Karen Cross Presents MIMOSA Diagnostics at LSI USA ‘23


Karen Cross

Karen Cross

CEO, MIMOSA Diagnostics
MIMOSA has developed a tiny, hand-held device that democratizes the collection of tissue information in patients with peripheral vascular disease (PVD), wound care, diabetes, burns, and potential post-operative surgical complications.


Karen Cross  0:05  

I'm Karen Cross, I'm the CEO and co founder of MIMOSA Diagnostics. At Mimosa, we're making the invisible visible. What you might not know in this audience is that skin injuries are happening every day in our healthcare system, but they're not visible to the naked eye. Yet our vision is how we make this diagnosis. And if you look at this picture, we have a healthy foot that looks like this, a tissue injury that looks like this. And I think this audience can see, you can't tell the difference. And if you're a person of color, it's really really far along before we pick it up with the naked eye. At Mimosa, we call skin the Overlook vital, it's happening every 12 hours and our health care facilities where we're doing these skin checks, yet we have no technology to make this assessment. There are 500 million people at risk. And to put that in context for you, there's 18 million people living with cancer. Most people think as well when you think of pressure injuries or skin injuries that this happens in our elderly or senior population. But it also happens to these little babies in the ICU who are on ventilators who get ventilator assisted injuries who lose limbs, Mimosa, we aim then to address the problem both from cradle to grave. How do we actually solve or when we think of that risk, and risk, I guess, have a family that was everyone including me. So why did I start this company? Why did I set out to try to change this problem? And it's because as a key opinion leader, I'm a plastic surgeon by training. I've spent over 20 years in this space. I also have a full academic lab as a PhD in optical imaging. And I've really academically looked at why do people injured? Why do people have skin injuries and why do people heal? Yet in rural Canada, I couldn't save my own grandfather who had an undetected skin injury had an amputation and went on to die. It's a come from this injury. It really though informed how we were going to change it and what kind of technology needed to be placed in the health system in order to solve that problem. How do we actually do that? Well, skin is actually the sixth vital and as I mentioned earlier, every 12 hours when you enter a facility, someone is checking your skin and make sure it's okay. But as I mentioned, you can't see if there's been any changes. Currently, right now the types of medical conditions where this is important would be things like poor circulation in your legs or peripheral vascular disease, diabetic feet, post op surgical management, or as I mentioned in babies in the intensive care. Moving on then to pressure injuries, infield or military operations as well as burns, I'm a fully trained burn surgeon as well. If you don't pick up this skin injury or don't see that first blush in the skin that leads to wounds, those wounds can be the size of my head, I can put my entire arm up the side of someone's back. They lead to amputations of death. The cost of the system is about 25 billion US and that's not including litigation costs. Some of these injuries are never events an automatic payouts by the health system. How do we actually solve that problem? What we have to do is look below the surface of the skin to measure the skin vitals, things like the skin temperature, temperature telling us when the skin could have an infection or inflammation, or using that multispectral piece to this camera, which is the moment Melissa device of skin tissue oxygenation. This is really how well does the skin perfused and how well is it nourished. Mimosa is actually a classroom medical device and we've just received our FDA clearance. It takes us about 750 milliseconds to take these images, as well as something called standard image capture, which I'm going to talk about. If we can detect these injuries at earlier time points and we treat them earlier, we can certainly save the system money. We then upload those images to a HIPAA compliant portal so it doesn't live on the device. Again, we can track our patients over time enabling that big data or big insight. So all patients have outcomes associated with their data, but enable us to triage and treat. So as a clinician in Toronto, I can remote monitor patients in rural New Brunswick and we were able to do that in the pandemic for 350 patients. What are we currently doing? Well, we're currently in the wound care market. So we're looking at once you have the wound helping clinicians differentiate, what do you do next? Is it a revascularisation of the limb? Is that a hyperbaric oxygen treatment? Or is it a skin substitute or regenerative medicine, we have all the data that case has been proven as well as the reimbursement is confirmed. We're currently signing deals, whisking regenerative companies in the space or channel partners, we've just started the process of moving into our pediatric indication. So ICU or post surgical post surgical indications, we're working with the Cleveland Clinic, again with a very