[Music] [Applause] [Music] [Applause] [Music] welcome to this week in hearing i'm your host bob trader and i have a couple of very special guests with me today who uh have been involved in the development of a vestibular uh device which could be of extreme benefit to our patients with distributor disorders today my guests are sam owen from auto lift labs and the chief science officer at automotive labs dr didier dupree and uh and i appreciate your your indulgence as i as i introduce you very very terribly um but let's uh let's move on to to looking at the device itself now uh sam did you need to have me uh set you up so you can show some slides sure so let me know in the the first question is and i'll go to the problem my first question is sam give us a little idea of how you came about number one i know your background is is in physics but how did you come about to work with the vestibular system and and so on and and look at founding this company for this particular purpose yeah so as i said my background is actually physics it's not in medicine um and when i was working on a phd in physics i had taken a course in acceleration sensors and then i happened to read this article that you have acceleration sensors in your inner ear called the vestibular system and you know just as a curious scientist i was like well i understand how acceleration sensors work i wonder if i can interact with that and and the acceleration sensors in the inner ear really do work exactly like an acceleration sensor in a car or a phone or something like that does they there are inertial sensors and what i mean by that is they're typically composed of two primary things there's some mass and then there's some force sensor in the presence of some acceleration the inertia of those mass uh will essentially hold things in place which will then cause uh stimulation of that force sensor and again um very much like what i learned right in uh in school except you know in this case the mass instead of it being a weight is the otoliths and instead of being a piezo or some other force sensor it's the cilia and so very straightforward to understand as a physicist i was just like well i wonder if i can interact with the human acceleration sensor somehow and the idea of introducing mechanical stimulation um seemed pretty straightforward you use you know a loudspeaker use a you know bass speaker and eventually found out about bone conduction and how there's already this technology that's designed to transmit through the skull to um to the hearing organ and right next that's the vestibular system so i want to see can i use some sort of off-the-shelf component to to to do that it is possible to do it with off-the-shelf components i was actually able to build a prototype with off-the-shelf components and again if you're just trying to vibrate things it's it's not that difficult um the issue is trying to do it safely and so great for lab experiments i had something that that worked originally we started trying to treat motion sickness i get terrible car sickness i was the very first person to be tested that's how actually i was able to bring didier death perot onto the team was he also gets carsick and he was pretty skeptical until he tried it and then he's like wow there's there's actually something here and then it was only later on that we realized that we can put this into um use this to treat vertigo it took us about two years but eventually we were able to develop a new technology that basically is small enough to be worn yet incredibly efficient incredibly silent and is safe to be worn for extended amount of times and it treats vertigo an interesting thing and i and i understand that that um in in some of the background information that it was given um the device was pretty big to start with but now it's been it's been digested into a smaller smaller device and dr depro do you have some i know you are originally were originally at the university of maryland but on but now uh working with autolift labs in dc and and uh can you tell us a little bit about yourself and and how you've been involved in the development of this product yes i was in academia for a long time mostly involving research on the in-ear pathways with a position at the school of medicine and a position in the engineering department in college park and um i was looking to do something a little more concrete than what you can do in academia i was doing research mostly in tinnitus and then it's a long story but as sam said he wound up contacting me and i thought this there's no way this works but he was pretty persuasive so to shut him up i tested it on myself and for the first time in my life i was able to read in the back of the car and so i thought you know i need to join this because at some level it made sense because you know for in tinnitus you can have tinnitus maskers that provide relief for about half of the tinnitus population or so by simply adding noise masking the definitives you can still hear the tinnitus but you can cope with it you can ignore it and i saw a lot of analogies between what i found earlier on with sam's device and tinnitus it was like having a noise masker but instead of being for tinnitus or the hearing it was for the vestibular system we believe it works as a masker for the vestibular system and um so then after that once i joined it was a question of doing research in order to you know focus on the parameters that are actually important and having opinions from the ents and reorienting ourselves also towards you know motion thickness is important but you can live even if you have motion sickness whereas vertigo patients were a very interesting group that we felt could help and we had a lot of indications early on we could really help a lot of people with