Kingscrowd's Teddy Lyons and Léa Bouhelier-Gautreau join Brian Belley to review DermaSensor: an FDA-cleared handheld device that helps primary care doctors decide which skin lesions need a dermatologist, its hardware-as-a-service model, and its $72M valuation.
Kingscrowd senior investment associates Teddy Lyons and Léa Bouhelier-Gautreau join host Brian Belley to break down DermaSensor, the Miami company behind an FDA-cleared handheld device that helps primary care clinicians decide whether a suspicious skin lesion needs a dermatologist.
Most medtech deals on equity crowdfunding platforms are still years from market. DermaSensor received FDA clearance in January 2024, launched commercially, and has passed $2 million in contracted annual recurring revenue. The device shines light into the skin and uses spectroscopy plus AI to flag lesions that warrant follow-up. It doesn't diagnose cancer and doesn't replace a biopsy. It is cleared for use by non-dermatologists on patients 40 and older.
Teddy explains why the investment question here is about adoption rather than regulatory risk. Léa walks through the hardware-as-a-service model: $199 or $399 a month instead of a five-figure device purchase, with a payback inside a year for the company. Brian uses an airport metal detector to explain sensitivity and specificity, and why a device that catches nearly every real case will also flag a lot of people who turn out to be fine.
In this episode:
● Why an FDA-cleared, commercialized company raising on ECF is rare, and how DermaSensor compares with Koios Medical
● The hardware-as-a-service model and the unit economics behind it
● Sensitivity vs. specificity, explained with a metal detector
● What 16 scans per device per month means, and why dermatologists are buying a device built for primary care
● How the device works: a xenon arc lamp, a spectrometer and an AI trained on lesion "fingerprints"
● Deal terms: the $72 million valuation, the $48 million already invested, and what an exit would need to look like
● The reimbursement flywheel: insurers pay about $100 per scan
● Four channel partnerships rolling out in Q4 2026
Host: Brian Belley, Kingscrowd
With: Teddy Lyons and Léa Bouhelier-Gautreau, Senior Investment Associates, Kingscrowd
DermaSensor is raising on Wefunder, open to accredited and non-accredited investors. Kingscrowd's full analysis, including the rating, the deal terms and whether it was named a top deal, is available to Kingscrowd Edge members at kingscrowd.com.
Disclosure: This episode is for informational purposes only and is not investment advice. Investing in early-stage companies is risky and illiquid, and you may lose your entire investment.
[00:00:13] Brian Belley:
Welcome back everyone to the Kingscrowd Podcast. I'm your host, Brian Belley from Kingscrowd. Imagine this. You're at your annual physical, you walk in to see your doctor, you have a suspicious mole that you're kind of curious about. So you ask your doc to take a look. Now there's a decision to make. That doctor, that clinician is probably not trained in looking at moles and making really good determinations like a dermatologist. So does it actually end up needing a dermatologist's attention in a follow-up?
[00:00:41]
And what additional information would help to make that determination? Uncertainty in questions like this, or something that I've personally dealt with, I'm sure many of you who are watching this podcast have, of you don't want to miss it, but you also don't want to go to an unnecessary appointment, have that additional time burden and the cost. That's the problem that the company we're talking about today is trying to tackle. That company is DermaSensor. Now they make a handheld device that essentially, and it can be used by any clinician, and it shines a light into the skin region to analyze it and determine if it's a benign, kind of just typical mole or if it's something that needs follow-up attention.
[00:01:21]
We're gonna be diving all into not only the device and the technology, but a lot of the business model and everything else. But essentially it is to help those primary care physicians and clinicians decide whether that further investigation is needed. It doesn't diagnose cancer. It doesn't replace a biopsy, but this tool is an FDA authorized use device, and it's currently for patients 40 and older. So we're gonna be taking a look at DermaSensor, the business case, and diving into the questions. We are welcoming our two senior investment associates, Léa and Teddy, to the conversation. So, Teddy, I know that you've done a lot of the work on this company. Why don't you start out?
