Hepatorenal Syndrome

– Pooled analysis from Phase 3 clinical trials highlights liver transplant rates in adult patients with HRS with rapid reduction in kidney function treated with TERLIVAZ1 – DUBLIN, Oct. 26, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation on TERLIVAZ® (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 at Kidney Week 2024, the annual meeting of the American Society of Nephrology (ASN) taking place in San Diego from October 23-27, 2024. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,3 making it a very rare condition; and rates of hospitalizations are increasing.4 Please see Limitation of Use and Important Safety Information, including Boxed Warning, below. The poster presentation highlights a pooled analysis of data from the CONFIRM and REVERSE Phase 3 placebo-controlled trials of TERLIVAZ.5 The analysis examined the rates of hepatorenal syndrome-acute kidney injury (HRS-AKI) reversal, renal replacement therapy (RRT), and liver transplant (LT) among a subpopulation of patients listed for LT at baseline who met FDA label guidelines for treatment with TERLIVAZ (SCr <5 mg/dL, ACLF grade 0–2, and MELD score <35).5 In this patient subpopulation, treatment with TERLIVAZ increased the rate of HRS-AKI reversal and reduced the need for RRT at all time points assessed.5 The increase in HRS-AKI reversal with TERLIVAZ did not negatively impact the LT rate in patients listed for LT at baseline.5 The rate of HRS-AKI reversal was 43% in the TERLIVAZ group (n=53) and 20% in the placebo group (n=35).5 The rate of RRT in the TERLIVAZ and placebo groups was 28% and 46% by Day 30; 32% and 54% by Day 60; and 36% and 54% by Day 90, respectively.5 The LT rate was similar in the TERLIVAZ and placebo groups at all time points assessed: 53% and 51% by Day 30; 66% and 57% by Day 60; and 66% and 63% by Day 90, respectively.5 The limitations of this study include, but are not limited to, small sample sizes, variables in methodology, and possible errors and omissions within the data sets.5 "This analysis of data from our Phase 3 trials furthers our understanding of the appropriate patient subpopulations and the potential impact of treatment on liver transplantation rates," said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer. "For these critically ill patients with HRS-AKI, a liver transplant is the definitive treatment, and we know there are significant challenges associated with RRT; which makes continued research important." This study was sponsored by Mallinckrodt Pharmaceuticals. Presentation details can be found below: Poster #PO0102-2: Hepatorenal syndrome-acute kidney injury reversal and liver transplant rates in patients treated with terlipressin5 Presenter: Justin Belcher Session Type: Poster Presentation Session Title: AKI: Clinical, Outcomes, and Trials - Management Session Date and Time: Saturday, October 26, 2024; 10:00 a.m. – 12:00 p.m. PT INDICATION AND LIMITATION OF USE TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit. IMPORTANT SAFETY INFORMATION WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%. Contraindications TERLIVAZ is contraindicated: In patients experiencing hypoxia or worsening respiratory symptoms. In patients with ongoing coronary, peripheral, or mesenteric ischemia. Warnings and Precautions Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms. Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure. Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks. Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions. Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus. Adverse Reactions The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. Please click here to see full Prescribing Information, including Boxed Warning. ABOUT HEPATORENAL SYNDROME (HRS) Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.2 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population,3 making it a very rare condition; and rates of HRS hospitalizations are increasing.4 If left untreated, HRS with rapid reduction in kidney function1 has a median survival time of less than two weeks and greater than 80 percent mortality within three months.6 ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to TERLIVAZ®, its potential to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with TERLIVAZ; and other risks identified and described in more detail in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Green Room Communications 908-577-4531 [email protected] Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Mallinckrodt, the "M" brand mark, TERLIVAZ, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2024 Mallinckrodt. US-2400773 10/24 References 1 TERLIVAZ® (terlipressin) for Injection. Prescribing Information. Mallinckrodt Hospital Products Inc. 2023. 2 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: . Accessed October 2024. 3 United States Census Bureau: Quick Facts. Available at: . Accessed October 2024. 4 Singh J., Dahiya D.S., Kichloo A., et al. Hepatorenal Syndrome: A Nationwide Trend Analysis from 2008 to 2018. Annals of Med. 2021;53:1. 2018-2024 doi.org/10/1080/07853890. 