Q3 2023 Perimeter Medical Imaging AI Inc Earnings Call
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Speaker 1: Good afternoon, ladies and gentlemen, and welcome to the Perimeter Medical Q3 2023 conference call.
Good afternoon, ladies and gentlemen, and welcome to the perimeter Medical Q3 2023 conference call.
Speaker 1: At this time, all lines are in listen-only mode. Following the presentation...
At this time all lines are in listen only mode. Following the presentation.
Speaker 1: We'll conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, November 14, 2023. I would now like to turn the conference over to Jody Ray. Please go ahead.
We will conduct a question and answer session. If at any time during this call you require immediate assistance.
Please press star zero for the operator, this call's being recorded on Tuesday November 14th 2023, I would now like to turn the conference over to Jody rate. Please go ahead.
Speaker 2: Thank you. Good afternoon. Thank you for joining us on this call and webcast to provide the third quarter 2023 for perimeter medical imaging.
Thank you. Good afternoon. Thank you for joining us on this call and webcast to provide the third quarter 2023 results for permit perimeter medical imaging AI. Joining me on today's call is Adrian Mendes Perimeters, Chief Executive Officer, who will provide an overview of perimeter.
Speaker 2: Joining me on today's call is Adrian Mendez, Perimeter's Chief Executive Officer, who will provide
Speaker 2: progress across the business, along with Sarah Bryan, Chief Financial
Progress across the business.
Long with Sarah Bryan Chief Financial Officer, and Andrew Berkeley, Perimeters, Chief Innovation Officer, who are available to answer questions. When we open up the call for Q&A after our prepared remarks.
Speaker 2: and Andrew Berkeley, Perimeter's Chief Innovation.
Speaker 2: who are available to answer questions when we open up the call for Q&A.
Speaker 2: Please be advised that during this call we will make a number of statements that are found on the end of this video neither if orALo
Please be advised that during this call we will make a number of statements that are forward looking including statements regarding the future financial position business strategy and strategic goals commercial activities and timing competitive conditions research and development activities projected costs and capital expenditures research and clinical testing out.
Speaker 2: including statements regarding the future financial position, business strategy, and strategic…
Speaker 2: commercial activities and timing, competitive conditions, research and development activities, projected costs and capital expenditures.
Comes the potential benefits of our products, including perimeter F series OCG parameter B series O C T and perimeter image assessed the efficacy of our clinical trial designs, the timing and anticipated enrollment in our clinical trials and the timing of potential publication or presentation of future clinical data.
Speaker 2: The potential benefits of our products, including Perimeter S-Series OCT, Perimeter B-Series
Speaker 2: the efficacy of our clinical trial designs, the timing and anticipated enrollment in our clinical trials, and the timing of potential publication or presentation.
Speaker 2: forward-looking statements are subject to numerous risks and uncertainties.
Yeah.
Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in our SEDAR filings. Our results may differ materially from those projected on today's call. We undertake no obligation to publicly update any forward looking statement.
Speaker 2: including the risks and uncertainties described from time to time in our
Speaker 2: Our results may differ materially from those projected on today.
Speaker 2: We undertake no obligation to publicly update any forward.
Speaker 2: For additional information about the risks and uncertainties facing our business, management encourages you to review the company's public filings and press releases, which are posted.
For additional information about the risks and uncertainties facing our business management encourages you to review the company's public filings and press releases, which are posted on SEDAR plus start see a.
Speaker 2: The news release summarizing this quarterly update is available under the Investor section of our website at PerimeterMed.com and filed with CDAR Plus.
The news release summary, summarizing this quarterly update is available under the investors section of our website at perimeter med Dot com and filed with SEDAR class now I would like to turn the call over to Adrian.
Yeah.
Speaker 3: Thank you, Jody. Good afternoon. Thanks everyone for joining us.
Thank you Jody good afternoon, and thanks, everyone for joining our call today I will walk you through some of the highlights for the quarter and zero in on advancements made within both the clinical development and commercial sides of our business.