vestibular issues i know those are those that see patients every day in the clinic we do see a lot of patients who are unsteady or a little dizziness rather than not necessarily vertiginous but but some dizziness that goes along with things and i also see that um that one of your your ent research people that's uh that's associated with your company is dr michael hoffer who uh who was with us on our american the american tennis association board for a number of years as well so i know that he's probably involved in in providing some of the ent information which does offer substantial credibility as well to the project um i know that you guys just just got some some new funding to facilitate your research and development process and uh uh sam would you like to talk about that just a little bit uh sure it's a little bit premature to speak too much of it we did raise uh so at this point we've raised 3.8 million dollars and we've also received 1.8 million dollars in non-diluted funding from groups like the air force and the defense health agency who care about vertigo and care about motion sickness um but we are currently looking to raise somewhere between around eight to around 20 million dollars to get us through our pivotal trial get fda approval um and if we raise more like the 20 million raise the sales for build a sales force and actually bring it to market um yeah so um so what what do you think this technology is going to do to the standard of care i'll throw that out to either of you guys to uh to facilitate that answer yeah so this is the current patient clinical path that we've come to understand is that when vertigo first comes on or you know severe dizziness it's a very scary experience um you know oftentimes people will end up at the er very quickly people want to test is this a stroke is this something that's time sensitive over 90 of the time it's peripheral vestibular disorder it may be completely debilitating but it's not going to kill you so the er docs just want to get rid of that patient they prescribe antivert valium some sort of suppressant it knocks you out and hopefully in a couple of days when you come get better uh when you wake up you're better than the vertigo is resolved but for the millions and millions of people where they aren't better usually the first touch point is the ent and you know in ent there's there's not a lot of there's no imaging that will tell you what's causing your vertigo except for in a few rare cases it's hearing the natural history seeing if you're responsive to the eppley maneuver that sort of thing and so there you're given one diagnosis and it might be that you kind of fit what looks like migraines and ents and audiologists don't like prescribing migraine medication because that is outside their field so they send someone to a neurologist neurologist might prescribe migraine medication maybe it works maybe there's an adverse event to it um maybe it doesn't fully solve the vertigo and oftentimes uh they end up right back at the ent or the audiologist and they'll try something else okay go see a physical therapist all right well they go to see a physical therapist and you know the provocative maneuvers are really um you know they get sick they they have trouble with it and this revolving door of medicine is really what chronic vertigo patients run into so there's been a bunch of studies but basically chronic vertigo patients have seen somewhere between three and seven specialists a study done by the vestibular disorders association showed that only 20 percent report an accurate and timely diagnosis and you know eventually people just become these these self-care experts where they join the vestibular disorders association or other support groups and just you know what is helping anyone and does it work for me i'll go see a chiropractor across the country if it just stops my vertigo and what we are hoping to do is stop this cycle so the going back to the the original question how are we changing the standard of care there is no standard of care treatment for the symptom management of chronic vertigo and dizziness patients the antiverse the uh valiums the these suppressants work counter to any long-term recovery of um of chronic vestibular disorders so the suppressing of the vestibular system prevents your brain from compensating for that that issue so we are the very first symptom management treatment that doesn't suppress the vestibular system but just works hand in hand with the um the physical therapy and the long-term treatment in training the brain to naturally compensate for that asymmetry somewhat similar to the tinnitus masking issues and things of nature so uh dr dupro could you give us a little orientation how does this relate with the epley maneuver we have a lot of colleagues that do that you know in their clinics and so on and would this be a replacement for that maneuver or would it be a in addition to that maneuver somehow uh maybe as a compliment so early on in 2019 we had multiple clinical trials that were ongoing calorics on physical therapy and other things nausea associated with chemotherapy and of course all these trials got cut short in academic centers thanks to kovid and so we had to turn around and start a telehealth trial whereby people we recruited online would give us their diagnosis and we send them device for some number of weeks and then we can go into the details of this what we found is that we had the usual categories of people that get helped so um so we had bbp and this with a migraine vespreneuritis labyrinthitis and associated and meniere's disease and among the people who had who reported to us that they had bppv we found that most of them had gone through the airplane maneuvers maybe five maybe 20 times and it just did not help them and