First Pediatric Patient Treated in a Commercial Setting With SeaStar Medical's FDA-Approved QUELIMMUNE Therapeutic Device
First Pediatric Patient Treated in a Commercial Setting With SeaStar Medical's FDA-Approved QUELIMMUNE Therapeutic Device
DENVER, July 23, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) reports treatment of the first patient in a commercial setting with QUELIMMUNE, its U.S. Food and Drug Administration (FDA)-approved, patented cell-directed extracorporeal therapy to treat acute kidney injury (AKI) in pediatric patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy (KRT). With this development, the Company has now met the August 20, 2024 FDA deadline to begin patient treatments, which is designated in the FDA's approval of QUELIMMUNE.
SeaStar Medical Holding Corporation（Nasdaq：ICU）（SeaStar Medical）於2024年7月23日發佈公告，宣佈在商業環境下使用其U.S. Food and Drug Administration（FDA）批准的專利細胞定向體外治療QUELIMMUNE，治療重症感染兒科患者（體重大於10千克），包括休克或感染性疾病需臨床替代腎功能（KRT）的急性腎損傷（AKI）。隨着這一進展，該公司現已達到2024年8月20日FDA治療患者的最後期限，這是FDA批准QUELIMMUNE的標準。
"This commercial milestone is highly gratifying to the SeaStar Medical team that has worked so hard to make QUELIMMUNE available to patients in need. Results from completed clinical trials show the potential of QUELIMMUNE to save the lives and decrease dialysis dependency of these severely ill children with AKI, and we are dedicated to ensuring widespread access to our therapeutic device," said Eric Schlorff, CEO of SeaStar Medical. "We have now met the FDA's requirement for a timely first treatment."
"這一商業里程碑對於致力於讓QUELIMMUNE可用於患者的SeaStar Medical團隊來說非常令人滿意。完成的臨床試驗結果表明，QUELIMMUNE有潛力挽救AKI中這些重症兒童的生命並減少透析依賴性，我們致力於確保讓我們的治療設備廣泛地被人們使用"，SeaStar Medical的首席執行官Eric Schlorff表示。 "我們已經滿足了美國FDA及時治療第一患者的要求。"
Each year in the U.S., approximately 4,000 children with AKI require continuous KRT, with a mortality rate of approximately 50%. Many of those who survive experience long-term complications that can include chronic kidney disease and a lifetime of dialysis. Pooled analysis from two non-controlled clinical studies, one of which was funded by the FDA office of Orphan Products Development, showed that children with AKI weighing 10 kilograms or more requiring continuous KRT treated with QUELIMMUNE had a 77% survival rate with no dialysis dependency at 60 days, and had no device-related serious adverse events or device-related infections.
在美國，每年約有4,000名患有AKI的兒童需要持續治療，死亡率約爲50％。 許多幸存者會經歷可能包括慢性腎病和終身透析等長期併發症。 來自兩項非對照臨床研究的彙總分析顯示，10千克或更重的AKI兒童使用QUELIMMUNE接受持續KRt治療，60天的生存率爲77％，沒有透析的依賴性，同時沒有設備相關的嚴重不良事件或感染。
About Acute Kidney Disease (AKI)
關於急性腎損傷（AKI）
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as COVID-19, sepsis, severe trauma and surgery. In critically ill patients with AKI, a dysregulated immune response can lead to hyperinflammation, which may contribute to significant morbidity, including prolonged ICU stays, increased reliance on dialysis and mechanical ventilation, and higher hospital costs. Damage resulting from this dysregulated response in AKI can progress to other organs, such as the heart or liver. Multi-organ dysfunction or even failure can lead to worse outcomes, including increased risk of death. Even after resolution, these patients may face chronic kidney disease or end-stage renal disease requiring dialysis, among other complications.
AKI的特點是腎功能突然而暫時的失常，可能由COVID-19，感染，嚴重創傷和手術等許多情況引起。 在患有AKI的危重病人中，失調的免疫反應可能導致過度炎症反應，從而可能導致重大的併發症，包括延長的ICU住院時間，透析和機械通氣的增加以及更高的醫院費用。 AKI中的這種失調反應所導致的損害可以向其他器官（如心臟或肝臟）發展。多器官功能障礙甚至衰竭會導致更糟糕的結果，包括增加死亡風險。即使在病情緩解之後，這些患者可能面臨慢性腎病或終末期腎病需要透析等其他併發症。
About QUELIMMUNE
關於QUELIMMUNE
QUELIMMUNE is SeaStar Medical's first Selective Cytopheretic Device (SCD) to receive FDA approval. This therapeutic device selectively targets the most highly activated proinflammatory neutrophils and monocytes and restores them to a reparative state. QUELIMMUNE consists of a SCD pediatric (SCD-PED) cartridge and blood tubing set that are connected in-line to an existing hemodialysis delivery system's extracorporeal continuous KRT circuit in a process that takes about 15 minutes. The Company expects that, on average, a full course of treatment for children with AKI will require three to seven days of treatment, with the disposable SCD-PED cartridge being replaced every 24 hours.
