Amaan Mazhar, Modulim - Wide-Field Imaging System for Diabetic Foot Ulcers | LSI USA '24

Amaan Mazhar  0:03  
My name is Amaan Mazhar. I'm the CEO at Modulim. And we are empowering healthcare teams with microvascular imaging and data insights to save lives and to save lives and improve lives. So before I get started, I'd like for each of you to think about one person who's managing either diabetes or chronic kidney disease in your life. And the reality is they're oftentimes dealing with taking labs and looking at their creatinine levels and their a one to a one C levels. But what's missed is they're, they're really at tremendous risk for getting lower limb ulcers and amputations. They go to their primary care if they have a good primary care doctor, they'll tell them to look out for a potential wound or ulcer. But the reality is, they'll get an ulcer or wound and they'll show up at a specialist office. And that's when they're having a very tough conversation about whether to have an amputation or not. The proportion of patients that are at risk for this is staggering. 34% of patients who have diabetes get an ulcer in their lifetime, about a third of diabetes cost is estimated to be related to these hospitalizations about 80 billion. And then when you look at the total population, diabetes, chronic kidney disease, and also those who are pre diabetic 61 million patients in the US are at risk. The opportunity is vascular testing at the point of care. We know from all the science and literature that if you have microvascular disease or macrovascular disease basically compromised circulation due to chronic condition, you're 22 times more likely to get an ulcer or an amputation. The problem is they're very hard to diagnose. For example, 50% of patients who have macrovascular disease, or peripheral arterial disease aren't diagnosed and thought to be missed. And that's where we come in, we've developed a solution that can map to the SIR microcirculation. In the bottom of the foot, you can see here, this was overlaid with a foot that had no wounds, and you have dark spots, highlighting areas that are at risk. These are risk areas that are primed for breakdown over time. That data is then uploaded to the cloud after being captured in seconds, and transported to a health care team that can evaluate and determine a clear plan. In this particular case, a podiatrist would be able to look at this foot and be prescribed the foot to protect those areas that are at risk. Similarly, you could do the same thing with the vascular disease patient and get them into advanced faster care. Why is this important? Every time that we put these specialties in the same roof under the same roof, people have shown they can decrease amputations up to 56%. What we're doing is we're connecting with the patient where they are and bringing them under the same digital roof. So we can reduce these amputations. The technology follows the patient. The core technology, the heart behind it is this thing technology called spatial frequency domain imaging. SF Di. That's what was invented at UC Irvine. And it's able to capture the data in seconds. And it's easy to use and train. And that's where all the IP is generated. From that we get proprietary biomarkers that have reimbursement, and can be used to understand physiology and a number of different use cases. And then we take that data and create clinical insights, and are able to then aggregate the data for our customers to do population management, the idea being as they can direct care as they see fit for their healthcare practice. And of course, machine learning and AI is embedded throughout at all we've been using AI to and machine learning to automate finance, the way that we think about that is that machine learning can help improve quality and can help improve scale of our solutions. Most Recent advances we've done is to use some image processing to actually make our device smaller and handheld, which I'll talk about lately and bring the cost of goods down because of all the recent advances. So we keep a pulse on the latest there to make sure that we can scale the technology. So when we look at the market, the challenge with this market is the patients are distributed everywhere, that the most patients are at home or in primary care, where basically they're not seeing a specialist. They're showing up with a wound at a later point. There are patients and dialysis clinics who don't see a specialist but are being managed for a chronic disease. And then of course, there are patients who are in basketball clinics and pediatric care, we're more likely to get this faster test. So where we focused our attention is to look at the patients who aren't getting care really to bridge that gap and care access and care equity. That's where the market is about $2.6 billion out of a $3.6 billion dollar tam that's an annual recurring revenue based off of our pricing and reimbursement. That's where a large proportion of the limb complications happened for the first time and can be addressed. And that's where the compliance of foot checks are actually very low in a system wide level. And so when we talk to pair providers and integrated delivery networks, that's where we get the most traction in terms of wanting to deploy this type of solution and are offering to the customer is a hardware enabled service. Basically it can assess the patient at the point of care and connect the team with microvascular insight So we have our imaging solution, that's a hardware tool that empowers the technician to assess the patient. We then have a viewer software that allows someone to look at that data remotely and decide on a care plan. And then we have aggregated data that can be looked at by the chief medical officer to decide on how they want to actually manage your patient population based off of their care plan in their regions. And the pricing ultimately comes down to the deployments in the particular care points and then a per patient per year process. And I'll go over that next. So if you look at a sample IDM, think about Intermountain or a Kaiser or VA or anyone in a Medicare Advantage Program. When you think about deploying our solution and the utilization that you have in orange, you'll see what the price per patient per year is $44. With our reimbursement code for our biomarkers, you can see that they can get reimbursed in a fee for service world for 75 per patient per year amount. And then if you think about closing care, back care gaps and risk adjustment, and also savings from amputations, they can save about $184 per patient per year. So our solution is ideal for someone who's practicing not only fee for service, but really the upside is on value based care. And these are conservative estimates in terms of what you can do. And it actually grows over time as you get people to prevent that primary ulcer. The other benefit for us is when we target customers like this is they're typically like managing a lot of patients. So it's all about landing that account and then expanding with that account to be able to get a capital efficient land and expand commercial model. So here's an example. The system on the left is our FDA cleared card system. It was used in an outpatient clinic to image a number of feet of patients at risk, you can see visually, there's not much wrong with the feet. When you overlay with the with our microvascular maps immediately four feet pop out. These are then referred to by the specialist depending on the care paths they have. And basically you're practicing proactive care. Our clinical collaborators and publications at Arizona USC Kaiser Permanente presenting at some Bebo and nephrology have done a lot of pilot and club publication work to really validate two things, the operational benefit, and the clinical benefit. What we found is operationally we're not adding any extra time to the to the workflow and aren't from a clinical standpoint, we're really identifying that micro and macro macro vascular disease, the thing that we did learn as patients, that these customers want to go further out in the market and make a handheld device. And that's where we are, we're raising $6 million to launch our handheld system, we've got a solid foundation of the clinical data and the science validated, the handheld device will be our own predicate, we have a prototype in place. So we just need to get that through the FDA and then also build in our clinical data that exists. And that will get us to a point where market launch and be able to raise the next round of financing. The team I stepped into the CEO CEO role last year, 14 years medical device experience, mainly on the product and clinical side, David co chairs, the CTO and he has been really spearheading the handheld effort. And then we have a great team of clinical Krab light collaborators and Kol Wells, who span the different specialties that manage these patients and really give us some insight on how to to move this solution forward. And then I'll just also add that it's a platform technology, we think about meeting the patients where they are, we've got preliminary data and a number of different applications. We got recently funded for two and a half million dollars by M tech to do burn digital assessment tool. And so with the right partner and licensing opportunities, we can do post market studies that are currently clear device and get some data in those specific application fields. And then lastly, this isn't just about the lamb, the American Heart Association has recognized how big of an issue this is. They've got a call to action to reduce amputations by 20%. And 2030. I would go back to the person that asked you to think about at the beginning of the presentation. If anything, maybe reach out to them and let them know that their limbs may be at risk and get checked out. And then we talked about company milestones one big milestone for me as the person that I think about when I'm building this technology, we were able to image that person and actually get them preventive care and more importantly, get them more aware and activated about keeping care of that health and that that is a milestone that's really hard to quantify and keeps us going. So with that if you're interested in joining our journey, please reach out to me and thank you very much