Fluid In the Ear? New Imaging Technology Aims to Revolutionize Middle Ear Assessment

Fluid In the Ear? New Imaging Technology Aims to Revolutionize Middle Ear Assessment

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[Music] [Applause] [Music] [Applause] [Music] welcome to this weekend hearing my name is amin amlani i'm joined today by jeff heider chief commercial officer of photonic care and dr seth pransky a pediatrician a pediatric ent physician together we will be discussing how photonic here is providing better and simple to use diagnostic technologies to clinicians welcome gentlemen thanks for having us it's my pleasure so jeff you're the chief commercial officer can you tell us a little bit about yourself before we talk about your company yeah absolutely so uh my name is jeff heider uh chief commercial officer at photonicare i have been in the medical device space for over 20 years and bringing new technologies to market both in the imaging space as well as in soft tissue implantables really love the idea of bringing something that's new and novel to the market where people can improve the care they're delivering our providers can improve their care but also are making a difference right it's not just a me too product i really enjoy bringing new true technologies that are novel to the marketplace great and then we also have dr seth pransky again he's a pediatric ent would you tell us a little bit about yourself sir be happy too good day everyone my name is seth pransky and i am a pediatric otolaryngologist i've been in practice here in san diego for 36 years and for 20 of those years i was the chief of the department of pediatric ent at the radio children's hospital and my career has been both as a clinician and as an educator we have had a fellowship program here in san diego since 1990 and we train both residents and um uh of the ent world and the pediatricians and i also have been the director of the cme department for 17 years educating the primary care physicians and allied health personnel for 17 years and so um it's a pleasure to be able to be part of this discussion regarding what i see is an incredible advancement in the ability to correctly diagnose and manage your problems wow well we appreciate both of you gentlemen being here and talking about this so jeff let's start out by talking about photonic here tell us a little bit about the company when it was founded where you're located and those kinds of things please yeah so photonic here came out of the university of illinois um urbana champaign uh ryan shelton one of our co-founders co-founders along with steve beaupart we're in a lab working on optics and optical coherence tomography uh ryan nolan had joined them um and the three of the comp the gentleman founded the company in 2015 out of the need of really was was a parent need uh ryan shelton's child had been going to the uh doctor with repeated ear infections and he just thought this is really um archaic the way we're diagnosing this a lot of guessing and they developed the technology to be very objective which is what otocite middle ear scope is and um as i said in 2015 we we've uh commercialized the company and really began to develop the product product received fba clearance in uh beginning of 2020 and we really began to commercialize that then and again we're co-located between champaign illinois and durham north carolina durham has a ton of knowledge base and uh a ton of talent in the world of optics and optical coherence tomography and we've been commercializing the product since uh as i said 2020. wow so you mentioned the odocyte middle ear scope so can you tell us a little bit about that yeah for sure so the otosite middle ear scope is an imaging device that allows you to really assess what's going on in the middle ear a lot of times with kids come in with ear complaints or ear infections uh you have a doctor using something essentially a magnifying glass and a pen light that was developed over 150 years ago to look in the ear and kind of guess is there fluid is there not fluid is this infected or not and they're really doing their best to do this in a subjective manner what otostate does is it uses optical coherence tomography to look through the tympanic membrane into that middle ear cavity and that middle ear cavity is where the fluid is if there's fluid present so we're actually able to identify the presence or absence of that fluid the turbidity of that fluid and what's nice we can do that even when there's earwax present in the ear so we're giving very objective data in a a form factor that's very similar to the common otoscope that you're used to using just with a whole lot more specificity than you would have otherwise okay all right so as i'm as i was looking at your website here uh doing my homework for for this uh webinar this webcast and you talk about a 90.6 accuracy compared to a 50 accuracy with a traditional odor scope so you've got some clinical evidence here can you talk a little bit about that for us of course uh yeah so there's data published in 2001 by kakarot out of rochester new york that showed that um clinicians were accurate about 50 of the time when diagnosing an ear infection and this was done by showing them images and then they had a clinical diagnosis and he's kind of patient history and other uh material water information involved we followed that study out using the technology within otocite to look at uh similar images showing them in a surface image of the ear drum along with an uh middle ear scan and those combined they showed about a 90.6 accuracy rate and again this was against all comers so we had everything from fellowship trained pediatric ents to hospital administration and they all were very uh very equal in how they assessed and um diagnosed it if there was fluid or not in the ear now the benefit to this is this technology can be used by