Q4 2020 Helius Medical Technologies Inc Earnings Call
Please standby.
Good evening, ladies and gentlemen, and welcome to the fourth quarter and fiscal year 2020 earnings conference call for Helios Medical technologies.
At this time all participants have been placed in a listen only mode. Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly.
Before we begin I would like to remind everyone that our remarks and responses to your questions. Today may contain forward looking statements that are based on the current expectations of management.
These forward looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated including among other things risks and uncertainties around the clinical development process and F. D. A regulatory submission and approval process and other risks identified in the risk factors section.
<unk> of our most recent annual report on form 10-K, and quarterly reports on form 10-Q.
Such factors may be updated from time of time in our other filings with the SEC, which are available on our website.
All statements made during this call are as of March 10 to 22021, we undertake no obligation to publicly update or revise our forward looking statements as a result of the new information future events or otherwise except as required by law.
I would now like to introduce and turn the call over to Mr. Dean Andrius.
Helios Medicals interim President and Chief Executive Officer. Please go ahead Sir.
Thank you operator, and welcome everyone to Helios medical fourth quarter and full year 2020 earnings conference call.
I'm joined on this call today by choice of the Viscount Our Chief Financial Officer, The Chief operating Officer, and Mark Leno, Our Vice President and general manager of our Canadian operations.
Let me provide you with the quick agenda of what we are going to focus on today is part of our <unk>.
The new strategy to reposition elas to create intermediate and long term shareholder value.
I'll begin my remarks with a brief update on our U S regulatory strategy and the recent progress we've made.
All of them in this discussion Mark will provide you with an update on our commercial activities in Canada.
For the annual review, our fourth quarter financial results. The recent progress we have made to secure additional capital and enhance our balance sheet condition and share some thoughts on her expectations as we enter 2021.
All of them enjoys his remarks.
I will share some closing thoughts on our near term initiatives in 2021 and longer term outlook before we open the call for questions.
With that let's get started with an update on our U S regulatory strategy and progress as we announced in March of 'twenty 'twenty. Our U S. Regulatory strategy is focused on pursuing an indication in multiple sclerosis, where I'm asked is the pathway for obtaining the first U S clearance for our Pons.
Device.
Our target indication represents a large patient population with the high unmet need medical need as a reminder, in the United States. There are approximately 1 million patients estimated to be living with that math.
It's the provide and that patients with gait deficit of non drug non implantable treatment that has the potential for significantly improved their walkie, which made greatly impact the safety and quality of life.
Despite the onset of COVID-19 pandemic.
We made strong progress wrote Twenty-twenty, obtaining breakthrough device designation from the FDA for our and that's the indication in may and committing our request for the FDA for de Novo classification and clearance of the Pons device I know I get for it.
During the fourth quarter of 2020, we received a request from the FDA for additional information approximately 75 day into the review process for our de Novo request, which we announced on October 19th.
As a reminder, the FDA stated goal is to provide a decision within 150 days for 60 per cent of the de Novo request that were submitted in 2020.
A request for additional information stops the Fda's view clock until the agency received a response from the sponsor.
Our regulatory affairs team worked swiftly to prepare and submit a thorough response to the Fda's request.
Part of this effort they conducted an analyst of each aspect of the request with the goal of per site fully aligning our response to address the information requested.
As a result of their efforts we were proud to announce on January 11 debt, we submitted our formal response for.
For the Fda's request.
We look forward to the Fda's continued review of our de Novo request and hope to receive de Novo classification of U S clearance during the first half of 2021.
In addition to our strong pace of progress on the regulatory front, we have been closely monitoring the development of the Medicare coverage of <unk>.
The beta of technology for M set rule.
<unk> represents a new pathway to Medicare coverage for F. D. A designated breakthrough medical devices, which received clearance developed by the centers for the Medicare and Medicaid services or CMS.
And Seth will provide national Medicare coverage as early as the same day as FDA clearance for breakthrough devices.
