Jon Greenwald Presents Caira Surgical at LSI USA ‘23

Transcription

John Greenwald  0:00  

Good morning, everyone. I'm John Greenwald, co founder and CEO of Caira Surgical. So after 25 years developing advanced, developing commercializing advanced technology in the orthopedic space, I've got two unfortunate statistics to share with you. The first is that over 50% of us in this room will suffer from knee osteoarthritis at some point in our life. And if you're a woman, your risk is twice that of a man. In 1993, only 200,000 patients sought knee replacement to address their pain. By 2012. That was that risk rose to 630,000. And by 2023. Today, there's over a million knee replacements done in the United States. Now moving out within this within this decade, that's anticipated to reach 3.5 million. Now, the other leads me to the other unfortunate statistic. There's been a number of advances over the years to help surgeons optimize outcomes for total knee replacement. The unfortunate statistic though, is that only 20% of surgeons utilize advanced technology like surgical robotics or navigation. Why is that? Because it's very simple because current technology impedes adoption. As you heard in the last talk, you'll hear more about pins and complexity. But what you see on the screen here is a state of the art contemporary surgical navigation system. It's made up of several components. On the left, you can see a monitor that's often often requires assistance from a tech or another sales rep in the room. And then here you can see fiducial trackers, these trackers are held in in place in the patient's bone utilizing to buy cortical pins, what that means is that a pin goes all the way through the bone, so four of those in total for a total knee replacement. These pins increase the risk of complications, including an up to 5% increase in the risk of fracture or infection. What you see at the top of the screen is a camera. Now this camera has to maintain unobstructed line of sight with those fiducials throughout the entire procedure, which means that nobody can walk in between or position themselves in between that camera and the patient. So current tech is also very expensive, up to a million dollars for the capital equipment and up to $1,000. On a per surgery basis. It's slow adding time to the operation, increasing the risk of infection and the cost. And also, as I mentioned before the four by cortical pins that are required to hold the fiducials in place. Complexity is high on these systems with a substantial learning curve of up to 20 cases and obstructive, in other words, these by cortical pins get in the way of the team moving around the patient and also advancing cutting tools or other instruments into the space. So I want to introduce to you Kyra surgical radar tracking surgical radar tracking. What you see here is our first product and that is a navigation system for total knee replacement. So we broke through part of the design ethos was to break through all of the existing barriers to adoption for advanced technology and joint replacement. So first, we looked at affordability, our system is 75% less expensive than traditional systems. A lot of that has to do with the innovation of utilizing radar in this space as a tracking technology. Speed is a big deal. So we take landmark registration, which is now up to a 10 minute process with either navigated to robotic procedures, we've reduced that down to about a 92nd landmark, landmark registration. And it's safe. There are no additional incisions to accommodate the bike cortical pins, and those pins aren't required at all. It's also simple. The workflow has been optimized to be very quick, easily learned. And with a learning curve of only about five cases. Also unobtrusive. There is no line of sight obstruction with our system. Radar enables us to do a couple of things that overcomes the line of sight problem. So these are we're attacking a very large market. We anticipate that just in the our application just in the United States is a $3 billion a year market. And when you grow that to our target international markets, it becomes a $13 billion opportunity. We also fit into areas that our competitors navigate existing navigation robotics literally just physically don't fit by 2030 68% of orthopedic procedures will be done in ASCs, many of which have space space limitations and they are also cost constrained with low reimbursement. So as you can see, our system was purpose built to overcome the real pain points that orthopedic surgeons experience. As a result, we're we've worked we've developed a network of 23 surgeons at 13 joint centers around the United States and it's also attracted discussions with As you can imagine, the largest strategics in this space, we scheduled a early clinic limited clinical release in 2024. With these 23 surgeons, it's 13 centers across the country, we are working with the surgeons to already initiate the sales process, work through the value analysis process and get this clinical trial or get the early clinical release underway. So in comparison to other systems, we've dramatically lower cost both installation costs for capital equipment, which we virtually don't have. And then also on a per surgery basis. We have a our disposables or consumables for surgery, our instruments are actually reusable, but that's also dramatically lower than what's what's available today. And it's far more efficient, and minimally invasive. Lastly, you saw there, it's also open platform. So it can be used with any implant system whatever implant system the surgeon chooses. As you may know, a lot of that specially the robotic systems are closed to the systems to the to the implant systems from the OEM that selling the robot. So our roadmap looks as such, we've raised almost 6 million to date and deployed that a capital very capital very efficiently, such that we will be submitting a 510 K in the second half of this year. And then starting our limited clinical re release with an image list knee in 2024. Later down it later, in 2024, we'll be introducing our fast landmark registration, which is driven by a handheld scanning device. And then looking at Oh US markets. Also we are platform technology, so building hip and spine products in tandem. We built a very big IP moat focused on protecting radar, radar surgical tracking, and then also fast landmark registration. And then also our key differentiating advantages which is unobstructed line of sight and low invasiveness. We have a 510 K regulatory pathway. We've identified multiple predicates to which we can compare that switch, we can establish substantial equivalence. We're confident in this pathway because our CTO obtained, worked on the teams that obtained 510 ks for multiple, several of these predicate devices. We also are proud to introduce what we believe is the first solution to have a comprehensive ESG lifecycle. Why do we do this to lower our cost and to lower our our ar, ar AR, lower cost of goods and also also due to limit it limits a student's Sterile Reprocessing task at both hospitals at ASC is particularly important for ASCs which oftentimes do not have the same sterile processing infrastructure as large hospitals. We put together a fantastic team, my co founder, Dr. Morteza left as a thought leader, key opinion leader at NYU, and experienced joint surgeon. I've been in the space about 25 years, commercialized products on four continents, and worked through two exits, one to striker one to j&j, our CFO, Irina minima. vich spent 10 years in investment banking structured a number of large deals within the orthopedic space. Gordon, our CTO, originally spent his his undergraduate years developing surgical navigation. In fact, he wrote the software for the first surgical navigation procedure in Canada in 1992. He and I worked together at ortho sensor in between Gordon has worked at Medtronic, Zimmer, and Conmed. And then, in addition to our internal team, we have a fantastic group of surgeon advisors and scientific advisors, as well as a network of partners that have assisted us in development in advanced semiconductor and radar technology, and also surgical robotics. So our path to revenue begins in 2024. With a knee as I said, the image list neat product, adding an image knee product later in the year with our handheld scanner. We then will expand the platform to include hip and spine building to what we projected 43 and a half million dollars in revenue in 2027. And we're raising $10 million dollars to cover cost to support our clinic early clinical release. In the last two years, there have been over $3 billion worth of deals in this space with an average multiple revenue of 12 12x. So in summary, we've got a very experienced team broad IP moat 13 billion very large market, strong partnerships, both clinically and scientifically and technologically, we minimize, make it less invasive 75% more affordable. So we we invite you to join us on this journey to make advanced technology more accessible to orthopedic surgeons, patients, hospitals and ASCs around the world. And in so doing really what we think to define the future of orthopedic surgery. Thank you