anybody right it could be the the m.a in the office could be the nurse it could be the provider but it was very objective there was no art that had to be learned in how to use the technology and be able to correctly diagnose a presence around the fluid and and or the turbidity of that fluid interesting so we'll turn this over to dr pransky here so you had mentioned that you train fellows and you've got residents that are coming in and traditionally we've used an older scope to look in the middle ear can you talk a little bit about how well that particular instrument the otoscope has allowed you to look at middle ear and how this new product could potentially change the way that health care is being delivered uh in in people who have middle ear issues i think it's important to understand that ent is a tech heavy specialty and we have seen magnificent changes in our ability to manage diagnose and treat a variety of diseases that involve the the head and neck and it was an interesting interaction that i had with the photonic care co-founders when walking through the academy meeting one year i saw them began a dialogue was interested in what they were offering and as i learned more about it saw the otocite as a sea change in the ability to appropriately and accurately diagnose what's going on in the middle ear for me as a clinician i've spent a lot of time having to discuss with patients what they may have been told which may not have been accurate in terms of their ear problems of course as an otolaryngologist i have technology i have a microscope i have the ability to have binocular vision i have all the things that we need within our specialty which does not is not available to the vast majority of those that are looking at the ear so an otoscope is small the light may vary depending on whether the battery is running down or not and it is quite frankly challenging especially when dealing with wax that might be in the way with a struggling 18 month old who is irritable or crying or doesn't like something going into their ear um and consequently what mike picaro showed back in 2001 is that diagnostic accuracy is limited with an otoscope and i saw the odocyte as a sea change in the ability to visualize the tympanic membrane to record it to be able to review it to show parents what's going on and to assess the middle ear for the presence or absence of fluid which quite frankly can be rather challenging and takes years and years of of clinical acumen to really get right so this has been an amazing development for routine standard care ear infections are the most common cause for going to the pediatrician after going for vaccinations and standard things like rashes and routine pediatric care it's an enormous number of patients that go there being diagnosed correctly or sometimes not correctly with an ear infection and being placed on antibiotics needed maybe sometimes not needed that's very telling of the clinical efficiencies that new technologies are starting to bring in as jeff pointed out and you brought up the point here uh um that it's using this on an 18 month old but can this also technology also be used on adults or is it primarily only for children um of course this is a wonderful tool for all patients the the what you get with the instrument the ability to visualize the eardrum to see what's going on in the middle ear to spend some time to review what you've seen so you don't get just a snapshot you get a recording that you can stop and look at and spend time trying to figure out is it or it is is it not something that's wrong with the tympanic membrane or the middle ear is a massive improvement furthermore all patients parents the patients themselves adults love to see what's going on in their body we know that in the ent world because we use scopes all the time we're passing scopes to look at different parts of the anatomy and patients are more than just curious they're fascinated by what their what's going on and now they can understand with a little bit greater clarity why a particular type of intervention has been recommended be it do nothing or or intervene with antibiotics or a recommended surgery so of course this is excellent for children for adolescents for adults for for literally for everyone and and in all marketplaces i mean it can be done in an emergency department in an urgent care in the primary care office the audiologist um will benefit from this as well patients are curious they want to see they're used to it from the technology that we have in all other fields to be able to see and then be able to make a more informed decision wow and i'm glad that you talked about the fact that you know there's different um medical entry points in which this technology is going to be used so jeff can you talk a little bit about how this is potentially being used in hearing care uh versus for example the medical setting a pediatric office or an ent's office yeah so i i'm gonna open the door but i don't let dr pransky uh really put the exclamation point on the statement so you know a lot of times you know kids aren't very communicative uh or able to convey what their hearing loss is because they don't know what hearing loss is uh what's really nice about this is when you're looking at this you're not gonna get a baseline for that patient of what their drum looks like or what that is but i think dr branson we've had this conversation before you know when your your kid has repeated fluid presence and you do a hearing test and they have a decibel hearing loss right talk about how you have that with some of your patients if you don't mind well i think if we just back up a little bit and talk about the fact that when you're dealing with an ear and either an ear infection or hearing impairment the assessment has to be comprehensive so you get the physicians look at the ear and the patient goes to the audiologist for