David Danielson Presents Cairn Surgical at LSI USA '23

Transcription

David Danielson  0:04  

Thank you all for being here this morning. My name is Dave Danielson with Cairn Surgical, you get a double whammy here get two companies chasing the same objective right now. And thank you by the way, we may be competing, but we're both trying to do good. So thank you. Cairn Surgical started with a breast cancer surgeon saying we can do better, we can do better for patients. And we need to. So from that, we have developed a platform technology that we call image derived surgical guidance. Our first product is for breast cancer. As you just heard 20% At least and we say this conservatively, just like you did 20% or more of patients, for the last 30 to 40 years have to come back for additional re excision surgery. It's unacceptable. It's amazing that it's lasted this long, it's painful, it's costly, it's just not good. So we're focused on that. Our goal is to make it 0%. The most important thing here is it is not about the skill of the surgeon. It's not about the skill of the radiologist, it's about the tools and the information that's provided to them. So our solution which we call the breast cancer locator. It's a image derived surgical guidance system. So we started with and most important thing was saying let's do or let's enable imaging of the patient in the supine position, that's the position she is on the table. Historically, it's always been a compressed mammogram or a prone MRI. And those are good for the radiologist to detect or to define the cancer. I would submit and many others would too. It's kind of meaningless for a surgeon when you're looking at a woman lying face up on the table. Secondly, we started with another premise. Let's use MRI. It's widely known to be the best imaging modality for breast cancer. So with a supine MRI, we started and then from there we developed proprietary software in box number two, this software does the or enables the image analysis, the tumor segmentation, and the design of the breast cancer locator, which I'll talk about in just a second. It's specific to her tumor, it's specific to her breast size and shape. So it's a patient specific device. But on top of that it's designed based on decades of experience with people in our team surgical experience imaging experience physician physicists, we know what we're doing. But if that's not enough, we also send a web link to the surgeon that's performing the surgery, saying here's the design, please look, please approve. So this whole patient specific solution is central to our theme. Picture number three is the breast cancer locator itself. So this is designed based on all that information. The surgeon places this in the woman's breasts at the start of surgery. These posts actually have holes in the center and through those, the surgeon inserts a needle with a localization wire, carefully removes the needle removes the breast cancer locator and you now have five wires, one in the center of the tumor. And for that bracket the tumor with a one centimeter clear margin. It was done in the operating room in three, four, maybe five minutes under anesthesia. Let's contrast that with the current standard of care. One wire or maybe one seed is placed by a radiologist in a different room could be the morning of surgery could be a week before surgery, under mammographic guidance with the woman screaming the entire time. So we're doing a painless, more accurate because it's derived from her imaging. We're doing a painless, more accurate solution in the AOR. And we're consolidating all that workflow into the AOR. So not only we we save the pain, but we save that radiologic procedure, it no longer needs to happen for replacing the wire. In addition to all that we have an interactive 3d model that we call the visualizer that the surgeon uses prior to surgery they can look at and they can see the shape the size location of the tumor in 3d in the supine position so they can plan their surgery. We already talked a little bit about the market. I will add this. There are over 450,000 lumpectomies sadly per year just in the United States in Europe. Virtually every one of them is applicable To the breast cancer locator, if you can image it and see it and segment it, we can provide a locator that'll help you do the surgery. from a competitive standpoint, much like some of the information you just heard, wire localization is still, despite all the problems, the standard of care, about two thirds of the global market still uses wire localization. In the last five to 10 years, seeds have replaced wires in about a third of the of all cases, seeds are placed again by the radiologist. But it's still just a point in space. We're trying to provide all the dimensions the location, the size. Our results have been proven in clinical studies. So in two small pilot studies, if you add them up together, we've done 33 cases with 100% success, zero positive margin, zero re excision. Those were four cases in palpable cancers, we also have cases. Now with our limited launch in Europe for nonpalpable cancers. We've just started that study, we're up to five out of five, no positive margin, no re excision. So we're doing great in terms of clinical results. But we wanted to prove that beyond the shadow of a doubt. So we are currently in the middle of a large, randomized prospective study. Here in the US and also two sites in the UK in one site in Canada. Our objective is very simple. We want to prove clinical superiority, go to market with that saying on label claims, this is better than the standard of care. Importantly, we're using sites or working with sites that are big small community hospitals, rural general surgeons, breast surgeons, academic you name it, we want to prove that anybody can use this. Our current operations, we have manufacturing in the US, we have manufacturing in Belgium, we have the two studies going on. And we also have the limited launch that I just mentioned. How do we do all this, we take the data that the surgeon provides with the breast semi with the supine MRI, we do the D identification of the data. So it's all HIPAA and GDPR compliant. We do the quality check, we do the design of the BCL we then print it, sterilize it, and kit it ourselves in one manufacturing cell. And then we have that in the doctors hands within seven to 10 business days. No delay to surgery, no change to the surgeons workflow. And it's been working very well, we're well over 100 bcls. We've never once delayed a surgery. From an intellectual property standpoint, we have 15 Total Assets, nine of which have already been either allowed or issued, especially including the core IP in the bottom left, and some additional IP that we developed in license to expand the applications of this solution. Our objective is to finish our clinical study later this year or early in q1, and then file with the FDA. And our goal is to be commercially available by the middle or the end of next year. From a financing perspective, we were originally grant funded and then we've been working with Morningside ventures for our Series A funding and also a bridge funding. Why the bridge funding, we went to Morningside and explained the opportunity to do the limited launch in Europe. And they said, Great, let's do that. So we opened up a $10 million convertible note, Morningside closed 6 million of that. One of my objectives here today is to seek partners for closing the additional 4 million to ramp up our limited launch. At the same time, we plan to do a series B by the end of this year or early next year. So we want to meet with and get into the funnel for several larger VCs for a series B. Like all good companies, we have a fantastic team. We come from industry, we come from academia, we have functional experts who know what they're doing. Myself and George born from industry, we have managed and launched dozens of products and we know what we're doing. I will close with a quick summary. The value propositions for the breast cancer locator are three better clinical outcomes. But with that we save costs for the hospital by eliminating a procedure and providing simpler workflow. And also importantly, we bring down the costs to the healthcare system. reducing risk surgeries is going to take millions of dollars out of the healthcare system. Thank you for your time.