Q1 2022 ENDRA Life Sciences Inc Earnings Call
Good afternoon, everyone and welcome to the under a life Sciences first quarter 2022 financial results Conference call.
Good afternoon, everyone, and welcome to the Endra Life Sciences first quarter 2022 financial results conference call.
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At this time, I'd like you to turn the floor over to Yvonne Briggs with LHA. Ma'am, please go ahead.
At this time I'd like to turn the floor over to Yvonne Briggs with L. H a ma'am. Please go ahead.
Thank you operator, this is Yvonne Briggs without la Jay Good afternoon, and welcome to <unk> first quarter 2022 business update and financial results Conference call earlier today <unk> issued a press release on this topic, which is available in the investors section of entrants website.
Thank you operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to Endra's first quarter 2022 Business Update and Financial Results conference call. Earlier today, Endra issued a press release on this topic, which is available in the Investor section of Endra's website.
Before we begin please note that today's discussion will include forward looking statements.
Before we begin, please note that today's discussion will include forward-looking statements.
all statements by management other than statements of historical facts, including statements regarding the company's strategies, financial condition, operations, costs, plans, and objectives, as well as anticipated results of development and commercialization efforts, the timing of clinical studies, potential partnership opportunities, and expectations regarding regulatory processes.
All statements by management other than statements of historical facts, including statements regarding the company's strategies financial condition operation.
<unk> plans and objectives as well as anticipated results of development and commercialization efforts the timing of clinical studies potential partnership opportunities and expectations regarding regulatory processes receipt of required regulatory clearances in product launches are forward looking.
Received of required regulatory clearances and product launches are for looking statements.
Statements.
Accepted as otherwise required by federal securities laws, the company disclaims any obligation to update or revise any forward-looking statements.
Except as otherwise required by federal Securities laws, the company disclaims any obligation to update or revise any forward looking statements.
Please refer to the company's 2021 Form 10K and subsequent SEC filings for more information about risks and uncertainties related to forward-looking statements.
Please refer to the company's 2021 Form 10-K, and subsequent SEC filings for more information about risks and uncertainties related to forward looking statements.
In terms of the structure of today's call, Francois Michelin, Chairman and Chief Executive Officer, will begin the prepared remarks, followed by Mike Thornton, Andrew's Chief Technology Officer.
In terms of the structure of today's call Francois Michelin Chairman and Chief Executive Officer will begin the prepared remarks, followed by Mike Thornton and dress Chief Technology Officer.
followed by Renault, Mella Berti, Endra's Chief Commercial Officer, and then Irina Pestrikova, Senior Director of Finance. With that, I will now turn the call over to Francois Michelin.
Followed by Renault Mellow Bertie interests, Chief Commercial Officer, and then arena Petra Koga Senior director of finance with that I will now turn the call over to Francois Michelle on Francois.
Thank you, Yvonne. Good afternoon, everyone, and thanks for joining us today for a discussion of ENDRA's 2022 First Quarter financial results and an update on our business.
Thank you Yvonne.
Good afternoon, everyone and thanks for joining us today for a discussion of Andrew's 2022, first quarter financial results and an update on our business.
We're very encouraged by the recent progress we've made in advancing our TAEA system toward global commercialization. And I'm delighted to share some of the highlights with you today.
We're very encouraged by the recent progress we've made in advancing our Tia system toward global commercialization and I'm delighted to share some of the highlights with you today.
As many of you know, subsequent to the quarter close we were able to raise $7.8 million through our at the market equity facility without the overhang of once or convertible debt.
As many of you know subsequent to the quarter close we were able to raise $7 $8 million through our at the market equity facility without the overhang of warrants or convertible debt.
This fundraise bolsters our cash position to fund operations through several important milestones.
This fundraise bolsters, our cash position to fund operations through several important milestones.
including ramping up our commercial activities in Europe and advancing the TAIS system through the regulatory process in the US.
Including ramping up our commercial activities in Europe , and advancing the tastes system through the regulatory process in the U S.
What's more, I believe our ability to raise capital efficiently in this very challenging macro environment reflects investor confidence in our progress, our technology, and our market
What's more I believe our ability to raise capital efficiently in this very challenging macro environment reflects investor confidence in our progress.
Our technology and our market opportunity.
The six weeks since our fourth quarter earnings call. It's been a very productive time for Andrew with several noteworthy accomplishments.
The six weeks since our fourth quarter earnings call has been a very productive time for Andrew with several noteworthy accomplishments.
