Q3 2023 ENDRA Life Sciences Inc Earnings Call
[music].
Speaker 1: Good day and welcome to the Endro Life Sciences third quarter 2021-2023 financial results conference call.
Good day and welcome to the and your life Sciences third quarter 2023 financial results Conference call.
Speaker 1: All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.
All participants will be in a listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero.
After today's presentation there'll be an opportunity to ask questions.
Ask a question you May press Star then one on your Touchtone phone to withdraw your question. Please press Star then two please.
Please note. This event is being recorded I would now like to turn the conference over to Yvonne Briggs. Please go ahead.
Thank you operator, this is Yvonne Briggs without la Jay Good afternoon, and welcome to address third quarter 2023 business update and financial results Conference call.
Speaker 2: Thank you, operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to Andra's third quarter 2023 business update and financial results conference call. Earlier today, Andra issued a press release on this topic, which is available in the investor section of Andra's website.
Earlier today, Andrew <unk> issued a press release on this topic, which is available in the investors section of Antares website.
Speaker 2: 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.
Speaker 2: All statements by management other than statements of historical facts, including statements regarding the company's strategies, financial conditions, operations, costs, plans and objectives, as well as the anticipated results of the development and commercialization efforts, the timing of clinical studies, potential partnership opportunities, and expectations regarding regulatory processes.
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 statements.
Speaker 2: receipt of required regulatory clearances and product launches are forward-looking statements.
Speaker 2: except as required by securities laws, the company disclaims any obligation to update or revise any forward-looking statement.
Except as required by securities laws, the company disclaims any obligation to update or revise any forward looking statements.
Please refer to the company's Form 10-K for the 2022 fiscal year and subsequent SEC filings for more information about risks and uncertainties related to forward looking statements.
Speaker 2: Please refer to the company's Form 10-K for the 2022 fiscal year and subsequent SEC filings for more information about risks and uncertainties related to forward-looking statements.
Speaker 2: In terms of the structure of today's call, Francois Michelon, Chairman and Chief Executive Officer, will begin the prepared remarks, followed by Michael Thornton, Endres Chief Technology Officer.
In terms of the structure of today's call Francois Michelle on Chairman and Chief Executive Officer will begin the prepared remarks, followed by Michael Thornton and dress Chief Technology Officer.
Speaker 2: Mr. Thornton will be followed by Irina Pestrakova, Senior Director of Finance, to review the third
Mr. Thornton will be followed by arena Petra Kolber Senior director of Finance to review the third quarter financial results with that said I'll now turn the call over to Francois Michel Francois.
Speaker 2: With that said, I'll now turn the call over to Francois Michelon. Francois?
Speaker 3: Thank you, Yvonne. Good afternoon, everyone, and thanks for joining us today to discuss Endra's third quarter 2023 financial results and business highlights.
Thank you Yvonne and good afternoon, everyone and thanks for joining us today to discuss Andrus third quarter 2023 financial results and business highlights.
Speaker 3: I'm delighted by the momentum that's building for our thermoacoustic enhanced ultrasound liver system known as PEA.
I'm delighted by the momentum that's building for our thermal acoustic enhanced ultrasound liver system known as pay us.
Speaker 3: This momentum checks a number of boxes, including clinical, regulatory, and commercial, along with a convergence of a number of factors that put Endra in the right place at the right time.
This momentum checks a number of boxes, including clinical regulatory and commercial along with the convergence of a number of factors that put Android in the right place at the right time.
Speaker 3: We spent the last few days of the liver meeting held by the American Association for the Study of Liver Diseases where we interacted with experts in the field, clinical users, prospective customers and partners.
We spent the last few days of the liver meeting held by the American Association for the study of liver diseases, where we interacted with experts in the field political users prospective customers and partners.
Speaker 3: Steatotic liver disease, known as SLD, is the umbrella term for a multifaceted metabolic disorder resulting in too much fat in the liver.
They are ptotic liver disease known as S. L. D is the umbrella term for a multifaceted metabolic disorder, resulting in too much fat in the liver.
