{"success":true,"data":{"pressRelease":{"id":"152030","rtpr_id":"nGNX8PcGxz-20260924","ticker":"ICU","exchange":"NASDAQ","all_tickers":["ICU"],"title":"SeaStar Medical Congratulates H. David Humes, M.D., on Receiving the University of Michigan 2026 Distinguished University Innovator of the Year for Development of the SCD Therapy","author":"Globe Newswire","published_at":"2026-09-24T12:16:00.125Z","article_body":"Prestigious honor recognizes Dr. Humes’ pioneering work in developing the\nSelective Cytopheretic Device (SCD) therapy, commercialized by SeaStar Medical\nas QUELIMMUNE(®) for critically ill pediatric patients with acute kidney\ninjury (AKI)\n\nSeaStar Medical’s SCD development pipeline of indications holds promise for\nmultiple additional indications\n\nDENVER, Sept. 24, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation\n(Nasdaq: ICU), a commercial-stage healthcare company focused on\ntransformational treatments for critically ill patients facing organ failure\nand potential loss of life announced today that H. David Humes, M.D., is being\nawarded this year’s Distinguished University Innovator of the Year award at\nCelebrate Invention, an annual event hosted by Innovation Partnerships at the\nUniversity of Michigan (U-M). The award is the highest honor for U-M faculty\nmembers who have developed transformative ideas, processes, or technologies\nand helps them to reach the market for broad societal impact.  \n\nDr. Humes discovered and developed the Selective Cytopheretic Device (SCD), a\ndisease-modifying therapeutic device that neutralizes over-active immune cells\nand stops the cytokine storm that yields destructive hyperinflammation and\ncreates a cascade of events that can rapidly lead to organ failure and death.\nThe SCD therapy was successfully developed by SeaStar Medical in clinical\ntrials of pediatric patients with severe AKI, resulting in the first and only\nFDA-approved therapy specifically for children with AKI and sepsis or a sepsis\nlike condition. The Company subsequently launched QUELIMMUNE (SCD-PED) into\nthe pediatric critical care community. QUELIMMUNE has demonstrated a 50%\nreduction in patient mortality at 60 days, compared to the standard of care,\nin clinical trials and published preliminary outcomes analyses to date. The\nCompany is also conducting the pivotal NEUTRALIZE-AKI clinical trial of the\nSCD therapy in adult patients with life-threatening AKI receiving continuous\nrenal replacement therapy.\n\n\"We extend our warmest congratulations to Dr. Humes on this well-deserved\nrecognition from the University of Michigan,\" said Eric Schlorff, Chief\nExecutive Officer of SeaStar Medical. \"His visionary science transformed how\nthe medical community views immune system dysregulation in critical illness.\nBy targeting activated white blood cells to stop the hyperinflammatory\ncascade, his life's work paved the way for our QUELIMMUNE therapy, giving\nclinicians an invaluable tool to save the lives of critically ill children. We\nare proud to build upon his legacy as we advance the SCD therapy beyond the\npediatric indication, with clinical development underway for a second\nindication in adult patients with AKI on continuous renal replacement\ntherapy.\"\n\n\"It is an immense honor to receive this award from the University of\nMichigan,\" said Dr. Humes. \"Translating benchtop discovery into a commercial\ntherapy that reaches patients at the bedside requires a dedicated team of\nresearchers, clinical trialists, and commercial partners. Seeing the SCD\ntherapy make a tangible difference in the pediatric ICU has been the most\nrewarding chapter of my career.\"\n\nDr. Humes will be formally presented with the award during the University of\nMichigan’s annual Celebrate Invention event on September 24, 2026, in Ann\nArbor, Michigan. In addition to the award, Celebrate Invention will offer\nattendees a presentation entitled “From Bench to Bedside: A Sepsis\nBreakthrough Two Decades in the Making” and an accompanying panel\ndiscussion. Both Dr. Humes and Mr. Schlorff will be panel speakers along with\nDr. Lenar Yessayan, Clinical Professor of Internal Medicine, Director MPLAN\n– Inpatient Hemodialysis and Director of the MDS Dialysis Unit, Michigan\nMedicine, and Kelly Sexton, Associate Vice President for Research –\nInnovation Partnerships and Economic Impact.