Cuộc họp công bố kết quả kinh doanh Quý 2/2026 của SeaStar Medical (ICU): Doanh thu tăng 82%, thử nghiệm AKI đạt tiến triển

Thông tin trọng tâm

• SeaStar Medical đã báo cáo doanh thu thuần quý 2/2026 đạt 615.000 USD, tăng 82% so với khoảng 338.000 USD trong quý 2/2025. Doanh thu thuần 6 tháng đạt 1,1 triệu USD.
• Lợi nhuận gộp duy trì ở mức trên 90%, nhất quán với 4 quý trước đó. Chi phí hoạt động tăng lên 4,4 triệu USD từ 2,1 triệu USD do các hoạt động thử nghiệm lâm sàng và chi phí doanh nghiệp gia tăng.
• QUELIMMUNE đã được 20 trong số 50 bệnh viện nhi hàng đầu tại Mỹ mua và sử dụng, gấp đôi so với 10 khách hàng vào đầu năm 2026. Mục tiêu cuối năm của công ty vẫn là 25 bệnh viện.
• Thử nghiệm lâm sàng then chốt NEUTRALIZE-AKI đã tuyển chọn 223 trong số 339 bệnh nhân người lớn dự kiến. Ban quản lý kỳ vọng quá trình tuyển chọn sẽ hoàn tất vào khoảng cuối năm 2026 hoặc quý 1/2027, đồng thời giữ nguyên mục tiêu nộp mô-đun PMA cuối cùng vào cuối năm 2027.
• Tiền mặt giảm xuống còn khoảng 7 triệu USD tính đến ngày 30 tháng 6 năm 2026, từ mức 12 triệu USD tính đến ngày 31 tháng 12 năm 2025. Lỗ thuần quý 2 nới rộng lên khoảng 3,7 triệu USD.

Dữ liệu tài chính trọng yếu

Hiệu quả kinh doanh và hoạt động vận hành

Tăng trưởng doanh thu của QUELIMMUNE phản ánh đóng góp từ cả các bệnh viện mới và các khách hàng hiện hữu. Ban quản lý cho biết các cơ sở lâu năm có tỷ lệ mua lại rất cao, trong khi các cơ sở mới thường mua hàng tồn kho để chuẩn bị cho những bệnh nhân đủ điều kiện.

SeaStar Medical đã tăng gấp đôi tệp khách hàng bệnh viện nhi lên 20 cơ sở trong năm 2026. Ban quản lý tiếp tục đặt mục tiêu 25 bệnh viện vào cuối năm và tin rằng cơ hội có thể mở rộng ra ngoài tốp 50 trung tâm y tế nhi khoa từ năm 2027 trở đi.

CMS đã cấp mã ICD-10-PCS cho liệu pháp SCD của công ty. Việc áp dụng bắt đầu từ ngày 1 tháng 10 năm 2026, điều mà ban quản lý kỳ vọng sẽ tháo gỡ rào cản hành chính bằng cách giúp các bệnh viện thanh toán chi phí cho QUELIMMUNE trong điều trị AKI nhi khoa liên quan đến nhiễm trùng huyết.

Công ty cũng đã hoàn thành đăng ký theo dõi SAVE quy mô 50 bệnh nhân theo yêu cầu của FDA. Báo cáo sơ bộ đã được nộp và SeaStar Medical đang chuẩn bị báo cáo cuối cùng để FDA xem xét.

Đối với bệnh AKI ở người lớn, thử nghiệm NEUTRALIZE-AKI đã tuyển chọn 223 trong số 339 bệnh nhân dự kiến. Tốc độ tuyển chọn gần đây đạt trung bình khoảng 8 đến 12 bệnh nhân mỗi tháng. Hai cơ sở bổ sung đã bắt đầu tuyển bệnh nhân, bốn cơ sở sắp sửa kích hoạt và ít nhất tám cơ sở nữa đã cam kết tham gia. Ban quản lý đặt mục tiêu tăng tốc độ lên 15 đến 20 bệnh nhân mỗi tháng khi có thêm nhiều cơ sở mở cửa.

