Profound Medical Corp.

Q4 2022 Earnings Conference Call

3/7/2023

spk_0: the day of thank you for standing by welcome to the profound medical fourth quarter and full year two thousand and twenty two financial result the conference call at this time off to stencil listen only mode after the speakers presentation they'll be a question and answer session the ask a question during the session you need to press star one one on your telephone you will then here an automated message advising you your hand is raised to withdraw your question please press star one one again please be advised that today's conference is being recorded of a now liked him a conference over the years bigger they seven kilmer investor relations please go ahead
spk_1: thank you good afternoon everyone let me start by pointed out the good cop and call will include for looking statements within the meaning of applicable security laws and united states and canada all for looking statements are based on the pounds can't believe for thumps with much and relate to among other things expectations regarding the up a copy of the couple treatment technologies result of future clinical trials the ability to obtain coding and army and person and third or errors and physically the financial performance that with prospect strategies regulatory developments market acceptance and future commandments such statements about known and unknown risks and search deep and other factors that may cause actual results performance or achievements to be materially different the multiply by such statements know for looking payment can be guaranteed listeners are caught a not the place undue reliance on his for like and statements with speak only of the day the conference call but on undertake no obligation to publicly update or revise any for looking statements what are as a result of little information future events or otherwise other than as required by law for the benefit both were new to the town story i was also like to take a moment the family business propounded off the markets customizable and physically therapies for the ablation entities these tissue we are currently course it was a problem the technology the combine real time and i robotically try the treasury through also found a global temperature feedback control the technology is the binds applied customizable predictable radius of replace that assertions of i pod a volume but i could be protecting the urethra and rectum help preserve the patience battle functional doughty ah the is the marked healthcare approved by think clicked five bank a cleared by that game and the us with employ a pure recurring revenue model for topical whereby we charge customers on a per procedure basis for tulsa from conceivable leave a medical devices conservative for says with it fell apart outside of the united states we primarily to play a capital inconceivable for of and service model separately as the situation warrants that we are also commercializing finally is an their be very therapeutic platform for the see marked the treatment of uterine fibroids the pelvic pain treatment of pomposity finally the probably the prove by the china's national medical products administration for the man who for treatment of you don't fibroids and as recently appeared at the approval or humanitarian device exemption for the treatment of us field me feel it i feel that the business model for families but since it's currently at one time spell couple clement on the top a rather than in the company or doctor room and a lot for bounce chief executive officer chairman and russia the on the company's chief financial officer with that said on ultra call over to reset
spk_2: afternoon everyone and welcome to our fourth quarter when twenty two conference call on behalf of the management team and every one of the fan i'd like to thank you for your ongoing interesting our company what do the be you who are shareholder he appreciates your continued interest in the for i will turn the called either too early in a few moments for an update on a commercial activity however if i do i would like to provide a brief of the on or fourth quarter y twenty two financial results
spk_3: he seemed like thing
spk_2: all of the numbers will refer to have been around for their profit the three month period ended december thirty one twenty twenty two the company recorded revenue of one point three million dollars with a fool them on coming from becoming a rabbit what order twenty twenty two revenue increased twenty six percent from one million from the theme pure and twenty twenty one which also did not include any capital robbie that they are kept a project pipeline in market outside you at is rock and we do expect to have capital revenue in the future period as previously stated we only sell capital in the or us market this margin for between months and you're in the december thirty one twenty twenty three why forty four percent and forty five percent respectively compared to fifty percent and forty three percent for the same period of twenty twenty one while i was more urgent you're good at this early stage as a recurring revenue increases with fact the margin will improve from the crime level long term week fact are gross margin to the better than seventy five percent as recurring revenue a kept capital rabbit total operating expenses in the twenty twenty two fourth quarter which consisted er in de janeiro and selling and speak distribution expensive why nine point four million dollars a decrease of eight percent compared with ten point two million dollars in the fourth quarter of twenty twenty one primarily due to decrease noncash share the compensation expensive week back or live cast iron neither to operation to be in the five to six million dollar range seen as financial the or twenty twenty two reading that down partner expenditures for already decree thirty four percent on a year over the yard easy to keep on one million dollars yannick fences decrease by thirty five percent to two point one million dollars and telling and diffusion expensive decreased by twenty seven percent to one point seven million dollars partially offsetting the decreases in our the vienna and selling and distinction expensive we recognize and non cash in care men of approximately two point five million dollars in the fourth quarter of twenty twenty two presenting all the goodwill associated with the family business as the returned to be missing china continue to be delayed due to call the nineteen net final cause for the twenty twenty two fourth quarter was happy million dollar consisted of the same three month period of twenty twenty one overall the company recorded a fourth quarter twenty twenty two net loss of nine point five million dollars or forty six them are common share compared with a net loss a pin point two million dollars or forty nine and are common share for the same three month period in twenty twenty one as add december thirty one twenty twenty two profound had cash a forty six point five million dollars being on the company's current barn great we believe that it kind of cash position is the fission the fun is operation into que one twenty twenty five with that i will not turn the called over to earth
spk_4: thank you i said beginning with our financial performance a recurring revenue continues to meet expectations
spk_2: and was the sole driver of this quarters revenue increase compared to queue for twenty twenty one we reported no capital equipment sales for the quarter largely due to continued covered nineteen related headwinds in select my kids such as japan and china while we do not believe this is representative of the future we cannot predict when international capital sales will resume hat or above the way we have reported in previous course regardless i men task he's about driving utilization of tulsa in the united states
spk_4: as you know it is a game changing technology and the hurdles that we have paid mostly the lead to the changes required to instill the new practice or the substantive new technology
spk_2: we believe that the flywheel of adoption of our technology is finally turning and it will gain speed and twenty twenty three by the end of que for twenty twenty two the utilization of tulsa began to grow at the rate of about five percent per month and now would be installed base of thirty five system we believe that growth rate is sustainable and will likely increase has argued all the just continue to gain more experience now that we have done over three thousand cases we have also analyzed what type of cases are being done commercially as that is a critical early indicator of the potential of the adoption of our technology from the very beginning we have indicated that our technology has the potential to treat a significant part of the prostate cancer patient population and now our commercial patient treatment data is proving it over fifty percent of patients being treated with tulsa have prostate larger than forty c c and we have treated profits as large as two hundred fifty feet inside covering the full range of the potential patient population as for the stage of the disease treated approximately half of the patients we have treated or those with midstage busy but i'm particularly pleased to see that over thirty percent of patients being treated belong to higher risk categories from great group three up to five or very high risk patients and we have even feed it many palliative patients about sixty percent of our patients treated received whole glenn ablaze him about thirty three percent received greater than fifty percent prostate abrasion but less them hoagland had about fifteen percent receive focal ablation which is less than fifty percent of the frosting all the data put together clearly indicates that tulsa can be used to treat a vast majority of the pit prostate cancer patient population
spk_5: bottom line
spk_2: we believe that the precision of tulsa which enables hard clinicians the treat cases with confidence the flexibility of tulsa which allows them to use it for a variety of patient population and are compelling clinical data are all factors that continue to give with conference in driving widespread adoption of closer twenty twenty two was also an unusual year in certain steps doctors the anti our first commercial you that
spk_6: hardly did any cases in the year
spk_2: as he was busy switching from it old practice to becoming the chief your alley her at halo the axe now that he's there he's looking to start using tulsa again for majority of his cases he's also training his colleague at foresight to make tulsa the first line treatment option for prostate cancer
spk_4: then another situation
spk_2: i read that site which was slow to start finally finish their first fifty patients
spk_4: please with their outcomes they've opened their second sight in arizona
spk_2: which is off to a very good start
spk_4: similarly a number of sites
spk_2: that we're cautious when they started have now completed their first thirty to fifty cases and have confirmed that their clinical outcomes are as good as that in the tech trial or better as they have the flexibility to customize treatment and commercial settings
spk_4: generally speaking the sites are now looking to increase utilization and are open to treating a wider variety of patients
spk_2: another growth driver that we are seeing is that the number of cheating sites continue to increase and the teaching sites that have done about fifty cases are adding at least one more you're on the just to use the technology which has the potential to increase the overall site usage at that site
spk_6: summarizing on the usage of tulsa in the us
spk_4: no doubt it has been tough
