How AI and 3D Imaging Could Transform Spine Surgery | Ep. 103 [Erez Lampert]

What if spine surgeons could operate with real-time 3D guidance while reducing their reliance on intraoperative radiation? In this episode of Industry Ignited, Dr. Leeanne Aguilar sits down with Erez Lampert, CEO and founder of PathKeeper Surgical, to explore how AI, optical 3D imaging, and surgical navigation are changing the future of spine surgery.

Erez shares how his background in aerospace, defense, and digital dentistry helped shape PathKeeper’s approach to precision and safety in the operating room. They discuss the limitations of traditional X-ray-based navigation, the challenges of building trustworthy surgical AI, PathKeeper’s vision for an AI perception layer for surgical robotics, and what it takes to bring complex MedTech from FDA clearance to commercialization.

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Transcript

Dr. Leeanne Aguilar 0:06

What if spine surgeons could operate with real-time 3D guidance without exposing patients and surgical teams to inoperative radiation? Welcome to Industry Ignited. I'm Dr. Leanne Aguilar, and today I'm joined by Ares Lampert, CEO and founder of Pathkeeper Surgical, an Israeli med tech company using AI optics and 3D imaging to transform spine surgery. Ares, thank you for joining me.

SPEAKER_00 0:33

Thank you, Leah.

Dr. Leeanne Aguilar 0:34

Yeah. So your career began in aerospace and defense before moving into medical imaging. How did that journey shape the way you think about precision, safety, and technology?

SPEAKER_00 0:44

Right. So I think aerospace in industry is a very interesting one. And it's similar to medical device industry from many aspects. The first of all is a really holistic view of everything. It's not just software or just mechanical elements. You really have to look at a lot of elements at the same time. The physics of the world, the electronics, the mechanics. So you have to really do a multidisciplinary analysis of a project. And safety is, of course, very, very important, and so does regulatory aspects. You can't have a space shuttle or a satellite without doing a lot of testing. The price of payment of mistake is big, is expensive. So there's regulatory, there's a huge cost of an error. Thing about safety in satellite launches is also super critical. So all those aspects are easily transformed into spinal surgery in our general medical device.

Dr. Leeanne Aguilar 1:44

Right. Interesting. Yeah, I guess you never thought of it that way, but just like the multidisciplinary approach and the use of technology is transferable, and yeah, I just hadn't thought about it that way. So I know you helped lead the development of aligned technologies, Iteroscanner, which became a major success in digital dentistry. What did that experience teach you about bringing complex imaging technology into everyday clinical practice? Right.

SPEAKER_00 2:09

So I think the most important element in the Itero element was user experience. The previous technology that we used in Invisalign, where I joined the what we call the 2.9 version, was a great system. It was accurate, it did the job clinically, but it was not easy to use. We're talking about 10 minutes where the user, dental technician, the dentist had to really work hard to make sure that every picture is good and that the flow works well. And it was heavy, it was about two-pound of a device. So although the clinical outcome was great, the user experience was terrible. So really very few dentists joined the club. They appreciated the clinical value, but they didn't want to make all the efforts to get it. So when I designed my first 3D scanner, user experience, you know, was the first thing that was on my mind. I knew I had to do something to really change the industry to make it not just better than the alternative, but easier. Easier than the alternative. Really, really crazy overnight success. Because the quality stayed, we didn't make a system that was clinically superior to the previous version, but the user experience, the flow, the time, the effort that the dentist needed to expand to use it was so much smaller, it was so much easier to use, then it was like, why not?

Dr. Leeanne Aguilar 3:41

Yeah. Well, that makes sense. I mean, if it's saving them time and effort and energy, and and if it's easy to use, then it's a no-brainer. If it's something that's complicated and and you know a pain to use, they're gonna avoid it. So exactly, exactly.

SPEAKER_00 3:54

You I mean that's that's what I realized. You know, if it's easy, as you said, it's a no-brainer. If it's harder, then now and right right so they will expect very high level of proof of clinical value.

Dr. Leeanne Aguilar 4:09

And what inspired you to take the concept of optical 3D imaging from dentistry into spine surgery?

SPEAKER_00 4:15

Right. So I met uh Professor Josh Rudder, he's the spine director in Hadassah in Israel, and he has been using robots and navigation in spine uh for many years. This technology has been around for more than a decade before we even started. And he was basically unhappy with the current state of the art. I mean, it was too expensive for him, too big. Uh yes, it works for a big, you know, HSS style hospital where they can afford the money, the infrastructure, and so on. He realized it will not work for smaller hospitals. So adoption was limited, but not just adoption for Professor Schroeder as a surgeon who traveled and work in Africa and Southeast Asia. He wanted a system that he can use everywhere. Suburban in Israel, suburban United States, but also any place in the world. And I think that was that was his passion: bringing the best in-class technology to every patient in the world. And together we realized that similar concepts that work so well for Invisalign, use of AI, and use of 3D imaging could be transformed into orthopedics in general and spine specifically, and really change the industry the same way it did in dentistry.

