Gregory Fischer, AiM Medical Robotics - Portable MRI Compatible Surgical Robot | LSI USA '24

Greg Fischer  0:03  
Well thank you very much. I'm Greg Fisher, founder and CEO of a medical robotics. We're bringing to market a compact, MRI compatible surgical robot that allows real time MRI to be used during stereotactic neurosurgery procedures. This overcomes the significant challenges related to inaccuracies and inefficiencies in current procedures, including neurostimulation implants like DBS for Parkinson's, targeted gene therapy, cell therapy and other pharmaceutical injections as well as ablations for tumors. And the idea here is that we can use real time imaging to guarantee that you can compensate for motion that can and does happen during surgical procedures so that you can hit the first target the first time, every time and guarantee that you hit that target. This can be done while also reducing the time and the cost for the procedures. And this is based on 15 years and about $15 million dollars of NIH funded research that's been transitioned into the company through a tech transfer agreements. So what's the problem? Many neurosurgery procedures are based on needle like instruments that we're trying to place into the brain. This can again be used for ablation applications, this can be used for putting neuro stimulators in there anywhere that we want to put these instruments into the brain. But what happens is these procedures actually are based on the fact that are typically based on the fact that nothing moves relative to the skull, the procedures haven't changed much since the stereotactic frames that are attached to the head that you're used to from the 50s through today, and even the most complex new surgical robots still have the same fundamental problem, that they're based on accuracy relative to the skull, rather than based on target tissue anatomy inside the brain. So as patients move, different patient orientations, registration errors, CSF loss, error, getting into the brain swelling, all of these cause these anatomical targets within your brain to move. And that can be the meaning between a successful and unsuccessful surgical procedure.

So Amy, is looking to neuro Earth and revolutionized neurosurgery by enabling real time imaging, soft tissue imaging during surgical procedures to guarantee that you actually perform this procedure, the way you intend to perform that procedure, while at the same time reducing the time it takes to do these procedures, reducing the cost to do these procedures, and reducing the error rates. And one of the issues you'll notice is up to 34% of DBS replacements for Parkinson's actually had to be removed or revised about half of those due to miss placements. And because of that only about 15% of patients these days that are actually really good eligible patients do this due to patient hesitancy. So there's a huge opportunity not only for new applications and new growth, but to actually capture this portion of the population that really need these procedures would benefit from these procedures, but are reluctant to do it due to the challenges. So we're combining real time streamlined workflow of the MRI with a robot where we can adapt that procedure as the procedure is going on. What's out there today? Well, there's robots. But these robots don't operate within the MRI. So these robots really show that you can get increased accuracy, you can get increased precision. But again, they have the same fundamental limitation that they're based on cranial anatomy. And using something like a CT doesn't compensate for this error. So stereotactic error, which is often reported for most traditional robots, and reported by most surgeons for these placements, really misrepresents the accuracy of these, those targets aren't in that spot anymore. And then there are systems out there, like the Clearpoint, that I'm showing here, that in my mind really paved the way for putting MRI guided procedures into the mainstream, right, there is a clinical need, there is a demand for it. But I think there's a huge opportunity to build upon this and take the advantages of robotics, coupled with the advantages of MRI. And by doing this, we can make procedures that can be much faster, much less expensive, and also can scale well to multiple targets. So if you're doing deep brain stimulation for Parkinson's, often they're bilateral two procedures. I was recently at demands conference, and now they're scaling up to potentially, you know, for leads, in some cases to hit multiple targets. And sometimes we're also adding additional leads for sensing. So now you're looking at six leads, if you look at something like targeted drug delivery, that can be six, eight, sometimes 10 targeted injections. So having a robot that can scale and very effectively do these procedures fast is very, very important. We put together an all star team, my co founder is Dr. Julie politis, who has been the president of the Nan society. She's put together an all star team of clinical advisors, as well as a really strong team of business advisors that have allowed us to really push this forward and be very, very capital efficient, but get our system to the point that we are able to demonstrate this. We actually had life cadaver studies about a week and a half ago where we did a live demo fully demonstrated this procedure. Working this to us what do we mean by stereotactic neurosurgery interventions? Right so we can use this for brain tumor biopsies. We can do this for thermal ablation, which was actually the focus of about $7 million that we had NIH funding for with Dr. Julie Politis. We can do intra tumor injections, which in my mind, this idea of targeted drug delivery is really gonna be the killer. After this robot as the pharmaceutical companies are dumping a billions of dollars into, you know, how can we do gene therapies, cell therapy, viral oncolytics, target inter tumor injections, all of these needs to be put in exactly the right spot. And that's really where the market is gonna go. But in the short term, or immediate market is functional neurosurgery. And this is putting Deep Brain Stimulation leads in and doing this very precisely so we can