spk_2: but as i mentioned before the flywheel of adoption is turning in the right direction as er physicians gain more experience and the number of sites continue to increase we believe that the adoption rates will increase the other team main driver of adoption has you know a reimbursement at least twelve of the hospital system began to use the temporary c code approximately and twenty twenty two
spk_4: these sites are also getting payments in the range that they are satisfied with
spk_2: our goal is to continue to educate the sights on the proper use of the code and we find that the sites that are using it has have a backlog of patients and be approximate range of three to four month as for the permanent code the cpp category one code
spk_4: the next am a cpt committee meeting is scheduled to be in chicago
spk_2: from a sport to may fixed and consideration of the unique tulsa code is on the agenda according to this agenda the summary of the results and absence of this meeting will be published on or before june second you might recall last year we pulled back as the utilization data that was submitted reflected only twenty twenty one data but this year twenty two the twenty twenty twenty two data is included and we believe that it is substantially higher and sufficient to get over the utilization threshold
spk_6: another difference this year
spk_4: is that the application is completely sponsored by the relevant society
spk_2: and profound is not a cosponsor which may give more credence to the application and the process we are now less than two months away from this milestone at a potential major inflection point and we're looking forward to discussing it further on the q one endless call in early may in addition to the progress we've made in driving utilization of tulsa in us and other bite filing of the cpp code application the also made progress
spk_6: on the critical front
spk_2: we expect at least three additional substantial publications this year in peer reviewed journals as well as at least eight podium presentations at relevant conferences including the a way for forty and presentations regarding tulsa took place earlier this week and the society of interventional radiology annual meeting our captain trial recruitment continues every remain confident that preliminary results from this prospective randomized comparative trial which radical prostatectomy can be announced in early twenty twenty five which will coincide with the effectiveness of the permanent cpt code if approved
spk_4: increasing utilization of tulsa in us
spk_2: achieving approval of the permanent pretty code and continued recruitment and captain trial the main the main agenda of our country i'm also pleased to tell you that we have submitted or first tulsa a i software to the ft a for clearance
spk_7: i encourage you to visit our website
spk_2: that describes this product in are updated corporate presentation that was posted a few minutes ago i know that day i has become a big buzzword in the recent past
spk_7: our program
spk_2: more than two years old
spk_4: and it is designed to have the specific purpose
spk_2: of improving tulsa treatment planning times as well as making it a continuous learning system as i mentioned before we have a significant amount of image based patient data
spk_6: we have said over fifty four million parameters
spk_2: trump over seven thousand images into our a i engine along with validated thirteen hundred treatment plants that work manually produced by our expert physicians to treat their patients the tulsa ai is now and had on software module that can be added to tulsa pro and the module has the ability to produce suggested treatment design based upon it's learning from the database
spk_4: the suggested design is primarily about saving treatment planning time
spk_2: but given that it is based upon prior successful treatment it also give our urologist additional confidence in the automated time
spk_4: we have
spk_6: reviewed the module with the sta
spk_4: i have received clear guidelines
spk_8: as to what it will take to achieve clearance
spk_2: which include thing for alignment of the suggested design with physician treatment plan on a of basis we believe this is doable my summers this year at which point we will submit the final do the stats to the ft for approval we're very excited about the first a i product as this internally developed capability will serve us to make tulsa a continuous learning system as we automate various aspects of the posts are pros system
spk_9: as well as the patient care continue
spk_4: summarizing
spk_2: we believe that the fly you have toss up for adoption is accelerating at the rate of five percent per month growth and will likely further gains team in the second half of the year
spk_10: we also believe that achieving and install base of fifty thought systems
spk_4: in united states
spk_2: by end of twenty twenty three is very possible
spk_6: we look forward to reporting on the progress of the application of the category one cpt code which we believe will be a major inflection point for our company
spk_2: we expect that the captain trial which is already recruiting at a pace faster than any other comparative trial in prostate cancer will continue to recruit a good pace judge naval preliminary results in early twenty twenty five
spk_4: and finally we are excited about our tulsa a high initiative if cleared by the ft later this year
spk_2: it has the potential to not only significantly reduce treatment climbing time but also give or clinicians substantial padded conference further driving adoption this and are prepared remarks for today
spk_4: lift that rochelle ny are happy to take any questions
spk_11: you might have
spk_0: after hitter thank you as a reminder to ask a question press star one one on a telephone and way for your name to be announced to withdraw your question press star one one again please stand by while we compile the q and a roster
spk_12: our first question comes from michael sarcone with jeffries your line is open
spk_13: hey good afternoon and thanks for taking my questions
spk_14: good i love
spk_4: first question to you talk about exiting a twenty twenty two were some utilization grow that about five for fat per month he just talk about how to have been tracking for the first few months of the year and and how you expect that he were rap the course of the year
spk_15: yeah michael that's a simple question as a glance at it we are definitely tracking her that five percent that much right now
spk_16: okay thanks
spk_4: yeah that he had more
spk_5: no i think that's fairly straightforward i think that it
spk_2: the some of the new install base
spk_12: as they begin to get more experience i think they will continue to increase also which is why you know and i'm in a word guess emitting right now the second half we can do that but five percent in definitely there understood bag in and then just one more
spk_2: have you think about the the pace of system placement through the year and the us
spk_4: sure michael of our pipeline is definitely very strong
spk_2: and i think that as i said in the repaired remarks getting the fifty my end of the this year is we think is day feasible
spk_4: ha and i think continue to increase that number substantially in twenty twenty four them in on in the raid of maybe seventy five is doable i'm
spk_12: so i think what our anticipation here is that the card sites will
spk_17: continue to increase utilization and the number of sites will also continue to increase okay thank you
spk_0: thank you
spk_18: my mom and for our next question or next question comes from rahul sargassum from raymond james your line of open ah good afternoon of and reset the thanks so much for your particular question so congratulations on ah having easy topic isn't included in the air made me
spk_4: recognizing that is often last year to withdraw the application primarily based on number of patients now referred to know one not have two thousand patients he referred to several caucus promises
spk_2: and and publishes of the last year maybe it is get a little what color in terms of how you if these are the keep key criteria intensity was conducted in that regard than an hour
spk_4: the that within the application that that how could to at the risk it sure
spk_2: no it's a good question in that is one of the big big milestone that we need to
spk_19: a t b c or
spk_2: and i'm i think some of the little luck and furniture the
spk_4: i'm the number of patients that were treated in twenty twenty two our with tulsa is high
spk_6: then
spk_4: the number patients that were included in fire filings of other technologies in prostate cancer that were approved so i think that on that basis we have crossed the lakers and hurdle you to and the main issue last fight but i do think that one of the things that we goodness to as we were communicating with the for silence is that the enthusiasm of the society is also have continued to increase and for that reason the society basically said we've got this you don't need to even you know if you choose not to you and want to sponsored in of they will take it from here and i think should be honest god is a very good sign because majority of the applications the do get sponsored by the society's a go to get through so you know i know it's not ago june and pain but i do think that the clinical data is there the for society for colada the utilization a there
spk_20: week i think that we're sort of in the mainstream so i am most certainly much more enthusiastic and optimistic about it then i was last year
spk_4: and you don't there's always a backup plans in a company and
spk_18: for some reason a new issue does come up i'm in a we do have to my meeting this year so if so and so i think that there's no issue that i know of at the moment
spk_4: but if a newish it does come up biting we have the upper to go back in september and that you still keep the effectiveness made to january twenty five a tax attorney up or banking sector and i'm from an accomplishment on of on the captain trial
spk_6: you indicated that i do a good looking at potential preliminary data in a twenty five and course you've been balancing illinois seeing of the trial and was your commercial efforts could give it a alabama color in terms of how recruitment is going
spk_21: and that have any other miles dog that we might be able to count on our or look to before early twenty five
spk_4: he's sure you don't either said in be prepared to mars gear recruiting a pretty good peers who taught were about twenty five percent done
spk_20: in the trial and a high number states has no increase to key
spk_4: well as compared to eight am
spk_20: about six months ago
spk_4: i think that probably another two or three states that have expressed interest in participating so probably will go to maybe fifteen or sixteen
spk_21: ah within the next ninety days or so
spk_4: ah lee holmes you know we have really good team that is following up on recruitment and so the number of patients being recruited even in the first two months of twenty twenty three is higher than what we're doing in twenty twenty two so i do feel pretty up domestic that we will build a complete recruitment come time in in or first half or twenty twenty four
spk_6: and that means that we should be able to produce
spk_2: it was fixed it
spk_6: six to nine month data my que one twenty twenty five and he does she look at the tech trial data
spk_4: what we are we find is that once you cross the six month mark the high level of predictability aware that patient is going in the future
spk_2: and so that i think
spk_4: it was her less well that history will serve as well
spk_20: i'm to your other question in terms of and the other clinical publication
spk_2: tom
spk_4: we do expect five year data to be coming out this year which is you know the final up
spk_8: he is a dataset that you are legitimately looks for i don't anticipate i need
