Eli Thomssen Presents Adlore at LSI USA '23

Transcription

Eli Thomssen  0:05  

Thank you very much. Yes, my name is Eli Thomssen, the President CEO of SenLore of Adlore. And we're introducing SenLore, which is a new device to both treat and monitor of diabetic foot ulcers. These will happen generally on the bottom of the foot, either in the planter area or the toes, it starts with a callus and then develops into a wound as depicted in those middle pictures. On the right hand side is a picture of one of the actual patients we had one of our studies now show you the results after four weeks in future slide. And this problem is caused by vascular and neuropathic problems. It also has a high mortality and cost. It compares to cancer. For example, in the left hand side of the the pink is breast cancer. Third bargraph is diabetic foot ulcers. They can be caused by or there any diabetic that has diabetes can develop these these ulcers, in fact, about 12% will 40% recur within a year 65% within five years, and you'll treatment cost depending upon the areas between 13 and 17,000. There are 130,000 amputations usually starts with tau in the United States, and the cost of the Medicare index or the medical industry is about $11 billion. So one of the partners is Dr. Darrell Lawson, he got his master's degree at USC then practice for 10 years and Reno and a lot of patients who was seeing had wounds that weren't healing, and decided you want to spend time finding out how you're going to improve these, these healing rates. So he got his doctorate at Loma Linda, work with Dr. Petroski. And what they determine is that the combination of heat and electrical stimulation are synergistic, and will improve blood perfusion. They're improving healing rates. And the research that they did, they had healing rates up to 70% Compared to 25%, for the standard of care. And this data has been published in nine different peer reviewed journals. So we formed the company to commercialize this technology. And we're we're focused when you look at the standard of care is number five, they'll use a number of products, antibiotics, dressings, what have you, but they'll always put them into a boot to offload the weight. And it's either a total cast or a boot that I've shown there on the on the bottom. So what we're doing is building an improved version of this walkable boot. And it starts with three different sizes for a treatment insole. And the electrodes are printed, and we have a total of eight of them. And when it goes on the bottom of the foot, we will activate those that are in the closest proximity to the wound. And what we found in the research is that by using four electrodes, you get about 3x The blood perfusion, you do and you use it to. And as I mentioned that, when you add heat is synergistic with the electrical stimulation. And part of the rationale is that these people are vaso constricted. And once you apply the heat and electrical stimulation, you get into nitric oxide released into the smooth muscle to reduce the inflammation, thereby improve circulation. When they're not being treated, we'll have a custom made insole that will go bottom on the bottom of the foot, so can be used as a walkable device. On the left hand side, it just demonstrates all the components that we have, the heat will actually be administered from just below the knee all the way the tip of the toe. Another important feature is Wi-Fi, so that we can communicate information back to the patient, as well as to the clinic. So we do have remote patient monitoring. Then the next booth shows it will be a wearable device and then the finished product can be on the right hand side. These are the components that we'll have in the booth, the electrodes, the sensors, and we'll have an SPL two sensor to measure blood perfusion. A temperature sensor to mate determine whether or not there's an infection present. And then compliance. And when we talk to clinicians, this is the one they really jump on because these people aren't compliant. The recommendation is that hour per day, seven days a week, if they're only doing it 10 minutes, there'll be a message going back to the patient as well as to the clinic. We've had two US patents issued and we filed PCT and they're going through the normal routine right now. We're working with technical engineering, and they've laid out a four phase development project. And where we are right now is on phase one. We have developed the prototype and raising funding to do the other three phases. As and then have a product that will take into clinical development also the product will eventually go to market. This is a prototype contains modified components, but we'll have all the components we'll have in the final product. And we have done a small pilot study using heat, heat plus electrical stimulation for diabetics, as well as non diabetics. And an important feature is even after you discontinue treatment, there's a carryover effect where you continue to have improved circulation. And this is a study that was done in North Carolina. That picture on the left is the picture that we had showed you on the second slide. And then four weeks later, the closure on that particular wound. And four weeks is kind of a predictor of whether or not a particular therapy is working. If it is continue until you have total wound healing, if not reassess your treatment. And on this particular study, the average closure rate was 54% Compared to 24%. For the controls. We do have competition, but the competitors all have these offloading boot, some attempt to do some of the things that we're doing the one on the right, for example, the vascular boot, they use compression to try and improve circulation, it doesn't work nearly as well as what the electrical stimulation and heat do. So we have all the components that are necessary that the other competitors do not have. And terms of the markets by $11.5 billion market, we estimate the market for this boot is about 2 billion. And the clinicians that treat diabetic foot ulcers lot of times the family practitioner is the first one to see him. But they immediately refer them out to a podiatrist, wound clinic endocrinologist for for treatment. Where we are in terms of development, we have raised $500,000 Plus we have one grant, and that money was used to develop the prototype conduct the part of the pilot study as well as fund intellectual property. We're doing a seed round right now to complete the development work for the boot. And that will be a boot that will take into the clinical study. And they will do another series to complete the clinical study to obtain a 510 K approval and the plan is to sell the company. In terms of the management team or President CEO. I was formerly with Pharmacy, a pharmacy and Upjohn, which is now Pfizer, and then started a group called App John to start life science companies I've been involved with starting five had four exits one failure. Steve Nimbus is a CFO, he's had both startup and and a fortune 500 experience. And then the two patent holders one is Darryl Lawson, who is on the faculty at Western Michigan University and treating wounds right now. And Chris arena who has a PhD in Biomedical Engineering, we're a virtual company. But with this skill set, we can design the type of boot is going to be necessary. In terms of a summary, a lot of the risk has been mitigated because we're using components that are already being used for other products. diabetic foot ulcers are a problem are expensive. Anytime you're going to reduce healthcare costs, you're meeting an unmet need, and we feel we're efficient in terms of utilization of capital. The other thing I'll mention I should include on this is that in terms of adoption, they're already putting them into a boot. It's just a matter of convincing the wound care people to put them into boot with these other components. As I mentioned, we want to sell the company once we obtain the 510 K approval of identified potential acquirers. These are companies that are currently acquiring businesses. We have had conversations with three of them, primarily that keep them aware of what we're doing so at the appropriate time, we can go back to them and they're familiar with, with the product. That's a similar story. Thank you very much.