SeaStar Medical Holding Corp (ICU) 2026 Q1 法說會逐字稿

Hello, and welcome to the SeaStar Medical first-quarter 2026 financial results conference call. (Operator Instructions) I would now like to hand the conference over to Jackie Cossmon. You may begin.

您好，歡迎參加 SeaStar Medical 2026 年第一季財務業績電話會議。（接線員指示）現在我想把會議交給 Jackie Cossmon。您可以開始了。

Thank you, Towanda. Good afternoon, and thank you for joining the SeaStar Medical First 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; Dr. Kevin Chung, Chief Medical Officer; Tim Varacek, Senior Vice President of Commercial and Business Operations; and Mike Messinger, Chief Financial Officer.

謝謝您，Towanda。各位下午好，感謝您加入 SeaStar Medical 2026 年第一季財務業績電話會議。我是 Wheelhouse Life Science Advisors 的 Jackie Cossmon。今天與我一同出席、來自 SeaStar Medical 的有：執行長 Eric Schlorff；醫務長 Kevin Chung 醫師；商務與營運資深副總裁 Tim Varacek；以及財務長 Mike Messinger。

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 and 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.

我想提醒各位聽眾，管理層在本次電話會議中的評論將包含符合聯邦證券法定義的前瞻性陳述。這些前瞻性陳述涉及風險與不確定性，可能導致實際結果與任何預期結果存在重大差異。關於這些風險與不確定性的清單與說明，請查閱 SeaStar Medical 向美國證券交易委員會提交的文件。

Furthermore, the content of the conference call contains information that is accurate only as of the date of the live broadcast, May 13, 2026. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law.

此外，本次電話會議內容所包含之資訊僅在直播當日（2026 年 5 月 13 日）為準確。除法律要求外，SeaStar Medical 不承擔修訂或更新任何陳述以反映事件或情況變化之義務。

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

現在我想把電話交給 Eric。Eric？

Thank you, Jackie, and thank you all for joining us today. We are making good progress towards achieving our 2026 goals and also maintaining a disciplined use of our financial resources. The increase in our QUELIMMUNE customer base has helped propel our first quarter QUELIMMUNE net revenue with a nearly 70% increase from the first quarter of 2025, with 7 new hospitals adopting the QUELIMMUNE therapy in the first quarter of 2026.

謝謝你，Jackie，也感謝各位今天加入我們。我們在達成 2026 年目標方面進展良好，同時也持續以嚴謹態度運用財務資源。QUELIMMUNE 客戶基礎的增加，推動我們第一季 QUELIMMUNE 淨營收較 2025 年第一季成長近 70%；2026 年第一季共有 7 家新醫院採用 QUELIMMUNE 治療。

Our goal this year is 15 new customers, and we are well on our way to achieving that. With our growing presence and the continued adoption of QUELIMMUNE in the pediatric AKI market, we believe we are on track to meet our net revenue goal of approximately $2 million for the year. More importantly, we are setting the stage for our next and potentially far larger market opportunity in the adult AKI market.

我們今年的目標是新增 15 家客戶，目前正穩步朝此目標前進。隨著我們的能見度提升，以及 QUELIMMUNE 在兒科 AKI 市場的持續採用，我們相信有望達成全年約 200 萬美元的淨營收目標。更重要的是，我們正在為下一個、且可能規模更大的市場機會奠定基礎——成人 AKI 市場。

To that end, we continue to enroll patients in the NEUTRALIZE-AKI pivotal trial with 198 patients enrolled of our planned total 339 patients. Last year, we determined that we would add new clinical sites to expand our enrollment efforts to reach completion of enrollment around the end of 2026.

為此，我們持續在 NEUTRALIZE-AKI 關鍵性試驗中招募病患，目前已入組 198 名病患，目標總入組數為 339 名。去年我們決定新增臨床試驗中心，以擴大招募力度，力求在 2026 年底左右完成入組。

Kevin and his team are working diligently to make this happen. It has been extremely rewarding to see the highest caliber medical institutions participate in our trial with UCLA as an example of one of the latest hospitals to join in and more on the way.

Kevin 與他的團隊正全力以赴推動此事。看到最高水準的醫療機構參與我們的試驗令人非常振奮；以 UCLA 為例，它是近期加入的醫院之一，且後續還會有更多機構加入。

In addition, we continue to work closely with the FDA on several fronts. First, we are discussing the elements of a modular PMA submission for the adult AKI indication, which we believe could speed the approval process.

此外，我們也在多個面向與 FDA 保持密切合作。首先，我們正在討論針對成人 AKI 適應症採用模組化 PMA 申請的要素，我們相信這可能加速核准流程。

Second, we are working with the FDA to obtain agreement on a rapid approval pathways for our SCD therapy. The SCD therapy is a potential life-saving therapy for indications where there are no treatments today, and we believe patients with hyperinflammation should have more immediate access to therapies that could reduce or avoid severe organ damage and potential loss of life.

