Video Transcription
David Danielsen 00:02
Dave. My name is David Danielsen with CairnSurgical. CairnSurgical started when some surgeons and biomedical engineers got together and said, we can find a better way to be more precise and more accurate when removing tumors. So we have developed, based on that origin, a platform technology that we call image-derived surgical guidance solutions. And our first product is for breast cancer lumpectomy. There has long been a clinically unmet need in this space. For the last 30 to 40 years, over 20% of all the lumpectomies that have ever been performed have failed to remove the entire tumor. That's simply unacceptable. Surgeons hate it. Hospitals and payers hate it because of the cost, but most importantly, patients, women deserve better. They deserve not to have to come back for a second surgery. I want to be clear, the problem has nothing to do with the skills of the surgeon. It's only about the tools and the information that are provided for the surgeon. So with that, we've developed the breast cancer locator. This is a paradigm change. This is a patient-specific custom device that a surgeon uses at the start of surgery. We started with two very important premises. First, let's enable imaging to be done in the supine position. This is the position the woman shows up in the operating room. Secondly, let's use MRI. This is the most specific, most enabling imaging modality for breast cancer. So with that, we've developed number one, this is a supine breast MRI. We've tested and validated this in over 350 patients, and it works very well to see the tumor. Secondly, in picture number two, this is proprietary software we developed that enables the design or the image analysis by a radiologist, and the design of the breast cancer locator by a team of engineers from there that's based on decades of experience with surgeons, radiologists, and everything. But from there we also say, Dear surgeon on an email, please approve this design, because you're the surgeon. From there, we send it to the printer. This is an example of a breast cancer locator. The surgeon uses the 3D printed custom device, places this on the woman's breast at the start of surgery. Through these posts, they're hollow, you place localization needles and wires. Mind you, the patient is under anesthesia. She feels none of this. You place one in the center of the tumor and four that give you a one-centimeter clear margin of healthy tissue. You take the needles out, leave the wires in. You carefully remove this, and now you're left with five wires bracketing the tumor and in the center, this is more information than the surgeon has ever had. Now let's contrast that to the standard of care. Typically one wire is placed by a radiologist in a different room, sometimes a different building, placed under mammographic guidance so the woman is in pain the entire time, it's not fun. And then when the surgeon gets to the end of that wire, he or she has to say, how much do I remove? What shape do I remove? This defines that perfectly. So let's talk a little bit about the market. Unfortunately, there are almost half a million lumpectomies done every year in the United States and Europe alone. The most important thing about the market here is the breast cancer locator is applicable for virtually every single one of them. It's not dependent on stage. It's not dependent on location. If you can see it in an MRI, we can design the breast cancer locator to enable precise excision. Why are localization? Has been the standard of care, as I mentioned, despite all of its limitations, quite frankly, it's been lousy outcomes, but it's also painful, it's costly, it's an extra radiology procedure. What's happened in the last 10 years has been the advent of some new technologies. One is probes that detect whether the cancer is still there, low, beep, beep, beep. That's called tissue inspection. Another is seeds that replace the wire, and another is specimen imaging. Let's talk a little bit about the seeds. They have done a fantastic job of positioning themselves as decoupling the wait time from radiology to surgery. This decouples it too. This puts it all into surgery. But more importantly, this focus is on clinical outcomes we have, and I'll show you in a minute, we have the best clinical outcomes. The seeds have done a great job also of having fantastic exits, two of which were exited just in the last three or four months at great valuations. We've got some great results already proven in three different studies, two in the United States, one in Europe, totaling 66 patients. We had two positive margins. That's a 97% success rate, 3% positive margins. If these had been done, these cases had been done by wires or maybe even seeds, we would have been looking at 10, 11, 12, maybe 13, maybe 14 positive margins. And that's based on historical standard of care data. We want to go to market with definitive clinical data, not just small studies. So we are currently embarking and in the middle of a very large randomized prospective study, 448 patients, half go to wire localization, half go to the breast cancer locator. We're performing this study at over 20 sites, most in the US, two in the UK, and one in Canada. Look closely, these are some of the most recognized names in breast cancer, but if you look closer, you will recognize none of these small community hospitals as well. We have a deliberate mix. We want to prove that it works in any location with any surgeon, breast cancer or general surgeon's hand. How do we do this? From the moment that the supine MRI is complete and we receive that data on a standard DICOM data transfer into our cloud packs, to the moment that we deliver this to a surgeon at his or her desk is about seven to 10 business days. We do not delay surgery that's within the standard scheduling time. We've done over 200 breast cancer locator cases so far in all of our studies, and we've never delayed one surgery. In addition to the physical infrastructure, we've also built an end-to-end platform that enables order management, tracking, and coordination of all the work and shipping and coordination of any post-market data management. This system is designed because we know that you know this loop. We need to do this more than one time. We need to do this not more than four or eight or 16 or whatever. We need to do this thousands of times per year, so we've built that infrastructure already. Additionally, this is a custom device we can enable the surgeon to choose, do I want a one-centimeter clear margin, or do I want a half-centimeter clear margin? You tell us, we'll design it. Do I want the hospital radiologist to do the image analysis? Sure. We can do that too. In fact, they can log on to the system, do the image analysis, and they've just created a reimbursable event. But more importantly, they've kept the local radiologist connected. That's a team. We're not breaking the team. We can do it if you choose. We can also choose where to put the ports within the device, here or over here. It's all surgeon preference. We have significant intellectual property already in place, much of it allowed, several more in prosecution. I'm glad to go through the details with you in a private meeting. We've built a team of industry veterans as well as key opinion leaders, leading physicists, leading radiologists. We built a team also of entrepreneurs who have serial experience, and this team is hitting on all of its milestones and meeting all of its objectives. Our goal is to finish the randomized clinical study in the spring of next year, file with the FDA, and we want to be on the market by the end of next year. From a financing perspective, we started with grant funding. We received private funding from Morningside Ventures. Morningside has been a fantastic partner with us, and to date, we've been financed at $26 million. Right now, we're preparing for a series B to enable our launch and our scale-up in 2025, so we're seeking to raise approximately $30 million in the first half of 2025. I'd like to summarize by emphasizing the value propositions. This is the breast cancer locator. It's better for patients. It's better for hospitals because we're reducing their cost by eliminating a radiology activity. It's better for payers because we're taking 20% of their breast cancer cost out of the system. I appreciate your time, and I'm glad to answer any questions you.
