrence. So so when a patient is treated for breast cancer, this is kind of the patient journey here. So when when a patient is treated with breast cancer, the objective is to remove the entire tumor, and a small amount of healthy tissue surrounding the tumor to ensure nothing's left behind. Often, as you see in box number two surgeons in order to get a complete resection will take unguided shave. So they'll take additional tissue based on intuition based on touching the tissue that's been removed looking at it, but they'll take cavity shaves, just to get a complete resection. And then seven to 10 days later, they'll come back and as you see, in this case, here in box number three, they'll find out that first of all, they had a positive margin. And in this case, there's tumor in the surgical cavity. But what's concerning is often there's an undetected skip lesion, there's additional tumor in the surgical cavity that's, that's completely missed. Because here are the facts around and these are, these are the facts around breast cancer surgery alone 20 to 40% of the time, the patient needs to have a second surgery, because they have a positive margin. But when they do a second surgery, 65% of the time, they're not even finding tumor, so they're doing a second surgery and not getting additional cancer. Now, to me, what's even more concerning is that 19% of the time, there's tumor left behind. So clinical studies have demonstrated that 19% of the time standard of care completely misses tumor, because the standard of care has very well known limitations. What we've developed at Lumicell is the first of its kind solution that allows the surgeon to see inside the breast cancer cavity at the time of the initial surgery. So we combined a fluorescent imaging agent that is activated to the bot by the body's host immune response to cancer. So it's not a targeted molecule, it's an activated molecule so truly makes it pan cancerous. We combine that with our own imaging device. And it's important to know we developed this device in conjunction with breast cancer surgeons, because there is no other device on the market that looks inside the breast cancer surgical cavity. And then the third part of the of the equation here is a patient calibrated tumor detection software that guides a surgeon specifically where to take to take additional tissue that's suspected to be in cancers. So the the the last point here on our solution that I want to raise is that we designed this system to fit seamlessly into the surgical workflow. So the agent is systemically administered via a three minute IV push to the patient two hours before surgery. So the patient's not required to come in early the day before a couple or more hours than early to get the injection, the three minute IV push and then join the initial procedure. So after the surgeon has removed the primary tumor, it takes less than 10 minutes to scan the cavity, remove tissue, remove residual cancer and then scan again to ensure that the patient is completely cancer free. So in this case, as I as I go back to the patient here that we that I demonstrated before in this case by using the Lumicell solution as an app adjunct to standard of care, not only are they avoiding the patient avoids a second surgery. So we find that we detect the positive margin, we remove that tumor that's, that's remaining in the cavity. The rest of the cavity is scan to ensure that it's clean. But we're also we're also picking up that missed tumor so that that skipped lesion that otherwise would have been left behind. And this patient there, therefore is able to go back to to complete their next level of treatment and get back to normality sooner than they would have otherwise. And as I mentioned, we are filing because we have a drug edit device, we're filing a PMA and an NDA. We have been granted breakthrough designation on the device and fast track on the drug on the drug side. So as I mentioned, the NDA has been submitted, the PMA is on track to be submitted by the end of April. And we're focused on on approval and commercialization in early in early 2024. So, before I get to the data, the clinical data, I want to point out the strength of the study. So we have some of the largest academic centers thought leaders in our clinical trial MassGeneral stand for MD Anderson and others. And then we also because we wanted to have a complete, very robust trial. We also have some very large community cancer centers. We completed our pivotal study 406 patients. And that data will be presented by Dr. Barbara Smith from Mass General next month at the American Society of breast surgeons meeting. What I'm pointing out here is prior to our pivotal study, we completed a pre pivotal 234 patient study and got great results. So it starts with negative predictive value. So by using Lumicell solution, our clinical data has demonstrated 98% probability that will Luma Sal says the patient is cancer free, they truly are cancer free. The other thing I want to point out is that in that trial, we detected and guided removal in 11% of patients. So by the surgeon using the Lumicell solution direct visualization system, identify cancer in 11% of patients that would have been missed in that initial surgery. More importantly, more than half of those patients had negative margins. So more than half of those patients would have been told that they were truly cancer free, except that we found by using the Lumicell solution that the surgeons were able to find residual cancer. In the pivotal study, we took this a step further. And we we gathered the characteristics of that tumor and I will tell you, it's not microscopic tumor, this is material, grade two grade three tumor. That's that that's missed in the surgery. So and again, that will be presented next month at the American Society of breast surgeons meeting. You know, looking at looking at the strength of the clinical data, we are focused on getting reimbursement via TPT, the transitional pass through payment, which which fits really well into our drug device combination. We have a strong razor razor blade model here. And we're focused on driving to 300 million in revenue by year five in breast cancer alone. But when we think about the broader market here, all solid tumor cancers, we really see this as a $4 billion market opportunity, the ability to identify and remove residual cancer using fluorescent guided surgery is a large market. You know, breast cancer alone is a $1 billion market. That's one of the reasons why we started in breast cancer here. So we've got a lot of opportunity after breast cancer in which comes down to you know, what's the long term strategy exit exit partnership opportunities, and it goes back to the D the care continuum. So if you look at the major players here in in these are just in breast cancer itself, but you know, its whole logic, it's It's GE medical, it's it's magnitone Danner, her and others so so it's it's it's a very large universe here of potential partnering opportunities. So I'll just wrap up where I started. You know, we're addressing a significant need in residual cancer being left behind. We have We demonstrated that we that we identify and remove that tumor. The program is is significantly direct says we've completed our pivotal study have great data on track to submit to the FDA and and again raising to commercialize in breast cancer so I'll be here the rest of the rest of the day today so if you'd like to learn more like to follow up please let me know thank you