Speaker 3: Today I will walk you through some of the highlights from the quarter and zero in on advancements made within both the clinical development and commercial sides of our business.
Speaker 3: Before getting into these detailed updates, I wanted to provide some high-level observations on progress made across the business.
Before getting into these detailed updates I wanted to provide some high level observations on progress made across the business.
Speaker 3: Since joining the company this past summer, we have made some key changes at the leadership level, which are all driven by our goals to improve team morale, increase employee retention, and remove any silos preventing effective collaboration across the organization as a whole, all with the intent of greatly increasing our pace of execution.
Since joining the company. This past summer we have made some key changes at the leadership level, which are all driven by our goals to improve team morale increase employee retention and remove any silos, preventing effective collaboration across the organization as a whole.
All with the intent to briefly increasing our pace of execution.
During our last quarter, we welcome Sara O'brien, as our CFO and Andrew Berkley, One perimeters co founders to his new role as Chief Innovation Officer today, I would like to extend a warm welcome to Adam Hodges, who joined perimeter senior leadership team as our vice President of sales and marketing in early September.
Speaker 3: Adam's extensive MedTech background represents a great fit for us with his focus on advancing category first novel technologies that challenge the clinical standard of care and add value to the health care system.
Adams extensive med tech backhaul represents a great fit for us with its focus on advancing category one novel.
<unk> that challenge the clinical standard of care and add value to the health care system. In fact, I believe he has already made a positive impact both in his department and across the company and we expect that our sales and marketing team will continue to benefit from his leadership as we expand the number of surgeon champion and geographic regions adopting our <unk>.
Speaker 3: In fact, I believe he has already made a positive impact both in his department and across the company. And we expect that our sales and marketing team will continue to benefit from his leadership as we expand the number of surgeon champions and geographic regions adopting our commercially available S-series imaging platform and ultimately the adoption of our next-gen AI-enabled B-series technology when it reaches a commercial world at stake.
Firstly available F series imaging platform and ultimately if the adoption of our Nexgen AI enabled BCS technology when it reaches a commercial rollout stage.
Speaker 3: We have been very deliberate in how we've approached these org changes, as we are hyper aware of the importance of not just attracting, but also retaining top talent. I'm proud of the team we have in place, and as we grow, I believe we are creating a strong culture that will enable us to achieve our ambitious business goals.
We've been very deliberate in how we've approached these <unk> changes as we are hyper aware of the importance of not just attracting but also retaining top talent.
Out of the team we have in place and as we grow I believe we are creating a strong culture that will enable us to achieve our ambitious business goals.
Speaker 3: Let's dig in now on the clinical development side of the business and the progress made again across our next gen AI development and the ongoing pivotal.
Let's take it now on the clinical development side of the business and the progress made again across our Nexgen AI development and the ongoing pivotal trial.
Speaker 3: This quarter, we reported the outcomes of our positive interactions with the FDA that resulted in us reaching alignment on key elements of our clinical trial, which is evaluating perimeters B series device when used during breast conserving surgeries, otherwise known as lumpectomy.
This quarter, we reported the outcomes of our positive interactions with the FDA that resulted in us reaching a live is a key element of our clinical trial, which is evaluating perimeters be serious device when used during breast conserving surgery, otherwise known as lumpectomies.
To be serious device combines perimeters innovative OTT platform with our image assist AI technology, which will further accelerate customer adoption a perimeter solution.
Speaker 3: This quarter marked an important milestone in our clinical development program.
This quarter marked an important milestone in our clinical development program.
Speaker 3: First, we received regulatory approval to implement our substantially enhanced AI algorithm in the ongoing pivotal clinical trial under the existing study protocol. As a result, all clinical trial sites are now using the updated AI as patients continue to enroll in the ongoing study.
First we received regulatory approval to implement are substantially enhanced AI algorithm in the ongoing pivotal clinical trial under the existing study protocol.
All clinical trial sites are now using the updated AI as patients continue to enroll in the ongoing study Andrew.