[00:01:59]
We have seen a lot of FDA cleared companies. Have we seen, I guess, a lot of FDA cleared companies raising on ECF before, equity crowdfunding platforms? And how does DermaSensor kind of compare to some of those? What are the differences? Kind of give us the overview of just where they are from that med tech pharma positioning that we've backed in the past.
[00:02:19] Teddy Lyons:
Yeah, so I'd say it's relatively rare to see a company that's fully through FDA clearance and commercialized raising an equity crowdfunding round. The I guess the most recent one that is similar is Koios Medical, who's another company that we've backed. they have an FDA cleared AI technology that helps physicians detect breast and thyroid cancer through ultrasounds. So that's a a FDA cleared software product. and I'd say in general though, with a lot of the with most I'd say of the pharmaceutical and med tech companies we evaluate, investors are really still betting on the company getting through clinical trials, receiving regulatory clearance, and just sort of balancing this timing risk of, you know, this company is going to take several years before it actually brings this product to market.
[00:03:11]
So it's kind of a very different risk profile, I'd say, than investing in a company like DermaSensor or Koios Medical, where they're already in the commercialization stage and the analysis is more so how are they gonna scale this up and get in with the right distributors and yeah just grow grow revenues to a to a point where you can get at get an exit. And I think what's what's really interesting about DermaSensor is they've cleared all of these hurdles. They've received FDA clearance in January 2024. As mentioned, they've launched commercially and they've already surpassed $2 million in con contracted ARR.
[00:03:52]
And what makes this company a bit different than Koios is this isn't a software algorithm ex analyzing existing medical images. It's, as you mentioned, Brian, a a completely new handheld medical device that uses light to really analyze the underlying structure of the skin tissue at the at the cellular level. so yeah, I think the the thesis is really around whether this technology will ever reach the market. sorry, it's less about whether the technology will will reach the market. It's more so ca kinda how quickly can they scale up adoption. 'cause they've gone through the studies that show this device works.
[00:04:32]
We'll get into specificity and the other one. What is it? sensitivity and specificity. Yeah, we'll get into that.
[00:04:40] Brian Belley:
Sensitivity and specificity. What are we getting at?
[00:04:41] Teddy Lyons:
But so the the device works and the PCPs that have used it really like it, but it's just about how are they gonna really scale up to you know tens of thousands of of primary care physicians. So an interesting thing about DermaSensor is their business model. I want to bring in Léa here. they're they're operating this hardware as a service model. So rather than requiring primary care physician physicians to purchase an expensive medical device up front, they offer it through this hardware as a service model with monthly subscriptions. and I think the economics of it are are quite interesting. They cost around $1,800 to manufacture, and the average customer value is about lifetime value is about $4,000 per year.
[00:05:30]
So, Léa, what kind of how do you think about this model, hardware as a service for driving adoption, especially when you're really trying to convince PCPs to incorporate a complete completely new technology into their practices.
[00:05:46] Léa Bouhelier-Gautreau:
Yeah, I think that this is going to be removing one of the big barriers to adoption. right now you're only asking PCPs to pay either 199 a month if they are using it for only a couple of tests a month, or $399 a month if they want to use the device. if they want to have unlimited usage. so $400 a month, let's say for the maximum usage, versus for a product that cost $1,800 to make, and on which have to add about $2,000 of marketing spend per sale. So that's about close to $4,000 of cost a year for the company. You only ask the provider to pay $400 a month. So basically in just one year the company gets its payback.
[00:06:30]
I think $400 is low enough because if they wanted to just sell the device by itself, they probably, in order to get a good margin, probably would have to sell it for somewhere between $10,000 and $15,000, which is just a lot of money, if even for physicians. The device lasts about five years on on average. At least this is what is projected from DermaSensor. So that gives DermaSensor a revenue of about $20,000, maybe more, on over the five years. And I think that it just gives a very, very good margin of about $16,000, maybe more than that, over five years. So that lowers that lowers the barrier to adoption, increases the revenue for DermaSensor.
