James Lancaster, Solenic Medical - Magnetic Fields to Eradicate Biofilms on Implants | LSI USA '24

James Lancaster  0:03  
I'm here to talk about Solenic Medical and our goal is to keep you moving. We have a great team just start the introduction there we got about 50 years entrepreneur experience, we have a numerous medical device, medical device and orthopedic experience as well as regulatory also have a great board won't go into that specifically. But the best thing about this, the company has been together for four years and four of the five of the six people here you see here, I've been together the entire time. So a lot of stabile stability from the early team. What I'm going to talk about is infections on implants, specifically prosthetic joint implants. And the importance here is people got these prosthetics joint implants to retain their mobility, the biggest risks to losing their mobility at that point is a prosthetic joint infection, biofilm on that metal surface hinders treatment. And the catch is you can't just scratch it off. Everyone here is familiar with biofilm, you brush it off your teeth one or more times a day, it's easy enough to open your mouth and brush your teeth. You can't do that to a knee, it's a surgical intervention. And the standard of care is to do a surgical intervention and essentially do a tooth teeth brushing type procedure. So once a patient has been indicated with a prosthetic joint infection, it's about a half a million dollar lifetime cost of care, it usually cascades to amputation within five years. And there's a very high risk of mortality. In fact, the five year mortality is similar to breast cancer. Breast cancer is about 89% mortality rate with that level indication. And ours is prosthetic joint infections at 7%. So it's extremely high. Within five years of that indication. There are millions of knees and hips, there'll be 1.3 million knees in the US alone this year, many multiples outside of the US to be 650 or so 1000 hips, and that excludes tibial nails and a variety of others. And mentioned the standard of care is surgical intervention starts with antibiotics and it might be six to 12 weeks of antibiotics usually does not do much because it can't really penetrate the biofilm. Again, you know, the bodies, the body can't really do the same thing you can when you open your mouth and brush your teeth. So the dare is a debridement antibiotics and implant retention procedure, then it escalates to implant removal and replacement. And that might be a six to 12 months bed bed bound kind of situation for that patient who at a stage in that patient's life, six to 12 months off their feet is going to shorten their life immediately. And these are high morbidity patients may be diabetic, they may be obese, they may be cancer patients, all those things have compromised their immune system, which is why their body's not fighting it very well. The solution is our alternating magnetic field device. Alternative many other fields generate eddy currents on the surface of the implant, these eddy currents generate thermal medicine. If this sounds vaguely familiar, an alternative magnetic field device is very familiar as an MRI, they tell you to take off your jewelry and ask if you have metal on your body. The catch is not trying to generate heat on implants, it's to generate a very smooth and even distribution of heat on implants to make it a very controlled thermal dose. And that's what our IP is. And that's where all our magic is. One thing we discovered very early on is that MF is synergistic with antibiotics as the standard of care. It's broadly synergistic in vitro, in vitro, in vitro and in vivo demonstrations and sheep. It's crossed pathogens, gram positive gram negative and across multiple bacteria from Mersa to to other lower, you know, lower indications of bacteria that's been identified on implants and across multiple antibiotics. So the synergistic effect is great. It allows us to provide a lower thermal dose but high level of efficacy that's beneficial to paper patient and our magic is shaping the field. I said it's not hard to generate implants, thermal medicine on implants externally with MRI, what is hard is generating in even thermal dose and you see here our thermal dosage has been described by the shape of the implant if we know the shape of the implant, the material and titanium, cobalt chrome are the most common ones. And we know the target thermal dose, then we can hit it pretty accurately and the most convoluted infection or the most convoluted implant in the body is a knee implant. We didn't intentionally so Start with the most convoluted geometry. But there's actually synergy is saw it forced to solve a lot of geometric problems that add a lot of synergy. And the ability to get a very, very tightly targeted thermal dose is the result of all that work. In addition to getting a very even heat distribution across a wide variety of implants, we also can dial it down. So we initially started with a high level of efficacy, and a high level of, of safety kind of filter. So the FDA, one image shown there is that that the that's a implant on a sheep tibia up there, the reintegration even after a very, very high degree of dose above what we would target therapeutically, a high level of thermal dose had incredibly good bone in growth, healthy bone cells, reintegrating with the implant, even if they were damaged by the infection itself. So the bone in growth was really wonderful. In fact, it that bone, bone grew back thicker than the control animals, but we also have the ability to dial it down. Eventually, we would want to get to prophylactic care and be used after every procedure. The clinical and reimbursement model, the initial indication we're going after is that surgical intervention that surgical toothbrushing, open it up to a wash out or a deer procedure or revision. There are fluids flexible treatment options, I showed you the thermal dose on the previous page, but the ability to use this inpatient outpatient, and to shape the transducer for knees, hips or trauma is there now one of the things we're going through right now is the device revenue model. For a for an indicated infection, the hospital typically gets $30,000 to treat infections every 90 days. So what we're targeting is the ability to have either a delaying effect or a target for a control patient with a hyper, hyper compromised immune system or for an acute infection to be able to to treat it at a high dose every 90 days. So that 90 day window is huge for retaining the implant as well as the cost effectiveness of fighting the implant infections. The device is what you see right here. This device we actually introduced on the show floor at ACC is the American Association in hip and knee surgeons in November, we had a really great booth presence at aos back in February and a lot of great discussions with physicians, the FDA has indicated has accepted a breakthrough device designation. We've We've met with them about six times. There's been a lot of education with them about our simulations on our thermal dose and what that means and the educational process to get them dialed into what we're trying to do and how we're trying to do it has been very effective. Our sixth breakthrough, our sixth meeting with them as next Wednesday, hopefully will will fine tune the clinical path and get ready for first in human studies in May. So we're right on the cusp with a very well defined device. Now we got to get the first inhuman approval. The timeline that I've kind of described here is there. We've already started on we've been working on knees for a while we've already started on hips we've actually got a good progress on tibial nails as well which are three the the highest volume and the highest infection problems as well. Our lead investors are Johnson & Johnson Xiang Bay High Point and Pierre seven years the latest investor in a bridge round Isle total we've raised about 10 point 2 million with management and angels involved as well. We are that bridge that we closed literally last week a week ago Friday will lead to a series B that will fund the pivotal human trials getting ready for market launch. As I mentioned Solenic Medical is here to keep you moving for implant infections that are taking patients off their feet. Thank you very much