QUELIMMUNE是SeaStar Medical的首件獲得FDA批准的選擇性細胞治療設備（SCD）。 這種治療設備有選擇地針對最高度活躍的促炎症性中性粒細胞和單核細胞，並將其恢復到可修復狀態。 QUELIMMUNE由用於兒科的SCD（SCD-PED）芯片和血液輸送系統組成，這些芯片和系統與現有的血液透析傳遞系統的體外持續腎替代治療電路線相連接，在15分鐘內完成。 公司預計，對於AKI的患兒，一個完整的治療療程需要三到七天的治療，每24小時更換一次一次性SCD-PED芯片。
SeaStar Medical is actively enrolling patients in the adult NEUTRALIZE-AKI pivotal clinical trial. The adult AKI population is 50 times larger than the pediatric population, which the Company believes represents a multibillion-dollar market opportunity. The SCD is a platform technology with potential in multiple disease conditions affected by hyperinflammation.
SeaStar Medical正在積極招募受試者參加成人NEUTRALIZE-AKI關鍵性臨床試驗。 成人AKI患病人群是兒童人群的50倍，該公司認爲這代表了一個數十億美元的市場機會。 SCD是一種具有潛在用途的平台技術，可用於多種受高度炎症影響的疾病。
About SeaStar Medical
關於SeaStar Medical
SeaStar Medical is a commercial-stage medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical's novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit or visit us on LinkedIn or X.
SeaStar Medical是一家商業化階段的醫療技術公司，正在重新定義體外治療如何減少對重要器官的過度炎症影響。 SeaStar Medical的新型技術依賴科學和創新爲危重病人提供挽救生命的解決方案。 公司正在開發和商業化定向細胞治療設備，針對推動全身性炎症的效應細胞，引起直接組織損傷並分泌一系列促炎症細胞因子，這些細胞因子也是引發並傳播失衡免疫反應的主要推動力之一。 欲了解更多信息，請訪問或訪問我們的領英或X頁面。
Forward-Looking Statements
前瞻性聲明
This press release contains certain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical's expectations with respect to the amount and timing of future QUELIMMUNE commercial sales; commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical's control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to access funding under existing agreements; (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical's products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical's Annual Report on Form 10-K, including those under the "Risk Factors" section therein and in SeaStar Medical's other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
本新聞稿包含了《1955年私人證券訴訟改革法》中“安全港”規定下的某些前瞻性聲明。這些前瞻性聲明包括但不限於SeaStar Medical對於未來QUELIMMUNE商業銷售額的數量和時間的預期；QUELIMMUNE的商業接受程度；SCD治療AKI和其他疾病的能力；預期的規管批准進程和商業化時間表；以及SeaStar Medical能夠達到預期時間表的能力。諸如“相信”，“計劃”，“預期”，“預計”，“估計”，“打算”，“策略”，“未來”，“機會”，“計劃”，“可能” ，“應該”，“將會”，“將繼續”，“很可能會導致”等類似表達旨在識別此類前瞻性聲明。前瞻性聲明是關於未來事件的預測、投射和其他聲明，這些聲明是基於目前的預期和假設，因此它們可能面臨重大的風險和不確定性，這些風險和不確定性可能導致實際結果與預期結果極爲不同。其中大多數因素超出了SeaStar Medical的控制範圍，並且很難預測。可能導致實際未來事件與預期結果極爲不同的因素包括但不限於：（i）SeaStar Medical可能無法獲得其SCD產品候選物的規管批准的風險；（ii） SeaStar Medical 可能無法籌集足夠的資本來資助其經營活動，包括當前或將來的臨床試驗；（iii）SeaStar Medical及其現有和未來的合作伙伴無法成功開發和商業化其產品或服務或經歷顯着延誤，包括未能通過適當的聯邦和州監管機構獲得其產品的批准，（iv）SeaStar Medical可能永遠不會實現或維持盈利能力；（v）SeaStar Medical可能無法按照現有協議獲得資金；（vi）第三方供應商和製造商無法完全並及時履行其義務，（vii）與SeaStar Medical的產品和服務有關的產品責任或規管訴訟或訴訟程序的風險，（viii）SeaStar Medical無法安全或保護其知識產權的風險，以及（ix）SeaStar Medical其他時不時指出的風險和不確定因素，包括其《10-k表中的“風險因素”部分和SeaStar Medical與SEC的其他文件。以上因素列表不是詳盡無遺的。前瞻性聲明僅在其發佈日有效。讀者應注意不要過度依賴前瞻性聲明，SeaStar Medical不承擔義務也不打算更新或修訂這些前瞻性聲明，無論是因爲新信息、未來事件還是其他任何原因。
Investor Contact:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
投資者聯繫人：
LHA投資者關係
Jody Cain
(310) 691-7100
Jcain@lhai.com
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Source: SeaStar Medical Holding Corporation
消息來源: SeaStar Medical Holding Corporation
譯文內容由第三人軟體翻譯。