SeaStar Medical Holding Corp (ICU) 2024 Q4 法說會逐字稿

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 Medical year-end 2024 financial results conference call.

下午好，感謝您的支持。我叫 Calvin，今天我將擔任您的會議主持人。現在，我歡迎大家參加 SeaStar Medical 2024 年年終財務業績電話會議。

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

（操作員指示）謝謝。現在我想把電話轉給 Jackie Cosman。請繼續。

Thank you, Calvin. Good afternoon, and thank you for joining the SeaStar Medical year-end 2024 financial results conference call. I'm Jackie Cosman with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, Chief Executive Officer; David Green, Chief Financial Officer; Dr. Kevin Chung, Chief Medical Officer; and Tim Varacek, Senior Vice President of Commercial and Business Operations.

謝謝你，卡爾文。下午好，感謝您參加 SeaStar Medical 2024 年年終財務業績電話會議。我是 Wheelhouse Life Science Advisors 的 Jackie Cosman。今天與我一起出席 SeaStar Medical 會議的還有執行長 Eric Sc​​hlorff；大衛·格林（David Green），財務長；首席醫療官 Kevin Chung 博士；以及商業和業務營運高級副總裁 Tim Varacek。

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 our list and descriptions of risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission at sec.gov.

我想提醒聽眾，管理階層在本次電話會議中發表的評論將包括聯邦證券法所定義的前瞻性陳述。這些前瞻性陳述涉及風險和不確定性，可能導致實際結果與預期結果有重大差異。有關風險和不確定性的清單和描述，請查看 SeaStar Medical 向美國證券交易委員會提交的文件（網址為 sec.gov）。

Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, March 27, 2025. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law.

此外，本次電話會議的內容僅包含截至現場直播日期（2025 年 3 月 27 日）準確的資訊。除非法律要求，否則 SeaStar Medical 不承擔修改或更新任何聲明以反映事件或情況的義務。

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

現在我想把電話轉給艾瑞克。艾瑞克？

Yeah, 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. With the launch of QUELIMMUNE, which Tim will talk about shortly, we have witnessed truly amazing patient outcomes about how our SCD therapy has saved lives.

是的，謝謝你，傑基。感謝大家今天的到來。我們很高興與您分享我們過去一年的成就，更重要的是，我們未來的計劃以及我們對 SeaStar Medical 所做工作的熱情。隨著 QUELIMMUNE 的推出（Tim稍後會談到這一點），我們見證了我們的 SCD 療法如何拯救生命的真正令人驚嘆的患者結果。

One example was recently sent for publication by investigators at the University of Michigan, where the patient had a 95% 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.

密西根大學的研究人員最近將一個例子送去發表，其中患者的預期死亡率為 95%。經過SCD治療後，他們的腎功能恢復正常，恢復化療，回家了。我們也見證了幾乎可以肯定的關鍵器官損傷得到阻止，兒童可以從 ICU 或重症監護病房出院，而無需終生進行腎臟替代治療。

For us, these truly amazing clinical cases speak loudly of the opportunity for our SCD therapy as a potential treatment for the approximate 1 million patients that each year face the consequence of destructive hyper-inflammation that can damage critical organs and take lives. 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.

對我們來說，這些真正令人驚嘆的臨床病例充分說明了我們的 SCD 療法有機會為每年約 100 萬名面臨破壞性過度發炎後果的患者提供潛在的治療，這種發炎可能會損害重要器官並奪走生命。我們估計，治療其他嚴重發炎疾病（如心腎症候群、肝腎症候群和慢性透析）的長期機會將使我們的機會遠遠超出我們為 SCD 療法確定的初始市場。

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 QUELIMMUNE and the achievement of our clinical development efforts with institutions like Stanford, Cleveland Clinic, and Mayo Clinic going to the NEUTRALIZE-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.

簡而言之，我們對所獲得的機會感到非常興奮，並將 2025 年視為增長和發展勢頭的一年，新的頂級兒科醫療中心將採用 QUELIMMUNE，我們與斯坦福、克利夫蘭診所和梅奧診所等機構合作開展臨床開發工作，將進行 NEUTRALIZE-AKI 成人關鍵研究，將我們的第二種治療產品推向比兒童市場的主要 KI 市場。

Our strong momentum coming into 2025 has been fueled by our significant accomplishments in 2024. We not only received our first product approval for QUELIMMUNE, but we advanced our NEUTRALIZE-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.

我們在 2024 年取得的重大成就推動了我們在 2025 年的強勁發展勢頭。我們不僅獲得了 QUELIMMUNE 的首個產品批准，還推進了 NEUTRALIZE-AKI 臨床開發計劃，並透過獲得 CMS 保險來支付醫療中心治療參加試驗的 Medicare 或 Medicaid 患者所產生的某些費用，從而降低了試驗成本。我們還獲得了第四個慢性透析突破性設備稱號，並且透過在主要期刊上發表手稿和在醫學會議上發表演講，擴大了醫學界對我們的 SCD 療法的理解。

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 2024. 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.

