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hello good afternoon everybody thank you so much for giving up part of your sunday to join us um today we are speaking to uh ian roberts ceo of truespine technologies uh and professor frank bowen who is the inventor of a new spinal safety device to be used in surgery um to hopefully improve safety of patients decrease the chances of infection and also mean that they have to spend less time in surgery so that it's safer both for the surgeons themselves um so just to make you all aware please type into the question type into the chat questions as we go along um after a short interview with myself we will be opening it up to the floor so that you guys can ask questions and i'll be asking them on your behalf and just when you do submit questions please please do be aware that truespine technologies are a currently publicly trading company so they will not be able to disclose any information that isn't already in the public domain so let's get started um gents thanks thanks very much for joining us i think it makes most sense really to um start with you professor professor bowen um what was your kind of eureka moment clearly you've been within the industry a long time everybody kind of says ultimately one day lightning just seemed to strike and i had this great idea and tell us about what happened how what was it that led to the invention of the survey lock and fussy lock devices you've created well good morning to everybody and i really appreciate you taking time to talk with us um it's it's an honor to be uh appearing before this august audience so um i was a practicing neurosurgeon for better than 20 years and one of the most frustrating things that occurs to anybody that does any kind of spine surgery is a condition called the failed back surgery syndrome which is you have a patient with severe back pain and some or in some cases neck pain and you do your best you do a wonderful operation on them um they're no better and sometimes worse as a matter of fact about 25 of the time they're actually worse after their surgery and many of you in the audience may know somebody who's had spine surgery and didn't do well with it or have heard you know have heard the old there's an urban legend don't ever have spine surgery because of this very entity and i have to say that spine surgery done correctly and done for the right indications can often be a life-changing a positive life-changing event but we have so many patients that had this experience and you see we we don't know enough about the spine yet to fully be able to predict even with mris and all the wonderful testing that we have we don't know enough about the spine it's a complex structure 24 bones 72 joints and over 360 muscles joints and muscles tendons and ligaments so there's a lot of room for things to go wrong what we discovered is that we often would do spine fusion which would be to try to get two or more vertebrae to go together to grow together and become one that's what a spine fusion is and we typically would put in screws in the vertebra that we want to fuse so that we can hold them together and then put pieces of bone in that will promote a bony bridge to grow between these vertebrae that's what a spine fusion is and what you're going to do is you're going to stop the motion at the level where you think the disease is but here's the problem you have these patients where you do a good operation and postoperatively the x-rays show you have a very good fusion and they're worse so i started to say to myself there has to be a way that we can predict better who's going to do well when you fuse when you fuse the spine and who isn't in older times surgeons would actually put patients in body casts to try to simulate what a fusion looked like that's really isn't very predicted and it doesn't necessarily tell you much information uh we were trying putting patients in braces and everything then i read a couple of reports about surgeons that were actually putting the screws in as a test they didn't put bone in to grow together they just put the screws in and left the screws in for a few months to see if those patients would report whether they were better or not and i thought to myself that was clever but the problem is screws are very destructive they leave great big holes in the bone they can introduce infections so i started thinking there has to be a way to do this where we can stop the movement in a non in invasive way and that was my eureka moment i thought rather than putting screws in there are strategic places on the spine on the surface of the back of the vertebra that we can grab and stabilize the spine that way and that led to the genesis of both the serverlock and the vaseline yeah it's almost like a bit of a grappling hook isn't it that links onto the the vertebrae and kind of then hold them in place it's very impressive um i mean you've mentioned sorry before you go on um just with regards to there being some difficulties and problems that can occur in surgery um i mean next month it's it's we've been made aware today that next month is uh national spine surgery safety month so clearly there is a lot of go that can go wrong if people are trying to raise awareness of how safety has to be improved how does the survey lock and fussy lock help improve safety what what what problems does it overcome yes it is thanks for mentioning that next month is the first annual national spine safety month here in the u.s well let's talk about the server lock which is going to be our first product to market this is designed for the cervical spine and the upper thoracic spine there is a very serious complication associated with screws put into the cervical spine where the screw errantly injures an artery called the vertebral artery and the vertebral artery feeds the brain stem and nationally every year although it's a rare occurrence it's a very very lethal injury most patients don't survive a brain stem stroke if their vertebral artery is injured the absence of screws completely eliminates doesn't just reduce completely eliminates the possibility of injuring this artery by stabilizing the spine using our technique another complication is injury to nerve roots because again