Lung cancer biopsies are still being done blind more often than you’d think, leading to costly diagnostic errors.
In this episode, Reza Khorasaninejad, Founder & CEO at LEADOPTIK, discusses how advances in photonics and metasurface engineering are enabling highly miniaturized imaging systems for minimally invasive procedures. These innovations aim to address a major challenge in lung cancer biopsies: a lack of imaging guidance that can lead to significant diagnostic errors. Early clinical pilots across multiple sites are demonstrating strong performance, with one hospital already converting into a paying customer. Looking ahead, the company is partnering with Stanford Medicine to develop AI-driven decision support tools to further improve diagnostic accuracy.
Tune in to learn how next-generation imaging and AI are changing that reality and helping physicians hit the right target the first time!
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[00:00:03] Hello everyone, welcome back to the Outcomes Rocket, recording live here from Device Talks Boston. Today I have the privilege of hosting Reza Khorasaninejad. He is the CEO and founder of LEADOPTIC. Reza, thanks so much for joining us today. Thanks for having me. You're doing some really interesting things in the imaging space, and I'm excited to dig in. You also had a panel which I want to share with the folks that couldn't make it.
[00:00:31] But before we get into all that, help us understand a little bit more about your background and what LEADOPTIC is on a mission to do. Okay, sure. So, my name is Reza Khorasaninejad. I think Saul is one of the few people can pronounce my last name correctly. Basically, my background is in physics and photonics. I did a PhD in Waterloo, Canada. And then after PhD, I came to Boston, Harvard. I did a postdoc there. Okay.
[00:00:58] And I worked on a technology called ETA Surfaces. Okay. In the nuts, we combine advanced optical design and nanofabrication. We can miniaturize the imaging system thousands of times. Wow. And I was the co-inventor of one of the first efficient metal surfaces that was cover of Science Magazine. And at that point... Oh, yeah? You got on the science? The cover of Science. Dude. Top 10. That's huge, man. Yeah. Wow. When did that happen? 2016. Okay. That's my laser achievement.
[00:01:28] Yeah, that was my last year at Harvard. Super cool. At that point, I realized it might have a big impact in medicine, especially for minimal invasive procedure. So, for visualization system and minimal invasive procedure, there are two important pillars. One is, I mean, it's very important to make the visual system small. Yeah. So, it can integrate with the tools, either in a surgical device or in a biopsy tools. That's what we are doing.
[00:01:57] And at the same time, you need to have a high fidelity. You should provide high quality image. The physician can differentiate. That's basically my background now. It's all about imaging in medical space. That's very cool, man. So, really, we're looking at miniaturization. But while you're doing that, keeping high fidelity images so that you're able to discern. That's the key. Yeah. There's another key.
[00:02:24] When you come to the industry, you realize you need to keep the cost down as well. Yes. That's part of the quadruple aim, right? Exactly. Keeping the cost down, for sure. We've been talking, a lot of themes have come up around access, and so cost is a big part of it. In your kind of view, firstly, I wanted to ask you, what brings you to device talks? Like, why are you here? It's device talk, as you know, is community sitting in the intersection of innovation and clinical insight.
[00:02:54] Yeah. That's exactly where LeadOptic lead. I love that. And are you still in Boston? Are you still based in Boston? No, no. So, you moved to Cali? Yeah, I love Boston. Yeah. But... California's great, man. I'm in San Diego. Oh, that's great. You're in the warmer part, so... Yeah, it's great. Okay, so you're in California now, and tell us about your panel. What was your panel about? I came to device talk. I had a speech before FDA, and I had a really good memory about the device talk to just start about.
[00:03:23] So, last time I was device, we were pre-FDA. Was that last year or a few years ago? Two years ago. Two years ago. And an NIH program manager approached us and asked us to apply... From the audience. ...one of the grants, yeah. Oh my God. For lung cancer. How cool is that? And we... Nine percent get it. We already have the score. That's why I have a good feeling about the device talk. So, we're part of MTI. Okay. Oh yeah. Give me an all-in team. Yeah. Yeah, MedTech Innovator. Yeah, MedTech Innovator. I know Paul very well.
[00:03:52] He's a friend of mine. Yeah, he's fantastic. And the program is one of the best of the best. Kudos to the MTI team. You guys are awesome. It gave me an opportunity to come back. This time, we had an FDA. And we already deploy and have a pilot program. We need a physician who are using the device. And more importantly, hopefully, a patient is benefiting from our device. That was... I shared some initial results from our pilot side.
[00:04:20] So far, we have done 40 patients. The good news is, in all of the cases, our device could differentiate different healthy tissue and lesion. One of the big problems in lung cancer biopsy is, effectively, they do blind biopsy. Meaning, when they're acquiring the sample, there is no imaging technology to guide the physician. So, there are 30% error. One out of three patients, most probably, they take the sample from wrong place.
[00:04:49] 4% of the patient come back because they have an inconclusive biopsy. It's a big problem. And my panel were all about how lead optics and imaging technology can reduce this error accidentally, the lung cancer diagnosis. That's a really important error reduction. And does it tend to be a lot of false positives? Yeah, a lot of false positives. That's exactly what happens, right? All right. Listen, great that you have it.