此外，我們透過在美國和加拿大獲得關鍵專利，進一步確保了我們一流的專有技術。我們也於 2024 年 1 月任命醫療保健產業資深人士 David Green 為財務長。在向商業階段公司過渡期間，戴夫一直在努力管理我們的資本結構，確保額外資本，並加強我們的控制環境。

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. We activated two additional sites in our NEUTRALIZE-AKI pivotal clinical study, and the FDA approved a feasibility study for our SCD therapy as a treatment for cardiorenal syndrome as a bridge to left ventricular assist device implantation.

2025年已取得開門紅。在 2024 年轉變銷售和分銷模式後，短短三個月內我們就增加了兩個新客戶，即商業客戶。我們在 NEUTRALIZE-AKI 關鍵臨床研究中啟動了另外兩個站點，FDA 批准了我們的 SCD 療法作為心腎綜合徵治療的可行性研究，作為左心室輔助裝置植入的橋樑。

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 QUELIMMUNE therapy. Previous winners have included Merck, Johnson & Johnson and UnitedHealthcare. This is a huge honor and recognition to our team at SeaStar Medical, who continues to focus on improving clinical outcomes.

就在上週，著名的腎臟疾病倡議組織美國國家腎臟基金會宣布，SeaStar Medical 榮獲 2025 年企業創新者獎。該獎項旨在表彰透過解決未滿足的臨床需求或改進現有的實踐、治療或技術來推動腎臟病學領域發展的行業領導者。我們很榮幸今年獲得該獎項，因為我們透過批准和引入 QUELIMMUNE 療法為改善 AKI 兒科患者的生活做出了重大貢獻。往屆得獎者包括默克公司、強生公司和聯合健康保險公司。對於我們 SeaStar Medical 團隊來說，這是一個巨大的榮譽和認可，我們將繼續致力於改善臨床結果。

Now, before I turn it over -- the call to Tim, I'd like to talk about our expectations for QUELIMMUNE 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.

現在，在我把電話轉給Tim之前，我想談談我們對 QUELIMMUNE 作為商業產品的期望。我們的第一款產品正處於商業化的啟動階段，預計在美國每年約有 4,000 名兒科患者進入這個小型市場。與任何發布一樣，存在一定程度的不可預測性，帳戶轉換時間可能會大不相同。

This dynamic is further compounded with QUELIMMUNE, 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.

這種動態在 QUELIMMUNE 中進一步加劇，特別是因為我們的採用過程要求我們與研究審查委員會 (IRB) 合作，以實施患者登記，這是我們根據人類設備豁免批准對 FDA 做出的承諾的一部分。

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 QUELIMMUNE into their workflow protocols.

正如我之前所說，我們對迄今為止第一批商業客戶的回饋感到非常高興，現在我們有越來越多的客戶正在參與採用流程。我們的 2024 年銷售情況反映了吸引客戶並讓他們快速將 QUELIMMUNE 納入其工作流程協議所需的時間表。

As this process becomes more routine for them, we expect customers to expand their use of QUELIMMUNE 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 QUELIMMUNE 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.

隨著這個過程對他們來說變得越來越常規，我們預計客戶將擴大 QUELIMMUNE 的使用範圍，讓更多符合該療法使用標準的患者受益。也就是說，隨著我們推出 QUELIMMUNE 並擴大其在新站點的使用範圍，我們的銷售額將會不穩定。在這個早期階段，更重要的指標是關注有多少機構經歷了採用過程，最終將帶來產品銷售和收入的成長。

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.

我們打算提供有關透過 IRB 採用流程的客戶數量的最新信息，以便在發佈時提供更有意義的指標。由於推出產品本身存在不確定性，我們不會提供指導，但我們會說，我們對我們的進展感到滿意，並相信我們有望實現 2025 年的內部收入目標。

With that, I'd like to turn the call over to Tim.

說完這些，我想把電話轉給提姆。

Thanks, Eric. And thanks, everyone, for joining us today on the SeaStar Medical call. I'd like to start by highlighting a couple of points about our QUELIMMUNE 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 QUELIMMUNE have a very poor prognosis, and their mortality rate is greater than 50% when receiving the current best standard of care treatment of continuous renal replacement therapy, also known as CRRT plus antibiotics.

謝謝，埃里克。感謝大家今天參加 SeaStar Medical 電話會議。首先我想強調一下我們的 QUELIMMUNE 療法的幾點。首先，這種療法確實為重症病患兒、他們的家庭以及醫學界帶來了新的希望。接受 QUELIMMUNE 治療的兒童預後非常差，在接受目前最佳標準治療方案連續性腎臟替代療法（也稱為 CRRT 加抗生素）時，其死亡率超過 50%。

Prior to the introduction of QUELIMMUNE, 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.

在 QUELIMMUNE 推出之前，尚無核准的療法或藥物可以阻止細胞激素風暴，這種風暴對這些年輕患者造成多重器官衰竭和生命損失的巨大風險。

The clinical data of QUELIMMUNE that was reviewed by FDA in their decision to approve the product under humanitarian device exemption, or HDE, observed that almost 8 in 10 patients with pediatric acute kidney injury and sepsis survive with QUELIMMUNE therapy on board versus only 5 in 10 patients on standard of care. That is a 60% observed higher survival rate. And this data has fueled great interest from the most highly regarded children's medical centers through regional and community pediatric hospitals.