evaluation of what their hearing level is and that in turn is a complex set of of tasks to identify is there is there not a hearing impairment so you have the hearing test then you have a tympanogram so a tympanogram done by both primary care physicians and certainly by audiologists is an adjuvant tool to help determine if there is or is not fluid in the ear or what the status of the tympanic membrane may be um but it's exactly that it's um it's a um in some cases a confirmatory evaluation it is not a diagnostic evaluation it cannot tell you whether the fluid is infected or not it cannot tell you if they're a significant retraction area or a mass behind the ear versus fluid whereas with the otosite you get a chance to really see the eardrum and assess what's going on behind the eardrum so in that case it's it is a far more diagnostic tool taking a lot of the guesswork out of the recommended management and again you can show the parent or the individual what's going on and maybe explain why they have a hearing loss yeah so it sounds like this particular instrument is a great differentiator in the marketplace jeff can you talk a little bit about that yeah so i my mind right away goes to the whole continuum of care uh from the entry point of a patient into the care system to ending up um you know at someone like dr pransky's office or any other you know sub-specialist so you know one thing we have with like a broken bone for example we have a common language we take an x-ray that x-ray goes into the emr and no matter who looks at that you have a pretty good idea that there's a broken bone there is visual proof of that with an ear infection we hear this very consistently that you know you could back up to the entry point of the care system the pediatrician never trusts the urgent care provider the the ent doesn't trust the pediatrician no one knows that anybody is doing the job properly well with this with otosite you get that scan it goes into the medical record and everybody who's asked that can clearly see the presence or absence of the fluid in the ear they can see what the eardrum looks like they can get that from anywhere so when the urgent care provider says you have an ear infection or you don't have an ear infection we're not going to prescribe in a box i want you go see your pediatrician tomorrow and the pediatrician shows up and sees the converse they can look at that and say okay well the disease is progressing the disease is in decline or if it carry it from the pediatrician to the ent you know the guidelines call for three ear infections in a six month period or four and 12 months well some of those are subjective and if you're a parent taking your kid to a primary care office you may not see the same provider twice in a row so now you have what is your ear infection works versus with somebody else again we talk about objective proof there's no more opinion there's no more i don't think so i do think so it's very clear so that when they show up or suspected tube placement or you know uh further evaluation at a ent office and in the ent office that's very clear there's no argument there's no opinion and having launched other technologies in the plastic surgery space that provided similar objective proof the quality of care increased for everybody uh everyone's worried about referral patterns and i don't want to upset my pediatrician this takes that argument away it either was or it wasn't so you know even the audiologist when they make their assessment uh utilizing say for example otocite instead of tympanometer it's very objective there's no how good was the exam how good was the technician who did the exam it's very clear objective and the proof was there in the images you see in the medical record if i can expand on that as an otolaryngologist we're referred patients for a variety of abnormalities and the indications for tube are are multi or for tympanostomy tubes or are multiple um and so uh what jeff was just referring to was the um baseline indications for placement of tubes for recurrent ear infections there's also placement of tubes for persistent middle ear fluid and um the the truth is that for many many many years there's been this problem of believability the patient comes into the office they've been told by their uh primary care provider that they just had their fifth ear infection in six months and they're on yet another course of antibiotics and as you go through the evaluation you evaluate the ear the ears are looking normal well this is problematic for many many years and several years ago our academy the american academy of otolaryngology and our mother organization american society of pediatric glutathione came out with a guideline saying in order for the otolaryngologist to be comfortable placing tubes for recurrent otitis media for ear infections they should see an abnormal eardrum and that's this concept of believability um it's not meant to um uh be a pejorative comment about primary care providers it's meant to be a comment about the challenges of really making an accurate diagnosis in a squirming kid with um an otoscope and so this removes that aspect of things to be able to say well here it is it's the same thing as if we're going to place an ear tube for persistent middle ear fluid we want to see an audiogram which is as objective as one could get in terms of assessment of of the hearing if the ortogram is normal maybe we don't need to place in your tube quite yet maybe we need to wait and watch a little bit longer and so i think that the the otocyte provides that extra sense of of objectivity and if you will believability that allows the otolaryngologist to more comfortably say to the parent i think the time has come to move to the next step in management yeah and as you're saying it as i think about my children right um one of them one of them struggled with with ear infections as a