[00:07:17]
And I think that there's it's also a benefit for the company because let's say you have a first batch of a hundred devices that are sold. For the first year they're just kind of paying back whatever has been spent, but that money can also be used in order to finance the production and the marketing for new devices and in order to get more customers. So I feel like at some point the more the company sells, obviously less is going to be relying on outside capital to be able to grow. and yeah, that's why I absolutely like it. Teddy, you you say something important, you say between sensitivity and specificity, there's kind of quite a difference. I think Brian, you can kind of tell us more about that.
[00:08:08] Brian Belley:
Yeah, and whenever you're assessing any type of medical device, right? Med tech device in the space, you're gonna hear of these two different terms, sensitivity and specificity. I heard this example. I think this is the easiest way to just kind of think of that and try and remember the two. So let's take a metal detector. I think most of us have been through TSA at an airport. You're aware, right? When you go through, it either beeps or it doesn't beeps. And if it beeps, maybe you have some metal on you. You know, it's kind of indicating, hey, there might be something here. If it doesn't beep, you're good to go. Let's use that as our kind of sample detector in this case. If I want to make that metal detector 100% specificity on the specificity scale, I can easily do that.
[00:08:47]
It's a very dumb detector that will just beep every single time anyone walks through it, regardless of whether or not they have metal on them. Right. So goes through it, beeps, doesn't matter if you have metal or not, because what it's going to do is it's going to catch every single person because it's beeping every time who does have metal. So that's what sensitivity is. It's basically the true positive rate. So are you catching 100% or whatever percent of all the people who do have metal, or in this case, who do have that you know, other thing that requires the follow-up investigation from the lesion. Now, the downside of that approach, if you have a device that beeps every single time, is that you're going to have a very high false positive rate. And that's where the specificity comes in.
[00:09:30]
So specificity on a metal detector that just beeps every time regardless would be 0%. Because basically it's saying, is it going to beep if a person doesn't have metal on them? so think of it as like false positives. now, which you reality, right? You don't want something that's 100% specificity and zero percent sensitivity. That's not really very helpful. in addition, you don't want something that never ever beeps. If you just have a metal detector, you unplug it from the wall, you'd have something that's 0% specificity because you would not detect anyone with any metal, even if they had it, but it would have a hundred percent specificity because you would basically never false alarm on anyone. So in reality, it's a balance, right? And I think kind of the hallmark study, if I recall for the the pivotal study that DermaSensor references, they reported a 95.5% sensitivity. So that basically means they are catching 95.5% of the people who actually have some of those other skin conditions that required the follow-up, you know, basal cell, squamous cell melanoma, those types of things. And 20.7% specificity.
[00:10:36]
So what does that 20% roughly, call it 20% specificity number mean? That means that 80% of the time, four out of five people are being flagged as having a concerning something to be checked out when actually they didn't have anything. There are real costs to that. There are psychological costs for the person. If you are getting this check and it says, hey, requires further investigation and you actually don't have anything, there's an added stress to that. In addition, there's cost to the medical system. If they're going to be sending four out of, or four out of five people are going to be going who don't actually have a basal cell carcinoma, squamous cell carcinoma, melanoma, it's a lot of additional waiting lines and cost to the medical system, right? So I think it's all a balance. You want something that has a high sensitivity, like the device does at the 96%, but 20% specificity is not that great, you know, in all honesty. Now, it depends on the types of device and everything else.
[00:11:36]
You definitely want to have a balance there. But I think just in general, right, the FDA has approved this device for very specific populations. Over 40, has to be something that, you know, a, a lesion or something else that is somewhat concerning already. So I think the FDA probably thought of some of those additional restrictions because they don't want to create a huge line of people who don't end up having— But you know, talking about the testing, so again, these are clinicians using this device. you can think of it that they're not going to be trained like a dermatologist. So they're not looking at hundreds or thousands of moles every day, every week, which is why something like this can be helpful. Now, when you look at the DermaSensor claims, they basically are talking about, I believe, 16 lesions per device per month in terms of current usage.