spk_18: significant differences are given the trend that we've seen the first four years but that will be suddenly another dataset that will come out
spk_22: there is a european trial that will start new that was also a comparative trial which which serve we saw the pattern our captain trial behind that trial
spk_4: they will start announcing their numbers starting this upcoming a way meeting in may
spk_2: citing that will also start so the some early indicators of
spk_4: you know the comparative study great that se very helpful thank writer and ago and dog one quick last question ah craig see the sugar look at a a i enabling the couple of the program you talked about potential a completion of the prospect of a patient by the summer so would be reasonable to assume that the fight and came with going by the fog looking at hawking at the a early twenty four yeah i think of we found that is the plan in obviously left in each show the ft eight but that is the plan that we will be able to get this product in the market in early twenty twenty four and i think the only other color i can give you every urologist that we have presented this too
spk_6: has given amazingly positive feedback so that it world
spk_18: he did i don't you the will actually lift off but this is something i'm very very ah
spk_23: i'm excited about i think it is the first have a family but will be coming out and i think the continuous learning process the continued learning of this technology
spk_0: i believe has that potential to actually continue to improve clinical outcomes and i think that's the part that is most exciting me
spk_24: i'm this the there's some video was better be placed on our website including the tulsa a ai videos and you will actually be able to see it and so you'll be able to see for example the the there's a quick the automatic treatment plan shows up on the screen and then the you see the pen will show up and leave you are just just makes the modifications where they see fit and then they go to the next month for you'll actually be able to see how well the technology works great thanks gonna run it takes like a question will get back in the get
spk_6: thank you know we have a question from ben hey north some alliance here line is open
spk_25: the governor john the picture taken the questions
spk_20: it to me on that specific you want to call
spk_2: he realized that either side is are smarter than me i don't need that spouse or yourself as well tennis of you as the society is the only good songs you deal away on that ah have a feeling aware of the it weighed when it it off
spk_4: i only the society's vs your about societies and that company and and so forth yeah it's you know statistically it's hard to find it i can go to face member really good were sort of i'm relying on a little bit
spk_18: one is that when we submitted the application last year really the only issue that had come up was the utilization rate of twenty twenty one and nowadays twenty twenty two data and as i said we think that it's better than what the am a approved for other products so i think that probably them
spk_24: a good way to to think about it the other thing is that the societies
spk_4: certainly are saying that page or league their approve of so
spk_20: i'm so i think they're certainly seem to be confident
spk_4: i cannot tell you statistically i don't think i have any data like that then i'll just try to stay at this hour and a for the set up the i now have yeah
spk_2: i get that mm
spk_4: our separate say me it i obviously do have a discussion of the at the eighth a key issue
spk_2: how many cases they expect to do it it will a summit the data that the ft eight ah is looking for
spk_4: yes most certainly so
spk_2: we've done
spk_4: one hundred and fifteen that lead good share with the f a
spk_26: we think we will do another twenty to thirty additional one
spk_24: and they're actually three upset that they have requested a type of data that they requested none of them actually will require like patients with her anymore leave are more comparison ah simulation or a core lab where a you are the distillery radiologist will ga there and they will look for comparison to the automated plan so i think that
spk_2: where were we have about eighty percent of what the asked year is looking for we will give them as to the a gun in the next a couple of months and we feel that given that what you've already done
spk_27: meet the criteria that be should be able to heal suddenly die and we shouldn't be fun space
spk_28: there
spk_4: kaka know that that they imagined
spk_27: the the whole your presented to so far better universally pas de about me
spk_4: investigation year and you get that you don't have to measure a year and actually talking about is that
spk_20: your ancestors the devil those that procedure on the other they say is that are going well what does that the commission and then ah our well i mean is there anything specific way that gets the these these are faults ah we don't watch tiger then
spk_6: on one feature or another are within the ai
spk_4: who been first will be the two separate applications one of them is for the contrary assistant
spk_6: second one is for
spk_29: the booth
spk_4: i'm i talked to the obvious be the feedback we're getting is very positive for both of them the first one as big as a month and be
spk_30: you know those a psychological
spk_4: shift that is taking place as you know this is so game changing as a technology that when we first talked about the hey you need to you that i'm alive to do as
spk_2: no there this little hesitation that first shows up i've never used them i for and that just now shifting true hey i'm going to look at camera images from the perspective of treating that patient and i'm looking at the biopsy data that i'm looking at now how i'm going to design the treatment and that is a very differ
spk_24: when perspective then the perspective of the a radiologist redesigning designing who's actually died know thing and they're looking at the cellular structure from the and right and they're not thinking about designing a treatment plan for be the two very different things that they have to do it i think that the you all just are now wow we're done this or are getting to that a single to i'm using these images for different purpose at the when we presented to them the idea of automated treatment planning using this knowledge and then be able to simulate what that means to them and tempo
spk_20: not just
spk_31: time but the confident that the treatment design is based upon the knowledge of will patients who have been treated successfully in the pocket
spk_1: that's the key point
spk_32: the feedback or getting his kid hundred and under be over
spk_33: so after you know as usual i want to be cautious and and in a lecture deliver on this but we feel defeated the a project me started on the two years ago and we have an amazing
spk_24: a i g m a company with have the capability and i think this is the beginning of it on putting ai into our our product
spk_4: he gets it is just the it true but the upper equivocation that for the contour enough sisters what's going on with him and this initial appeared permission a and there's the think the on as that all the hope i can be either that's correct the country the first one and them will produce everything them both it'll bring you up to speed as we do other things but at the moment there to applications one is the kind to insist and the second overtime of boost that there are in after a consideration
spk_6: okay got it
spk_24: i haven't read the be your come up here comes out they are but crackle publications and podium presentation ah very quickly as the doctor study paid hourly stowaways is likely that the presented at the the european the focus of your eyes of come up here a lot not too long
spk_2: yeah
spk_8: yeah
spk_34: bad guy
spk_24: that's not really a between high school and top i will be a when the data comes the is that supply to start or are unclear at this point
spk_2: i'm you know we're we're not in the uk taught him they are obviously because of and because and they're doing all of the now
spk_4: my information is not hundred percent accurate probably but
spk_24: my best guess is because these are different
spk_4: technology that they will have to delineate them
spk_0: okay
spk_35: okay i'll be out stages without they love it you do it was surprised
spk_8: the first publication that the first point presentation at the anyway
spk_4: i think will be investing in may
spk_21: the don't do
spk_2: yeah
spk_20: but you got that and the a un
spk_4: cbp want out come up and next couple few months here so yeah hopped on a two months
spk_36: the next two months of very eventful much the right
spk_2: that's good for your like russia will that runs on now all the pirates
spk_37: thank you thank you for much men
spk_4: thank you know our next question comes from frank the clean up with lake street your lines open a thanks for i pick my questions wanna start with asking about mentioned some of your your ear latest new users starting to build a three to four month backlog great to hear that a patient are being built out on those was wondering if you could talk a little bit more about those and a week talk to them of the bottlenecks they're facing to getting those patients through the fall
spk_6: so i'm
spk_4: craig it's you know i think it's just like any other thing it's good be
spk_35: it's an entirely new technology yes we attacked clinical data that look good but all of that was initially sort of the market and tree that this sort of said to them this is a technology that the want to
spk_6: in a evaluate or try and
spk_2: i think as you seen it many of the sites that started a couple years ago have vowed done he'll fifteen hundred and maybe even thirty cases and they have bowed done their evaluations and based upon both evaluation they're say this is a technology
spk_21: it is too
spk_6: it is here for the future and they want to start increasing it's usage
spk_38: hum hand so
spk_10: to to provide a little bit more colored what you're asking is
spk_2: that as they increase are looking at you know what my backlog and harmonies of the
spk_6: physicians are my is the to be tulsa users how much am i time do i need to allocate for my pipeline of patients and so on so i think what they're seeing is they get to a couple of to three my backlog and then they're saying i gotta increase
spk_2: my capacity and in that capacity it might be adding a urologist adding some more am our time and it'll or training another technician and so on that's how they're sort of slowly but surely getting to it
spk_4: i hope i'll answer your question frank
spk_39: not perfect a topical and then wanted to decide what are on doctor crts evaluation process i understand it's always been a early user of provence technology but when he switched over to halo gags via run an expensive evaluation process to you
spk_21: value it some of the other alternative prostate cancer treatment options or was he afraid that set up on implementing thousand across all the site
spk_40: oh
spk_0: thank the some what he told us
spk_41: i'm and little thought have been lost family early winter time is that he and halo as he was doing
spk_42: ah be evaluated multiple technology
spk_43: and
spk_8: one of the primary criteria
spk_4: ah that they used was did they felt that tulsa was the most standardized way of treating the patient and was
spk_6: of all of these alternative technology the be looked at it was the most gullible technology also and so their goal is they did not want to stand rag on something that could be very user it on your allergy skill based on day one
spk_4: to how a technology that he could sort of go over too many many practices
spk_2: and that was a a very large part of the his criteria a great of that the same crashes sounds great thanks frank one moment
