Per Langoe, GT Medical Technologies - Surgically Targeted Radiation Therapy (STaRT) | LSI USA '24

Per Langoe  0:04  
Hi Per Langoe, I was appointed to CEO for GT medical technologies about two weeks ago. So I'm fairly new, so please bear with me. I'm still learning the ins and outs of the company. Before I joined the GT team, I was the co founder and chief executive officer of pallet life sciences, and we sold palette last year to Teleflex for a bit of a bit north of 600 million US dollars. And I wasn't really planning on embarking on a new adventure this quickly, but the GT boarded it out to me at the end of the year, and I just fell in love with this opportunity. It's a mission driven company with a great passion to improve patients quality of life, patients with brain tumors, and it's just a great commercial opportunity. So I couldn't really resist this challenge. So we have been commercial for quite a while. We generate about $20 million in us revenue. This is a big unmet medical need. Statistically, no one in this room will ever develop a brain tumor. It's less than 1% chance to develop a brain tumor at any point in your life. But still, there are more than 300,000 cases in the United States each year, and about 40,000 of them, they will require surgical resection of the tumor, because the tumor is growing so quickly and is so big that radiation alone will just not do the trick. Fairly sizable market. I will speak about it a bit later in the presentation. We have a growing body of clinical evidence. There are more than 30 peer reviewed publications on gamma tiles. And we have solid key opinions, key opinion leader support. You will see utilization of our product at MD Anderson, Slovak, Kettering, Vanderbilt and Miami Cancer Institute and the list Jesko, on and on and on. So we are growing from a commercial presence point of view, decent reimbursement. Most patients with private insurance will generate a profit for the hospital or for the private practitioner. We're going to work to improve that. But it's not not bad at this point in time, at the end of last year, we acquired certain manufacturing assets from Ice Array, so we're going to integrate our supply chain going forward, and in a couple of years time, you will see a fully integrated medical device company. So standard of care for brain tumors hasn't really evolved at all for the last 20 years, and there is a significant issue that leads to a high rate of recurrence for these tumors. And the issue is that with the bigger tumors that needs to be resected, the patient needs to rest for about two to four weeks before you can radiate the tumor bed. And the reason for that is that the skull and the skin needs to heal before you can initiate radiation. And what happens during that period of time is that in many cases, the tumor will start to grow back. Some cases, you will see almost half a tumor in the cavity when you start radiation. In other cases, you will see a cell lining of tumor cells, but there is always going to be some level of regrowth of the tumor, and that's a big medical medical issue. So what about if you could radiate this tumor bed already from the beginning? And there's a way to actually achieve that, and that is called gamma tile. So gamma tile is a collagen based tile. In the tile, there are four radioactive sources. Those radioactive sources, they will provide treatment for about up to 10 weeks, and they are placed there at the time of surgical removal of the tumor. And that means that radiation will start even before the patient have been sutured up, and that will result in improved quality of life long term, and you will see fewer recurrences of tumor in these patients. This tile does not only provide radiation, it also provides spacing exactly like space or burial wood for prostate cancer, you see the three millimeter difference in the tile that is in the center of the image that will actually provide spacing to the healthy brain tissue. So that distance will minimize the amount of radiation that will reach into the brain, so the issue of necrosis is actually minimized. So if you look at the bottom part of this image, this is the issue with traditional radiation therapy that on the right, with IMRT, the radiation will penetrate the brain, it will do its job in the tumor, and then will exit and it will create necrosis around the tumor. With gamma tile, you get the exact amount of radiation you need, about six degree with very little disbursement to the to the rest of the brain, just enough to kill any tumor cells that would be on the on the lining of the tumor bed. So we have a fairly decent set of clinical data. In the upper right corner, you see some of the work done by Peter Nikai a few years back. So this was in reoccurring Mets, and you see the patients that were treated with gamma tiles at the time of resection of the tumor. After two years, more than 80% of the patients had not relapsed into Tumor Disease. Well, if you compare it to standard of care, around 20% of patients, they had not relapsed, which means that the vast majority they they would have the brain cancer back again. And we see more and more of this clinical data coming out. Pretty convincing, very consistent data. The bottom part of the slide talks about glioblastoma, so that's the most serious form of brain tumors. It kind of spreads into the brain little fingers, and it's very hard to manage still with gamma tile at 16, you have 16.7 months of disease free months post surgery, while the corresponding number for traditional treatment is only 10 months and six months might not seem that much, but for these patients, it's going to be a tremendous difference. Could be the time that you need to spend with your daughter for graduation or any important family event. So I think that's very clinically meaningful. There are a couple of important studies going on. We have Rhodes and Gestalt. The Rhodes study, it's radiation, one and done, and it's basically patients with newly diagnosed metastatic cancers. It's led by MD Anderson, comparing it to standard of care. We are halfway through enrollment, a bit north of halfway through enrollment, and it's going to be fully enrolled. This slide says beginning of next year, but we are actually shooting for full enrollment this year. The second child Gestalt is a single arm study, and it combines, actually standard of care with gamma tile. So patients first receive gamma tile, then chemotherapy, and then we put them on regular radiation therapy. So we kind of cherry picks and gives them the best of both worlds. And the early results in these trials is actually really promising. Patients are almost doing too good for us. There's also a third study going on at Sloan Kettering, they look at recurrent metastasis, where they compare us with salvage, regular therapy. And that study is also going well. We're going to add a couple of sites that to that trial. Henry Ford is going to join them mid year, and we will probably have that study for their role as well by q4 so we have about 100 users in the United States today. You will see most of the prestigious institutions utilizing our technology and product. Some of them have recently onboarded. Some of them have been with us from the beginning. So far, we have treated about 1300 patients since we're trending to be north of probably 2000 patients at the beginning of 2025 from a funding point of view, our first founders were medtech venture partners from California. They were joined by MBM capital and Kyle Dempsey in 2020, and in 2023 Gilda led our last round, which was a bit more significant, 45 million US dollars. We're going to raise money this year. We're probably going to raise around 50 million US dollars. It's going to help us to get to a cash flow positive position, and it's also going to help us to integrate the supply chain and wrap up our clinical work. So just to summarize, significant unmet medical need when it comes to larger brain tumors, there is literally no other option other than gamma tile that can provide local tumor control. Growing body of clinical evidence, a lot of key key opinion leaders support reimbursement is is unusually good for a device at the stage where we are at, and in a couple of years time, we will see a fully integrated medical device company treating these tumors with significantly more revenue than today. So thank you so much for your time, and if you're interested in partnering up with us, Brian Martin and I are here for today and tomorrow, and more than welcome to entertain any any discussions in that front you.