\n\nAbout QUELIMMUNE\n\nThe QUELIMMUNE\n(https://www.globenewswire.com/Tracker?data=kdlMGoXaq3Q3k845Kmk3v32qrSwpGgUhvS6DwNviLnuulFlYSOLjJ9ws480X5ncNF3tAufFBhvePdO8n8b94ERt9HMtSh9WZjcKNuzTxIJjMXRaneCXTKPx2StujSjOGVdz6h3qAdKaFHmhtU-0vL4VyzwV_CP-CNjt5pwGqgge4t4hR5r8losN7zV581g4Wqzcd7kV1c7_VjMo1S5hlx7iyhqtwXwDtuf1hl_i0y0vMi1SyBOqFIvumOQnQjw6oFcYNtHim8bvvU9iWi5iYSQ==)(®)\n(https://www.globenewswire.com/Tracker?data=G1fjUqx8DRZWu0n494W7MIIXGqvCvcz1N0n4V1J4mgB-bQAut9dILPcXFAxjUBSeEk0PHziDdZX7fKIGLt675zUCYjQP1YwuVF6X2nHXbTqKflfeXdBMmw3D_kwTt_1YcWqQF6bsJ5nArzh_oJcPFOT3rXullUFA9harcDZzrBp4cUbr3X4DGWHQDaOUtI5UxbH852qdYce8V60a0jIrk9jVWT63y2u-y570DPotpX8DqN81vqdjoPj0lEfr-44SMw0Ux3M85GXRQ1v2uO89jQ==)\n(SCD-PED) therapy\n(https://www.globenewswire.com/Tracker?data=a_RlG-ZVmCn2R7mPuPWEh2dGXD5EmmjK5liElDjMn9wtrI3o8kmq9mBLmSz1mLs2K4QuzzVdG-cVmUpy0KIekGI8zbCnnBnc7nPcMlwehkhaugCVoRL-h3o6DCStjH9e1X3V4Ujlp8wcv3L3u8cbl8SuJ-xk7MLCj_1w19cfQxSYoT_FqQxocmAcjxsqHeHQvtSVbGgQLJD46HW2Z7tChPi3GGXVqotWs989z7t6I12f-TA818j94HzTipSZQPWmu8rEdFVFYxN5FV0m21VHNLM214lrAsY3YESouLMO3eQ=) is\nbeing commercialized for children with AKI and sepsis or septic condition\nweighing 10 kilograms or more who are on antibiotics and being treated in the\nICU with RRT. It was approved in February 2024 under a Humanitarian Device\nExemption application.\n\nData from two clinical trials of the QUELIMMUNE therapy, published in Kidney\nMedicine\n(https://www.globenewswire.com/Tracker?data=BJFhoYs_zEceTxAW3fZu9wXmiAQnxjJaGXrTtsG_f7NB5g2FLxIOJRP_sHyZEMtlX-wZkCmMpvuMaEEA0d98U89jGnFLoxR0PF4vi6PJo5F36tHDVqCsvy3AgCVnzwEsuNxUyF66rB3hWYI7bzTu0q3HeFgqm5EnC9dLhA0nmWU4m4tODtfKARpvmQ90fjshKHVgBBaVoqkGlsLM82aSeyl6Za2J8x89LzMgsjNcBzWe9aLuIgMKKvzpIUIY_XBii7_l7HTWlZMrlQFuM87-fyLq-ggx7M7WVpc4M1EsfxVELpZeojzqj0d691bPADedkkLamtk80od_sudBEqy-KeS6nnwh1pCedWPXdnPYoIU=),\nshowed a 77% survival rate in patient treated with QUELIMMUNE versus standard\nof care, representing an approximate 50% reduction in loss of life compared to\nhistorical data in this patient population. No dialysis was required for\nsurvivors, and 87.5% of survivors had normal kidney function at Day 60 after\nICU discharge. In February 2026, data published in the prestigious,\npeer-reviewed journal, Pediatric Nephrology\n(https://www.globenewswire.com/Tracker?data=XNInv2NM2_JEhmeiXJ9hRs2DgX_zwp3xsdBSNaWa4C_84pREiz53qYKNvgw_G9OhQiMpymfa8UMkzx7H5bPE3FEK350m5VBTn-lSMTGg9RYdHwykkruyz0XSfRi93pN83PdqXa7Nw6uMHPUBtA7GfCyBBI3Z5rXN2vlqGv1MpHAbfeg2g44qZ9VvFqXB5nM1cTsidDvPdyGjnHsEHcAT9bKZyVTYkY-cK_NaT1zeuvF6Ut4kUzlLnBO3IaxGqMVNA0OL9IZvALvQVBZP6Y6I7kI-ItbYO4B_TrajhMOnCq8=),\nhighlighted the early experience from the QUELIMMUNE SAVE Registry\n(https://www.globenewswire.com/Tracker?data=EU9hUERUt4OenJhODVuXLuXQzlbiBq-pZ_2Cqo8ZC0kQLWku6zEQsMhnmaxTeauirFcb42fbyJn9oeFW30N3VklqGes8C5kerV9vbizP2xDe4hjh-a6dZNpoThTMJXWop2Hyk44qKULrMPXtRQBqNF0gYdlVkhP65NDbAV6MZEE=),\na post-approval surveillance registry, evaluating the role of the QUELIMMUNE\ntherapy in the treatment of critically ill pediatric patients with\nlife-threatening Acute Kidney Injury (AKI) and sepsis requiring renal\nreplacement therapy. Observations from the first 21 pediatric patients with\nAKI and sepsis requiring renal replacement therapy showed no device-related\nadverse events or infections and no reports of immunosuppressive effects by\nthe device. In addition, preliminary outcomes analyses show a 76% survival\nrate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data\nare on track to validate a 50% reduction in patient mortality at 60 days\ncompared to historical data, similar to what was observed in the registration\nstudy reported in Kidney Medicine\n(https://www.globenewswire.com/Tracker?data=BJFhoYs_zEceTxAW3fZu96djUuyq_TDPa6NLPle6I89mz_ain-Fl8cxy7_Em7pYoX8AdWsIgd5gMXsJhQNJP28KbDqjH2J2_aAaLYdTDFlbRNam4sLm92r0hIyZPlyZU_0lhWLV1UD7RgfYrvgB7DHr0ASBvXMdtxzdMV_6FvvYT_1NvO7EDM_xiZBB-hZMO9yvK-jwwIjRegOMbfBh7fbXxO7izqzOrDGMQeNKqCjG-Axqtshlsi124hjgDYu_RTN1jD5BDrpGE9MLrgkLQmZ2nMB2_g4sFtCnoVHoCNIRFJpooN2lHY8IhpEcqRNX6W1oU0LEvrka8_CRvrsDN8UM7Ce3awMt1ioNtGQ6mCxg=).\n\nThe patented technology behind QUELIMMUNE is known as the Selective\nCytopheretic Device (SCD) therapy and has broad applications for treating the\ndestructive hyperinflammation that shuts down organ function and causes loss\nof life.\n\nAbout the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy\n\nThe SCD therapy is designed as a disease-modifying device that neutralizes\nover-active immune cells and stops the cytokine storm that yields destructive\nhyperinflammation and creates a cascade of events that wreak havoc in the\npatient’s body. The SCD therapy is designed for broad applications in\nmultiple acute and chronic kidney and cardiovascular diseases, representing\npatients who today have no FDA-approved options for treating their disease.\nUnlike pathogen removal and other blood-purification tools, the SCD therapy is\nintegrated with an existing continuous RRT hemofiltration system to\nselectively target and transition proinflammatory monocytes to a reparative\nstate and promote activated neutrophils to be less inflammatory. This unique\nimmunomodulation approach may promote long-term organ recovery, eliminate the\nneed for future continuous RRT, including dialysis, and prevent loss of\nlife.  \n\nAbout NEUTRALIZE-AKI Pivotal Trial\n\nThe NEUTRALIZE-AKI\n(https://www.globenewswire.com/Tracker?data=lWAILg_f9IyYiBRuDOM2HCbKIexTqlBQSegP-WRnldK7bRJ8KV7bwGKwuRPP41oI_eQGJWCINguBADFaz0lUNeJ9SayOExihpDUHmzhW7ButLDTYchsOzfikckhV2THgDzegWyo_dBNL-08JQCz1_j1M1kVqqOCUbw6wNmOI0xez2nCVe57JiYvf2HyeERjG9FS2iRrNu7TK-B03MZG9Dw==)\n(NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a\nrandomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating\nthe safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU\nreceiving continuous RRT. The trial’s primary endpoint is a composite of\n90-day mortality or dialysis dependency of patients treated with the SCD\ntherapy in addition to continuous RRT as the standard of care, compared with\nthe control group receiving only continuous RRT standard of care. Secondary\nendpoints include mortality at 28 days, ICU-free days in the first 28 days,\nmajor adverse kidney events at Day 90 and dialysis dependency at one year. The\nstudy will also include subgroup analyses to explore the effectiveness of the\nSCD therapy in AKI patients with sepsis and acute respiratory distress\nsyndrome. \n\nAbout Acute Kidney Injury (AKI) and Hyperinflammation \n\nAKI is characterized by a sudden and temporary loss of kidney function and can\nbe caused by a variety of conditions such as severe infections or other septic\nconditions, severe trauma, surgery, and organ failures. AKI can cause\ndestructive hyperinflammation, which is the overproduction or overactivity of\ninflammatory effector cells and other molecules that can be toxic. Damage\nresulting from this destructive hyperinflammation in AKI can progress to other\norgans, such as the heart or liver, and potentially to multi-organ dysfunction\nor even failure that could result in worse outcomes, including increased risk\nof death. Even after resolution, these patients may face complications\nincluding chronic kidney disease or end-stage renal disease (ESRD) requiring\ndialysis. Extreme hyperinflammation may also contribute to added healthcare\ncosts, such as prolonged ICU stays and increased reliance on dialysis and\nmechanical ventilation.\n\nAbout SeaStar Medical\n\nSeaStar Medical is a commercial-stage healthcare company focused on\ntransformational treatments for critically ill patients facing organ failure\nand potential loss of life. SeaStar Medical’s first commercial\nproduct, QUELIMMUNE (SCD-PED)\n(https://www.globenewswire.com/Tracker?data=kdlMGoXaq3Q3k845Kmk3v5xBoo8AJEjsMJvAHzHTV-G13mtft4LN_UtS5YimrrFpkG7AXzxL9fJrg6lZ2926RkoSN44vZFeAad1jz5ISL9RIfdhMW_XoqcNhlYNhdD_wJg90FrLlTRvp9rf1zUqK-vVWmzo2PJVkA6WULrYjn5d4h58GC42Gk4RYX04dYqjoB-cpFJK56sVmEo8sX2NEUz1NA5hXI-sr1R-hLvruaAQ9kYMGnYFlu0k9ORaIdtQzrBbB_ydK_YeA7-iEiTEuxwJHB3nDyywx1npom24aK_k=),\nwas approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the\nonly FDA approved product for the ultra-rare condition of life-threatening\nAcute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal\nreplacement therapy (RRT) in critically ill pediatric patients. SeaStar\nMedical’s Selective Cytopheretic Device (SCD) therapy has been awarded\nBreakthrough Device Designation for six therapeutic indications by the FDA,\nenabling the potential for a speedier pathway to approval and preferable\nreimbursement dynamics at commercial launch.\n\nFor more information visit www.seastarmedical.com or visit us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=PnkyEfSowR8KIgoi0FO9f1PG51ijrBt8-wGAUEdcXVc8sx0ifDp_EOnv8gSfnbqDsjH_U3oiCuOo8lkEZT2wJcwtPru63oho4Usz-zzdpKpOQY2jFp75mm5zyUTQl9BQArDXgYYFX1azB57fFtO8WD5Q4wXj1EjCh84KUIYPbueHbeWyPC9EcXlCWnXU1y5IpQYcak1OYmGOctoUE_fAzqeq60_lBsgHGTooh9qhaWjIzaMU11eQ9wq5jsUWX17gs_R98WXj225csb85QfxEWA==) or X\n(https://www.globenewswire.com/Tracker?data=mNTcuhILTyu4-i38LV9s2jsGPqKdtORQ0tsYAIB97xOPFFeqU-7MKFfVZcn7tmvQCnyZ2GpnG8XozPeEKDGJmfV89ST-Hn8JTSIG8VxI-eC26Rjf3JxRwmGoTnoF-0KCOuXTbTfAoNNIDVXAm3jfpJAdwOdKMngyw6HlA2qCzdLUvybJ_tYa80sOZHzio0UHl0I7KeBbvRF7f8OojOXOnfgnnb7ntN6o2bIQ4IZspb0=).\n\nForward-Looking Statements\n\nThis press release contains certain forward-looking statements within the\nmeaning of the “safe harbor” provisions of the Private Securities\nLitigation Reform Act of 1955. These forward-looking statements include,\nwithout limitation, SeaStar Medical’s expectations with respect to\ncommercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with\nAKI and other diseases; the expected regulatory approval process and timeline\nfor commercialization; and the ability of SeaStar Medical to meet the expected\ntimeline. Words such as “believe,” “project,” “expect,”\n“anticipate,” “estimate,” “intend,” “strategy,” “future,”\n“opportunity,” “plan,” “may,” “should,” “will,”\n“would,” “will be,” “will continue,” “will likely result,” and\nsimilar expressions are intended to identify such forward-looking statements.