Dr. Leeanne Aguilar 5:30

Right. Yeah, with spine surgery, it requires an extraordinary amount of precision. What are the biggest limitations surgeons face with current navigation and imaging systems? Right.

SPEAKER_00 5:41

So it's interesting to think about there's just today have two options. One is fluoroscopy. So you wear a lead vest, which is uncomfortable and doesn't really provide full protection. You take a low resolution 2D scan, an X-ray scan, real time basically, and almost guess where you are space because it's just 2D, it's not very accurate. So it gives some sort of a feedback for a surgeon. But the surgeon has to be experienced and the anatomy has to be normal for that to work. So it's a very simple, low-cost solution with a lot of problems for the surgeons with radiation and everything, but it's not good enough. And that's still the most common solution. That the high-end surgery centers they use robotics. And robotics, robotics or navigation, but let's call it robotics for the sake of simplicity, use an X-ray machine in the surgery room to create like the anatomical map of the patient. Since the X-ray doesn't work all the time, you trust some sort of a reference array. That's how we call it. You clamp or you attach some sort of an attachment to the patient's anatomy, and you use that to guide the robot. So you take the 3D scan, the 3D CT scan, you put your reference array, you know where everything is versus the reference array. But if the reference array moves, there's no way for the robot or the surgeons to know it moves. And that's what we call reference array anxiety. If it moves by 3mm, it means that you're going to drill three millimeters off. And that could be the difference between a happy child and you know a very unhappy child out of your surgery room. So this reference array anxiety is a huge problem that robotics technology just doesn't solve. So even if you are you have the money to buy a robotic system, you have the big infrastructure, you're willing to spend the time to take the 3D CT scan of the patient, of the child, or any one of us, most people will have some sort of orthopedic surgery in their lives. If you take the time, you do the extra, you're still not sure. And for surgeons that are trained, you know, 15-20 years to be expert, real expert, to buy a million-dollar technology, and then you cannot trust it because maybe something changed that you don't know. That's kind of a terrible situation, a terrible trade-off.

Dr. Leeanne Aguilar 7:56

Yeah, so there are huge implications not only for the surgeon being able to do their surgery correctly, but for the patient and for liability for a mistake to happen, potentially.

SPEAKER_00 8:08

Yeah, those technology works perfectly when everything is perfect.

Dr. Leeanne Aguilar 8:12

Exactly.

SPEAKER_00 8:13

But then you don't need them so much. You need them to make sure that nothing goes sideways. But they can go sideways as well. So you need something to support you to make sure that this doesn't go sideways. Yeah. That's that's the main problem.

Dr. Leeanne Aguilar 8:29

So why is reducing intraoperative x-ray exposure so important, especially for pediatric and scoliosis patients?

SPEAKER_00 8:37

Right. So if you think about pediatrics, most pediatric surgeries are done on women, but anyway, young adults or teens, and each CT scan in the surgery room is equivalent to hundreds of x-rays. So you don't need to be a clinician, which I'm not, I'm an engineer, to imagine that hundreds of x-rays in the abdomen for a teenage girl is not a good thing. A lot of very sensitive things for everyone, but especially for women are in that area and they get a lot of x-ray. And there's actually research proving that those kids, if they get too many x-rays, we're talking about five city scans. That's not a lot, it could happen in one surgery. There is a proven increase of cancer in their lives. Oh wow. And it's the same thing, you know, those lead vests are not suitable for women's surgeons, and there's proof that wearing those women's surgeons has more cancer than regular women, breast cancer. And every surgeon has more cancer in you know, cataracts and their throats, their hands. So both surgeons and patients, especially young patients, but all of us, but especially young patients, are just high risk of cancer because of that. And it's if we can eliminate that or reduce it, then we should.

Dr. Leeanne Aguilar 9:53

Oh, interesting. So, yeah, not only the patients, but it it um exposes the surgeons, is what I mean. And the surgery stuff.