Speaker 3: Anything over 5% liver fat is of clinical significance. And this fat can irritate and inflame.
Anything over 5% liver fat is of clinical significance and this faq and irritate an inflamed deliberate.
Speaker 3: then scar it and ultimately lead to irreversible end-stage liver disease.
Then scarlet and ultimately lead to irreversible end stage liver disease state.
Speaker 3: steatotic liver disease is estimated to affect more than 2 billion people worldwide and it's predicted to become the leading root cause of liver transplant in the US by
They had ptotic liver disease is estimated to affect more than 2 billion people worldwide and it's predicted to become the leading root cause of liver transplant in the U S by 2030.
Speaker 3: The American Association of Clinical Endocrinology and the American Diabetes Association have updated their guidelines over the past 18 months to include the screening for fatty liver in adults with obesity, prediabetes, and type 2 diabetes.
The American Association of clinical Endocrinology, and the American Diabetes Association have updated their guidelines over the past 18 months to include the screening for fatty liver in adults with obesity pre diabetes and type two diabetes.
The good news is that the new G. L. P. One obesity drugs have demonstrated clinically significant reductions in liver fat and a rich pipeline of targeted therapies to treat S. L D and both obese and non obese patients is approaching commercialization.
Speaker 3: The good news is that the new GLP-1 obesity drugs have demonstrated clinically significant reductions in liver fat and a rich pipeline of targeted therapies to treat SLD in both obese and non-obese patients is approaching commercialization with the first drug approvals expected in early 2024. This intersection of variables, a heavy public health.
The first drug approvals expected in early 'twenty 'twenty four.
This intersection of variables.
Heavy public health burden.
A lack of practical diagnostic tools.
Speaker 3: and the near-term availability of the first treatment.
In the near term availability of the first treatments.
Speaker 3: creates an opportunity to address the large unmet clinical need for a non-invasive, cost-effective tool to assist in identifying and monitoring patients. That's where
It's an opportunity to address the large unmet clinical need for a noninvasive cost effective tool to assist in identifying and monitoring patients.
That's where Andrea in terms can lead.
Speaker 3: As discussed on our last conference call, we submitted the TAIS de novo request to the FDA on August 14th of this year, and since then, the submission has entered the substantive review period.
As discussed on our last conference call, we submitted the pay us de Novo request to the FDA on August 14th of this year and since then the submission has entered the substantive review period.
Speaker 3: The de novo submission was a significant milestone for INDRA as this regulatory pathway should strengthen our competitive position with distinctive patent-protected capabilities as a non-invasive point-of-care tool to aid in the characterization of liver fat. We look forward to working with the FDA during the review process, and the FDA's published goal is to make a decision on a de novo request within 150 review days.
The de Novo submission was a significant milestone for Andrew as this regulatory pathway should strengthen our competitive position with distinctive patent protected capabilities as a noninvasive point of care tool.
And the characterization of liver fat, we look forward to working with the FDA. During the review process and the Fda's published goal is to make a decision on a de Novo request within 150 review days.
Since our FDA submission, we've had our second positive clinical dataset reviewed and accepted for presentation by the European Association for the study of the liver.
Speaker 3: Since our FDA submission, we've had our second positive clinical data set reviewed and accepted for presentation by the European Association for Study of the Liver.
Speaker 3: These clinical abstracts are available on Endra's website under the tab Research and Media.
These clinical abstracts are available on <unk> website under the tab research and media.
Speaker 3: The most recent abstract includes 45 subjects comparing Ender's taus liver measurements to MRI, and we're very pleased with the results.
The most recent abstract includes 45 subjects comparing andrus Te is liver measurements to MRI and we're very pleased with the results.
We believe the data in these published abstracts and related presentations are crucial to building awareness of the <unk> system and its capabilities with clinical users and to supporting commercial adoption of our new technology.
Speaker 3: We believe the data in these published abstracts and related presentations are crucial to building awareness of the TAIS system and its capabilities with clinical users and to supporting commercial adoption of our new technology.