Hướng dẫn từ ban quản lý

SeaStar Medical duy trì mục tiêu doanh thu thuần năm 2026 cho QUELIMMUNE là 2 triệu USD. Doanh thu 6 tháng đạt 1,1 triệu USD, đại diện cho 55% mục tiêu đó.

Ban quản lý dự kiến chi phí R&D theo quý so với quý trước sẽ tăng ở mức khoảng 4-6% trong phần còn lại của năm 2026 khi các cơ sở lâm sàng bổ sung mở cửa và quá trình tuyển bệnh nhân tiếp tục.

Công ty dự kiến quá trình tuyển chọn bệnh nhân cho NEUTRALIZE-AKI sẽ kết thúc vào khoảng cuối năm 2026 hoặc quý 1/2027. Lộ trình nộp mô-đun PMA cuối cùng vẫn là cuối năm 2027. SeaStar Medical đang sử dụng quy trình PMA theo mô-đun để các phần kỹ thuật có thể được xem xét trước khi nộp kết quả thử nghiệm lâm sàng.

Rủi ro và các điểm chính cần theo dõi

Việc tuyển chọn bệnh nhân thử nghiệm vẫn phụ thuộc vào việc xác định những bệnh nhân đáp ứng các tiêu chuẩn làm giàu mẫu và tiêu chuẩn loại trừ của nghiên cứu. Ban quản lý nhấn mạnh rằng việc lựa chọn những bệnh nhân có tình trạng bệnh lý có thể can thiệp cải thiện được ưu tiên hơn so với việc đẩy nhanh tốc độ tuyển chọn.

Thử nghiệm loại trừ những bệnh nhân có nồng độ protein phản ứng C ở mức 3,5 mg/dL hoặc thấp hơn. Thử nghiệm này cũng loại trừ một số bệnh nhân có bệnh nền có thể làm mờ hiệu quả điều trị. Những tiêu chuẩn này có thể làm hạn chế tốc độ tuyển bệnh nhân.

Ban quản lý thừa nhận tính không chắc chắn về việc liệu toàn bộ tám cơ sở thử nghiệm cam kết bổ sung có được kích hoạt cuối cùng hay không. Trong khi đó, việc mở rộng sử dụng QUELIMMUNE trong các bệnh viện đòi hỏi phải đào tạo lâm sàng liên tục vì sự thay đổi nhân sự và sự hoài nghi ban đầu có thể ảnh hưởng đến mức độ tiếp nhận.

Chi phí hoạt động đã tăng hơn gấp đôi so với cùng kỳ năm ngoái, trong khi lượng tiền mặt giảm 5 triệu USD trong nửa đầu năm 2026 do SeaStar Medical mở rộng thử nghiệm lâm sàng then chốt.

Điểm nổi bật từ phiên Hỏi & Đáp với chuyên gia phân tích

Ban quản lý cho biết hồ sơ nộp PMA cuối cùng chủ yếu chỉ cần phần lâm sàng sau khi cơ sở dữ liệu được khóa và các kết quả được phân tích, với giả định rằng các mô-đun khác đã được nộp và thảo luận với FDA.

Về việc tiếp nhận QUELIMMUNE, ban quản lý mô tả việc bệnh viện phê duyệt chỉ là bước đầu tiên. SeaStar Medical tiếp tục đào tạo các đội ngũ lâm sàng trên khắp các ca trực và khoa phòng để giúp liệu pháp này luôn được chú ý hàng đầu khi các bệnh nhân nhi đủ điều kiện bước vào phòng chăm sóc tích cực.

Ban quản lý cho biết các bệnh viện mới hơn thường ban đầu sử dụng QUELIMMUNE như một liệu pháp giải cứu. Các trung tâm có nhiều kinh nghiệm hơn đang bắt đầu phát hiện bệnh nhân sớm hơn, phản ánh sự quen thuộc lâm sàng tốt hơn đối với thiết bị này.

Đối với các chỉ định SCD khác, công ty vẫn tập trung vào AKI ở trẻ em và người lớn nhưng đang đánh giá các nguồn tài trợ không gây pha loãng cổ phiếu, các cuộc thảo luận chiến lược và cơ hội phát triển kinh doanh. Nghiên cứu NEUTRALIZE-CRS do NIH tài trợ là một trong số các chương trình bổ sung này.