第二，我們正與 FDA 合作，爭取就我們的 SCD 治療取得快速核准途徑的共識。SCD 治療對於目前尚無治療選項的適應症而言，可能是挽救生命的療法；我們相信高發炎反應（hyperinflammation）患者應能更即時取得可降低或避免嚴重器官損傷、並可能避免死亡的治療。

Finally, and before I turn the call over to Tim, we have maintained a strong financial discipline. Mike will share our efforts on this front shortly. And now I will turn the call over to Tim to discuss not only our commercial achievements, but how we are building a strong presence in the pediatric AKI community.

最後，在我把電話交給 Tim 之前，我們一直維持強而有力的財務紀律。Mike 稍後將分享我們在這方面的努力。現在我把電話交給 Tim，請他談談我們的商業成果，以及我們如何在兒科 AKI 社群中建立強勢的存在感。

Thanks, Eric, and thanks, everyone, for joining us today. I'm pleased to report that we ended the first quarter with strong momentum, and it's continuing into the second quarter of this year. As Eric noted, we added 7 additional customers in the first quarter, and importantly, we are seeing an uptick in orders from many of our customers.

謝謝你，Eric，也謝謝各位今天加入我們。我很高興報告，我們在第一季結束時展現強勁動能，且這股動能延續到今年第二季。如 Eric 所提，我們在第一季新增了 7 家客戶；更重要的是，我們看到許多客戶的訂單量正在上升。

Our QUELIMMUNE net revenue in the first quarter was $495,000, a solid increase of 69% from the first quarter of last year. As Eric indicated, this is a small but important market to us, not only because we believe QUELIMMUNE is saving lives and sparing organ function for young kids, but it also provides great validation of our SCD technology and importantly, it paves the way for future potential opportunities in the adult market.

我們第一季的 QUELIMMUNE 淨營收為 49.5 萬美元，較去年第一季穩健成長 69%。如 Eric 所指出，這對我們而言是一個規模不大但很重要的市場，不僅因為我們相信 QUELIMMUNE 正在拯救生命並保全幼童的器官功能，也因為它為我們的 SCD 技術提供了強而有力的驗證；更重要的是，它為未來在成人市場的潛在機會鋪路。

We're seeing great enthusiasm by the pediatric health care community for QUELIMMUNE therapy. Recently, for example, we sponsored and hosted an educational symposium at the AKI and CRRT meeting in San Diego. Our presence at the meeting and a number of other activities are designed to increase awareness, knowledge and implementation of QUELIMMUNE therapy to continue to build our brand in pediatric AKI and also position SeaStar Medical in a leadership role to help educate the pediatric medical community about this serious unmet need.

我們看到兒科醫療社群對 QUELIMMUNE 治療抱持高度熱忱。舉例來說，近期我們在聖地牙哥舉行的 AKI 與 CRRT 會議上贊助並主辦了一場教育研討會。我們在該會議的出席以及其他多項活動，旨在提升對 QUELIMMUNE 治療的認知、知識與落地實施，持續在兒科 AKI 領域建立我們的品牌，同時讓 SeaStar Medical 站上領導位置，協助教育兒科醫療社群了解這項嚴重且未被滿足的醫療需求。

The symposium 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 and utilize the learnings to establish QUELIMMUNE therapy at the hospitals in which they practice. The broadening impact of QUELIMMUNE therapy and the desire by the pediatric health care community to learn more about QUELIMMUNE reinforces a key focus for SeaStar Medical to deepen the educational effort on QUELIMMUNE therapy and how to implement it in the treatment of pediatric AKI.

該研討會讓兒科社群有機會獲得關鍵營運問題的解答，接觸前沿科學與臨床數據的豐富內容，並運用所學在其執業醫院建立 QUELIMMUNE 治療。QUELIMMUNE 治療影響力的擴大，以及兒科醫療社群希望進一步了解 QUELIMMUNE 的需求，強化了 SeaStar Medical 的一項重點：深化對 QUELIMMUNE 治療及其在兒科 AKI 治療中如何落地實施的教育工作。

Now turning to our commercial efforts for QUELIMMUNE in 2026. We have great expectations to help patients by delivering QUELIMMUNE therapy to more pediatric hospitals. We continue to focus on adding new sites as quickly as possible. And once a site adopts QUELIMMUNE, ensure pull-through by educating the patient care teams so they are focused on pediatric AKI and the option of QUELIMMUNE therapy for appropriate patients. We believe this is only the beginning of the commercial opportunities for our SCD therapy.

接著談談我們 2026 年 QUELIMMUNE 的商業推進。我們對於透過將 QUELIMMUNE 治療帶到更多兒科醫院以幫助病患抱持很高期待。我們持續聚焦於盡快新增據點；而一旦某據點採用 QUELIMMUNE，我們會透過教育照護團隊來確保使用滲透（pull-through），使其聚焦於兒科 AKI 以及針對合適病患可選擇 QUELIMMUNE 治療。我們相信，這只是我們 SCD 治療商業機會的開始。

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

接下來，我把簡報交給我們的醫務長 Kevin Chung。Kevin？

Thanks, Tim, and thank you to everyone for listening to our call. I want to echo Tim's enthusiasm about our presence at the AKI and CRRT meeting in late March. As a critical care physician, I was struck by just how embedded QUELIMMUNE has become in the conversation. The interest wasn't limited to our own events or data presentations. It showed up organically in plenary and breakout sessions, where clinicians and researchers were referencing QUELIMMUNE unprompted.

