James Lancaster Presents Solenic Medical at LSI Europe '23

Transcription

James Lancaster  0:05  
Today I'm going to talk about technology that keeps you moving. Some of you may be reality show fans and you may recognize the name Ollie Mirrors, who is a reality show participant in the UK. And he broke his leg a few years ago and had serious infections on those implants, which a lot of implant patients face, whether on knee or hip implants or trunk, trauma joints, rods, so forth. This Solenic Medical team spun this technology out of UT Southwestern in Dallas, Texas, so I'm kind of obligated to give you a howdy from Texas. But the infectious disease physician Dave Greenberg reached out to receive Chopra, and the thermal medicine interventional radiology group there and they tried to come up with the technology that would fight infections on implants. And that started about five seven years ago, and led to the invention we're going to talk about today. The problem is that metal is a nice defensive barrier if bacteria settles on it, and it's easy for biofilm to form on that metal. When the biofilm forms you have a metal backside that doesn't transmit many of the body's immune system or antibiotics. And then you have this mucus layer on the front that is going to resist the penetration of antibiotics in the body's immune system. So the biofilm formation hinders treatment by the common techniques. The pain is shared by all parties. Obviously, the patient with nice swelling or pain is going to feel it but the payers, the physicians, the hospitals themselves when they have infection problems on just a handful of patients, it can affect the reimbursement rates. The total cost of care average for a single knee infection is half a million dollars. And some of these are multiple surgery procedures that lead to amputation. The Cascade process for each surgical procedure has met a 35 to 40% failure rate of proceeding to the next procedure. Prosthetic joint infection so the most common, there'll be about 1.3 million knees. Artificial knees in the US alone this year, you about three four times that worldwide in the major markets. The standard of care is complex starts with antibiotics, then a couple of dare procedures, revision procedures to amputation. The problem you have is that many of these patients have a significant number of comorbidities, they may be diabetic, they may be obese, they may be former cancer patients, they may be on blood thinner. So the problem is the healthcare complications they have that caused the the infections to linger. The technology I'm going to talk about is an alternating magnetic field device. It's non invasive, outside the body and it concentrates energy on the implant surface, which is pretty much by definition where the infection is. We have one patent issued for other filings underway and you see it this diagram, hit on the implant thermal medicine which the body uses fevers to try to target infections, but we escalate we can escalate that temperature up as far as needed to kill that infection. One thing we did not expect to see here was the EMF is synergistic with the standard of care use of antibiotics. This has been demonstrated in vitro in vivo, across pathogens, gram positive and negative and across multiple antibiotics. And you see in this diagram, it's kind of doubling the effect. But with a log order, it's actually 100 times more effective than antibiotics alone. The reimbursement, the clinical and reimbursement model you see here, it's kind of a in or outpatient kind of procedure. It will the patient on the table for a knee treatment would be a little bit different for hip, they lay on the side, for a tibial nail, which is the indication we're going after next. It's also very similar devices. We are not targeting a clinical kind of capital asset sale we're targeting at least plus reimbursement per procedure ton of model. FDA interaction in the US has been quite positive early and often we've had five pre sub meetings with the FDA and the response has been quite positive de novo path anticipated. We are following our first inhuman feasibility study in the December 4 timeline is their deadline. So we're off by that for a few days, we'll let you know we'll blame it on Thanksgiving holiday, but we are looking at being an inhuman patient treatment in the February time period. One thing to be clear on the path to market we do not have a predicate device. However, there's a huge body of knowledge on what alternating magnetic fields do in the human body thanks to MRI and other treatments. So that combined with the quite sophisticated energy In thermal simulations has resulted in a reasonably modest path to market through the FDA and then with the CE marks and bodies in Europe. One thing also we've learned recently is that we cannot just create a transducer that can target an implant, we have proven that we can treat create transducers that target multiple implants with a single number of transducers, you see this histogram over on the right, the core, the core premise here is if you can create a very tightly controlled field on a very complex shape, and the implant is about as complex the shape as you can get in the implants in the human body, then you have the ability to target a very effective efficacy level with a very controlled safety level. In addition to that, one thing really exciting is that the target temperature determines the range. So at lower temperatures, where you're trying to stimulate the body's growth cycle and immune system to higher levels where you're actually trying to create targeted kill of chronic or, or acute infections. And the breadth of temperature control there vary somewhat, but it can be very tightly controlled at the lower levels. The timeline, we're at work now we are in the process of assembling our first devices. For our first in human studies after the first of the year, they're going to go in 60601 testing, as well as cadaver studies here this fall. And into the clinical trials. We're going to start with cruciate retaining knees, then posterior segment stabilizing knees, then tibial, nails, hips, and so forth. So we have a rapid path, progress and you see various different images there on how the the field is shaped for the different devices. Really excited, say our first device and Yeah, kinda looks like R2D2 to the first device that will go into 6061 testing is physically being assembled right now, and will be sent to 6061 testing and then another a second one will be assembled for cadaver testing right now. The we funded our progress today with a $1.3 million NIH grant and then an eight and a half million dollar equity investment including a leading investor Johnson and Johnson in this fall. Our next series B investment that's targeted about 15 million will be triggered or at least that conversation will start the lead investor has verbally the day we filed the IDE we can start talking about the series B with 15 million so about 60% of that round is pledged per se soft pledge based on the following of FDA from our current investors. So it'd be rounding out that the goal of Solenic Medical is to keep you moving to resist the impact of infections, taking out the implant and to resist the loss of mobility that comes with it. Be happy to answer any questions here at the conference. Thanks for your time.