these screws and i'm going to i'm going to ask ian to make a comment about when he was in the laboratory uh about a year ago and we were looking at the saw bones would you like to just comment as a sort of independent third party observer how narrow the tolerance is oh yeah i mean you're talking you're talking millimeters um and it's not just the actual positioning it's the angle that you have to go in and we were only using sore bones with no soft tissue or anything like that it was pure sore bone um and there was actually dr tim evans and myself um who would have caused very serious danger or damage to to the spine if that had been a real spine so it is even in the hands of experienced surgeons you know there's there's so much that can go wrong in terms of placing these screws because you have to be so accurate you have to be you know engineers we accurate since we have a time limitation let me uh just tell you the most dramatic story i've seen in the last couple of years there was a 15 year old boy a young man who was an absolute stellar individual he was a scholar he was an athlete he was they thought he was going to be an olympic swimmer but he had a scoliosis of the spine and he went to the hospital for special surgery in new york city broadly considered the best hospital in the u.s if not the world for spinal surgery and orthopedic surgery he had an operation to repair his scoliosis and straighten out his spine they used state-of-the-art neuro-navigation million dollar computers in the operating room to dictate where to put the screws he came out of the operation with a screw right through his spinal cord at the seventh thoracic vertebral level which left him completely paralyzed from the waist down at the age of 15. this boy unfortunately died at the age of 19 from repeated urinary complex urinary tract infections and complications from this disastrous complication that is a rare but very very bad complication another complication i have seen in the last year was another young lady who was having her scoliosis surgery had scoliosis surgery and one of the screws that was supposed to be in the thoracic vertebra wound up right into the tip of her aorta which is the main artery that feeds the entire body now it hadn't pierced the aorta but the aorta is a pulsatile structure so if you have a sharp screw right here and the wall of it beating against that screw well you don't have to be a brain surgeon to figure out sooner or later you're gonna have a problem um so these kinds of complications can be avoided with this technology in addition we can reduce the amount of intraoperative radiation very significantly we can reduce the amount of surgical time the longer that the surgery long longer that the surgical field is open the higher the chance of an infection so if we can reduce the surgical time we can reduce the chances of infection and one of the other advantages is that right now even if a screw is perfectly placed perfectly placed the screw goes into the main portion of the vertebra and the screw can introduce infection there have been a plethora of recent studies that have shown that these screws which are used already and also talk about the sets and the screws that are used time and time again not they're not using the same screw but you have a set of screws and they can carry infection so infection can be introduced that way ian would you like to just expound upon that for a second yeah in verbal you you'll have a screw rack because there's different sizes in terms of length and diameter so a typical screw rack will have between 60 and 100 screws and a normal a normal or an average procedure we'll we'll use anywhere in the region of eight to twelve screws so that leaves four fifths if you like of the tray um haven't been used so they don't throw that away ultimately what will happen is they will then take fresh screws to replace the ones that have been used and the whole screws will go through an autoclave um now some screws especially the the upper and lower ends of the spectrum of that screw range might go through 50 60 70 autoclaves and because of the nature of the thread on the screws is is very tiny you know any microbiome infection that gets in there will stay on that screw even if it goes through an autoclave the problem then is that goes deep into the bone because obviously it's the threads that go into the bone um and so a deep bone infection is extremely serious a to the patient first and foremost it's a lengthy process it's a very painful process and it's also if we're talking about healthcare it's also a very costly process because it means considerable additional time actually as an inpatient for for that for that patient you know they basically have to stay in the hospital until they got rid of that infection so i was just going to say clearly it's a very very very needed product then by the sounds of it just in terms of all the facets that it addresses but i suppose the big question is then frank what else have you got in the pipeline if you've got any other brilliant ideas up your sleeve we have to watch this space for that one but i can assume i can assure you lockdown has not locked down frank's brain and i'm being serious there are a suite of products there's not just the first three first for truth buying we we are launching the first three but there are probably about seven or eight additional products that we'll be developing in in the near future all spinal related um but as i say locked out locked down as kept frank rather busy um i've had to ask him to put stuff on hold until we get these across the line but but yeah he is a serial inventor i can imagine him just handing you a watch of papers and saying what do you think of these even that actually happens doesn't it every now and then um one one thing that we should also mention about the infection everybody uh thinks of an infection as something that you know you give them antibiotics and they eventually get better uh we've seen that's not the case here in covid but that's also not the case with deep bone infections of the spine one to three percent of those patients do not survive they die in those infections so um but we have we have products uh that are going to expand the use