謝謝你，Tim，也感謝各位收聽本次電話會議。我想呼應 Tim 對我們在 3 月下旬 AKI 與 CRRT 會議上表現的熱忱。作為一名重症醫師，我深刻感受到 QUELIMMUNE 已經在討論中變得多麼根深蒂固。這份興趣不僅限於我們自己的活動或數據發表；在大會全體會議與分組討論中也自然浮現，臨床醫師與研究人員在未被引導的情況下就主動提及 QUELIMMUNE。

That kind of grassroots visibility in a specialty community is a meaningful signal. Adding to that momentum, the American Society of Nephrology's Kidney News, widely regarded as the newsroom of the nephrology world, dedicated not one but two articles to the SCD therapy in its most recent issue.

這種在專科社群中由下而上的能見度，是一個重要訊號。進一步推升這股動能的是，美國腎臟學會（American Society of Nephrology）的《Kidney News》——被廣泛視為腎臟醫學界的新聞室——在最新一期中不只一篇、而是兩篇文章聚焦於 SCD 治療。

The first, a feature on the evolution of extracorporeal therapy identified the SCD therapy as one of the most exciting frontiers in the shift from passive blood filtration to active immune modulation. The second was devoted entirely to the SCD therapy, its mechanism, clinical evidence and future potential.

第一篇以體外治療的演進為主題，將 SCD 治療列為從被動血液過濾轉向主動免疫調節過程中最令人振奮的前沿之一。第二篇則完全聚焦於 SCD 治療本身，包括其作用機制、臨床證據與未來潛力。

When the premier Nephrology Society's publication gives a therapy of this kind of editorial attention, it is a meaningful signal that the SCD therapy is entering mainstream clinical consciousness. This recognition from conferences and publication is most welcome, but the most compelling recognition comes from the bedside. Every month, we convene a virtual clinical users call with current and prospective pediatric nephrology and critical care teams from across the country to review every QUELIMMUNE case together.

當頂尖腎臟學會的刊物對此類療法給予如此程度的編輯關注時，這是一個重要訊號，代表 SCD 治療正在進入主流臨床認知。來自會議與刊物的肯定固然令人欣喜，但最具說服力的肯定來自臨床第一線。每個月，我們都會召開一場線上臨床使用者會議，邀集全國各地現有與潛在的兒科腎臟科與重症照護團隊，一起回顧每一個 QUELIMMUNE 病例。

The stories we hear on these calls are truly remarkable, and they continue to validate and reinforce why getting this therapy to a broader patient population is so important. The SCD's unique immunomodulatory mechanism positions us to potentially reshape treatment paradigms across a range of serious conditions, not only for AKI, but cardiorenal syndrome, cardiac surgery, end-stage renal disease and other states of pathologic immune activation where dysregulated cytokine release drives organ failure and death.

我們在這些會議中聽到的故事確實令人驚嘆，並持續驗證與強化：讓更廣泛的病患族群獲得此療法是多麼重要。SCD 獨特的免疫調節機制，使我們有機會在一系列嚴重疾病中重塑治療典範，不僅限於 AKI，還包括心腎症候群、心臟手術、末期腎臟病，以及其他病理性免疫活化狀態；在這些狀態中，失調的細胞激素釋放會驅動器官衰竭與死亡。

To that end, we are working diligently to complete enrollment in our NEUTRALIZE-AKI pivotal trial. As a brief overview, NEUTRALIZE-AKI is a randomized controlled trial designed to assess whether up to 10 sequential 24-hour SCD treatments can improve 90-day survival or renal recovery in critically ill adult patients with acute kidney injury requiring continuous renal replacement therapy.

為此，我們正全力以赴完成 NEUTRALIZE-AKI 關鍵性試驗的入組。簡要概述，NEUTRALIZE-AKI 是一項隨機對照試驗，旨在評估在需要連續性腎臟替代治療的重症成人急性腎損傷患者中，最多 10 次連續、每次 24 小時的 SCD 治療，是否能改善 90 天存活率或腎功能恢復。

The primary endpoint is a composite of mortality or dialysis dependence at 90 days. We continue to onboard additional clinical sites and now have enrolled 198 of our target of 339 patients. We are targeting completion of enrollment around year-end, which positions us to potentially report top line results in mid-2027.

主要終點為90天內死亡或透析依賴的複合指標。我們持續新增臨床試驗中心，目前已招募198名患者，目標為339名。我們的目標是在年底前完成招募，這將使我們有機會在2027年年中公布主要結果。

We are already working with the FDA on our plans to submit a modular PMA, enabling us to complete most of the submission with the exception of pivotal data, then submit pivotal data as the last element of the submission. This is designed to allow FDA early review of the modules that don't relate to the clinical trial data. It often speeds the overall review of the applications.