The clinical data is the most critical element, we're getting commercial traction with clinical customers, Mike Thornton will provide more detail on our clinical data in a moment.
Speaker 3: The clinical data is the most critical element for getting commercial traction with clinical customers.
Speaker 3: Mike Sorton will provide more detail on our clinical data in a moment.
In terms of promotional activities, we've been actively showcasing our tastes liver system at the key clinical conferences.
Speaker 3: In terms of commercial activities, we've been actively showcasing our TAIS liver system at the key clinical conferences in hepatology, endocrinology, and radiology, in our target markets of the UK, Germany, France, and the US.
Herpetology endocrinology and radiology in our target markets of the U K, Germany, France, and the U S.
Speaker 3: We've participated in eight clinical conferences this year, including five since September , namely the British Association for Study of the Liver, the European Association for the Study of the Heart.
We've participated in eight clinical conferences this year, including five since September, namely the British Association for study of the liver.
The European Association for the study of diabetes front.
Speaker 3: French Society for Hepatology, Drillande Treffen, which is the annual meeting of the ultrasound societies in Germany, Austria, and Switzerland. And I've just returned with Mike Thornton from the American Association for the Study of Liver Diseases in Boston, which is the preeminent liver meeting in the US.
French society for Herpetology drill.
<unk>, which is the annual meeting of the ultrasound societies in Germany, Austria, and Switzerland, and I've just returned with Mike Horton from the American Association for the study of liver diseases in Boston, which is the preeminent liver meeting in the U S.
Speaker 3: We also sponsored a great multidisciplinary panel discussion on liver disease while at ASLD from the perspective of a hepatologist, the liver experts, an endocrinologist, the metabolic, obesity, and diabetes experts, and a radiologist, the imaging.
We also sponsored a great multi disciplinary panel discussion on liver disease, while at a S. L. D from the perspective of a herpetologist the liver experts and endocrinologists, the metabolic obesity and diabetes experts and a radiologist the imaging experts.
Speaker 3: Steatotic liver disease resonates with each of these specialties, and there's a growing interest in the primary care arena as well.
Stay at Ptotic liver disease resonates with each of these specialties and there's a growing interest in the primary care arena as well.
Turning to intellectual property, we continue to bolster our portfolio and recently achieved a great new milestone of 70 issued patents with three additional patents issued during the third quarter and three more patents issued in Q4, thus far.
Speaker 3: Turning to intellectual property, we continue to bolster our portfolio and recently achieved a great new milestone of 70 issued patents, with three additional patents issued during the third quarter, and three more patents issued in Q4 thus far.
Portfolio with 70 issued patents.
Speaker 3: portfolio with 70 issued patents and no in-licensing dependencies is a remarkable achievement for a company of our size.
And no in licensing dependencies is a remarkable achievement for a company of our size and a testament to the innovation of Andre and the proprietary nature of our technology.
Speaker 3: and a testament to the innovation of Andra and the proprietary nature of our technology.
Speaker 3: These newly issued patents protect and further differentiate Endra's thermoacoustic systems in areas of high unmet clinical need, such as the early detection of steatotic liver disease.
These newly issued patents protect and further differentiate andrus thermal acoustic systems in areas of high unmet clinical need such as the early detection of stay atopic liver disease.
Speaker 3: The company is also actively exploring licensing opportunities in non-court indications with outside partners to augment the value of our growing intellectual property portfolio.
The company is also actively exploring licensing opportunities in noncore indications with outside partners to augment the value of our growing intellectual property portfolio.
Speaker 3: With that update, I'll turn the call over to Mike Thornton for more details on our clinical and regulatory progress. Michael.
With that update I'll turn the call over to Mike Thornton for more details on our clinical and regulatory progress Michael.
Thank you Francois.
Speaker 3: We're very pleased to have submitted a de novo request to the FDA for our TAIS system in August and to report that our file has advanced to the substantive review stage.
We're very pleased to have submitted a de novo request to the FDA for our test system in August and to report that our file has advanced the substantive review stage.