Importantly device manufacturers will be able to choose the start date for coverage, enabling them to potentially a line the start of Medicare coverage with the commercial launch of their device. However, the coverage period because of limited for years from the date of clearance.
<unk> completed their collection of public comments on the emphasis during the fourth quarter and announced that they were finalizing this rule on January 12.
With approximately 60 million Americans enrolled in Medicare obtaining coverage via M. Sip.
<unk> represents an important potential tailwind to our initial U S commercialization efforts and we look forward to continue to work with CMS.
Obtained more information on the pathway and the move forward with implementation activities.
Our casino will now provide you with the review of our fourth quarter revenue performance and an update on our commercial activities in Canada.
Thank you Dan.
For the fourth quarter, we reported a total revenue of $191000 compared to 152000 in the fourth quarter of prior year. Our revenue in both periods was driven by sales to neural therapy clinics in Canada that have been authorized to provide our pons treatment.
During the quarter, we continued to experience significant business disruption in Canada as the result of the COVID-19, pandemic and the protocols implemented to ensure patient health and safety, which impacted our sales performance.
Similar to the trends experienced in Q3, our pons authorized clinics continued to be constrained by federal and provincial requirements limiting their capacity.
The 50% of.
Of normal services.
Based on surveys of our clinics. We also continued to see the capacity and productivity throughout Q4 remained significantly lower than the 50% due to several factors. We've discussed on our recent earnings calls most notably the impact of close clinic specific protocols that are being implemented.
To ensure social distancing and the impact of Covid on patient willingness to seek in clinic treatment.
As a result of MF patients typically represent a high risk patient population when it does come to the COVID-19 as they often take a disease modifying medicine medications that suppress the immune system.
In addition to these factors beginning in late November many of the largest cities and provinces in Canada implemented Lockdowns and stay at home orders in response to the resurgence in Covid cases.
The resurgent in cases, along with these government restrictions represented some incremental headwinds that further impacted this patient willingness to pursue treatment during the quarter.
Importantly, our commercial team however continued to execute on our 2020 commercial strategy, including engaging training and authorizing targeted clinics and the most densely populated areas of Canada.
In response to the destruction caused by Covid, we developed a new approach to avoid or minimized in person interactions.
Our focus has been on engaging with clinics that fit our targeting criteria via virtual means.
Once the claim has been engaged we then employ of virtual process to authorize them and conduct a series of live online training modules. So the therapist in order to provide pons treatment.
As a result of our efforts in the fourth quarter, we were able to further expand our clinic network of Pons authorized clinics to 31 clinic locations by year end <unk>.
Exceeding our previously stated expectations.
And given that we entered the year with a total of seven Pons authorized clinic locations.
Our impressive progress on this front is the reflection of our successful shift to a virtual approach and more importantly, the hard work and dedication of our team under these challenging circumstances.
While the COVID-19 related restrictions of headwinds that we experienced during the fourth quarter have continued to persist into 2020 one.
We believe that our expanded clinic network represents an important foundation that will improve our access to pons treatment and position us for growth once the COVID-19 restrictions are lifted.
And the overall environment begins to normalize.
And with that I'll, the turn it over to Joyce to discuss our fourth quarter financial results.
Thanks Mark.
For the fourth quarter of 2020, our gross loss decreased by 146000, or <unk> 94 per cent year over year to 10000 due to changes in the inventory reserve impacting the cost of goods sold and lower direct cost of manufacturing support personnel versus the prior year.
Operating expenses for the fourth quarter of 2020 decreased by $2 5 million or 45 per cent year over year to 3 million.
<unk> the continued benefits of the cost reduction initiatives that we implemented during the past year.
Operating loss for the fourth quarter of 2020 was 3 million compared to $5 6 million for the prior year period.
Yeah.
We reported a net loss for the fourth quarter of 2020 of $2 5 million or minus $1.77 per basic and diluted common share compared to a net loss of $5 3 million or minus $6 71 per basic and diluted common share for the.
The same period last year.
