Nick Talamantes 0:14
Cody, thank you so much for joining me in the LSI studio today.
Cody Simmons 0:17
Thanks for having me, excited to speak.
Nick Talamantes 0:19
Tell me a little bit about what you're doing a DermaSensor?
Cody Simmons 0:22
Sure, happy to. So DermaSensors developed the world's first point and click skin cancer detection tool. Our goal is really to improve access to effective skin cancer checks. And so our approach to doing that has really been to equip primary care providers. So PCPs are the most accessible, accessible, most common kind of provider. I believe as Medicare stats that patients visit PCP is about six times more than dermatologist but of course, they're not specialists in assessing skin. So our focus is really on upskilling PCPs ability to effectively assess and detect skin cancer and correctly refer that to dermatologist.
Nick Talamantes 1:07
So does that mean that if the general patient is going to identify a worrying skin lesion, a mole or anything of that nature, their first instinct is actually to go to the general physician, instead of to a dermatologist?
Cody Simmons 1:22
So a lot of dermatologists comment that actually more dermatologic care is provided by primary care than by dermatologists just because there's 20 times as many of them about 250,000 primary care physicians and about 10,000 dermatologist. So but PCPs often are not the ones that are necessarily diagnosing or treating whatever the condition is, right. But they're often that initial assessment. And so they're often kind of like with so many specialties, they're that frontline, and having to make those triage decisions. But skin is notoriously challenging. Studies show that PCPs are referring a biopsy in 30 to 50 patients for every one melanoma. And so, you know, there's a lot of unnecessary referrals. But there's also studies that have shown PCPs miss up to half of skin cancer, and think that no, that's okay, that's not concerning. Right. And they're just typically doing maybe a few second visual analysis, you know, just looking at the lesion. And really, that's been unchanged. Our technologies is a type of spectroscopy, totally light based, so completely non invasive and harmless. That pulses, hundreds of wavelengths of light on the lesion measures the reflectance. And so the different light wavelengths are sensitive to things like nucleus size, chromatin, cellular and sub cellular characteristics that change when lesions are malignant. And so basically the device, you know, touch to a mole whole process around 30 seconds, and then you get you as a provider get a result to better inform that referral decision.
Nick Talamantes 3:03
So is it then actually able to see if the lesion is malignant? Or is it more making a helping with the triage of the patient to say, this lesion looks? It's giving us some concerning feedback concerning data? We're gonna take the next step to refer you to a Dermatoligist?
Cody Simmons 3:20
It's more of the latter. Yes, it's not a definitive diagnosis, the gold standard for that which we're not at all trying to replace is pathology. So do a biopsy, it sets off and dermatopathologist look at that in our microscope and kind of identify whether that's cancerous or not. But there's a couple of steps that get to that point, right. lesion presents that you can imagine internists, family physician, you know, there's primary care physicians at work or retail health clinics, right. And so patient, often it's often not their primary complaint, like the reason they they went there that, that upper respiratory tract issues or, you know, they're for an annual wellness visit, like, oh, by the way, you know, my wife, or my partner, husband, you know, noticed this mole on my back, or, you know, I think this weird kind of light lump on my leg is like changing size. And, you know, I mean, so it's often kind of brought up as a secondary issue. And that PCPs the average PCP just has a few hours of training in med school on assessing skin lesions for cancer. And what's challenging is, and they're the first ones to say like, yeah, it's tough being good at assessing skin lesions and the risk for cancer because there's no feedback loop. We're typically referring the patient off, but we don't like photograph the moles and then get the diagnosis back. So dermatologist who almost always do a biopsy, they assess the lesion. They okay, it has some risk, I'm going to do a biopsy and they get the definitive diagnosis back typically two to four days later. So you get better right because you get used to seeing lesions I go okay, that one was malignant that one was not. And especially when it when you're doing skin all day every day, and you have that feedback loop, they get really effective at assessing lesions for cancer, whereas PCP is not only do they not see skin conditions as much as the dermatologist, obviously. But they're also typically just referring patients out. But that's those referral decisions that PCP is making, that we're we're able to improve, like, that's our goal, helping them detect more skin cancer. The other aspect that device can help with I think, is prioritizing referral. Right? If you as a provider, like okay, the lesions a bit suspicious, I want to refer it, but you also get, you know, positive results from the device, they go ok actually, and you message out to the patient, like you really need to get a dermatologist, maybe you send a note to a dermatologist, and hey, can you get this patient in the next month? I mean, there's health systems that we've spoken to I won't name names that have eight month wait times for dermatologists visits. And yeah, so they've implemented tele Derm, they tried to like, Okay, can we maybe have sort of prioritization protocols somehow. And so that's something we think the device could help with also,
Nick Talamantes 6:11
You probe the legion with the device. Is there any software component that's making sense of all this data that's coming back.
