SeaStar Medical Q4 2024 Earnings Call Transcript

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March 27, 2025

There are 6 speakers on the call.

Operator

Good afternoon, and thank you for standing by. My name is Calvin, and I will be your conference operator today. At this time, I would like to welcome everyone to the Seastar Star Medical Year End twenty twenty four Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Operator

Thank you. I would now like to turn the call over to Jackie Cosman. Please go ahead.

Speaker 1

Thank you, Calvin. Good afternoon, and thank you for joining the Seastar Medical year end twenty twenty four financial results conference call. I'm Jackie Kosman with WheelHouse Life Science Advisors. Joining me from vStar Medical today are Eric Schlorf, Chief Executive Officer David Green, Chief Financial Officer Doctor. Kevin Chung, Chief Medical Officer and Tim Baracek, Senior Vice President of Commercial and Business Operations.

Speaker 1

I would like to remind listeners that comments made during this call by management will include forward looking statements within the meaning of the Federal Securities laws. These forward looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results. For a list and description of risks and uncertainties, please review Seastar Medical's filings with the Securities and Exchange Commission at sec dot gov. Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, 03/27/2025. These Star Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law.

Speaker 1

And now, I'd like to turn the call over to Eric.

Speaker 2

Eric? Yes. Thank you, Jackie. And thank you all for joining us today. We are excited to share with you our achievements over the past year and more importantly, our future plans and our passion for what we are doing here at SeaStar Medical.

Speaker 2

With the launch of Quellimmune, which Tim will talk about shortly, we have witnessed truly amazing patient outcomes about how our SCD therapy has saved lives. One example was recently sent for publication by investigators at the University of Michigan, where the patient had a ninety five percent predicted mortality. And after SCD therapy, they have normal kidney function, resumed chemotherapy and are at home. We have also witnessed stopping almost certain critical organ damage and children being discharged out of ICU or intensive care units without the need for lifelong renal replacement therapy. For us, these truly amazing clinical cases speak loudly of the opportunity for our SCD therapy as a potential treatment for the approximate one million patients that each year face the consequence of destructive hyper inflammation that can damage critical organs and take lives.

Speaker 2

In our estimation, the longer term opportunity to treat other serious inflammatory conditions such as cardiorenal syndrome, hepatorenal syndrome and chronic dialysis expands our opportunity well beyond the initial market that we have identified for the SCD therapy. In short, we are very excited about our opportunities and look to 2025 as a year of growth and momentum with new top tier pediatric medical centers adopting QualImmune and the achievement of our clinical development efforts with institutions like Stanford, Cleveland Clinic and Mayo Clinic going to the neutralized AKI adult pivotal study to bring our second therapeutic product to a market that is 50 times larger than the important yet smaller market for pediatric patients with AKI. Our strong momentum coming into 2025 has been fueled by our significant accomplishments in 2024. We not only received our first product approval for Quellimmune, but we advanced our neutralized AKI clinical development program and also eased the cost of the trial by obtaining CMS coverage to pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the trial. We were also awarded our fourth breakthrough device designation for chronic dialysis, and we expanded the medical community's understanding of our SCD therapy through manuscript publications in key journals and presentations at medical conferences.

Speaker 2

In addition, we further secured our first in class proprietary technology through the award of key patents in The United States and Canada. We also appointed David Green, a healthcare industry veteran, as our Chief Financial Officer in January of twenty twenty four. Dave has been working diligently to manage our capital structure, secure additional capital and strengthen our control environment during this time of transition to a commercial stage company. 2025 has started off with success. In just three months, we added two new customers, commercial customers, after transitioning the sales and distribution model in 2024.

Speaker 2

We activated two additional sites in our neutralized AKI pivotal clinical study and the FDA approved a feasibility study for our FCD therapy as a treatment for cardiorenal syndrome as a bridge to left ventricular assist device implantation. Just last week, the National Kidney Foundation, a prominent kidney disease advocacy group, announced that Seastar Medical has been awarded its 2025 Corporate Innovator Award. The award was established to recognize industry leaders that advance the field of nephrology by addressing an unmet clinical need or improving upon existing practice, therapeutic or technology. We were honored with the award this year based on our significant contribution to improve the lives of pediatric patients with AKI based on the approval and introduction of our Quell immune therapy. Previous winners have included Merck, Johnson and Johnson and UnitedHealthcare.