我們已經就提交模組化PMA的計畫與FDA合作，使我們能在缺少關鍵性（pivotal）數據之外完成大部分申請內容，並將關鍵性數據作為申請的最後一個要素提交。此設計旨在讓FDA能及早審查與臨床試驗數據無關的模組，通常可加快整體申請的審查速度。

Upon completion and review of the NEUTRALIZE-AKI clinical trial and contingent on positive efficacy and safety outcomes, we intend to move quickly to submit the remaining PMA components under our breakthrough device designation, positioning us for a potentially accelerated FDA review.

在NEUTRALIZE-AKI臨床試驗完成並經審查後，且在療效與安全性結果為正向的前提下，我們計畫在突破性醫療器材（breakthrough device）資格認定下，迅速提交其餘PMA組件，以爭取FDA可能加速的審查。

A PMA approval of SCD therapy for adult AKI would enable commercialization as a therapeutic device without the IRB-related barriers that exist with QUELIMMUNE. This would significantly simplify hospital adoption, and we believe it will support more rapid commercial expansion.

若SCD療法取得成人AKI的PMA核准，將可作為治療性醫療器材進行商業化，且不再受QUELIMMUNE所面臨的IRB相關障礙影響。這將大幅簡化醫院導入流程，我們相信也將支持更快速的商業擴張。

Now let me turn to our SAVE Registry, which tracks the commercial use of QUELIMMUNE in critically ill children. In March, we announced completion of enrollment at 50 patients, a meaningful milestone. We are currently completing the 28-day safety analysis on our final enrolled patients and expect to submit top line safety data to the FDA shortly. Alongside that submission, we will formally request that the SAVE Registry transition from its current mandatory status to a voluntary post-marketing study.

接下來談我們的SAVE登錄研究（Registry），其追蹤QUELIMMUNE在重症兒童中的商業使用情況。3月，我們宣布完成50名患者的招募，這是一個重要里程碑。我們目前正在對最後入組患者完成28天安全性分析，並預期不久將向FDA提交主要安全性數據。與該提交同步，我們將正式請求將SAVE登錄研究由目前的強制性要求轉為自願性的上市後研究。

If the FDA agrees, this would meaningfully reduce the administrative burden on children's hospitals, accelerating adoption and expanding access to QUELIMMUNE across more pediatric centers, a clear win for patients, providers and the health care system.

若FDA同意，將可大幅降低兒童醫院的行政負擔，加速導入，並擴大QUELIMMUNE在更多兒科中心的可及性，對患者、醫護提供者與醫療體系而言都是明確的利多。

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

接下來我把時間交給我們的財務長Mike Messinger。Mike？

Thank you, Kevin. It's great to be a part of this, and thank you all for being part of our call today. I'll provide a brief overview of our financial results for the first quarter of 2026. Please note that our Form 10-Q will be filed with the SEC within the next 24 hours, and that will include a lengthier discussion of the company's financial results for the 3 months ended March 31, 2026.

謝謝你，Kevin。很高興能參與其中，也感謝各位今天參加我們的電話會議。我將簡要概述我們2026年第一季的財務結果。請注意，我們的Form 10-Q將在接下來24小時內向SEC提交，其中將更詳細討論截至2026年3月31日止三個月的公司財務結果。

You can find the 10-Q at sec.gov or through our website at seastarmedical.com. We recorded net revenue from QUELIMMUNE sales of approximately $495,000 for the first quarter of 2026 compared to $293,000 in the first quarter of 2025. And as Tim mentioned, we continue to see strong adoption of QUELIMMUNE sales here in the second quarter of 2026.

您可在sec.gov或透過我們的網站seastarmedical.com查閱10-Q。我們在2026年第一季來自QUELIMMUNE銷售的淨營收約為49.5萬美元，較2025年第一季的29.3萬美元增加。正如Tim提到的，我們在2026年第二季也持續看到QUELIMMUNE銷售的強勁導入。

Turning to gross profit. Our first quarter statement of operations reflects a gross profit margin of over 90%, consistent with the prior 3 quarters. As a reminder, we didn't recognize cost of goods sold in the first quarter of 2025 as the QUELIMMUNE units sold were originally expensed to research and development prior to approval and commercialization, consistent with U.S. GAAP.

接著談毛利。我們第一季損益表反映的毛利率超過90%，與前3季一致。提醒一下，2025年第一季我們未認列銷貨成本，因為當時售出的QUELIMMUNE單位在核准與商業化之前，已依照美國一般公認會計原則（U.S. GAAP）先列為研發費用。

Operating expenses were unchanged at approximately $4.1 million in the first quarter of 2026 compared to the first quarter of 2025. This represents our continued discipline and leverage of our team's ability to take on multiple tasks within our organization due to our broad experiences, talent and enthusiasm to ensure the company's success.

