And the company's near-term outlook. After the presentation, we'll commence a Q&A session, which will include written submissions from the audience. I want to take this moment just to thank you for all submitting the questions through. We've been inundated with the questions, so we'll try to get through as many questions as time permits.
I would like to acknowledge the significant turnout today. For those who are unable to attend, a copy of the webinar will be available on Echo IQ's website and social media platforms later today. For now, I'd like to pass it over to Dustin to commence the briefing. Dustin, over to you.
Great. Thank you, Alex, and welcome everybody to the call. Understand there'll probably be some folks still dialing in as we progress here, so apologize for those that missed the first part here. Sorry.
Look, we're going to kick off today. I think everybody is aware of what we have to discuss, and obviously this is a frustrating call that we obviously are going to have to deal with. We're going to talk to you guys a little bit about what happened in the process, talk to you a little bit about where we are currently today. I think we're having some technical difficulties still.
Yeah, some stuff. Sorry about that.
Give us one second to get the slides up and going here.
I don't know why it's not
Just do a stop share and then do it.
Yeah, I think we're going to have to do a stop share.
All right. Give us one second, everybody, and we will get the slides back up and going. Click on that.
Yeah, first the share. Oh. See if we can do that.
Okay. Nick, do you see the slides?
I see the first slide, yes.
Just the first slide. Yeah. I'm having trouble putting the second slide up. Sorry about this. Let's see. Make sure I share one more time, full screen. Close it. See, the document is the problem.
Okay.
Do I have a-
All right. I think we're going to go ahead and get started as Matt's pulling this up. I do apologize to the teams here for this, but you guys care more about what we say than what we're showing at the moment anyway. Look, I appreciate everybody being on the call.
Obviously, this is the news that I don't like to deliver and I know many of you are probably just as frustrated as we are here at Echo IQ. We're going to go ahead and talk a little bit about what happened from the regulatory perspective. Matt's going to jump in after that, talk a little bit about the business, where we're at. I think it's important to have some highlights about where we're at currently in the business.
I think it was great to have Nick come on and talk a little bit about where we're at from a commercial perspective. Then we'll wrap up with next steps in Q&A. I'm going to preface this call by letting a number of you know that while we'll do our best to answer every question we can on this call, I will be very clear here in the fact that I won't have an answer to every single question.
I'm hoping many of you will appreciate receiving this notice from the FDA at 5:00 on a Friday afternoon, which was right before a three-day federal holiday weekend in the U.S. So by the time we actually had a chance to get our first conversation started with the FDA, it was this morning, which was really only about four or five hours ago.
I will apologize in advance if I don't answer every single question yet. But I can guarantee you, and you should be rest assured, that as a management team, we are going to have significant progress over the next several weeks as some of the questions that you have may not get answered today. Okay. We're going to start first off with the regulatory update. We're not able to get slides to-
I guess this is what they see.
Do they see that? Okay. The first piece here obviously is some disclaimers. Everybody understands the legalese that comes to this. If we go to the next slide. What happened? We put the press release out yesterday afternoon at the end of close. I am going to pretty much stick to the press release for the most part.
I will give you some color around each of the bullet points and why this is significant and what we are doing as an organization to address it. Obviously, the first thing you guys have seen is that we did not receive our clearance for the 510(k) application for the EchoSolv Heart Failure Solution. This was a not substantially equivalent letter from the FDA. I will talk to you a little bit about what that actually means and what it is here in a minute.
Obviously for us as a company, we are assessing every single possible opportunity that is in front of us. There are, for those of you that know this space well. For those of you that don't, there are a number of options we have in front of us that we will be looking to explore. Those options, we will walk through a few of those. Each one of them comes with their own pros and cons for doing the options.
Each one comes with their own set of unique timelines. The first question I will get from most people is, okay, so you are telling me that we can solve this. How long is it going to take? I will tell you that will be mostly the frustration for most people, as it is for me, is I do not have a definitive answer today.
We have some general ideas of what we can do to rectify this very quickly. Of course, you saw in that one of the things that is important about us, we are a different company than we were, let us say, six months, even 12 months ago. Obviously, as well-funded cash in the bank, this gives us a chance to opportunity to deal with some of these setbacks.