\nForward-looking statements are predictions, projections and other statements\nabout future events that are based on current expectations and assumptions\nand, as a result, are subject to significant risks and uncertainties that\ncould cause the actual results to differ materially from the expected results.\nMost of these factors are outside SeaStar Medical’s control and are\ndifficult to predict. Factors that may cause actual future events to differ\nmaterially from the expected results include, but are not limited to: (i) the\nrisk that SeaStar Medical may not be able to obtain regulatory approval of its\nSCD product candidates; (ii) the risk that SeaStar Medical may not be able to\nraise sufficient capital to fund its operations, including current or future\nclinical trials; (iii) the risk that SeaStar Medical and its current and\nfuture collaborators are unable to successfully develop and commercialize its\nproducts or services, or experience significant delays in doing so, including\nfailure to achieve approval of its products by applicable federal and state\nregulators, (iv) the risk that SeaStar Medical may never achieve or sustain\nprofitability; (v) the risk that SeaStar Medical may not be able to secure\nadditional financing on acceptable terms; (vi) the risk that third-party\nsuppliers and manufacturers are not able to fully and timely meet their\nobligations, (vii) the risk of product liability or regulatory lawsuits or\nproceedings relating to SeaStar Medical’s products and services, (viii) the\nrisk that SeaStar Medical is unable to secure or protect its intellectual\nproperty, and (ix) other risks and uncertainties indicated from time to time\nin SeaStar Medical’s Annual Report on Form 10-K, including those under the\n“Risk Factors” section therein and in SeaStar Medical’s other filings\nwith the SEC. The foregoing list of factors is not exhaustive. Forward-looking\nstatements speak only as of the date they are made. Readers are cautioned not\nto put undue reliance on forward-looking statements, and SeaStar Medical\nassumes no obligation and do not intend to update or revise these\nforward-looking statements, whether as a result of new information, future\nevents, or otherwise. \n\nContact:  \nIR@SEASTARMED.COM\n\nQUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e5c40d1b-8302-4e46-be95-030dbb3dc6d0)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8PcGxz-20260924","title":"SeaStar Medical Congratulates H. David Humes, M.D., on Receiving the University of Michigan 2026 Distinguished University Innovator of the Year for Development of the SCD Therapy","author":"Globe Newswire","ticker":"ICU","created":"2026-09-24T12:16:00.125Z","tickers":["ICU"],"exchange":"NASDAQ","article_body":"Prestigious honor recognizes Dr. Humes’ pioneering work in developing the\nSelective Cytopheretic Device (SCD) therapy, commercialized by SeaStar Medical\nas QUELIMMUNE(®) for critically ill pediatric patients with acute kidney\ninjury (AKI)\n\nSeaStar Medical’s SCD development pipeline of indications holds promise for\nmultiple additional indications\n\nDENVER, Sept. 24, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation\n(Nasdaq: ICU), a commercial-stage healthcare company focused on\ntransformational treatments for critically ill patients facing organ failure\nand potential loss of life announced today that H. David Humes, M.D., is being\nawarded this year’s Distinguished University Innovator of the Year award at\nCelebrate Invention, an annual event hosted by Innovation Partnerships at the\nUniversity of Michigan (U-M). The award is the highest honor for U-M faculty\nmembers who have developed transformative ideas, processes, or technologies\nand helps them to reach the market for broad societal impact.  \n\nDr. Humes discovered and developed the Selective Cytopheretic Device (SCD), a\ndisease-modifying therapeutic device that neutralizes over-active immune cells\nand stops the cytokine storm that yields destructive hyperinflammation and\ncreates a cascade of events that can rapidly lead to organ failure and death.\nThe SCD therapy was successfully developed by SeaStar Medical in clinical\ntrials of pediatric patients with severe AKI, resulting in the first and only\nFDA-approved therapy specifically for children with AKI and sepsis or a sepsis\nlike condition. The Company subsequently launched QUELIMMUNE (SCD-PED) into\nthe pediatric critical care community. QUELIMMUNE has demonstrated a 50%\nreduction in patient mortality at 60 days, compared to the standard of care,\nin clinical trials and published preliminary outcomes analyses to date. The\nCompany is also conducting the pivotal NEUTRALIZE-AKI clinical trial of the\nSCD therapy in adult patients with life-threatening AKI receiving continuous\nrenal replacement therapy.