Speaker 4: At this point, we're engaged with the FDA in addressing their questions in a timely and complete manner to keep advancing the process. As we noted earlier, if there are any significant updates, we'll share those with shareholders as we've always done.
At this point, we're engaged with the FDA addressing their questions in a timely and complete manner to keep advancing the process. As we noted earlier if there are any significant updates we'll share those with shareholders as we've always done.
Speaker 4: As Francois mentioned, our clinical study activities support both our regulatory and early commercialization efforts.
As far as Paul mentioned, our clinical study activities support support both our regulatory and early commercialization efforts.
Speaker 4: Our second presentation of clinical data was presented at the recent European Association for the Study of Liver Diseases Steatotic Liver Disease Summit in September .
Our second presentation of clinical data was prison presented at the recent European Association for the study of liver diseases stay at Toric liver disease summit in September.
The clinical study that was presented included 45 study participants exams, comparing pay us estimates of liver fat fraction to the established gold standard MRI measurements of liver fat fraction.
Speaker 4: The clinical study that was presented included 45 study participant exams comparing KS estimates of liver fat fraction to the established gold standard MRI measurements of liver fat fraction.
Speaker 4: The study cohort included a wide range of body size with body mass index ranging from 24, that is normal, to 45, which is classified as class three obese.
Study cohort included a wide range of body size with body mass index ranging from 24 that is normal to 45, which is classified as class III obesity.
Speaker 4: The cohort included four study participants with confirmed fibrosis.
The cohort included for study participants with confirmed fibrosis.
No study subjects were excluded due to a high body mass index or liver fibrosis.
Speaker 4: No study subjects were excluded due to high body mass index or liver fibrosis.
This is a key point.
Speaker 4: Conventional quantitative ultrasound methods are not able to accurately estimate the liver fat fraction in individuals with high body mass index, and often overestimate liver fat fraction in subjects with confirmed liver fibrosis.
Conventional quantitative ultrasound methods are not able to accurately estimate the liver fat fraction and individuals with high body mass index, and often overestimate liver fat fraction in subjects with confirmed liver fibrosis.
Speaker 4: In other words, conventional tools for the assessment of steatotic liver disease are not capable of accurately assessing the wide range of possible patient body size and medical conditions, which creates an urgent market need for a device like TEA.
In other words conventional tools for the assessment of the iconic liver disease are not capable of accurately assessing the wide range of possible patient body size and medical conditions, which creates an urgent market need for a device like tax.
Speaker 4: The TAIS system estimates of liver fat fraction in this study were highly correlated to MRI PDFS scores of liver fat fraction with a correlation coefficient R value of 0.87.
The payer system estimates of liver fat fraction in this study were highly correlated to MRI P. D. F F scores of liver fat fraction with our coalition coal Fisher our value of 0.87.
Speaker 4: In biology and medicine, two variables are considered to be strongly correlated if the Pearson correlation coefficient is greater than 0.8.
In biology, and medicine to variables are considered to be strongly correlated if the Pearson correlation coefficient is greater than 0.8.
Speaker 4: and that a large part of the measurement variation in the gold standard measurement can be explained by the new measurement method. The sensitivity...
And then a large part of the measurement variation in the gold standard measurement can be explained by the new measurement methods.
The sensitivity of chaos and detecting side.
Speaker 4: fatty liver disease was 95%, with a specificity of 77%. The negative predictive value, which is the probability that a negative test result is correct, was 95%.
Fatty liver disease was 95% with the specificity of 77%.
The negative predictive value, which is the probability that a negative test result is correct.
It was 95%.
The negative predictive value is an important measure of test performance because in a cost constrained health care environment.
Speaker 4: Negative predictive value is an important measure of test performance, because in a cost-constrained healthcare environment, it is often important...
Is often important.
Speaker 4: to correctly identify healthy subjects and preclude additional costs as it is to identify those individuals with the disease.
To correctly identify healthy subjects and preclude additional cost.
As it is to identify those individuals with the disease.
We're excited by the performance of the system and our aim is to continue to expand the collection of clinical data at the published results from our clinical collaborations.