FDA 在根據人道主義設備豁免 (HDE) 批准該產品時審查了 QUELIMMUNE 的臨床數據，結果發現，在接受 QUELIMMUNE 治療的兒童急性腎損傷和敗血症患者中，幾乎有 80% 的患者能夠存活，而接受標準治療的患者中只有 50% 能夠存活。這意味著存活率提高了 60%。這些數據引起了最受尊敬的兒童醫療中心、地區和社區兒科醫院的極大興趣。

Pediatric medical centers are truly interested in bringing QUELIMMUNE 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 2024. 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 QUELIMMUNE.

兒科醫療中心確實有興趣將 QUELIMMUNE 引入其設施。我很高興地報告，從 2024 年第三季到第四季度，正在實施該方案的兒科醫院數量翻了一番。隨著我們繼續將希望採用 QUELIMMUNE 的新兒科醫院加入隊列，今年第一季這一數字進一步增加。

As mentioned, we currently have five pediatric hospitals that are up and running, have been purchased, and utilize QUELIMMUNE 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 QUELIMMUNE, 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.

如上所述，我們目前有五家兒科醫院正在運作、被收購並採用 QUELIMMUNE 療法。這些醫療中心採用任何新設備的過程可能都很漫長，並且涉及一些典型步驟，例如開發產品冠軍、進行站點的價值評估過程以及成為合格供應商。就 QUELIMMUNE 而言，FDA 的批准後註冊要求為流程增加了一個額外的步驟，這通常會花費更多時間。每個醫院系統在所需的監管框架內的做法略有不同，我們會進行調整以支援它們，並儘可能快速有效地完成流程。

Ultimately, this boils down to time to activation, and that can vary from several months to 8 to 10 months. 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 QUELIMMUNE 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.

最終，這歸結為激活時間，並且可能從幾個月到 8 到 10 個月不等。隨著我們了解兒科醫院的具體流程並發現我們可以經常延續的效率，我們不斷地改善對兒科醫院的支援。需要明確的是，我提供了有關激活過程的更多細節，因為我想強調我們在採用 QUELIMMUNE 療法的願望與兒科醫院激活的漫長過程之間存在的巨大差距，並強調兒科腎病學和 ICU 團隊在我們與他們一起完成採用過程時對支持這一努力的堅定承諾。

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 7 out of every 10 pediatric hospitals we approach the gauge interest ultimately commit to QUELIMMUNE 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 QUELIMMUNE sales in our first quarter of 2025 compared to the fourth quarter of 2024. 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.

換句話說，我們認為在這些兒科醫院，採用不是是否的問題，而是何時的問題。我們迄今為止的內部追蹤表明，我們接觸的每 10 家兒科醫院中，有 7 家最終承諾採用 QUELIMMUNE 療法。我很高興地說，我們目前活躍的兒科醫院報告了良好的結果。與 2024 年第四季相比，2025 年第一季 QUELIMMUNE 的銷售額有了顯著成長。正如 Eric 所說，在更多兒科醫院投入運作並且我們能夠了解這些醫院內病患就診節奏之前，銷售額將會不穩定。

With that framework of our QUELIMMUNE launch efforts, I'll now discuss our commercial opportunity for the SCD therapy platform. As mentioned, the pediatric AKI market is small, but there is a very high unmet medical need for treatment. When we obtained approval for QUELIMMUNE 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.

在我們的 QUELIMMUNE 啟動工作的框架下，我現在將討論 SCD 治療平台的商業機會。如上所述，兒科 AKI 市場規模較小，但未滿足的治療醫療需求非常高。當我們獲得針對該患者群體的 QUELIMMUNE 的批准時，我們意識到了一個極其重要的機會，可以為那些迫切需要治療的兒童提供一種治療方法，這種治療方法可以真正挽救他們的生命，或者減少或消除對長期腎臟替代治療的需求。

To put the market opportunity in perspective from the standpoint of SeaStar 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 million. 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 QUELIMMUNE therapy, and that will lead to consistent initial revenue for SeaStar Medical. 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.

從 SeaStar Medical 首次產品發布的角度來看待市場機遇，根據我們的估計和內部假設，我們認為總目標市場規模約為 1 億美元。現在，我們當然無法佔領整個市場，但考慮到目前嚴重的未滿足臨床需求和缺乏任何治療方法，我們相信，隨著時間的推移，我們將透過 QUELIMMUNE 療法滲透到相當一部分患者群體中，這將為 SeaStar Medical 帶來穩定的初始收入。我們未來的適應症針對的是更大的市場，我們正走在堅實的發展道路上，以獲得更多批准並在這些市場中佔有一席之地。

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 2026, assuming positive clinical trial results and FDA approval.