First, we helped advance studies that are underway or being planned by our clinical researchers.
First we helped advance studies that are underway or being planned by our clinical research partners. These.
These studies will support the commercial adoption of payers in Europe and will provide the additional clinical data needed for our FDA de novo submission in the US.
These studies will support the commercial adoption of tariffs in Europe , who will provide the additional clinical data needed for F. D. A de novo submission in the U S.
We're leveraging the vast majority of our previous 510K application and are gathering data from a subset of our clinical partnerships to submit the de novo request as quickly as possible. We're on track to do so in the third quarter. Mike Thornton will.
We're leveraging the vast majority of our previous five 10-K application and are gathering data from a subset of our clinical partnerships to submit the de novo request as quickly as possible.
We're on track to do so in the third quarter.
Mike <unk> will provide more details in a few minutes.
Second we're ramping up our sales and marketing efforts across Europe as pandemic restrictions continue to EES, where no will speak specifically about these activities in a minute.
Second, we're ramping up our sales and marketing efforts across Europe as pandemic restrictions continue to ease.
We know we'll speak specifically about these activities in a minute.
Yeah.
And third, we significantly strengthen our intellectual property portfolio, not only to protect our technology, but also to enhance our license,
And third we.
We significantly strengthened our intellectual property portfolio not only to protect our technology, but also to enhance out licensing opportunities.
Here to date, five patents were issued in the U.S., two in Europe , and four in China.
Year to date.
Five patents were issued in the U S. Two in Europe and four in China.
These additions bring our global IP portfolio to 90 assets, including 46 issues.
These additions bring our global IP portfolio to 90 assets, including 46 issued patents.
One of the issued U S patents, we announced earlier this week that has the potential to expand licensing and revenue opportunities for the company into a new space.
The patent protects a proprietary method for acquiring analyzing and sharing data on equipment not connected typically to the internet.
Although this technology was developed specifically for Andrus tier system based on our market research and industry discussions it has broad applicability and out licensing potential within the health care industry, where it could help lower service and maintenance costs on things like laboratory equipment, thereby enhancing equipment uptime for laboratories and hospitals.
I'll turn the call over now to Mike Thornton, Our Chief Technology officer to provide updates on our clinical studies.
Mike.
Thank you Francois.
This is a very exciting time at Andrew our team and development partners have accomplished a tremendous amount in creating a first of its kind clinical technology to our knowledge <unk> fatty liver assessment device is the first thermal acoustic device that combines RF energy delivery and ultrasound detection and one handheld unit.
Through the efforts of the Andrew team, we produced a completely novel technology and achieve the first regulatory clearance in Europe for our thermal acoustic application on a personal note as the first employee at Edinburgh spin incredibly gratifying to contribute to the development of chaos from concept to device deployment and ultimately.
First clinical application.
Let me update you now on our recent clinical activity.
Let me update you now on our recent clinical activities, we deployed <unk> systems to two U S sites last year and I recently visited one of the U S sites and was able to observe study subjects undergoing payoffs fatty liver exams with.
With each new clinical technology, there is naturally a new workflow, exam procedure, user interface, and data display. I find it very encouraging to observe the learning curve where the clinical user transitioned from familiarization with TAIS to completing routine exams all in the same.
With each new clinical technology, there is naturally a new workflow exam procedure user interface and data display I find it very encouraging to observe the learning curve, where the clinical user transition from familiarization with chaos to completing routine exams all in the same day.
So far this year, approximately 40 study subjects have had tests.
So far this year approximately 40 study subjects have had tests exams remain confident in our goal of achieving 200 plus subjects scanned by the end of the year.
remain confident in our goal of achieving 200 plus subjects scanned by the end of the day.
as current studies progress and additional sites come online.
As Kurt studies progress and additional sites come online throughout the year.
To that end, I'm happy to announce today that we've deployed a TEA system, trained the staff, and will begin scaling.
To that end I'm happy to announce today that we've deployed a tia system train the staff and will begin scanning patients next week at a new clinical research collaboration site in Germany that will contribute clinical data provide usability feedback and help and reevaluate new task product features ease of.
at a new clinical research collaboration site in Germany that will contribute clinical data, provide usability feedback, and help Endra evaluate new TEAOS projects.
This is a big milestone for us as it represents our first active site.
Big milestone for us as it represents our first active site in Europe .
These ongoing and planned studies in the U.S. and Europe are essential to the clinical validation of our technology and will support the commercial activities and additional regulatory submissions in new markets.
