Latest / Zero Friction / ADOM's Stan Miele on Revolutionizing Eye Care & the Tear Film Imager || Zero Friction Podcast
Transcript
- Terry Coutsolioutsos/RevRx AI: Well welcome guys, I have an exciting day today on the Zero Friction podcast. I am blessed to be with Stan Miele and I actually go way back into the stent and anti-platelet wars and we'll make that part of our conversation. why Stan is here today, he up operations for ADOM Advanced Optical Technologies and they a very unique imaging machine called the Tier Film Imager. And Stan's here to talk about his career. Stan Miele: Thank you. Terry Coutsolioutsos/RevRx AI: his leadership style, what he's done to actually get the Tier Film image to market in its current place, and where he sees it going in the future. So Stan, I appreciate you being here today. Why don't we start off with a little background on yourself and we'll lean into the Atom Advanced Optical Technologies. Stan Miele: this talk. Thank you, Terry. It's a pleasure to be with you this morning. And boy, we did have some fun conversations as it relates to early interventional cardiology worlds, but very quickly looking at my background. Post-military, I've been in the ⁓ device, biotech, pharmaceutical realm for approaching 40 years. Started with big I was a sales guy and eventually migrated to medical device and was fortunate enough to be with a big company like Abbott Laboratories. And really cut my teeth there with 2200 products, very focused on the hospital segment, ⁓ from ⁓ IV bag to infusion pumps. But it really gave me some good insight into ⁓ landscape associated with certainly hospital sales, but ⁓ critical care environment. And when you're converting big health systems like Duke Medical Center to infusion pumps. It's it's a all hands on deck to try and execute something like that over a two to three month period. But with all that being said, eventually migrated to the biotech world really loved that type of environment. The, I the term often building the plane as you're flying it. ⁓ I that nascent startup mentality where ⁓ everyone's multiple hats, perhaps here an inch deep and a mile wide, but I really enjoyed that smaller nimble type of biotech, small med tech type of environment. And through that had many great experiences, again, getting into the anti-platelet world with a 2B3A inhibitor, ⁓ was ⁓ great experience and calling on some key ⁓ medical centers and the like, ⁓ eventually moved up in the food chain with Core Therapeutics. Core was acquired by Millennium. I moved to the Boston area. at that time and at that point was heading up the US sales operation for the interventional cardiology team. after that, it's just been a real run and with nascent startup biotechs from there went to Sucampo Pharmaceuticals. After 10 plus there, eventually at one point was president of the US subsidiary ⁓ was with the when they went through an IPO ⁓ involved in global agreements and That to me was sort of the pinnacle of pulling many different types of things together from all of my background, because it was everything from frontline sales, but then also to building infrastructure ⁓ license agreements and getting everything going. ⁓ pivoted over to ⁓ med device and have stayed in the biotech realm on multiple consulting realms, ⁓ have been with the dome for several years now initially as an advisor working with them in this pretty exciting technology and we'll certainly have time to get into that as well. Terry Coutsolioutsos/RevRx AI: That's great. Well, it was a great career. And tell us where a dome is today where see a dome going in the future, because I think that's a really exciting play. Stan Miele: has an exciting technology. You mentioned it earlier, the tear film imager. And when we think of ⁓ standard visit to a general ophthalmologist or an optometrist, Over 60 % of office visits typically surround the surface of the eye. And we hear very frequently and we see a lot of television commercials for the retina area, whether it's dry or wet AMD. But the surface of the eye, ironically has been an area that's somewhat neglected. And what I mean by that is when we look at a lot of the therapeutic developments as well, a little bit of hit or miss when we think of things when it's ocular surface disease. For example, if a patient comes in, they say, and I happen to reside in the Arizona area where it's an exceedingly dry climate, dry eye disease is a very, very common disease state here. the patients, they up becoming what we refer to as frequent flyers. ⁓ The clinician will say, look, try this over the counter drop, try this, try that. Often, ocular surface disease becomes a bit of a secondary type of diagnosis. But again, it becomes a bit of a nuisance. And the workup on a patient is everything from a simple questionnaire to, can be more involved to invasive tests like the Schirmer's test, or ⁓ testing for inflammation with an MMP9 test, but it can end up ⁓ at five minutes could end up being a 45 minute workup. And in the end, the objective here is to see if there is a simple holistic type of method that can do a thorough assessment of the surface of the eye, like they do for the back of the eye. And I think that the simple analogy is when you look at Terry Coutsolioutsos/RevRx AI: Okay. Stan Miele: devices that are