我們的技術可擴展至多種適應症，並且我們突破性的設備指定應該能夠使 FDA 對 SCD 療法進行嚴格的審查流程。我們的關鍵試驗 NEUTRALIZE-AKI 正在研究成人 AKI 適應症，這代表著一個大約相當於兒科人群 50 倍的治療機會，每年約有 200,000 名患者面臨器官衰竭並可能失去生命，除了目前由 CRRT 和抗生素組成的標準治療外，沒有 FDA 批准的治療選擇。假設臨床試驗結果呈陽性並獲得 FDA 批准，我們目前預期成人 AKI 的上市時間表是 2026 年下半年。

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 QUELIMMUNE in hospital systems where we already have a commercial presence combined with the fact that there are no other therapies to address this condition. At our current projected revenue per patient, this would present a total market opportunity of $4.5 billion. Even at modest market penetration projections, the revenue upside would be significant for SeaStar Medical.

我們相信，與兒科 AKI 相比，採用該療法的時間將更加有利，因為我們應該能夠利用客戶在醫院系統中對 QUELIMMUNE 的學習和經驗，我們已經在醫院系統中擁有商業存在，再加上沒有其他療法可以治療這種疾病的事實。以我們目前預期的每位患者收入計算，這將帶來總計 45 億美元的市場機會。即使市場滲透率預測不高，SeaStar Medical 的營收成長空間也將十分可觀。

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 1 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 SCD therapy may serve. So this is why we are so excited at SeaStar Medical.

對我們來說，成人 AKI 適應症只是後續一系列適應症的開始。我們估計，整個市場規模約為 100 萬名患者，目前尚無核准療法來治療慢性透析、心腎症候群、肝腎症候群、急性呼吸窘迫症候群以及我們的 SCD 療法可能治療的其他適應症。這就是為什麼我們對 SeaStar Medical 如此興奮。

And now I will turn the call over to our Chief Medical Officer, Kevin Chung. Kevin?

現在我將把電話轉給我們的首席醫療官 Kevin Chung。凱文？

Thanks, Tim. And thanks to our listeners for joining us today. I am pleased to report that our NEUTRALIZE-AKI 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 24-hour treatments with the SCD therapy will improve 90-day survival or recovery from kidney failure in patients with AKI requiring CRRT when compared to CRRT alone.

謝謝，蒂姆。感謝我們的聽眾今天加入我們。我很高興地報告，我們的 NEUTRALIZE-AKI 關鍵試驗繼續以穩定的招募速度進行，預計 200 名受試者中已有 94 名參加了試驗。眾所周知，NEUTRALIZE-AKI 是一項隨機對照關鍵試驗，旨在確定與單獨進行 CRRT 相比，使用 SCD 療法進行長達 10 次連續 24 小時治療是否可以改善需要 CRRT 的 AKI 患者的 90 天生存率或腎衰竭恢復情況。

We plan to enroll approximately 200 patients in an intensive care unit setting in the trial. The primary endpoint is a composite of mortality or dialysis dependency of 90 days. We plan to conduct an interim analysis once we have reached the 90-day primary endpoint in the first 100 enrolled subjects. [Pulled] data will be analyzed and presented to our Data Safety Monitoring Review Board, or DSMB.

我們計劃在試驗中招募約 200 名重症監護病房患者。主要終點是死亡率或 90 天透析依賴性的綜合結果。我們計劃在前 100 名入組受試者達到 90 天主要終點後進行中期分析。 [提取的]數據將被分析並提交給我們的數據安全監測審查委員會 (DSMB)。

At that time, based on the differences in outcome between the treated subjects versus controls, the DSMB will provide a recommendation to SeaStar Medical and the NEUTRALIZE-AKI 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. 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 [and will come time] in April.

屆時，根據接受治療的受試者與對照組之間的結果差異，DSMB 將向 SeaStar Medical 和 NEUTRALIZE-AKI 研究人員提供有關如何進行試驗的建議。雖然我們不能確定獨立 DSMB 的建議，但我們設計了中期分析以確保我們能夠正確地進行研究。如果我們這樣做了，DSMB 的結論就是繼續按計劃進行試驗，以實現 200 的目標。我們知道，四月我們將接待 100 名患者。

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 CRRT circuits along with the SCB. In spite of this, we managed to enroll 24 new subjects in just the past three months. Thankfully, the shortage has now resolved. We are incredibly grateful to our fantastic investigators who jumped through many hoops to get subjects recruited.

鑑於我們最近新站點的啟用，我們預計今年剩餘時間的招生速度將保持穩定，甚至加快。最近，我們面臨一些挑戰，因為我們的 CRRT 電路和 SCB 中使用的檸檬酸鹽在全國範圍內短缺。儘管如此，我們僅在過去三個月就招收了 24 名新學生。值得慶幸的是，短缺問題現已解決。我們非常感謝我們優秀的研究人員，他們克服重重困難招募受試者。

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 NEUTRALIZE-AKI 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. You can be sure they will be armed with definitive outcomes data from our pivotal trial.

自今年年初以來，我們還增加了兩個新站點，最近增加了位於達拉斯的德克薩斯大學西南分校。正如 Eric 所提到的，我們有許多著名的醫療機構，包括史丹佛大學、克利夫蘭診所和梅奧診所，現在正在招募患者參與 NEUTRALIZE-AKI 研究。我之所以強調這些站點，是因為我們預計，當將這種療法推廣到成人 ICU 市場時，它們和其他知名站點將成為我們早期的臨床冠軍。您可以確信，他們將獲得我們關鍵試驗的明確結果數據。

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 NEUTRALIZE-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 loss, we intend to rapidly analyze and report our data to the international medical community.