You are going to hear me use that word very clearly, setback. I think that is what this is a setback. It is not a catastrophic event for the organization. Because we do have a strong balance sheet, because we do have multiple products we are looking at in R&D pipeline, because we do already have one FDA-cleared product and we are commercializing. This is a frustrating moment for the company.
It is a setback, it is a delay, but it is not a catastrophic event. I want to highlight that very clearly. We are very confident in our abilities to not only turn this one around, but to continue to drive the business to effectively deliver shareholder value. The last piece here is just simply, we are going to talk a little bit about what we are working on.
I know that doesn't soften the blow, but it does talk a little bit about the opportunities that this organization has. I think this is the same opportunities that the organization had when did the capital raise. We are still the same company. We still have the same opportunities in front of us, albeit now a bit of a delay. We will discuss that. We can go next slide. Oh, there we go.
Next minute.
Next minute. Beautiful. Okay, so let's talk about the FDA determination, not substantially equivalent determination from FDA. I think this is an important one to really focus in on. I will move it forward. That's fine. What's important to focus in on here, this is a 510(k). I think we even saw some earlier news that came out before we even got our press release out, kind of defining it and comparing it to other companies.
I want to be really clear here, right? We are not a biologic. We are not a pharmaceutical. This is not a denial from the FDA where we go back and have to do a Phase III study. We have to do a patient enrollment, and this takes years. This is not that type of process. This is a 510(k). We are a Software as a Medical Device.
There are some unique benefits of these types of approaches here, which will allow us to be very expedient in the way that we resolve this with the FDA, and then we focus on the things that we want to get accomplished in a very short period of time with the FDA.
I think that's an important one, because I think for many people, there was an early comparison looking at something like a pharmaceutical company, who in these moments would be a devastating blow when they would have to go back and think about years of work to get back to that same place.
For us, many of you guys have heard me speak before. With our model, we are able to run r etrospective analyses. We are able to do those very quickly. In many cases, a validation set can get done very rapidly.
In many cases, a reanalysis can get done in a matter of days, if not weeks. This is a really important distinction for us, which is why I say this is a setback and not a catastrophic event for the organization. I will tell you, a not substantially equivalent letter from the FDA is not necessarily a no.
It oftentimes is a not right now. We have more discussions to happen with the FDA. Let us just keep that as a placeholder as we go through the rest of the information here. What is our view here as a company? Look, obviously, I have my own personal view, and it is not differing from the company's, in the fact that we are incredibly disappointed.
More importantly, I think there is a disagreement we have with a number of the factors that are within the determination from the FDA, and that is fair. This is why the lines of communication remain open with the FDA for us to continue to have the conversations. We intend to continue to clarify the matters with the FDA.
In this letter, obviously, there are a number of options that come to us during that clarification period that we can have, including an open line of communication with the FDA to continue to have the conversations about the filing and some of the deficiencies that we are having some disagreements about. We believe there is a very clear path forward for clearance under a 510(k) route, and we intend to engage with the FDA to find those paths forward.
Guys, I know people are going to ask on this call, what are all the pathways? What is the timing on that? How long can you get this across? What I can tell you is that we will be back in the market at some point in the future with a very clear understanding of what we are going to be doing.
What I am telling you today is that there are multiple pathways, and I cannot tell you today if I am going to do one, two, three or all four of the different pathways in front of us. We made all of them in order for us to be able to get this clearance across the line.
We will be using all of those that are at our discretion at the moment, including using outside counsel, which we have retained as one of the best in the U.S. that focuses on dealing with matters with the FDA. We are going to ensure that we have every single possible solution in place to be able to help resolve this challenge.
If we go forward one. What is it that we know here? Key points on this is this is not a safety concern. In fact, this probably really is not even a data concern. There are just some questions about how we want to go about a ground truth with the FDA, and I think this is fair and reasonable.
As we start to continue to have our dialogue with the FDA, while I was surprised that we did not get the clearance, I think the letter gives us some clarity on what we will do now as we start to have our conversations with the FDA. We remain confident in the underpinnings and the rationale for the clinical development program with the heart failure.
Many of you saw the top-line data. Many of you seen the impact this can have. I remain committed that at the end of the day, this is a tool that is going to have significant impact on patient outcomes in the future, and we want to make sure that this is in the hands of the clinicians to utilize that. I do not necessarily think the FDA disagrees with that.