Cody Simmons 6:18
A big benefit of the device, is that you do not need an active WiFi connection, there's not photos that have to be uploaded and shared, and etc. So the algorithm was developed on 1000s of biopsies lesions, and each lesion we take multiple scans of so that one was developed on 1000s lesions and over 10,000 scans of lesions. So that algorithm is like locked and loaded because it's cancer detection. So this is not a constantly evolving changing algorithm. Right? You kind of developed the algorithm lock it, conduct these studies show its performance. You know, I think every couple years, we may want to work with the FDA and say, Okay, now instead of 1000s lesions, we have 10s of 1000s of lesions, so we can improve the algorithms performance significantly, which is definitely exciting for us, because it is a brand new technology type. There's no medical device on the market right now, that uses this type of spectroscopy. So not only is it performance strong now, but I think what's arguably just as if not more exciting, is that we know there's room to grow. But ya know, the software side is relatively straightforward. It's really just the local program computers chips inside the hand held device, that process that capture and process the spectroscopy data and provide that result all there locally.
Nick Talamantes 7:40
You mentioned that the device doesn't require a WiFi connection to operate and function. Is that an intentional decision to help enable access and make this device usable in certain, let's say, underprivileged areas or things like that?
Cody Simmons 7:56
100% Yeah, I mean, a big part of our focus is access, as I mentioned earlier, and our thinking was okay, not needing a, you know, strong active Wi Fi connection could definitely help with that. The device is Wi Fi Bluetooth enabled. So it's helpful to periodically connect, for example, the device, storage can basically fill up the local storage. And so our back end software, right when you sync it with Wi Fi can pull all that data off the device to make sure there's enough local storage and programming to run effectively. So periodically, it needs to connect, but it does not need to constantly be connected Wi Fi to operate.
Nick Talamantes 8:34
Are there any competing technologies at the point of care like this? I know dramatiscopes are frequently used, but that's I'm pretty sure it's just they're visualizing with a microscope.
Cody Simmons 8:44
Dramatiscopes are basically polarized magnifying glasses, like not many primary care providers use the last study I saw it was 8% because it takes a lot of training. And so PCPs obviously, there's 1000s of different diseases are kind of responsible for initially evaluated and triaging. And so spending 10s or hundreds of hours to learn some new visualization technique just for one disease type. Not many of them do it. Honestly, the only relevant thing in primary care is really tele dermatology. So besides your mattiscopes, visual assessment, like ABCs is telling them and ology. So kind of taking a photo, sharing it with the dermatologist and a lot of health systems have implemented teledermatology specifically for skin lesion assessments are often kind of explaining or clarifying to folks that there's not a single image or optical based tool or device of any kind that's FDA cleared or approved. That provides any type of automated or immediate risk assessment available to dermatologists to primary care providers to patients. There's nothing that uses photos or light like our device available right now. So we hope to be the first And we'll also be the first available for primary care providers, which is our focus, as you know, because I think in the, in the popular media, there's a lot like, oh, using photos, applying algorithms. So there's like publications, there's like buzz in the popular media and kind of different types of photos. And people come up with acronyms to acronyms to like, try to sound like it's some exciting new novel thing. But yeah, there's there's a couple apps that were shut down by the federal government a few years ago, because they're on the App Store being like, Oh, we have like a high medium low rating for melanoma. That's a highly regulated FDA medical device, just because it's like on a smartphone. You know, because the camera is hardware.
Nick Talamantes 10:43
Yeah, I imagine there are also several limitations to using a camera based approach to for tele dermatology, lighting, all these things can affect how an AI algorithm would evaluate an image. Why don't you tell me a little bit more about the clinical research you guys are doing and where that is going to be taking you in the near future?
Cody Simmons 11:01
Sure. And I'm glad you mentioned that actually, yeah, a challenge in the photo based world is that not only image quality, any well primary care physician, but certainly dermatologist. Yeah, capturing high quality photos, especially for evaluating a lesion. You know, maybe like a rash or acne or something. But getting a high resolution. Like we've seen studies that have excluded like 40% of the pictures in the study, because, you know, the algorithm didn't run out well on them, or whatever their quality definition didn't make the cut, right. So that's what's great about us, like, you don't need to like shave the area, because there's hair there, you know, that the probe tip kind of just touches directly to the mall. And another aspect is because it's not visual based on like surface level photos. We haven't seen any indication that patient's skin type affects performance. So we haven't done a study specifically like power to say, okay, darker skin types and lighter skin types, the device performs the exact same. But the large studies we have done so we just presented two of the four major studies that we submitted to FDA, at the American Academy of Dermatology actually just a few days ago, over 2000 lesions, I think around 1400 patients. And we didn't see any sign of any notable performance difference between darker skin types and lighter skin types, which is really important, because there's lots of publications that about how darker skin types, physicians and algorithms based on photos have a tough time with, because neither the algorithm nor physicians are trained as well on darker skin types. So in terms of bringing in that kind of equity, and again, improved access, we think our technology can help a lot with that,
Nick Talamantes 12:48
in addition to the clinical work you're doing and bringing this product to market, what are you trying to achieve by being in an event like LSI?