of course that matches you know the published literature that play maneuver revolt resolves issues of bppv in about seventy percent of patients there's like five or ten percent of patients for whom it doesn't do anything and then we have about twenty percent of patients who feel that play maneuver makes it worse and so these are the typical bdpv patients that we get and those it seems that we help them we have fairly uniform uh success rate we ask people to try the device for two weeks and report on every episode and so on and we find that 70 or so of patients across all diagnosis categories but especially bppv uh to say that they're better that they play maneuvers made them either didn't work or made them worse and without device they were finally able to deal with these episodes of vertigo that they get wow yeah it's it you know this has always been an issue with the vestibular issue with the vestibular concerns is that um they would go to the ent the first thing he gets an eng then to go back and say well you got a little weakness on one side or the other end and here's some here's some stuff to try to fix that you maybe give them some coffer and quicksi exercises and and and so on so we really haven't and haven't had a way to kind of treat these things with something that's efficient for quite a long time and now we're beginning to see more and more audiology people become kind of certified by the american balance system system and things of that nature but um but it it's interesting that there may be a product that could be used similar to a a tinnitus device that may facilitate a real benefit for for patients um so so my guess is this is is is not necessarily a a a brand new idea but it certainly is a brand new technology that will be uh available at some point to to patients um and and i know that that uh that this may be available for my guess is it's more for dizziness patients than it is for vertiginous patients is that is that a true statement it it seems to work across the board i mean it's not a magic bullet across all trials we find about fairly uniform success rate of about 70 to 80 of patients report improvements uh for instance in the main years patients in the manure population um they're really happy about the fact that they have this constant kind of dizziness you know background of dizziness but they have these violent episodes of vertigo and they what they say is that this is really where the device really helps them it's when they have these very severe attacks and the device does not cure anything just like tinnitus masker but it helps you cope with it and it helps you deal with your vertigo although sometimes it's probably all that's needed for instance in one of the trials that got aborted we had on device in a vestibular physical therapy clinic and patients who normally would only be able to go for maybe five minutes with the exercises that make them even more vertiginous that they normally are uh we're now able to do a full 30 minutes right from the get-go because they were able to cope with their their vertigo you know the the deal is that in the past uh the virginians patients particularly some of the veneers episodes people just have to go sit next to a wall someplace and hope that they don't fall down somewhere so so this really does offer some hope for patients now uh i i know you guys are in an expedited fda uh program so how does that uh correlate with possible uh availability for patients with these issues yeah so as you mentioned last summer we received uh fda breakthrough designation the breakthrough device designation which is to say that the fda recognizes that we are treating a degenerative condition in a way that there exists no treatment options and so the fda has prioritized getting approval for this technology now we still have to pass all the same clinical rigor of anything but the moment we have that done will be fast track to approval so up to this point we've had roughly 120 people with chronic vertigo in pilot studies understanding um who should be included in the who we're helping how do we help etc and that's informed what is going to be our pivotal trial which is the trial that the fda is asking for so we've had five uh conversations with the fda at this point and uh we're proposing them a finalized pivotal trial here soon with funding we'll be able to execute on that um our goal is to have that done in roughly a year and then with this uh breakthrough designation this fast track to the fda we hope to have fda approval by late 2023 wow so this would be then available to our to our patients that uh that have this issue so um so are there some upcoming trials that uh that patients can sign up for somehow to facilitate the the development of the product and get it to that place where it'll become available yeah uh so like i said we recently completed a 120 person trial we recruited from people who came to our website and you know signed up saying let me know when this is available the upcoming pivotal trial will actually be an at-home uh trial so the device will be sent to um patients it may be a little bit more region specific as the fda's asked for the patients at the beginning of the trial to have a physician checkup but if someone is interested in participating in this trial they sign up when we have irb approval and this is a kicked off trial we will let everyone in our database know about it and let them know which physicians are and what clinics are recruit helping us recruit these patients um so that's that's the big upcoming trial uh we anticipate doing additional trials as well the time frame is a little bit uh less clear uh just because we are focused on getting this pivotal underway but we'll be looking at long-term improvement you know what happens with the