These ongoing and planned studies in the U S and Europe are central to the clinical validation of our technology and will support the commercial activities and additional regular regulatory.
Regulatory submissions and new markets on this last point as we announced in February Andrew will leverage our existing clinical study sites and previous five 10-K application to support the expected submission of our de Novo request to the FDA in the third quarter <unk>.
On this last point, as we announced in February , Andrew will leverage our existing clinical study sites and previous 510K applications.
support the expected submission of our de novo request to the FDA in the third quarter.
To mentor it with the DeNovo process, we intend to provide smaller-scale, TAS human study data from our existing market adoption.
Commensurate with the de Novo process, we intend to provide smaller scale pay us human study data from our existing market adoption sites and importantly, this is not expected to add material expense to Andrew.
Importantly, this is not expected to add material expected.
I'll now turn the call over to Renault Meloberti for a commercial update.
I'll now turn the call over to Renaud mellow bare teeth for a commercial update Bruno.
Thanks Mike. Indeed, we are really happy to start scanning patients on TAS in Germany and look forward to initiating the other European evaluation sites in the coming months.
Thanks, Mike Indeed, we are really happy to start scanning patients on taste in Germany, and look forward to initiating the other European evaluation sites in the coming months.
As a reminder, we have four clinical.
As a reminder, we have four clinical.
evaluation sites in France, Switzerland, and in the UK, as well as a second site in Germany.
Evaluation sites in France, Switzerland, and in the U K as well as a second site in Germany.
We've recently returned from the DGIM conference in Wiesbaden, Germany. DGIM is the annual meeting for the Society of Internal Medicine Specialists.
We've recently returned from the D. G I am conference and be spud in Germany D. G. I am is the annual meeting for the society of internal medicine specialists, which attracts over 5000 attendees, including many ultrasound users.
which attracts over 5,000 attendees, including many ultrasound users.
This was the first in person gathering for this large clinical conference in over two years and we received a lot of interest from visitors at our booth, where we demonstrated the Tia system on medical imaging platform Phantoms and made new connection with potential customers in Germany.
This was the first in-person gathering for this large clinical conference in over two years and we received a lot of interest from visitors at our booth where we demonstrated the TS system on medical imaging platforms and made new connections with potential customers in Germany.
attending this trade show is part of our outreach to clinical specialties outside of radiology and hepatology who are interested in the study of the lever.
Attending the Street's shoe is part of our outreach to clinical specialties outside of radiology in herpetology, who are interested in this study of the liver.
Like other specialties, the need in internal medicine for a noninvasive point of care device to assess liver health was evident in the multiple meetings we had with clinicians.
Like other specialties the need in internal medicine for non invasive point of care device to assess liver health was evident in the multiple meeting we had with clinicians.
Yeah.
Coming up, we are actively focused on preparing for NRAS participation in the European Association for the Study of the Liver, known as EASL. After a two-year online-only presence, this event will be held in person in London next month. This is the biggest liver-focused clinical conference in Europe and typically is attended by over 10,000 hepatologists and dog chronologists and other specialists.
Coming up we are actively focused on preparing for and rasp participation in the European Association for the study of the liver known as easily after a two year line only presence. This event will be held in person in London next month.
This is the biggest labor focus clinical conference in Europe , and typically is attended by over 10000, Herpetologist endocrinologist and other specialists.
The conference will continue to reinforce the importance of naffoponache and the growing need for innovative new diagnostics and treatment.
The conference will continue to reinforce the importance of naphtha with Nash and the growing need for innovative new diagnostics and treatments.
Andra will have a booth at IZLE, and Mike Thornton and I will be staffing it along with our European team.
Andrew I will have a booth at Eagle and Mike Thornton and I will be staffing it along with our European team.
Yeah.
will be demonstrating our taste product, and we are looking forward to meeting our clinical partners and developing new relationships.
We'll be demonstrating our tastes product.
We're looking forward to meeting our clinical partners and developing new relationships.
The week leading up to EASL will be preceded by a cadence of targeted communication to clinicians in our NRAS proprietary database, inviting them to our booth.
The weeks, leading up to Eagle will be preceded by a cadence of targeted communication to clinicians in our N dry proprietary database invading them inviting them to our booth.
Yeah.
As TAS gains recognition through our sales team activity and engagement, we are receiving a growing number of requests from clinicians asking us to share publicly available TAS product information so they can incorporate it in their peer-to-peer presentation.
As T S gains recognition through our sales team activity and engagement, we are receiving a growing number of requests from clinicians asking us to share publically available T. As productive information. So they can incorporate it into their peer to peer presentations.