in just about every ophthalmology or optometry practice today. A device that's very common is the OCT. It's been out 30 years, standard practice. It helps diagnose retina disease, glaucoma, ⁓ cetera. But if you say, what's the singular device that ⁓ cornea specialist or an ophthalmologist will use to assess the surface of the eye? ⁓ There is no one simple device, right? And I think the beauty of the tear film imager is twofold. Number one is it's the only device that's able to look at all the layers of the surface of the eye. And I think that's a real critical success factor in that the surface of the eye has multiple lipid layers, but no one to this date has been able to look at a key layer, which is called the muco-aqueous layer. And if you're unable to see all the layers of the eye, you can't determine the health the surface of the eye. And so it's a bit ⁓ and they use surrogate methods to try and triangulate to this. So in summary. ⁓ You have a device now, it's a simple device that can do a 40 second assessment for each eye and give the clinician and the patient very significant, both qualitative and quantitative information on the entire surface of the eye over a 40 second exam. And it will help the clinician clearly determine what is the state of the surface of the eye. So there's more predictive and precision medicine to say you have X. and then give the appropriate treatment. And then you can have the appropriate follow-up. So it's like if you get knee surgery, right, you have an MRI before, you do the surgery and then you do the post-surgical imaging. Right now there's really no before and after. So the beauty of this, again, it falls into the realm of assisting the clinician and the patient from a precision medicine standpoint. But I think that's going to be the key to the future is getting this device more mainstream as a very important tool in the Terry Coutsolioutsos/RevRx AI: Okay. Stan Miele: kit of the clinical practice. Terry Coutsolioutsos/RevRx AI: So what are the implications of not having this type of precision medicine? We talked about frequent flyer capabilities, but it's just people coming back when things don't work. But what are the potential implications that the tear film imaging technology is actually going to solve for? Stan Miele: Well, the term precision medicine, I use that almost like AI, right? Sometimes these terms get thrown around loosely, all right? But in the realm of the medicine world, whether it's diagnostics or certainly therapeutics, Terry Coutsolioutsos/RevRx AI: Sure. Sure. Stan Miele: The objective for all clinicians is to be more precise. If you can be very definitive on the initial diagnosis know, for example, when it comes to dry eye disease, is it aqueous deficient? Is evaporative dry eye or is it a combination of both? Terry Coutsolioutsos/RevRx AI: correct. Stan Miele: The objective is to not do sort of try this, try that, be more honed in specifically on the exact type of treatment that would be required. again, that can immediately reduce the frequent flyer syndrome, right? But also it's a better ⁓ for the patient, we would hope. And certainly they're gonna be more pleased with ⁓ clinician if they know that they're able to not have the right diagnosis, but then also Terry Coutsolioutsos/RevRx AI: Sure. Better experience, right? Yeah. Stan Miele: also know when they show them after post imaging, you can say, ⁓ at the improvement on the health of the eye. Again, I think the best way to equate this is to think of something ⁓ an invasive knee surgery, right? There's the before and after. ⁓ patient may feel better, but in the end, you also want to be able to prove to them that there's actually been improvement on the health of the surface of the eye. ⁓ Terry Coutsolioutsos/RevRx AI: That's great. So you get the right diagnosis and I'm guessing off of that there are different. options of treatment, right? So there's a surgical treatment, there's probably a pharmacological treatment, there might be other types of wellness treatments, functional treatments, that type of thing. So really makes it interesting. Where do you stand today? I know that you talked a little bit about where you do have some industrial at this point, but it really hasn't hit the mainstream in terms of the ⁓ and ophthalmologic marketplace yet. Stan Miele: Right, and I think that's what brought us actually together from a quote unquote friction perspective, right? And when we think of companies that have somewhat of a traditional launch cadence, there's usually one launch, right? One robust launch. And the company did from a regulatory perspective, and I think we both know ⁓ there's types of path. There's a new technology or there's what's called a 510k exempt registration where you ⁓ Terry Coutsolioutsos/RevRx AI: Yeah. Stan Miele: parlay your regulatory filing with the FDA as where there's different types of predicates. And so due to speed to market, it was elected by the company to move forward with a 510k, which is perfectly fine. But what that allowed us to do is instead of doing what we called a robust launch, it was let's get the existing technology, the tear film imager in its current form the marketplace. ⁓ so we have it at key academic medical centers. We have it with industry, some of the top companies that