[00:12:30]
Now, Teddy, I'm curious when you think take a look at those kind of usage stats. You know, when we just talked about a little bit of the business model, right? If it's 399 a month, you kind of get unlimited. I believe they actually have a business as well or a a tier where it's 199 a month for five. So the economics there kind of works out to like 40 bucks a scan if they're on the lower plan. and it's 25 bucks or less, you know, if they were basically doing it at sixteen per month. But is that a good number? Is that high?
[00:12:57]
Is that low? Like how do you think about the market opportunity here when you hear about that current usage?
[00:13:04] Teddy Lyons:
Yeah, so I I sort of likewise when I first heard the sixteen scans per month, it didn't didn't seem like a lot to me as, you know, as an outsider looking in. but I I talked we we did a lot of deep diligence with the with the CEO of DermaSensor. and that sixteen scans per month is actually higher than they expected when they went through their pivotal pivotal clinical study. primary care clinics that they were working with were averaging around five scans per month. So the current utilization is basically three times what they were seeing during during their study and I think what you need to remember about this FDA clearance that they have is it's cleared it's cleared for a very specific use case.
[00:13:52]
So the FDA cleared indication for DermaSensor is for physicians who are not dermatologists to evaluate suspicious lesions in patients over 40. so it's not a device that is the current indication would say is intended to be used on every patient. through who walks through the door of of one of these clinic of one of these PCP offices. but that doesn't mean that other clinicians can't use it. So the FDA indication limits who they can market the device to. So they can only market to to PCPs that see patients that are over 40 years old. but one of their biggest users right now. So so they're not able to market those devices to anyone that's not a PCP, but dermatologists have purchased the device and are using the device and already make up around 10% of of DermaSensor's customers.
[00:14:45]
And the dermatologists, they're averaging over a hundred scans per month, which makes sense, is because they're dermatologists. They this is what they do every day. so dermatologists average over a hundred scans a month compared to the 16 for primary care physicians. So There obviously is this kind of much higher utilization opportunity in dermatology, but DermaSensor can't market to them yet, which they will be able to eventually. They just have to go through the the proper FDA clearances for that. And but we're already seeing really high usage from dermatologists that aren't even being marketed to, but you know, hear about the device, buy it, and now use it quite frequently, just to kind of help them in their own analysis, even though they are far more trained to determine whether a a lesion is is cancerous just from their own eyes. That kind of using a device to help them with that is something that they've that they've been using it for and and are really using it, you know, high utilization rates there.
[00:15:51]
DermaSensor also they're pursuing an expanded FDA clearance for nurse practition nurse practitioners and physician assistants, which could obviously open up kind of even more clinical settings. For them to not only market the device to, but to actually sell into. So I think the 16 scans, kind of tying it back to that, is it is actually, even though it's on the surface level, it seems low, it actually is a positive sign of adoption in primary care. Who, you know, analyzing these lesions isn't what they're doing all day. It's kind of something that only a certain amount of of patients are coming in for. so I think the the real opportunity of for scale with DermaSensor is can they expand beyond their cleared indications and and be able to market to these other segments and clinical settings.
[00:16:41]
So yeah, so 16 is good. It is the is the real idea here. but yeah Brian wanted to bring it back to you on AI and healthcare because usually, you know, with someone a company like Koios Medical, they're software analyzing medical images, but DermaSensor is doing something quite different in that it's actually using a handheld physical device, it's using hardware to measure the underlying cellular structure of the skin lesion. So from a tech standpoint, what in what interests you most about how this device works, how it was brought to market, and do you think it will give kind of DermaSensor this this competitive advantage over a traditional based traditional based kind of photographic AI used for for skin lesions?
[00:17:27] Brian Belley:
Yeah, so that's a really good point because I think it's important to understand, you know, the hardware item, what this is, it's not just taking a photograph of the skin. Basically, what it is, it's a xenon arc lamp. So it produces this really broadband white light. It's delivered through a fiber optic tick tip when and then there's another fiber that kind of collects the backscatter that feeds into a micro micro spectrometer. So what this essentially gives them is this curve of wavelengths and intensities.