This is an extremely positive trend that augurs well for the future of Therese commercial acceptance as typically physician prefer to learn about new products and technologies from other physicians.
This is an extremely positive trend that augurs well for the future to use commercial acceptance as typically physicians prefer to learn about new products and technologies from other physicians.
In summary, we have a well-trained and active sales team on the ground in Europe . We are expanding our outreach to new high-value clinical segments.
In summary, we have a well trained and active sales team on the ground in Europe , we are expanding our reach to new high value clinical segments, including endocrinology and internal medicine, we are increasing our presence at clinical conferences by some 40%.
including endocrinology and internal medicine. We are increasing our presence at clinical conferences by some 40% this year, and we are developing new rental programs to facilitate customer adoption of TAIS as we look forward to generating revenue for Android.
This year and we are developing new rental programs to facilitate customer adoption of T. S. As we look forward to generating revenue for Andrew.
Now, I'd like to turn the call over to Irina to review the financial results for the first quarter of 2022. Irina?
Now I'd like to turn the call over to Arena to review the financial results for the first quarter of 2022 Arena.
Thank you right now our financial results for the first quarter of 2022 are as follows.
Thank you Renault. Our financial results for the first quarter of 2022 are as follows.
For the quarter ended March 31, 2022 our operating expenses increased to $9 million from $2 $6 million for the same period in 2021.
for the quarter ended March 31, 2022, our operating expenses increased to $2.9 million from $2.6 million for the same period in 2020.
The increase was primarily due to higher spending for commercialization of chaos and ongoing product development.
The increase was primarily due to higher spending for commercialization of kits and ongoing product development.
Our research and development expense increased year over year by approximately $70000 due to ongoing product development work.
our research and development expense increase year over year by approximately $70,000 due to an ongoing product development work.
Our sales and marketing expenses increased by approximately $180,000 for the quarter, as we began to expand our sales efforts, as we're not just described, including adding to our heads.
Our sales and marketing expenses increased by approximately $180000 for the quarter as we began to expand our sales efforts as Bernard just described including adding to our headcount.
general administrative expenses, increased by approximately $30,000, and due to higher professionals.
General and administrative expenses increased by approximately $30000 due to higher professional fees.
Our net loss per share for the 2022 first quarter was seven cents compared with the net loss of six cents per share a year ago.
Our net loss per share for the 2022 first quarter was 77.
With a net loss of six cents per share a year ago.
Well, thank you Nick to advance our commercialization initiatives with an asset light operating model and conservative cost structure.
We'll continue to advance our commercialization initiative with an effort-like operating model and conservative culture.
As of March 31, 2022, we had cash and cash equivalents of $7.1 million.
As of March 31, 2022 we had cash and cash equivalents of $7 $1 million.
Year to date, the company raised 8.7 million in gross proceeds through our ATM facility of which 7.8 million was raised subsequent to the close of first quarter.
Year to date, the company raised $8 7 million in gross proceeds through our ATM facility.
$7 8 million was rate subsequent to the close the first quarter.
Given this additional fund and our strengthened balance sheet, we believe we're well capitalized and have cash runway to support our commercial activities in Europe as they prepare our Denver quest for the M D.
Given this additional fund and our strength and balance sheet, we believe we're well capitalized and have cash one way to support our commercial activities in Europe as we prepare our agenda request for the FDA. Now, I'll turn the call off.
Now I'll turn the call back different time points.
Printer.
Thanks, very much arena Renault and Mike in summary, I'd like to reiterate the significant milestones were focused on achieving this year. They include first advancing take us through the U S regulatory process and submitting a de novo request planned for Q3.
Thanks very much, Irina, Renault, and Mike. In summary, I'd like to reiterate the significant milestones we're focused on achieving this year. They include, first, advancing TAIS through the US regulatory process and submitting a de novo request planned for Q3.
Second, demonstrating pay us as clinical value by generating additional data with our strategically positioned study sites to support the regulatory submission and our commercial.
Second demonstrating <unk> clinical value by generating additional data with our strategically positioned study sites to support the regulatory submission and our commercialization.
Third accelerating our commercial channel and marketing activities in line with the reopening of global markets to generate orders and revenue curtails in Europe .
Third, accelerating our commercial channel and marketing activities in line with the reopening of global markets to generate orders and revenue for Teos in Europe .
Fourth.
securing additional industry partnerships to expand the opportunity for TAS outside the clinical end user market.