you can imagine that are, ⁓ know, the allergens of the world, for example, very big players in ⁓ therapeutic as well as the wellness center, but very big. the eye space. then we also have a program where it's in high volume clinics, right? So between the three key pillars, I look at that as a foundation, ⁓ have 13 devices placed where we've been gaining tremendous insight on the device itself, almost like a pilot launch. ⁓ I'm stating this more as it's like real world. quantitative and qualitative market research. So they have this device and we're getting great feedback from all of these, but at the same time, we're using it as an avenue to say, let's work out the kinks before we go mainstream. And one of those areas, for example, was related to automation. Right now in its existing form, the device is not 100 % automated. Terry Coutsolioutsos/RevRx AI: That's awesome. Stan Miele: Data from the readings is uploaded to the cloud. It goes to a reading center. It's fed back to the device. Well, look, if that takes longer than five minutes, that doesn't have great applicability into a mainstream, very busy general ophthalmology or optometry practice. They're moving patients through. So. Terry Coutsolioutsos/RevRx AI: correct. Stan Miele: We're working on the AI automation piece as an example. We want to make the device footprint much smaller than its existing state. And in a similar vein, we're building one device at a time. So our cost of goods. are not exactly what one would say are highly efficient. So we have to scale to a commercial scale manufacturing drive down our cost of goods. we're in the midst of a capital raise, but in the meantime, we're still making great product progress. We've already improved dramatically the automation piece and we're basically down to five minutes due to the AI integration and having thousands of readings. Cause you use that as a normative database and then you're in a great position. Terry Coutsolioutsos/RevRx AI: Right. Sure. Stan Miele: So to summarize, the device is right now being. I would say and enhanced based on a lot of this great feedback we've received. ⁓ then with the capital raise, intend to scale to get get our cost of goods down dramatically, scale commercially. And then we will be in a position to hit the where we would hit all of the dry eye disease centers of excellence, ⁓ all of key cornea departments and every academic medical center. ⁓ It's very and specific. to who is your top tier of the market, right? And we know those that do the most procedures. And then another big segment of this market, quite frankly, is ⁓ that do cataract surgery, right? When talk about precision medicine, like the optimum outcome of a cataract surgery. is really derived by the health of the surface of the eye before the cataract is implanted. So if the surgeon knows the health of that surface of the eye is pristine, the probability of having a more optimal outcome. is dramatically improved. And so we're talking with cornea specialists, the cataract surgeons, dry eye disease centers of excellence, and we're building this groundswell. Not to mention the fact that we have 15 publications. So the company is very based. Terry Coutsolioutsos/RevRx AI: Wow. Stan Miele: in strong evidence-based medicine where you have publications supporting this technology. And I think that's also something that's been very important to me in my entire career, whether it's med tech or biotech, evidence-based medicine is the key to everything. So the more peer-reviewed publications and data you have, that can then become even that much more helpful when you do find yourself in the position to do the significant launch that everyone's expecting. Terry Coutsolioutsos/RevRx AI: That's awesome, so you've got an approved technology in place. You have 13 centers today that are utilizing the technology, you to actually get it to your V2 or your 2.0, right? And then the next phase is getting it to the mainstream, sort of upper tier of the where you can having that dramatic impact a... a larger array of patients, right, whether they are surgical candidates or whether they're pharmaceutical candidates, right, so along those things. other side is for me that really, you know, coming from a device background ⁓ more of a surgical approach is that, you I think precision medicine is a great term and I don't think you're overusing it by any stretch of the imagination, by the way. I think that Anytime that you're treating a patient for something, having that really nice narrow channel of what you're going to do, what it is today, creating the baseline and what it is tomorrow, or not that candidate's a great candidate for this surgery or not a great candidate for this surgery. ⁓ Stan Miele: Thank you. I have to say, I'm really excited. Terry Coutsolioutsos/RevRx AI: All those things are really gonna help better care, better patient experience, better economics for the whole healthcare marketplace, which we all know is economically broken. ⁓ so these are the technologies that really not only advance patient care, but it also ⁓ us to be an economically viable healthcare provider as well. So I think these are all really good things. So which pivots me to the next point. you're ⁓ in process of building a strategy around the next round. Stan Miele: you