James Lancaster Presents Solenic Medical at LSI USA '23

Transcription

Well howdy, I'm from Texas. So you got to put up with this for a minute. How many of you are NFL football fans? Okay, you know the name Alex Smith. He is no longer an NFL player because he broke his leg on a football field. And unfortunately, in the trauma surgery afterwards, he got an implant infection. I'm here to talk about technology that will keep you moving. Real briefly, I'm going to talk about second and third person here who are the inventors of the technology and this literally came from the second person, Dave, who has constant referrals of infection problems, variety of kinds. And after they dose antibiotics, there's not much they can do. If the antibiotics don't work, which sometimes it's six to 12 weeks with antibiotics, they start doing surgical procedures in the surgical procedures escalate and they have failure rates in the range of 35%. So 35% requires a second procedure 35% requires revision, and then the cascades to removal of the limb. Dave talked to receive on campus who is a member of the association of thermal medicine, an interventional radiologist physicist, they basically brainstorm a way to treat those infections in place. The problem is infections on metal implants and the reason is, the body's immune system doesn't penetrate the metal from the backside. And the biofilm on top of the infection prevents biofilm the body's immune system. So biofilm formation hinders treatment, and basically makes all the other approaches except surgical scraping debridement happen now the pain is shared by all parties. Alex Smith certainly had a lot of pain, but the infection risk impact on the physician practice the hospital. The impact of infection rates and brighter things means everyone effects it. We're starting in prosthetic joint infections, largely because it's a big market. There's a lot of knees, there'll be over a million knees put in this year, the standard of care which I've talked about going from antibiotics to debridement, multiple debridement surgeries, revisions are highly invasive and expensive. And part of the complication is not all these patients are young, healthy athletes like Alex Smith, what Alex Smith went through, if you were 80 years old, possibly would have taken the limb not just injured his athletic availability, but would have probably cascaded to to amputation. So these are older, highly immunocompromised patients with immune system problems, and high risk of excuse me dying on the table, which you said. Now, this is a big market prosthetic joints alone starts with 1.3 million hips this year, knees aren't so far behind about 650,000 Knees, you esalaam the infection rate over two and a half billion dollars will be spent this year in the US alone on infections on these core first implants. The trauma case like Alex Smith, there's about a 30 to 35% infection rate of open wound injuries on a football field or on a motorcycle accident or something like that. So if only 20% of those cases are treated, that's another billion and a half the end game is to move this up closer and closer to the point of surgery so that this infection is cured at the time and before it becomes a chronic or an acute infection. Now, the way we're treating this is with intermittent alternating magnetic fields, okay. Now, ultimately, magnetic fields might sound recognizable because we're talking about what an MRI does, at different energy, different fields shape and different frequencies. So what we're doing is shaping and targeting the energy for therapeutic effect, we're not using it for alignment of iron atoms for imaging affect the energy is complex is concentrated on the energies on the implant surface through creating eddy currents just get geek out for a second. And those eddy currents generate heat on the implant that dissipate quickly into the body of the implant, as well as dissipating a little bit into the soft tissue. But to the point where injury is minimized, we in we injure far less tissue than is taken out through a typical debridement surgery dare procedure which involves removing, you know, sometimes a centimeter of tissue. We have one patent issued three more filings and a couple more on the way. One thing we did not expect when we started doing these surgeries doing these studies was that we are synergistic with the antibiotics standard of care. Now antibiotics being the standard of care, we had to show that we did not disrupt the effectiveness antibiotics. And the process of doing that doing that study. We totally did not expect even at very modest temperatures that we double The impact of antibiotics in this graph, this was repeated repeated in vitro in mice, as well as sheep study. So the result here was consistent across the board. And this this, you know, killing the bacteria to the level of detection is what this is showing, was pretty amazing when it was repeated so many times. But again, it was unexpected synergy that it works together with it. The clinical model, if you look at this device kind of looks like a rolling cart ultrasound machine, it's going to roll in the room, place the transducer on the knee, and maybe they sit there for 30 minutes, pulsing every couple of minutes, flexible treatment options, the coil can be shaped to the particular implant and a simple nerve block and it can be run at very high energy levels, especially for chronic or acute patients with no role, no real patient impact. The economics are quite attractive, the FDA interaction, just to be clear, we have no predicate device is a new innovative application of this. However, the FDA has been very responsive, understanding the unmet need that's out there, but also that there is a large body of safety knowledge. Because of the MRI, we inherit a lot of body and knowledge what happens with alternating magnetic fields in the body. And the fact that simulations in tissues have gotten so good, you see some images here. The goal is you see that knee is to get a very even consistent heat distribution on the surface, it's pretty much where the infection could occur. Or if we know we want to target a certain area, we can also shape a field to have hotspots on that thing if we want. So that's what the hip implant is showing a lot of stuff on this page. This you know, the typical timeline shows a lot of stuff and this true. What we care about right now is the red arrow. The red arrow shows we're doing our final definitive GLP study. Everything else has been highly effective for efficacy and safety. We're now doing a definitive GLP study for bone histology. Bone histology is a lot of fun, extensive process, but we're doing that in a very isolated environment on sheep studies. And we're doing the translation of the animal device to a human device. We're getting ready to go in first inhuman What this doesn't show you'll see Johnson and Johnson listened a couple of times and Depew sent these we have had support and validation studies from Johnson Johnson Johnson Johnson was our lead investor in the series A and they've been a great partner to us. They provide a bunch of a whole bunch of attune Depew, attune knees for our validation studies of all sizes and types, whatever. So they've been a great partner for us. I really can't say too much about them. And the goal is to be in first inhuman with at least a feasibility study in January February next year. The key summary points this is a non invasive treatment completely outside the body. It can be done in conjunction with a surgical procedure either pre or post surgery implantation closed, but the the, the feasibility study will probably be a double blind study post treatment, pre or post to a dare procedure. So it's it's a very non invasive, low effort study, but we will do it initially as part of a surgical treatment, mainly because the surgical treatments have about a 33% failure rate of solving the infection. So there's a big statistical number to move there. But it's a breakthrough device. Large multibillion dollar market I showed you in the US alone worldwide it's even more exciting. We are at the late large animal study sighs sheep stage patents pending as well as a patent issued and positive outcomes for all the physicians love it. The word game changer comes up more common than anything. The payers love it. And the ability for an implant vendor to potentially have a game changing reduction in infection rate is has really been attractive when I walked floor of aos a couple of weeks ago. So appreciate your time. Listen to this Linux story.