\n\n\"We extend our warmest congratulations to Dr. Humes on this well-deserved\nrecognition from the University of Michigan,\" said Eric Schlorff, Chief\nExecutive Officer of SeaStar Medical. \"His visionary science transformed how\nthe medical community views immune system dysregulation in critical illness.\nBy targeting activated white blood cells to stop the hyperinflammatory\ncascade, his life's work paved the way for our QUELIMMUNE therapy, giving\nclinicians an invaluable tool to save the lives of critically ill children. We\nare proud to build upon his legacy as we advance the SCD therapy beyond the\npediatric indication, with clinical development underway for a second\nindication in adult patients with AKI on continuous renal replacement\ntherapy.\"\n\n\"It is an immense honor to receive this award from the University of\nMichigan,\" said Dr. Humes. \"Translating benchtop discovery into a commercial\ntherapy that reaches patients at the bedside requires a dedicated team of\nresearchers, clinical trialists, and commercial partners. Seeing the SCD\ntherapy make a tangible difference in the pediatric ICU has been the most\nrewarding chapter of my career.\"\n\nDr. Humes will be formally presented with the award during the University of\nMichigan’s annual Celebrate Invention event on September 24, 2026, in Ann\nArbor, Michigan. In addition to the award, Celebrate Invention will offer\nattendees a presentation entitled “From Bench to Bedside: A Sepsis\nBreakthrough Two Decades in the Making” and an accompanying panel\ndiscussion. Both Dr. Humes and Mr. Schlorff will be panel speakers along with\nDr. Lenar Yessayan, Clinical Professor of Internal Medicine, Director MPLAN\n– Inpatient Hemodialysis and Director of the MDS Dialysis Unit, Michigan\nMedicine, and Kelly Sexton, Associate Vice President for Research –\nInnovation Partnerships and Economic Impact.\n\nAbout QUELIMMUNE\n\nThe QUELIMMUNE\n(https://www.globenewswire.com/Tracker?data=kdlMGoXaq3Q3k845Kmk3v32qrSwpGgUhvS6DwNviLnuulFlYSOLjJ9ws480X5ncNF3tAufFBhvePdO8n8b94ERt9HMtSh9WZjcKNuzTxIJjMXRaneCXTKPx2StujSjOGVdz6h3qAdKaFHmhtU-0vL4VyzwV_CP-CNjt5pwGqgge4t4hR5r8losN7zV581g4Wqzcd7kV1c7_VjMo1S5hlx7iyhqtwXwDtuf1hl_i0y0vMi1SyBOqFIvumOQnQjw6oFcYNtHim8bvvU9iWi5iYSQ==)(®)\n(https://www.globenewswire.com/Tracker?data=G1fjUqx8DRZWu0n494W7MIIXGqvCvcz1N0n4V1J4mgB-bQAut9dILPcXFAxjUBSeEk0PHziDdZX7fKIGLt675zUCYjQP1YwuVF6X2nHXbTqKflfeXdBMmw3D_kwTt_1YcWqQF6bsJ5nArzh_oJcPFOT3rXullUFA9harcDZzrBp4cUbr3X4DGWHQDaOUtI5UxbH852qdYce8V60a0jIrk9jVWT63y2u-y570DPotpX8DqN81vqdjoPj0lEfr-44SMw0Ux3M85GXRQ1v2uO89jQ==)\n(SCD-PED) therapy\n(https://www.globenewswire.com/Tracker?data=a_RlG-ZVmCn2R7mPuPWEh2dGXD5EmmjK5liElDjMn9wtrI3o8kmq9mBLmSz1mLs2K4QuzzVdG-cVmUpy0KIekGI8zbCnnBnc7nPcMlwehkhaugCVoRL-h3o6DCStjH9e1X3V4Ujlp8wcv3L3u8cbl8SuJ-xk7MLCj_1w19cfQxSYoT_FqQxocmAcjxsqHeHQvtSVbGgQLJD46HW2Z7tChPi3GGXVqotWs989z7t6I12f-TA818j94HzTipSZQPWmu8rEdFVFYxN5FV0m21VHNLM214lrAsY3YESouLMO3eQ=) is\nbeing commercialized for children with AKI and sepsis or septic condition\nweighing 10 kilograms or more who are on antibiotics and being treated in the\nICU with RRT. It was approved in February 2024 under a Humanitarian Device\nExemption application.\n\nData from two clinical trials of the QUELIMMUNE therapy, published in Kidney\nMedicine\n(https://www.globenewswire.com/Tracker?data=BJFhoYs_zEceTxAW3fZu9wXmiAQnxjJaGXrTtsG_f7NB5g2FLxIOJRP_sHyZEMtlX-wZkCmMpvuMaEEA0d98U89jGnFLoxR0PF4vi6PJo5F36tHDVqCsvy3AgCVnzwEsuNxUyF66rB3hWYI7bzTu0q3HeFgqm5EnC9dLhA0nmWU4m4tODtfKARpvmQ90fjshKHVgBBaVoqkGlsLM82aSeyl6Za2J8x89LzMgsjNcBzWe9aLuIgMKKvzpIUIY_XBii7_l7HTWlZMrlQFuM87-fyLq-ggx7M7WVpc4M1EsfxVELpZeojzqj0d691bPADedkkLamtk80od_sudBEqy-KeS6nnwh1pCedWPXdnPYoIU=),\nshowed a 77% survival rate in patient treated with QUELIMMUNE versus standard\nof care, representing an approximate 50% reduction in loss of life compared to\nhistorical data in this patient population. No dialysis was required for\nsurvivors, and 87.5% of survivors had normal kidney function at Day 60 after\nICU discharge. In February 2026, data published in the prestigious,\npeer-reviewed journal, Pediatric Nephrology\n(https://www.globenewswire.com/Tracker?data=XNInv2NM2_JEhmeiXJ9hRs2DgX_zwp3xsdBSNaWa4C_84pREiz53qYKNvgw_G9OhQiMpymfa8UMkzx7H5bPE3FEK350m5VBTn-lSMTGg9RYdHwykkruyz0XSfRi93pN83PdqXa7Nw6uMHPUBtA7GfCyBBI3Z5rXN2vlqGv1MpHAbfeg2g44qZ9VvFqXB5nM1cTsidDvPdyGjnHsEHcAT9bKZyVTYkY-cK_NaT1zeuvF6Ut4kUzlLnBO3IaxGqMVNA0OL9IZvALvQVBZP6Y6I7kI-ItbYO4B_TrajhMOnCq8=),\nhighlighted the early experience from the QUELIMMUNE SAVE Registry\n(https://www.globenewswire.com/Tracker?data=EU9hUERUt4OenJhODVuXLuXQzlbiBq-pZ_2Cqo8ZC0kQLWku6zEQsMhnmaxTeauirFcb42fbyJn9oeFW30N3VklqGes8C5kerV9vbizP2xDe4hjh-a6dZNpoThTMJXWop2Hyk44qKULrMPXtRQBqNF0gYdlVkhP65NDbAV6MZEE=),\na