Terry Coutsolioutsos/RevRx AI: looking to attract from that next round? Who you think would be a equity partner, venture partner, family office partner, strategic partner? What's next for on that side? Stan Miele: you Well, it's a great question and I think it starts with when you're looking at your ask and if it's X million dollars that drives well. Do you want to talk to big institutional And we all know that standard healthcare, big names in the ⁓ device realm, ⁓ certainly are several ophthalmology institutional investors well on the venture capital side, as well as offices as well. ⁓ They tend to a very pivotal role depending, in fact, one of the current inside lead investors is someone who's with great net worth. but has been a bit personal because he personally has actually had access to the device, right? ⁓ I think, ⁓ know, those types of things make it fun at some level while raising capital is never ⁓ ⁓ easy. It is great to know that you making a difference. And when it to the strategics, ⁓ that's a broader. But my vision from a strategic standpoint, there's all the big household Terry Coutsolioutsos/RevRx AI: Right. Stan Miele: I've even mentioned the Allergans and the Alkons of the world. there's many, many companies that fall in the realm where they have great technologies, whether it's stem cell companies ⁓ companies that are looking at, ⁓ do regenerative work on the surface of the eye and they're excited about demonstrating the before and after effect of what's happening. Do they truly reset the surface of the eye? What a beautiful complimentary type of cell. Terry Coutsolioutsos/RevRx AI: Thank Stan Miele: that could be if you have a device that can truly help them in the diagnostic realm but then prove great improvement after particular technology. ⁓ And ⁓ in similar vein, there's the device companies that the infrared sort of pulse technology that works on the my bovine glands ⁓ those with excessive dry eye where it's driven from the glands. They're to all of these dry eye disease centers of excellence, right? So there's a great, again, great strategic that we think of if we ⁓ end up to the point where we wanna collaborate a strategic partner. There's certainly numerous and many on the treatment side that I think this could be a nice one-two punch. want to get a better ⁓ in terms of market penetration. ⁓ we are having ongoing discussions already with some of those strategics, which I think will ⁓ out quite nicely, especially as we start proving that their technologies are having a benefit. Then it becomes a win-win. Terry Coutsolioutsos/RevRx AI: So we talk about before and we talk about after using the tear film imager. What about during? Like what about during some of these procedures that know you don't have to wait until you come back? Is it something that you could actually use during the procedure to make sure that ⁓ directionally correct while you're doing it or no? Stan Miele: answer to that is no, but when we use that, but I will just simply redefine your during, right? So if we ⁓ before, ⁓ the upfront component of saying, all right, we've done an initial assessment of your ⁓ and have A, B and C. Then we want you to start X, Y, Z treatment. And then we're gonna have you come back in a month. And then at that point, we'll call that the during, right? Because then we can start to see if there's impact actually happening, whether it's a month or two months or whatever the timeframe, that in my mind is what would be considered the during. And then after the treatment has been completed, then when the patient comes back, it can just be subsequent visits to see if they've reached somewhat of a steady state, if there's been any further changes or if that they need subsequent follow-up type of treatment. Many of the therapeutics Terry Coutsolioutsos/RevRx AI: Right. Good. Stan Miele: as you can imagine for any sort of eye surface disease are going to be chronic in nature. with that in mind, the is to get them through that inflection point where they're having difficulty, but then it can migrate to a little bit more of a steady state where we're just trying to make sure from a maintenance standpoint, the therapeutic or the invasive treatment is doing what it's supposed to do. ⁓ Terry Coutsolioutsos/RevRx AI: Well that's awesome. moving forward, it's ⁓ the funding, ⁓ to version two, which is going to be a more economical version of what you currently have today. ⁓ Correct. Stan Miele: Correct. Terry Coutsolioutsos/RevRx AI: And I'm sure with AI every day changing the world, mean AI is moving so fast. What you have in AI today is probably not what you're gonna have when you get it out there later as well, right? So you'll have all sorts of opportunities of improvement. pretty exciting. When do you think, ⁓ you were to have money today, like when do you think that next version would be able to be ⁓ to go? Stan Miele: Well, we would anticipate if with the tech transfer and the manufacturing process, as soon as that happens, it's anywhere from probably eight to 12 months where we would actually have that revised version two. To your earlier point about AI, already having a dramatic impact on the software enhancements, right? From a programming standpoint. Terry Coutsolioutsos/RevRx AI: Okay, pretty fast then. Stan Miele: Those