of these products to almost every aspect of treatment of the spine and we also know that for instance on the horizon rather than fusing everybody there's uh some patients that are better off treated with what's called motion preservation technologies where you you may have heard of the so-called artificial disc and things like that um and we'll be we already have plans for using the platform technology that we've established with the server lock and the faster lock and rather than a stabilizer introducing a motion preservation component to those bone anchors and still maintain our mantra of preserving nature's design that's true spine's mantra preserving nature's design as much as we possibly can preserve what nature gave us to begin with so i suppose given that we've just heard your strapline and kind of what you're dedicated to doing really um ian you're leaving the charge at truespine technologies what's your vision for the company where can you see it going where would you like to take it well i'd just like to say you know i i was first introduced to truth bar about two years ago um a very simple i think 10 12 page powerpoint presentation and i've been out of orthopedics for some time at that point um more investing to sorry i prize into investment companies and life companies and when i saw this it just blew me away and i thought wow this if this does what it says then this is revolutionary um but i haven't been out the industry for as i said seven or eight years i then took it to a very large spinal center here in the uk where i had some friendly surgeons to have a look at and i was inundated i ended up being in the coffee room literally all day so instead of seeing a couple of ex-colleagues you know there was about 12 surgeons and what the one thing they were all saying was when can we have it when can we have it when can we have it so i had to explain it was in in development just as an aside um three of those surgeons actually invested in the company before we listed as well that's how how keen they were so i knew we had something very very special because the orthopedic world and the spinal world in particular hasn't really seen any developments for probably 30 years the developments have been aesthetic rather than technological breakthroughs and i was very lucky to meet frank a couple of weeks after i'd first been introduced to truth bar and he was over here in the uk and it was just a meeting of mines you know we i don't think he knew my background before we actually met um and he thought that either done the greatest amount of research given my knowledge of the company and the products um but when i told you know explain that i'd worked for striker as european director for a number of years um and that spine and and trauma were my were my greatest loves if you like um it was just a meeting of minds we'd even walk out and go off into a different room and let the finance people talk amongst themselves while we were talking products for me the vision is is is if you've known anyone with back pain and most people do um and i i know within the group there's people who've actually experienced spinal stabilization if it's unsuccessful as frank said the the failed back surgery syndrome which can occur with a perfectly placed set of screws you know done in a perfect technique by a highly experienced surgeon so it's not about bad technique or bad implants it's just a pathological occurrence but what actually happens then is is people become very depressed because they don't see a future for themselves without pain that future often includes you know dependence on opioids um i've known of instances where you know people have lost their job they've lost their home and the the saddest thing about these people is there's a huge incidence of of these failed back surgery patie ts that actually commit suicide uh because just because they don't see a future so my vision was you know having seen a number of these people because i've worked in orthopedics for so long in the spinal sector you know was was this this is going to a make the operation so much easier for people as frank alluded to earlier uh or i think it might be new map a lot of people say it's the last resort to have spinal surgery it's the absolute last resort if you can manage it with physiotherapy if you can manage it with steroids whatever you need to do don't have surgery this take breaks that barrier our products break that barrier down we believe um we still can't ensure that there won't be the failed back surgery syndrome with our products and i want to make that clear to everyone the efficacy of our products and our biomechanical testing is coming out as superior to pedicle screws but there will still be people who have failed back surgery using the survey lock and the fatty lock as i said just because it's physiological the difference with ours is if that's the if that's the case by removing the implants as frank said you've not damaged the spine in any way shape or form you've not taken away any bone because ultimately if you take away bone uh from the spine just considerably weakening that structure um so that's one of the one of the big pluses for us um and i think when frank introduced where his light bulb moment came from it was it was really he was looking at ways to be more efficient and this was originally going to be a diagnostic tool a diagnostic tool really to see if people were suitable for stabilization whether the numbers could be reduced in terms of these failed surgeries but it actually developed very quickly because the actual anchor and the security was considerably better in terms of pull-out strength than the screws so where do we see we've got relatively conservative commercialisation targets i'm really we're looking at it being very much an educational community of key opinion leaders initially within the us we'll be looking our initial batch will be 20 to 30 centers in the us that we'll be supporting and i think it will grow literally by word of mouth is is the honest answer we have got various plans for other geographies as well um so by 2022 i believe will probably be evident in in between 10 and 12 countries and you know there'll be distributor ships um some of those will be by