2026年第一季的營業費用約為410萬美元，與2025年第一季持平。這反映我們持續的紀律，以及憑藉團隊廣泛的經驗、才能與熱忱，在組織內承擔多項任務以確保公司成功的能力。

For the remainder of the year, we anticipate meeting our enrollment goals. We expect our research and development expenses to increase modestly around 5% each quarter as we continue to drive enrollment and support more clinical sites. However, we continue to expect our general and administrative spend to remain pretty consistent from quarter-to-quarter for the remainder of 2026.

在今年剩餘期間，我們預期能達成招募目標。隨著我們持續推動招募並支援更多臨床試驗中心，我們預期研發費用每季將小幅增加約5%。然而，我們仍預期2026年剩餘期間的一般及行政費用將在各季之間維持相當一致。

Net loss for the first quarter of 2026 was approximately $3.5 million or $0.90 per share based on weighted average shares outstanding of approximately 3.9 million shares. This compares with a net loss of approximately $3.8 million or $4.38 per share in the first quarter of 2025 based on approximately 862,000 weighted average shares outstanding. We have over $9.3 million of cash on our balance sheet as of March 31, 2026, compared to $5.2 million at March 31, 2025.

2026年第一季淨損約為350萬美元，或每股0.90美元，係以約390萬股加權平均流通在外股數計算。相較之下，2025年第一季淨損約為380萬美元，或每股4.38美元，係以約86.2萬股加權平均流通在外股數計算。截至2026年3月31日，我們資產負債表上的現金超過930萬美元，較2025年3月31日的520萬美元增加。

And now I'll turn it back to Eric.

現在我把時間交回給Eric。

Thanks, Mike. Our goal today was to share with you our recent achievements, but also express how keenly focused we are on the key value drivers for our stakeholders, in particular, patients, the medical community and investors. With a small but passionate team, we believe we are reshaping the possibilities for kids that often face organ failure or death without new therapies to modulate the cytokine storm in AKI.

謝謝你，Mike。我們今天的目標是與各位分享近期的成果，同時也表達我們對利害關係人關鍵價值驅動因素的高度專注，尤其是患者、醫療社群與投資人。憑藉一支規模不大但充滿熱情的團隊，我們相信我們正在重塑AKI中調節細胞激素風暴的新療法可能性，為那些若無新療法往往面臨器官衰竭或死亡風險的孩子帶來希望。

Also, by bringing together the pediatric care community to broaden the understanding of critical care in this setting, we believe we are helping to set a higher standard for all kids that face the trauma of acute kidney injury. In addition, we have established relationships with many of the top nephrologists in the country through the participation in our NEUTRALIZE-AKI pivotal trial.

此外，透過凝聚兒科照護社群以加深對此情境下重症照護的理解，我們相信我們正在協助為所有面臨急性腎損傷創傷的孩子建立更高標準。再者，透過參與我們的NEUTRALIZE-AKI關鍵性試驗，我們已與全國許多頂尖腎臟科醫師建立關係。

These relationships will serve us well as we look to potentially launch our SCD therapy in the adult indication. And finally, we are actively engaged with our stakeholders to continue to communicate our value proposition and long-term vision for SeaStar Medical. We believe that the opportunities that lie ahead for SeaStar are significant, and we look forward to reporting our future progress.

當我們展望SCD療法在成人適應症的潛在上市時，這些關係將對我們大有助益。最後，我們也積極與利害關係人互動，持續溝通我們的價值主張與SeaStar Medical的長期願景。我們相信SeaStar未來的機會相當可觀，並期待向各位報告後續進展。

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

接下來我請接線員開放提問。接線員？

(Operator Instructions) David Bautz, Zacks Small Capital Research.

（接線員指示）David Bautz，Zacks Small Capital Research。

I appreciate the update today. So first question is, have you begun seeing repeat orders from any of these existing pediatric centers? And kind of if you have, how quickly are those repeat orders having -- or happening from the first time that they come online?

感謝今天的更新。第一個問題是，你們是否已開始看到現有兒科中心的重複下單？如果有的話，從他們第一次開始使用到出現重複下單，通常間隔多久？

Yes. David, this is Eric. Thanks for joining. Great question. Tim, do you want to take that?

是的。David，我是Eric。謝謝你加入。這是個好問題。Tim，你要回答嗎？

Sure. Happy to do it. Thank you for the question. So to answer the first part of your question, we absolutely see repeat orders from our customer base. In terms of the speed at which that happens, it is really driven by the presentation of the patient when the patient arrives.

當然，很樂意。謝謝你的提問。先回答你問題的第一部分，我們確實看到客戶群有重複下單。至於發生的速度，主要取決於患者到院時的病況表現。

In some cases, it could be some time between patients. And in other times, they may finish therapy on one patient and several more will appear in the ICU that are appropriate patients for QUELIMMUNE. So it's fairly unpredictable that way, but it is definitely safe to say that from overall customer base, once they use the product, they gain experience with it, we definitely have repeat orders.

有些情況下，患者之間可能會隔一段時間；但也有時候，他們剛完成一位患者的治療，ICU裡就又出現好幾位適合使用QUELIMMUNE的患者。因此這方面相當難以預測，但可以很確定地說，就整體客戶群而言，一旦他們使用產品並累積經驗，我們確實會看到重複下單。

Okay. Great. And then you mentioned earlier about the SAVE Registry and of course, how encouraging all the data is from that. So at what point do you talk about if that's going to influence treatment guidelines or like standard of care discussions?