As a reminder, on December 31st 2020, we completed a one for 35 reverse split of our class a common stock in order to regain compliance with the NASDAQ stock market continued listing requirements. We received written notice from NASDAQ on January 19th 2021.
<unk>, which confirmed our compliance with all applicable listing standards.
Turning to a discussion of our balance sheet condition and recent financing activities.
As of December 31, 2020, we had $3 3 million of cash compared to $5 5 million as of December 31, 2019, we had no outstanding debt obligations in either period.
Our average cash burn from operations during the fourth quarter of 2020 was approximately 700000 per month compared to approximately $1 5 million per month in the fourth quarter of last year, reflecting our continued efforts to control our expenses and allocate capital prudently.
On October 26, 2020, we closed a private placement.
All thing in net proceeds of approximately $3 2 million, which was led by Dan and myself and included participation from existing and new shareholders.
Subsequent to quarter end, we raised $1 3 million in net proceeds through the exercise of warrants in January and closed an underwritten public offering of common stock and warrants for net proceeds of approximately $9 6 million, including a full 15% over allotment.
February 1st this is completed.
We believe the proceeds raised from these transactions along with our existing cash will be sufficient to fund our operations into the first quarter of 2022.
Importantly, this expectation does not include any potential incremental benefit to our cash position due to proceeds raised from the exercise of additional warrants during the remaining months of 2021.
There are currently approximately 594000 warrants with a weighted average price of 16, 32, which could yield an additional $9 7 million if exercised although there is no assurance that these warrants will be exercised in 'twenty 'twenty, one or ever.
Looking ahead, we will continue to maintain a disciplined approach to spending well evaluating options to strengthen our balance sheet and support our operations.
In terms of our outlook for 2021.
Given the uncertainties associated with the duration and impact of the COVID-19 pandemic, we are not providing revenue guidance for the full year 2021 at this time.
However, we understand the investment community's focus on obtaining additional clarity during this period and would like to provide some thoughts regarding the near term trends and our assumptions for 'twenty, one 2021.
As Mark mentioned, the headwinds and restrictions experienced in Canada. During the fourth quarter have continued to persist in 2021 impacting clinic capacity and patient will it patient willingness to seek treatment.
Given these continued headwinds we would anticipate total revenue in the first quarter of 2021 to be approximately $80000.
We expect our sales performance will continue to be significantly impacted by the COVID-19 related business disruption in Canada. During the first half of 'twenty, one followed by gradually improving trends as the Empire begins to normalize during the second half of the year.
And lastly, we do not anticipate any revenue from sales of our pons device in the U S. During 2021, assuming we receive FDA clearance during the first half of this year, we would expect to begin our commercialization in the U S. During the first quarter of 2022.
With that I'll turn the call back to day, Inc.
Thank you Joyce.
In summary, while 2021 was for.
Undoubtedly a challenging year, we were very impressed by their resourcefulness demonstrated by our tea as well as their commitment to <unk>.
Ensing, our regulatory and commercial initiatives.
With our de Novo request currently under review by the FDA and expanded network of 31 Canadian clinic locations and enhanced balance sheet. The support our operations. We are pleased by the progress made this past year.
And excited about our long term growth prospects.
As we enter 2021.
We remain focused on executing as efficiently as possible against our two near term growth initiatives, obtaining U S regulatory clearance and facilitating the commercial adoption of our pons treatment in Canada.
In the United States, we will continue to work with the FDA as necessary to facilitate the review of our de Novo request, while proactively engaging with CMS to obtain clarity on the new EMS Sip world and work towards obtaining coverage via this pathway with FDA clearance.
In Canada, we will expand the access to our pons treatment by continuing our clinic targeting virtual engagement and virtual training efforts with the goal of adding nine.
Target clinic locations to our network of Pons clinics by year end and working closely with the clinics to increase patient throughput.
We will also focus on supporting our recently expanded network of Canadian clinics. During this challenging period by partnering with them to first raise the awareness and reduced potential barriers to patient engagement during COVID-19 and second educate the face of clinician prescribers on <unk>.
Pons treatment and its potential benefits.