SPEAKER_00 10:00

The nurses, the technicians, there's a lot of people. I mean, we always think about the surgeons as the leaders of the operation, but right many times there's like one or two surgeons and six, seven, eight of stuff. Nurses, technicians, scrub techs, all of those guys are still in the room while the x-ray is taken or exposed to that. So we want to protect them, and we don't want to have the surgeon in a situation where there's a trade-off between risk for themselves and the patients to take another x-ray and risk for the surgeon for the patient of not having the screws or the implants in the right place.

Dr. Leeanne Aguilar 10:37

Right, yeah. So, how does Pathkeepers' camera-based AI-guided navigation system work inside the operating room? Right.

SPEAKER_00 10:43

So, our expertise as a team is those 3D imaging in medical device. So we did it for Invisalign, we're doing similar concept in Pathkeeper. We are building it our own 3D camera, specifically suitable for the surgery room. And the beauty of optical, we call it OTI, optical topographic imaging, a real 3D measurement device versus sterile imaging. So we can really, once the surgeon exposed the bone, we can really track the bone for the surgeon in practically whenever the surgeon wants it. It makes sure that every time the surgeon wants to know what is exactly the situation, they can take a 3D optical screen, update the registration, you know, the positioning of the patient anatomy, and therefore make sure that everything is accurate. We have been able to prove to the FDA that we can be a submillimeter accuracy in our registration and navigation capabilities. So this is a very critical point because it's about five times better than the standard. And we can do that basically eliminating what we call the reference or anxiety, eliminating the time wasted on taking X-ray. And we actually realize that once we can track the anatomy, we can do other things that are impossible to do with an X-ray based system. Talk about it later. When you have 3D imaging and you have the AI to understand what's happening in the surgery room, you can create something we started to call situational awareness of the surgery. And we can really measure in real time the anatomy position and give the surgeon feedback in ways that did not exist before. We can measure and give feedback and analyze and give specific data that is relevant for the surgeon for what they are doing now, not in general, not you have you give them 100 parameters that they have to choose. We know what the surgeon needs to see, we track it and we show them. And that does not exist today.

Dr. Leeanne Aguilar 12:34

So it's so it creates a surgical situational awareness. Yes. Yeah, and that eliminates that anxiety and just provides a lot of, like you said, reference data, and so they can make uh decisions and and uh it's a win-win situation for everybody.

SPEAKER_00 12:51

Yes.

Dr. Leeanne Aguilar 12:52

Yeah. Now many companies talk about AI in healthcare, but surgical AI has a much higher trust threshold. What makes AI in the operating room uniquely challenging?

SPEAKER_00 13:03

So you're right. I mean, if you look at AI companies, um, you'll see that in most places, either they're doing what is you know a chat GPT-like or a chatbot-like, or you know, helping with organization, scheduling, and stuff like that. So although it's in healthcare AI, it's not really clinical AI. And in clinical AI, most successful companies are still in the area of offline where you upload your CT, your MRI, even partially real time, where you upload data and the system helps you decide if it's it's a high priority patient or not. But it's still find something. Tell the radiologist, for example, what's the problem, the radiologist make a decision. So it's controlling the priority and helping and so on. When you're thinking about surgical AI, you're starting to think about something like with cars. When you have autonomous cars, you need to have real-time feedback and it has to work. You cannot be in a situation where you're gonna miss. And although it's level two, level three, level four, you're starting to move into an area where decision making has to be done instantaneously and be accurate all the time. And that's the that's the risk that highly worse of involving decision making or decision support system in a surgical environment. Surgeons want data or feedback now, and they want to.

Dr. Leeanne Aguilar 14:26

Yeah. Then how are you thinking about building AI safely, step by step, similar to levels of autonomy in vehicles?

SPEAKER_00 14:34

Exactly. So I think the first success in cars was navigation, right? So Waze and Google Maps and all those stuff. So it gives you guidance. You could do whatever you want to actually make sure that it's your responsibility to choose to turn right where Waze tells you to turn right. But it still helped. So that was step one. And now they're starting to be mobile eye and other cars, systems like that to give you feedback and guide you and make sure and tell you, hey, we think you might be wrong. We are not forcing you, we are not, we are just trying to give you data in a more active way, in a more accurate way. And that's starting to be you know level two, level three, and that's where we are in the surgical world. We track what the surgeon is doing, we are helping them with navigation, so we help them see the stuff that they cannot see in real time, right? And we tell them, hey, you might get in this off, maybe the reference are removed, maybe there's a problem. But we're not making decisions out, we're not taking this the surgeon out of the decision hoop. We're just floating data or pushing data that we think is important for the surgeon now, and that means that we help. It also means that we need to get better all the time and move from 90% to 99%, but because it's still decision support, it's not actual decisions, and if we get it wrong once in a while, the surgeons is just double checking us, so it's kind of building it up. We are not yet, not us, and not I think everybody else is in the level of enormous robotics for surgery. But I think people are going there, and we have done hundreds of surgeries already. So we have data sets from hundreds of surgeries, we have data of thousands of decisions that surgeons did in real time in Spark. And that's part of building the AI, part of building the data to make those decisions and automate them as deep. The same way that like the car, Tesla is having the data collected from thousands and thousands of people.