Securing additional industry partnerships to expand the opportunity for tests outside the clinical end user market.
And finally <unk>.
And finally, continuing to strengthen our intellectual property portfolio to protect our proprietary technology, expand its potential areas of use, and increase our license.
<unk> to strengthen our intellectual property portfolio to protect our proprietary technology expand as potential areas of use and increase out licensing opportunities. So.
So with that review of our business highlights and financial results, I'd now like to open the call for questions.
So with that review of our business highlights and financial results I would now like to open the call for questions operator.
Ladies and gentlemen, at this time we'll begin the question and answer period. If you would like to ask a question, you may press star and then one on your touchstone telephone if you are using a speakerphone. We do ask that you please pick up your handset prior to pressing the keys to ensure the best sound quality.
Ladies and gentlemen at this time, we will begin the question and answer period.
If you would like to ask a question you May Press Star and then one on your Touchtone telephone. If you are using a speaker phone. We do ask that you. Please pick up your handset prior expressing the keys to ensure the best sound quality.
To withdraw your questions you May press star two.
To answer all your questions, you may press star and two.
Once again, that is star and then one to join the question.
Once again that is star and then one to join the question queue.
Our first question today comes from Vernon Bernardino from H.C. Wainwright. Please go ahead with your question.
Our first question today comes from Vernon Bernardino from H C. Wainwright. Please go ahead with your question.
Hi Vernon.
Hi Francois, thanks for taking my question and congrats on the process progress. Just wondering if you could talk a little bit more about the the happenings in Europe . It's intriguing the comments you made as far as the growing interest shares. I was wondering if I could give a little bit more detail and insight and especially how other people are having the payment.
Hi first of all.
Thanks for taking my question and congrats on the process progress.
Just wondering if you could talk a little bit more about the the.
And Europe is intriguing the the comments you made as far as the growing interest and I was wondering if you could give him a bit more detail and insight and especially how that.
People are pounding the pavement.
Sure, and maybe I think let's pass that to Renault if you could give us a sense of some of the anecdotal feedback and themes that you're hearing at these conferences, Renault, and as well as some of the tactics that we're executing in Europe .
Sure and maybe I think let's surpassed that of Renault if you could give us a sense of.
Some of the anecdotal feedback and themes that you're hearing at these conferences Renault and.
As well as some of the tactics that we're executing in Europe .
Yeah, no, absolutely. Thank you for the question. Yes, I mean, as we go, hi, how are you, Vernon? As we are going back to in person trade show in Europe and conference in Europe , it is becoming very clear to us that the more and more specialists, whether they're hepatologists or endocrinologists, are very interested in our technology.
Yeah no absolutely. Thank you for the question yes.
Hi, how are you Vernon.
We are going back to in person trade show in Europe and conference in Europe . It is becoming very clear to us that the more and more.
Our specialists, whether they herpetologist toward duck Chronologist are are very interested in our technology.
in order to start really understand liver health on their patients, that of their patient population. You know, we've had multiple requests for demonstration. We are organizing multiple lunch and learn with our partner, GE, at various sites in Europe , and as I commented earlier, we have multiple physician who was asking us for materials
Order to start really understand liberty.
<unk> helped on the on their patients that patient population.
You know we've had multiple a request for that.
Demonstration.
We are organizing multiple lunch and learn with our partner GE.
Sites in Europe .
And as I as I commented earlier, we have multiple physician was sks from materials when they can talk about.
our technology in their own talk to their colleagues and friends when they do different talks and conferences as well as their students. So I see a very high uptick of interest in the solution that we provide as well as in the technology and how it differs from the existing ways of measuring leverage.
Our technology in their own talk to their colleagues.
And friends when they do a different toxin conferences as we're out there as their students so I see a very high.
Uptick interest in the India solution that would provide as well as into the technology and I would differs from the existing.
At the existing ways of measuring liver fat.
Hey, Renault, if I could, I just wanted to piggyback on that, if I might, Vernon, as you know, we started with GE and the radiology.
Hey, Renault if I could if I just wanted to go back on that if I My Vernon.
As you know, we started with GE and the radiology part of their business, which is their strength, but <unk> like a lot of medical device companies have other divisions, including what are called point of care ultrasound and these are the ultrasounds that are typically used in emergency rooms, or internal medicine or non radiology setting.
part of their business, which is their strength. But GE, like a lot of medical device companies, have other divisions, including what are called point-of-care ultrasound. And these are the ultrasounds that are typically used in emergency rooms, or internal medicine, or non-radiology settings. And we're seeing that that solution, portable ultrasound, the size of a laptop, the size of an iPhone.