I think we are now fundamentally at the final discussions around a couple of the points, and I think we will significantly be able to move the needle with the FDA over time. Right. What we are going to do now, guys, is we are going to jump over to Matt and have a chance to talk about the business. I know that was not everything you wanted to hear in this call.
We will focus a little bit in the Q&A around what are the options in front of us. Obviously for many of you, if you typed it into ChatGPT or any other AI model, you probably got all the different things you can do with the FDA. We will discuss those. We will talk a little bit about timelines, but I cannot give you any definitives because we just do not know as a company yet.
We will be committed to being transparent when we have a really good understanding. What I can tell you from an executive management team is the confidence at this point to put a solution in place is very high. We are committed now to be able to solve this and rectify it. I know for many people, they have asked questions around, are there other predicate devices out there that are not predicates, but other companies that have gone through this?
Unfortunately, this is the reality for companies in this space. When you are in a medical device field, these NSE letters are probably very common, and something that does happen. Many companies have the ability to rectify these challenges, either through a resubmission or an appeal with the FDA. We believe that is something that we will be able to be successful at doing.
I am going to kick it over to Matt now to talk a little bit about where we are in the business. I will come back to you guys around what we have for some future next steps, and then we will get into Q&A.
Right. Thanks, Dustin. I will cover where the business stands financially and what does and does not change as a result of the NSE determination. Let us start with the balance sheet. Cash at bank was over AUD 105 million at the end of July. That follows our institutional placement completed in early July, which delivered to us net proceeds of AUD 104 million.
The NSE determination does not change the cash position. It does sharpen our responsibility to spend it carefully, and that is the lens for everything on this slide. Second, the burn rate. As the chart shows, through fiscal 2026, operating cash outflow ran between AUD 2.5 million and AUD 2.7 million a quarter, and AUD 10.6 million for the year in fiscal 2026. That is the base we are going to be scaling from. The placement was raised to invest in the U.S. commercial build-out and R&D clinical work for expanded indications.
The spending will step up, but it primarily steps up with commercial milestone achievements. Third, let us walk through what continues and what is deferred. What continues is everything on the right-hand side of the slide. That includes investments in commercializing the EchoSolv AS in the U.S., and Nick is going to walk you through the commercial engine in a moment.
It also includes investment in the R&D pipeline, which will include additional disease states for the EchoSolv platform and new clinical modalities. What is deferred is the launch-specific spend for EchoSolv HF in the U.S. until the regulatory pathway is settled, as Dustin just let you know. This is a rationale for rephasing, not a change of strategy.
The regulatory program for heart failure itself, which includes our regulatory council, our study partners, our independent statisticians, that is fully funded and is a modest relative spend to the overall balance sheet. At planned investment levels, this view represents a multiyear runway for the company.
Quickly on Pro Medicus, the convertible note arrangement remains in place, and we have not yet drawn down on the initial AUD 10 million investment note to date. The takeaway on the bottom of the slide is the balance sheet funds for the EchoSolv HF regulatory program, the additional EchoSolv indications, U.S. commercial plan are more than ample to cover us for quite a while. With that, I will turn it over to Nick.
I appreciate the both of you, Matt and Dustin, turning this over to me. I think one of the things that we do want to reiterate is EchoSolv AS is unaffected by the heart failure determination. The last thing I want to say is it is business as usual, but it is fully execution as usual. I think one of the things that a quote comes to mind, "Smooth seas never made a skilled sailor."
I will let you know that the team that we do have in place is capable of executing and continuing to execute in an environment like this. When you work in the regulatory space from a sales perspective, from a commercial perspective, and everybody is bringing 10 to 15 years of experience to that, these are the kind of things that you need to execute through. That is what we are continuing to do.
If we look at it from a commercial perspective, AS is continuing to be that engine that is going to flywheel the future of our portfolio. We look at it from a clear perspective, what we are doing to expand that, and then how that compounds. That does not change. It does not change what we plug into EchoSolv AS.
We are FDA-cleared. We are operating as an FDA-cleared product. We are live in important health systems in the U.S. Our late-stage contracts are moving to revenue. This is no longer a pilot growth curve.