Toàn văn biên bản cuộc họp báo cáo kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Good day, and thank you for standing by. Welcome to the SeaStar Medical Reports Second Quarter 2026 Financial Results.

[Operator Instructions]

Please be advised that today's conference is being recorded.

[Operator Instructions]

I would now like to hand the conference over to your speaker today, Jackie Cossmon.

Jackie Cossmon

Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical Second Quarter 2026 Financial Results Conference Call. I'm Jackie Cossmon with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, Chief Executive Officer; Tim Varacek, Senior Vice President of Commercial and Business Operations; Dr. Kevin Chung, Chief Medical Officer; and Mike Messinger, Chief Financial Officer.

I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of 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 these risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission.

Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, August 12, 2026. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law.

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

Eric Schlorff

Thank you, Jackie, and thank you all for joining us today. We are very pleased with our progress this quarter. Our pediatric AKI market penetration and continued strong QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market that is 50 times larger than the pediatric market in the United States.

Successful treatment of pediatric AKI with QUELIMMUNE therapy by patient care teams is driving greater clinical confidence from the tight knit critical care pediatric community, which we believe will only strengthen the future potential launch of this therapy in the adult AKI market.

Tim will speak further on our plans for our continued adoption of QUELIMMUNE in the pediatric AKI market and also discuss how we are strategically planning for a potential launch of this therapy in the adult AKI market. And Kevin will describe our progress in our NEUTRALIZE-AKI pivotal clinical trial and our regulatory strategy for the adult AKI indication.

Before I turn the call over to Tim, if you are new to SeaStar Medical story, I'd like to clarify that the same foundational therapy in QUELIMMUNE, known as the Selective Cytopheretic Device or SCD, is the same therapeutic device that we are evaluating in our pivotal study for the adult AKI indication. The adult version is simply a larger device to accommodate larger blood volumes.

Also, I'd like to emphasize that our SCD therapy is first-in-class. It is the only immunomodulatory therapy that targets and neutralizes hyperactive leukocytes and monocytes and the immune cells primarily responsible for causing the cytokine storm that shuts down organs and takes the lives of far too many patients with AKI requiring renal replacement therapy.

Given the unique mechanism of our SCD therapy and the significant value of finding a potential solution to this continued unmet need, I would note that we anticipate our current pharmacological or pharmaceutical like gross margins to continue for QUELIMMUNE and to extend to our adult therapies if approved.

Furthermore, we believe that the FDA understands the importance of bringing innovative treatments advancements to critically ill patients with AKI. The FDA approved QUELIMMUNE for pediatric AKI under humanitarian device exemption and also awarded us breakthrough device designation for the SCD therapy for adult patients with AKI on continuous renal replacement therapy, which should support a more collaborative and rapid approval process.

We also have received breakthrough device designations for our other pipeline indications, including systemic inflammation from cardiac surgery and chronic inflammation in end-stage renal disease, among others. I provide this context today to reiterate our strong belief that our opportunity is significant. We remain keenly focused on achieving our near-term goals and understand the importance of driving new customer adoption for QUELIMMUNE and enrolling patients in our NEUTRALIZE-AKI trial. By the same token, we are not losing sight of our long-term opportunities and what SeaStar Medical can achieve for all our stakeholders.

With that, I'll turn it over to Tim. Tim?

Tim Varacek

Thanks, Eric, and thanks, everyone, for joining us today. We are making great progress in our efforts to establish QUELIMMUNE as an important therapy in the critical care of pediatric patients with AKI and sepsis. Currently, 20 of the 50 premier children's hospitals in the U.S. have purchased and used our QUELIMMUNE therapy. Recall that our goal for 2026 is to increase the number of hospitals to 25 by the end of the year from 10 at the beginning.

So we have already doubled our customer base this year, and we are well on our way to achieving that goal. And as Eric indicated, the use of QUELIMMUNE therapy is broadly resonating in the pediatric critical care community.

Let me describe how. We discussed in our first quarter call the considerable interest in QUELIMMUNE at the AKI and CRRT meeting in San Diego. Adding to the buzz we observed there, we sponsored and participated in this year's KidneyBee Summit a few weeks ago. The summit occurs annually and brings together a highly specialized interdisciplinary team, including nurses, advanced practice providers, nephrologists and critical care physicians from across the country. Its core importance stems from tackling the exact systemic failures that leave pediatric kidney failure under-recognized.

