Video Transcription
Manios Dimitrakakis 00:02
Every minute I'm Manios, I'm the CEO at Panda Surgical. We are a UCL University College London spin-out, and we've been in operation for a year and a half. Prior to this being an independent company, this, or a fundamental version of this, used to be my PhD, so it holds a very dear place in my heart. At Panda Surgical, we have an incredibly focused mission, and that is to introduce the first-ever hand-held robotic platform for minimally invasive neurosurgery to make these operations safer, more effective, and more widely adopted through enhanced dexterity. The reason we're focusing on neurosurgery is that we think there's a dire need for innovation in this space. Neurosurgery hasn't been updating at the same pace that other disciplines have, say, laparoscopy. When we're specifically discussing removing tumors from the brain and spine, what surgeons used to do back in the day was cut the patient open, which, of course, was incredibly dangerous, leading to a lot of fatalities. So in the 90s, they came up with these newer approaches where they would gain access to those confined spaces through natural orifices such as the nose or the eyes or tiny incisions on the top of the head or at the back of the patient. While they could gain access to those spaces and see tumors with cameras, and navigate to them with modern navigation systems, they are still using instruments they were using in the 90s. These cross procedures, dissectors, are very rigid instruments that make it very difficult to manipulate tissue, even when you get to those confined spaces. Of course, this leads to a lot of incomplete resections. When resection is complete, you very often have complications because of how difficult these procedures are, and even in successful procedures, it still takes a very long time to learn how to do these operations. Our inspiration on how to help in this space came from other disciplines where robotics is primarily used, such as laparoscopy. What robots give you in surgery is enhanced dexterity, this articulation that can make tissue manipulation much more effective. In laparoscopy, the Da Vinci system has been primarily used and has even replaced some of the standard approaches entirely. Sadly, this isn't the case in neurosurgery at all. The only couple of robots available are for biopsy or needle navigation, with no enhanced dexterity system commercially available out there, until right now, because at Panda Surgical, this is exactly what we're developing: a miniature three-millimeter-diameter dexterity-enhancing hand-held platform. Using our instrument, surgeons can penetrate deep tissues within the brain and spine anatomies and perform previously impossible delicate maneuvers with wrist-like dexterity for more effective tissue manipulation, increased tumor resection, and reduced complications. We have an array of different end effectors, such as cross procedures, curettes, and dissectors, depending on the task, and we've been testing the system in both cadaver and phantom models, pretty much in the preclinical stage. The reason we went hand-held with this technology is that, first and foremost, neurosurgery is very expensive. A very large teleoperated system would only add to that cost. But also, maybe more importantly, these procedures are very intricate. They have a lot of tool changes, and they have long operative times. So with a quick, seamless, incorporated solution like a hand-held robot, we think we can enhance these operations in the most effective manner with our hardware. We're also developing software assistance tools. What these tools do is take our robotics data, combine it with video data, and come up with strong data analytic solutions that can make our surgeons better at using our technology, thus improving patient outcomes even further. While we think this is a very good solution for neurosurgery, we might be biased. We have chatted with the community. We have interacted with almost 16 neurosurgeons now all around the world, and they have all identified the lack of dexterity as one of the main issues in these procedures. Very importantly, the vast majority, when asked, saw some value in our technology. And maybe most importantly of all, of the 47 non-neurosurgeons that have hands-on experience with the device, 95% said they would use this in their clinical practice. Everyone else said, "Let's see it used in clinical data first." We think that's a very fair argument. Our journey to date started in May 2023, when we closed our first private investment from a medical device company called Prima Nova Technologies. Shortly thereafter, we followed up with a UK Government grant for another million British pounds. We've been using that money to develop our product and protect the technology as much as we can. We've held cadaver labs both in the UK and the US. Just earlier this year, we hired our first FDA pre-submission consultant, which shaped our pathway moving forward. We have two different approaches in Europe and in the US, and we do expect that FDA approval will come before European approval. So while we are attempting both processes, we are focusing on the US market. We think we could achieve regulatory approval by the end of 2026, hoping for a quick follow-up in the European market. Our first portfolio product would be those tissue manipulation instruments I have been describing, which would allow for better tumor resection, but we hope to very quickly follow up with specialist instruments such as cameras, suction, and energy tools. Concurrently, we, of course, have been developing our software assistance, and while we want to offer this for neurosurgery, brain and spine specifically, we think neighboring disciplines such as ENT could benefit from the same technology. What all these procedures share is the clinical need for better dexterity and enhanced articulation in confined spaces. By bundling up all those different procedures, we think we can make an argument for a global problem that needs immediate solving, thus creating a very attractive proposition for a sustainable business. Because we think that market opportunity is large, it's only natural that there are a lot of competitors in the space. While there are both teleoperated and Hamilton robotic devices on the market, we think that none of them could be readily used in minimally invasive neurosurgery. The reason we think that is because they're either too large or their control interfaces aren't designed for these long and narrow corridors. Our device, on the other hand, has been specifically designed for these approaches at three millimeters. We tie some of the smallest commercially available instruments out there, and in combination with how inexpensive we are and our software systems, we think we can make a strong argument for a complete solution for minimally invasive neurosurgery. Because I've been describing a grand problem, I do want to back it up with the expertise in our team. Panda Surgical was founded by a team of experts in both robotic and spine surgery. My clinical co-founder, Hani, is also now our Chief Medical Officer. He's a practicing neurosurgeon in the UK and is even going to write some of the guidelines on how to perform these intricate procedures. Dan, our other co-founder, is a UCL professor and is also affiliated with Medtronic through his prior med tech exit, when they sold that company to Olympus a few months or years back. We have a full-time team of incredibly talented engineers that have taken us to this place at an accelerated pace. Because we hadn't done this before, except for Dan, from day one, we recruited some very experienced med tech veterans, Jeff and Dave, both in chief roles with Mon Surgical, with Jeff specifically sitting on our board of directors as well, advising us on both business strategy and technology. We're a university spin-out, meaning we have both the support of the union as well as the University Hospital, and as I mentioned prior, we've been having both private and public investments. Finally, we are looking to raise pretty soon. We would like to close this round by early next year, and we will be asking for 6 million USD, hoping that this will get us to expand our team, further develop our pipeline products, and do our first human trial in the UK, which we have already been organizing with a clear goal that after that, we will focus on our first FDA submission for US market approval. Thank you so much. If you'd like to learn more, I'd be very happy to discuss.
