SeaStar Medical Holding Corporation announced enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). SeaStar Medical expects to receive U.S. Food & Drug Administration (FDA) approval for its SCD Pediatric (SCD-PED) under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with AKI and sepsis or a septic condition requiring continuous CKRT anytime within the next 30 to 45 days and to commence commercialization of the SCD-PED in First Quarter 2024. The NEUTRALIZE-AK I (NEUTRophil and monocyte deActivation via SeLective CytopheretIic Device - a randomiZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 patients.

The trial's primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CKRT as the standard of care, compared with the control group receiving only CKRT 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 SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.

words such as "believe," "project," "expect," "anticipate," "intend," "str strategy," " future," "opp opportunity," "plan," " may, should," "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 difference materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including 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 SeaStarMedical may never achieve or sustain profitability; (v) the risk that SeaStarmedical may not be able to access funding under existing agreements, including the equity line of credit and forward purchase agreements; (vi) the risk that third-parties suppliers and manufacturers are not able To access funding under existing agreements; (vi) the risks that SeaStar Medical may not been able to access funding under existing agreement, including the equity line of Credit and forward purchase agreements; (ii) the risk that third-Parties suppliers and manufacturers are not ability to fund the SCD-PED.