Modulim | Amaan Mazhar, Chief Product Officer

(Transcription)

Amaan Mazhar  0:02  

Hello, everyone. My name is Amaan Mazhar. I'm the Chief Product Officer at modulo. Imagine we're delivering transformative optical imaging and decision support solutions that help people live healthier, longer lives. Sorry. And we're focused on the lives of patients that are managing their diabetes, kidney and cardiovascular health, specifically 43 million patients that are at risk of getting lower limb complications. These complications start with peripheral vascular disease and diabetic foot ulcers and end up in an amputation. Our solution is the clarify imaging system, which helps clinicians assess, manage and preserve limbs for at risk patients. The clarify imaging system has FDA clearance and a CE mark. It's a proprietary technology that also outputs micro Maskull maps, as you see on the left hand side, we also have our own reimbursement code and have recently published in vascular and diabetes journals. These milestones lead to a strategic round of financing and 2021. To enter the market to manage high risk kidney and diabetes patients are now out raising capital to support commercial scaling and our solution roadmap. The problem this problem is real because current limb care is highly reactive. Care occurs after complications are visible, and it's highly fragmented. I can see this when I'm with my parents as they go see multiple specialists. The current standard is a foot check, because none of the current non invasive testing methods actually have good sensitivity. In fact, in diabetes patients, pap assessment has a sensitivity lower than 50%, which means 50% of patients are undiagnosed. This leads to $80 billion in reactive spending. The clear the unmet need is clear limb assessment at the point of care, especially in terms of evaluation of circulation, these Bhasker insights can help clinicians manage the right patients at the right time. That's where our solution comes in. The clarify imaging system is a point of care microvascular imaging tool to help clinicians practice proactive lead management, it can be done at the point of care with a snapshot of light. And it generates these 2d color coded maps of hemoglobin oxygen, hemoglobin, oxygenation and distribution. And the solution is comprehensive, we use visible near infrared light to see 10 times deeper than you can with your eye structured light to actually map that over a wide area using a technique called spatial frequency domain imaging. That's what we've patented and licensed from the University of California at Irvine, and computational model modeling to actually quantify the hemoglobin distribution and oxidation. We put that all together. And we use that for in a predictive decision support manner to actually guide the patient journey so you can get the right care at the right time. And here are some of the key clinical insights we can get into limb health. This is from a publication in 2020. Where if you look at the visual inspection, there's no actual insult to the foot. If you overlay that one of our biomarker maps, you see a dark blue area underneath that second toe. That's decreased perfusion in our area. This was an observational study. After 13 weeks, there was an ulcer that formed in that same area due to repeated trauma and that area. This also didn't heal for 33 weeks. And when we showed this to our podiatrist, colleagues, they basically said that they could have prevented this with targeted offloading, and customized shoes. We've done more than case studies we've published with the University of Arizona University of Southern California and Kaiser Permanente and diabetes and vascular journals. And most recently, we've also completed a pilot with Fresenius medical care, looking at the highest risk kidney patients. And the highest risk kidney patients are at incredibly high risk, especially those undergoing dialysis, over 50% have diabetes, a quarter have peripheral arterial disease 13% will get an ulcer within a year, and about 20% of those patients who have the most severe peripheral arterial disease, critical limb ischemia will get an amputation in a given year. That's half a million patients at risk. And they're being seen at a very specific point of care, the dialysis clinic. We're partnered with the number one and number six large dialysis organization to augment what they do today, the current visual foot check and do vascular assessment at the point of care. And the reason why this is really becoming even more attractive is the shift in the kidney care space. value based care is here in 2022, CMS launched a program where they're doing total cost of care for these high risk patients, and not only for dialysis patients but upstream CKD, four and five patients. This has created an ecosystem of nephrology practices, large dialysis organizations, and new practice management groups. And we are now partnered and launched one of them at the largest nephrology practice in California. And we've created our first nephrology limb network, where we do point of care imaging at the dialysis center. We upload those images to a HIPAA compliant cloud and the nephrologist reviews those reviews those images and decides what to do in terms of care management. Typically that's a specialist referral to a vascular podiatry specialist specialist. You see this ecosystem is what really can prevent complications from happening and on the far right hand side is a real case, a visual foot check resulted in no complications that are visible. Our assessment showed decreased oxygenation, both limbs, this person was referred to vascular. And when they did a detailed ultrasound workup and an angiogram, they found critical limb ischemia. Remember, that's a 20% chance of getting an amputation and 80% vessels stenosis, they ended up performing an angioplasty to reinstate blood flow in that in that leg. Our acquisition model is flexible. And as a service model, we place hardware at the clinics at approximately $1,000 a month per site. Or we can do a capital option to the practice so chooses. And then we have a recurring software model of $15. A set study. This works in both the value based care setting and the fee for service because we have our own reimbursement code that pays at $50.20. A study. This is unique to our technology. No value proposition from the practices is quite simple. If they were can reduce amputations and ulcers by 20%, which is very doable with multidisciplinary care studies have shown you can actually get a 50% accomplishment, they can save about $80,000 per clinic, while having an operating budget of the equipment and staffing at $30,000. That's $50,000. Net per clinic, a typical nephrology practice will manage 20 clinics, that's about a million dollars in net savings. We validate all of our operational assumptions with our rollout. By validating how long it takes to do the assessment less than five minutes how long it takes to deliver you about three to four minutes. And how many patients actually need are sort of being seen by specialists care. One of the key use of funds of our future financing is to do an outcome study to really track the full decrease in amputations. And our solution roadmap is targeting the larger market. This is a target target a $90 million market of high risk patients but the overall limb market is about $1.5 billion. That's 43 million patients being seen at a number of points of care, our microvascular assessment target technologies available at these dialysis clinics and we've created these limb preservation networks. The outcome studies are being driven to enhance our insight so that we can apply machine learning approaches and improve their predictive utility of the technology. Lastly, we do have a vision of miniaturizing the hardware with the advances in commercial cameras and lighting so that we can actually take this to outpatient and home care use and that opens up the upstream kidney diabetes and peripheral arterial disease market. We have a team that's got a track record of commercial scaling, innovation and value creation. David and myself are from the founding lab at UC Irvine. We started this company with NIH grants event trends in transition to venture capital. We're really excited that we recruit Charlie here to the company who couldn't be here last last week or last year sorry. He has a tremendous track record and scaling companies both in aesthetics and telemedicine and that's and leading them to exits and so and our VP of sales is Gary Marston. He's got a lot of med tech experience in small and large companies and also has a tremendous experience and market x axis which is why we were able to get a reimbursement code. Our clinical team is multidisciplinary and represents all the different stakeholders can actually lead to limb preservation. microvascular assessment can be occur anywhere in the body we believe that core technology has multiple market expansion packs 99% of your bath basket sure is the microvasculature will be we believe there are opportunities to expand in the surgical space the OR space, the patient monitoring and outside the US with the right partner. And lastly, I close with this we believe the time is now if you want to be are part of our mission to help people live healthier, longer lives. Please come have a conversation with us. The American Heart Association put out a call to action for reducing non traumatic lower extremity amputations by 22% by 2030. This is extremely achievable with the multidisciplinary care and tools like microvascular assessment. And I will also say this, if you do have a loved one who's suffering from diabetes, cardiovascular health or kidney health, please ask them to have their limp child limb checked. Not only could it save their lives, but it could actually save their life. Thank you