Cody Simmons 12:55
Yeah, I mean, really connecting with potential partners, right? There's some corporate folks here that have you know, large, relevant Sales force, right, I think the exciting thing for us is that there's hundreds of 1000s of primary care providers that could benefit from our device, the challenge is, how do you access them? Right? You know, we're a six person startup, we don't have 1000 sales reps, and we're not going to in a year, to kind of have access, kind of promote our product to everyone. So thinking about that, certainly investors are a big focus. And yeah, I think also a lot of the panels, you know, really interesting kind of knowledge sharing, especially given the macroeconomic environment right now, from a fundraising standpoint, because we're certainly gonna want to raise significant funds, we've raised 27 million to date, we'll probably do another significant financing to fund our US launch.
Nick Talamantes 13:48
You were on a panel earlier this week about the next generation of founders. As a younger founder, are you finding that there any specific challenges that you are facing?
Cody Simmons 13:59
Yeah, I think some some things definitely, you know, I kind of the estimate estimate or level of complexity, I was off the mark. Sometimes overestimated typically underestimated. So for example, clinical CSRs clinical study reports, like the write ups of clinical studies, you know, kind of spoke with a couple of folks, I go, Okay, those don't seem that hard, way more involved and complex than I had expected. So that resulted in an extremely busy few months. Last year for me, and a couple other team members. There's probably like 20 people involved in the FDA submission, but it kind of few persons sort of core team. Yeah, so I think definitely, you know, I joined the company when I was 27. So definitely some things and I mean, hindsight is 2020. And I think regardless your experience level, but yeah, I think if I had another decade under my belt or now joined a similar startup, I think what have made some better decisions along the way. But I think fortunately, like potential missteps or major missteps, most of those were avoided due to kind of the active involvement of our board. So we've got great board members. So there's a couple co-founders that started the company in 2009. So really kind of identified the early technology at Boston University Dr. Murray's Forae, Zhan, the Board of Trustees there and so connected with a brilliant researcher Professor Irving Biggio, who invented this field of spectroscopy. And, and, you know, kind of have this initial 30 pound microwave size device that they worked with his lab to develop and that's what I was handed when I when I joined in 2016. So there's been some early studies done kind of showing proof of concept that like other cancer types, it could also work well for skin. And so the goal was to kind of miniaturize that 30 pound micro sized device down into the little one pound device it is today. And Maurice has had two exits. First company sold to GE second company took public and sold a striker for 1.6 billion is called Mako Surgical. So having you know him Chris Dewey, Fred Maul, a few other very seasoned medical device entrepreneurs and executives, Yvonne Televic, Devin Matlin involved, and you know, certainly quarterly board meetings, but also, you know, can call or email whenever I need to, and when we're in a tricky situation or a question comes up, that some guidance is helpful on so they've been great.
Nick Talamantes 16:38
So then the key takeaway there being building a strong team around you, both seasoned players, and young innovators can result in a very successful operation,
Cody Simmons 16:50
Yeah, great summary, I think definitely, if you're kind of a first time founder and CEO, especially. Yeah, especially in our highly regulated industry, having some seasoned folks around you, not just for insights and advice, but also, you know, hiring the right people getting the right, kind of legal and consulting folks involved, you know, it can be overwhelming, like, how do I navigate you know, there's dozens of recruiting firms I could work with what are good ones. And so I think, having those kinds of folks involved, whether they're investors or advisers, so, you know, we recently brought on because Maurice, a lot of the, those individuals I mentioned, have really focused on surgical related tools like surgical robots. But you know, we're a bit of a novel right point of care, primary care triage tools, there's not really many of those. So we we recently brought on two commercial advisors. Steve, Steve Mayer, he's the ex CEO of all Shaolin. So definitely a lot of experience and knowledge when it comes to primary care devices. And also Jason Bola is the co founder of Echo health, which is the AI stethoscope. So AI enabled stethoscope that automatically evaluates stethoscope, sounds for afib, heart murmur, etc. And they're in use by about 350,000 clinicians mostly in the US. So I think we've got a lot of great folks that helped with the development stage. And now some people involved that really know these kinds of primary care tools very well and like how to get them adopted on a widespread basis.
Nick Talamantes 18:37
Sounds like you've built a very impressive team to help you bring this product to market.
Cody Simmons 18:42
I'm trying hopefully, hopefully, it'll do the trick. We'll see.
Nick Talamantes 18:44
I think you're gonna have great success. Thanks so much for stopping by and telling me about the work you're doing at dermacentor.
Cody Simmons 18:49
It's been a pleasure. Thanks so much for having me.