post-approval surveillance registry, evaluating the role of the QUELIMMUNE\ntherapy in the treatment of critically ill pediatric patients with\nlife-threatening Acute Kidney Injury (AKI) and sepsis requiring renal\nreplacement therapy. Observations from the first 21 pediatric patients with\nAKI and sepsis requiring renal replacement therapy showed no device-related\nadverse events or infections and no reports of immunosuppressive effects by\nthe device. In addition, preliminary outcomes analyses show a 76% survival\nrate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data\nare on track to validate a 50% reduction in patient mortality at 60 days\ncompared to historical data, similar to what was observed in the registration\nstudy reported in Kidney Medicine\n(https://www.globenewswire.com/Tracker?data=BJFhoYs_zEceTxAW3fZu96djUuyq_TDPa6NLPle6I89mz_ain-Fl8cxy7_Em7pYoX8AdWsIgd5gMXsJhQNJP28KbDqjH2J2_aAaLYdTDFlbRNam4sLm92r0hIyZPlyZU_0lhWLV1UD7RgfYrvgB7DHr0ASBvXMdtxzdMV_6FvvYT_1NvO7EDM_xiZBB-hZMO9yvK-jwwIjRegOMbfBh7fbXxO7izqzOrDGMQeNKqCjG-Axqtshlsi124hjgDYu_RTN1jD5BDrpGE9MLrgkLQmZ2nMB2_g4sFtCnoVHoCNIRFJpooN2lHY8IhpEcqRNX6W1oU0LEvrka8_CRvrsDN8UM7Ce3awMt1ioNtGQ6mCxg=).\n\nThe patented technology behind QUELIMMUNE is known as the Selective\nCytopheretic Device (SCD) therapy and has broad applications for treating the\ndestructive hyperinflammation that shuts down organ function and causes loss\nof life.\n\nAbout the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy\n\nThe SCD therapy is designed as a disease-modifying device that neutralizes\nover-active immune cells and stops the cytokine storm that yields destructive\nhyperinflammation and creates a cascade of events that wreak havoc in the\npatient’s body. The SCD therapy is designed for broad applications in\nmultiple acute and chronic kidney and cardiovascular diseases, representing\npatients who today have no FDA-approved options for treating their disease.\nUnlike pathogen removal and other blood-purification tools, the SCD therapy is\nintegrated with an existing continuous RRT hemofiltration system to\nselectively target and transition proinflammatory monocytes to a reparative\nstate and promote activated neutrophils to be less inflammatory. This unique\nimmunomodulation approach may promote long-term organ recovery, eliminate the\nneed for future continuous RRT, including dialysis, and prevent loss of\nlife.  \n\nAbout NEUTRALIZE-AKI Pivotal Trial\n\nThe NEUTRALIZE-AKI\n(https://www.globenewswire.com/Tracker?data=lWAILg_f9IyYiBRuDOM2HCbKIexTqlBQSegP-WRnldK7bRJ8KV7bwGKwuRPP41oI_eQGJWCINguBADFaz0lUNeJ9SayOExihpDUHmzhW7ButLDTYchsOzfikckhV2THgDzegWyo_dBNL-08JQCz1_j1M1kVqqOCUbw6wNmOI0xez2nCVe57JiYvf2HyeERjG9FS2iRrNu7TK-B03MZG9Dw==)\n(NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a\nrandomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating\nthe safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU\nreceiving continuous RRT. The trial’s primary endpoint is a composite of\n90-day mortality or dialysis dependency of patients treated with the SCD\ntherapy in addition to continuous RRT as the standard of care, compared with\nthe control group receiving only continuous RRT standard of care. Secondary\nendpoints include mortality at 28 days, ICU-free days in the first 28 days,\nmajor adverse kidney events at Day 90 and dialysis dependency at one year. The\nstudy will also include subgroup analyses to explore the effectiveness of the\nSCD therapy in AKI patients with sepsis and acute respiratory distress\nsyndrome. \n\nAbout Acute Kidney Injury (AKI) and Hyperinflammation \n\nAKI is characterized by a sudden and temporary loss of kidney function and can\nbe caused by a variety of conditions such as severe infections or other septic\nconditions, severe trauma, surgery, and organ failures. AKI can cause\ndestructive hyperinflammation, which is the overproduction or overactivity of\ninflammatory effector cells and other molecules that can be toxic. Damage\nresulting from this destructive hyperinflammation in AKI can progress to other\norgans, such as the heart or liver, and potentially to multi-organ dysfunction\nor even failure that could result in worse outcomes, including increased risk\nof death. Even after resolution, these patients may face complications\nincluding chronic kidney disease or end-stage renal disease (ESRD) requiring\ndialysis. Extreme hyperinflammation may also contribute to added healthcare\ncosts, such as prolonged ICU stays and increased reliance on dialysis and\nmechanical ventilation.