And just yesterday, we assembled leading experts in the treatment of pediatric AKI to speak at a SeaStar Medical educational webinar. The webinar was entitled Rethinking Pediatric Sepsis-Associated AKI, what Clinicians should know about QUELIMMUNE. We brought together practicing pediatric nephrologists, critical care physicians, advanced practice providers and nurses to learn more about pediatric sepsis-associated AKI, the use of QUELIMMUNE therapy through case reviews and how to navigate QUELIMMUNE adoption within hospitals.

Both events were very well attended and provided an opportunity for the pediatric community to get answers to key operational questions, gain exposure to the rich content from cutting-edge scientific and clinical data in sepsis-associated pediatric AKI and how to apply that knowledge to employ our QUELIMMUNE therapy at the hospitals in which they practice. As previously stated, this is an ultra-rare population with a very high unmet need and as the first and only therapy available to treat children with AKI and sepsis, QUELIMMUNE is helping to drive new thinking in the pediatric AKI community.

Now turning to our revenue targets and future opportunities in this ultra-rare pediatric market. We reported QUELIMMUNE net revenues of $615,000 in the second quarter, a strong 82% increase over last year's second quarter. And with 6-month net revenue at $1.1 million, momentum remains strong as we advance toward our 2026 net revenue target of $2 million. In short, we are very encouraged by the current rate of QUELIMMUNE adoption, and we continue to focus on adding new customers as quickly as possible.

We have great expectations of helping more patients by bringing our QUELIMMUNE therapy to more pediatric hospitals. And as we look to 2027 and beyond, we believe we can expand our overall market opportunity beyond the top 50 pediatric medical centers. We announced in June that the Centers for Medicare and Medicaid Services, also known as CMS, assigned ICD-10-PCS codes for our SCD therapy, allowing hospitals to efficiently bill for QUELIMMUNE therapy when used in treating sepsis-associated pediatric AKI. And we believe all future potential indications from our SCD therapy will use the same PCS code.

The implementation of the new ICD-10 PCS code initiates on October 1 of this year. This is an important administrative development as it removes another potential barrier to QUELIMMUNE adoption. In addition, we have completed the 50-patient SAVE registry that was required by the FDA to further evaluate the safety of our QUELIMMUNE therapy. Our preliminary report was submitted, and we are now preparing the final report for FDA review.

Our results from the first 21 patients were reported in the prestigious peer-reviewed journal, Pediatric Nephrology, and that alone has driven continued interest in adopting QUELIMMUNE.

So in summary, the future for our QUELIMMUNE therapy looks bright as we continue to expand into the pediatric market and work in parallel on pre-commercialization efforts focused on the adult AKI population, which is estimated to be 50 times larger than the sepsis-associated pediatric AKI population in the U.S.

Thank you for your attention. And with that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

Kevin Chung

Thanks, Tim, and thank you to everyone for listening to our call. I want to echo Tim's enthusiasm about our growing presence in the pediatric critical care community. It is rewarding to hear how these nephrology and critical care teams are adopting the QUELIMMUNE therapy and understanding that it is truly the first of its kind. These kids have days, if not hours, to live, and we have heard many stories about first-time use of QUELIMMUNE with life-saving outcomes. These stories are truly remarkable, and they continue to validate and reinforce why getting this therapy to a broader patient population is so important.

And to be clear, we believe that QUELIMMUNE for pediatric AKI indication is just the first of a broad range of indications for our SCD therapy. To our knowledge, no other pharmaceutical therapy or medical device on the market today is able to identify, target and neutralize the specific immune cells that cause hyper-inflammation. That means the SCD's unique immunomodulatory mechanism positions us to potentially reshape treatment paradigms across a range of serious inflammatory conditions, not only for AKI, but cardiorenal syndrome, systemic inflammation from cardiac surgery, chronic inflammation in end-stage renal disease and other states of pathologic immune activation where dysregulated cytokine release drives organ failure and death, which brings me to the discussion highlighting our efforts to bring our SCD therapy to critically ill adult patients with AKI requiring CRRT.

