welcome to CEO insights I'm Marilyn dezman with Inn edics technology a Canadian based research and product development company has just announced the completion of the animal study for its innovative edics accommodating lens it's a key Milestone as the company progresses its product toward commercialization and here to talk about what this recent Milestone means for the company is edics president and CEO Dean Burns hi Dean hey how are you Marilyn I'm good so let's I guess start our


conversation with just providing us a highlight of the the highlights of the results of the animal study that you just announced absolutely we are so excited about the results of our animal study so the study was a three-month study eight rabbits were the the uh subjects for the study all the rabbits completed the 90-day Milestone which is really important to make sure that we don't have uh any of the animals expired during that period of time the results were extremely favorable compared to the


available control that we use and that uh device is used extensively in cataract surgery today so it's an FDA approved device uh from a very large company that she used in cataract surgery so that was our control uh that we use and the important thing was the results of it were extremely favorable now why is that really important uh biocompatibility is the entry point basically into the FDA process if you do not pass the biocompatibility threshold chances of getting an FDA approval are slim to none


and the reason for that is biocompatibility is really the safety threshold for most materials or surgical devices so for us we were very comfortable to what's currently available uh in the uh Global Market for cataract surgery the the um process that we took the animals through are typical protocols that you would use for FDA type studies like this and once again as I mentioned earlier our results were extremely favorable and we're pretty excited about that so in addition to uh biocompatibility with this animal study


are there other things that you were trying to achieve with the study and what were some of the outcomes as well yeah so when you look at what we were trying to achieve we had three goals going into the study the very first goal was just to look at uh uh what we call postsurgical inflammation and that is the tissue reaction to the m the form material being put in the eye the second was uh a clinical term that I'm going to use is called opacification and that's typically associated with something being cloudy


but in this particular case uh it wasn't cloudy it was just a fibric response to the material being put in the eye and then the last thing is we wanted to make sure that we passed the safety threshold so that we could actually go into our first inhuman study which is slated for early 2024 so I guess might this might be a good time to give our audience a little bit of um a background of what your technology is and how it compares to existing um products that's commercially available in the market now okay thank


you very much for that first of all aimic is a 17-year-old company it's been around for 15 years just doing research in the interocular space and and for the last two years we've been optimizing a lens that we have designed that we have now uh passed the biocompatibility threshold and now we're taking that into first inum so we call it the U viw lens um and the U viw lens uses what we refer to as the eyes biokinetic uh and what biokinetics is is the ability of the eye without you thinking or trying to do something to be


able to see in distance intermediate to read say your computer or near to read a book and your eye does that automatically you don't think about it the brain and the eye work together to allow that to happen well as you get older and you get into that 45 year uh range of age you enter into what we call presbyopia and so the ey no longer has that ability to do that ocumetics has come up with a unique lens design that takes advantage of how the eye naturally works so that we can give you distance


Vision intermediate vision and near Vision Without You really thinking about it because we're using some of the eyes natural practices to do that and we do it by uh we have two lenses that are part of our Optical complex and sandwich in between those two lenses is air that's really important because when you look at the competitive lens most of the competitors are using silicone oil now silicone oil is a good media to use the only concern that we all have with silicone oil is it's basically toxic to the body if it


escapes and so we saw that with the Plastics industry with uh breast implants silicone oil was leaking out and women were having trouble with that and so we personally didn't think that was a good idea to put that in the eye so what we use is two Optical elements a posterior and interior element and we have air sandwiched in between that and then we use the I's normal biokinetics to actually make the uh the lens work and so we're really excited about our technology going into the future and


when you know investors are are obviously uh considering or evaluating a company they like to know you know the people behind the company maybe it's it's a good time to talk about some of the experts that you work with um at aimed yeah absolutely so uh let let me talk about myself for just one second uh so I've spent almost 28 years in the iare space 40 years in total in healthcare I retired uh from Alcon Laboratories which is the largest ailment company in the world and when I retired I was running our cataract uh


business or part of our cataract business and and one of the things that I've had a pleasure of seeing is a lot of different Technologies come into this space coming out of retirement I looked at this technology and said I have to be a part of this this is the most exciting thing I've seen in the last 20 years so that's why I actually came out of retirement why would investors want to work with a company like aimic well first of all we have 12 of the top uh advisors in the iare space giving us advice on which


direction we should go with lens design protocol de development for our studies and how we should even commercialize this technology so we have 12 of the top around the world uh that's part of that those individuals represent eight of the top medical research facilities in the world so we've got the top investors working with our team of individuals so myself and Dr St te and our regulatory people uh if you put us all together we probably got 130 years worth of AIC experience just with the ocumetics


leadership team plus you add uh double that with the uh with the investigators but when you get beyond the team itself and you start looking at why would investors want to uh look at this particular industry versus Cardiology or other areas number one it's a very large dynamic Market that everyone who turns age 45 now becomes a candidate for this technology in the US that's about 138 million people that have turned uh 45 and that number just continues to grow so that's first and foremost secondly