distributor ships some of them will be a combination so in the us it will be a combination of distributors and our own sales and education team um and we're very much going to follow the the philosophy that you know we want surgeons to be part of our family and part of our journey um you know so whilst as ceo you know i've got to look after the pennies and we've got to generate sales and revenues etc the actual procedures themselves that we forecast are very very low um i i personally think we will so surpass what we've actually put in the admission documents and the realistic goal is you know if we if we can capture one percent of the spinal stabilization market and let's not not be naive here you know ninety percent ninety percent of all revenues in this field are generated by 10 percent of companies the big companies have massive resources that we don't have in terms of sales marketing and distribution but if we could capture within three to four years one percent of the market that would have a a turnover of over 100 million dollars um you know that's just on one percent which are seriously impressive numbers um so so with regards to obviously you mentioned the surgeons asking look when can we have these when can we get our hands on them um both products are eligible for the 510k fast track method and what are the advantages of of using 510k how much quicker is it in terms of getting the products approved it can be years literally years because obviously we don't have to do clinical clinical trials clinical trials in themselves take a lot of time you know a lot of input with the fda to do those trials and it takes an awful lot of money because obviously setting up those trial centers um you know is a very costly experience so by going down the 510k route we we probably save anything up to two or three years or even more um two or three million dollars let me just add to ian's very good answer the fda does have a protocol that if they make you down the class three you have to give at least two years from the end of the clinical trial from the end of the clinical trial you have to give it two years most clinical trials are going to take between nine and 18 months so you're talking about a minimum of three to four years to get something on the market in terms of monies the average i ide is what we call the the third class the average ide costs a country a company between 10 and 20 million dollars and the cost of the 510 k is around 60 thousand dollars so which i'd imagine is probably why 90 of the products are done by 10 percent of the market because they're the ones with the big bank balances but it sounds as though by using five the five 10k fast track method that this will kind of be substantially shortened and hopefully you'll be to mark it quicker um i mean in terms of then a long-term goal because there are these such big players in the marketplace how do you see your evolution as a company happening are you expecting to be acquired at some point or would you prefer to continue being a company in your own right how can you see that going i personally believe that sort of three years from now um we'll certainly we're already on the radar of some of these larger companies but i think in three years would be the optimum time for for an acquisition because we'll have traction in the marketplace we'll have our have our products being used and hopefully used extensively but the biggest thing for me is the the the acquisition market in this industry in the spine industry is huge a lot of companies have actually taken away their r d budget and put it to an m a budget so they'd rather have the little companies like us and people with frank's brain you know develop the products and then they just come in and snap them up um so the the absolute goal is that if that happens which we think is a is a highly likelihood it happens for the right reasons for one of these larger players to be able to expand the sales and roll out of our products given the huge resources you know in terms of sales and marketing what we don't want is someone to acquire us literally to stop our technology hitting the market and that's a possibility when you think someone like medtronic annually has sales of way over 100 million dollars just in pedical screws you know so those kind of companies it might sound a lot you know that if they were coming in to acquire us for 100 or 200 million but if it's to preserve their products when i talk about medtronics revenues you can tange that by five the amount of inventory they've got in hospitals because a lot of this is is consigned inventory so they put it into the hospitals and the hospitals only use it when they've actually uh sorry they only pay for it when they've used it so medtronic has millions and millions and millions and i'm not just picking out medtronic you could apply the saying to synthesis you could apply the same to globus you know um striker all of these companies have a massive investment so if we are acquired down the line it would it would very much be if i had any control over it it would be to take the company forward to take the company further rather than to show our technology so we want to leave a legacy we want to we want to make back surgery as accessible for everyone who who absolutely needs it because we it is a game changer yeah absolutely and i think um i understand as well frank that you potentially have have had some other inventions historically within the back surgery space that kind of attest to that i suppose that have had some success um which which one was probably the most successful do you think well um it's interesting that now we're we're shooting down pedicle screws but i actually developed a pedicle screw system in 2004 which was called the paramount pedicle screw system and it was brought to the market and it won the frost and sullivan ward as the best new technology to be introduced in north america in 2006 so um we were very happy with how that how that went um earlier i had sold talking about shelving technology this is this was one of my first lessons because the first patent i had actually been awarded was for an expandable inter-body fusion system which i sold to medtronic in 2004 and they contacted me