Speaker 3: Andrew spoke on our last call about some of the anticipated significant benefits of the new enhanced AI, which takes advantage of additional training data and perimeter's latest AI advancements that demonstrate improved sensitivity, specificity, precision, and recall.
Andrew spoke on our last call about some of the anticipated significant benefits of the new enhanced AI, which takes advantage of additional trading data and perimeters latest AI advancements that demonstrate improved sensitivity specificity precision and recall.
Speaker 3: It is expected that this updated version of ImageSynth AI will contribute to more accurate classification as well as fewer false positives and false negatives.
It is expected that this updated first off image that AI will contribute to more accurate classification as well as fewer false positives and false negatives.
Speaker 3: Second, we now have a planned interim analysis in the trial, which will provide us with an early readout of results based on the use of the newest algorithm. If key endpoints are met at the time of the interim analysis, we may opt to conclude the trial and begin preparing regulatory submissions supporting market clearance. Alternatively, the interim analysis could support continuing the trial to build a stronger submission package for additional subjects.
Second we now have a planned interim analysis in the trial, which will provide us with early readout of results based on the use of the newest algorithm. If key endpoints are met at the time of the interim analysis, we may opt to conclude the trial and begin preparing regulatory submissions supporting market clears.
Alternatively, the interim analysis could support continuing the trial to build stronger submission package for additional subjects. Ultimately our goal is to expedite the development of our Nexgen AI technology and deliver it to our surgeon customers still good clinical and economic outcomes and breath surgical oncology.
Speaker 3: Ultimately, our goal is to expedite the development of our next-gen AI technology and deliver it to our surging customers to improve clinical and economic outcomes in breast surgical oncology.
Speaker 3: Third, we are permitted to enroll additional subjects up to 531 and have received clearance to increase number of trial sites with the goal of further supporting and expediting patient enrollment. I'm pleased to report that we recently added a clinical trial site at the University of Washington Fred Hutch Cancer Center located in Seattle as a quick follow-on to the recent site initiations at Baptist MD Anderson and Mayo Clinic in Jacksonville, Florida.
Third we are permitted to enroll additional subjects up to 531 and have received clearance to increase number of trial sites with the goal of further supporting and expediting patient involvement I'm pleased to report that we recently added clinical trial site at the University of Washington, Fred Hutch Cancer Center located in Seattle.
As a quick follow on to the recent site initiation at Baptist MD, Anderson and Mayo clinic in Jacksonville, Florida.
Speaker 4: Importantly, patient enrollment is tracking well and is likely better than modeled. And we continue to guide that we expect an interim analysis in the second quarter of 2024. If we determine that more data is needed, anticipate study completion by the end of 2024.
Importantly, patient enrollment is tracking well and slightly better than modeled and we continue to guide that we expect an interim analysis in the second quarter of 2024, if we determined that more data is needed anticipates that anticipate sub study completion by the end of 2024.
Speaker 3: We continue to hear from KOLs that the potential of combining AI with ultra-high-resolution interoperative imaging has the potential to become a new standard of care during breast conservation surgery. Our clinical development team is extremely driven to conduct a well-run study that provides us with important data, allowing us to chart a clear path forward to our next-gen technology. We look forward to keeping you updated on our progress.
We continue to hear from Kols about the potential of combining AI with ultra high resolution Inter operative imaging has the potential to become a new standard of care can breast conservation surgery. Our clinical development team is extremely privileged to conduct a well run study that provides us with important data, allowing us to choose.
A clear path forward to our next Gen technology, we look forward to keeping you updated on our progress.
Speaker 3: Turning now to our 510 Clear Perimeter S-Series technology. Briefly, for those newer to the perimeter story, this is our flagship interoperative OCT imaging technology, which provides surgeons with resolutions capable of visualizing tissue structures at the cellular level down to the critical two millimeter depth with 10X higher image resolution than X-ray and ultrasound and 100X greater image resolution than MRI.