Dr. Leeanne Aguilar 16:40

Right, exactly. And the more data it has, the better decisions they'll be able to make ultimately. But right, it's first about collecting good information and then populating the AI so it has that to reference. Right. So Pathkeeper has FDA clearance and commercial partnerships in the US. What does the next phase of commercialization look like? Right.

SPEAKER_00 17:00

So we are working very closely with Higher Ridge Medical, which is one of the biggest plant companies in the United States. They have a great sales team and relationship and distribution teams all across the United States. They have spent about a year testing Pathkeeper, making sure that we are as a small new startup, is really up to their high standards. And now they're starting to basically share our system, our technology with their customers. And we know hospitals, capital equipment takes time, but they are doing a lot of great jobs, they are working hard, and we see a lot of interest. We are already starting discussion, negotiations, financial negotiations with more than 20 or even 30 hospitals already in the United States that are interesting to evaluate, test, and review pathkeepers. So the numbers are high, the numbers are impressive, and we are very optimistic that we can really bring change into the market in not a very long time.

Dr. Leeanne Aguilar 17:55

Very exciting. Yeah. So tell me more about how partnerships with major players like spine companies and GPOs help a startup build trust and scale.

SPEAKER_00 18:05

All right. I mean, the question is how you do it without it, right? It's very hard for a small company and without raising hundreds of millions to create a name for itself in the market. And so we we work with KOLs, we brought the system to surgeons all around the United States to test and verify our technology and help us improve. And we have surgeons from many hospitals that use the system, gave us feedback and help. So that's critical, and that's that's step one. And now we can go to those big guys, those more established units and hospital systems and implant companies, and tell them, look, if this is what we have, and they go and review it. And it's it's it's a reputation risk for them. You know, if they endorse Pathkeeper and Pathkeeper is not good enough, their customers will complain to them. They don't know me at the beginning. So when we go to a big conference and high rich put Pathkeeper in its booth and say, We endorse Pathkeeper, surgeons know. Surgeons, High Ridge is Zimmer Biomat, has many years of reputation. Surgeons know if they endorse Pathkeeper, that's a real company, that's a real technology. And I see that. I get people reaching out after you're working with high rich. It means something. Now I have some sort of this brand recognition coming from those groups, and credibility, and they're the gatekeeper for scalability. It's very hard to scale as a small company, and they can do it. Those big GPOs or health systems, the big input companies, they have their relationship, commercial acumen, the commercial power to sell. So that's the best way for a startup to grow. And that's where they I mean our expertise is design and building new technology.

Dr. Leeanne Aguilar 19:43

Yeah, so it's really developing those relationships and utilizing their networks, their supply chains, their relationships with other vendors and to get the word out and credibility building and uh access to their networks, is what I'm hearing. Exactly. Yeah. So where do you see Pathkeeper expanding beyond spine surgery in the future?

SPEAKER_00 20:05

Right. So the obvious expansion is within orthopedics and neurosurgery. And we see a lot of orthopedic surgeons asking us to go to knees. One of the big problems in knee surgery today is putting pins in the tibia and the femur. It's an extra clinical step that has clinical risk. Usually older people go to knee surgery, they have usually weaker bones. That's why they're going to knee surgery, and putting those pins might create infection and might even create a fracture in the bone. We can eliminate that. We can track the bone directly and eliminate it. There are a few other companies who are trying to do that, but we are the only company that has proven that it works in spine and has shown that it can do it in needs. We still don't have FDA for that, of course. We are now actually working, I still can't really talk about it. We are working with a few other companies to build like a next generation new robot, which I think would be very, very exciting and really create a synergistic value with the Spongebob. I think we've built an imaging technology for 3D scanning. Yeah, we we have built an AI layer that can take this 3D imaging, understand the anatomy, and give actionable feedback for surgery. We started with spine, we want to go to NIS, but it's not limited to that. I we it's easy for us. Anything that has bone in it, I can track, analyze, and guide. But I think we can do more on the spine. I think there's a way for Pathkeeper to take our cameras and our technology into basically every surgery. So if you ask me, my vision as a company is not to have more robotic systems, but to build the AI layer, you know, the understanding layer for surgical robotics. There's other robotics company that has sophisticated mechanics. Robots for surgery, what most of them lack, and what we are expert in, is bringing the sensing and the understanding, the perception layer for surgical robotics. That's where I would like Pathkeepers to be in the next five years. The standard of perception layer, AI perception layer for surgical robotics.