about nine months after i made the sale i sold it for a pittance they contacted me and said you know we've really examined this thoroughly and there is no place for expandable inter-body fusion cages in spine no surgeons would would ever use them which i disagreed with but you know i had sold them it and that was that and ian how many expandable cages are in the market now last counts i think about 212. yeah something like that yeah um so that was when i first learned about the they would they had a an inter-body fusion cage that was not expandable that they wanted to protect and that they wound up making almost a half a billion dollars on so they didn't want somebody coming along upsetting the apple cart so they bought it from me so that they could put it on the shelf and i promised myself i would never allow that to happen again with something that i thought was actually good and that's why ian and i have so quickly been a a melding of minds in the melding of hearts when it comes to this project you know medtronic would be ahead of the game if they walked into our office tomorrow if they walked into ian's office tomorrow and wrote him a check for 100 million dollars they'd be ahead of the game in terms of what inventory they'd be protecting and i could tell you that if they offered him 100 million dollars tomorrow we likely wouldn't take it because we know what they would do with it this would never see the light of day well it sounds like that you're all but you're both absolutely doing this for the right reasons and um actually you've learned a lot of lessons historically in the past so that history won't repeat itself um you mentioned introducing things to america uh currently you're listed on the aqueous market um we know how um amazed by med tech and medical products the americans do get is there an appetite to potentially list on nasdaq or say lse main market rather than acquisition in the future yes is the answer there's always that option but at this moment in time we just want to get our products um through fda clearance and at that point we will make a decision um do we go with our planned rollout and sales and marketing plan or do we potentially need to raise further funding to accelerate that but at the moment you know we've been i've been quite impressed with aquis um since they took over the next exchange um i know it's still relatively illiquid in comparison to others but the their actual sales and marketing team are doing a very very good job in terms of motivating brokers um you know and and so at the moment we're quite happy but the the bottom line is we can always change you know either to to a lse listing um there are other things you know that will come out over the coming months relating to that but i can't say at this moment in time that sounds all very cryptic but exciting and we look forward to hear it um so i suppose my final question then before we move on to questions from the audience so please feel free to continue submitting them in the chat and i'll ask them on your behalf um the big question really is is why now why is now this moment that the exact right time for this product and for true spine technologies to really grow and develop if anything the the the current pandemic i was going to say recent the current what we're experiencing one of the impacts that i think will come out um very shortly is that despite the the the gruesome nature nature as some people would say of spinal stabilization it's still considered an elective procedure so it's not considered an emergency procedure and what that means is in in globally number of procedures that have been done has dropped significantly which means the number of patients still in pain has increased dramatically i and the number of surgeons that i speak to here even when they were allowed to do surgery instead of doing five or six cases on a typical operating list they were down to two purely and simply because the the cleaning protocols because of cover between patients has been ramped up considerably so their waiting lists are increasing they still only have the same amount of operating time and this is where i think you know the true spying advantage and survey lock initially is going to be is going to be very very well received it is with every surgeon i speak to but one of the big things for me is that it will reduce operating time by about 50 percent so what would typically be a 90-minute procedure we believe can be done in about 40-45 minutes so the benefits of that are huge not only to the patients because you know as frank will tell you that the shorter time you know you know you're actually anesthetized the better the reduction in risks the reduction in fluorescence fluoroscopy but a recent study showed that in the us or time for spinal surgery is equates it equates to 375 dollars per minute a minute per minute wow if you're reducing that time by half then it's a significant impact to to you know the person paying for that procedure from a surgeon's point of view he can essentially do twice as many in the same amount of time as he would normally using screws so you know we expect to be to be commercial by the end of this year early next year and you know we're very excited about the future it's frank and i frank and i are on our we have our sort of monday evening uh in the uk engineering talk and the last few weeks you know with what's happened with the products and actually getting hard copy prototypes we're like a couple of little school boys at times because the advancements have been so fantastic uh and the support that we're getting from the people who are doing our testing you know is is is just fantastic and beyond our wildest dreams to be honest so you know i'm just hoping we're out of lockdown for that first implantation because boy do i want to be there well well i'm assuming that you that you won't be fitting the devices though i'll be an observer excellent that's good to hear um so fantastic well thank you very much for being so candid thus far gents i think it'd be great to now move on to answering some questions from the audience um so the first one on the list is a question with regards to distribution you mentioned earlier that you are um ideally looking to go into 