Reza Khorasaninejad, LEADOPTIK - Image-Guided Biopsy Needle for Lung Cancer | LSI USA '24

Reza Khorasaninejad  0:04  
Hi. I'm Reza Khorasaninejad, CEO of LEADOPTIK. At LEADOPTIKs, we design an image guided biopsy needle to increase the accuracy of the lung biopsy. Lung cancer killed more than three next cancer combined. So it's a big issue. And despite the fact that there are a lot of technology development, there are three major step in lung cancer, biopsy. First step is a screening step. Normally, what does it do is they will go through the CTS scan, find whether they can the patient have a nodule, and depend on that nodule, go to the second step, which is finding the nodule, and that's where the battle of robot is happening. Monarchical Johnson. Johnson, island of intuitive built the entire hardware and software system to navigate through the maze of the lung and get close to the nodule. The last step is to taking the tissue. No matter people are using a million dollar robot or a manual bronchoscope, they still rely on one old technology and one new technology, but very expensive. The old technology is ultrasound, 30 70% of the long nodule in the long periphery. What happened is they need to use a small bronchoscope, a small bronchoscope as a small working channel. It just only allow for ultrasound to go in after they find the nodule, they need to take ultrasound out to make the room for the needle. So this exchange between device increased the error and error can be up to 44% four out of 10 people were told you don't have a cancer, and they come back in six months, in a year, with much, much larger nodules. The other technology that mostly robotic company uses Cone Beam CT, that's very expensive and also put everybody at radiation. Our technology called Leah system, basically last inch assessment. What we do is we rely on any other technology to get cellos to the nodule, and we finish the last step, so we have an imaging console and a disposable device, and we will place the imaging console in the hospital based on the placement agreement that we have. But the disposable device, like any other needle, which is can be used one time for the patient. Why it hasn't done before is it's really hard to miniaturize imaging system and integrate it with the needle. So we leveraging in a cutting edge technology called metasurface. Is basically in a nutshell, we combine advanced optical design and nanofabrication, we can shrink optics 1000s of time that allow and enable integration with the needle. There is another part that we use this technology normally. When you use optics, your resolution is great, but what happened your distance from your optics and the tissue need to be in a specific distance. I'm sure everybody using a microscope. When you use a microscope, if there is any vibration in your system, image go blurry. That means your depth of focus is really as small. We solve this problem by, again, metasurface technology that allow us to do imaging anywhere in the long so normally long airway is from two centimeters from an adult to some millimeter size. In my newest slide, I have put the two centimeter diameter. Basically this is a cross section of long airway. What we do is our device would be at the center of it, and we can image all the way when the airways become smaller because we have a higher resolution imaging is 50x better than ultrasound. We can basically differentiate between healthy tissue and tumor. Here in the top two images done by us on a human cadaver, a patient have a lung cancer. Image on the right is from healthy tissue as we expected. IT network like a structure, in a very good agreement with pathology image and histology image that we have from a third party, the part of the tissue that has a tumor and cancer become homogenous, and you can see there is an at least for me, it's easy to differentiate between an homogenous medium and a network like a structure, and it has been in a huge study that specificity and sensitivity of this depth imaging technology is above 95% for detecting the cancer. So histology normally, but how they do is they cut the tissue, they send it to the lab, slice it, put it in a slide, put in the microscope. What we do is everything in vivo while they're doing the biopsy. In a long term. What we do is we want to unify the workflow with one device for the last inch delivery as of today, when the robot or manual system gets close to the nodule, they rely. Several technology to make sure they can collect the tissue after they're collecting the tissue, either they bring a pathologist in the room or send it to the pathology lab to see. What we want to do is we want to unify in the last three step are we in the right place? Are we collecting correct tissue? Is it cancerous or not? In US alone, there are 659,000 cases, so that it put our beachhead market around $800 million and we have come in a long way. So we raise our first check on a slide deck in 2021 now we already freeze our design. We are in sprint to submit our 510, k by August, 24 of this year, and we build our killing room. We can do our device in our own killing room, prepare for verification and validation. We are in contact with a lot of strategic partner to either work with them for CO development or just use their stair channel for selling our disposable device. So we're raising our Series A to basically commercialize this technology and do our pivotal study. After FDA, we have 510, K, class two. We don't need human study. So the team is my co founder. Has a decade of experience in medical imaging. Alex chi, I know him from Harvard. He was our advisor for one and a half year, and he is now his chief medical officer. I have Nick here as well. He has a fantastic record of sale and marketing in big and a small company. And we have a really strong engineering team. Two of our mechanical engineering have eight exit as an early stage medical device employee, and they just completely change our device outlook. We have great advisor. One of our advisor is basically the founding father of this imaging technology. And we have a lot of great IP interventional polymeris in our team, we are supported by a great institutional investor and angel investor, and thank you so much for your attention. Thank.