And we're seeing that that solution portable ultrasound the size of a laptop the size of an iPhone.
are an increasingly attractive element to combine with our technology when we're talking to an endocrinologist or a hepatologist who doesn't necessarily own an ultrasound the way you have it in radiology. So we're finding that the partnership and discussions and field work with GE are actually in many regards evolving as we learn more about the market and as customers draw on us with their needs.
In an increasingly attractive element.
Combined with our technology, when we're talking to and endocrinologists are herpetologist, who doesn't necessarily own an ultrasound. The way you have it in our in our radiology.
Radiology, so we're finding that the other partnership and discussions and field work with GE or actually in many regards evolving as we learn more about the market and as customers draw on us with their needs I hope that's helpful.
Definitely. And that's very neatly with my second question, and that is, how were people asking how to use it? Do any of them ask how much it cost? I know that it's a...
Definitely and that's high grade very.
My second question and that is how or people are asking how to use it do any of them ask how much it costs I know that it's it's a.
too early, perhaps, but because they have familiarity with ultrasound, I would imagine a doctor who already uses ultrasound might wonder what additional cost it may entail.
A.
Two early perhaps but because they have familiarity with ultrasound.
They I would imagine a doctor who already uses ultrasound might wonder what additional costs that may entail.
And I think we were as strategic as we could be when we originally started setting price. Now we all know there's a difference between price setting and price getting, but our price setting and so far what we're hearing in the marketplace is the 50,000 U.S.
Sure and I think we were as strategic as we could be when we originally started setting price now we all know theres a difference between price setting and price getting.
But our price setting and so far what we're hearing in the marketplaces. The 50000 U S price for our technology is something that is appealing because many in our radiology certainly the the ones doing the ultrasounds of the liver today for golf stones and other reasons.
price for our technology is something that is appealing, because many in radiology certainly, the ones doing the ultrasounds of the liver today for gallstones and other reasons.
are investing $75,000, $150,000, $200,000 for an ultrasound. So having an add-on technology that enhances their ultrasound at a reasonable price point.
Our investing 70 550 $200000 went ultrasound so having a add on technology that enhances their ultrasound at a reasonable price point.
was certainly something in our consideration and so far Renault I don't know if you've got any additional feedback that the feedback we're getting along with the rental programs that we're putting in place to facilitate acquisition of the technology has certainly been well received. Any additional comments Renault from your side?
It was certainly something in our consideration and so far Renault I don't know if you've got any additional feedback, but the feedback we're getting along with our rental programs that we're putting in place to facilitate acquisition of the technology has certainly been well received any any additional comment we know from your son, Noah I think.
No, I think the price point that we have talked about has been very well received and accepted by the customers.
Price point that we have talked about has been very well received and accepted by the customer.
So I am very confident that we should be able to get that price going around, that price point when we...
So I am very confident that we should be able to get that price going around placement when we.
So.
Great.
Thanks. I hope that's helpful to you, Vernon, and your investors.
Thanks, I hope that helps.
Helpful to you Vernon and your investors.
Definitely, because obviously these days I think everybody's thinking about the cost of things. Thank you for taking my question and follow-up question. Always.
Definitely because obviously these days I think everybody's thinking thinking about the cost of things. Thank you for taking my question and follow up question.
Always thank you so much Wayne.
And our next question comes from Edward Wu from Ascendient Capital. Please go ahead with your question.
And our next question comes from Edward Woo from <unk> Capital. Please go ahead with your question.
Congratulations on the progress in the quarter and also on your first Germany or first, you know, site in Europe , your clinical study partner. Just how many of your eight partners are actually scanning today and what is the timeline to get them all up and running?
Yeah, Congratulations and congratulations on the progress in the quarter and also on your first Germany are our first site in Europe Your clinical study partner.
How many of your partners are actually actually scanning today and what is the timeline to get them all up and running.
Sure. So we've with the German site, we just mentioned that'll be our third side going live.
So with the German site we just mentioned, that'll be our third site going live.
We have the remaining sites certainly phasing in here over the coming months. Our goal is to have all of them.
We have the remaining sites certainly phasing in here over the coming months. Our goal is to have all of them up and running COVID-19 permitting obviously, but are certainly getting them all up and running this year and our our I would say even more a central goal is to have upwards of 200 patients scanned.
up and running, COVID permitting, obviously, but certainly getting them all up and running this year. And our, I would say, even more essential goal is to have upwards of 200 patients scanned.
because we feel like that's really reaching a new level, a new level of critical mass needed to support both commercial activity, being able to support both commercial activities.