此外，我們知道許多冠軍將與國際重症監護和腎臟病學界分享他們的個人經驗，最終目標是將我們的治療方法納入臨床實踐指南。NEUTRALIZE-AKI 試驗的積極結果將有助於提高所有患有危及生命的 AKI 患者的當前護理標準。我們非常幸運能夠在合適的地點有合適的研究人員參與我們的試驗。一旦我們完成試驗並實現 100% 數據遺失，我們打算快速分析並向國際醫學界報告我們的數據。

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 2026.

如果我們達到主要終點，我們計劃完成 PMA 申請並將其提交給 FDA。我們為成人 AKI 授予的突破性設備頭銜應該有助於促進我們與 FDA 在審查和批准過程中的快速溝通。因此，我們希望在 2026 年下半年某個時候向患者提供該產品。

Now looking into the future, our stepwise goal is to inspire wide clinical adoption of the SCD therapy, first to treat as many of the approximate 200,000 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.

展望未來，我們的逐步目標是激發 SCD 療法在臨床上的廣泛應用，首先治療美國約 20 萬名 AKI 患者。時機成熟時，我們將把業務擴展到美國境外，為全球數百萬可能從我們的 SCD 療法中受益的患者提供治療。

Our strategic goal as a company is to widen the addressable market rapidly to target other critical unmet medical needs. I would like to emphasize that the NEUTRALIZE-AKI study is really three trials in one. We intend on analyzing and reporting the impact of the SCD in the cohort of patients with sepsis and ARDS as well. Based on the mechanism of action of SCD, we have good reason to believe we will be able to show benefit in these two subpopulations.

作為一家公司，我們的策略目標是迅速擴大目標市場，以滿足其他關鍵的未滿足醫療需求。我想強調的是，NEUTRALIZE-AKI 研究其實是三項試驗合一。我們打算分析和報告 SCD 對敗血症和 ARDS 患者群體的影響。基於 SCD 的作用機制，我們有充分的理由相信我們將能夠在這兩個亞群中展現益處。

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. We believe that AKI is just the beginning.

除了這種適應症之外，我們還獲得了另外三項突破性設備稱號，包括治療心腎綜合徵患者、肝腎綜合徵患者和終末期腎病患者。鑑於我們的療法具有與器官和疾病無關的特性，未來還會有更多適應症。我們相信 AKI 只是一個開始。

Additionally, we announced last year that the NIH provided a $3.6 million grant for a clinical trial to evaluate our SCD therapy in patients with cardiorenal syndrome awaiting LVAD implantation. And in January, the FDA approved a feasibility study for this indication. The trial will be led by the inventor of the SCD therapy, Dr. David Humes from the University of Michigan and one of our key scientific advisors. The [NEUTRALIZE-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.

此外，我們去年宣布，美國國立衛生研究院 (NIH) 提供了 360 萬美元的資助，用於一項臨床試驗，以評估我們對等待 LVAD 植入的心腎綜合徵患者的 SCD 療法。今年一月，FDA 批准了此適應症的可行性研究。該試驗將由 SCD 療法的發明者、密西根大學的 David Humes 博士和我們的主要科學顧問之一領導。[NEUTRALIZE-CRS] 試驗預計將在最多 5 個臨床地點招募 20 名患者。這項初步研究的結果將有助於我們了解該適應症的下一步。我們的醫療事務和研究團隊正在與蒂姆和他的商業團隊密切合作，以確定最合適的下一個最佳疾病狀態，以透過我們的疾病和器官不可知療法來應對。

With that, as a summary of our clinical development efforts and goals, I'll turn the call over to our CFO, David Green.

就此，作為我們臨床開發工作和目標的總結，我將把電話轉給我們的財務長大衛‧格林 (David Green)。

Thank you, Kevin, and thank you all for joining us today. I'll start with a few comments about our fiscal year ended December 31, 2024, and conclude with some of our expectations for 2025. First, for some housekeeping, please note that our Form 10-K will be filed with the SEC in the next 24 hours. You can find it at seastarmedical.com or at sec.gov.

謝謝你，凱文，也謝謝大家今天加入我們。我將首先就我們截至 2024 年 12 月 31 日的財政年度發表一些評論，最後總結我們對 2025 年的一些期望。首先，為了方便處理，請注意，我們的 10-K 表格將在接下來的 24 小時內提交給美國證券交易委員會 (SEC)。您可以在 seastarmedical.com 或 sec.gov 上找到它。

As you've heard from my colleagues, 2024 was a transformative year for SeaStar Medical. We made great strides in strengthening our financial position, gaining FDA approval to sell and launch QUELIMMUNE, our first commercial product for pediatrics, and pushing forward our NEUTRALIZE-AKI pivotal trial for adult AKI patients.