spk_44: our next question comes from prying cadnano some gag nonsecurity sir line is often
spk_41: hi guys a couple a question for you
spk_4: for progress on the tpp i am a meeting that's terrific is there any ability to use the c code and an outpatient setting
spk_10: in the interim
spk_21: and what are you guys think about though
spk_2: yeah that's a good question
spk_38: so the c code right now is not only as he which is the outpatient reading list
spk_4: and as part of this as a separate
spk_2: conversation we have actually made the request the new cms directly that they should consider that and it basically involves safety and it a mouse you know whether or not patients who have been treated today are daytime patients ah or not and we do have
spk_45: really very strong data that are pressured go home the same day
spk_20: and with respect to safety in i'm we don't even create an incision so
spk_2: got a it's hard to fake out whether they will accept this criteria or not but suddenly that is a possibility mine
spk_44: okay
spk_41: ah that would be important to continue to drive adoption between now and when you get a full tp take out and then i heard get a are i don't want be shortsighted cause that's not the way i think our but can you give us an idea of how installs are going in this quarter and have you really got a and the bigger picture question as to be gotten past the bottleneck friends got install that you've discussed in the past i'm i think we you know you know we are very the whole are it company we have date on on
spk_4: you know from the time
spk_2: we start we get a contract to the time
spk_4: i'm we treat the first patient
spk_2: and
spk_27: what i look at that information suddenly doing the deed kobe period i think those times were running as long as
spk_2: six to eight months and you saw that because the install the is sort of was delayed and it's only the last three four months where we're finally getting after and for hobbies curve hillside i look at the latest data
spk_4: i think the have been able to cut it down to from six to at least three months now
spk_2: and i do think that
spk_6: as time goes on things in a to begin to get to more normal which we are suggesting that we will be a cut it down to in our target which is about sixty days
spk_4: okay that would be much more manageable and give you a little more clarity i'm another bigger picture question are you saying doc switching
spk_46: any of their days from profit acclimate to tulsa
spk_4: wow that's a very good question actually hum it's something that i actually watch very closely
spk_2: in income so who is switching to confide in general and generally
spk_4: it to the of these are actually robotic person who are switching to tulsa
spk_18: i'm and
spk_2: i'm i'm i'm into the on it's not only that i'm watching were watching him with you know we have many of them who are
spk_4: i actually explicitly i gonna wash them you know like and why are you doing tulsa ah and why did you searched this case from a robotic plastic or to me to tulsa
spk_6: and and i'm getting to the on a really really
spk_4: comments that that is why
spk_2: you know my confidence level is increasing i'm and i'm happy to share in fact some of these comments are played here
spk_4: i'm in italy
spk_21: one of the sites that had done in a thirty cases for example they were like very slowly doing cases and and then
spk_4: i actually talk to them and i said no you don't you guys started by saying we'll do it of thirty to forty per year you've taken longer to get there and they are you know
spk_10: they can have confirmed at what they were really doing is they want to do at least thirty cases
spk_6: and see how their places were doing before they really increase their usage and so they basically said look we have done these cases we have now confirmed that our own outcomes are similar to the packed clinical trial outcomes that is what they were looking for
spk_47: and they said now that we've confirmed the clinical trial outcomes
spk_41: we think that tulsa is gonna be in in our to be too because it's to give you good he said this is gonna be one of the big three it's gonna be tulsa it can be robotic was that to me it's get the radiation
spk_2: i said okay and this are listed i'll take that overtime will think about who is the number one in that space
spk_41: and
spk_48: you don't
spk_4: i'll of on publisher like oh sure one and anecdotal example with you which is which really had an impact on the action so i was i attended a case with one of our urologist and for some reason robotic post attack he actually came up as a conversation and
spk_21: he said that he had been doing a robotic case a week prior to the has
spk_6: that he actually lost good the robotic on last little it took him about thirty minutes to find him everything will be and no problem for what he said was he said while he was looking for that needle he said this would have never happened with tulsa
spk_2: he said you guys don't realize how inherently safer the technology
spk_20: so
spk_21: and it really heard him pester me is that we talk about safety we talk about clinical outcomes
spk_2: and these urologists are now seeing it in real walk so yes it's taking longer but i'm finding that the reasons to they're giving a really really good i'm at and quite frankly i'm happy about that i want them to tough test our technology and see the some
spk_49: terrific
spk_4: a mac a couple a more and them because i think i'm a dmg are lined up he he talked about this five percent per month without the auntie can you talk about the i think you said halo was gonna be a multi center group and he's training additional urologists and he will actually come online i think a month oh where are these additional stunners going to be and he i do you think you get into all the nfl studies
spk_11: throughout the balance for this year
spk_38: we
spk_4: so for saw your right so see on t a m i mean it was another interesting example of how it does take longer to get things we have gotten the that he was actually originally me going to start my end of last year but it is because of some approval that were needed in the state of florida
spk_44: oh we had nothing to do with on her or a our technology
spk_4: it was related to the site that it is took another ninety days to get going so he's definitely
spk_8: her slated to start in the next couple of weeks
spk_50: but to answer your question so she's there are two of the site or florida sites one is certain historical site which is just up and those another side which is jacksonville florida also and under two sides in california
spk_35: so those are the first foresight we have talked about are adding fight they're headed in a relatively a good pace but again the same model is let's get the site going let's get paid all of the
spk_4: in different things that can cause delays are in our recruitment so on let's create an efficient process and then most certainly the idea that we will grow
spk_51: in and build additional thoughts
spk_4: great
spk_27: read that they've got to open they've got doctor hong running the one here in arizona
spk_6: where are the fights gonna be for them and do you think you can grow that into the pan was that you had hoped for or when you originally signed the contract
spk_4: overtime
spk_20: ah yes i think so i think that again they did something similar the their first fifty cases analyze it and then decided yup
spk_4: ah they want to go there have been very supportive of to cpt application they have help educate from our society members are there are because that is on the their primary customer is a his reimbursed bill not a very big cash right now in arizona it's actually how cash and they're doing very well ah but their their message is there are have identified the next two sites already there to give purchased new and my eyes for the fight and we think that me
spk_41: later this year will be operational
spk_6: and gum
spk_17: i think once we have thirty feet on the city code and if we do get a approval to be able to get to see code into this is see then i think you will feel
spk_0: faster adoption but totally those two things are hardly to happen for them to go beyond of for that we're talking about
spk_10: great add to ask questions the one the the cat to are you close to completion on that
spk_2: a yes i think we're a couple of recent away and we'll get to the about two hundred and forty hundred fifty said thank patients or two hundred fifty and will close it up so and it'll have five year data next year and will continue to add those new or patients and you've got to see the impact of that in the final outcome
spk_52: okay last question for me
spk_2: does this shift from ultrasound biopsy k m r i n bore biopsy help with this shift to the inboard tulsa procedure
spk_10: yes so this is sort of a long term the dialogue by and and i take over the next couple of years certainly we will be talking about it cause i think right now are so focused on our short time getting the site going on in getting the fitted he called me
spk_52: but you're you're on your thinking
spk_4: the way that were kind of thinking is that what tulsa does is that it for the first time a neighbor have a very am are centric strategy farm screening the and to diagnosing the patient to an m r centric our biopsy to then tough for treatment and then father and
spk_6: you that all of a sudden become a continuum of care from beginning to the end and there is a lot of dialogue in the your algae company the about this and i take that on it
spk_4: has to some extent it is going from okay i have never used to the my before for now i can feed her family like that in the propelled march that i can think about
spk_2: m r i from the perspective of treatment designed by the diagnosis
spk_10: to you know i probably should old my own m r i
spk_2: and so i think that shift is you don't get it was gonna happen in one day but i definitely can tell you that they are number of urologist who are thinking that we're already
spk_4: terrific i'll get back in line thank you so much
spk_2: thank you bye play kill one moments or next question
spk_53: we have a question from scott mccauley from paradigm capital your line is open
spk_0: thanks john on the not allow keep it quick
spk_44: just to follow up on that the ai software
spk_2: come and go to do you see as being a default it's packaged in wet she's your cost
spk_54: that's currently a charging or that the leadership central add on upgrade
spk_44: said that subscription
spk_4: such a project much that
spk_20: yeah he's got good question to the way we are structuring this is called south pole
spk_4: is one cost per patient and there is going to be a value proposition for each of the module that we provide to the hospital or the logs practice and our plan is that there will be some kind of military action to the our company for those module food though it is not a free add on it will have it's own value proposition and it will either have a additional price associated with it or we'll have thirty other commitments associated with but most certainly it is an increase in the value proposition of my company absolutely i out and then i think i just met get paid off the top you say and at five to six nine dollar range of have expected for some of it
spk_0: i think i watched best of luck that was if you later i got it bad that it should
spk_4: i'm i can get some a were said question i think that's combined yeah that he was yeah though you said do you have anything to add to that our children no are basically what we're still thought if we are facing to hold for on our part right in our to maximize our runway and that's how we are getting the obvious that the cash that we haven't had will give us the wrong way to go to all the way to you on twenty twenty five at will make sure that we have just a lever