Because we feel like that's really reaching a new level, a new level of critical mass needed to support both commercial activity being able to say to <unk>.
clinicians who are considering a purchase, hey, we have scanned this many patients. That's always extremely confidence building. And also to be able to support the regulatory submission for the FDA. I wanna emphasize the de novo path, as Mike Thornton described, is not at all a long-term, large,
Clinicians who are considering a purchase hey, we have scanned. This many patients that's always extremely confidence building and.
And also to be able to support the regulatory submission for the F. D. A I want to emphasize the de Novo path as Mike Gordon described is not at all a long term a large study with hundreds of patients the way a pre market approval for an invasive device or a drug that might be a P. M. A S. R.
study with hundreds of patients the way a pre-market approval for an invasive device or a drug might be a PMA, as they're called. So I won't be able to define at this point, because the FDA has not prescribed it. We have to come back to the FDA with a representative cohort of in vivo data to complement the 510 work we've done. We're definitely going to be able to do that within the pool of...
So I I won't be able to define at this point because the FDA is not prescribed it we have to come back to the FDA with a representative a cohort of in vivo data to complement the fact and work we've done we're definitely going to be able to do that within the pool of XI.
sites that we've already got started and certainly as we add more we'll have even greater flexibility and volume in terms of clinical data. I hope that's helped.
It's that we've already got started and certainly as we add more will have even greater flexibility in volume in terms of clinical data I hope that's helpful.
that is very helpful. Then congratulations on obviously making a lot of progress in Europe , in the EU, obviously, your device has already been got C marked. Do you anticipate focusing a lot more of your marketing in Europe until you do get FDA approval in the US?
That is very helpful and then congratulations on obviously.
Make a lot of progress in Europe , and the EU obviously.
Your devices already been got CE, Mark do you anticipate are focusing a lot more of your marketing in Europe until you do get a FDA approval in the U S.
Absolutely. Yeah, I mean we as Americans often forget how large
Absolutely Yeah, I mean, we as Americans often forget how large although culturally diverse Europe is but it's a very large market and certainly from a health care market are very very attractive. We believe we have people on the ground in the key markets in France, and Germany and the UK.
although culturally diverse, Europe is, but it's a very large market and certainly from a healthcare market, very, very attractive. We believe we have people on the ground in the key markets in France, in Germany, in the UK. And I think our focus should be there. We've been very careful not to spread ourselves too thin. Obviously, by getting the clinical study site in the US up and running ahead of our regulatory approval will give us a head start when we do get approval to add.
And I think our focus should be there we've been very careful not to spread ourselves too thin.
Obviously by getting the clinical study sites in the U S up and running ahead of our regulatory approval will give us a head start when we do get approval to add salespeople.
salespeople here in the U.S., and as we mentioned also earlier in the year, we signed a prestigious
Salespeople here in the U S and as we mentioned also earlier in the year, we signed a prestigious cordner ship with Shanghai General Hospital in China, and I would say after Europe and the U S will be certainly turning our attention to Asia, which is as we all know the world's most populous health care market, but I wont.
partnership with Shanghai General Hospital in China, and I would say after Europe .
And the U.S. will be certainly turning our attention to Asia, which is, as we all know, the world's most populous healthcare market. But I want you to hear, I want investors to hear, we're not trying to be everywhere at the same time. One, we're preserving capital, we're focusing on what we think is going to be the highest return. And that's starting in Europe , definitely.
You to hear I want investors to hear we're not trying to be everywhere at the same time, one we're preserving capital we're focusing on what we think is going to be the highest return and that's starting in Europe definitely.
Oh, great well, thanks for answering my questions and I wish you guys. Good luck. Thank you.
Great. Well, thanks for answering my questions, and I wish you guys good luck. Thank you. Thank you so much.
Thank you so much Ed.
Ivan have we received any additional.
Yvonne, have we received any additional questions possibly by email?
Questions, possibly by email.
Yes, one question we got is, can you further discuss the licensing opportunities with the recently issued patent regarding data transfer?
Yes, one one question. We got is can you further discuss the licensing opportunities with the recently issued patent regarding data transfer.
Yeah that's actually really exciting. Before I turn it over to Mike to kind of give you a real sense of that one, I do want to contextualize it. I mean, ENDR has been very active in the last five years, patent thing, you know, comprehensive range of innovations that spans thermal acoustic applications and enabling technologies.