Dr. Leeanne Aguilar 22:22

Any type of not yeah, and not limited to one specific, right? Like you said, part of the body, but it has multiple applications potentially when it comes to surgery.

SPEAKER_00 22:32

Exactly.

Dr. Leeanne Aguilar 22:33

So what have been the biggest leadership challenges in moving from deep RD to commercialization?

SPEAKER_00 22:40

Sales. I've transitioned, you know, one of my mentors in the beginning told me that you think you're a CEO, you think you're a founder, you think you're an entrepreneur, you're a salesperson. Today that's that's your job. You're in sales. You have to sell your vision, you have to sell your company, you have to sell. So it's a different mindset. It's a really different mindset. You have to reach out to people actively, you have to accept hundreds of nodes for each yes. Uh you have to perfect your pitch and how you explain it, to know what to say to whom. So salesmanship is an art. I wish it was engineering, but it was art. And that's what I had to learn mostly to run a company.

Dr. Leeanne Aguilar 23:29

Yeah, and I think that's you know, across the board with any in any industry, the CEO is that salesperson that, you know, gets buy-in, needs to get buy-in from all of the stakeholders, right? So it's selling the vision, it's selling their vision, their mission, and getting everybody into alignment and then moving forward and getting customers to buy into that same vision. Yeah, exactly. So, what advice would you give to founders building complex medical technology in highly regulated environments? Right.

SPEAKER_00 23:59

I I think there is one thing that I did not know and I wish I known, and that's that there's like a death value after FDA. And I think that's critical. It's probably not true for any type of medical device. I know there are companies that are basically sold once they get FDA. But for all of you that don't expect the MA to happen once you get an FDA, and you should probably already know that's going to happen pre-FDA, then there is a transition between getting an FDA and getting revenues. And the transition takes time. It's not a three-month process. You go to the market, there's competition, there's change, it takes time. And you need to know that, you need to plan for that financially, and you need to prepare your investors for that. Understanding, I mean, people were okay, you got FDA yesterday, how many millions of dollars have you already sold? And it doesn't work like that. And I think this is something that I wish I've known, and I'm telling every entrepreneur that I meet. Remember this death valley. And I remember I was talking to this investment banker, and she was, yeah, yeah, of course, there's this. Everybody knows that there's a death valley for medical device company after FDA. And I said, Okay, I wish I knew that. I wish I've met you before. And um, so yeah, so some people know, but those younger entrepreneurs that thinks that FDA and investors as well that think that FDA is is everything. Well, it it is, but it isn't.

Dr. Leeanne Aguilar 25:30

It's just a transition into the next phase of business where you get to then commercialize and and push forward. But but like you said, getting ready to make that push and and market and get out there takes time, it doesn't happen overnight. And you've got to prepare for that, like you said.

SPEAKER_00 25:46

Transitions are hard. You can expect when you move from prototype to FDA, you expect it's gonna be painful. All the little things to get FDA will be painful. Right, you have to remember, as you said, every transition is hard. Moving from something that's like three guys doing and building some improvised thing to a company that tried to do a real moving from a working prototype to an FDA system, moving from an FDA system to a commercial-ready system, and next steps which I have not arrived yet. Each step has its transition and the pain of change, the pain of transition.

Dr. Leeanne Aguilar 26:24

Yeah, yeah, that's a good point, right? So, looking ahead, what excites you most about the future of AI, 3D imaging, and surgical navigation?

SPEAKER_00 26:32

Reducing surgical risks for everybody. That's that's what excites me, and that's where we want to be. We want to really change lives, reduce revision surgeries, reduce reducing surgical mistakes, allowing surgeons to be, you know, at the top of their performance every time they go to surgery and make it accessible for everybody any vacation, accessible for everybody.

Dr. Leeanne Aguilar 26:56

Well, very exciting indeed. So, Aries, thank you for joining. Uh, how can listeners learn more about you and Pathkeeper Surgical?

SPEAKER_00 27:04

So please go into our website. There's more information there, and happy if you reach out to me over LinkedIn or through our email, happy to talk and please do.

Dr. Leeanne Aguilar 27:13

Great. Thank you again. And thank you to our listeners for tuning in to Industry Ignited. Be sure to subscribe and join us for the next episode. Until next time, stay bold, stay curious, and keep igniting industry.