12 different countries um is there any way that people in the call today if they're interested in licensing the technology in uh some of the countries for example the middle east that they could get in touch to have those sort of discussions to become a distributor absolutely at this moment we haven't made any hard and fast decisions um now really is the optimum time you know the next three or four months to be identifying that once we can we can give a definitive time frame but if you've got experienced people in in particular geographies would be very happy to talk to them excellent and you also you also mentioned as the next one um a hundred million pounds as as a figure for potential projected future revenue with one percent of the market um on the flip side of that what do you expect the worst case scenario to be i don't think there is going to be a worst case scenario um the worst case scenario is is surgeons say you know because surgeons closure is frank but surgeons are creatures of habit when they've perfected a technique they like to kick stick to a technique and you know so it's changing their technique because we're gonna we're gonna meet opposition especially from the more experienced surgeons who say well i'm fine with pedicle screws yes i'll accept the misplacement of twenty percent mine's only ten percent or w atever it may be um no they're the ones they're the ones that never missed the pedicle yeah exactly exactly um so it's the worst case scenario is that we have uptake that's slower than we expect but from communications because frank and i are communicating with surgeons and surgical centers i just can't see that happening because everyone's so excited and and and literally you know the the the key opinion leader group that we we are developing and already have with our medical advisory board um you know they could hit our first year's forecast on their own without us having any new surgeons so you know as i say very conservative and i think the 100 million per year revenues once we're in eight or ten countries is extremely conservative as well but i'd rather under under promise and over deliver i think to just add for to add to ian's answer here in the united states um you know there's been a change a fundamental change in how things are marketed at one point it was only the surgeons you were interested in talking to if you could get the surgeon i mean i remember being a young surgeon a million years ago and i wanted something in the operating room i just went to the director of dor and and told her listen get this in for my case next week and it would be done that would be the end of it nowadays there's so many levels of decision makers that surgeons are only part of it you know and whilst it is very important to get the surgeons on board we are seeing in the united states more and more examples of where surgeons are being dictated to as to what kind of instrumentation they can use so ian mentioned something that was very key a moment ago and that was that if you save time in the operating room you're gonna you're gonna appeal to the hospital administration and to the insurers who are the people that are ultimately paying for it you know surgical instrumentation is kind of like the toy industry the end user is usually not the one who's paying for it so you have to make some appeal to the people that are paying for it and again going back you know to the late 80s early 90s when i first started doing this there was so much money around that you know whatever surgeon wanted he could get that's not the case anymore also i read a very important statistic just a few days ago now more than 50 percent of surgeons in the united states are employees of the hospital so if you're an employee of the hospital you do what the hospital says the hospital says you learn the fast lock technique because it saves us a lot of money and guess what the surgeons are going to have to do that insurance companies so we have a four-tier approach to bringing this to the awareness are raising the awareness here in the u.s first of all surgeons always still very important but ian's comments were critical surgeons can get locked into a mindset and can be very difficult to move them from that the second people we want to appeal to is the insurance companies because when you talk about saving money they're all ears when you talk about saving money they're all ears third people and almost on par with the insurance company is the hospital administrations if you make them aware that you're cutting all our time in half you're gonna be what huh talk to me about this yeah that's they're going to be response and finally there is a group of people that have become critical in decision making over the last 10 years and that is the patients the patients themselves we will be setting up a website here in the us where patients can go and find out about this i remember that i when the last few years that i was in active practice i would have patients come into my office and say you know i have a herniated disc do you do an endoscopic discectomy and i'd look at them and say well i'm not sure a candidate for that well listen if you don't do that i'll find somebody who does now if you have two or three patients walk out of your office because you don't do the procedure guess what you do you go out and get yourself trained to do that procedure if you're a surgeon so there are multiple factors that are coming to it and coming to bear on decision-making process it's no longer just the surgeons and as ian said sometimes the old surgeons they're just gonna do what they do we want to especially target the young surgeons especially the surgeons that are in the latter years of their training because if they learn this before they even leave training this is what they're going to do and we're going to be expanding our marketing department soon yeah 100 and and it's interesting that you mentioned patience because of course ian you mentioned earlier that having spinal fusion surgery is seen as an elective surgery um i'm sure the patients would beg to differ and that they would argue that actually it's absolutely necessary given the pain that they're going through um so the chances are that you're absolutely