正如您從我的同事那裡聽到的，2024 年是 SeaStar Medical 的轉型之年。我們在加強財務狀況、獲得 FDA 批准銷售和推出我們第一款兒科商業產品 QUELIMMUNE 以及推進針對成人 AKI 患者的 NEUTRALIZE-AKI 關鍵試驗方面取得了長足進步。

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 million and we were very careful with the use of the new capital. We used $16 million to fund operations which are focused largely on our adult clinical trials and selling QUELIMMUNE for pediatrics. We extinguished approximately $6 million of debt. We reduced accounts payable by $1.3 million and ended the year with $1.8 million in cash.

從財務角度來看，我對我們 2024 年的表現非常滿意。我們透過增加新資本和減少債務和其他負債大幅改善了資產負債表。我們籌集了大約 2500 萬美元，並且非常謹慎地使用新資本。我們使用了 1600 萬美元來資助主要集中於成人臨床試驗和銷售兒科 QUELIMMUNE 的運作。我們償還了大約 600 萬美元的債務。我們將應付帳款減少了 130 萬美元，年底的現金餘額為 180 萬美元。

Further, as we reported last month, we also raised another $6 million 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. With all of that hard work behind us, we've positioned the company to build on the first two quarters of commercial revenue for QUELIMMUNE and complete the adult AKI pivotal trial.

此外，正如我們上個月報導的那樣，我們還在今年 2 月又籌集了 600 萬美元。除了加強資產負債表之外，我們還克服並解決了先前存在的重大缺陷，並對財務報告實施了更強有力的控制。經過所有這些艱苦的努力，我們已準備好讓公司在 QUELIMMUNE 前兩個季度的商業收入基礎上再接再厲，並完成成人 AKI 關鍵試驗。

From a commercial perspective, after receiving FDA approval for our pediatric product, QUELIMMUNE, in Q1 2024 and launching in Q3 2024, 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.

從商業角度來看，在2024年第一季我們的兒科產品QUELIMMUNE獲得FDA批准並於2024年第三季推出後，我們進行了重大策略轉變，從分銷網絡模式轉變為直銷模式。這項變更使我們能夠全面管理銷售和分銷週期，並避免昂貴的分銷費用。它還使我們能夠更好地利用我們的產品專業知識以及與針對醫院的 ICU 和腎臟病臨床醫生的密切關係。

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 QUELIMMUNE therapy into their hospital for their pediatric patients. 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 QUELIMMUNE and complete the adult AKI pivotal trial.

這項措施已初見成效。正如提姆之前提到的，我們聯繫過的許多醫院最終都承諾將 QUELIMMUNE 療法引入醫院，用於治療兒科患者。這最終將帶來客戶群的不斷增長，並平滑最初訂單速度不均勻的問題，這是在初始發布階段預期會出現的。隨著銷售模式調整的完成，我們已做好準備，在 QUELIMMUNE 前兩個季度的商業收入基礎上再接再厲，完成成人 AKI 關鍵試驗。

Now for a few top-line comments on our income statement. With the launch of QUELIMMUNE 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 QUELIMMUNE. 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 new hospitals coming on as customers as we enable more children to benefit from our life-saving therapy.

現在，讓我們針對我們的損益表提出幾點重要評論。隨著第三季 QUELIMMUNE 的推出，我們在 2024 年實現了第一筆產品收入，淨收入為 134,000 美元。正如蒂姆所描述的，這筆微薄的收入反映了客戶採用的及時性。雖然我們預計在推出初期銷售情況會不穩定，但我們預計，隨著購買 QUELIMMUNE 的客戶總數的增加，我們將看到收入整體呈現成長趨勢。事實上，我很高興地報告，隨著購買客戶的不斷增加，我們在第一季迄今的銷售額出現了良好的上升。總而言之，我們對新醫院成為客戶感到非常樂觀，因為我們可以讓更多的兒童受益於我們的救命療法。

Moving on to our cost of goods sold, the current financial statements reflect no GAAP cost of goods sold from the sale of QUELIMMUNE. 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 QUELIMMUNE.

談到我們的銷售成本，目前的財務報表並沒有反映出出售 QUELIMMUNE 所產生的 GAAP 銷售成本。GAAP 會計要求將庫存作為研發成本計入費用，這些庫存是在我們獲得 FDA 批准銷售 QUELIMMUNE 之前製造的。

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. We anticipate these costs to hit the P&L later this year. Our operating expenses for 2024 increased by approximately $3.6 million compared to 2023, primarily due to increased spending at our commercial launch and growing enrollment in the NEUTRALIZE-AKI trial. And finally, our net loss for the year declined to $24.8 million versus a loss of $26.2 million in 2023, with approximately $6.9 million of the 2024 loss from non-cash items.

當我們作為一家商業公司收購、製造和銷售新庫存時，我們將根據 GAAP 會計將這些費用記錄為銷售成本。我們預計這些成本將在今年稍後影響損益表。我們 2024 年的營運費用與 2023 年相比增加了約 360 萬美元，這主要是由於我們在商業發佈時的支出增加以及 NEUTRALIZE-AKI 試驗的報名人數增加。最後，我們今年的淨虧損下降至 2,480 萬美元，而 2023 年的虧損為 2,620 萬美元，其中 2024 年的損失中約有 690 萬美元來自非現金項目。

Looking forward, we expect to focus our resources at our top three objectives: One, commercial sales of QUELIMMUNE; two, completing our NEUTRALIZE-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.

