Video Transcription
Daniel Laser 00:02
Dan, good morning. I'm Daniel Laser, CEO at Myka Labs. Thanks to the organizers for the opportunity to come present today on how we're leveraging multimodal AI for procedures in the abdomen. Considering procedures in the abdomen, there is a tremendous opportunity to benefit tens of millions of patients each year, whether we're considering patients who have conditions like infections in the bile duct, some 1.4 million procedures per year. In fact, conditions such as obstruction at the stomach outlet associated with cancer account for over a quarter million procedures per year, or conditions involving the pancreas itself, such as necrotizing pancreatitis, which involves some 3 million procedures per year. Diving into what these procedures entail and what the unmet needs are, here's the anatomy we're working with: the stomach, the liver, the pancreas, and the bowel nestled around it. Endoscopes, tubes with cameras mounted at the tip, can be introduced into the stomach via the mouth and are a powerful tool for procedures in the abdominal organs. Here's a scan from a patient with cancer that is blocking the flow of bile from the liver into the stomach. This is a very dangerous condition, one that can potentially be addressed by bringing in an endoscope and using it to place a stent. When a stent is successfully placed, patient outcomes can be very favorable, but given the complexity of the anatomy and with current tools, all too often, the stent ends up in the wrong location where it can harm the patient instead of benefiting them.
Another condition to consider is gastric outlet obstruction. Specialized stents that connect two organs are available and could potentially be used with endoscopic ultrasound to bypass obstruction. When this is successfully accomplished, there is a high rate of durable per oral intake that's restored. However, with current technology, when the scope comes in, all too often the stent is misdeployed, and instead of conferring the intended benefit, the patient might, for example, end up with the stent connecting the stomach to the colon, as shown here, where it has no benefit and confers harm. I think we've seen from these examples that surgical teams performing these kinds of procedures could benefit tremendously from new solutions for improving their awareness of the anatomy they're working in, and around that anatomy is complex and mobile. At Myka Labs, we're leveraging artificial intelligence to do just that, to provide a really compelling surgical team awareness solution.
In doing so, we're taking inspiration from the way the minds of the best surgeons are themselves trained to be able to picture anatomy beyond what's in their immediate field of view. You can see at the right here what the solution looks like. It's a box that fits onto an endoscopy tower or robotic surgery tower that's already installed in the hospital's operating theater. The box takes in information from conventional imaging sources and produces the awareness environment that the team can flip between to perform a procedure. The benefit is about getting better patient outcomes for individual patients, as well as reducing uncertainty around procedures, the uncertainty that can make it difficult for hospitals to achieve the goals they want, not just for the patient on the table at that moment, but for all the ones who are to be seen over the course of the day. Other benefits include expanding patient populations, so if your patients are inoperable, enabling the top surgeons and gastroenterologists to go even further with what they're able to do for patients.
What we're doing here is we're taking even better advantage of existing imaging modalities. There's so much information that comes in from an endoscopic ultrasound feed that is not currently utilized when the team is just looking at it in real time. At the level of the individual artificial intelligence, the advantage that our specific solution confers is precluding the opportunity for hallucinations, and that's through the use of sensor systems that ground the AI models in reality. Here's what it looks like when the system is running. At the center is the Myka multimodal AI engine, that module that's running on the box that's been set on the tower. Conventional imaging feeds are fed into it, along with the feeds from Myka Labs' proprietary sensor catheters. The combined outcome then is the imaging system, the navigation environment, the surgical team awareness solution that's seen on the right. At the bottom here is the system architecture, the highly scalable architecture. The box fits on the tower. The catheters are single-use consumables, and that's a key part of the revenue story.
So with this solution, the procedure shown earlier, involving bypass construction of the stomach outlet, can now be performed much more readily with a higher confidence in achieving the intended outcome. The Myka Labs multifunctional catheter is introduced into the jejunum, the scope comes in, and now, as the scope is scanned, the Myka AI is performing inferences to produce the surgical team awareness environment that allows the procedure to be completed successfully. Look at what's going on under the hood here. This is a really powerful set of technologies. What's shown on the left are examples of how readily this system can differentiate different tissue types in real time from a noisy source like endoscopic ultrasound. At right is shown an example of a real-world benefit where a gastroenterologist is able to better perform a specific key step of the malignant gastric outlet obstruction procedure with the benefit of the Myka AI surgical team awareness solution. This is real-time AI edge computing based. So what you can see here is the way the system is in real time, segmenting out distinct tissue types to provide the input to the awareness environment.
We have a broad and deep pipeline. We're very excited to report that our Connect system, which is used for repairing a set of birth defects involving the trachea and the esophagus, has just reached its enrollment target, so we expect to have this on the market next year. It's a compelling solution for a set of infants born with a really challenging set of conditions. Our conflict system for gastric outlet obstruction is coming close behind. It has moved well through preclinical studies and will be in the clinic very soon. Our products for conditions in the biliary system and in the pancreas are coming close behind as well, bringing the product to market. Our sales and marketing focus has a strong emphasis on key centers. Those are the ones that will drive broad adoption. And you'll just see in a moment, we have an excellent group of key opinion leaders who are closely tied to the company that allows us to do this for our Connect system. Our clinical study partners are LMU Klinikum in Munich, Germany, as well as Vanderbilt and Stanford in the US. Our regulatory pathway is a mix of 510(k)s and de novo 510(k) reimbursement. We're able to heavily leverage existing surgical reimbursement as well as existing CPT codes. We're partnering extensively with companies with complementary technology and solutions.
In the IP side, we set the company up three years ago, filed a bunch of patents at the time, and have had excellent success with three of them already having issued as US patents that provide strong coverage for our key systems. We have a terrific team. I'm joined by Lee Swanstrom and Dr. Mike Harrison at the senior leadership level, who are pioneers in minimally invasive surgery and pediatric surgery. Our seed round was led by Mission Bio Capital. Drew Crawford sits on our board, where he's joined by Glen French, Ashley Donkowski, and Mackenzie Davis. Our clinical and scientific advisory board includes individuals not only in our core procedure areas in the gastrointestinal tract but also in other organ systems like structural heart, and it's a reflection of the great diversity of procedures that this powerful technology can go into. We're starting the process of raising our Seed 2, and we welcome discussions with potential investors as well as partners. Thank you so much. Thank you.