spk_0: she between can make sure we invest in the right area like without feel the marketing and will adjust the cost in the other places to keep their aren't great stable
spk_55: got it
spk_0: gallup thank you one moment
spk_1: we have a follow up from buying a man from get on a security issue lines up and i'd so reset open the door talk about the self worth growth if you would i think you have for now oh where are you have to be investing in the felt forced this year gonna go rap genius feet on the street hunter farmer would you guys think about yeah coburn been vr are aggressively adding to our sales team right now given the pipeline and the larger install base and down in some reform the answer is all of the now we are adding a new hunters because of the the demand the pipeline that is going we you to close those deals where definitely hiring some really really good i'm farmers who can take the sites that are the have already cleared for example fifty cases and for one the beer demand in terms of our presence is lawsuit lot less than what it would be for the newer site and then for the newest i've ever been on we are adding a junior services so that he can continue to support is unlikely did the earlier dr phil in the answer to that is absolutely all three of them were adding aggressively like now thank you thank you and i'm showing no other questions i'd like to call back to doctor men a lot for closing remarks so thank you so much calm i think there is definitely a lot going on
spk_2: ha as someone tried to make call the next couple of months will be very interesting can i really appreciate the question because we are in a we are doing something that is where unique and are so many dimensions to it that i'm happy to answer the questions and thank you for anything and i look forward very much to the cuban call thank you and yet this concludes today's cousins car thank you for participating you may now disconnect everyone have a great day the conference will begin shortly to raise and lower your hand during una you can dial star one one day of thank you for standing by welcome to the profound medical fourth quarter and full year two thousand and twenty two financial results conference call at this time off christensen listen only mode after the speakers presentation they'll be a question and answer session the ask a question during the session really depressed star one one on your telephone you will then here an automated message advising you your hand is raised to withdraw your question please press star one one again
spk_3: please be advised that today's conference is being recorded i would now like him the conference over the years bigger they even kilmer investor relations please go ahead
spk_2: thank you good afternoon everyone let me start by pointed out that the coffins call will include for looking statements within the meaning of applicable security laws and united states and canada all for looking statements are based on for pounds can't believe presumption expectations and relate to among other things that occasions regarding the other feel the company's pick out it's result of future clinical trials the ability to obtain coding and are members of and third or years anticipated financial performance that was prospect strategies regulatory developments market acceptance and future commandments such statements about known and unknown refs and search deep and other factors that may cause actual results performance or achievements to be materially different the multiply by customs know for the favor can be guaranteed listeners are caught and not the place undue reliance on his for looking statements with speak only after the data the conference call for the undertake no obligation to publicly update or revise any for looking statements weather as a result of new information future events or otherwise other than as required by law for the benefit both were new to the pound story i would also like to take a moment the from hijackers us profound off the markets customizable and physically therapies for the ablation onto these tissue we are currently commercialize life impulse approach the technology to come by the real time and i robotically dragon treasury through ultrasound and close temperature feedback a job the technology is the by supplied customizable unpredictable radiation free a of assertions of i pod bay biden for i could be protecting the urethra and rectum help preserve the pacers battle functional doughty how the pro scene how healthcare prove that bites i clicked five okay cleared by decade and us with and play a pure recurring revenue model for topical whereby we charge customers on a purposes or basis for tulsa from conceivable leave a medical devices conservative associated with it fell apart outside of the united states we primarily to play a couple on configurable for of and service model separately of the situation warrants that we are also commercializing finally is an innovative their be very therapeutic platform for the see marked the treatment of uterine fibroids out of pain treatment a pompous attitude finally the papa been approved by the china's national medical products administration for the not and face of treatment of uterine fibroids and as recently a at the approval other humanitarian to both exemption for the treatment of a field hospital it i feel that the different model for families but since it's currently at one time spell capital club on the carpet a representing the company or doctor room and a lot propounds chief executive officer chairman and russia do on the company's chief financial officer with that that are now the call over to reset afternoon everyone and welcome to our fourth quarter when it's wanted to conference call on behalf of the management team and every one of the thought i'd like to thank you for your ongoing interesting our company for those of you who are shareholders he appreciates your continued interest in the for i will turn the called over to earn in a few moments for an update on a commercial activity however if i do i'd like to provide a brief of the on honor fourth quarter y twenty two financial results
spk_56: he seemed like thing
spk_2: all of the numbers will refer to have been around for their profit the three month period ended december thirty one twenty twenty two the company recorded revenue of one point three million dollars with a fool them coming from becoming a rabbit what order twenty twenty two revenue increased twenty six percent from one million from the theme pure and twenty twenty one which also did not include any capital rabbit that they are kept a project pipeline in market outside you us his shot and we do expect to have capital revenue in the future period as previously stated we only sell capital in the or us market this margin for the three month and you're in the december thirty one twenty twenty three why forty four percent and forty five percent respectively compared to fifty percent and forty three percent for the same period of twenty twenty one while i was more urgent you're good at this early stage as a recurring revenue increases with bag the margin will improve from the crime level long term week fact are good margin to the better than seventy five percent as recurring revenue pasted capital rabbit total operating expenses in the twenty twenty two fourth quarter which countries that are in de janeiro and telling and his feet distribution expensive
spk_4: why nine point four million dollars a decrease of eight percent compared with ten point two million dollars in the fourth quarter of twenty twenty one
spk_2: primarily due to decrease noncash shared they've computation expensive week fact our live cast iron neither cooperation to be in the five to six million dollar range same as financially or twenty twenty two reading that down partner expenditures for id decrease thirty four percent
spk_4: on a year over the your the thing to keep one one million dollars
spk_2: yeah expensive decreased by thirty five percent to two point one million dollars
spk_4: and darling and the same issue an expensive decreed by twenty seven percent to one point seven million dollars
spk_2: partially offsetting the decreases the normandy cnn and selling and distinction expensive we recognize and non cash in care men are approximately two point five million dollars in the fourth quarter of twenty twenty two president thing all the goodwill associated with the finale do it as a return to be missing china continue to be delayed due to call the nineteen net final cause or the twenty twenty two fourth quarter was happy million dollar consistent with the same three month period of twenty twenty one overall the company recorded a fourth quarter twenty twenty two net loss of nine point five million dollars or four weeks them are common share compared with a net loss of pin point two million dollars or forty nine in are common share for the same three month period in twenty twenty one i'll add december thirty one twenty twenty two profound had cash a forty three point five million dollars being on the company's current barn great we believe that it kind of cash position if the fish in the fun is operation into que one twenty twenty five
spk_5: with that i will not turn the call over to our of
spk_2: thank you i said beginning with our financial performance or recurring revenue continues to meet expectations and was the sole driver of this quarter's revenue increase compared to queue for twenty twenty one we reported no capital equipment sales for the quarter largely due to continued covered nineteen related headwinds in select markets such as japan and china
spk_4: while we do not believe this is representative of the future we cannot predict when international capital fails will resume at or above the rate we have reported in previous course
spk_2: regardless are men task is about driving utilization of tulsa in the united states as you know it is a game changing technology and the hurdles that we have paid mostly relate to the changes required to instill the new practice or the substantive new technology
spk_4: we believe that the flywheel of adoption of our technology is finally turning it will gain speed and twenty twenty three
spk_2: by the end of que for twenty twenty two the utilization of tulsa began to grow at the rate of about five percent per month
spk_4: and now would be installed base of thirty five system
spk_2: we believe that growth rate is sustainable and will likely increase has argue rather just continue to gain more experience
spk_4: now that we have done over three thousand cases we have also analyzed what type of cases are being done commercially as that is a critical early indicator of the potential of the adoption of our technology
spk_2: from the very beginning we have indicated that our technology has the potential to treat a significant part of the prostate cancer patient population and now our commercial patient treatment data is proving it
spk_4: over fifty percent of patients being treated with tulsa
spk_2: have prostate larger than forty c c and we have treated prostate as large as two hundred fifty feet inside covering the full range of the potential patient population as to the stage of the disease treated approximately half of the patients we have treated or those with midstage busy but i'm particularly pleased to see that over thirty percent of patients being treated belong to higher risk categories from great group three up to five or very high risk patients and we have even feed many pavia do patients about sixty percent of our patients treated received whole glenn ablaze him about thirty three percent received greater than fifty percent off played abrasion but less than hoagland had about fifteen percent receive focal a blazer