展望未來，我們預期將資源集中在三大目標上：一、QUELIMMUNE 的商業銷售；二、完成針對成人的 NEUTRALIZE-AKI 關鍵試驗；第三，準備在成人關鍵試驗完成後提交上市前授權 (PMA)。我們非常高興能夠為成年 AKI 族群提供服務，據估計，成年 AKI 族群的數量大約是兒科族群的 50 倍。

And finally, as we move our strategic objectives forward, we expect the momentum to continue as we bring our lifesaving SCD therapy to more patients and clinicians, and as more investors notice the significant market opportunity developing for our products.

最後，隨著我們策略目標的不斷推進，我們預計這種勢頭將繼續下去，因為我們將拯救生命的 SCD 療法帶給更多的患者和臨床醫生，並且更多的投資者註意到我們產品的巨大市場機會。

And with that, I'll hand the call back to Eric.

說完這些，我就把電話交還給 Eric。

Yeah, 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 2025, 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 a near-term opportunity to capture a sizable portion of a large market for treating adult patients with AKI on CRRT, we believe that SeaStar Medical is a highly differentiated company with derisked assets and poised for growth.

是的，謝謝，大衛。我們今天舉行的第一次財務業績電話會議的目標是向您概述我們在 2024 年和 2025 年初取得的成功，並清楚地說明我們為何相信 SeaStar Medical 的未來機遇巨大。憑藉市場上的商業產品和近期在 CRRT 治療成人 AKI 患者的龐大市場中佔據相當大份額的機會，我們相信 SeaStar Medical 是一家高度差異化的公司，擁有去風險資產並準備實現成長。

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. 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.

除了這些適應症之外，我們相信，我們在商業環境中為患者提供救生產品的能力還受到三個關鍵因素的加速：第一，突破性的設備指定，有可能加快審批速度；二，我們的治療是通過一種僅需一次關鍵試驗即可獲得批准的設備進行的；第三，我們現有的設備可以適用於多種適應症。換句話說，我們不需要為尋求批准的每種治療適應症製造專門的設備。我們相信，這可以縮短產品上市時間並實現規模經濟，這是我們行業中的公司通常無法實現的。

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 as a substantial gap in our current market cap and the outlook that we have for the company.

簡而言之，我們相信我們將繼續為我們的投資者和利害關係人創造巨大的價值，並且我們將努力縮小我們目前市值與我們對公司的前景之間的巨大差距。

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

說完這些，我將請接線生開始回答問題。操作員？

(Operator Instructions) Anthony Vendetti, Maxim Group.

（操作員指示）Anthony Vendetti，Maxim Group。

Thanks. Yes. So I wanted just to first start on the NEUTRALIZE-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 90 days after that, right? And after the 100th 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 expect?

謝謝。是的。所以我只想先開始 NEUTRALIZE-AKI 試驗。凱文，我想也許您說過，預計 200 名患者中已經有 94 名入組。您預計在 100 人之後提供中期分析，所以您很快就能在 90 天後讓他們入學，對嗎？第 100 名學生入學後，情況是否正確？鑑於我們距離這一目標僅剩 6 名患者，那麼您對此的最佳估計是什麼？您對這一目標將在哪個季度、哪個月發生或預計發生的最佳估計是什麼？

Hi, Anthony, this is Eric. Thanks for joining today. Hey, I think Kevin did have to drop off, so let me take your question in a couple parts. So the first one is, yes, we are 94 patients. We anticipate being able to get to that 100 sometime likely to be the beginning of April, somewhere in that first part of April. As it relates to the timing of once we get to 100 patients, yeah, it is 90 days. That's what the primary endpoint is. It's a 90 day to get out 90 days to either mortality and or dialysis dependency.

你好，安東尼，我是艾瑞克。感謝您今天的加入。嘿，我認為凱文確實必須下車，所以讓我分成幾個部分來回答你的問題。第一個問題是，是的，我們有 94 名患者。我們預計能夠在 4 月初，也就是 4 月初的某個時候達到 100 這個數字。至於我們一旦達到 100 名患者的時間，是的，是 90 天。這就是主要終點。這是 90 天的時間，可以擺脫 90 天的死亡或透析依賴。

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 90 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.

然後收集此時的數據並提交給 IRB 或 DSMB 進行審查。因此，我們預計在 90 天後不久，我們將能夠分享一些來自資料安全監測委員會 (DSMB) 的成果和評估。

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 would be enrolled 90 days after that. Let's say that gets us to beginning of July, and then a couple weeks of analysis before you provide it. So end of July, beginning of August to provide an interim look or interim analysis.

好的，艾瑞克，如果我要稍微安排時間的話，那將是在四月份的某個時候，四月初，100 名患者將在 90 天後入組。假設我們到 7 月初，然後進行幾週的分析，然後您才能提供它。因此，7 月底、8 月初將提供中期展望或中期分析。

Yeah, that sounds about in the ballpark.