have guaranteed outcomes. And one you do it right until you don't leave the operating room until you're sure you've done it right. So what do we mean by DBS? Right? DBS is effectively brain pacemakers. There's three main companies on the market, all these companies have doubled down on their tech development, I'll have new features on this. They all see enormous potential for growth. There's five FDA approved indications so far Parkinson's is the most common these days. But epilepsy, severe OCD, those numbers, dwarf Parkinson's, and those are growing tremendously. And there's a whole host of other applications on the horizon. Some are already in clinical trials, some even an off label regular use. Where else can we do this, so we're going to neurostimulation focal ablation is really key. So we can do interstitial ablation. One of the advantages to doing interstitial ablation through a needle based instrument is we can also do concurrent biopsy, which is really critical for planning adjunct therapies, we can do stereo EEG placement, which is becoming standard of care. And this is an area again, where robots are incredibly beneficial, because now we can be doing all of these different targets at one time with a drug delivery. And then a research platform to the last thing you want to do is to do a drug delivery study and add the variable of aid, we maybe didn't even get it in the right spot in the first place. So it's really important to be using this and there's a huge population, and this is only going to grow. And as I said, if we can overcome the patient hesitancy which I think having faster asleep procedures, and MRI with guaranteed outcomes is really going to overcome a lot of that patient hesitancy, these numbers can grow substantially. So where are we at? As I said, we've had a substantial amount of NIH funded research that's been leveraged into the company. We're currently in our cadaver trials. We're currently in Iraq cadaver stars, we just started a new tranche of these, we're looking to do them over the next few months in a regular cadence with our clinical advisors. We're currently raising our Series A round to put us into a first inhuman trial over at the Brigham and Women's Hospital, we're looking to do that this summer. Beyond that, we're looking to going to be raising a much larger round toward the end of this year through the commercialization efforts to build up manufacturing vnv FDA approval, and we're anticipating an initial launch of the product towards the end of next year. Who's Who's interested in this, right, so we look at this, there's the imaging companies. And we've actually spoken with a number of these imaging companies, one is really important for having a very streamlined workflow. In order for this to be successful, we need to have tight integration with the imaging systems. On the surgical navigation side, ultimately, we're building surgical navigation platforms where we need to have certain 3d modeling, we need to bring in real time imaging, we need to guarantee that we can actually control the robot while visualizing this tissue. And then there's the delivery companies, right. So if we look at the delivery companies, there's neuro stimulators, there's several companies doing that we have tumor ablation, and then I just listed a few examples on the gene therapy, Cell Therapy side of things. All of these are companies that will be interested in what we're doing for either licensing deals or ultimately acquisition as well as sales channel partners. And I'm not just throwing up names, the large majority of these we've spoken with some of them, we're actually actively in partnerships with these days. We have a revenue model that can come in from Capitol sales of the robot through annual service as well as consumables. So while we can still come in substantially less expensive than the other competitors on the market, there's still substantial potential for revenue. And the big value proposition to the hospital is that if we can take this all day a procedure for let's say, using micro electrode recording for DBS replacements, it takes six plus hours, drop it to a two or three hour procedure that can be done in the MRI scanner. Now, you can do two to three procedures a day. So it's not a new reimbursement code, but we can increase throughput substantially, as well as having much much better outcomes. And one thing I want to point out is, you know, while we're in robotics, we're not competing with all these soft tissue robots, that there's a huge number of folks on the market, this was not a crowded space, there's no clear market leader and there's a huge opportunity. So it's real, we've done cadaver studies, this is an example in the operating room on the right, because as we, as we said, this can work in the MRI, but also in the operating room, it's really important because we can have this flexibility and allow this system to be used in every space. So we can use this robot in the operating room, we can use it in the MRI and in the MRI, we also get the added benefit of real time imaging. We've had a previous Sidra, and we've raised about one and a half million dollars in convertible notes tours are a round, we're looking to close out our Series A in the next couple of months. We have substantial amount of IP around this technology both around the neurosurgery robot as well as much more broadly around MRI guided intervention. So ultimately, we really see this as a platform play all over the body. And as I said, there's a huge number of applications that where we can use this well beyond deep brain stimulation. So thank you very much. I really appreciate everybody and the one thing I just want to leave as a final point is one robot it can be used in multiple different modalities. There's a lot of companies that will be interested in this both for partnering with us for distribution as well as for ultimately acquisition down the road. There's a substantial market even just for Parkinson's disease alone, let alone all of these other key applications. And we're currently doing our series a fundraiser and ultimately followed by a much larger round toward the end of the year. So thank you very much. I appreciate