Speaker 2

This is a huge honor and recognition to our team at CStar Medical, who continues to focus on improving clinical outcomes. Now, before I turn it over to the call to Tim, I'd like to talk about our expectations for Quellimmune as a commercial product. We are in the launch phase of commercialization of our first product into a small market of what we estimate to be about 4,000 pediatric patients annually in The United States. As with any launch, there is a level of unpredictability and the time to conversion of accounts can vary widely. This dynamic is further compounded with Qualimmune, especially because our adoption process requires that we work with investigational review boards or IRBs to implement the patient registry that is part of our commitment to the FDA under the Human Device Exemption approval.

Speaker 2

As I said earlier, we are thrilled with the feedback to date from our first commercial customers and we now have a growing pipeline of customers working through the adoption process. Our 2024 sales have reflected the timelines required to bring customers on board and get them up to speed with incorporating Wellimmune into their workflow protocols. As this process becomes more routine for them, we expect customers to expand their use of Qualimmune to more patients that meet the criteria for use of the therapy. That is to say that our sales will be lumpy as we work through the launch of Qualimmune and expand its use at new sites. In this early period, the more important metric to follow will be the number of institutions going through the adoption process, which ultimately will lead to product sales and growing revenue.

Speaker 2

We intend to provide updates on the number of customers working through the IRB adoption process to provide a more meaningful metric on launch. We are not providing guidance due to uncertainties that are inherent in launching a product, but we will say that we are pleased with our progress and believe we are on track to meet our internal revenue targets for 2025. With that, I'd like to turn the call over to Tim.

Speaker 3

Thanks, Eric, And thanks everyone for joining us today on the C STAR medical call. I'd like to start by highlighting a couple of points about our Quellimmune therapy. First, this therapy truly represents new hope for critically ill children, their families and the medical community. The kids that are being treated with QualImmune have a very poor prognosis and their mortality rate is greater than fifty percent when receiving the current best standard of care treatment of continuous renal replacement therapy also known as CRRT plus antibiotics. Prior to the introduction of Qualimmune, there was no approved therapy or drug to stop the cytokine storm that poses a great risk of multiple organ failure and loss of life for these young patients.

Speaker 3

The clinical data of Qualimmune that was reviewed by FDA in their decision to approve the product under Humanitarian Device Exemption or HDE observed that almost eight in ten patients with pediatric acute kidney injury and sepsis survived with Qualimian therapy on board versus only five in ten patients on standard of care. That is a sixty percent observed higher survival rate. And this data has fueled great interest from mostly the most highly regarded children's medical centers through regional and community pediatric hospitals. Pediatric medical centers are truly interested in bringing Qualimmun into their facilities and I'm pleased to report that the number of pediatric hospitals going through the adoption process has doubled from the third quarter to the fourth quarter of twenty twenty four. And that number increased further in the first quarter of this year as we continue to add new pediatric hospitals into the queue that want to adopt QualImmune.

Speaker 3

As mentioned, we currently have five pediatric hospitals that are up and running, have been purchased and utilized QualImmune therapy. The process at these medical centers for the adoption of any new device can be lengthy and it involves typical steps such as developing a product champion, going through a site's value assessment process and getting set up as a qualified vendor. In the case of Qualimmune, the post approval registry requirement by the FDA adds an additional step to the process and that typically takes more time. Each hospital system does things a bit differently within the required regulatory framework and we adjust to support them and complete the process as quickly and efficiently as possible. Ultimately, this boils down to time to activation and that can vary from several months to eight to ten months.

Speaker 3

We continually evolve our support for pediatric hospitals as we learn their specific processes and discover efficiencies that we can often carry forward. To be clear, I have provided additional detail on the activation process because I want to emphasize the significant gap that we bridge between the desire to adopt our quality and therapy and the lengthy process of pediatric hospital activation and to highlight the strong commitment in terms of championing this effort that the pediatric nephrology and ICU teams are delivering as we go through the adoption process with them. In other words, we believe adoption is not a matter of if but when at these pediatric hospitals and our own internal tracking to date indicates that seven out of every 10 pediatric hospitals we approach to gauge interest ultimately commit to Quell immune therapy adoption. I am very pleased to state that our current activated pediatric hospitals are reporting good results and we have seen a nice increase in Qualimmune sales in our first quarter of twenty twenty five compared to the fourth quarter of twenty twenty four. As Eric said, sales will be lumpy until more pediatric hospitals are activated and we can gain an understanding of the cadence of patient presentation within these hospitals.