Turning now to our 510 cleared perimeter F series technology briefly for those newer to the perimeter story. This is our flagship intra operative OTT imaging technology, which provides surgeons with resolutions capable official likely tissue structure at the cellular level down to the critical two melamine.
Her depth with Tenex higher image resolution that extra and ultrasound and a 100 X greater image resolution that MRI.
Speaker 3: Cancer surgeons have long recognized the challenge of achieving clean margins while preserving healthy tissue during surgery. And since it's several days or weeks before pathology reports on margin status are available, if they show positive margins, patients must typically return to the operating room for another procedure due to cancer left behind.
Cancer Surgeons couple all recognize the challenge of achieving clean margins, while preserving healthy tissue during surgery and since it's several days or weeks before pathology reports on margin status are available if they show positive margins patients must typically return to the operator for another procedure due to cancer left behind.
Speaker 3: We conducted a thorough review of the business when I came on board as CEO , and I firmly believe that there continues to be a compelling product market fit for Primrose commercially available S-series OCT.
We conducted a thorough review of the business when I came on board as CEO and I firmly believe that there continues to be a compelling product market fit for premise commercially available F series OTT.
Speaker 3: Our focus today is to build a network of early adopters capable and driven to use our groundbreaking technology.
Our focus today is to build a network early adopters capable and driven to use our ground breaking technology.
Speaker 3: While this does begin to establish an early stage revenue pipeline, perhaps more importantly, it allows us to have a clear channel to customers to gather product feedback.
While this does begin to establish an early stage revenue pipeline, perhaps more importantly, it allows us to have a clear channel to customers to gain product together product feedback.
We are applying an agile approach to our commercial business to learn in the field with the goal of constantly iterating and improving upon the current state.
Same early champions and reference sites will take on an EBIT more portable when we launch our nexgen AI enabled tech to reach our goal of significantly broadening our user base in the U S.
Speaker 3: Our team continues to make good progress reaching these targeted customers. We have a clear game plan to further expand our install base by connecting with high potential surgeons, leveraging existing institutional relationships within healthcare networks, and identifying the optimal geographic locations. In particular, those which offer the lowest barriers and costs providing image training.
Our team continues to make good progress for each of these targeted customers. We have a clear game plan to further expand our install base by connecting with high potential surgeons leveraging existing institutional relationships within health care networks and identify the optimal geographic locations in particular, those which offer the lowest barriers that costs, providing image training support.
Speaker 4: A few additional comments on our most common pricing model. Healthcare facilities typically receive a free placement of the perimeter S-series device.
A few additional comments on our most common pricing model health care facilities typically receive a free placement of the perimeter F series device.
Speaker 4: and then paid per procedure with the purchase of our proprietary specimen immobilizer consumables, which we sometimes refer to as the razor blade model.
And then paid per procedure with the purchase of our proprietary specimen and Mobilizer consumables, which we sometimes refer to at the razor Razorblade model.
Speaker 4: Importantly, assuming we establish clinical validation regulatory approval for AI technology, the console can be easily updated with the new AI feature. Looking ahead, we believe we can leverage this combination of imaging and AI across multiple indications as we grow this.
Importantly, assuming we established clinical validation regulatory approval for a technology the console can be easily updated with the new AI feature.
Looking ahead, we believe we could lever just combination of imaging AI across multiple indications as we grow our business.
Speaker 4: Our go-to-market strategy is further supported by a strong IP position. We hold six issued patents and a proprietary image database of over 2 million images related to breast cancer alone.
Our go to market strategy is further supported by a strong IP position, we hold six issued patents and if a party image database of over 2 million images related to breast cancer alone.
Speaker 4: We also recognize that there are further opportunities outside of Fresno.
We also recognize that there are further opportunities outside of breast cancer. Looking ahead, we continue to identify viable growth opportunities through the expansion of indications and tissue types as well as exploring new point. They can't just surgery workflow for example, using perimeter technology to assist the pathologists as well as the surgeon.