Speaker 4: We're excited by the performance of the system and our aim is to continue to expand the collection of clinical data and to publish results from our clinical collaboration.
Speaker 4: In support of this effort, we recently deployed a KS flip system.
Part of this effort, we have recently deployed a T S flip system.
Speaker 4: to a new U.S. clinical collaborator site and are scheduling a European study site deployment in the next few weeks.
To our new U S clinical collaborators site and rescheduling of Europeans study site deployment in the next few weeks.
Speaker 4: These new clinical study sites, along with the authorization.
These new clinical study sites along with the authorization.
Speaker 4: for new studies at past clinical collaborator sites will drive our goal of obtaining several hundreds of study participant exams with our approach to estimating liver fat frac.
Four new studies at past clinical collaborator sites will drive our goal of obtaining several hundreds of state purchase been exams with our approach to estimating liver fat fraction.
Speaker 4: As Francois mentioned, we recently participated in the American Association for the Study of Liver Disease annual meeting in Boston.
As far as Walt mentioned, we recently participated in the American Association for the study of liver disease annual meeting in Boston, where.
Speaker 4: where we showcase the TAIS system and highlight its capabilities.
Where we showcase the payer system and highlight its capabilities.
Speaker 4: Our system generated a great deal of interest from both health care providers.
Our system generated a great deal of interest from both health care providers.
And industry attendees during the conference. We also hosted a panel discussion of multidisciplinary experts in the fields of herpetology, endocrinology and radiology and a discussion of the multidisciplinary nature of the diagnosis treatment and management of metabolic associated stay at Cod liver disease.
Speaker 4: The discussion highlighted the importance of liver fat fraction as a biomarker of diseases that expand beyond the liver, namely hypertension, diabetes, cardiovascular disease, and the increased risk of cancer that will drive interest in our technology beyond hepatology.
The discussion highlighted the importance of liver fat fraction as a biomarker of diseases that expand beyond deliver namely hypertension diabetes cardiovascular disease and the increased risk of cancer that will drive interest in our technology beyond hematology.
Speaker 4: To further emphasize the relationship between steatotic liver disease and the complex of diseases that make up metabolic syndrome, recent GLP-1 obesity drug studies have illustrated the relationship between weight loss, a reduction in liver fat fraction, and cardiovascular disease risk.
To further emphasize the relationship between the iconic liver disease in the complex diseases that makeup of metabolic syndrome. Recent G. L. P. One obesity drug studies have illustrated the relationship between weight loss, a reduction in liver fat fraction and cardiovascular disease risk.
Speaker 4: Overall, the discussion with clinicians and the focus on issues directly addressed by TAIS during the panel discussion demonstrates not only a clear market need for our system, but also an awareness and urgency from practitioners, which we are hopeful will soon translate into our first sales.
Overall the discussion with.
Clinicians and the focus on issues directly addressed by task during the panel discussion demonstrates not only our clear market need for our system, but also in awareness and urgency from practitioners, which we're hopeful will soon translate into our first sales.
Speaker 4: Now I'd like to turn the call over to Irina to review our financial results for the third quarter of 2023. Irina?
Now I'd like to turn the call over to Arena to review our financial results for the third quarter of 2023.
Anna.
Thank you Mike.
Speaker 1: For the quarter ended September 30, 2023, our operating expenses decreased to $3.1 million from $3.4 million for the same period in 2020.
But what it ended September 32023, our operating expenses decreased to three $1 million from $3 $4 million for the same period in 2022.
Speaker 1: The decrease was mainly due to decrease in research and development and sales and marketing expenses.
The decrease was mainly due to a decrease in research and development and sales and marketing expenses.
Speaker 1: Our research and development expenses decreased year-over-year by approximately $197,000 as we completed the development of our initial TASC.
Our research and development expenses decreased year over year by approximately $197000 as we completed the development of our initial thought it.
Speaker 1: Our sales and marketing expenses decreased by approximately $177,000 mainly due to the departure of our chief commercial officer.
Our sales and marketing expenses decreased by approximately $177000, mainly due to the departure of our chief commercial officer.