when you just look at the I category which is the category that we participate in that category is a 4.5 billion doll category and so there is a lot lot of opportunity uh financially within that category and once again everyone who turns 45 now becomes a candidate for the ubw technology uh our technology in this is based on what I know today but our technology is the only one that I'm aware of that uses the natural eyes biome mechanics to actually create a accommodative effect which allows you


to see up close and a disaccommodation that's a safety issue and so we're pretty proud about that so I think we're the only company that is working with the bio the the eyes natural biokinetics and then the very last thing is we have a large range of accommodative amplitude up to 14 diopters and we've measured that uh on the bench now when we go into our multicenter clinical trial we won't create a lens that has 14 diopters worth of accommodative effect I the I won't like that but our design has the ability


to go that high should we need to you mentioned uh you're getting ready for your first inhuman uh study in q1 2024 so looking to the next year uh could you talk a bit more about sort of what we're looking at in terms of in addition to that inhuman study after that what happens in sort of the timeline yeah so uh we are excited to be gearing up for our first inhuman study which we have targeted to start uh at the beginning of 2024 in that study uh we're going to have 15 subjects and we'll have uh the


ocumetics lens in one eye and we'll have a control lens in the other eye uh just doing a natural uh comparison of the effects of the lens and during this study we're looking for performance so we have already passed bio biocompatibility so we know that the body can accept the material that we've put together with our ey lens design we want to make sure that we can actually perform and that performance is two things one we want to make sure that the patients are act so their best corrected


vision is realized if we don't do that then it doesn't matter that we get accommodative effect they just can't the patient can't see well so we want to make sure that the patient sees extremely well the second thing is we want to make sure that we maximize whatever the accommodative effects that we can can accommodate uh with this technology and so we can allow that patient to basically see like they did when they were 30 years old for distance intermediate and and near uh a a couple


other things uh that we're looking to do is we want to complete our FDA prub that's a application that we have to complete with the FDA and during that application process we actually have the opportunity to ask very specific questions of the FDA so that when we do our study we make sure that we address and answer the questions that they may have when they start uh reviewing our PMA supplement at the end of the process so we want to make sure that we Engage The Agency very nicely with that uh in


2024 after we uh start and complete the first inhuman study it's a six-month study with some uh level of followup we will enter into our multicenter clinical trial application process which actually starts with a FDA document called an IDE investigational de uh device exemption application we have to do that because this device is not approved for any kind of usage in the US so first inum is going to be in the Dominic Republic uh our first multicenter clinical trial uh Center will be a us-based center so there's some


additional paperwork that we need to fill out the IDE uh is that paperwork that we'll get approval from the FDA they'll also review our six Monon uh first in human study and they'll give us uh whatever recommendation will come out of that application review and then we will begin our phase one uh study for the multicenter clinical trial we're hoping to start that first quarter of 2025 so we're already looking at our commercialization Horizon with respect to this technology as you may or may not be aware the FDA


process is a very well-defined process so there's no way to accelerate the FDA process it is what it is so once you enter into I call it FDA land the timelines are very very very consistent so it starts with about compatibility and first in human so with those two together that's an 18-month process then when you start your multicenter clinical trial that's three months so the whole process can take a little less than uh five years to complete so when you look at our timeline we're hoping to be uh through


the FDA process uh by the middle to end of 2027 but we're also hoping to be uh commercially available outside the US before that time frame so we don't have to fully wait until we have FBA approval to actually begin to sell this technology outside the US we just have to achieve what's called a c mark on the technology and uh to do that we have to apply to the different Ministries within the uh countries that we want to sell in and get them to approve our technology and they typically approve it after


about the first uh phase of the FDA process so that they can actually see what the data is telling them so data is really important to us and good data is what we are working to achieve we want to make sure that patients see well and if we're advertising that they have the ability to accommodate we want to make sure that they can accommodate based on what we're advertising so uh when you look at our value proposition of why we would want investors working with us uh number one we designed a lens that will go through


the normal standard incision that is used for cataract surgery today so there's really no adjustment to a surgeon technique nor nor will there be an adjustment to uh what their learning is it's just a matter of them understanding what our lens is capable of doing so that that's number one number two is uh the thing that I've just harped on and that is the uh devices designed to give up to 14 diopters worth of accommodative amplitude the next thing is you know we can uh accommodate and dis accommodate in less


than a second which is which is safety issue and the last thing is we have no silicone oil so we don't have the uh issues associated with if a seal braks uh oil spilling out into the eye so we've got a very strong value proposition with our technology and we're just looking forward to partnering with uh organizations that are very futuristic in their thinking and very Innovative in their way so thank you so much for having me on thank you and I'm hoping to uh hear more about your uh


results of the study uh in the coming months all right thank you and thanks everyone for watching join us again next time for another engaging conversation on CEO insights if you like this video make sure you subscribe to our Channel and turn on notifications so you don't miss future updates and interviews see you next [Music] time