right they will go from surgeon to surgeon until they can find someone that they believe can can help alleviate their pain ultimately yeah i mean so much better informed you know because of the internet you know you can actually as as your associates have have put up in the telegram group you know you can get online videos you can see the procedure you can see who the you know from a company's point of view you can see failure rates all that information is available that 15 20 years ago wasn't readily available for patients you know it's quite common if someone's going for a hip or a knee they'll name the hip that they want you know and they're not the surgeon um so frank is very very right and actually i have to tell you along those lines i've done my own little kind of informal survey of just people just non-surgical non-medical people and i'd i would say to them would you rather have this screw and i actually show them a pedicle screw would you rather have this screw in your spine or something that clamps on the spine and can be removed and leaves the bone perfectly intact what do you think 100 of the people i've surveyed have said what would you say if you needed spine surgery and you had that choice what would you say matt would you like screws in your spine or i think i'd go with the clamps thanks i'm guessing that's the answer that everybody else said as well funnily enough 100 yeah and to add to that you know a lot of companies talk about minimally invasive um you know minimally invasive means minimally invasive surgery means it goes through a very small incision but very much like a bullet a bullet only makes a very tiny hole when it goes in to the body but it can cause catastrophic injuries so can screws so we also we emphasize that we're minimally invasive but more importantly we're minimally intrusive because we don't damage the bone and therefore we don't damage the liga the ligaments um the the arteries it's highly unlikely that will damage the arteries so we truly are going to be the most minimally intrusive minimally invasive company in the sparring field which is a great moniker to have so um one of the questions that's coming is that you're currently going through um a period of fundraising and what's the money that's being raised going to be used for and if there is another possible raising that you mention would it still be open to private investors yeah i mean the the company our original raise and and then this has really been you know to to avoid wherever possibly institutional investors because we don't want the control of the company being taken away um you know a lot of institutional venture capitalists they just want control of it they're only interested in the in the dollar sign they're not interested in in the actual company and the philosophy and and ultimately the patient this this next fundraise which is in our admission document is for up to about a million pound sterling and it's really to cement our sales and marketing efforts we want to be state-of-the-art not just with our products but with the way we deliver the products to hospitals so essentially you know the plan is that each each facility will have a pre-loaded tablet or of some device um so inventory management can be done and automatic upload of um you know a number of suites will have educational videos supporting videos on there and there'll also be a direct link into um if you like our medical advisory board and that's saying we do believe there's going to be a huge uptake in the ambulatory centers in the u.s as well um whereby it might be more orthopedic surgeons than spinal or neurosurgeons doing this procedure so we want our marketing plan to be as good as our product if you like um and so that's what this money is going to go to we're now at the position that we believe we've got to start investing in that we've already started a search frank and i have initiated a search for top drawer sales and marketing director or vice president whatever you want to call it in the us we're working with a very good company to to identify that individual as we speak but that's what the you know this initial raise is for is just to get ready for commercialization and i have to just circle back for a second ian just mentioned that we're working with a very very good firm they're actually with they're rated by forbes is one of the 10 best headhunting firms in the us and the number one in term number one firm in terms of spine and orthopedic devices they're actually in the number one search company um and so they know spine and the two guys that we talked to have between them over 50 years in the spine world ian how excited were those guys about our product i've never seen a recruiter like it um it was off the charts it was they they were just you know we want to be part of this project and they also see that you know we when we expand with there's going to be more so whilst the headhunters they were just so excited about the the product because they said you know that what we've been saying for many many months you know this is going to be a paradigm shift in the spinal sector and they want to be part of it but yes for head hunters extremely excitable man no it certainly sounds i mean it sounds like you're heading rapidly at a rate of not towards that commercialization side of the business now and the only thing that's kind of being weighted up on if you like is is the fda approval i mean what are the time scales expected for that well that's that's where we've had the delay um really covered is and just for people on here i mean maybe frank can embellish but unlike the uk were essentially we've got four different lockdowns england ireland wales and scotland in in the america every state is different they might follow a similar path but they might be very different and frankly some way away from where our manufacturing and testing facility is so frank's in upstate new york our testing facility is near salt lake city in utah and they've had various different lockdown issues they they for a period they weren't allowed into the actual manufacturing facility everyone was working at home um then they have special commissions where they can go in if it's if it's um you know pre-authorized