Speaker 4: Looking ahead, we continue to identify viable growth opportunities through the expansion of indications and tissue types, as well as exploring new points in the cancer surgery workflow. For example, using perimeter technology to assist the pathologist as well as the third
Speaker 4: I also wanted to highlight that Perimeter is shortlisted in a grant funding process sponsored by the Advanced Research Projects Agency for Health, otherwise known as ARPA-H.
I also wanted to highlight the perimeter has shortlisted in a grant funding process sponsored by the advanced research projects agency for health, otherwise known as <unk> each.
Speaker 4: under its Precision Surgical Interventions or PSI program.
Under its precision surgical interventions or Tsi program.
Speaker 4: We attended a proposal stay in early September and subsequently submitted an abstract, which has been selected to advance to the next stage of the grant funding process. We remain on track to submit a full proposal by the deadline.
We attended a proposer stay in early September and subsequently submitted an abstract which has been selected to advance to the next stage. The grant funding process. We remain on track to submit a full proposal by the deadline distance there.
Speaker 4: Clearly, we are excited to participate in this important Biden Cancer Moonshot Initiative and thrilled that the Federal Advanced Research Project Agency for Health has selected Dallas as one of the two regional hubs in its $2.5 billion health innovation network.
Clearly we are excited to participate in this important by didn't cancer Moonshot initiative and thrilled that the federal advanced research projects Agency for Health has selected Dallas as one of the two regional hubs and it's $2 5 billion dollar health innovation network.
Speaker 4: In addition to being a potential source of non-dilutive funding for the company, the goals of the PSI program align precisely with the mission of Perimeter and further validates the significant healthcare problem that our team is committed to solving, ensuring that no patient needs to return for repeat surgery due to cancer left behind.
In addition to being a potential source of non dilutive funding for the company.
Goals of the PSA program aligned precisely with the Michigan perimeter and further validates the significant health care problem that our team is committed to solving ensuring that no patient needs to return for repeat surgery due to cancer behind.
Speaker 4: OK, turning briefly to our financial position, as of September 30th, 2023, cash and cash equivalents were approximately 18.1 million US dollars. For more details, please refer to the quarterly report and press release filed today.
Okay, turning briefly to our financial position as of September 32023, cash and cash equivalents were approximately $18 1 million U S dollars for more details. Please refer to the quarterly report and press release filed today.
Speaker 4: With this strong cash position, our prudent fiscal management, and additional CPRIT grant money still available to us, we're confident we'll be able to support our planned clinical development activities and fund the continued commercial roll out of our product.
With this strong cash position, our prudent fiscal management and additional separate grant money is still available to us. We're confident we'll be able to support our planned clinical development activities and fund the continued commercial rollout of our product.
Speaker 4: In summary, on behalf of the whole Perimeter team, we are very excited about the future ahead. We believe no other technology comes close to what we have, and Perimeter's technology is perfectly positioned to address a widely accepted $750 million problem in breast oncology in the U.S. alone, and many multiples of that across other indications and other geographies.
In summary on behalf of the whole perimeter team. We are very excited about the future ahead. We believe no. Other technology comes close to what we have and perimeters technology is perfectly positioned to address a widely accepted $750 million problem in breast oncology in the U S alone and many multiples of that across other indications.
Patients and other geographies not to mention the significant emotional challenges with today's standard of care.
Speaker 4: not to mention the significant emotional challenges with today's standard of care. We continue to add and redeploy resources to support the key areas of our business and remain focused on our goals that include expanding our base of key opinion leaders who will champion the use of Perimeter S series, supporting ongoing enrollment in our pivotal trial using the improved AI algorithm.
We continue to add and redeploy resources to support the key areas of our business and remain focused on our goals that include expanding our base of key opinion leaders, who will champion to use a perimeter S series supporting ongoing enrollment in our pivotal trial using the improved AI algorithm exploring additional tissue indications another war.
Speaker 3: Exploring additional tissue indications and other workflow expansion opportunities. And continuing to grow a high-performance team that is driven to transform cancer surgery.
