Video Transcription
Olivier Delporte 00:02
Thank you. LSI, good morning everyone. So I'm Olivier Delporte, CEO of SamanTree Medical, and with SamanTree, I'm bringing you to the world of cancer surgery or biopsies. And the key question for surgeons when they excise a tumor, whether it's breast, prostate, ENT, skin, or GI, is I need to take out enough, but not too much, as little as possible, but enough to make sure the patient is cancer-free for tomorrow. So how do we do that? We do that with our Histolog scanner solution, which is based on a scanner, a piece of equipment, imaging consumables, and a digital suite allowing for remote collaboration and AI guidance. But a video is always better than a few words. So here is how it works in an operating room setting, again, fairly agnostic to which surgery. An excised tumor is taken out by the surgeons. No change to the workflow for preparation; there is a Histolog Dip, which is a consumable we sell prepared as well as saline. The tumor, which is a mark one, is dipped for 10 seconds into the Histolog Dip and rinsed for five seconds in saline, then dried and positioned on the Histolog scanner for imaging of the margin. We're talking about margin assessment. The image acquisition takes 50 seconds, less than a minute, and in that less than a minute, the margin is appearing on the screen at a histology-like resolution, two-micron resolution, allowing for the surgeon and/or the pathologist to make a decision: did I cut enough, or do I need to take another cut? That image can also be connected remotely, so that a pathologist, for example, will have access to the image remotely. Pathologists do not like to be in the operating room. That's not their DNA. It's not their business. So on a static slide, this is the workflow: one, excision of the tumor; two, preparation, 15 to 20 seconds pre-image; three, 50 seconds per image; and four, evaluation and decision-making in the operating room or in the point of care, if it's a biopsy, for example. The uniqueness of the technology is the combination of high resolution, speed, and field of view. It's an almost 20 square centimeters field of view, allowing for large specimen assessment. As you can see there, it's actually a prostate, and the pictures were taken during a live case last year. So what this does is really bring decision-making to the point of care. Today, pathology takes anywhere from a few days to a few weeks, and patients wait, and surgeons wait to know if the patient is cancer-free. At best, pathologists will do a frozen section analysis, which takes an hour. We talk about minutes, and so that's why Histolog allows us to bring the decision-making and the pathology to the operating room, looking at margin assessment as a space. There are a number of companies that are working in this space, and there are a number of other technologies that are being used or have been used. If we look at a comparison of what is possible intraoperatively and the resolution, what the SamanTree technology, the Histolog scanner, allows us to do is to bring pathology-like histology-like resolution to the point of care during the procedure while the patient is asleep. So that's why the solution and the product are so versatile and benevolent, leading to a number of use cases. As of today, we have had the Histolog scanners being used in more than 4,000 patients, getting to 5,000 soon, over a variety of use cases, starting with breast cancer. Most of you know that breast cancer leads to a 20% to 30% reoperation rate. The female patients wait for a number of days after the first surgery for the surgeon to call and say, "It's good," or "You have to come back." So breast cancer is a big first unmet need. It's one of our beachheads. But prostate is on the rise, and there are a number of other urology-related use cases on the rise, including bladder, TURBT, high volume, 30% redo procedures. We do more and more of those, nephrectomies, as well as cystectomies, spinal surgery, moving on to skin pathology, triaging brain and lung, which are also use cases that are being evaluated as we speak. So that really speaks to the polyvalence and versatility of the solution, which imaging-wise is use case agnostic; it works for any fresh tissue. So that leads to a large market, which is multi-billion dollars, just starting with cancer surgeries across breast, prostate, GI, and a few others. We're talking about $3.5 billion in Europe and the U.S. Add to that biopsies and workflow efficiencies for pathologists, and that leads to around $10 billion. I mentioned Europe and the U.S.; I'm actually very happy to announce, we just announced that Friday that we received FDA clearance for the Histolog scanner, the dish, and the dip very recently, opening up, obviously, the largest medical device market in the world. The value proposition is based on patient outcomes and time savings. The solution improves outcomes by reducing reinterventions and saves time for providers, pathologists, and healthcare systems. So that's the basis for the value proposition, and we have health technology assessments already showing in prostate, for example, that the Histolog scanner is dominant with a very low ICER, meaning it is cost-effective and should be used. A snapshot about clinical results that we have generated already: in our two beachhead use cases, prostate and breast. In prostate, we've shown and published that the Histolog scanner is as accurate as frozen section analysis, yet in eight minutes versus 50 to 42 minutes; time-saving over a procedure is a major time-saving for hospitals. In breast, we're showing that the reinterventions can be reduced by 70% to 75%; that has been published, and there is actually an intervention, prospective study doing the same that has been presented recently, not published yet, showing also a 70% reduction of the reinterventions, helping patients with peace of mind after leaving the operating room. The business model: we have equipment, we have consumables, and we have software with remote collaboration tools with AI that will help the physicians read the image quickly and improve their reading of the image. So we have different business models, from selling the equipment and the disposables, renting/leasing the equipment, as well as price per procedure, which, as you know, has risen significantly in the last years, especially in the U.S., with the advent of robotic companies, for example. So we're very flexible on the business model, having the razor-razor blade model with the equipment and the consumables, but also having the option of a number of options on the software side, whether it be subscription or price per procedure based. We are hybrid in Europe, having started commercialization about 18 months ago with a few countries direct and distributors in a number of European countries, and in the U.S., we are going direct. We have recently hired our first members of the commercial team. So looking ahead, the strategic map is really about growing sales in the U.S., sales being strategic. Obviously, it's clinical results, clinical data that will feed into medium-term adoption, into reimbursement, into guidelines. So we have plans for clinical studies in a variety of use cases. It always starts with exploratory feasibility cases, as we have someone going in lung, for example, and we're designing also larger adoption trials, definitive trials in indications like prostate and breast. And there will continue to be product improvements on the software and digital side as well as on the hardware side. Finally, obviously, I play professor; I take the credit, but they do all the work. An incredible management team, very global, both sides of the ocean. We've got our first two U.S. leaders, one in sales, one in marketing and reimbursement. We've got a number of people in Europe and a very relevant board of directors: two U.S., two investors from Europe. The latest addition is Henry Charlton, who is independent and who is actually the Global Chief Commercial Officer of Intuitive, speaking to the link between what our technology does and prostate, i.e., robotic surgery. And finally, I'm here because we have a Series B round going. We have closed $14 million; we have about $5 million open until the early November timeframe, which will close by mid-November. So anyone interested, happy to speak after this session. You.