好的，很好。接著你先前提到SAVE登錄研究，當然那裡的數據都很令人鼓舞。那麼在什麼時間點，你們會談到這是否會影響治療指引，或是像標準治療（standard of care）的討論？

Yes, that's a great question. So Kevin, do you want to tackle that?

是的，這是個很好的問題。Kevin，你要回答嗎？

Yes. So standard of care and implementation into guidelines takes a long time. However, if you look at the pediatric ADQI consensus document that was published a little over a year ago, immune modulation -- extracorporeal immune modulation is mentioned.

好的。標準治療以及納入指引的落地需要很長時間。不過，如果你看一下大約一年前發布的兒科ADQI共識文件，其中有提到免疫調節——體外免疫調節。

So I believe that if we continue down this path, and we have a positive NEUTRALIZE-AKI study, that pediatric ADQI and consensus statement will bring forward the SCD as a therapy that's recommended.

因此我相信，如果我們持續沿著這條路走下去，並且NEUTRALIZE-AKI研究結果為正向，那麼兒科ADQI與共識聲明將會把SCD作為建議的治療方式提出。

And so for these clinical practice guidelines, it takes typically multiple randomized controlled trials and wide adoption for recommendations to surface. But we're already mentioned there. So that's a good thing. And I have no doubt that with continued use of the therapy as clinical teams see the results, this will become something that everybody is talking about.

至於這些臨床實務指引，通常需要多項隨機對照試驗以及廣泛導入後，建議才會浮現。但我們已經在其中被提及，這是好事。我也毫不懷疑，隨著治療持續被使用、臨床團隊看到結果，這將成為大家都在討論的事情。

Okay. Great. And then lastly, of course, you mentioned the write-ups in ASN Kidney News. One of the things that they mentioned in there was that integrating the SCD into the ICU workflow is I think they used the term nontrivial. But I mean, how nontrivial is it or how easy is it for the unit to be integrated into the protocols at a hospital?

好的，很好。最後一個問題，當然你提到ASN Kidney News的報導。他們其中提到的一點是，把SCD整合進ICU工作流程，我想他們用的詞是「並非易事」（nontrivial）。但我的意思是，這到底有多不容易？或是對醫院而言，把這個裝置整合進院內流程有多容易？

Yes. Thank you for that question.

是的，謝謝你的提問。

Go ahead, Kevin.

Kevin，你來回答。

Yes. Thank you for that question. So clinically, the addition of the SCD cartridge, connecting it serially to an already existing CRRT circuit. A CRRT technician, dialysis technician or CRRT ICU nurse can do that. It takes minutes to connect, and it is as simple as it can be.

好的，謝謝你的提問。從臨床角度來看，加入SCD濾匣是把它以串聯方式接到既有的CRRT迴路上。CRRT技術員、透析技術員或CRRT的ICU護理師都可以操作。連接只需要幾分鐘，已經是能做到的最簡單方式了。

The other thing that a lot of centers around the country have experience with is citrate anticoagulation.

全國許多中心的另一項豐富經驗是檸檬酸抗凝。

And we're fortunate that, that's the case because that is a critical component of our therapy. And so with regards to whether or not it's difficult, if you already have a citrate protocol and you're used to doing CRRT, which 99% of all ICUs in the country, that's a true statement, that the implementation of SCD is not going to be difficult.

而我們很幸運情況確實如此，因為那是我們治療的一個關鍵組成部分。因此，至於是否困難，如果你已經有檸檬酸流程並且習慣進行 CRRT（全國 99% 的 ICU 都是如此，這個說法是真的），那麼導入 SCD 並不會困難。

Anthony Vendetti, Maxim.

Anthony Vendetti，Maxim。

So yes, I just wanted to talk about the hospitals that are currently using the product. Do you have like a particular ordering pattern? Anything -- any other color you can give there? I know you said the reorder frequency, you don't have that exact number, but how many patients total have been treated? And do you currently have like, if not, a reordering pattern for the hospitals, an average revenue per center?

所以是的，我只是想談談目前正在使用該產品的醫院。你們是否有特定的訂購模式？在這方面還能提供任何其他補充資訊嗎？我知道你說過再訂購頻率，你沒有確切數字，但總共有多少名病患接受過治療？另外，你們目前是否有——如果沒有——醫院的再訂購模式、每個中心的平均收入？

Or is it really just patient dependent and can vary widely?

還是說這真的只是取決於病患，且可能差異很大？

Yes. Thanks, Anthony. Great question. Thanks for joining today. I'll tackle some of this, and then I'll have Tim also come in.

是的。謝謝你，Anthony。問題問得很好。謝謝你今天加入。我先回答其中一些，然後也請 Tim 一起補充。

One of the things is how many patients have we treated. We did disclose a couple of months back that we had reached the 50 patients for the SAVE Registry. So it kind of gives you a general sense of how many have been treated. Maybe, Tim, you could give a little bit more color on some of Anthony's other questions.