child a little bit of a language delay you know if i with this tool was available at that time we could have potentially correlated their performance on the on the otoside device with their abilities to acquire language development because as the fluid dissipates then you would see an improvement in their language abilities and so um you know from a i think from a parental standpoint you could almost and even from a clinician standpoint you can go in and say hey mom look these things are changing they're changing for the better so you should now see an improvement in your child's behavior or your child's language development or whatever the case may be am i correct i think indeed you are i think that we have seen so many technological advancements um throughout the the medical world and of course in the non-medical world with iphones and and the newest and the best um and it's been a long time in coming in for the ear examination world to catch up in terms of this technological advancement to be far more accurate to be able to show the parent to be able to discuss the situation and to and to move forward there as you know there have been issues with the use of antibiotics for the last 30 years in terms of overuse misuse and concerns with developing resistance versus the incredible benefits of antibiotics when you're treating an acute ear infection and so um this makes it much easier to have that conversation from the parents when you can show them that this is an ear infection and you can compare it to what is not an ear infection and so either the four using an antibiotic or the not using an antibiotic is far more easily discussed when you have an objective view of the tympanic membrane and looking at what's going on in the middle ear just just a brief story on that so i i have a daughter who is um you know had recurrent ear infections from 12 years old on um and she just kept getting these things and were like are they real are they not and they would look in the ear and ultimately it just became dogma like oh she has another ear infection they almost didn't even look in the ear they just gave her another round of antibiotics well you know now at 20 years old um i started to work with with platonic hair and we you know came home at thanksgiving two years ago a year and a half ago and we looked in the ear and there was no fluid but yet she had just been diagnosed for her you know what it was about her 12th round of antibiotics lo and behold no fluid she goes back to the ent and said well maybe it's something else and she ended up having some some nerve damage from cheerleading of kids landing on her so here's a kid for eight years that received multiple rounds of antibiotics and and again through that time right you're going to different primary care providers you're going to a urgent care at a university nobody is consistent in the care but had that objective view been done early on we would say no fluid no fluid now refer to physical therapy and all these rounds were in a box and to this point i mean she's for the most part resistant to the most common antibiotics that are on the market you know there's to to expand upon this um one of the incredible advantages of this tool is beyond parents and beyond the physician practitioner but in terms of education of our trainees because it's hard to learn what is right and wrong in the middle ear it's hard to differentiate infection from fluid it's hard to know at what point in the whole process you're coming in is it midway in in the whole process of infection is it resolving is it just starting and this provides the ability to take our trainees our pediatricians our um our general practitioners the urgent care doctors the emergency room physicians and to be given them to give them the training that they need to make the right diagnosis in in the ent world we have all encountered the patients being urgently added on for yet another ear infection for which they have yet another course of antibiotics the prescription is still in the parent's pocket but they were just seen 12 hours ago with an obvious ear infection and you look at the ear and it's completely normal and that's problematic it leads to a lot of misdiagnosis and a lot of mistreatment and the ability to have this instrument and even within an urgent care setting or in an emergency department to make a recording and to discuss it immediately with your colleagues if you're not sure is yet another way of making sure that a patient's getting the appropriate care that they need yeah and what's going through my mind as you're speaking dr pransky and i really appreciate your comment is some of my colleagues might be saying well do you have this otocyte device is it replacing the tympanometer or should they work cohesively together can you elaborate on that a little bit yes um so you have to understand uh exactly what a tympanom what tympanometry does it's not a diagnostic tool i can't tell you what the diagnosis is it's a wonderful tool as in adjuvant or complementary to the evaluation but what it does is it provides a pressure wave and it tells you whether the eardrum is in a particular position or whether it's not moving appropriately or perhaps the volume is such that there's a hole in the ear drum but it doesn't give you a diagnosis and consequently when you have something in which you can look at it and objectively say it meets the criteria of x y or z then that will um pretty much obviate the need for tympanometry not completely eliminated there will be times when tympanometry will be useful but as a routine test that needs to be done well when you get a look at the ear and you have it recorded and you can memorialize it in the medical record and use it to compare for the future it's it provides something beyond symphonometry remember that audiometric evaluations are complex and involve a lot of different tools to assess