What we are demonstrating and what we have demonstrated on previous calls is the ability to show quarter-on-quarter growth from an echo volume perspective. That is going to continue. The commercial utilization is strong, and we do not anticipate that changing, even in the event of what has recently happened.
From a team standpoint, we have full U.S. coverage, which is a slight change from the last call. Area Sales Directors representing the entire United States. That means that our pipeline is continuously growing. It is continuously getting stronger. We have a BDR organization that has contracted with us, 150 specific targets to contract at the cardiovascular service line and above.
Those introductions to the commercial team that we have are turning into legitimate larger enterprise opportunities. I think last time we spoke, there were three enterprise opportunities that we are still engaged in and progressing, and we have added two to that.
The reimbursement pathway is advancing. Dustin has mentioned this on previous calls, but if it is HHS, if it is CMMI, or it is CMS in general, we are advancing on those strategies and executing as we would have been regardless of the recent news with heart failure.
What does all this do? As we land that commercial base, and as we expand it cart by cart, PACS by PACS, health system by health system, that means that no new product we bring to the market is going to start from zero. It is going to inherit a commercial engine. That is what we are in the process of building.
While the news is not what we would have liked, the execution of this team is not changing. What does that commercial engine look like when we have additional opportunities? Same echocardiography workflow, same integration, amended contracts, the same sales process delivered by an experienced group of professionals that are used to working in and competing in a regulated environment.
The last thing I will say is that, and we cannot let this go in light of the recent news, is that this commercial engine is built upon what we are doing with EchoSolv AS, and I do not anticipate that to change. We are bringing new physicians and new opportunities to the table every day.
My confidence from that aspect and the confidence in my team, the confidence in business development that we have brought on and has hit the ground running to bring additional opportunities via partnership, expand our deployment opportunities, all add to this flywheel foundation that we are building right now to create all future opportunities into 2027.
Fully remain confident the commercial engine is live and well, and the team that we have in place is mature enough to execute through, as I will say, the choppy waters at times. Not putting down the sails, just adjusting them and moving forward. With that, I will turn it back over to Dustin on our path forward.
Great. Thank you, Nick . This will be our last slide, and we'll get into Q&A, and I'm sure there are plenty of questions in the queue, so we'll get Henry and Alex ready for those. Look, I think what we're trying to paint here in a picture on is that, yes, while we are incredibly frustrated, and there are not enough curse words in the English language to cover what I had said on Friday night when we received this.
We've also now turned very quickly to what can we control, and how can we get this righted to where we want to go. I think you guys are seeing that from a business perspective. We are still healthy, even though frustrated.
We are now progressing very nicely with Nick and the team, and I can't be more proud of what the team is developing, even though it takes some time for that. That foundation is being built, and we'll continue to grow that. Then I think as you look at a slide like this, you start to realize, why did Echo IQ actually raise the money we raised? Nothing has changed from that thesis, and it still sits here.
Obviously, for us, the first thing is management team is buckling in very determinately now to get the EchoSolv heart failure solution back on track and into a clearance. We will be working on that day and night, and I can tell you sleepless nights have been had all over the weekend. We'll continue to drive commercial success.
That is never a doubt in my mind, that this team is the team that we built to do that, and we will continue to deliver. One of the things that we didn't talk about, but we will have more conversations, the reimbursement opportunities are continuing to develop and building very nicely in front of us.
As Nick and I have been in Washington, D.C., a number of times over the last several months, working with CMS and many of the payers as well as HHS, we know that there is a very clear pathway that's going to continue to build momentum for EchoSolv platform as we go forward. Our R&D pipeline has not slowed down.
In fact, if anything else, we've actually become more excited about what we have there with the acquisition of the newest dataset with Advara, which is going to allow us to escalate things like mitral valve, tricuspid valve regurgitation as part of that R&D pipeline. Continue to watch this space deliver.
Clinical evidence is coming. We've been privy to seeing some early reads, and so data's not ready for primetime yet. Once it is, we'll get you guys information in the public domain. There's clinical evidence continuing to support the work that we're doing with the model, and this is where I think the model starts to shine when you start looking at real world evidence and the implication in the clinical setting. This is going to be exciting for not only AS, but for future products.
