00:00And it is my pleasure to welcome in the CEO and Chairman of Microbot Medical, it's Harel Gadot.
00:10Great to be with you today.
00:11Thank you, Dan.
00:12It's great to be here as well.
00:14Very excited to be here, especially after the exciting news this morning that we have
00:18submitted to the FDA for commercialization of the Liberty Endovascular Surgical System.
00:23Yeah, very, very big news.
00:24We'll get into all of that.
00:25I just wanted you to give an overview of Microbot for those people out there that might not
00:29be familiar.
00:30Sure.
00:31It's my pleasure.
00:33If we look into where we're playing, we're playing into the robotic surgery in general
00:38and specifically in the endovascular space within the healthcare.
00:43If we look in general into robotic surgery, it is one of the fastest growing trends in
00:48healthcare.
00:49For example, if you look at the penetration rate of robotic surgery in general surgery,
00:54it went from about 1.8% in 2012 to more than 17% currently with a CAGR of 15%.
01:03This is in a market that includes elective surgeries such as hernia repair.
01:08When you consider the endovascular space, it accounts for more than 6 million endovascular
01:13procedures which reform annually in the US alone.
01:18Most of them are life-saving treatments, which include cancer, for example, stroke, and vascular
01:24blockage.
01:25Moreover, some of these procedures are time-sensitive.
01:28There is a phrase in the medical community saying, time is brain, which refers to the
01:32very narrow window of opportunity that a patient suffering from stroke, for example, has until
01:38he or she gets treated before suffering an unreversible brain damage.
01:43This procedure was historically done surgically.
01:46Think about, for example, when your fix is clogged.
01:50In the past, you'll break the wall in order to fix the sink, where today, you can go through
01:56the pipes to get to the sink and unclog it.
01:59Just instead of the snake your plumber uses, physicians use delicate tools called guidewires
02:04and microcatheters to build a railroad from outside the body to treat the site inside
02:11the body.
02:12This market also has clear unmet needs.
02:15That's where we're coming in and really changing the game.
02:21Those unmet needs include radiation exposure, physical strain on the operators, shortage
02:25of skilled providers, and accessibility to local medical centers.
02:29Think about the stroke person that now needs to travel 60, 100 miles, where time is brain.
02:36We believe that many of these challenges can be solved by robotic technologies, yet there
02:40are no robotic solutions in the endovascular space in the US.
02:47Therefore, we believe that introducing the right robotic technology to endovascular procedures
02:53can address many of those unmet needs and add value, such as improving efficiencies,
02:58reducing risk of radiation exposure for both the physician and the staff, and increase
03:03access to quality health care for all patients.
03:06Now, it really is incredible, and you mentioned the jump over the number of how many more
03:09people are getting that kind of surgery.
03:11It's unbelievable, and I know that that's obviously very exciting for what you guys
03:14are doing.
03:15But talk about that Liberty system, as you mentioned.
03:17What makes it so unique?
03:20So as they say, a picture worth 1,000 words, right?
03:23So this is Liberty.
03:25That's it.
03:26It's a robotic system that fits in the palm of my hand, but Liberty is much more than
03:32just a small robotic system.
03:35It is the world's first fully disposable robotic system.
03:38By comparison, if we look at it, conventional robotic system that are pretty much, I can
03:43describe them as an F-150 truck.
03:46If you go into the OR, that's what you will see there, right?
03:49They require a large capital equipment system that usually costs somewhere between $1 to
03:55$2 million.
03:56This is upfront, just to buy the robot.
03:58This is before you even tried it and see that it adds value to your specific patient population.
04:06Then on top of the capital expense, many of those robotic system will require additional
04:11investment in customized infrastructure.
04:14It's always amazing me when I walk into the OR and I see this robotic system, but then
04:18I see all the walls that were moved around, all the IT infrastructure.
04:23It probably costs you the same for the infrastructure as buying the robot.
04:28On top of that, you have to buy procedural kits, service, and maintenance.
04:34With Liberty, the hospital avoids all of these major costs, which we expect will significantly
04:41reduce the cell cycle, allow more medical centers to adapt robotic in their endovascular
04:46practice, and in return, enable access to improved care for more patients.
04:51In addition, Liberty allows physician to steer those guide wires and catheters.
04:56If you remember, the snake, the plumber are using.
04:59Those very delicate guide wires and catheters now can be used by a remote control, which
05:07enables precise control of the guide wires and catheters, which are required in almost
05:13every endovascular procedure while operating at a safer distance away from the X-ray radiation
05:18source and improve ergonomics for the physicians.
05:21It is amazing to see how many physicians cannot operate because they have a herniated disc,
05:27for example.
05:28I would say it really does give you Liberty in the greatest sense.
05:32Raul, I wanted to ask you, why is medical robotics and specifically the endovascular
05:37segment an attractive market right now?