其中一點是我們治療了多少名病患。我們在幾個月前披露過，SAVE 登錄研究已達到 50 名病患。因此這大致能讓你了解已治療的人數。Tim，也許你可以就 Anthony 的其他問題再補充一些細節。

Sure. I think one way to think about this, Anthony, and thank you for the question, is as it is with many products in the hospital, hospitals, once they understand their utilization patterns will set a par value. So that is basically an inventory level that they want to keep on hand at all times based on their utilization.

當然。我認為可以這樣理解，Anthony，也謝謝你的提問：就像醫院裡許多產品一樣，醫院一旦了解自身的使用模式，就會設定一個「par value」。基本上就是他們希望隨時維持的庫存水位，依其使用量而定。

And to be sure, there are par values that have been set with many of the customers that we have. Others that are -- we're scaling -- we're still scaling our business here, right? So we have 17 customers. At this time last year, we -- I don't even -- we had 3 or 4 customers. So it's still new.

確實，我們的許多客戶已經設定了 par value。也有一些客戶——我們仍在擴展業務，對吧？我們目前有 17 家客戶。去年這個時候，我們——我甚至不確定——只有 3 或 4 家客戶。所以這仍然很新。

And so many of these new customers, they order product, they use the product, and then they're seeing what the cadence is of patients that come through the system that helps them establish the par value.

因此，許多新客戶會先下單、使用產品，然後觀察進入系統的病患節奏，藉此建立 par value。

In addition to that, too, the more they use this, the more they think about pediatric AKI. And you heard me talk about the educational efforts that we are really engaging in with a lot of these sites to make sure that there really is a ripple effect of QUELIMMUNE across these institutions so that many people know about it and they're actively looking for patients.

此外，他們使用得越多，就越會思考小兒 AKI。你也聽到我提到我們在許多這些據點積極推動教育工作，確保 QUELIMMUNE 在這些機構內產生真正的擴散效應，讓更多人知道並主動尋找病患。

And when you're actively looking for patients, you're going to tend to find more of those. So that's basically how it works. We don't single things out in terms of revenue per hospital at this point. This is an ultra-rare indication and condition. And so it really is driven by the presentation of a patient within the hospital system itself.

而當你主動尋找病患時，往往就會找到更多這類病患。基本上就是這樣運作的。我們目前不會特別按醫院拆分每家醫院的收入。這是一個超罕見的適應症與病況，因此確實是由病患在該醫院系統內的出現所驅動。

Okay. So as you're looking to kind of drive the patient volume, and like you said, it's heavily dependent on the patients needing the treatment. But is there any additional education that's going on at the hospitals that you're in and at the new hospitals that you're trying to sign up that maybe accelerates the adoption at other centers?

了解。所以當你們希望推動病患量時，正如你所說，這高度取決於需要治療的病患。但在你們已進入的醫院，以及你們正嘗試簽約的新醫院，是否有任何額外的教育正在進行，可能加速其他中心的採用？

Yes. That's a great question. No, it's okay. I actually would -- Kevin, maybe you could talk about the monthly users call that we have with who's on those calls, what gets discussed, et cetera.

有的。這是個很好的問題。沒關係。我其實想——Kevin，也許你可以談談我們每月的使用者電話會議：有哪些人參加、會討論什麼等等。

Sure. Thank you, Anthony, for that question. I mean this is a very tight community, the nephrology, the pediatric nephrology and critical care community, and they all talk to each other. They all share experiences. We sort of leverage that spirit and have been having monthly clinical users calls that we talked about in the update.

當然。謝謝你，Anthony，這個問題。我的意思是，腎臟科、小兒腎臟科與重症照護社群非常緊密，他們彼此都會交流、分享經驗。我們某種程度上利用這種精神，並且如同更新中提到的，我們一直在舉辦每月的臨床使用者電話會議。

And that is attended by -- when we invite about 135 or 50 individuals. Most often, we have about 60 callers that dial in. And they get to hear from the previous month's cases that have occurred at each of the sites that are active. And we go into detail about the cases, how sick they were, why they decided the reason and rationale for therapy and what happened to them.

該會議——我們邀請大約 135 或 50 位人士。通常大約有 60 位來電參與。他們可以聽到前一個月在各個活躍據點發生的病例。我們會深入討論病例：病情有多嚴重、他們為何決定治療、治療的原因與理據，以及病患後續情況。

And now we can't save everybody. But for many of these patients, actually, for all these patients, they're very -- they're initiating the SCD at a very, very dire -- during a dire situation where the patient is very, very sick. And virtually all the patients, I don't think would have lived without this option. And what we're doing is giving them a chance and these cases are discussed where the patients are sick, sick, sick, they start QUELIMMUNE.

