MagForce USA | Ben Lipps, CEO

(Transcription)

Ben Lipps  0:00  

Thank you, it's a pleasure being here with you. I'll see if I can. Okay, it works. I'll talk a little bit about what we're doing in the US and Europe. Our technology is nano therapy, what we have is basically iron oxide coated particles. It's that state dispersed in water as we shipped them. But once they're injected into human tissue, the surface changes and they basically conjugate and form an implant. And it took us a couple years to convince the FDA that this is not a drug. This is an implant, but they're well on that. And of course, the other technology that was developed back in the late early 2000s, was the modified MRI machine where you have the field strength is basically alternated about 50,000 times a second. And so these little particles heat up. And this technology can be used, as I mentioned when we talked last year as monotherapy for ablation, or it can enhance radiation and chemotherapy, which we do in Europe versus the prostate in the US. Now, right now, we've divided our efforts in terms of Europe, we have the CE mark, and we're basically focusing on treating glioma brain tumors. And in the US, I decided back in 2015, that we would focus on basically focal therapy for prostate cancer here in the US. Now, we've modified our procedure over the last couple of years in Europe. And what we have now is a procedure that really works quite well. We allow the neurosurgeon to essentially most of the time, they're about 20 CC's. So you have to have a resection, and then the neurosurgeon what before he puts a gauze around the outside surface of the resection cavity, they basically pour our nanoparticles onto the gauze, they adhere to the gauze, and then that's implanted around the outside of the of the cavity. And we then heat to 42 to 45 degrees, it enhances radiation. And it also enhances chemotherapy will show now we have done a couple patients where they could not get more radiation. So we took it to 50 degrees. And of course, in a place like we know from the prostate cancer, we've had very good results, with this. We've been slowed down a little bit from the pandemic and all the issues in Europe. But we ended up having a significantly improved overall survival. When we combine this with chemotherapy versus chemotherapy alone, we will be bringing this to the US in 2023. There's a number of patients in the US that can benefit from this that fact the US there's about 17,000 patients with glial that are diagnosed each year. So that's part of what we're doing now to prostate cancer. Our target here is to basically once prostate cancer is identified either with an MRI or with a basically a PSA elevation. They do a biopsy, and they confirm that it's a basically, it's a intermediate risk prostate cancer. So what we're doing is treating about four cc's of volume in the prostate, and stage one, we solved all the problems that we have to in terms of how do we get the material to stay in the injected area, we had to thicken it up so it doesn't flow out. But now we're into stage two, and stage 2A where we essentially showed the FDA that we could very accurately place this, these particles in the designated CTV clinical target volume. And we did biopsies to show that we totally ablated within that area. And interestingly, because of the perfusion in the in the human biopsy, we'd had no damage more than one or two millimeters outside the the basically the deposit. So that was better than we've seen with our other dog work, or other types of studies that we basically had total ablation, we essentially had no side effects because you're dealing only from the inside out and you're only dealing with a temperatures, what we found is we could ablate in 45 minutes at 46 degrees, or if we are targeted 46 to 50. We of course monitor the temperature during the time so we know exactly what the temperature the temperature is. So if we get to 50 degrees, it only takes about 12 minutes to basically bleed the cancer. So we essentially have something now that we convince the FDA that we don't need to go above 46 to 50 degrees and that's our target. And obviously it's that area and with all the heating from the inside. We had no no side effects. In fact, our patients laid out for dinner with their wives afterwards and then went home. Now we see this as a bridge between active surveillance and definitive therapy, such as surgery, we did get the approval to move forward to the final clinical protocol in November. And basically, it was very important to us that it took us a while to deal this with the FDA on this because we wanted to make sure whatever we're doing for the final stage of the clinical trial is exactly equal to what we're going to do commercially, we have been able to receive an AMA approval for our category code. So we'll be filing for, basically for a category three code, CPT code. And we this, this approval allows us now to to also go for Medicare coverage for the rest of the study. So we're expecting to get most of these done here 2022. And as far as the procedure and what we've done, what we've decided, basically last year, and the year before, we decided to have our own clinic, just like I did in dialysis where the patients come in, they're treated, but it's our staff that does the treating. So we have our own clinic now three of them. And we basically use some of the technology that came on the market in 2018. For a reverse biopsy, we have a CT machine, a portable machine in these clinics, so that we can at the during the installation, we can make sure we know the concentration is sufficient for ablation at 45 to 46 to 50 degrees. And we basically know that we've covered the clinical target volume, the CTV, so we look at that with it with a with a CT scan. And basically, when we meet those criteria, then one hour later, we basically treat the patient in our activator, we decided to stay with the large activator, it's expensive, but it allows us to treat any part of the body and and we'll use this for treating glial also with our new procedure, dental pacer procedure. So this is a very, very useful type of facility. They're owned by ag force us owns it. And it's our staff that's doing the work. And basically what we've seen is we'll have enough of these, we have three now, two more out in in 2022, early 23. But the patient comes there and basically comes in the night before and they're treated the next day and they can go home or they can stay one more day. But it's easier for us and of course they go back to the urologist so the patients are not being taken away from from their urologists, they're being basically saved a large number of side effects, the markets very large as, as you could expect, basically, in the US. And so we're very pleased this is we've basically got everything pretty much together. Now technically, we're working on the reimbursement. And we'll be on the market and 23 2023 and thank you very much. This is data on MagForce AG, which is the owner of MagForce US about 65%. I own about 20 and the rest of us investors and I'm CEO of that company also which is doing the the work in glial and I think I made by nine minutes. Okay, thank you very much.