Manfred Franke, Neuronoff - Studio Interview | LSI USA '24

Manfred Franke  0:00  
Hi. My name is Manfred Frank. I'm the CEO of Neuronoff. We are a small medical device company working on chronic pain. So chronic pain is a condition that affects about 51 million adult individuals in the US. So it's obviously a global problem, but we're focusing with our device, initially, in the US for FDA approval, there is highly debilitating chronic pain that affects 20 million individuals in the US who cannot work or live a normal life without getting a treatment. We work on a solution for chronic pain that's a small injectable device instead of a drug. We basically looked at what exists in the clinic today. That's a drug based pathway like a steroid injection or lidocaine injection to treat pain, we replace this with a device injection. Basically, we inject the small lead with electrodes on it that allows us to apply what's called neurostimulation to then treat that pain. Neuromodulation has been shown in the past and is a well established approach in the industry to treat even those patients that are refractory to all other treatments, but neuromodulation is coming in through surgery, and because of that, it's very, very expensive. And our idea was, okay, can we inject our device through a small needle and replace surgery with an injection, save the clinic, the clinician some time and in the process, save the insurance company money. We just reached clinical stage with first human trial, and so far, results look fabulous. So the standard of care today in the clinic is that a patient is referred to a pain physician from their primary care provider. That's usually when the primary care provider doesn't have an idea how to treat the chronic pain, then the then the pain physician will start with an assessment what is causing the chronic pain? They might do a diagnostic block, lidocaine injection, type of injection, and verify that they can find out what causes the pain. After that, they might go for a steroid injection. Then they might choose to refer to a chiropractor. They might choose to refer to physiotherapy. After that, a typical next step is radio frequency ablation that uses a small needle and ablates the nerve, and after that, a typical next step is surgery. So you basically see that from non invasive just an over the over the counter drug to invasive by a needle injection, the invasiveness gets bigger and bigger, the cost increases with that as well, the side effects become larger, and obviously there's always the pathway that you can take an opioid on top of that. But since we're actually trying to get out of the opioid epidemic, the only way to do that is to eliminate opioid based pathways. Once that all other options are exhausted, usually you go to higher expense, more expensive steps such as neuromodulation, those are treatments that usually cost somewhere in the range of 30 to $40,000 one more element you need to include in that, that's ER visits, because the pain might get so bad, the patient actually has to go to the ER conventional medical management CMM usually calculates a typical chronic pain patient at about $8,000 per year. So if your treatment that you provide can be falling below that level and save on other expenses, you're in business, and that's where we come in. We looked at conventional treatment such as a steroid injection, where a clinician has the patient on the table visualized via fluoroscopy or ultrasound, where they want to place a needle, they use, usually, fluoroscopy guidance to bring the needle right to the spot of interest, inject, for example, through an 18 gage needle drug and then send the patient home. We took that as an inspiration, and we inject a small wire that has exposed parts on it so that they become electrodes, so it's in the field. We call that a lead. We inject only the lead. We do not inject the electronics. We keep the electronics on the outside as a result of it, with that lead being fully injected in the body, you don't need surgery. You don't even need a big needle diameter. We're talking needle diameter this size about a 20th of an inch. When the device is being injected, it comes straight out of the needle, hits tissue, folds up on itself. Because it folds up on itself, it now requires more volume in that location. So we call that bunching up of wire. That bunch the wire becomes an anchor. That's important, because when you pull the needle back, that anchor stays right on the nerve. You put another anchor in the middle, on the way from the nerve to the skin, and you put a second, a third, anchor right underneath the skin, so now you have outside, nothing below the skin, and anchor lead wire and anchor in the middle, anchor down on the nerve. This kind of setup allows the patient to move, stretch, bend, without the device moving inside the patient. We're actually fixing one of the biggest problems that other companies have a neuromodulation that these leads are pistoning inside a location between the nerve and wherever they are connected to. The other aspect of having an external stimulator right on the outside of the skin is that you can more easily adjust the technology if you have to. You can update it over the air, if you can push an update to your phone or. To your car. Why is neuromodulation stuck in the 1970s but very few companies actually thinking about a better lead technology that can integrate and stimulate peripheral nerves without pistoning around. So our our focus as a small company is, how do we fix the biggest problem, and that is lead migration for these big companies. So we become interesting as a tuck in solution for them for the future, usually it takes about five to 10 minutes to train the clinician how to place it, because it's very similar to how they place a steroid injection, and then they walk away happy, but they come back really happy with usually two or three friends and start training them on how to do the device placement with our device. It's amazing to me to see that a clinician who we might have met an hour ago comes back with their buddies and starts showing them how to place our device on a specific angle to treat a specific area of pain that they interested in. I've seen that very often because the placement itself takes about a minute or two. One more interesting aspect is that the injector is so easy and fast to place under fluoroscopy or ultrasound visualization that you can really make this a 15 minute visit, handshake to handshake, meaning patient comes in, handshake. How are you doing? Oh, we should potentially put this device on your knee, on the shoulder or lower back. Why don't you lie down on the table? I'll have somebody prep you, and I'll come back. In the meantime, the patient is being prepped on the table, ready to go. A clinician walks into the Ambulatory Surgical Center or visualizes where to where to place the device under fluoro, places the needle, places the device, puts a stereo strip on top. Patient gets off the table and can go home. And so we just are in the process of finishing up our first human clinical trial. Right now. There is other clinical work for reimbursement purposes that's in preparation at this point. The goal is to be able to have the data to then show to CMS, Medicare, Medicaid, to show to private insurers the ad nauseam, glucose, etc, that this will actually save the money. So for that, you need to have different kind of clinical trial designs that allow the insurance company to then say, okay, we believe that your therapy is not just more cost efficient than other therapies, but is equally efficacious in helping the patient and reducing our financial load versus other steps that we would have to take. We're scaling production, and we're looking into European expansion. So we're in conversation with Fraunhofer Institute, which is a notified body in Europe for MDR approval. Once we're FDE approved, let's look beyond us. We have mdsab so that we can go to Canada and or other nations that are part of the MDS app Consortium. But obviously Europe is a big player there as well. So we want to make sure that not just IP wise and manufacturing wise were set up to do this under ISO 1345, and manufacturing in Cleveland, UI and us, for us and outside US sales, but also get the approval in these nations. I.