changes have occurred and again, as mentioned, the automation piece is already well underway and we're probably about 95 % there even as of today. But I think the blocking and tackling associated with just the fundamental building a device one at a time manually to then moving to more of a robotic full scale manufacturing operation take a little bit of time. ⁓ that's probably the eight to 12 month mark. And then with that also comes refinements of shrinking the size to a certain degree, the molding associated with just the simple structure of the the device itself, within 12 months, we would absolutely envision from the moment of ⁓ funding ⁓ ⁓ would be well on our way. Terry Coutsolioutsos/RevRx AI: That's great. That's a pretty quick turn too. pretty exciting. Well, Stan, as we close this thing up a little bit, I do have a surprise question for you. it's a pretty, ⁓ it's a good one and ⁓ more personal than anything else. So, ⁓ know, if you could go back and offer advice to 22 year old Stan, what advice would you give Stan? Stan Miele: Okay. 22 year old Stan, boy, if I think about what I was doing at that time, boy, that was having a nice military career. And I was thinking, do I want to move forward in my military career? Or do I want to get out of the military and start getting into this rat race of the medical device world or the med tech world? But in all seriousness, I think the biggest advice is just more about Terry Coutsolioutsos/RevRx AI: Right. Stan Miele: staying focused and not getting distracted, right? And I think one of the things that, and I've had, we've all had several mentors over our respective careers and. in particular, just ⁓ sometimes ⁓ have a tendency, and this is just to your point getting personal, right? But, ⁓ know, I mentioned the fact that I loved biotech because it's an inch deep and a mile wide when you're with a nascent startup organization. And that can be true for med tech as well. But at the same time, when you're an inch deep and a mile wide, sometimes you don't get to the depth that you need to And you're not having that quote unquote focused execution because you're focused on so many different things. Right. And I think for me it's about, sometimes you can't that fence. If you want, have to, ⁓ you can't, you be an expert at everything. So as much as I personally love ⁓ the. Terry Coutsolioutsos/RevRx AI: Mmm, yep. Stan Miele: nascent startup type of environment. There are cons that come with that because at some point, expertise and specific areas drops off because you do need sometimes expertise in some of those specific areas. I think whether it's whether it's relating specifically to a dome or other experiences in my life, I think with that I've been with, it is important. I think there's a balance between that. right, that at some point you can't have it both ways. If you want focused execution, sometimes you need true expert expertise all of those respective areas, as opposed to ⁓ inch deep, mile wide mentality, because you can only get so far. And best example of that, I think, is just ⁓ as been with companies, sometimes when you're too nascent and you're struggling for capital, you do not do the appropriate that you really know you should do, okay? And at some point you will reach a plateau. And I think it's important to sometimes keep your eye on the ball for the bigger picture and not lose focus. And as much as you can get to a certain point with the inch deep, mile wide mentality, ⁓ some point that will only get you so far. And I hope that answers your question. Terry Coutsolioutsos/RevRx AI: Right. It's great. It was not, you know, really is not my question. It's more your question. know, ⁓ I agree with you totally. And in the startup world, it does not afford you the ability to have all these experts sometimes because ⁓ you're balancing getting to market and cash burn and ⁓ these different things and experts typically they do cost money, right? And so ⁓ where, ⁓ know, advisors and leaders like yourselves trying to lift these startup companies off the ground. Stan Miele: Yeah. Terry Coutsolioutsos/RevRx AI: You know, ⁓ need to have expertise in different channels too, which is what sounds like you have developed some of those skills. But again, ⁓ because you're good at ⁓ skills doesn't mean you should be doing all 10 either, ⁓ Just because, ⁓ I truly, totally believe that whole, that... That lens of focus is such a great point that wish I would have had when I was 22 years old. And way you can find your North Star, ⁓ understand important, and then deliver on those things that are important. So I really appreciate you kind of delivering that from a personal perspective. again, ⁓ Stan from ⁓ They've a great technology with the Tier Film Imager. We'll be putting this out in various channels. with Apple, with Spotify, and with YouTube, Stan. And we look forward to next steps and hearing your success story down the road. Thank you so much. Stan Miele: Well, thank you, Terry. I really appreciate the opportunity that you've given me and Edong to be able to share this exciting technology. And I look forward to further discussions with you and keeping you informed about the success of the company as we move forward. Terry Coutsolioutsos/RevRx AI: Thank you, Stan. Stan Miele: Thank you very much.