We are currently conducting the NEUTRALIZE-AKI trial and have plans to file a modular premarket approval or PMA with the FDA to potentially speed the overall approval process for this important indication. The modular PMA enables the FDA to review and potentially comment on portions of our application prior to submitting all modules, the last of which would be the submission of the NEUTRALIZE-AKI clinical trial results.

I would also note that we have been awarded breakthrough device designation for this indication, which should support expedited regulatory review. As a reminder, our NEUTRALIZE-AKI pivotal trial is a randomized controlled trial designed to assess the SCD therapy in critically ill adult patients with AKI requiring CRRT. The primary endpoint is a composite of mortality or dialysis dependence at 90 days.

We now have enrolled 223 of our total anticipated 339 patients in the trial and have stepped up our site recruitment to accelerate the pace of enrollment as we move forward. We recently onboarded 2 additional clinical sites who have already recruited patients. We have 4 additional sites that we anticipate will be screening patients shortly and at least 8 more sites that have committed to participating in the trial.

Our sites are extremely motivated and are continuously screening patients. When they identify potentially eligible patients, our sites are typically able to successfully consent and enroll those patients into our trial. This reflects highly on the site investigators and incredibly professional research staff who are tactfully approaching family members during a patient's most desperate hour in the ICU.

We must emphasize that we continue to be focused on enrolling the right type of patients. This careful selection of patients is essential to demonstrating therapeutic effect and avoiding the limitations that have confounded prior AKI and sepsis trials. One of our enrichment criteria is a C-reactive protein or CRP level greater than 3.5 milligrams per deciliter. Patients who do not have a CRP greater than 3.5 are excluded. Why? CRP is a very sensitive marker of inflammation and those patients with a low CRP are unlikely to benefit from our therapeutic device.

In past interventional sepsis or AKI trials directed at inflammation, many of these types of patients were included and those trials ultimately failed. Beyond CRP, we are also applying our carefully considered exclusion criteria to remove patients whose pre-existing conditions could obscure the true treatment effect, patients who might not survive regardless of whether the SCD works. This is the same disciplined approach we took in our pediatric trials, and it is the right way to design a study that can demonstrate therapeutic benefit. It is worth emphasizing that clinical trial populations are by design more narrowly defined than real-world practice.

We are seeing in the commercial setting, physicians who are already applying QUELIMMUNE to a much broader on-label population of pediatric patients than those enrolled in our trials, including patients with complex comorbidities who would not have met trial eligibility criteria. That broader real-world use reflects clinical confidence in the therapy and suggests the addressable patient population is larger than what our trial enrollment numbers alone might imply.

We are making meaningful progress in NEUTRALIZE-AKI and our confidence in the trial design and site execution has never been higher. As we discussed, enrolling the right patients takes precedence over enrolling quickly and our sites are delivering on that standard. While we expect to complete enrollment around year-end or in the first quarter of 2027, our PMA submission time line in late 2027 remains unchanged. The breakthrough device designation we hold for this indication means that when we submit, the FDA is positioned to move quickly.

A PMA approval of the SCD therapy for adult patients with AKI on CRRT would enable commercialization with ICD-10 PCS codes in place, significantly simplifying hospital adoption. Also, given the foundation we are establishing in the pediatric critical care community with QUELIMMUNE, we believe it would support more rapid adoption among nephrology and critical care experts in the adult AKI community. We are passionate about our ability to improve and potentially save lives of these critically ill patients and look forward to reporting our progress.

And with that, I'll hand it over to our CFO, Mike Messinger. Mike?

Michael Messinger

Thank you, Kevin, and thanks, everyone, for joining our call today. I'll provide a brief overview of our financial results for the second quarter of 2026. Please note that our Form 10-Q will be filed with the SEC within the next 24 hours, and it will include a lengthier discussion of the company's financial results for the 3 months ended June 30, 2026. You will find the 10-Q at sec.gov or through our website at seastarmedical.com.

We recorded net revenue for the second quarter of $615,000, reflecting increased demand for QUELIMMUNE. This represents an 82% increase compared to net revenue of approximately $338,000 for the second quarter of 2025 and this is an increase in the rate of growth from the 69% growth we had in the first quarter. And we continue to maintain our gross profit percentage of over 90% in the second quarter of 2026, consistent with the prior 4 quarters.