Speaker 3

With that framework of our QualImmune launch efforts, I'll now discuss our commercial opportunity for the FCD therapy platform. As mentioned, the pediatric AKR market is small but there is a very high unmet medical need for treatment. When we obtained approval for Qualimune for this patient population, it was the realization of an incredibly important opportunity to deliver a therapy to treat children who so desperately need it. One that could literally save their lives or reduce or eliminate the need for long term renal replacement therapy. To put the market opportunity in perspective from the standpoint of C Star Medical's initial product launch, in our estimation and based on our internal assumptions, we believe the total addressable market is in the range of $100,000,000 Now, we won't capture the full market of course but given the serious unmet clinical need and lack of any treatments today, we believe that over time we will penetrate a significant portion of this patient population with Quellimmune therapy and that will lead to consistent initial revenue for Seastar Medical.

Speaker 3

Our future indications address much larger markets and we are on a solid development path to obtain additional approvals and build a presence in these markets. Our technology is scalable across multiple indications and our breakthrough device designations should enable a tight review process of the SCD therapy by FDA. The adult AKI indication being studied in our pivotal trial NEUTRALIZE AKI represents an opportunity approximately 50 times the size of the pediatric population, about 200,000 patients annually that face organ failure and potentially loss of life with no FDA approved treatment options beyond the current standard of care comprised of CRRT and antibiotics. Our current anticipated launch timeline in adult AKI is the second half of twenty twenty six assuming positive clinical trial results and FDA approval. We believe the time to adoption will be more favorable compared to pediatric AKI as we should be able to leverage the customer learnings and experience with Queminal Immune in hospital systems where we already have a commercial presence combined with the fact that there are no other therapies to address this condition.

Speaker 3

At our current projected revenue per patient, this would present a total market opportunity of $4,500,000,000 Even at modest market penetration projections, the revenue upside would be significant for Seastar Medical. And for us, the adult AKI indication is just the beginning of a long line of indications that could follow. We estimate a total market size of about one million patients that currently have no approved therapies to address conditions such as chronic dialysis, cardiorenal syndrome, hepatorenal syndrome, acute respiratory distress syndrome and other indications that our FCD therapy may serve. So, this is why we are so excited at Seastar Medical. And now I will turn the call over to our Chief Medical Officer, Kevin Chung.

Speaker 3

Kevin?

Speaker 4

Thanks, Tim. And thanks to our listeners for joining us today. I am pleased to report that our neutralized API pivotal trial continues at a steady enrollment pace with 94 of our anticipated 200 subjects enrolled in the trial. As many of you know, NEUTRALIZE AKI is a randomized controlled pivotal trial designed to determine whether up to 10 sequential twenty four hour treatments with the STD therapy will improve ninety day survival or recovery from kidney failure in patients with AKI requiring CRT when compared to CRT alone. We plan to enroll approximately 200 patients in an intensive care unit setting in the trial.

Speaker 4

The primary endpoint is a composite of mortality or dalliance dependency of 90. We plan to conduct an interim analysis once we have reached the ninety day primary endpoint in the first one hundred enrolled subjects. Pulled data will be analyzed and presented to our Data Safety Monitoring Review Board or DSMB. At that time, based on the differences in outcome between the treated subjects versus controls, the DSMB will provide a recommendation to CSAR Medical and the neutralized API investigators as to how to proceed with the trial. While we can't be certain of the recommendation from the independent DSMB, we designed the interim analysis to ensure we powered the study properly.

Speaker 4

And if we did, the conclusion from the DSMB would be to continue the trial as planned towards our goal of 200. We know we will reach 100 patients in Moltum time in April. Given our recent new site activations, we anticipate a steady, if not accelerated pace of enrollment through the rest of the year. We have faced some challenges recently through a national shortage of citrate used in our CRT circuits along with the SCB. In spite of this, we managed to enroll 24 new subjects in just the past three months.

Speaker 4

Thankfully, the shortage is now resolved. We are incredibly grateful to our fantastic investigators who jumped through many hoops to get subjects recruited. We have also added two new sites since the beginning of this year, most recently adding the University of Texas Southwestern in Dallas. As Eric mentioned, we have many notable medical institutions, including Stanford, Cleveland Clinic, and Mayo Clinic that are now enrolling patients into the neutralized API study. I highlight these sites because they and other prominent sites are the ones that we anticipate will be our early clinical champions when the time comes to roll this therapy out to the adult ICU market.