the entire hearing status typinometry is one of those and that's not not the beyond end-all of assessing the the ear yeah and i appreciate you sharing that comment because again i you know a lot of my peers might be thinking it's replacing one or taking i really appreciate that comment jeff i'm going to come back to two questions really quick about the product and then we'll move on to um to reimbursement and revenue the two questions are training does the person that's using this need to be trained and if so do you all provide that uh so yes and yes um we find that a lot of times i mean dr franks can speak to this more directly but there's very little education done in medical school on how to properly conduct an otoscopy exam we spend a lot of time just going through the ear anatomy understanding why you approach the ear the way you do with the otocyte middle ear scope um training in in all actuality takes uh you know to get someone proficient using the device getting them trained in about a 10 to 15 minute time frame which you support electronically through a learning management system but also on-site and then it really takes about 10 to 15 exams for a user to get to that just normal muscle memory they're used to using with an otoscope it's not that much radically different but it is from the point of view is that we're depth dependent so you have to insert the device a certain depth to be able to get the proper reading within the middle ear space that exists as far as the ability to use it and learning very very simple just takes time and again the challenge is you're breaking a muscle uh breaking a muscle memory or a habit that you're used to using um and just approaching it slightly differently yeah and the second question that i have for you jeff you talked about the the data as the dr prensky but the data is somehow stored is it stored on a cloud is it stored on a local computer because it has to somehow access you have to be able to access it in your emr can you talk a little bit about that yeah so our device stores the data on the device and then can be transferred to your uh internal or on-premises um server for manipulation into the emr we not directly integrate to the emr i think is anybody uh within the world of the medical choice industry knows if you connected with one hospital you've connected with one hospital it's a challenging and expensive prospect so we find that through wi-fi getting it off the device into the network for users it works out very very well and again it saves on the device as well so you can go back either through your servers or through the device itself and pull historical data very cool i appreciate you sharing that so last uh last section here and that is practice revenue people want to know how is this going to benefit their bottom line can you both talk to us a little bit about that yeah so i'll i'll take it from a reimbursement perspective and um you know coming from uh the past wound care industry i'm always cautious to say that the terms of profit or revenue around making money off of a device but the reality is our device is reimbursed you've got a reimbursement code that can be applied for you either unilaterally or bilaterally for for reimbursement purposes we see a very robust reimbursement rate with that we are a category three code so that means that the user kind of dictates what they want to have for reimbursement there's not a set code at this point and then as far as revenue outside of reimbursement which is again a very positive situation for us you know when when a provider can uniquely offer this technology it really is a differentiator and a practice now um you know we we through our marketing have approached you know through through uh you know reaching out to parents and saying you know if your provider had this would you choose this one versus not and very clearly having advanced technology is something that parents want for their children every mom wants to do the best they can for their child this allows them to do that and and you know i know for myself if i can go to an office that is treating stomach upset stomachs and issues with coca-cola versus one that's saying hey here's a diagnostic we know what the problem is this is how it's being documented this is how to treat it i'm going to go to the ones a little bit more advanced and we find that to be the case here as well so really differentiating is a higher tech practice again frontline care doesn't get a whole lot of advancement there's not a lot of money being spent by and by industry to advance what's going on in the pediatrician's office or the family practice office or the primary care office so be able to honor a new and differentiated technology you know that's really important again that's the entry point for parents into an entire health care system so once they're in your primary care network of course you're going to get the whole idn supported with that dr prancey you are adding anything to that just make a few comments um first on the on a little bit of the more global level um years ago when lecturing to to the primary care physicians i would indicate that the otitis marketplace was a 15 billion dollar marketplace in terms of office visits in terms of cost of medications the use of antibiotics on this time from work and all the aspects of taking care of an ear infection and when you have proper diagnosis the ultimate result is reduce costs either you're treating a problem appropriately and avoiding problems that come with the treatment such as giving an antibiotic and having an adverse reaction or you're treating the problem and getting it taken care of appropriately more rapidly and in the end proper diagnosis leads to reduced costs on the health care system in general secondly in terms of just the day-to-day um environment of of families parents going to their primary care physician um