spk_6: which is less than fifty percent of the frosting
spk_4: all the data put together
spk_2: clearly indicates that tulsa can be used to treat a vast majority of the pit prostate cancer patient population bottom line we believe that the precision of tulsa which enables are clinicians the three cases with confidence the flexibility of tulsa which allows them to use it for a variety of patient population and are compelling clinical data are all factors that continue to get with confidence in driving widespread adoption of council twenty twenty two was also an unusual year in certain steps
spk_4: doctors the anti our first commercial you that hardly did any cases in the year
spk_2: as he was busy switching from it old practice to becoming the chief your ali her at halo the axe now that he's there he's looking to start using tulsa again for majority of his cases he's also training his colleague at foresight to make tulsa the first line treatment option for prostate cancer then another situation
spk_4: i read that site which was slow to start finally finish their first fifty patients
spk_2: please with their outcomes they've opened their second sight in arizona which is off to a very good start similarly a number of sites that we're cautious when they started have now completed their first thirty to fifty cases and have confirmed that their clinical outcomes are as good as that in the tech trial or better as they have the flexibility to customize treatment and commercial settings generally speaking
spk_4: the sites are now looking to increase utilization and are open to treating a wider variety of patients
spk_2: another growth driver that we are seeing is that the number of teaching sites continue to increase and the cheating sites that have done about fifty cases are adding at least one more you're on the just to use the technology which has the potential to increase the overall site usage at that site summarizing on the usage of tulsa in the us no doubt it has been tough but as i mentioned before the flywheel of adoption is turning in the right direction
spk_6: as our physicians gain more experience and the number of sites continue to increase we believe that the adoption rates will increase
spk_2: the other team main driver of adoption have you know a reimbursement at least twelve of the hospital system began to use the temporary c code approximately in twenty twenty two these sites are also getting payments in the range that they are satisfied with our goal is to continue to educate the sights on the proper use of the code and we find that the sites that are using it
spk_4: has have a backlog of patients and the approximate range of three to four month
spk_2: as for the permanent code
spk_6: the t category one code
spk_2: the next i made cpt committee meeting is scheduled to be in chicago from a sport to may fixed and consideration of the unique tulsa code is on the agenda
spk_7: according to this agenda the summary of the results and absence of this meeting will be published on or before june second
spk_2: you might recall last year
spk_6: we pulled back as the utilization data that was submitted reflected only twenty twenty one data
spk_2: but this year twenty two the twenty twenty twenty two data is included and we believe that it is substantially higher and sufficient to get over the utilization threshold
spk_7: another difference this year is that the application is completely sponsored by the relevant society
spk_2: and profound is not a cosponsor which may give more credence to the application and the process
spk_4: we are now less than two months away from this milestone
spk_2: at a potential major inflection point and we're looking forward to discussing it further on the q one endless call in early may in addition to the progress we've made in driving utilization of tulsa in us
spk_4: and other bite filing of the cpp cold application
spk_2: the also made progress on the clinical front we expect at least three additional substantial publications this year in peer reviewed journals as well as at least eight point presentations at relevant conferences including the a you way for for the and presentations regarding tulsa
spk_4: took place earlier this week and the society of interventional radiology annual meeting
spk_2: our captain trial recruitment continues every remain confident that preliminary results from this prospective randomized comparative trial
spk_4: which radical prostatectomy can be announced in early twenty twenty five which will coincide with the effectiveness of the permanent cpt code if approved
spk_7: increasing utilization of tulsa in us
spk_4: achieving approval of the permanency pretty cold
spk_2: and continued recruitment and captain trial the main the main agenda of our country i'm also pleased to tell you that we have submitted our first close up a i software to the ft a for clearance i encourage you to visit our website
spk_9: that describes this product in are updated corporate presentation
spk_4: that was posted a few minutes ago
spk_2: i know that day i has become a big buzzword in the recent past our program
spk_10: is more than two years old
spk_4: and it is designed to have the specific purpose
spk_2: of improving fair treatment planning times as well as making it a continuous learning system
spk_4: as i mentioned before we have a significant amount of image based patient data
spk_2: we have said over fifty four million parameters
spk_6: trump over seven thousand images into our a i engine along with validated thirteen hundred treatment plants
spk_2: that work manually produced by our expert physicians to treat their patients the tulsa ai is now and had on software module that can be added to tulsa pro
spk_4: and the module has the ability to produce suggested treatment design based upon it's learning from the database the suggested design is primarily about saving treatment planning time
spk_2: but given that it is based upon prior successful treatments it also give our urologist additional confidence in the automated plan we have
spk_4: reviewed the module with the sta
spk_11: and have received clear guidelines
spk_0: as to what it will take to achieve clearance which include testing for alignment of the suggested design with physician treatment plan on a prospective basis we believe this is doable my summers this year
spk_12: at which point we will submit the final the stats to the ft for approval
spk_13: we're very excited about the first a i product as this internally developed capability will serve us to make cosa a continuous learning system
spk_14: as we automate various aspects of the posts are pros system as well as the patient care continue
spk_4: summarizing
spk_15: we believe that the fly you have toss up for adoption
spk_16: is accelerating at the rate of five percent per month growth and will likely further gains team in the second half of the year
spk_4: we also believe that achieving and install base of fifty thought systems
spk_57: in united states
spk_2: by end of twenty twenty three is very possible
spk_12: we look forward to reporting on the progress of the application of the category one cpt code which we believe will be a major inflection point for our company we expect that the captain trial
spk_4: which is already recruiting at a pace faster than any other comparative trial in prostate cancer will continue to recruit a good pace
spk_2: yup naval preliminary results in early twenty twenty five
spk_4: and finally we are excited about our tulsa a high initiative if cleared by the f a later this year
spk_12: it has the potential the not only significantly reduce treatment climbing time but also give or clinicians substantial padded confidence further driving adoption
spk_17: this and are prepared remarks for today with that rochelle ny are happy to take any questions
spk_0: you might have
spk_18: after hitter thank you as a reminder to ask a question press star one one on your telephone and way for your name to be announced to withdraw your question press star one one again please stand by while we compile the q in a roster our first question comes from michael sarcone with jeffrey your line is open pig and afternoon and thanks for taking my questions good afternoon
spk_4: first question to you or talk about exiting at twenty for two were some utilization grow that about five for fat per month he just talk about how to have been tracking for the first two months of the year and and how you expect that he were rap how the course of the year
spk_2: yeah michael that's a simple question as a glance at it we are definitely tracking at that five percent that much right now
spk_4: okay thanks
spk_58: yeah that he had more
spk_2: no i think that fairly straightforward i think that it
spk_4: the some of the new install base
spk_2: as they begin to get more experience i think they will continue to increase also which is why you know and i'm in a word guesstimate right now the second half we can do that but five percent in definitely there
spk_4: understood baggy and and then just one more have you think about the the pace of system placement through the year and the us sure michael of our pipeline is definitely very strong
spk_6: and i think that as i said in the repaired remarks getting to fifty my end of the this year is we think is very feasible
spk_4: ha and i think continue to increase that number substantially in twenty twenty four dumb in on in the rate of maybe seventy five is doable i'm so i think what our anticipation here is that the card sites will continue to increase utilization and the number of sites will also continue to increase
spk_20: okay thank you
spk_4: the give
spk_6: my mom and for next question or next question comes from rahul
spk_4: sargassum from raymond james your line of open ah good afternoon of and reset the thanks so much for your particular question so congratulations on ah having an easy topic isn't included in the am a day
spk_20: recognizing that is often last year to withdraw the application primarily based on number of patients now referred to
spk_4: oh and wasn't not have two thousand patients he referred to several caucus promises
spk_18: and and publishers of the last year maybe it is give us a little what color in terms of how you if these are the keep key criteria intensity was asking isn't that what you're getting out that within the application that that how to the rescue sure no it's a good question in that is one of the big big milestone that we need to
spk_4: a key be c i mean i'm i think some of the little luck and funny share in the the number of patients that were created in twenty twenty
spk_59: kill you
spk_21: our but tulsa is high
spk_4: then the number patients that were included in
spk_20: fire filings of other technologies
spk_19: in prostate cancer that were approved
spk_4: so i think that on that basis
spk_20: we have crossed the utilization harder you try and the main issue last fight
spk_4: but i do think that
spk_60: one of the things that we goodness to as we were communicating with the society is that the enthusiasm of the society's also has continued to increase
spk_4: and for that reason the society basically said we've got this you don't need to even you know if you choose not to you and want to sponsor it in of they will take it from here and i think should be honest that is a very good time because majority of the applications that do get sponsored by the society's a go to get through
spk_2: i'm so in awe
spk_6: i know it's not ago change anything but i do think that the clinical data is there
spk_4: if a society support a yeah the utilization of their week i think that we're sort of in the mainstream so i am most certainly much more enthusiastic and optimistic about it then i was last year and he of there's always a backup plans in our company and if for some reason a new issued does come up i'm in a we do have a i'm a meeting this year so if so and