Let me take a minute to elaborate in two developments related to these aspects of our Canadian strategy.
As there are existing clinics reopened in 2020, we began working with them offering promotions with reduced pricing for pons treatment.
We continued this activity through out the second half of the year, which helped to mitigate the impacts on patient willingness to seek treatment.
In addition to our traditional raising awareness efforts, we would expect to continue working with our clinics in 2021 to offer promotions, while the effects of the pandemic persists.
I'm also pleased to announce that in December 2020, we added a new member to our commercial team in Canada as the form of therapist and clinic director she will be focused on working with our existing and newly engaged clinics to help them raise awareness of pons treatment and educate the clinician.
The referral networks on its ability to help patients suffer suffering from the effects of MF and mild to moderate traumatic brain injury.
We look forward to her contributions to our team in 2021 N D R.
Stepping back.
Pursuing near term initiatives I've outlined our goal is the position Helios spring Pons treatment to the large unserved population of.
MF patients in the United States, and Canada as quickly as possible.
Simply stated we believe this approach represents the best pathway for creating value for our shareholders.
It's different for these initiatives, we continue to develop our longer term strategy to capitalize on the innovation of the Pons technology and its potential as a platform technology by expanding its existing indications for use.
Pursuing new indications and exploring the potential applications.
Before opening up the call for questions I'd like to discuss the recent announcement that we made this afternoon and our 10-K filing with the SEC.
Our Chief Medical Officer, Dr. Jonathan fact back yet.
Transition transition the need from his current role for a consulting position with helix effective as of Monday March eight.
His new role as the helium consultant Jonathan will continue working with you is for at least one year following the transition date.
I'd like to take a minute to personally thank Jonathan for US an important achievements as the chief Medical officer.
I look forward to our continued work together in his new role.
I would like to close today's remarks by thanking our existing long term shareholders.
Welcoming the new shareholders, who participated in our recent financing.
We remain committed to repositioning the helium for the next phase of growth with an eye on creating shareholder value.
And we appreciate your support for our company and its mission.
And lastly, I'd like to acknowledge the dedication and ingenuity of our team during 2020, which made our rapid progress possible.
I remain more convinced than ever that our talented employees and their commitment to bringing ponds to our customers and patients for one of the defining attributes of our company and its potential for future successes.
With that operator, let's now open the call for questions.
Thank you.
If you'd like to ask a question. Please signal by pressing star one on your telephone keypad.
If you're using a speaker phone. Please make sure that your mute function is turned off to allow your signal to reach our equipment we.
We do ask that you limit yourself to one question and one follow up.
If you would like to ask additional questions. We invite you to add yourself for the queue again by pressing star one we will now take a moment to allow participants of join the queue. Thank you.
And the first question will come from Jeffrey Cohen with Ladenburg Thalmann. Please state your question.
Oh, Hi day, Mark and Joyce how are you.
No great Jeff how are you.
Just for into them I just wanted to review a couple of your line is your previous commentary for it so firstly as far as the.
The agency's concern some of the the the.
<unk> for the was halted on October 19th ish, and then you submitted the response back on the.
The 11th of January so the research the clock and what's the sort of look like as far as the anticipated 120 days.
Fatality with is that good for you to sometime in the April.
Yes, Jeff actually with the 150 days just to correct.
What you said, it's 150 days.
The first possible chance would be in April, but I'm, just being a very conservative minded.
You know in setting expectations.
Are we stated.
Debt, we would expect the first half decision by the FDA.
Okay, and where there are two points of the you mentioned the of the de Novo status and then the second point was the clearance true there's one contingent upon the other.
Oh.
Jeff can you just clarify that I'm sorry.
So you would expect the.
At some point in the first half for a period of about the de novo status as well as the clearance status.
Was it one or the other or both.
It's the.
Yes, it's the de Novo classic clearance that come together correct. So there wouldn't be any further questions regarding the classification of truly an issue of the clearance.
Yes, Okay got it and then.
Secondly, I guess more for the for March just trying to get a better understanding of the.