\n\nAbout SeaStar Medical\n\nSeaStar Medical is a commercial-stage healthcare company focused on\ntransformational treatments for critically ill patients facing organ failure\nand potential loss of life. SeaStar Medical’s first commercial\nproduct, QUELIMMUNE (SCD-PED)\n(https://www.globenewswire.com/Tracker?data=kdlMGoXaq3Q3k845Kmk3v5xBoo8AJEjsMJvAHzHTV-G13mtft4LN_UtS5YimrrFpkG7AXzxL9fJrg6lZ2926RkoSN44vZFeAad1jz5ISL9RIfdhMW_XoqcNhlYNhdD_wJg90FrLlTRvp9rf1zUqK-vVWmzo2PJVkA6WULrYjn5d4h58GC42Gk4RYX04dYqjoB-cpFJK56sVmEo8sX2NEUz1NA5hXI-sr1R-hLvruaAQ9kYMGnYFlu0k9ORaIdtQzrBbB_ydK_YeA7-iEiTEuxwJHB3nDyywx1npom24aK_k=),\nwas approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the\nonly FDA approved product for the ultra-rare condition of life-threatening\nAcute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal\nreplacement therapy (RRT) in critically ill pediatric patients. SeaStar\nMedical’s Selective Cytopheretic Device (SCD) therapy has been awarded\nBreakthrough Device Designation for six therapeutic indications by the FDA,\nenabling the potential for a speedier pathway to approval and preferable\nreimbursement dynamics at commercial launch.\n\nFor more information visit www.seastarmedical.com or visit us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=PnkyEfSowR8KIgoi0FO9f1PG51ijrBt8-wGAUEdcXVc8sx0ifDp_EOnv8gSfnbqDsjH_U3oiCuOo8lkEZT2wJcwtPru63oho4Usz-zzdpKpOQY2jFp75mm5zyUTQl9BQArDXgYYFX1azB57fFtO8WD5Q4wXj1EjCh84KUIYPbueHbeWyPC9EcXlCWnXU1y5IpQYcak1OYmGOctoUE_fAzqeq60_lBsgHGTooh9qhaWjIzaMU11eQ9wq5jsUWX17gs_R98WXj225csb85QfxEWA==) or X\n(https://www.globenewswire.com/Tracker?data=mNTcuhILTyu4-i38LV9s2jsGPqKdtORQ0tsYAIB97xOPFFeqU-7MKFfVZcn7tmvQCnyZ2GpnG8XozPeEKDGJmfV89ST-Hn8JTSIG8VxI-eC26Rjf3JxRwmGoTnoF-0KCOuXTbTfAoNNIDVXAm3jfpJAdwOdKMngyw6HlA2qCzdLUvybJ_tYa80sOZHzio0UHl0I7KeBbvRF7f8OojOXOnfgnnb7ntN6o2bIQ4IZspb0=).\n\nForward-Looking Statements\n\nThis press release contains certain forward-looking statements within the\nmeaning of the “safe harbor” provisions of the Private Securities\nLitigation Reform Act of 1955. These forward-looking statements include,\nwithout limitation, SeaStar Medical’s expectations with respect to\ncommercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with\nAKI and other diseases; the expected regulatory approval process and timeline\nfor commercialization; and the ability of SeaStar Medical to meet the expected\ntimeline. Words such as “believe,” “project,” “expect,”\n“anticipate,” “estimate,” “intend,” “strategy,” “future,”\n“opportunity,” “plan,” “may,” “should,” “will,”\n“would,” “will be,” “will continue,” “will likely result,” and\nsimilar expressions are intended to identify such forward-looking statements.\nForward-looking statements are predictions, projections and other statements\nabout future events that are based on current expectations and assumptions\nand, as a result, are subject to significant risks and uncertainties that\ncould cause the actual results to differ materially from the expected results.\nMost of these factors are outside SeaStar Medical’s control and are\ndifficult to predict. Factors that may cause actual future events to differ\nmaterially from the expected results include, but are not limited to: (i) the\nrisk that SeaStar Medical may not be able to obtain regulatory approval of its\nSCD product candidates; (ii) the risk that SeaStar Medical may not be able to\nraise sufficient capital to fund its operations, including current or future\nclinical trials; (iii) the risk that SeaStar Medical and its current and\nfuture collaborators are unable to successfully develop and commercialize its\nproducts or services, or experience significant delays in doing so, including\nfailure to achieve approval of its products by applicable federal and state\nregulators, (iv) the risk that SeaStar Medical may never achieve or sustain\nprofitability; (v) the risk that SeaStar Medical may not be able to secure\nadditional financing on acceptable terms; (vi) the risk that third-party\nsuppliers and manufacturers are not able to fully and timely meet their\nobligations, (vii) the risk of product liability or regulatory lawsuits or\nproceedings relating to SeaStar Medical’s products and services, (viii) the\nrisk that SeaStar Medical is unable to secure or protect its intellectual\nproperty, and (ix) other risks and uncertainties indicated from time to time\nin SeaStar Medical’s Annual Report on Form 10-K, including those under the\n“Risk Factors” section therein and in SeaStar Medical’s other filings\nwith the SEC. The foregoing list of factors is not exhaustive. Forward-looking\nstatements speak only as of the date they are made. Readers are cautioned not\nto put undue reliance on forward-looking statements, and SeaStar Medical\nassumes no obligation and do not intend to update or revise these\nforward-looking statements, whether as a result of new information, future\nevents, or otherwise. \n\nContact:  \nIR@SEASTARMED.COM\n\nQUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e5c40d1b-8302-4e46-be95-030dbb3dc6d0)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-24T12:16:00.1772008Z","server_sent_at_ms":1790252160177},"received_at":"2026-09-24T12:16:00.326Z","source_url":null},"analysis":{"id":"140832","press_release_id":"152030","analysis_json":{"industry":{"label":"Health Care Equipment & Supplies","sector":"Health Care"},"redFlags":[],"eventType":"other","narrative":"SeaStar Medical (Nasdaq: ICU) announced that Dr. H. David Humes, inventor of the Selective Cytopheretic Device, received the University of Michigan's 2026 Distinguished University Innovator of the Year award.