而現在我們不可能救得了每一個人。但對於許多這些病患——其實對所有這些病患——他們是在非常、非常危急的情況下啟動 SCD，病患非常、非常嚴重。幾乎所有病患，如果沒有這個選項，我想都不會存活。我們所做的是給他們一個機會；這些病例會被討論：病患病得非常非常嚴重，開始使用 QUELIMMUNE。

Next thing you know, the inflammatory indices start coming down, and they talk about patients doing well. And so when the participants who don't have QUELIMMUNE at their institution hear these stories, of course, they're going to want to get their hands on them because they want to give their children a chance. And so that's how we spread sort of the message with regards to the potential benefits of QUELIMMUNE.

接著你會看到發炎指標開始下降，他們會談到病患狀況變好。因此，當那些在其機構尚未有 QUELIMMUNE 的參與者聽到這些故事時，當然會想要取得，因為他們想給孩子一個機會。這就是我們如何傳播關於 QUELIMMUNE 潛在效益的訊息。

Additionally, we have presented at pretty much the premier conferences where all of the pediatric intensivists and nephrologists gather. PNRC, which is the Pediatric Research Network Consortium. We presented at it in Miami, pretty much 50 or so children's hospitals were represented, Society of Critical Care Medicine, AKI, CRRT, even the European meeting that I just returned from, there were several pediatric centers represented there from the United States.

此外，我們幾乎在所有小兒重症醫師與腎臟科醫師聚集的頂尖會議上發表過。PNRC（Pediatric Research Network Consortium，小兒研究網絡聯盟），我們在邁阿密發表，約有 50 家兒童醫院代表出席；重症醫學會（Society of Critical Care Medicine）、AKI、CRRT，甚至我剛從歐洲會議回來，那裡也有幾個來自美國的小兒中心代表參與。

And the conversation is always centered around how well these patients respond initially to QUELIMMUNE. Even when you have a death, they see the inflammatory indices come down and the patients initially improve. And sometimes because of the comorbidities, they may not survive. But they see the benefit.

而討論的焦點總是圍繞這些病患對 QUELIMMUNE 的初期反應有多好。即使出現死亡案例，他們也會看到發炎指標下降、病患初期改善。有時因為共病症，他們可能無法存活。但他們看得到效益。

And so really, it's amplified word of mouth is how I would like to describe it. And it's quite effective. And there are many centers that contact us, although they haven't even begun the process sometimes because they have a child that needs it. And we do what we can.

所以我會把它形容為被放大的口碑傳播，而且相當有效。有許多中心會聯絡我們，雖然有時他們甚至還沒開始流程，但因為有孩子需要，我們會盡我們所能。

Yes. Maybe, Tim, you could also just kind of share the newly formed group, this advanced practice group that you've put together.

是的。Tim，也許你也可以分享一下你組建的新團隊——這個你成立的進階實務團體。

Yes, happy to do that, Eric. So in addition to what Kevin was talking about, we are coming at this from a variety of different ways to educate the community -- and one of the things we've done is we formed an advanced provider -- practice provider ad board.

好的，很樂意，Eric。除了 Kevin 剛才談到的內容之外，我們也從多種不同方式來教育社群——其中一件事是我們成立了一個進階提供者——實務提供者顧問委員會（ad board）。

So these are folks that are really at the patient care level and they are very operational. They're the ones that kind of get a lot of the work done within these institutions to set up a variety of different orders and protocols. They set up training. And these folks are really -- they are, in many cases, the champions within these institutions and taking QUELIMMUNE through that hospital system.

這些人是真正在病患照護第一線，且非常偏向營運執行。他們是在這些機構內完成大量工作的人，負責建立各式各樣的醫囑與流程、安排訓練。而這些人很多時候就是機構內的推動者，推動 QUELIMMUNE 在該醫院系統內落地。

So we're working with them. We had a symposium at the recent AKI and CRRT meeting. We have several other planned events over the rest of this year. In addition to that, we also have some field-level clinical support at these systems, too, especially the systems that have adopted QUELIMMUNE, making sure that, again, more people know about it.

因此我們與他們合作。我們在最近的 AKI 與 CRRT 會議上舉辦了一場研討會。今年剩餘時間我們還規劃了數個活動。此外，我們也在這些系統提供一些現場層級的臨床支援，特別是已採用 QUELIMMUNE 的系統，確保同樣地，有更多人知道它。

There are a lot of people that work within a specific hospital. There are a lot of shift changes. And so there are a lot of people that need to be exposed to this information. So I think we have a good handle on what needs to be done, and now we're executing on that.

在特定醫院內工作的人很多，也有很多輪班交接，因此需要接觸這些資訊的人也很多。我認為我們已經很清楚需要做什麼，現在正在執行。

Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to Jackie for closing remarks.

各位女士、先生，目前問題佇列中沒有其他問題。我現在想把電話交回給 Jackie 作結語。

Thank you, Towanda, and thank you all for joining us today for the SeaStar Medical First 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.

謝謝你，Towanda，也謝謝各位今天參加 SeaStar Medical 第一季財務結果電話會議。如有問題，請透過 ir@seastarmed.com 聯絡我們，或造訪我們的網站 www.seastarmedical.com。謝謝，再見。

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.

各位女士、先生，今天的電話會議到此結束。感謝各位的參與。您現在可以掛線。