Expansion opportunities.
And continuing to grow a high performance team that is driven to transform cancer surgery.
Speaker 4: And with that, I will now open up the call for questions. Operator?
And with that I will now open up the call for questions operator.
Speaker 1: Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you wish to ask a question, please press star followed by one. If you'd like to withdraw your question, press star followed by two.
Thank you ladies and gentlemen, we will now begin the question and answer session should you wish to ask a question. Please press star followed by one if you'd like to withdraw your question Press Star followed by two.
Speaker 1: And if you're using a handset, please.
And if you're using.
Handset please.
Speaker 5: lift the keys before asking any questions your first question comes from Raul Seguers, from Raven James, please go ahead. Good evening Adrian, thanks so much for taking our questions and I apologize for a little bit of the background noise.
Lift the keys before asking any questions. Your first question comes from Raul <unk> Seguros SURA, sorry from Raymond James. Please go ahead.
Sure.
Good evening Adrian Thanks, so much for taking my questions and I apologize to all of it in the background noise.
Speaker 5: And I also apologize that I got dumped off the call for a little bit when you were talking about the the the AI trial and potentially be able to accelerate The 510k application, so it would be great to hear a little bit more about what you're seeing in terms of timeline numbers of patients any additional parameters and or thresholds that we should be looking for as we Try to get more resolution on
And I also apologize I got dropped off the call for a little bit when you were talking about.
The AI trial and potentially be able to accelerate.
The five 10-K application so it would be great to hear a little bit more about what you're seeing in terms of timeline numbers of patients any additional parameters and or thresholds that we should be looking for as we.
Try to get more resolution on that.
Speaker 4: Sure, yeah, thanks for the question, Raul. So.
Sure Yeah. Thanks for the question Praful so.
We are.
Speaker 4: So right now we've got, so if we run the trial all the way to the end, we should be complete in the fourth quarter of 2024. As mentioned, we have the opportunity to have an interim analysis and that
So right now we've got it so if if we run the trial all the way to the end.
We should be complete in the fourth quarter of 2024.
As mentioned, we have the opportunity to have a.
An interim analysis.
And that.
Speaker 3: you know, at the current rates we're at right now, projections will be in Q2. Right now, as of the end of November , sorry, end of October , we're tracking a little bit ahead of our projections, maybe about 15% ahead in our patient enrollment rates.
At the current rates, we're at right now the projections will be in Q2 right now as of the end of November sorry end of October we're tracking a little bit of ahead of our projections, maybe about 15% of Ed in our patient enrollment rates.
Speaker 4: So we're actually quite confident we'll be able to hit those deadlines. We brought on, as mentioned, maybe you didn't hear it in the call when you were kicked off, but we brought on Mayo and MD Anderson in Florida, as well as the University of Washington earlier this quarter. So that'll really pick up the rate of enrollments. So we're feeling pretty comfortable right now that we'll be able to hit the dates that we, you know, that we described.
Great.
So we're actually quite confident we'll hit those deadlines.
We brought on as mentioned maybe you you didn't hear it in the call that you were kicked off but we.
We brought on mail.
And MD Anderson in Florida, as well as the University of Washington earlier, this quarter, so that will really pick up the the rate of enrollment. So we're feeling pretty comfortable right now that would be able to hit the dates that we are that we described.
Speaker 6: Great. Thank you very much for that. And so, in terms of that interim analysis, can you give a sense of sort of the, you know, number or, you know, the number in the data set and any thresholds that we should be looking for in order to, you know, de-risk the likelihood of an improvement?
Great. Thank you very much for that and so in terms of Ah that interim analysis could you give a sense of sort of the number the number in the dataset.
And any thresholds that we should be looking for in order to derisk the likelihood of approval.
Yes, so the.
Speaker 4: The primary outcome that would allow us to have a successful interim analysis would be for us to have what they call conversions. So six conversions out of the hundred and...
The primary outcome that would allow us to have that a successful interim.
Interim analysis would be for us to have.