\n\nThe honor recognizes the science behind QUELIMMUNE, the only FDA-approved therapy for critically ill children with AKI and sepsis, which has shown a 50% reduction in 60-day mortality versus standard of care in trials and registry data.\n\nThe release contains no new financial, regulatory, or trial results; it is reputationally supportive but operationally neutral, with the pivotal NEUTRALIZE-AKI adult trial (339 patients) still the key catalyst.","sentiment":"neutral","agentHooks":{"shouldPost":false,"suggestedAngle":"Academic-award publicity for QUELIMMUNE science; no new catalysts -- NEUTRALIZE-AKI remains the key watch item."},"keyFigures":{"customDimensions":{"neutralize_aki_enrollment":339,"quelimune_mortality_reduction":"50% reduction in patient mortality at 60 days vs standard of care","save_registry_survival_rate_day90":"71%","save_registry_survival_rate_day28_day60":"76%"}},"quotedText":"His visionary science transformed how the medical community views immune system dysregulation in critical illness.","namedEntities":{"people":[{"name":"H. David Humes, M.D.","role":"award recipient, SCD inventor"},{"name":"Eric Schlorff","role":"CEO of SeaStar Medical"},{"name":"Lenar Yessayan","role":"Clinical Professor of Internal Medicine, Michigan Medicine"},{"name":"Kelly Sexton","role":"Associate Vice President for Research - Innovation Partnerships, University of Michigan"}],"products":["QUELIMMUNE (SCD-PED)","Selective Cytopheretic Device (SCD)"],"companies":[{"name":"SeaStar Medical Holding Corporation","ticker":"ICU","relationship":"filer"},{"name":"University of Michigan","relationship":"award-issuing institution"},{"name":"Michigan Medicine","relationship":"academic medical center"}],"dollarAmounts":[]},"materialImpact":{"score":1,"reasoning":"The release congratulates Dr. Humes on a University of Michigan academic award recognizing the science behind QUELIMMUNE. It contains no new financial, regulatory, or clinical-trial results and does not change the company's operating outlook."},"tickerRelevance":{"others":[],"primary":"ICU"},"globalImportance":8,"audienceRelevance":8,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap","newCatalyst":false,"eventGravity":"academic-recognition","issuerAuthored":true}},"event_type":"other","event_type_secondary":null,"sentiment":"neutral","material_impact_score":1,"narrative":"SeaStar Medical (Nasdaq: ICU) announced that Dr. H. David Humes, inventor of the Selective Cytopheretic Device, received the University of Michigan's 2026 Distinguished University Innovator of the Year award.\n\nThe honor recognizes the science behind QUELIMMUNE, the only FDA-approved therapy for critically ill children with AKI and sepsis, which has shown a 50% reduction in 60-day mortality versus standard of care in trials and registry data.\n\nThe release contains no new financial, regulatory, or trial results; it is reputationally supportive but operationally neutral, with the pivotal NEUTRALIZE-AKI adult trial (339 patients) still the key catalyst.","key_figures":{"customDimensions":{"neutralize_aki_enrollment":339,"quelimune_mortality_reduction":"50% reduction in patient mortality at 60 days vs standard of care","save_registry_survival_rate_day90":"71%","save_registry_survival_rate_day28_day60":"76%"}},"named_entities":{"people":[{"name":"H. David Humes, M.D.","role":"award recipient, SCD inventor"},{"name":"Eric Schlorff","role":"CEO of SeaStar Medical"},{"name":"Lenar Yessayan","role":"Clinical Professor of Internal Medicine, Michigan Medicine"},{"name":"Kelly Sexton","role":"Associate Vice President for Research - Innovation Partnerships, University of Michigan"}],"products":["QUELIMMUNE (SCD-PED)","Selective Cytopheretic Device (SCD)"],"companies":[{"name":"SeaStar Medical Holding Corporation","ticker":"ICU","relationship":"filer"},{"name":"University of Michigan","relationship":"award-issuing institution"},{"name":"Michigan Medicine","relationship":"academic medical center"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-24T12:16:06.295Z","global_importance":8,"audience_relevance":8,"importance_components":{"tickerTier":"micro-cap","newCatalyst":false,"eventGravity":"academic-recognition","issuerAuthored":true}},"durationMs":5959,"modelName":"glm-5.3-flashx"}}