[00:17:53]
And you can kind of think of it like a fingerprint in ways, right? And there's a lot of different ways that like spectrometers are used in science. we actually use it, you know, when trying to assess what the atmosphere is of planets so far away. We can't test that atmosphere. But if we look at the wavelengths coming back, we can see there are certain peaks that correspond to certain atoms. Based on that, we can actually determine, you know, a little bit of the composition of the atmosphere.
[00:18:18]
kind of in a similar way, this is using a technology like that to create these fingerprint signatures. And you know, going to your AI question. That's why AI is going to really important because it's just really hard. It's not like a very clean thing that you can do, but over thousands and thousands of images, if you train it with a really good database, that's where you can start developing, you know, something that can detect a basal cell, a squamous cell, carcinoma, those types of things. So just to use another analogy, you know, for anyone who's ever used a stud finder in your house, like an acoustic stud finder, trying to find those studs in your wall to hang a big picture frame or something else. You're you're emitting you know acoustics or whatever else into the wall to go a little bit sub-suble level.
[00:19:01]
So you're not taking a photograph of the wall, right? And based on the reflections that come back, it can tell you and inform you: hey, there's something here. In a similar way, the DermaSensor device, right, is not going to be able to diagnose that, hey, this is a squamous cell, hey, this is a basal cell carcinoma, but basically it will tell you if it warrants further follow-up. so the way it can do that, right, is again just the the way that the light hits it.
[00:19:27]
a benign lesion versus you know some of those different carcinomas will have different reflection patterns. but you can imagine that there are going to be some complications with this, right? So calibration is something that they're gonna have to put a lot of work into where you can just imagine not only the pressure, like how hard is the person pressing, differences in skin pigmentation, right, from different customers. Do you have tattoos and other things there? There's all these variations that they're gonna have to eventually build this database to train their models on so that it doesn't just work for one specific use case, but that it's actually practical in the real world. so those are you know some of the challenges they're going to have to overcome. But I think that what they've proven, right, with kind of their their pivotal study again is that they do have, you know, it seems like a technology and a good differentiator.
[00:20:15]
that between the hardware device and then building this database for being able to use that AI to train it to be able to detect these is something that is technically feasible that makes a lot of sense. Now, you know, we've dug into a lot on the kind of the business model and you know the technology side of things, but as there's one thing we all know as investors looking at any deal, the deal terms. Like what is it actually a good deal? This could be the the best device, it it works perfectly and everything else, but at the wrong deal terms, it might not make sense for an investor. Léa, I'm gonna kick it over to you. If we take a look at things like the valuation, the capital efficiency, everything else, what stands out? What's your what's your takeaway there?
[00:20:54] Léa Bouhelier-Gautreau:
DermaSensor is raising at 72 million. so to understand whether that's a number that makes sense or not, and then every investor can make their own judgment on whether they think this is good for them or not. but first, I think we have to understand where that comes from. So we have a company, we have a product that is working, that is doing a better job indeed than primary care providers, and that is FDA approved. So, like Teddy said earlier, this is actually pretty rare to find an investment opportunity with a product that is FDA approved that is on the market. But I think we also have to look at the previous funding.
[00:21:31]
It took 48 million dollars of investment already to get this product where it is right now. so you can imagine that if the founders wait to raise an any lower number, they will get extremely diluted and every early investors as well. And I think they deserve after having you know done all the hard work to still get some potential upside. And I think that's a good thing as well as investors to invest in a company where we know founders still have upside because that gives them upside potential, because that gives them a motivation to actually work hard and grow the company. And I'm gonna say at this point for us, it doesn't really matter how many millions have been invested into this company.
[00:22:12]
What matters is how many more millions do we need are going to be invested in this company. There's no like clear answer to that. It's kind of a back of a napkin kind of calculation and everybody can do their own kind of modeling. But I'm trying to think if we want a venture like return, we probably want a company that is going to exist as somewhere around seven seven hundred twenty million up to a billion dollars, which is not impossible, especially in MedTech, especially when there's revenue, especially when there's a good use case. And I'm thinking a company will need to reach anywhere between like 50, 100 million ARR. the it could be more if they have a lower revenue valuation multiple at the time of exit.