Turning now to our operating expenses. In the second quarter of 2026, we reported $4.4 million in operating expenses compared to $2.1 million in the second quarter of 2025. Our research and development expenses increased primarily to the additional clinical sites and increased patient enrollment compared to the same period in 2025. And our general and administrative expenses increased compared to the second quarter of 2025, primarily to an increase in compensation costs, legal and professional fees and certain SEC-related expenses.

As we indicated in our first quarter call, we expected our sequential quarterly research and development costs to increase based on adding additional clinical sites and our focused recruitment efforts. We did see a roughly mid-single-digit increase over our first quarter, and we continue to expect the same for the rest of 2026 as we anticipate meeting our enrollment goals.

Net loss for the second quarter of 2026 was approximately $3.7 million or $0.91 per share based on weighted average shares outstanding of approximately 4.1 million shares. This compares with a net loss of approximately $2 million or $1.77 per share in the second quarter of 2025 based on approximately 1.1 million weighted average shares outstanding. We had approximately $7 million of cash on our balance sheet at June 30, 2026, compared to $12 million at December 31, 2025.

And with that, I'll turn it back to Eric.

Eric Schlorff

Thanks, Mike. Our goal today was to share with you our second quarter achievements, but also express how keenly focused we are on the key value drivers, both short and long term for our stakeholders. We have a small but passionate team at SeaStar Medical, yet we believe we are reshaping the possibility for kids and in the future, potentially adults that often face organ failure or death without new therapies to modulate the cytokine storm in acute kidney injury.

Our goal is to set a higher standard for the treatment of all patients that face the trauma of AKI. We believe that the opportunities that lie ahead for SeaStar Medical are significant, and we look forward to reporting our future progress.

With that, I'll ask the operator to open the call for questions. Operator?

Operator

[Operator Instructions]

Our first question comes from David Bautz with Zacks Small-Cap Research.

Phần hỏi đáp

David Bautz

First one, I was wondering if you could comment on what the current monthly enrollment rate is for the NEUTRALIZE-AKI study? And if you're seeing any type of acceleration of enrollment at the newer high-volume sites?

And then lastly, can you quantify your confidence for hitting that 339 patients either by year-end or the first quarter of '27?

Eric Schlorff

Yes. So thanks for the question. So let me tackle the second one. What we've basically kind of guided the market is really our time line is around year-end or into Q1. Obviously, it's going to depend on Kevin and his team bringing on additional sites, et cetera, from an enrollment standpoint. But I'm really proud of what Kevin and his team are doing on bringing those kind of on pace.

But if I think about this, David, before he kind of talks about maybe enrollment, we still believe that we're really on track at the end of the day to have end of 2027 submission for the final PMA module, which obviously really not impacting the time line. But maybe, Kevin, you could talk a little bit about enrollment of various sites.

Kevin Chung

Right. Thank you, Eric. So on average, over the last few months, we've averaged somewhere around 8 to 10 to 12 patients in each of those months. And that's relatively slower than what I would like. However, I have to emphasize, we have to get the right patients. And by right patients, I mean those with modifiable disease. What's the point in getting finished with enrollment if we enroll a bunch of patients out of haste to try to just get our number, and we're not enrolling the right patients. That would be a flawed strategy.

For me, the focus is on getting the right patients enrolled so that we optimize our chance for success. That's number one. Number two, as we discussed in the report in our update, we're very busy right now activating in the process of activating numerous sites. As I said, there are 4 that are so close to getting activated, just some residual signatures and et cetera, those kinds of things, and we're ready to activate them. And so we're going to be very soon be seeing some reinforcements come in with an additional 4 sites ready to go, already trained. SIVs have already performed, site initiation visits. So we're ready to go with those sites.

There are additional 8 sites, half of whom contacted us because they wanted in on the trial. And so they've committed. Now whether or not we're going to be able to activate all 8 sites is still debatable. But we're going to try to get as many sites activated as possible because that's going to get us to 15 to 20 subjects per month, which is more at the pace that I would like. Again, though, focused on the right patients. We have to get the right patients. We have to get that right to have a chance for a positive trial.