The centers there then.
Sounded like certainly of way less than 50 per cent. We're open due to regulations for you now have.
31, the totality trained from Chevron, so kind of many of those now.
Our open or or enrolling or patients who are visiting could you give us an indication of how many might be.
Open today is it.
Yes.
Jim.
Yep, So I'm happy to clarify that so.
In Ontario, we have approximately 17 clinics in the out of those 17, the vast majority of them are in the greater Toronto area.
And so <unk>.
<unk> wise, we're seeing anywhere from a 20% to probably a 30% to 40% capacity across the country.
And you know.
I think that the challenge continues to be that our biggest.
Center of population, if you think of candidates 37 million people roughly.
13 in the half live in Ontario, and roughly nine live in the sort of broader Toronto area. So Toronto just this week came out of a very strict lockdown stay at home type of order.
So it's very restrictive here and in person.
<unk> our clinics, it's a very sort of challenging environment I have to say it. So it is very dynamic and unique and it's it's a it's a handle the headwind of.
We are we're fighting against every day.
Got it so then the.
The 31 train so 17 would be the subset of out of the total trend of 31 meeting.
Surely there are 14 kind of in the queue once things may open up.
But I was just sort of giving you a snapshot of our sort of.
Our biggest population center here in the greater Toronto area, but we have out of the 31 almost all of them are open to some small capacity.
But again at that 15.
<unk> to 30% range across the country based on on a whole lot of factors and provincial regulations being primarily the the main driver of their ability to open.
It is further impacted by of course risk tolerance of patients that may be prospective considered for pons treatment debt.
And then they want to wait until things are cleared up, particularly knowing that MF patients have a lot of other health issues.
Hum.
Our exacerbated by potential Covid risk.
Right. So it sounds like I'm sorry.
If I were two of our hope or assume the COVID-19.
Covid continues to decrease as far as impact in Canada.
With vaccinations for cases at some point in the coming months or quarters the.
Company could be.
30 ish clinics open.
Yes, again, I'll, maybe I'll clarify it we have 31 clinics that are open, but they're all of that varying rates of small capacity.
When you're in the most restrictive environment that being Toronto, Vancouver and Montreal.
The trial being the biggest the level of governmental restrictive measures for Covid have the greatest impact because of this is where our debt most density of.
Of clinics is located but all of the clinics are open to some degree just very very small percentage of throughput.
Sure.
Okay. So is that helpful.
Yeah, that's super helpful. And then lastly, George on the.
From the cash for the can you.
I know you went through a few metrics.
Give us a snapshot of of current or we can use or non search plus one three for three to four.
Plus the end of the year.
And we would get you to a about what know about.
And you have 332 of them for.
<unk> is up.
Well you have to take the you have to take your burn rate out of there as well. So if you have three three you would have to take out roughly that the one.
1.2 of months.
Oh from from that number and then put the additions that you've spoken of in the in that in all of that would get you there.
Okay.
Okay. So okay.
Sure.
Okay.
The it gets me to around 13 to 14 range.
Some of them efficiently.
For a simple yes, okay, that's reasonable for sure okay Super so well, but those are familiar we are anticipating and looking forward to the.
The agency, having a response for you and a bunch of small number of fish.
Great. Thank you Jeff.
Thanks, Jeff.
Thank you and just a reminder, task of question at this time press Star one on your telephone keypad.
Our next question comes from Mary per AUM. Please go ahead.
This might be unfair you probably don't know the answer.
But.
I've been using the ponds.
Trained in cash.
Canada, because I live in the state.
And then also of Medicare patients, so if and when it gets approved here in the states.
Do you have any idea if they would pay for the treatment.
Even though I got it in Canada, because I don't imagine clinics are going to be opening up here real soon.
You don't.
We needed to switch.
To the U S.
True.
Right.
Does that clear I don't know what's the right.
Very clear.
Clearly for you to understand.
Okay.
Yeah.
The choice do you want to take that one.
Regarding the yeah yeah.