Speaker 1: general administrative expenses increased by approximately $86,000 due to higher spending on professional fees.
General administrative expenses increased by approximately $86000 due to higher spending on professional fees.
Net loss in the third quarter of 2023 was $3 $1 million or 40 cents per share and this compares with a net loss of $3 $4 million or $1.90 per share in the third quarter of 2022.
Speaker 1: Net loss in the third quarter of 2023 was $3.1 million, or $0.40 per share, and this compares with a net loss of $3.4 million, or $1.09 per share, in the third quarter of 2022.
Speaker 1: Cash and cash equivalents were $3.3 million as of September 30, 2023.
Cash and cash equivalents were $3 $3 million as of September 32023.
Speaker 1: In the third quarter, we raised a total of $1.2 million in gross proceeds from the sale of common stock through our ATM facility.
In the third quarter, we raised a total of $1 $2 million in gross proceeds from the sale of common stock through our ATM facility.
Speaker 1: We believe our current capital position provides a runway into the first quarter of 2024, and we're currently evaluating alternatives to raise capital to provide for our future funding needs.
They live our current capital position provides a runway into the first quarter of 2024, and we are currently evaluating alternatives to raise capital to provide for our future funding needs.
Speaker 1: We maintain our asset-light operating model, but spreading hires in our operations and commercial team in anticipation of future growth.
Well maintain our asset light operating model, that's pretty hires in our operation and commercial team in anticipation of future growth.
Speaker 1: As we execute our regulatory and commercial strategy for TAIS, we plan to adjust our expense structure accordingly in support of these activities.
As we execute our regulatory and commercial strategy for <unk>, we plan to adjust our expense structure accordingly in support of these activities.
Now I'll turn the call back to trends.
Speaker 3: Thanks very much, Irina and Mike. In closing, we remain very excited about the value proposition for TAIS as a non-invasive, cost-effective tool to assess liver fat, especially as the clinical community prepares for the near-term arrival of the first treatments targeting the disease, which affects two billion people worldwide.
Thanks, very much arena and Mike in closing, we remain very excited about the value proposition for payers as a noninvasive cost effective tools to assess liver fat, especially as the clinical community prepares for the near term arrival of the first treatments targeting the <unk>.
<unk>, which affects 2 billion people worldwide.
Speaker 3: Endra's near-term focus is on the following four value-added caps.
Anders near term focus is on the following four value added catalysts.
Speaker 3: Number one, securing the first commercial orders for Arkais technology in Europe , where we have the CE market.
Number one securing the first commercial orders for our tastes technology in Europe, where we have the CE Mark.
Speaker 3: Second, supporting the FDA through their review process with a goal of achieving a favorable de novo decision for entry.
Second supporting the F D. A through their review process with a goal of achieving a favorable de novo decision for Andrew.
Speaker 3: Third, commercializing in the U.S. market upon FDA approval, along with our Vietnam distribution agreement that is tied to the FDA approval.
Third commercializing in the U S market upon FDA approval, along with our Vietnam distribution agreement that is tied to the FDA approval.
Speaker 3: And fourth, continuing to grow and diversify our base of clinical evidence at clinical study partner sites in our target markets in Europe and the U.S. to support commercial adoption of our technology.
And fourth continuing to grow and diversify our base of clinical evidence and clinical study partner sites in our target markets in Europe, and the U S to support commercial adoption of our technology.
Speaker 3: With that overview of our business and recent financial performance, I'd like to now open the call for questions. Operator?
With that overview of our business and recent financial performance I'd like to now open the call for questions operator.
Speaker 2: Thank you. We will now begin the question and answer session.
Thank you we will.
I will begin the question and answer session.
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Speaker 2: To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster.
To withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
My first question comes from Edward Woo with ascending capital. Please go ahead.
Speaker 2: Our first question comes from Edward Wu with Zendian Capital. Please go ahead.
Speaker 3: Yeah, congratulations on the progress. I had a question about the de novo submission. You said that it was a target of 180 days. Does the FDA typically keep it at 180 or is there a possibility that it could be quicker depending on the review?