David Bautz

Okay. Great. So with the enrollment expected by the end of this year, early 2027 and the PMA submission target for the end of 2027, I was wondering if you could just walk through what are the major activities for the PMA that need to happen, say, after enrollment or after database lock before you can fully submit it?

Eric Schlorff

Yes. So your question is what are some of the -- well, once we lock the database, obviously, then we'll give out top line results. Once it's locked, we can analyze, et cetera. And then really, it's just submitting the clinical section is really essentially because all the other previous sections will have been submitted by that time. And that's really what the goal is so that when the FDA then has their time, they can then focus just merely on the clinical sections and not have to go through things like device and description, et cetera. So that's really what the strategy is.

David Bautz

Okay. Sounds good. And then last one, talking about the increase in revenue. I was wondering if you could quantify the contribution from existing customers versus the new hospitals that you added during the quarter?

Eric Schlorff

Yes. Tim, do you want to tackle that one?

Tim Varacek

Sure. Yes. So it's a combination of new hospital systems as well as existing hospital systems that delivered that revenue. And we have a very high repurchase rate with the existing sites. And then obviously, the new sites that come on board, they want to stock the product as soon as they can so that they're ready to treat patients. So it was a group effort by all of the customers that were out there.

Operator

Our next question comes from Anthony Vendetti with Maxim Group.

Anthony Vendetti

Can you talk about the milestones between completing enrollment and then the final PMA submission? I think you mentioned you submitted the preliminary, right?

Eric Schlorff

No, we're submitting preliminary report. Yes. So we're submitting well, so you're talking about the PMA, right, for adults?

Anthony Vendetti

Yes. Yes, yes, yes.

Eric Schlorff

Yes. So yes, for that, I mean, obviously, what we're doing right now is a modular PMA. So there's various sections where you talk about the device, you talk about sterilization, you talk about all sorts of kind of the technical things that go into it. But then you get into that -- what the goal really is, Anthony, is to have those sections already submitted to the FDA, already have had the discussions with the FDA on those sections. And so really, what you're waiting for at the end is once you have data lock and then you can show top line and do the analysis, then you're really just submitting the clinical section of it.

Anthony Vendetti

Okay. And so you've submitted already the certain sections and...

Eric Schlorff

No, we're in the process. Yes, we're in the process of doing that.

Anthony Vendetti

Yes. Got it. Okay. And then you have right now about 20 pediatric hospitals, right?

Eric Schlorff

Correct.

Anthony Vendetti

So is there a process? Or what do you have to do to make sure they're not just sort of like, okay, there a hospital that uses this, but how do you get them to be a more meaningful recurring customers? Or just, hey, you just need the patients to come in and they're already on board and there's nothing really left to do with those particular hospitals?

Eric Schlorff

Yes. Maybe, Tim, you could kind of address it. And then Kevin, if you would like to add any additional comments on top of it. It is really a multidisciplinary approach that we take to these hospital systems.

Anthony Vendetti

Okay.

Tim Varacek

Yes, it absolutely is. Just to give you insight. So let's say, a hospital just came into the fold today. They've adopted QUELIMMUNE formally. There was a whole process that took place in terms of IRB approval, becoming a qualified vendor, all the associated things you have to do to basically be a customer to the hospital system.

Then a patient actually shows up in the emergency room, gets moved to the ICU and QUELIMMUNE becomes something that's top of mind. We have then the clinical team that will come over. They'll actually help the setup of that first patient to ensure everything goes smoothly.

Now in terms of what happens after that, there's a lot of work to do because these -- every hospital system is large. They have a lot of different staff. They have different shifts. And so there really needs to be an educational approach to that hospital system that never ends because there's turnover like in any other business. And our goal is to continually increase not just the breadth, but the depth that we get to within all of our customer base and the new ones that we'll add so that QUELIMMUNE is something that's top of mind for the patient care teams because we believe that while QUELIMMUNE is a super effective therapy, if you don't know about it and a patient comes in and there's not one of your advocates there, they may not realize that they could use QUELIMMUNE to treat that patient.

So it's a continual effort from a commercial standpoint and from a clinical standpoint to ensure that we really ingrain the brand into these hospital systems and they understand the clinical value of it so that they recognize patients when they come in and they can choose to use QUELIMMUNE therapy as an option when it's there and it's available.