Yeah, so as far as the M said, we are working with the CMS now to understand you know when the when the timing of what the timing will be to be able to get all of the coding and reimbursement put in place you know where we're developing our strategy for the U S.
And as he said there will be a delay in the in the time it will take us to get the commercial strategy to get our distribution licenses as well as get building relationships with the key neuro rehabilitation centers from a reimbursement perspective for them for Medicare.
You know certainly much more to come and I can't I can't say for certain but if you have a you'll have a prescription from a U S physician.
And then you know, it's it's up to debt the.
All of sea and the practice that's put in place.
To be able to get the reimbursement or not.
Okay. Thank you.
Mhm.
Our next question comes from Anthony Lamport, with Lambda Fund management and please state your question.
Could you please amplify.
Of the insurance reimbursement situation in Canada.
Is there any mandatory coverage the way we might have here for M. S.
And number number two absent that edge of private insurers.
The willing to pay or basically of revenues coming from just out of pocket at 100% from the patients.
Yeah.
Mark do you want to answer that in an update do you have to be.
Sure I'll take the I'll take the question. Thank you Anthony.
So essentially we are currently working on a strategy on the Tbi side. If you. If you recall here in Canada. We have also been given clearance by health, Canada for traumatic brain injury.
And so as a result.
We feel that that's probably the best strategy for us to lead with in an effort to get reimbursement.
Through the government side of of health care here.
And so we have of strategy, we're working on in an effort to.
To move that forward as it relates to the private insurers. We're also working diligently with a couple of our key clinics.
And some some private insurance companies on sort of a pilot the in order to demonstrate the.
The two these folks the efficacy and outcomes that we're seeing in the real world, but oftentimes they want to see it for themselves.
So we have some of those underway right now.
And I will.
We say that.
Things are moving in the way in which I would hope so that's good news.
But it's a long process because again.
Due to Covid.
This whole process has been.
Heavily restricted.
But.
As it relates to the private insurance, that's the commentary there, but the there is a strategy to also work at trying to find a way for us to use the <unk> piece for.
For getting government support for the product.
And so for now we are seeing a once in a while some insurers will cover in certain cases.
And.
Mostly though however in this current environment, we're seeing people having to pay out of pocket for the most part for the device, but again if people have.
Insurance through their employment for covering physical therapy. There are elements of that that can help offset some of the cost and Canada does have a of taxation.
The federal income tax.
Indications that you can apply for some additional medical expenses that are out of pocket that are also in some cases.
The offset through your through your federal income tax.
He used the word of strategy.
You know.
Strategy is sort of like you know our strategy is to win the war or something I mean, it doesn't imply any.
Time.
Action or anything.
I mean, the you would tell you when we're going to market our product of our strategy will be to obtain kind of.
Reimbursement.
But theres no time attached to it the strategy could take three years to put it into a factor or three months.
You know of course from Covid.
Things may take longer than expected, but.
How long does it take the I mean in the EU and the U S of of course, it's different because it's basically private insurers of though of course, we have Medicaid too but.
It can take a very long time, unless you have the special M S.
The payment.
It can take three years for the device to become.
The insurable or the dividend or didn't get reimbursement so is that.
Similar in Canada.
At that time.
Three years.
Yes.
I would hesitate to put any time on it I think in the spirit of your question. What you may be asking is are we actively working on this project or on the strategy and the answer would be yes.
At the at the rate limiting step of Covid, but.
There is nothing on the Healy of side that is impeding us from from continuing to execute against what we know.
We'll be the best.
Our strategy for us to do this but in the Covid environment. It is it is incredibly restrictive right now too.
Net patient throughput for the well.
Well I'm not I I understand the patients and the yen if you build it the has to come but well how long does it typically take leave out COVID-19 to obtain you'll have the new device in de Novo advice that is approved in Canada, which was of years.
All of the two years ago now how long does it take a.
To convince the insurers the government insurance should be applied.
Certainly there must have been some experience maybe obviously not for Helios line.
The other products.
You know generally how long does it take to obtain insurance in the U S debt numbers three to four years.