big KOL in the space. And then moving on into peripheral artery disease, as well as pressure injuries, which really is that nearly unlimited market. So we've had risk profile these patients prior to having an injury, certainly saving the system a lot of money. Our AI engine drives that enhanced care, and it certainly is our competitive advantage. So this is not just a device. It's also one because we collect these images in a standard way. So think of your chest Xray. It's the same image each time. We do the same thing with this digital or sorry with our imaging platform. By having those standard image captures that means we truly can perform machine learning. The first part of our AI algorithms is actually been able to sort of create that equity within the healthcare system through our melon and algorithms. Most technologies in this space are only good for cacasions, we've known about it for 30 years, yet there's been no changes in the healthcare space, we are the first company in a market that has solved the skin tone or melanin problem, and therefore are good for all people. So that's the first part of the equity, and sort of changing how we deliver this care to these patients. And then finally, that long term data asset, once you have the standard images, certainly, there's an asset there. And that's certainly what makes us very different from our competitors in the space. By being more of a predictive a proactive platform. You can either have a capital purchase or lease the product. So we have a software component to what we're doing. So it's either a capital purchase or lease depending on what sort of the type of facility or what's the preference for the physician, or go to market strategy. Currently, right now we're selling to healthcare providers. So again, this is a limited launch part of our company. So we are commercial ready with a reimbursement code. But it would be those private podiatry clinics, private vascular clinics, or small wind care clinics. So just small numbers of devices, and sort of that direct sales approach. This year, we're moving into network so people have multiple clinics associated with their practice, as well as small ambulatory surgical centers. And then moving on into our large hospital organizations, channel partners, as I mentioned in the previous slide, overall long term, then thinking to the distribution type model, but again, that's not for several years, we use a contract manufacturer located in Canada, but they're American. So we also can put the Made in America stamped by manufacturing in Florida, as well as they can also perform manufacturing in Mexico. Overall, we've collected one of the largest skin imaging databanks probably in the world as it relates to stereo image capture. Finally, we're growing fast. We're breakeven in mid 2024. So the company is growing quickly this year. So we've been doing well, especially with signing these channel partners and enhancing our sales force. Overall, with respect to fundraising, and milestones, I was planning to come here to tell you that I was raising money, but we actually just closed our round of funding. What did that round of funding or what were the milestones related to that it was to get our FDA clearance, which we which we achieved to achieve a reimbursement code again, which we achieved, and to start our premium rocket launch, which is the face that we're in currently. What we want to do now is sort of talk to future investors about what does that next round look like. And again, it's how we can use that money to expand the application as we expand the applications, as well as expand our team. The leadership team also is grounded. So there's a few people in the audience who've heard me speak before. And when I usually give this talk, it's myself, my co founder and our CFO. But within the last three months, we've been able to add our chief revenue officer here locally in the United States and Connecticut, a VP of operations. And we just acquired Dr. Yuan Fang spent 15 years at the FDA sitting on the class two class three submissions. And he just left at the VP of Google Health. So he was the VP at Google Health and regulatory policy now coming on board with us. Finally, and just to sort of close it out, if you look at what we're doing at MIMOSA, it's the fastest growing sector in med tech. We're in the portable medical device space. Clearly ultrasound dominating within the sector, where the light base version of what's happened within that sector. Also, just to highlight Canadians, and we have our trade commissioner here who very fortunate that we were able to come and present to you today. But just to show you the strength of Canada, we're a global company headquartered in Canada. The last exit in this space, which is called an optical imaging space, was no Videx by elite to inject dye and fluoresce. It was for one indication and interoperative breast imaging, it sold to Stryker for 701 million in 2017. MIMOSA is essentially spy without the die. And just to put that in context, I was a student in the lab when they commercialize an open ACC technology. So that's clearly watched that journey. Thank you very much for your attention, and I'll sort of end it there. So thank you so much.


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