What they call conversion so six conversions.
Out of the.
186.
Speaker 3: enrollments that we would have at that point in time.
Enrollments that we would have at that point in time.
Speaker 4: So, basically, you know, six patients that, if it were not for the use of OCT in their procedure, would have had to come back for a second surgery because the margins would not be where they need to be. But for having used OCT, the surgeon found the...
So basically you know six six patients that if it were not for the use of OTT in their procedure would have had to come back for a second surgery, because the margins would not be where they need to be but for having used OTT. The search and found the you know.
Speaker 3: you know, the inadequate margins, and was able to correct that within the first surgery. So that's really the target that we're looking for at the interim analysis point. Unfortunately, we're blinded to the data right now, so it's hard for us to, in fact, we just don't really know how we're progressing against that. However, when we look at...
The inadequate margins and was able to correct that within the first surgery. So that's really the target that we're looking for at the interim analysis place. Unfortunately.
Aligned it to the data right now so it's hard for us to in fact, we just don't really know how we're progressing against that.
However.
When we look at from anecdotal information from our commercial side of the house, which doesn't of course use the AI enabled products, but.
Speaker 4: from anecdotal information from our commercial side of the house, which doesn't, of course, use the AI-enabled product, but does use OCT, you know, in all the sites we have out there. We're seeing very, very good outcomes there from those surgeons. So we've got a high degree of confidence we'll be able to hit.
But does your OTT.
In all of the sites we have out there we are seeing very very good outcome.
Outcomes there from those surgeons. So we've got a high degree of confidence we'll be able to hit.
This trial.
Hopefully by the time, we get to the interim analysis, but certainly by the time, we won the entire trial.
Speaker 5: Great, thank you. And then just one last question then. You know, driving FDA clearance is one thing, and then having strong enough data to change hearts and minds of doctors is another. And so while, you know, you've expressed confidence and be able to, you know, engender an FDA clearance, how do you see that data playing in terms of as a marketing tool to be able to drive adoption? And that'll be
Great. Thank you and then just just one last question then.
Driving FDA clearance is one thing and then having strong enough data to change Hearts and minds of doctors isn't is another and so while you've expressed confidence and be able to.
Engender a N F D. A clearance how do you see that data playing in.
In terms of as a marketing tool to be able to drive adoption and that'll be it for anything.
Speaker 3: Yeah, so I think that's where the decision of whether we actually do, even if we achieve that outcome at the early analysis point, whether we choose to continue to run the trial to the end, just to gather more data. So that'll be one one aspect of.
Yeah. So I think that's where the decision of whether we actually do even if we achieve that outcome at the.
Early analysis points.
Whether we choose to continue to run the trial to the end.
Just to gather more data.
So that'll be one that one aspect of that.
Speaker 4: The other side of it in terms of the marketing side of even beyond the AI piece is really the outcomes we're seeing from the S series in the commercial world right now, which as I said, anecdotally is very positive. And there's data that we're looking to pull together to be able to publish over the coming few months. Great, thanks so much for
The other side of it in terms of the marketing side of even beyond the AI piece is really the the outcomes. We're seeing from the S series in the commercial World right now, which as I said anecdotally is very positive.
And and and there's data that we're looking to pull together to be able to publish.
Over the coming few months.
Great. Thanks, so much for taking my questions I wish you the best of luck I'll get back in the queue.
Thanks Carol.
Speaker 1: Ladies and gentlemen, if you wish to ask a question, please press star followed by one.
Ladies and gentlemen, if you wish to ask a question. Please press star followed by one.
Speaker 1: Okay, there are no further questions at this time. I'll turn it back to Jody for closing remarks.
Okay. There are no further questions at this time I'll turn it back to Jody for closing remarks.
Thanks, Colin Thanks, everyone for joining us today. This concludes our Q3 call. Thank you.
Speaker 1: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.
Ladies and gentlemen, this concludes your conference call for today, we thank you for participating and ask that you. Please disconnect your lines.