[00:22:55]
But that means they're still going to have to invest because as we discussed earlier, one device is 1800 cost of goods sold, and it's also two thousand dollars of marketing investment. And that is reimbursed basically in after one year. So it's kind of going to act as a a flywheel. I like imaginary flywheels that only work in a perfect world. but it's basically like let's say you have 100 let's say you have 100 devices on the market right now and you make about four thousand dollars a year with them. Well, that's cash that comes in the bank of DermaSensor of about four hundred thousand dollars every year. So then the company can use that and basically build another 100 devices and so on and so forth. So the following year they have 200 on the market and they can be building 200 or sell building and selling 200 new devices, et cetera, et cetera. So I feel like the more the company has cash, the more it actually has potential to sell.
[00:23:53]
The velocity of the sell will really tell us how much funding they will need for it or not. in the quick math I was doing, you know, I was thinking maybe they will need around like 20, 30 million more dollars. I feel like that would be a good number if we want a quick, you know, velocity of sales in the beginning. they could make it with less funding. It would just take a little bit longer to reach this higher valuation. So what I know is that adoption is I think going to be pretty good. And another reason that we did not talk about yet is the reimbursement of these devices. So we said it costs maybe on average anywhere between like forty dollars to twenty-five dollars a scan for a PCP if you divide the number of scans by the subscription.
[00:24:40]
Well, PCPs can get these subscription reimbursed by insurance for about $100 per scan. So they have a very good profit margin. So they only need, let's say, four scans that are reimbursed a month for them to recuperate their cost. And I think that's another reason why adoption is going too low and why I hope for them as the that flywheel can work. One risk here is that it's not guaranteed that every single insurance, every single plan is going to reimburse these scans. I think that's important to know. But let's say out of six this can amount, you only need four to actually be reimbursed for the PCP to recuperate their cost. So is the flywheel going to work? only the future will tell, but there is a math case to be made behind that company. And I think there is a future where it just works. There's obviously a lot of things that can happen in the way. it's a startup. It is a very risky investment like any other. but it there is a possibility where DermaSensor could actually give a good outcome.
[00:25:43] Brian Belley:
Yeah, that's awesome. And I think you know, again, for investors who want to learn more, say it rated a 4.1 overall. But if you want to see the full breakdown, if you want to see was this a top deal, did Kingscrowd invest? We have all this available for our Kingscrowd Edge members on our site. So make sure you head over there.
[00:26:03] Teddy Lyons:
Yeah, I was gonna say another thing you can find in the report is, you know, since they're in this inflection point of commercialization, how are they actually going to sell? Like how are they gonna expand their sales with MedTech devices? It's all about partnering with distributors and folks who are in front of your target customer segment. So in this case, primary care physicians. DermaSensor has four really exciting channel partnerships that are rolling out right now in Q4 of 2026. And that gives them X the potential to sell into nearly 200,000 primary care physicians in the United States. And for context, there's about 580,000 PCPs in the United States.
[00:26:46]
So through these partnerships, they're gonna be getting in front of hopefully a really large percentage of those PCPs. So dive into all that as well on the analyst report on Kingscrowd. So definitely go and read that.
[00:27:00] Brian Belley:
Awesome. Well, I think we'll wrap things up for there. If again, if you want this detailed analysis, the deep dive, go check that out. You can purchase the report. You can become an Edge member and you get all of the analysis that Teddy and Léa do. As you can tell, they just have a wealth of knowledge. They are talking to the founders, they are interviewing the founders, they're doing deep diligence to help to save you time and just provide hopefully some insights that again are not investment recommendations, but can help you make more informed investment decisions.
[00:27:26]
Wrap things up there. On the next podcast, we'll be diving in and reviewing another deal. Also, you know, we've been on the road a lot recently. So I'll just give a shout out to Teddy and Léa that we've done a couple different places from San Francisco to LA to DC to North Carolina, a whole bunch of in-person events. Make sure you're checking out the kingscrowd.com/events page. And I'm sure we're going to be doing some more of these events in different cities moving forward. Until next time, we'll see everyone back here on the Kingscrowd podcast. Thank you.