Speaker 4

You can be sure they will be armed with definitive outcomes data from our pivotal trial. Additionally, we know many of these champions will share their personal experience with the international critical care and nephrology communities with the eventual goal of including our therapy in clinical practice guidelines. A positive neutralized AKI trial will help elevate the current standard of care for all those suffering from life threatening AKI. We are very fortunate to have the right investigators at the right sites participating in our trial. Once we complete the trial and achieve 100 data lock, we intend to rapidly analyze and report our data to the international medical community.

Speaker 4

Provided we meet our primary endpoint, we plan to complete our PMA filing and submit it to the FDA. The breakthrough device designation, which we hold for adult AKI, should help facilitate speedy communication between us and the FDA during the review and approval process. And as such, we hope to have this product available to patients sometime in the second half of twenty twenty six. Now looking into the future, our stepwise goal is to inspire wide clinical adoption of the STD therapy, first to treat as many of the approximate two hundred thousand patients with AKI in The United States, and when the time is right, expand beyond their US borders to treat as many of the millions of patients worldwide who could potentially benefit from our SCD therapy for this indication. Our strategic goal as a company is to widen the addressable market rapidly to other target, to target other critical unmet medical needs.

Speaker 4

I would like to emphasize that the neutralized API study is really three trials in one. We intend on analyzing and reporting the impact of the FCD in the cohort of patients with sepsis and ARDS as well. Based on the mechanism of action of FCD, we have good reason to believe we will be able to show benefit in these two subpopulations. Beyond this indication, we have been awarded breakthrough device designation for three others, including the treatment of patients with cardiorenal syndrome, patients with hepatorenal syndrome and patients with end stage renal disease. Given the organ and disease agnostic characteristic of our therapy, there are several more indications to come.

Speaker 4

We believe that AKI is just the beginning. Additionally, we announced last year that the NIH provided a $3,600,000 grant for a clinical trial to evaluate our SCD therapy in patients with cardiorenal syndrome awaiting LVAD implementation. And in January, the FDA approved a feasibility study for this indication. The trial will be led by the inventor of the STD therapy, Doctor. David Humes from the University of Michigan and one of our key scientific advisors.

Speaker 4

The neutralized CRS trial is expected to enroll 20 patients at up to five clinical sites. The results from this pilot study will help inform our next steps for this indication. Our medical affairs and research team is working closely with Tim and his commercial team to identify the most appropriate next best disease state to tackle with our disease and organ agnostic therapy. With that, as a summary of our clinical development efforts and goals, I'll turn the call over to our CFO, David Green.

Speaker 5

Thank you, Kevin, and thank you all for joining us today. I'll start with a few comments about our fiscal year ended 12/31/2024, and conclude with some of our expectations for 2025. First, for some housekeeping, please note that our Form 10 ks will be filed with the SEC in the next twenty four hours. You can find it at cstarmedical.com or at sec.gov. As you've heard from my colleagues, 2024 was a transformative year for Seastar Medical.

Speaker 5

We made great strides in strengthening our financial position, gaining FDA approval to sell and launch Qualimmune, our first commercial product for pediatrics and pushing forward our neutralized AKI pivotal trial for adult AKI patients. From a financial perspective, I'm very pleased with our 2024 performance. We substantially improved the balance sheet by adding new capital and reducing debt and other liabilities. We raised approximately $25,000,000 and we were very careful with the use of the new capital. We used $16,000,000 to fund operations, which are focused largely on our adult clinical trials and selling Qualimmun for pediatrics.

Speaker 5

We extinguished approximately $6,000,000 of debt. We reduced accounts payable by $1,300,000 and ended the year with $1,800,000 in cash. Further, as we reported last month, we also raised another $6,000,000 in February of this year. In addition to strengthening the balance sheet, we overcame and addressed pre existing material weaknesses and implemented much stronger controls over financial reporting. And with all of that hard work behind us, we've positioned the company to build on the first two quarters of commercial revenue for Qualimmun and complete the adult AKI pivotal trial.

Speaker 5

From a commercial perspective, after receiving FDA approval for our pediatric product, Quellimmune, in Q1 twenty twenty four and launching in Q3 twenty twenty four, we made a significant strategic change from a distribution network model to a direct sales model. This change allows us to fully manage the sales and distribution cycle and avoid costly distribution fees. It also allows us to better leverage our product expertise and close relationships with ICU and nephrology clinicians that target hospitals. And this move has been paying off. As Tim noted earlier, a very large percentage of hospitals we approach to gauge interest ultimately commit to bringing quelimine therapy into their hospital for their pediatric patients.

