Prestigious honor recognizes Dr. Humes’ pioneering work in developing the Selective Cytopheretic Device (SCD) therapy, commercialized by SeaStar Medical as QUELIMMUNE^® for critically ill pediatric patients with acute kidney injury (AKI)

SeaStar Medical’s SCD development pipeline of indications holds promise for multiple additional indications

DENVER, Sept. 24, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life announced today that H. David Humes, M.D., is being awarded this year’s Distinguished University Innovator of the Year award at Celebrate Invention, an annual event hosted by Innovation Partnerships at the University of Michigan (U-M). The award is the highest honor for U-M faculty members who have developed transformative ideas, processes, or technologies and helps them to reach the market for broad societal impact.

Dr. Humes discovered and developed the Selective Cytopheretic Device (SCD), a disease-modifying therapeutic device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that can rapidly lead to organ failure and death. The SCD therapy was successfully developed by SeaStar Medical in clinical trials of pediatric patients with severe AKI, resulting in the first and only FDA-approved therapy specifically for children with AKI and sepsis or a sepsis like condition. The Company subsequently launched QUELIMMUNE (SCD-PED) into the pediatric critical care community. QUELIMMUNE has demonstrated a 50% reduction in patient mortality at 60 days, compared to the standard of care, in clinical trials and published preliminary outcomes analyses to date. The Company is also conducting the pivotal NEUTRALIZE-AKI clinical trial of the SCD therapy in adult patients with life-threatening AKI receiving continuous renal replacement therapy.

"We extend our warmest congratulations to Dr. Humes on this well-deserved recognition from the University of Michigan," said Eric Schlorff, Chief Executive Officer of SeaStar Medical. "His visionary science transformed how the medical community views immune system dysregulation in critical illness. By targeting activated white blood cells to stop the hyperinflammatory cascade, his life's work paved the way for our QUELIMMUNE therapy, giving clinicians an invaluable tool to save the lives of critically ill children. We are proud to build upon his legacy as we advance the SCD therapy beyond the pediatric indication, with clinical development underway for a second indication in adult patients with AKI on continuous renal replacement therapy."

"It is an immense honor to receive this award from the University of Michigan," said Dr. Humes. "Translating benchtop discovery into a commercial therapy that reaches patients at the bedside requires a dedicated team of researchers, clinical trialists, and commercial partners. Seeing the SCD therapy make a tangible difference in the pediatric ICU has been the most rewarding chapter of my career."

Dr. Humes will be formally presented with the award during the University of Michigan’s annual Celebrate Invention event on September 24, 2026, in Ann Arbor, Michigan. In addition to the award, Celebrate Invention will offer attendees a presentation entitled "From Bench to Bedside: A Sepsis Breakthrough Two Decades in the Making" and an accompanying panel discussion. Both Dr. Humes and Mr. Schlorff will be panel speakers along with Dr. Lenar Yessayan, Clinical Professor of Internal Medicine, Director MPLAN – Inpatient Hemodialysis and Director of the MDS Dialysis Unit, Michigan Medicine, and Kelly Sexton, Associate Vice President for Research – Innovation Partnerships and Economic Impact.

About QUELIMMUNE

The QUELIMMUNE ^® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application.

Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine.

The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life.

About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy

The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous RRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future continuous RRT, including dialysis, and prevent loss of life.

About NEUTRALIZE-AKI Pivotal Trial

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to continuous RRT as the standard of care, compared with the control group receiving only continuous RRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.

About Acute Kidney Injury (AKI) and Hyperinflammation

AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

About SeaStar Medical

SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch.

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Forward-Looking Statements

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 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 secure additional financing on acceptable terms; (vi) the risk that third-party 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.

Contact: 

IR@SEASTARMED.COM

QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.