Yeah, Yeah installations on the progress I had a question about the de Novo submission you set that target of 180 days do the does the F. D. A typically keep it at 180 or is there a possibility that it could be quicker depending on the review.
Yeah, It's it's actually a I don't know if I misspoke or my voice wasn't clear, it's 150 days a review time.
Speaker 3: Yeah, it's actually, I don't know if I misspoke or my voice wasn't clear. It's 150 days of review time, and, you know, that includes everything from invasive higher risk products to lower risk products.
And you know that includes everything from invasive higher risk products to a lower risk products. It's a bell curve I don't want to get any more specific than that but obviously there is a possibility of being somewhere around that I just wanted to get what's the official sort of target coming from the F.
Speaker 3: It's a bell curve. I don't want to get any more specific than that, but obviously there is a possibility of being somewhere around that. I just wanted to give what's the official sort of target coming from the FDA. And I hope now that we're past.
And I hope now that we're past the COVID-19.
Speaker 3: the COVID distraction that burdened the FDA for quite a lot of time in 2021-22 that, you know, the agency will return to its norms in terms of review cycles. So thanks for that question. Anything else on your mind? Yeah. Then a follow-up. Is it a binary process where you submit the application and then you just get a...
Distraction that burdened the FDA for quite a lot of time in 2020, one 'twenty two that the.
So the agency will return to its norms in terms of review cycle. So thanks for that question anything anything else on your mind. Yeah. Then a follow up is it a binary process, where it used to admit the application and then you just get a response after 150 days or is there a back and forth if they have follow up questions.
Speaker 3: response after 150 days, or is there a back and forth if they have follow-up questions, comments? No, no. Great question, and I may ask Mike to jump in here a little bit, but no, thankfully it's not a black box.
No no great question, and I may ask Mike to jump in here, a little bit, but no thankfully, it's not a black box.
Speaker 3: It is quite interactive and, you know, because it is a new technology and we're in this de novo category, there are a number of anticipated questions that we've been engaging on with the FDA and it's quite collaborative so far in tone and cadence. Mike, I don't know if you have other ways you might want to characterize our interaction with the FDA thus far.
It is quite interactive and you know because it is a new technology and we're in this de Novo category.
There are a number of anticipated questions that we've been engaging on with the F. D. A and it's quite collaborative so foreign tone and cadence Mike I don't know if you have other ways you might want to characterize our interaction with the FDA thus far.
Speaker 4: Yeah, we've had a number of interactions with them with some questions that came from the FDA, including two cycles of rapid turnaround responses within a matter of days. So, we're continuing.
We've had a number of interactions with them with some.
Questions that came from the F D a including two cycles of wrap it up.
Turnaround responses within a matter of days so.
We're continuing that process.
Speaker 3: Yeah, sorry, go ahead. So it's typically an iterative process until the end.
And so Ed.
So sorry go ahead, so as those typically are iterative process until until the end.
Speaker 3: Yeah, correct and I think along the way both parties kind of understand where they're going, address any issues, resolve any questions that may be open, but hopefully it's not a surprise at the end since you've been engaged along the path. So to be clear, it's not submit it and wait 150 days and get a yes, no.
Yeah, correct and I think along the way are both parties kind of understand where where theyre going address any issues are resolved any questions that may be open, but hopefully it's not a surprise at the end or since you've been engaged.
Along the path so to be clear, it's not submit it and wait 150 days and get a yes, no it's submit at engage.
Speaker 3: submit it, engage, address questions as we've been doing quickly and effectively, and collaborate with the agency to bring this.
Address questions as we've been doing quickly and effectively and collaborate with the agency to bring this to market.
Speaker 5: Yeah, that sounds good. And you know, congratulations. Good job. And my last question is just on, you know, as you guys get ready for hopefully a successful, you know, approval, what do you talk about? Can you talk a little bit about the, you know, commercialization plans that you guys are having set up in the US? Can you start now or do you have to wait until you actually get the final approval to really step on the gas?