Speaker 5

This will ultimately lead to a growing customer base and smooth out some of the initial uneven pace of orders, which is expected during an initial launch phase. With the sales model realignment completed, we are well positioned to build on the first two quarters of commercial revenue for Qualimune and complete the adult AKI pivotal trial. Now for a few top line comments on our income statement. With the launch of Clonium in the third quarter, we booked our first product revenue in 2024 with net revenue of $134,000 This modest revenue reflects the timeliness for adoption by customers as Tim described. And while we anticipate the sales will be choppy in the initial phases of the launch, we expect that we will see an overall trend of increases in revenue as we expand the total number of customers purchasing quality in.

Speaker 5

In fact, I am pleased to report that with the continued addition of purchasing customers, we are seeing a nice uptick in sales so far in the first quarter. Altogether, we are quite optimistic about the hospital about new hospitals coming on as customers as we enable more children to benefit from our life saving therapy. Moving on to our cost of goods sold, the current financial statements reflect no GAAP cost of goods sold from the sale of Qualimmune. GAAP accounting requires inventory to be expensed as research and development costs for that inventory which was built prior to our FDA approval to sell Qualibulin. As we acquire, build and sell new inventory as a commercial company, we will record those expenses as cost of goods sold consistent with GAAP accounting.

Speaker 5

We anticipate these costs to hit the P and L later this year. Our operating expenses for 2024 increased by approximately $3,600,000 compared to 2023, primarily due to increased spending at our commercial launch and growing enrollment in the neutralized AKI trial. And finally, our net loss for the year declined to $24,800,000 versus a loss of $26,200,000 in 2023 with approximately $6,900,000 of the 2024 loss from non cash items. Looking forward, we expect to focus our resources on our top three objectives. One, commercial sales of Qualibut.

Speaker 5

Two, completing a neutralized AKI pivotal trial for adults and number three, preparing to file a PMA following the completion of the adult pivotal trial. We are very excited about serving the adult AKI population, which is estimated to be roughly 50 times larger than the pediatric population. And finally, as we move our strategic objectives forward, we expect the momentum to continue as we bring our life saving SCV therapy to more patients and clinicians and as more investors notice the significant market opportunity developing for our products. And with that, I'll hand the call back to Eric.

Speaker 2

Yes. Thanks, David. Our goal today for our first financial results conference call was to provide you with a summary of our past successes in 2024 and into early twenty twenty five and also provide a clear picture of why we believe the future opportunities for Seastar Medical are significant. With a commercial product on the market and the near term opportunity to capture a sizable portion of a large market for treating adult patients with AKI on CRT, we believe that Seastar Medical is a highly differentiated company with de risked assets and poised for growth. Beyond these indications, we believe our ability to bring life saving products to patients in a commercial setting is accelerated by three key factors: one, breakthrough device designations that enable the potential for a speedier pathway to approval two, the fact that our therapy is delivered through a device, which requires only one pivotal trial for approval and three, the fact that our existing device is applicable as is for multiple indications.

Speaker 2

In other words, we don't need to build specialized devices for each therapeutic indication that we seek approval for. We believe this offers reduced time to market and economies of scale that are not often achieved by companies in our industry. In short, we believe we are continuing to create strong value for our investors and stakeholders, and we'll be looking to close what we see is as a substantial gap in our current market cap and the outlook that we have for the company. With that, I'll ask the operator to open the call for questions. Operator?

Operator

Thank you. Your first question comes from the line of Anthony Vendetti of Maxim Group. Please go ahead. Thanks. Yes.

Operator

So I wanted just to first start on the NEUTRALIZE AKA trial AKI trial. I think maybe Kevin you said there's 94 of the expected 200 patients have been enrolled and you're expecting to provide the interim analysis after 100 of them, so you're close to getting them enrolled ninety days after that, right, after the one hundredth is enrolled. Is that correct? And what's your best estimate for since we're only six patients away from that, what's your best estimate for what quarter that's going to occur or what month that will occur or expected?

Speaker 2

Yes. So, yes. Hi, Anthony. This is Eric. Thanks for joining today.

Speaker 2

Hey, I think Kevin did have to drop off. So let me take your question in a couple of parts. So the first one is, yes, we are ninety four patients. We anticipate being able to get to that one hundred sometime likely to be the April, somewhere in the April. As it relates to the timing of once we get to one hundred patients, yes, it is ninety days.