05:42We see all the big players playing in the space of robotics, J&J, Medtronic, Stryker,
05:47and the list goes on and on.
05:48First of all, it is exciting to see that almost every strategic recognizes robotics as part
05:54of their current and future offering.
05:56In a way, it is a kosher stamp of the directions the market is taking when it comes to robotics.
06:02However, we really need to consider that the large strategics lack the core capabilities
06:08to innovate in robotics.
06:10They were not structured from the beginning as a robotic company.
06:14If you look historically, you look at Medtronic buying Mazor, you look at Stryker buying Meco,
06:21and the main reason is to get into the robotic space by acquiring the core capabilities,
06:28not just the technology.
06:31That's what they do to get the capabilities, expand their portfolio.
06:34We believe that with our first mover advantage into the peripheral space in the endovascular
06:39space, which is right now, it's a completely blue ocean.
06:43There are no players playing in that space, so it's pretty much ripe to pick up by somebody.
06:49We will establish the required core capabilities and the market presence, and strategically,
06:54as we move forward in the future, expand into the other indications, such as the neuro and
07:00cardiac endovascular procedures.
07:02Yeah, listen, you mentioned some of those large companies like Johnson & Johnson, Medtronic,
07:07GE, Stryker, looking to enter the surgical robotics market.
07:10How do you see Microbot truly fitting in there?
07:15Our objective is to own the space that right now, as I mentioned, it's completely blue
07:19ocean.
07:21By doing this, we're not only going to change the endovascular space.
07:26Think about the business model that we're changing.
07:29If today, people are saying, my model is the razor and razor blade, we're actually only
07:34selling the blades.
07:35We don't have the barrier of adoption that now you go and spend money on the razor itself.
07:44Also, as we move forward, and we look into the process in the hospital, how do we fit
07:50in?
07:51Our objective is to start with a peripheral intervention in endovascular, own that space,
07:56and as we move into the following years, move into the cardiac and into the neuro.
08:02This is a really exciting time for the company, as we are transitioning right now from a clinical
08:06and regulatory-focused company into a commercial-focused company.
08:11With the news that we issued today about the submission of the 510K for the future
08:15commercialization of the Liberty system, for me personally, it's very exciting to see an
08:20idea that we brought from just inception all the way to the potential to treat more patients
08:27in the future.
08:28A couple of months ago, we successfully completed our pivotal human clinical trial, which coupled
08:35with other tests and studies allowed us to file the 510K.
08:39We will work closely with the FDA.
08:41Usually a 510K process takes somewhere between four to six months.
08:45We expect to launch Liberty post the FDA clearance, which we expect in Q2 2025.
08:53We also anticipate sharing the data from our pivotal human clinical trial in one or two
08:58of the major conferences in 2025, such as SIR, Society of Interventional Radiology,
09:05or Society of Interventional Oncology.
09:08In parallel, we are currently establishing our commercial team to prepare for the launch
09:13with the aim to launch in the U.S. immediately the FDA clearance.
09:18We are also working with what they call the MDR in Europe.
09:22We already received our ISO approval or clearance.
09:27Moving with the MDR process, we expect to also get the CMR approval going into 2026.
09:33As you mentioned, very exciting times for Microbot Medical right now.
09:38You mentioned a bunch of things that are going to be planned for the next several months
09:42when you kind of spin things forward.
09:44What's kind of the feeling of the future that you want to see for Microbot Medical?
09:49So first thing first is being successful with the submission to the FDA.
09:53Obviously, we announced the successful completion of the clinical study, which gave us a lot
09:58of comfort that we're providing something which is safe and going to benefit many patients
10:03moving forward.
10:04Next thing I would like to see is really the adoption of the market, showing the value
10:10added we bring to the table, not only for the physicians, the technologists, but to
10:17every stakeholder.
10:18And that's going to be a success.
10:19If we can really allow access to patients that right now, I live in Boston.
10:26Before that, I lived in New York City.
10:28So God forbid something happened to me, I have five minutes drive to get to the best
10:32health care I can get in the world.
10:34But what happened if I'm traveling to mid-America, people saying South America, Far East, I'm
10:40just saying even middle America, you get a stroke, you have a very window of opportunity
10:44to get treated.
10:45You have cancer, you don't want to drive 100 miles every time to get treated.
10:50Think about it.
10:51If we can really change the landscape and have accessibility to a technology that improve
10:57care, that's what excites us.
11:00That's where we see us moving in those steps of the clearance, getting adoption in the
11:04market and eventually changing the way robotic systems in general are being adopted in the
11:12market.
11:13You're getting me really excited as well.
11:14And it looks like the future very bright for you, of course, at Microbot Medical.
11:18It was an absolute pleasure talking with you today, Aurel.
11:20Thank you so much for your time.
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