Anthony Vendetti

Okay. So just to understand, so obviously, getting into the hospital is just the first step and trying to make sure all the trained health care professionals that could use it, a, know the benefit, know how to use it and you stay engaged because like you said, if there's new doctors, nurses or so forth that are coming in, you want to make sure that they are aware of the treatment of the application of the QUELIMMUNE, correct?

Tim Varacek

100%.

Kevin Chung

If I may add some color to the clinical perspective. So yesterday, we conducted a webinar that will make available very soon so that those of you who missed the webinar or had technical difficulties are able to dial in. During that discussion, it became -- it was -- this has been clear, but it became more clear to me that there's a big difference between new sites that have device and mature sites that have device.

New sites any time there's a new technology, even if it's life-saving, because of the natural skepticism that is very prevalent within the medical community, they have to see it work. And so generally, it's used as a rescue therapy. And what I mean by that is it's used for the new sites as a last resort, oftentimes with a bunch of other experimental therapies that are not even approved being applied prior to SCD. So that's new sites. That's the approach that they take. And that's been true for almost every site that have been activated because whenever a therapy is new, that's what's going to happen.

And I have to say and have to emphasize that even with those types of patients that have failed other therapies, we're talking about a 70% survival in that population, which I have to emphasize that's remarkable. But yesterday, we're starting to sort of notice a shift, especially with the mature centers, the mature sites that have been doing this now for over a year. These sites, everybody is already educated. Everybody is already has seen what I call the index case, the aha moment, the case that converted them and in their mind, made them think, "Oh my gosh, we need to do this. And this is occurring and adoption -- clinical adoption mentally is occurring pretty universally across our mature sites.

And so right now, as we speak, those clinicians are scanning their ICU to see who may benefit from the therapy. And so it's no longer now a rescue therapy. They're not waiting until the bitter end. They're starting these patients early, and we're seeing even better outcomes, which is just really remarkable. So that was my takeaway from the webinar. Again, we will make this available very soon. And hopefully, you'll be able to watch it and verify my statement.

Anthony Vendetti

No, that's helpful, Kevin. Yes. So I mean, we know the focus as it should be, is on the pediatric market and now the adult AKI with this trial enrollment and you're at 223 up to 339. And we know it's adult AKI is 50 times larger than the pediatric market. But there's other markets that your cytopheretic device can treat, whether that be acute respiratory distress, hepatorenal syndrome, cardiorenal syndrome and of course, sepsis. So I know you want to stay focused, like I said you should. But behind the scenes, can you give us some insight into what kind of work is being done on these other indications?

Eric Schlorff

So I can tackle that one. Yes. I mean, yes, so we do obviously evaluate all the other applications that we believe that, obviously, from our perspective, there's a pretty long laundry list of things that really would be on our wish list. But obviously, we, as a company, have to be focused on certain things, and that's really been on QUELIMMUNE for pediatric AKI and adult AKI and NEUTRALIZE-AKI.

Obviously, we've got the NEUTRALIZE-CRS study that's actually been funded by NIH. And I would say we have various discussions with various parties looking at everything from non-dilutive to strategic discussions, business development on all these types of things to be able to really advance this -- the other indications that we believe we have in our pipeline. But obviously, it will just take time for some of those things to mature, and we'll just have to see how they pan out.

Kevin Chung

If I may just add really quickly. I should remind everyone that for NEUTRALIZE-AKI, a priority, we identify patients with ARDS at the time of enrollment and sepsis at the time of enrollment, and we randomize via this technique called block randomization. What that does is it allows equal distribution of subjects to be assigned in the ARDS bucket, in the sepsis bucket and the combined sepsis and ARDS bucket. We will be able to, for sure, make a statement about those specific populations who have concomitant AKI, of course.

Operator

I would now like to turn the call back over to Jackie Cossmon for any closing remarks.

Jackie Cossmon

Thank you, Josh, and thank you all for joining us today for the SeaStar Medical Second Quarter Financial Results Conference Call. If you have questions, please contact us at ir@seastarmed.com or visit our website at www.seastarmedical.com. Thank you, and goodbye.

Operator

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.