spk_20: so i think that
spk_4: there's no issue that i know of at the moment but if a new issue does come up by think we have the upper to go back in september and that is still keep the effectiveness me to january twenty five a tax cut her out for banking sector
spk_8: i'm to listen commission on of on the captain trial
spk_18: you indicated that i do a good looking at potential preliminary data in a twenty five and course you've ballon thing that we are seeing up the trial and what's your commercial efforts could get alabama color in terms of have recruitment is going on and that of any other miles going that we might be able to count on our or look to before early twenty five
spk_22: he's sure you know i said in be prepared remarks year recruiting a pretty good peers were taught were about twenty five percent done
spk_61: in the trial hand a high number states has now increase to thirty
spk_4: ha as compared to eight about six months ago i think that probably at the two or three sites that have expressed interest in participating so probably will go to maybe fifteen or sixteen ah within the next ninety days or so i'm we have been know we have really good team that is following up on recruitment and so the number of patients being recruited even in the first two months of twenty twenty three is higher than what we're doing in twenty twenty two so i do feel pretty up the mistake that we will build a complete recruitment come time in in or first half of twenty twenty four
spk_6: and that means that we should be able to produce
spk_18: it'll fix it
spk_23: six to nine month data my cue one twenty twenty five and he does he look at the heck trial data
spk_0: what we are we find is that once you cross the six month mark
spk_24: the high level of predictability aware that patient is going in the future and so that i think it was her was wow that history will serve as well i'm to your other question in terms of and the other clinical publication
spk_6: tom
spk_4: we do expect five year data to the coming out this year which is you know the final
spk_2: he is a dataset that you are legitimately looks for i don't anticipate any
spk_4: significant differences are given the trend that griffin the first four years but that will be thirty and others dataset that will come out there is a european trial that will start new that was also a comparative trial which which serve we saw the pattern our our captain trial behind that trial gay will start announcing their numbers starting this upcoming a you a meeting in may
spk_2: i think that will also start so the some early indicators of
spk_62: tom know comparative study
spk_18: great that that he grew up with a character and to go and dog one quick last question i could see the sugar look at the a a i enabling up up up the program
spk_27: you talked about potential or completion of the prospect of a patient by the summer so would be really was seeing that the fight and came with going by the following looking at
spk_20: hajime updated early twenty four
spk_4: yeah i think of me well that is the plan on in obviously left in each show the ft a but that is peggy the plan that we will be able to get this product in the market in early twenty twenty four
spk_2: and i think the only other color i can give you every urologist that we have presented this too
spk_6: has given amazingly positive feedback so that it away
spk_63: he did i don't usually very often but this is something i'm very very ah
spk_21: i'm excited about i think it is the first have a family will be coming out and i think the continuous the learning process the continue learning of this technology
spk_2: i believe has that potential to actually continue to improve clinical outcomes and i think that's the part that is most exciting should be on this the there are some videos better be placed on our website including the tulsa ai videos and you will
spk_4: actually be able to see it and so you'll be able to see for example the the there's a quick the automatic treatment plan shows up on the screen and then the you'll see the pen will show up and leave you are just this makes the modifications way they see fit and then they go to the next month for you'll actually be able to see how well the technology works
spk_64: great thanks gonna run it takes like a questions or the fact that you
spk_24: thank you know we have a question from ben hey north from alliance your line is open the governor john the picture taken the questions it to me on that specific he was caught on his ally set that aside these are smarter than me i don't that a starter yourself as well as tennis of you as a society is the only good saw the or went on that ah harry the aware where the it wait what
spk_4: it it all started by only the society's vs your thoughts about societies in that company and so forth
spk_28: yeah it's you know statistically it's hard to find it
spk_4: i think they're to face men that he will good worse out of i'm relying on a little bit
spk_2: ah one is that when we submitted the application last year really the only issue that had come up was the utilization rate of twenty twenty one and now it as twenty twenty two data and as i said we think that it's better than what the me a approved for other products so i think that probably them a good way to to think about it the other thing is that the societies
spk_4: certainly are saying that page or knowledge their approve of so i'm so i think they're certainly seem to be confident
spk_2: i cannot tell you statistically i don't think i have any data like that then okay i trust that i've never seen this happen across to the uncertainty and now him
spk_30: yeah
spk_4: i get that sorted out and mm
spk_2: alice is pretty say me you know obviously do have a discussion of the at the a key shirt you know how many cases they expect expected do to to build a submit the data that the ft eight ah is looking for yes most certainly who we've done
spk_24: a hundred and says and we did share with the last year
spk_20: we think we will do another twenty to thirty additional one
spk_24: and there are increase subset of they have requested types of data that they requested none of them actually will require
spk_35: like pace
spk_32: anymore
spk_33: these are more comparison
spk_24: ah simulation or a core lab where he you on the distillery below this will draw their and they will look for comparison to be automated plan so i think that
spk_4: where were we have about eighty percent of what the year is looking for we will give enough to the a gun in the next couple of months and we knew that given that god you've already done meet the criteria that be should be able to in suddenly then we shouldn't be fun
spk_27: please
spk_4: there
spk_24: crocker know that up on it i can't
spk_2: the the whole to presented to so far better universally pas the about me and let that
spk_20: and year and you get that you don't have a lot of module for year initially talking about as as a casual else has been a double those the procedure on the other they said is that all going and it was disappeared commission and and them ah about that well i mean is there anything specific way that gets the
spk_24: these these are faults ah we are more excited than month
spk_2: in a odd one teacher and others are with the i
spk_4: so ben first was be the to separate application one of them is for the country within the second one is for
spk_24: the boost
spk_27: and i think could be honest be the feedback we're getting is very positive for both of them the first one as think as a month and be
spk_0: you know those a psychological shift that is taking place as you know this is cool game changing as a technology that when we first talked about the hey you need to use that am i to do this
spk_35: no there's a little hesitation that first shows up know i i've never used them i'd for and that is now shifting true hey i'm going to look at camera images from the perspective of treating that patient and i'm looking at the biopsy data and i'm looking at now how and when the design the treatment and that is a very different perspective than the perspective of the radiologist who is designing who's actually diagnosing thing and they're looking at the cellular structure from the and right and they're not thinking about this i a treatment plan for be the two very different things that they have to do it i think that the you all just are now we're have done this
spk_65: are getting to that a thing of the i'm using these images for different purpose at the when we presented to them the idea of automated treatment planning using this knowledge and then be able to simulate what that means to them and temple not just
spk_4: time but the confident that the treatment design is based upon the knowledge of that will
spk_21: patients who have been treated successfully in the pocket
spk_2: that's the key point
spk_20: the feedback or getting his kid hundred and to be over
spk_2: so after you know as usual i want to be cautious and and in a deliver on this but we feel in addition him the it project me started on the two years ago and we have an amazing
spk_6: a ai team in a company with have the capability and i think this is the beginning of you know
spk_2: putting ai into our our product
spk_37: i gets it was just the i put out as driven a ploy clarification that for the contrary not just as what's going on with him and this initial appeared permission and there's other things the on that that all the hope i can be either
spk_4: that's correct the country be the first one and then will produce other things and both don't bring you up to speed as we do other things but at the moment there to applications the one is the kind to exist in the second secondly the time of boost the that are in a consideration okay got it and then you are pretty busy year come up here turns out they are both crackle publications and podium presentations on the holy cow quickly the don't fire study paid hourly dollars is likely that the presented at the the european association roger come up here
spk_6: the not not too long
spk_4: yeah yeah
spk_35: as bad guy that that's not really a between haiku and top when a when the data comes other the is that supply discount or are unclear at this point
spk_6: i'm gonna we're we're not in be a bouquet titan they are obviously because of and because and they're doing all of the now
spk_2: my information is not hundred percent
spk_21: accurate probably but
spk_4: my best guess is because these are different technologies that they will have to delineate them
spk_20: okay
spk_2: okay i'll be out stages without love it it was isaac the first but publication that the first poland presentation at the anyway i think will be investing in may
spk_39: the downturn do
spk_27: yeah
spk_40: but it got that and the a un
spk_0: cbp one code come up and the next couple few months yourself yeah on a two month
spk_41: the next two months of very eventful max the right that's good the up like russia one that runs on mar all the pirates
spk_42: thank you thank you for my man
spk_43: thank you know our next question comes from frank the keenan with lake street your eyes open
spk_2: a thanks for i pick my questions i'm one of
spk_6: dirt with asking about mentioned some a your your your latest new users starting to build a three to four month
spk_4: backlog great to hear that a patient are being built out on those was wondering if you could talk a little bit more about those and maybe talk to some of the bottlenecks they're facing to getting those patients through the fall so i'm craig it's you know i think it's just like any other thing it's good be