Yeah, that's actually a really exciting before I turn it over to Mike to kind of give you a real sense of of that one I do want to contextualize. It Andrew has been very active in the last five years our patenting.
Comprehensive range of innovations that spans thermal acoustic applications and enabling technologies and those are focus on fatty liver as well as other applications and temperature monitoring things that could allow a surgeon or interventional radiologist who's trying to treat cancer or cardiological condition to be able to see the tissue.
And those are focused on fatty liver as well as other applications and temperature monitoring things that could allow a surgeon or interventional radiologist who's trying to.
treat cancer or cardiological condition, to be able to see the tissue being treated with heat or cold. We've mentioned that before. We think that's a very compelling opportunity, a real game changer for companies who are involved in that because today there's no way
Being treated with heat or cold and we've mentioned that before we think that's a very compelling opportunity a real game changer for companies who are involved in that because today, there's no way to easily see tissue temperature change when you're burning or freezing something below the skin.
to easily see tissue temperature change when you're burning or freezing something below the skin. So, you know, clinicians tend to do their very best, but they obviously have limited visibility to that. So we think that's a key area for Andra and the TAIS platform. But I'd love for Mike Thornton to speak a little bit more about this new space,
So.
Clinicians tend to.
Do their very best but they obviously have limited visibility to that so we think that's a key area for Android and the taste platform, but I'd love for Mike for him to speak a little bit more about this new space.
And I want to emphasize that this new space is a derivation of some work we were doing on TEA. So this is not a pivot of the company. This is an incremental opportunity for ENDRA, which we're very excited about from an out licensing perspective. So Mike, if you'd give us a sense of the most recent U.S. data points.
And I want to emphasize that this new space is a derivation of some work we were doing on pay us. So this is not a pivot of the company. This is an incremental opportunity for <unk>, which we're very excited about from an out license in perspective, So Mike if you could give us a sense of the most recent.
<unk> data point that'd be great.
Sure, and thanks. The most recently issued US patent broadly covers the transfer of equipment performance data in a really novel way. Specifically, our patent enables manufacturers of laboratory diagnostic and other types of equipment to
Sure and thanks.
The most recently issued U S patent broadly covers the transfer of equipment performance data and a really novel way specifically, our patent enables manufacturers of laboratory diagnostic and other types of equipment to.
easily extract performance data and service metrics where conventional wireless or network connectivity isn't available. Surprisingly, a lot of that information is not automatically downloadable from equipment and is often copied by hand by service techs in the field. As you can imagine, this is a fairly inefficient process.
Easily extract performance data and service metrics, where conventional wireless or network connectivity isn't available.
Surprisingly a lot of that information is not automatically downloadable from equipment is often copied by hand by.
By service Techs in the field as you can imagine this is a.
Fairly inefficient process.
This Ips and.
This IP is an example of Android innovations potentially expanding far beyond.
An example of and renovations potentially expanding far beyond Andrus Cortez technology.
Thanks, Mike. I think that's exciting. I mean, I want investors and our listeners to hear two things from us. One, we're laser focused on making chaos, liver, a success in Europe , generating
Thanks, Mike I think that's exciting I mean, I I want investors and our listeners too here.
Two things from US one where we're laser focused on making pay us liver our success in Europe generating revenue.
as well as securing U.S. regulatory approval. But we're also, you know, advancing in a very efficient way without distracting ourselves from those primary goals, other opportunities that we can leverage from our technology platform, including the IP that Mike mentioned, which might be of interest from an out licensing perspective. So I think that's compelling. I think investors
As well as securing U S regulatory approval, but we're also.
Advancing in a very efficient way without distracting ourselves from those primary goals other opportunities that we can leverage from our technology platform, including the IP that Mike mentioned, which might be of interest from an out licensing perspective. So I think that's compelling I think investors understand that broader longer term.
understand that broader longer-term potential to scale the business. But obviously, we're focused on the immediate, and we're looking forward to achieving some great things this year.
Potential to scale the business, but obviously, we're focused on the immediate and we're looking forward to achieving some great things this year.
If we don't have anything else, I think operator we can close the call now.
Ivan if we don't have anything else.
Operator, we can.
Close the call now.
That's it for me.
Okay, and ladies and gentlemen.
Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining today's conference call. You may now be seated.
Ladies and gentlemen, with that we'll conclude today's conference call and presentation.
Thank you for joining today's conference call.
You may now disconnect your lines.
Thank you.
Yeah.