Is it the same in Canada more or less.
So the.
Mark Let me Anthony let me answer this so in Canada, we are starting to see small amounts of of.
Reimbursement is.
Small and you're absolutely right it takes anywhere from.
Two to three years.
If we look at the United States.
It could be up to three years like you said the great thing is that we have of breakthrough designation.
And with the new policy with CMS that that jumpstarts, our commercialization I'm glad I'm restricting it to Canada because I.
Obviously, it's smoothed in the United States until you get approval and then it's quote instant Oh for at least the CMS. The question is in Canada, you usually think of it also.
Take two or three years now you've been in your improved in Canada about two years you can alert you yes.
Yes, It was March of 2019.
It's taken.
18 to 24 months to start getting reimbursement in Canada.
It's been slow it's the nature Eddy it art, but it's very true.
The interesting I, Yeah, you mean, Canada.
That is the governmental of the provincial governments are giving you are able to give reimbursement now or is it was sort of a special cases as it seems strange if you're willing to get reimbursement.
It seems to me a once patients want it and you're willing to give it if they qualify.
Yeah, I think are just the just to clarify the reimbursement that we have seen has come true.
The private insurance not the government insurance.
To just circle back Anthony to your to your question around government. Yeah. There is no there is no.
Unfortunately, there is no sort of set timelines are when you have a predicate device. That's already approved that's different than bringing a completely new device to any market as you can imagine right.
You're creating a new cloud.
Suffocation or category and that's that's the challenge, but again, there's a plan in place that we're working through to do that.
And what is how long would it take to implement that plan.
Yes.
Oh, that's your plan, we're asking it doesn't mean it will occur but.
But yeah Atlanta to gain approval by the year 20000.
Two for 2000 and charity or is the plan to get an approval within the next 18 months give some idea of what your plan is true.
Sure.
Bottom line is we're working as fast as possible with some pretty critical.
The individuals in the medical space here in Canada at large academic centers that will we believe bear fruit.
Can't tell you how long that's going to take.
We really have to work within the Covid environment in which we are unfortunately hampered by right now but.
I would.
Everything was at one point not standard of care and our efforts are trying to move that in that direction as fast as possible.
Can't give you an exact date, but.
We are we are working for Bentley to try and find the.
For the fastest way for that to happen well you know, we're working with some academics implies that oh.
In one case, you know part of the committee that advisers of the government and another it could be hey, the academics now want to run the clinical trials and see what happens and have their own pilot. So they can advise of the government is that the case or is it the former case.
It's a mix actually so you know.
We have some pilot programs working with two private insurance companies.
In the Tbi space here in Canada that are large large insurers.
I'm not going to disclose who they are but that is I don't know who they.
They are.
With this these pilot be abused to the academics, who are advising the government.
Did they buy their own separate trial.
Yeah.
They're they're probably six of them, they're a bit of both to be very candid with you insurers private insurers have different mandates then sort of.
The health care system as it relates to acute patients and things like that so without going down too far on this I will say this it's a parallel path you have to do both because not everybody is going to fall within the.
Of the public health care system, all the time and the one that's probably more nimble is the private paying side. So we're doing both.
Okay. Thank you thank.
The next question. Thank you just sort of minor task of question Press Star one on your telephone keypad.
Our next question comes from Mark Pailin with a a L. R. R of please state your question.
Yes, Hi, this is mark thanks for your information given the you guys are that we've got the breakthrough device for a breakthrough device designation from the FDA.
And I understand that means that there is enhanced communications with the FDA I'm, just wondering whether you've heard of anything from them. Since you submitted your response to the questions that they asked.
And if youre able to tell us about your communications with them. Since then if you've had any thank you.
The rest.
Do you want to take this one.
Yeah. So so we have not had formal communications.
Most of it would be described the informal a back and forth clarifying questions or whatever but nothing that nothing that we've heard can give any more clarity than what we have already disclosed to the the prepared comments and what's in our filings.
Thank you.
Thank you.
Thank you.
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