Speaker 2

That's what the primary endpoint is. It's a ninety day to get out ninety days to either mortality and or dialysis dependency. And then the data at that point will be collected and then presented to the IRB or to the DSMB for their review. And so, we anticipate that shortly after we get to that ninety days that we'll be able to share some of the outcomes from and the assessment from the DSMB or the Data Safety Monitoring Board.

Operator

Okay. So if I was going to timeline this a little bit, Eric, it would be sometime in April, beginning of April, the 100 patients will be enrolled 90 after that. Let's say that gets us to July and then a couple of weeks of analysis before you provide it. So July, beginning of August to provide an interim look or interim analysis?

Speaker 2

Yes. That sounds about in the ballpark.

Operator

In the ballpark. Okay, great. And then as I guess, you continue to roll the Qualimmune product out. What are your current plans in 2025 to expand your sales force capabilities? Maybe just give a little bit of an update on that?

Speaker 2

Yes. So, Tim, why don't you tackle that one?

Speaker 3

Sure. So, Anthony, I mean, the first thing I would say is, again, this is a small market and I would say we're right sized right now. We have field facing staff and we also importantly have operational support internally and it really is it's a group effort. It's not just about the commercial team. We have skilled nurses that actually are on-site that will train these accounts once they are ready for activation, they'll train them on how to use the product.

Speaker 3

So we have no shortage of new accounts that are interested in terms of our pipeline and we're working through the process with each of these folks and they really are unique by themselves one account to the next in terms of the process they follow and the timeliness of that process. So I think right now we feel good about where we're at. We have a healthy pipeline and we're just working through the IRB process and the customer setup process with them as we go into 2025.

Operator

Okay, great. That's helpful. But maybe just, and I know each customer is different, but maybe what have you learned from the first several hospital activations? And then what does a typical conversion look like from you convert a customer from a pipeline to an activation? How long does that typically take?

Operator

What does that look like? And like I said, what have you learned from the first, hospitalization?

Speaker 3

So, I mean, I think some of the biggest learnings are the IRB itself, there's really a couple of components to it. There's our device and then there is the patient registry which we've talked about. So the device piece of this is really the simpler portion of IRB review. The more complex portion of it is really the registry because it in some ways is a framework that's similar to, it's really a post surveillance registry. So there are more people involved in the hospital that will ultimately evaluate the patient.

Speaker 3

They'll take data that comes up with the initial profiling of that patient and all those things drive the whole administrative aspect of getting a registry set up within a hospital. And so that takes more careful review from an IRB standpoint. What was the second part of your question there, Anthony?

Operator

Yes. I guess, from the first several activations, was there anything particular that you've learned that you would tweak in terms of your process or you do differently?

Speaker 3

I think what we I would say, what we've learned is not really worth discussing on the call. It's more it's nuanced aspects of, just creating more efficient process for the customer once we understand their behavior and how they do things and modifying hours and our support to get them there. But the, you know, in general, the process is the same for all hospitals at a high level. It just breaks down into different components once you get into an individual system, some have a lot more support and resources than others. And so you just you kind of play the hand you're dealt.

Speaker 3

You work with these people and we do everything we can on our end to move as quickly and efficiently as possible through the process with them.

Operator

Okay, great.

Speaker 2

I would say the one thing, Anthony, to add on to all that is that probably one of the biggest key learnings that we had was the decoupling of the IRB process. So as Tim explained, there is the HDE approval process, which then could include things like the Value Assessment Committee and the purchasing, and then you've got the registry. But I think what we've been able to do here lately is really start to be able to decouple those because through kind of our relationships with the FDA, they've also encouraged us that if we can treat patients, even though the registry isn't up and maybe going at that site, we should try to save a child's life, which that's obviously that's our primary goal and that does allow us then to sell product directly to the hospital.

Speaker 5

Okay, great. Yes. Also, it's also which is very helpful that we've learned is getting the ICU docs and the nephrologists together in on the process early is also a big time saver.

Operator

Okay, great. That's very helpful. Thanks. Thanks for all the color. I appreciate it.

Operator

I'll hop back in the queue. There are no further questions at this time. With that, I will turn the call back over to Jackie Cosman for final closing remarks. Please go ahead.

Speaker 1

Thank you, Kelvin, and thank you all for joining us today for the Seastar Medical year end financial results conference call. If you have questions, please don't hesitate to contact us at ircstarmed dot com or visit our website and see our latest news, product pipeline and company information. Thank you and goodbye.

Operator

Ladies and gentlemen, that concludes our conference call. We thank you for participating and ask that you please disconnect your lines.

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SeaStar Medical Q4 2024
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