word travels quickly parents talk to each other mommy groups are all over the place and as soon as one parent goes in and sees what happens and says i saw my child's eardrum and now i understand why she didn't sleep last night it was horrible you could see one ear was okay the other year was bulging and red and inflamed now i understand and that word travels very very quickly and for the competitive marketplace within patient care the idea of being up to date at having the best technology having a comfort zone with your pediatrician i mean parents admire they love their pediatricians and they want to know that they're getting the best care possible and the best diagnostic decision making and the the the otoscope as i've mentioned is just so much better than working with a handheld otoscope regarding the the learning of the use of the tool there is nothing within the field of medicine that doesn't require from the medical school on up just as in basketball or football multiple reps you got to do it you got to do it again and again and again and you get better as you do it again and again and again so of course there's a learning curve but fortunately it's a it's not a steep learning curve you are used to putting something in the ear albeit in otoscope and this is an alternate form of it and you're using the same approach but you're using a different technology and it doesn't take long to get better and better at it of course there's steps along the way but the gains are so much more to be able to take this finding and discuss it with your colleagues or to take it to a meeting and show this picture of the ear and what happened by virtue of what you saw that aspect of training and education is so far superior to well i looked in the ear and this is what i saw and no one really knows what you saw it's just what you're describing so learning how to use the tool is like anything else a stethoscope um or any other device you've got to listen to the heart about ten thousand times before you can figure out what that murmur is well looking in an eardrum requires a similar sort of training but this requires it provides immediate feedback and the ability to sit there and talk to your students about what it is they just saw yeah i'm glad i'm glad you shared that because that's i think that's important for our viewership to to understand that and thank you both last question so jeff as i'm looking at your website um if your product is only available in the united states at this point in time so can you talk a little bit about any future developments without giving away the secret sauce of photonic care yeah so we're definitely globalizing the product as well we're working with some folks in japan a distribution group in japan they are going through our process there as well as some other countries so yes we continue to work towards globalization as far as the product itself uh we continue to iterate as you would with any technology whether it be portability size function the technology itself is in eye care right now and as we grow photonic here we'll begin to see it i'm sorry is in ear care right now but we have other tissue sites that we can use this technology with as well whether it be dental or cardiac or dermal or other so we have other places that we can go with technology as well right now we're very focused on the frontline care market with otis type middle ear scope and we know we're going to deliver excellence there once that's done we'll go to the next site yeah gentlemen as we wrap up any final comments for our viewership uh i'll go first and drank you can close it out but i i would just say thank you very much for the opportunity to talk a little about otocite to talk about optical coherence tomography outside of the eye in this case in the ear and we're very thankful to uh to be able to make you aware of it i think one thing that i would say in closing is everyone's used to the common technologies they're used to using and it's easy to just say i'm going to use my otoscope or whatever that is but just like when we started out with no phone and then we had a flip phone and then we had a blackberry then we got to an apple and now you know whatever your smartphone of choice is medicine needs to continue to iterate and get better and introduce technology and the more we do that the more objective data we get and the better quality of care we can deliver as a whole again from our my bit part as being part of industry but dr bransky is a provider i think can offer better care as well do you want to end anything that dr branski i think it's like most things in medicine it's the next step we've we've had this otoscope technology for x number of years and it's been begging to be improved and we're finally there we've got the next step and the bumps along the way have been ironed out as with any technology the difference between an iphone 5 and an iphone 13 things get better and better and like driving a tesla the software enhancements can be made um and it's just the the concept of quote prove it to me as the otolaryngologist or prove it to me as the parent has now been changed to let me show you why i'm doing what i'm doing so from my perspective uh this has been um a long time in coming and um i'm delighted to be able to share my experience and expertise with this and and uh will anticipate that this will um take off like wildfire in in the all of the medical community involved with hearing with ears and with medical management well gentlemen we really appreciate you all sharing your insights your product your services and how this can benefit uh the community uh and we look forward to you know catching up with you guys down the road here a little bit so again thank you for coming on and we'll be in touch soon [Music] [Applause] [Music] [Applause] [Music]

2022-02-16 05:02

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