Then, of course, we're going to be updating you guys along the way through the regulatory pathway, and sometimes we'll be giving you guys information. Sometimes we won't, as we're working with the FDA, because many of those things are confidential conversations with the FDA, but we'll be going forward.
We're going to go into Q&A. Before I do it, guys, I want to just reiterate, I'm going to answer every question we can to the best of our ability. For those I can't answer, I promise you we will get you an answer at some point here in the future.
But one of the things I can't stress enough is, as the CEO and the head of the executive team, I haven't seen a team put together a project plan over a holiday weekend as fast as this team has, to the point where we've already got multiple different swim lanes going to start to address this problem.
That happened with only a few hours into the first part of the U.S. week. Rest assured, we've got a plan. I think we've got a plan that can be successful here. This is not a drug development problem where we're 2 or 3 years out. This is a discussion we have with the FDA. We will find a solution here, and we will get you guys timelines for the future.
But with that, I'm going to kick it over to Henry and Alex to see if there's any questions that are coming through. We'll screen
Thanks, Dustin. As you mentioned, we have had a number of questions come through, and obviously cognizant that you will not be able to answer every single question that comes through.
We have a bank of questions here that we're going to start with. Firstly, how did the FDA's determination compare with Echo IQ's previous engagement with the agency, and where does the company's view differ from the FDA's assessment?
Yeah, obviously, we had the aortic stenosis solution cleared. We obviously had one round with the FDA of being able to get a cleared product, and now obviously each product is treated separately from the FDA's view, and sometimes there's similar processes and there's obviously different processes.
Heart failure is a different model than AS, and so obviously it's hard to compare the two. What I can say is that, we do have some fundamental differences that we believe from the FDA's view on the way that they looked at the analysis, and we are very eager to sit back down with the FDA and have a conversation. The great thing about the FDA is that they do offer those pathways. Those pathways can be as simple as having an email exchange with the reviewer to get some more clarification.
Obviously in our NSE letter, we do have some clarity from the FDA in terms of the things that they just couldn't get finalized before the deadline, that we'll obviously be addressing. Then obviously we've got more formal pathways, which are appeal processes, and of course, everything is always available to us to resubmit the 510(k) filing, which we obviously will be reviewing as we speak.
It's hard for me to compare the two. I can say through the conversations with the FDA, and many of you heard me speak publicly about this, that my confidence level was high because the conversations we were having in the review process were very positive.
I think that's where the frustration comes, is that we still believe that there is a very positive tone to where we're at with the FDA. It's just simply getting through some of these really complex discussions around statistical analyses that we think we will very easily be able to remedy.
Dustin, just for clarity, can you explain how this differs from a drug development company's regulatory pathway?
Sure. Obviously when you talk about PMA and those type of approaches, you are talking about manufacturing, you are talking about drug safety, you are talking about patient safety, you are talking about human trials. Those things are pretty significant when it comes to investment and time.
Those things are typically done through large studies that are done through a Phase III type of a program. 510(k) is a predicate program. 510(k) is simply saying, are you substantially equivalent to, or equivalent to whatever current device is in the market, and did you provide a clinical benefit?
So the bar is much lower on a 510(k) because it is very rarely are you putting any type of patient clinical trials in front of the FDA for review. So those two pathways are significantly different, and I think it is unfair to have any companies compared on those two pathways.
I think for those that understand the medical device space, 510(k) process is, even though for us it took a little bit longer, is a fairly shorter process when it comes to review time. Obviously there are steps in that that you need to follow as a device manufacturer. But for as a Software as a Medical Device, there are some leniencies in here.
So I think we will have a path that is much clearer and probably shorter than you would see from a pharmaceutical or a biotherapeutics approach to this if they were to receive a similar letter. Again, a 510(k) rarely is a no. A 510(k) on this, like an NSE, is usually a, "We would like you to resubmit, and we will continue the process.
What are the options available to Echo IQ from here, and what do you currently see as the most likely and efficient pathway towards regulatory clearance?
Yeah, this is where people will get frustrated, but I will have an answer to you at some point here in the future. I will talk to you about the pathways. I think I mentioned a few of them already. These are all kind of publicly available to do your research on. But obviously the first one is just a very open communication with the FDA, and that is available to us, and obviously we will be doing that within this week.