and things like that so so that's where the delay has been we're very close to our our final cadillac um we've actually booked that um but yeah frank you know what ian is saying actually cannot be emphasized strongly enough um because the virus hit different areas of the u.s at different times when new york was in lockdown utah was not by the time new york got out of lockdown utah was in lockdown so i we we couldn't really get from one to the other and actually have we were doing zoom meetings and we were identifying fine points of discussion regarding the final design but and they were sending stuff back and forth to me but when you're doing this kind of a project you have to have a one-to-one face-to-face discussion with between the the developers the various develop members of the development team and this just has prevented that so drastically then utah opened up and new york closed again uh our governor in new york every day we have a different there's a different set of rules every day and of course he's having his own problems now not related just partly related to covid and related to other things so it's been pretty crazy um we are i would say infinitesimally close to you know design freeze for the whole for the whole bowl of wax we're infinitesimally close i would guesstimate that we are probably wanted uh two to three months from absolute design freeze start the fda testing that has been prescribed that we have to do and i think it's very realistic i have no problems stating that i think we can file our fda application by the late summer early fall and i think we'll get it through in the 60 to 90 days that they've been approving things right now of course unfortunately the admin administration has changed uh i say unfortunately because whatever anybody else thought about trump he was pushing the fda to get medical devices through some people criticized maybe too fast although there's been no evidence that there's been a safety issue but he was making sure that they didn't just sit on things that they dealt with things one way or the other and this administration we're not sure where this is going to go yeah i'd imagine that one of the difficulties like you say with various different lockdowns is given all the testing that you'll have to do on on cadavers and actual physical bodies to see how it does interact and work and everything else it's not like you can just have a cadaver at home on your kitchen table to test it is it you've got to be in a proper center that's licensed to carry other procedures you don't know what my italian family business been like we could have had a cadavers when we needed them but my mother was italian um but on a serious note our independent tester is in toledo ohio his name is dr vijay gaul and he is internationally recognized as the foremost authority on spinal biodynamics he is literally internationally recognized as the foremost authority his university was locked down for almost seven months so we really couldn't get things even get him to to you know do any kind of testing even as we were on the process so frank said on a call which i thought summed it up a couple of weeks ago he said one lab session is worth a hundred zoom calls um and it is you know like i said when i first when i first was introduced to true spine you know surgeons wanted to touch and feel and see the product rather than powerpoint it is a very tactile thing um unfortunately i've only been at one lab which was before lockdown so february of last year and i was actually on that with a member of our board who is actually the queen's doctor um dr tim evans and an absolute charming man but he wasn't a surgeon he's he's a generalist he's a general medicine um you know what we call a gp um albeit you know he does look after 800 people in the royal household and he was so amazed in the lab and he was like he really was like a school boy with a fresh bag of sweets uh he he extended the lab he made us late for dinner and everything else because he said can i do another one can i do a bilateral and he did a three level assembly which you could almost pick this cadaver off the table with in 14 minutes and he's not a surgeon and he literally said if i can do that my god how how powerful will this be in the hands of truly you know trained neuro and spinal surgeons and he he was just literally blown away he said he's never seen anything so revolutionary in his life and it really was that lab for me you know it really cemented everything that i believed because again you can only see so much computer modeling and so many plastic prototypes which if you know two times the normal size three times the normal size when you actually see it on a spine and bear in mind the cadaver that we had i think someone had gotten from walmart it was not the best cadiver and what i mean by that is we had to cut down where was it frank about six inches would you say to get to the spine i i don't think i've ever seen i mean this guy had to be 350 pounds i don't think i've ever seen so much fat on it on the back of the neck it was amazing i mean i was down to about thi far down to touch the bones it was about this far down but even on that we could we could almost physically lift the the the category off the table um with our with our stabilization it was that secure it was well for me it was a light bulb moment well i think in essence that that's a perfect note to to finish on really just if it's if it's good enough for the queen's doctor then perhaps all the rest of us should be taking a much closer look at it and i'd like to thank you both for your time this afternoon um apologies to those people whose questions we haven't answered yet um what we will be doing is collecting all of those questions and then emailing out answers to the questions from the details that you provided when you signed up for this webinar and you will also be able to access um both the truespine technologies telegram group and the first look ventures telegram group by using the qr codes in the pictures and we would invite you to do so because any and all details of any opportunities to get involved with true spine technologies will be in both of those groups thank you very much for your time everybody good afternoon