是的，聽起來大致是如此。

In the ballpark, okay great. As I guess, you continue to roll the QUELIMMUNE product out, what are your current plans in '25 to expand your sales force capabilities? Maybe just give a little bit of an update on that.

在球場上，好吧，很棒。我猜，您會繼續推出 QUELIMMUNE 產品，目前在 25 年有什麼計劃來擴大您的銷售隊伍能力？也許只是對此提供一點更新。

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

是的。提姆，你為什麼不解決這個問題？

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. So we have no shortage of new accounts that are interested in terms of our pipeline.

當然。安東尼，我的意思是，我想說的第一件事是，這是一個很小的市場，我想說我們現在的規模合適。我們擁有面向現場的工作人員，更重要的是，我們還有內部的營運支援。這確實是──這是集體努力的結果。這不僅與商業團隊有關。我們擁有現場熟練的護士，一旦這些帳戶準備好激活，他們就會對其進行培訓。他們會培訓他們如何使用該產品。因此，我們並不缺乏對我們的管道感興趣的新客戶。

And we're working through the process with each of these folks. 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.

我們正在與每個人一起完成這個過程。就其遵循的流程和流程的及時性而言，每個帳戶都是獨一無二的。所以我認為現在我們對目前的狀況感到滿意。我們擁有健康的管道，在進入 2025 年之際，我們正在與他們一起完成 IRB 流程和客戶設定流程。

Okay, great. That's helpful. 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? What does that look like? And like I said, what have you learned from the first hospital?

好的，太好了。這很有幫助。也許只是——我知道每個客戶都是不同的，但也許你從前幾次醫院激活中學到了什麼？那麼，將客戶從管道轉換為啟動時，典型的轉換是什麼樣的呢？這通常需要多長時間？那是什麼樣子的？就像我說的，你從第一家醫院學到了什麼？

So 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.

所以我認為最大的收穫是 IRB 本身，它實際上包含幾個組成部分。這是我們的設備，還有病人登記處，我們已經討論過了。因此，設備部分實際上是 IRB 審查中較為簡單的部分。其中更複雜的部分實際上是註冊表。因為從某種程度上來說，它是一個類似的框架——它實際上是一個後監控登記處。

So there are more people involved in the hospital that will ultimately evaluate the patient. 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.

因此，醫院中會有更多的人參與，最終對病人進行評估。他們將獲取該患者初步分析的數據。所有這些因素都推動著醫院內登記處建立的整個行政管理工作。因此，從 IRB 的角度來看，這需要更仔細的審查。

What was the second part of your question there, Anthony?

安東尼，你問題的第二部分是什麼？

Yeah, 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 do differently?

是的，我想從最初的幾次激活中，您是否學到了什麼特別的東西，可以對您的流程進行調整或做些不同的事情？

I would say what we've learned is not really worth discussing on the call. It's more nuanced aspects of just creating more efficient process for the customer once we understand their behavior and how they do things and modifying ours and our support to get them there. But 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 kind of play the hand you're dealt. 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.

我想說，我們所了解到的情況並不值得在電話中討論。一旦我們了解了客戶的行為和做事方式，我們就會為客戶創建更有效率的流程，並修改我們的方法和支援以幫助他們實現目標，這涉及更細緻的方面。但整體來說，各個高階的醫院的流程都是相同的。一旦進入單一系統，它就會分解成不同的組件。有些人比其他人擁有更多的支持和資源。所以你就得按照自己手中的牌去行動。您與這些人一起工作，我們會盡一切努力與他們一起盡可能快速、有效率地完成整個過程。

Okay, great. 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's 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 obviously, that's our primary goal, and that does allow us then to sell product directly to the hospital.

好的，太好了。安東尼，我想補充一點，我們最大的關鍵經驗之一可能是 IRB 流程的脫鉤。正如蒂姆所解釋的，有一個 HDE 審批流程，其中可能包括價值評估委員會和採購等內容。然後你就得到了註冊表。但我認為我們最近能夠做的是真正開始將它們分開，因為透過我們與 FDA 的關係，他們也鼓勵我們，如果我們能夠治療患者，即使該站點的註冊尚未完成，我們也應該盡力挽救孩子的生命，這顯然是我們的主要目標，這確實使我們能夠將產品直接賣給醫院。

Yeah. 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.

是的。我們也了解到，讓 ICU 醫師和腎臟科醫師儘早參與到治療過程中也非常有幫助，可以節省大量時間。

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.

目前沒有其他問題。說完這些，我將把電話轉回給 Jackie Cosman 做最後的總結發言。請繼續。

Thank you, Calvin, 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 ir@seastarmed.com or visit our website and see our latest news, product, pipeline, and company information. Thank you and goodbye.

謝謝你，卡爾文，也謝謝大家今天參加 SeaStar Medical 年終財務業績電話會議。如果您有任何疑問，請隨時透過 ir@seastarmed.com 與我們聯繫，或造訪我們的網站，查看我們的最新新聞、產品、管道和公司資訊。謝謝，再見。

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

女士們、先生們，我們的電話會議到此結束。感謝您的參與，並請您斷開線路。