Obviously that is something that we can do as an informal discussion with the FDA on what is it exactly that we missed here? How do we get it across the line? Are there some things you can help us with that we can start to rectify? Obviously then the second one is what is called an ombudsman approach. That is available. That is out there.
It is a third-party mediated approach. Obviously we will be exploring that and having conversations with the ombudsman as to whether there is likelihood and opportunity for us to explore that manner. The third one is a little bit more kind of formalized, and that is a formal appeal process. We are reviewing that now.
Our outside counsel has already dug in over the weekend and read the file, and I think we have a very clear opportunity within that pathway. What we will know soon is what is the timeline on that pathway and what is the probability of success for us to go down that route.
Then a fourth one is always just a resubmission of the 510(k), and of course, we could do that today if we chose to, but obviously we want to make sure that we understand all the pathways, all the things available to us, and what are the ones that have not only the best probability of success, but also the timeliness to those, and which ones can we get done the quickest.
So, leave that with management here. Again, if I am really being brutally honest, we have had less than 12 hours to sit on the U.S. clock to really think through all the different strategies that we have. But I will tell you that we are going to employ each and every single one of them if needed, or we will choose the one that is going to have the best success and the fastest turnaround time here.
When it comes to a timeline, again, each one of those individually has its own unique set of timelines, and some of them are non-defined. What I cannot do and I would not do and I do not think you would want me to do is give you an unrealistic timeline, that we do not know exactly which of the processes we will be following. So stay tuned on that.
Again, what I can say is this is not a years-long process, but obviously this is not also a days-long process. We are going to have to sit with the FDA and understand our pathways and what we can do.
But there are a number of companies out there that have gone through similar experiences, and were able to turn these things back around in an expedient amount of time. We will get back to the market with a more defined timeline, when it makes sense to give you guys that information.
Dustin, based on your initial assessment, do you believe the matters raised can be addressed through further engagement, analysis or clarification of the existing evidence, or is there a possibility additional clinical work could be required?
Yeah, again, I don't know that I can specifically answer that. I can tell you, when I think people hear that they might think, "Oh my gosh, is this where you're going to pull this filing completely out and have to completely start over?" I think the answer to that is no.
What we've been able to do, even in the midst of our early review with the FDA is, when they ask for re-analysis, these are things that can get done very quickly, and we did that very quickly with our Mayo Clinic validation partner.
If it simply is a re-analysis of the data, I think we'll be able to do that very quickly. The robustness of the validation set we have is such that I don't think that's going to be required to have to do something different.
Obviously, some of the analysis we're looking at do factor around some of the ground truths and some things like that. But again, those are things that I think we can work through fairly expediently with the FDA. I don't think this is a path we end up having to do a completely new validation.
Again, remember, this model's been tested on the NETT database. We did it both with SCREEN and NILES. That was part of our early validation work. We've done it with Mayo Clinic, which was 17,000 patients. So really there is robust clinical evidence supporting this, and I don't think this is a clinical evidence concern. So I think this is really now just a discussion with the FDA about how we do the analysis.
What should shareholders expect over the coming months in terms of engagement with the FDA and regulatory milestones, and when may you maybe able to provide greater clarity on the pathway forward?
Yeah. Thanks, Alex, and I love to ask the same question a different way. I appreciate that. Yeah, look, again, I can't give some clarity on timelines. I can tell you when the first part of that question is, what should you guys expect from us from engagement with the FDA?
I can tell you that that engagement's going to be high. The outside counsel, the outside advisors, and the internal team, have a robust plan for a high level of engagement with the FDA. We are disappointed. We're frustrated. We're a little bit angry. We're a little feisty.
But we also want to be able to have the respect with the FDA to have the conversation to say, "Let's figure out a path forward here and get this solution across the line." I think all of that will lead to us having robust conversations with the FDA.
That has actually started as of today. Leave that one with us. I can't tell you the timeline on that again yet. But I will be doing my best to give some guidance to the market as and when it makes sense for us to do so.
Stepping back from EchoSolv HF, what impact does this have on Echo IQ's broader U.S. strategy, including EchoSolv AS commercialization, reimbursement, customer engagement, and the wider R&D pipeline?