spk_2: it's an entirely new technology yes we had tracked clinical data that look good but all of that was initially sort of the market and tree that this sort of said to them this is a technology that the want to you know evaluate or try and i think as you seem you seen many of these sites that started a couple years ago have vowed done he'll fifteen hundred and maybe even thirty cases and they have bowed done their evaluations and based upon both
spk_41: they're say this is a technology here too
spk_4: is here for the future and they want to start increasing it's usage
spk_27: hum and so
spk_6: to to provide a little bit more color what you're asking is
spk_2: that as they increase are looking at you know what my backlog and how many of the
spk_21: physicians all my practice the to be tulsa users how much am i time do i need to allocate for my pipeline of patients and so on so i think what they're seeing is they get through a couple of to three my backlog and then they're saying i gotta increase like
spk_2: capacity and in that capacity it might be adding a urologist adding some or am our time and you know or training and other technician and so on that's how they're sort of slowly but surely getting to it
spk_45: i hope i want to your question frank
spk_4: not perfect a topical and then wanted to just as one are on doctor crts evaluation process i understand it's always been a early user of provence technology but when he switched over to halo gags xkr run an extensive evaluation process to evaluate some of the other alternative prostate
spk_2: for treatment options or was he a pretty dead set on on implementing thousand across all the sites
spk_44: oh
spk_41: and thank the some what he told us i'm a little thought of been lost family early winter time is that he and halo
spk_4: as he was doing
spk_2: they evaluated multiple technologies and what are the primary criteria
spk_66: ah that they used why did they felt that
spk_2: tulsa was the most standardized way of creating the patient and was of all of these alternative technology the be looked at it was the most gullible technology also and so their goal is they did not want to standardize on something
spk_4: that could be very user it on your allergy skilled based but they wanted to have a technology that he could sort of go over too many many practices and that was is a very large part of the his criteria
spk_2: a great of that they're the same classes
spk_6: sounds great thanks frank
spk_20: one moment
spk_67: our next question comes from brine cadnano some gag not kid is your line is often
spk_4: hi guys a couple a question for you for progress on the tpp i am a meeting that's terrific is there any ability to use the c code and an outpatient setting
spk_46: and the an arm
spk_4: and what are you guys think about though
spk_2: yeah that's a good question so the c code right now is not only as he which is the outpatient reading list
spk_27: and as part of this as a separate
spk_4: conversation we have actually made the request
spk_2: to the cms directly that they should consider that and it basically involves safety and it a mouse you know whether or not patients who have being treated today
spk_4: our daytime patients ah or not and we do have
spk_6: really very strong data that are to go home the same day
spk_4: and with respect to safety in i'm we don't even create an incision so i'm not a it's hard to say where whether they will accept this criteria or not but suddenly that is a possibility mine
spk_6: okay
spk_4: that would be important to continue to drive adoption between now and when you get a full tp decode i'm in the library get a are i don't want be shortsighted cause that's not the way i think our but can you give us an idea of how installs are going in this quarter and have you really got it
spk_6: and the bigger picture question as to be gotten past the bottleneck friends got install that you've discussed in the past
spk_2: i'm i think we you know you know we are very the whole are it company
spk_21: we have date on on you know from the time
spk_2: we start we get a contract to the time
spk_45: i'm we treat the first patient and
spk_6: what i look at that information suddenly doing the deed kobe period i think those times were running as long as six to eight months and you star that because they install the is sort of was delayed and it's only the last ah three four months where we're finally getting after and to hobbies curve hillside look at the latest data i think the have been able to cut it down to from six to at least three months now
spk_47: and i do think that
spk_44: as time goes on things in a to begin to get them more normal which we are suggesting that we will be a cut it down to
spk_41: in our target bitches about sixty days
spk_2: okay that would be much more manageable and give you a little more clarity
spk_44: another bigger picture question or are you saying doc switching
spk_2: any of their days from prof the doctor me to tulsa
spk_44: wow that's a very good question actually
spk_48: i'm it's something that i actually watch very closely on income so who is switching to confide in general and generally
spk_4: it together these are actually robotic person who are switching to tulsa a hum
spk_21: and
spk_6: i'm i'm i'm into the honest not only that i'm watching were watching and with you know we have many of them who are on
spk_21: i actually explicitly i gonna wash them you know like and why are you doing tulsa and why did you search this case from a robotic
spk_4: pasta to me to tulsa
spk_6: and i'm i'm getting to the on it
spk_20: really really
spk_41: comments that that is why are you know my confidence level is increasing
spk_2: i'm and i'm happy to share in fact some of these comments are played few
spk_49: i'm in italy
spk_4: one of the sites that had done in a thirty cases for example they were like they slowly doing cases and and then
spk_20: i actually talked to them and i said no you don't you guys started by saying will do it of thirty to forty per year you've taken longer to get there and they are you know they can have confirmed at what they were really doing is they want to do at least thirty cases and see how their places were doing before
spk_4: or they really increase their usage and so they basically said look we have done these cases we have now confirmed that our own outcomes are similar to the packed clinical trial outcomes that is what they were looking for
spk_20: and they said now that we've confirmed the clinical trial outcomes
spk_4: we think that tulsa is gonna be in in our to be too because it's to give you good he said this is gonna be one of the big three it's gotta be tulsa it can be robotic was that to me it's got the radiation
spk_44: i said okay and this are listed i'll take that
spk_4: overtime will think about who is the number one in that space and
spk_41: you don't
spk_35: i'll have on publisher like oh sure one and anecdotal example with you which is which really had an impact on the action
spk_27: so i was i tend to the case with one are you all of this
spk_10: and for some reason robotic post attack he actually came up as a conversation and
spk_4: he said that he had been doing a robotic case a week prior to the has and that he actually lost good the robotic on last meal it took him about thirty minutes to find him everything will be and no problem for what he said was he said while he was looking for that needle
spk_20: he said this would have never happened with tulsa
spk_38: he said you guys don't realize how inherently safer the technology
spk_6: so
spk_4: and it really had an impact on me
spk_10: is that we talk about safety we talk about clinical outcomes
spk_4: and these urologists are now seeing it in real walk so yes it's taking longer but i'm finding that the reason to they're giving a really really good i'm at and quite frankly i'm happy about that i want them to tough test our technology and see the some
spk_41: terrific
spk_6: a mac a couple a more and them because i think i'm a dmg line
spk_17: he he talked about this five percent per month without the auntie
spk_0: can you talk about the i think you said the halo was gonna be a multi center grew and he's training additional urologists and he will actually come online
spk_22: i think does month
spk_2: oh where are these additional stunners going to be and you don't do you think you get into all the nfl studies throughout the balance for this year
spk_52: we
spk_22: so for saw your right fist the on t a m i mean it was another interesting example of how it does take longer to predict things we have one that he was actually over the me
spk_10: going to start my end of last year but it is because of some approval that were needed in the state of florida
spk_52: oh we had nothing to do it tomorrow or a our technology
spk_4: it was related to the site that it is took another ninety days to get going so he's definitely later to start in the next couple of weeks
spk_6: but to answer your questions toshi
spk_2: there are two of the site or florida it's one is from his legal fight which is just up and those another site which is jacksonville florida also and under two sides in california so those are the first foresight we have talked about are adding sites they're headed in a relatively a good pace but again the same model is not get the site going let's get be all of the are different things that can and cause delays are in our recruitment so on let's create an efficient process and then most certainly the idea that we will go in and build additional facts
spk_68: right
spk_4: read that they've got to open they've got doctor hong running the one here in arizona where are the i by it's gonna be for them and do you think you can grow that into the ten was that you had hoped for or when you originally signed the contract
spk_2: overtime ah yes i think so i think that again they did something similar the their first fifty cases analyze it and then decided yet
spk_53: ah they want to go there have been
spk_0: very supportive of to cpt application they have help educate some of the society members are there are because that is you know the their primary customer is a
spk_41: his reimbursed the not a very big cash right now in arizona it's actually how cash and they're doing very well i'm in by with their their message is there are have identified the next two sites already the actually purchased new am my eyes for the fight and we think that me
spk_2: later this year will be operational ah and gum
spk_54: i think once we have thirty feet on the city t code and if we do get a prove to be able to get to see code in live in a fee then i think you will feel ah
spk_44: faster adoption but totally those two things are hardly to happen for them to go beyond of for that we're talking about
spk_4: great add to ask questions the one the the cat to are you close to completion on that a yes i think we're a couple of recent away and we'll get to the about two hundred and forty hundred fifty said think they should try two hundred fifty and close it up so and it'll have five year data next year and will continue to add those new or patients and you've got to see the impact of that in the final outcome okay last question for me does this shift from ultrasound biopsy k m r i n bore biopsy help with this shift at the inboard tulsa procedure
spk_0: yes so this is sort of a long term
spk_4: the dialogue by and i take over the next couple of years certainly we will be talking about it cause i think right now are so focused on our short time getting the site going on in getting the fitted he called me but you're you're on your thinking
spk_2: the way that we're kind of thinking is that what tulsa does is that it for the first time a neighbor have a very am are centric strategy farm screening the and to diagnosing the patient to on m r centric our biopsy to then talk for treatment as a problem
spk_0: and
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