[00:05:19] And is it serving as a diagnostic or as a companion to therapy delivery? We are in the diagnostic procedure, but we don't diagnose. So, we make sure physician take the sample from the right targets. Understood. And the goal is to increase the accuracy of the diagnosis. Right now, as I said, 30% error. So, around 70% accurate. And we are hoping to push it above 90%. That's great.
[00:05:46] So, you get them to the right place to get the right sample based off of the imaging. Yeah, based off of the imaging. Yeah. Okay, great. Talk to us about what's been working really well up to this point in the year. So, this year was very exciting for us. We just got clear in December, end of December. That's awesome. Congratulations. Thank you. We started our pilot program in January. Okay. What went well is we have three pilot sites. Okay. The first one already completed their pilot program.
[00:06:15] And they're becoming a paid customer. Awesome. That's a good in two aspects. One is they're really happy with our product. The other thing is which means patients are using it more and hopefully they get a better result. Yeah. And they have two more pilot sites. And they're also at the end of their program. And we are serving more patients. That has been our north star from day one. I love it. I love it, Reza. And then what about roadblocks or barriers that you've faced with?
[00:06:45] I think the biggest thing that we haven't preferred or we knew it, but the roadblock was paperwork at the big hospital and medical center. I understand they are serving patient and safety the number one and is not negotiable. But sometimes for other things, it takes forever. Yeah. This isn't good news maybe for some entrepreneur to help them accelerate this process. Yeah.
[00:07:14] I mean, look, something so simple can create so much friction. And when you're making progress and you have to deal with this friction, it's discouraging. Yeah. It just, I think we provide maybe a hundred page of document for an IT. We don't even have a Wi-Fi in our system. Oh my God. That's terrible. This is a security thing probably, right? This is a security thing that we just, we understand. But it's got to be automated, man. Yeah.
[00:07:42] It's going to be automated or somebody just streamlines this. Listen, you got to get, so one of our clients, a sense in that, they automate that. You got to tell them to go call that hospital because. Yeah, exactly. They could use their own. I can tell them hospital lens. It's not one. All of them are like this. Oh my God. All of the big medical centers are like this. It's a big problem. And we need to automate some of these processes as part of technology adoption and acceleration.
[00:08:11] If we don't, things get stuck and things don't move fast. And then in the end, patients don't receive the care they need. So I love it, man. Thanks for sharing that. It's something that you think is so easy, but it's a big challenge for a lot of people. As you think about big bets that you're placing on the future, what are you thinking about? And what's a big bet that you're going to be making this year? I think the biggest thing that's coming our way is. So first, because we have an exceptional result in our imaging.
[00:08:38] And we always thought you need to build in a good hardware, provide a good imaging. Then you can leverage AI. So we have a clinical study, RISE study that's coming up with Stanford Medicine to reign our AI models. This is a decision support model to help physicians for borderline cases or difficult cases to make better or more efficient calls, whether they are in the right place or not.
[00:09:04] That's very exciting things for us coming, hopefully, in a couple of months. That's awesome. And it's going to take, by the end of the year, we should have some encouraging results. That's fantastic and exciting, RISE. And I'm glad you said that. It starts with the data. Because without the right data, the AI is worthless. That's something we need to, especially in the U.S., a lot of bets are done on the AI without having the hardware infrastructure, which is, it should be changed.
[00:09:33] And it's kind of changing. I can see manufacturing. This is true, yeah. Chip design versus previously, okay, it's all software. Now it's how the hardware and software intersection can work together, which should be a winning bet. Oh, yeah. I love it, RISE. Very exciting. Congratulations on your FDA approval. So great that you came back to share more about the studies of the pilots that you're doing.
[00:10:00] And so if people wanted to learn more about you, the company, where can they reach out? LinkedIn is the best place. I'm just, I raised our first 7 million on cold messaging on LinkedIn. Did you? Yes. That's awesome, man. I'm not encouraging people to do that. I didn't have any other choice coming from no medical background. I love it. The LinkedIn is the best place and we have a website, LinkedIn, leadoptic.com.
[00:10:30] And if somebody wants to send us a message, happy to be connected. That's awesome, Reza. There you have it, folks. If you, I'm going to put my marketing hat on for a second and give Reza major kudos. Because if properly used, the LinkedIn channel can be very effective. I mean, you raised 7 million through that channel. Yes. Let's see it from there. Yeah. And then there's email and there's a conferences. You put it all together.
[00:10:55] And if you're doing it right and if you have clarity in where you're going, you can make it happen. So I want to give major kudos to Reza on the marketing side. Even though this isn't a marketing podcast, I want to recognize his efforts there. Folks, in the show notes, you'll find all the ways to get in touch with Reza and his company, LeadOptic. Get in touch with him. Learn more. Share this episode with a friend.
[00:11:18] If something that he said resonated, if your health system can use this technology, if you're a physician and you feel like you could do better is available now. And it's about to get even better with AI. Thank you all for tuning in. And Reza, thanks for spending time with us. Thank you so much for having me. I appreciate that. Yeah.