Yeah, hopefully you guys heard from both Matt and Nick on that one that this is still full steam ahead on everything we are doing. Obviously, the heart failure solution getting clearance was always going to be an accelerant to the business. I think that was the words I had always used for everybody, that this was an accelerant on our revenue stream.
But it was not the hinge pin that we are leaning the entire company on. We knew that we always had a foundational base with aortic stenosis. We also knew the pipeline was a best in class, and if you look at our pipeline now with the advancement of the additional dataset we brought in, this is going to allow us to really escalate that and really accelerate some of the pipeline there.
I think the short answer is this has no impact on what we are doing as an organization. Obviously, there is a distraction that is happening here, and we are going to be focusing on that as a very select group of folks within the business. But those that are really good at what they do, which is out there and getting sales done, getting the integrations done, and that team in the background who is doing the R&D pipeline, they will not have distractions.
They will continue to have head down. Matt is ensuring that we have got the capital investment to make sure that those things will deliver the ROI. And then as the management team, we will make sure we get this right-sized with the heart failure piece and get it back on track to get the clearance as quickly as possible. So from my view, again, a setback for sure.
Nobody is more disappointed than I am, but this is not a catastrophic event. We are continuing all moments going forward with this to continue to drive business. And we are still looking at multiple different things, whether it is disease states or even different modalities to continue to build out that platform, because I think we have the right solution, to get us to a platform in the future that will be best in class.
Thanks, Dustin. We have a couple of questions to finish. Management has previously used language such as imminent and not if, but when discussing EchoSolv HF clearance, which understandably created a high level of confidence among shareholders. Given the NSE determination, how do you intend to rebuild the shareholder trust around the communication and expectations going forward?
Yeah, look, as I said, I do not think I could have been any more disappointed than anybody else because, well, I do not think I was unrealistic in expecting this to come across. The confidence level was high. Our job now is to get this onto the right track and get the clearance done.
Look, from my view, actions are probably the most important thing to see from us as a management team and probably mostly from myself around how do we address this situation, how do we get it right back on track, and then ultimately get us to where we wanted to be, which was a clearance on last Friday versus an NSE letter. Look, I cannot tell you how shocked I was on Friday when we got that, to be honest. I do not think that was unwarranted.
I think we were very confident with not a model, but the conversations we were having. I think right now, we are going to carry that confidence into the negotiations with the FDA now on how we get this one across. I do not have an answer for you on how I am going to build that trust back.
I think now it is watch us in this moment to see how we react, how we respond, and how a company like this continues to bring back shareholder value. We will invest for the right ROI. We will continue to get this one across the line because I think it is too important for clinicians and too important for patients out there that are going to need our help.
Thanks, Dustin. Well, that concludes today's webinar. Thanks to Dustin, Matthew, and Nick for the presentation and taking the time to answer some questions. Thanks also to our attendees and those who submitted questions for the Q&A.
Apologies if we did not get to your question, but as I said, we were inundated with questions today. As I mentioned earlier, a recording of the webinar will be on Echo IQ's website and social media platforms later today. Dustin, do you have any final comments to leave with us today?
No, just a huge thank you to Alex for collecting the questions. I know there were probably a number of questions we did not get to, and I apologize, but I think you guys probably did not want to continue to hear us ramble on that, and that is fine. What I will do is we will be doing a series of calls for folks who we did not get their questions answered, and we can.
We will try to do our best to get those questions answered either online or offline for folks. Again, thank you for everybody. Those that were early supporters of the business, thank you. For those that are new to the business, do not look at this as an opportunity to walk away from Echo IQ. I think right now, while I understand market dynamics, I understand the challenges that will be out there and facing many of you.
I think Echo IQ right now is still poised to be an incredibly valuable organization, and I think we will continue to deliver that shareholder value even in the face of this challenge today. As a management team, our job now is to convince and show you guys that we can deal through adversity here.
We can work directly with the FDA, and we can get this ship righted, as Nick used, in the choppy water. I thank everybody for your patience, and I appreciate everybody's support, and we will continue to communicate to the market as we have information to share.
Thanks, Dustin. Thank you again to the presenters and the attendees, and all the best, everyone. Have a great day.
You all too. Thank you.