dizziness handicap inventory when this is given to someone for six months or 12 months um you know what happens to the cost of care what happens to you know are they missing as many days of work you know kind of understanding that that true quality of life improvement not just the immediate are we helping the the individual episode but you know how does this improve people in the long term um eventually we want to look again at using this with physical therapy um but yeah so we have a bunch of other trials we'd like to do but right now the best way if anyone who's interested wants to find out more it's to go to our website uh www.otolithlabs.com and sign up to be on our on our list and that's that's how we reach out to people to let them know that trials are underway super so so this would also uh be appropriate that's the also appropriate avenue for not only patients but for say audiologists or ent people that would be interested in being involved with your program in the development of the product as well yes absolutely um so we would love to have a multi-site um we're planning on a multi-site trial for a pivotal and if someone says you know what i see a lot of dizziness patients and i would love to be one of these sites that you know can offer this to um patients we would love to get in touch with you um you know walk you through the protocol we'll you know have you involved and have an additional site to help recruit and move this forward super um so so i guess uh we'll be we'll be looking forward to seeing more from autolift labs and this particular product and how now how does that do you have a slide or something we could you could show us how it actually fits on a patient um and what the size is these days versus what it was before um i know i saw that in one of the one of the bat some of the background information that was of interest to me because a lot of patients wouldn't want to have a great big deal back on their head you know and and my understanding is that it's really pretty minimal uh in size anymore yeah so this is the device that we've used in our current clinical trials the you know the size is basically what you're going to see in the future devices both in the clinical trial and when we're prescription and ready to go very simple headband design right now so it's universally ergonomic you just have to make it comfortably snug don't make it too tight so it's causing headaches or anything it doesn't have to be that whole hard and basically the device just has to make contact with a bony area that had either the mastoid or the occipital we've been using the the right mastoid in our trials for consistency but we've done trials with cadavers to know that you can actually have a various number of placements and and find it effective what we're planning on doing for the upcoming trial and then eventually the release is a much more sleek looking device um and there will be a refillable component essentially the transducer this is crucial because in order for our device to be effective it actually is a very um precise level of vibration that's required um and so if this gets dropped or somehow loses calibration it's important that you know this is replaced regularly we can't guarantee this will be calibrated for three years which is the requirement of the dme so the what it would be is again a sleek little headband that has a device that's replaced every three months and when we do come to market we want to price this to encourage trial for those that this works for it's instantaneous and it's profound um a number of people in our trials were saying you know i've been able to do things for the first time in 10 years this is life changing um and so you know this isn't doesn't have the super expensive components of like a miniaturized hearing aid where you have very very unique you know circuit boards and batteries and stuff this is um it gives us some flexibility where we can encourage trial um we probably would look at a price point of what patients are currently spending out of pocket right now anyway um and again for those it works it works instantly and it's it's pretty profound and um sorry this is something that's fairly remarkable for me as a scientist is that i still have no understanding of is that either it works or it doesn't we haven't had a single patient say yeah after half an hour i felt a difference it's always like if they if it works for them they always say like it was like less than a minute and i knew this was it so it's i i just still find that just so amazing but it is an advantage too either it works or it doesn't and there's no in between yes it's interesting because as a clinician we could have one or two of these in the clinic and and see how they work as demos because it sounds like it either as as as dr dupreeh says it neither works or it does not and and so the um so you can just have it as a demo device and if it's working then then maybe give it him try it for a few days and see how it goes and then uh and then actually do an order or whatever as necessary as we do often with hearing aids to some degree yeah well i i thank you guys so much for being with us here on this week in hearing and providing some information about a fabulously interesting product that's possibly on the way to really help our patients though so audiologists and ent physicians as well as any of the patients that see this you can go to otolith autoliftlabs.com and register and be registered for either being a a professional involved in the project or a patient that really needs some assistance with this type of assistance thanks so much dr didier and sam for being with us today and telling us about your fabulous product at this week in hearing [Music] [Applause] [Music] [Applause] [Music] you
2022-03-06