Yeah that sounds good and congratulations good job and my last question is just on you know as you guys get ready for hopefully a successful.
Approval.
What do you talk about can you talk a little bit about the commercialization plans of yours that have you said anything up here in the U S. Can you start now.
I have to wait until you actually get the final approval there to really step on the gas.
Speaker 3: So, a couple of things. One, our focus right now is Europe because we obviously have regulatory approval there. We have a small, cost-effective sales team in France, UK, and Germany. And we're building our clinical study sites in those regions in each country, not only to build the base of clinical evidence.
So a couple of things one you know.
Our focus right now is Europe, because we obviously have regulatory approval. There we have a small cost effective sales team in France.
France, U K and Germany.
And we're building our clinical study sites in those regions in each country not only to build the base of clinical evidence as microphone, but also to become reference sites in each of those target markets. So our first focus and we think our first opportunity is clearly commercially in Europe, but those are very large markets.
Speaker 3: as Mike referred, but also to become reference sites in each of those target markets. So our first focus and we think our first opportunity is clearly commercially in Europe and those are very large markets. You know Germany, France and the UK are the largest healthcare markets.
Germany, France, and the U K are the largest health care markets are they have a mix of public and private.
Speaker 3: They have a mix of public and private structures, but there's plenty of opportunity for ENDRA there. And I would say, as we get closer to an FDA decision,
Structures, but theres plenty of opportunity for.
And are there and I would say as we get closer to an FDA decision.
Speaker 3: we would replicate some of that approach and certainly leverage anything we've learned in Europe in terms of clinical and economic value propositions that support the product. But also I think we'll be a little bit ahead because as Mike said, we have sites in the US that are currently scanning patients under what is called a IRB or Institutional Review Board Protocol which is a pre-FDA approval.
We would replicate some of that approach and certainly leverage anything we've learned in Europe in terms of clinical and economic value propositions that.
Support the product.
But also I think will be a little bit ahead, because as Mike said, we you now have.
Have sites in the U S that are currently scanning patients under what is called a I R. B or institutional review Board protocol, which is a pre FDA approval too.
Speaker 3: To use this study or use the taste technology on Subjects and patients and so we're going to be building our basic clinical evidence in the u.s. ahead
To use this study or use the tastes technology on subjects and patients and so we're gonna be building our base of clinical evidence in the U S ahead.
Ahead of getting the.
The FDA approval, which will help us once we get the FDA approval, then we'll carefully deploy.
Speaker 3: a targeted sales team, probably around the reference sites that I mentioned, the clinical sites where we can use and leverage those partnerships to be references for the next wave of adopters. But clearly the goal is to stay focused on Europe first, get the FDA approval, open up that market, leverage the clinical evidence that's being built around, and then.
A targeted sales team probably around the.
Reference sites that I mentioned, the clinical sites, where we can use and leverage those partnerships.
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The references for the next wave of adopters, but clearly the goal is to stay focused on Europe first get the FDA approval open up that market leverage that clinical evidence is being built around and then.
Speaker 5: pursue opportunities in Asia, but we have to be as focused and effective and cost-effective as possible as well. I hope that's helpful. Yes, that was very helpful. Thank you, and I wish you guys good luck.
Pursue opportunities in Asia, but we have to be as focused and effective and cost effective as possible as well hope that's helpful.
Yes, that's very helpful. Thank you and I wish you guys. Good luck. Thank you.
Thank you Ed very much.
Speaker 3: Yeah, I don't see any other questions. Thank you, operator, for facilitating that, and I very much want to thank our listeners, our investors today for joining our call. We look forward to keeping you informed of our accomplishments and to speaking with you again when we report our fourth quarter and full-year financial results, and I wish you all a good evening.
This conclude brighter.
Yeah, I don't see any other questions. Thank you operator for facilitating that in and I very much want to thank our listeners our investors today for joining our call. We look forward to keeping you informed of our accomplishments and speaking with you again, when we report our fourth quarter and full year financial results and I wish you all a good evening.
Speaker 2: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.