5 Belcher J.M., Regner K.R., Mujtaba M.A., et al. Hepatorenal syndrome-acute kidney injury reversal and liver transplant rates in patients treated with terlipressin. Abstract to be presented at the American Society of Nephrology (ASN) 2024 Annual meeting. October 2024. 6 Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in the United States and the Potential of Terlipressin. Liver Transpl. 2021;27:1191-1202. . SOURCE Mallinckrodt plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Data illustrate the potential of QUELIMMUNE™️ with cost neutrality starting at 6 days of therapy and a significant reduction in total hospitalization costs in children with acute kidney injury SeaStar Medical’s SCD was featured in four Company presentations at the premier nephrology conference CORRECTION: “Importantly, our findings underscore the opportunity for widespread adoption by hospitals to generate cost savings, while also saving lives” DENVER, Oct. 25, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that for the first time new data highlighting the cost savings of its first-in-class, cell-directed Selective Cytopheretic Device (SCD) Pediatric therapeutic device, QUELIMMUNE, were presented yesterday at the American Society of Nephrology’s (ASN) Kidney Week 2024, underway in San Diego. “We are thrilled to present a high-quality analysis highlighting the significant potential cost-saving benefits of QUELIMMUNE to the healthcare system in treating critically ill children with acute kidney injury (AKI) at this renowned nephrology conference," said Eric Schlorff, CEO of SeaStar Medical. “QUELIMMUNE is another tool in the arsenal for hospitals to defeat pediatric AKI with sepsis. Sepsis is a big challenge, which is why the Centers for Medicare & Medicaid Services (CMS) developed the SEP-1 protocol and quality metric for hospital systems to perform against. “Importantly, our findings underscore the opportunity for widespread adoption by hospitals to generate significant cost savings while also saving lives,” he added. “Utilization of QUELIMMUNE is also operationally efficient. It fits directly into existing continual renal replacement therapy (CRRT) circuits.” The poster, titled Cost Impact of An Immunomodulatory Selective Cytopheretic Device in Pediatrics (SCD-PED) in AKI due to Sepsis (AKI-S), presents an analysis of the Kids’ Inpatient Database (KID) revealing that the hospitalization cost of pediatric patients with AKI requiring CRRT, a majority of whom were septic, was $461,736 per hospitalization, highlighting an exceptionally high financial burden on institutions and the healthcare system. Data from KID and SeaStar Medical’s SCD-PED studies indicate that hospitalization costs were significantly lower for critically ill children with AKI on CRRT who were treated with QUELIMMUNE, a majority of whom were septic, compared with historical average hospital costs for children not treated with QUELIMMUNE. Treatment with QUELIMMUNE results in a projected cost savings of approximately $30,000 per hospitalization principally driven by the lower expected death rate and shorter length of stay versus standard of care. Additional benefits of QUELIMMUNE included a cost-effective solution for institutions starting at 6 days of QUELIMMUNE therapy, which produced cost neutrality for QUELIMMUNE afforded by the high survival rate of 77% in children ≥10 kg and age ≤22 years with AKI requiring CRRT treated with QUELIMMUNE, versus the control survival rate of approximately 50%. Further, the combined observed outcomes of 0% dialysis dependence at day 60 from the SCD PED-01 and SCD-PED-02 studies illustrate the durability of QUELIMMUNE therapy. The SeaStar Medical team has a significant presence at Kidney Week 2024, with a total of four posters being presented by the Company. A second poster describes the mechanistic effects of reducing hyperinflammatory markers in patients with AKI. Additional SeaStar Medical posters that highlight the design of the ongoing NEUTRALIZE-AKI pivotal trial and the upcoming NEUTRALIZE-CRS trial are summarized below: NEUTRALIZE-AKI: A Multicenter, Randomized, Controlled Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with AKI Requiring Continuous Kidney Replacement Therapy (L. Yessayan, et al.) The ongoing NEUTRALIZE-AKI trial aims to evaluate the safety and efficacy of the SCD in adults with AKI requiring CKRT. NEUTRALIZE-CRS: A Multicenter, Single-Arm, Open-Label Study to Assess a Selective Cytopheretic Device in Bridging Severe Heart Failure Patients to Left Ventricular Assist Device (LVAD) Implantation (L. Yessayan, et al.). This study is designed to evaluate SCD treatment in cardiorenal syndrome (CRS) patients and its effectiveness in bridging them to LVAD. The study aims to enroll 20 ICU patients with acute or chronic systolic heart failure and worsening renal function due to CRS who are awaiting LVAD implantation. Key outcomes include safety of the SCD, reversal of cardiac and renal dysfunction and the number of patients successfully transitioned to LVAD. ASN Kidney Week ASN Kidney Week is the world’s premier nephrology meeting with more than 12,000 kidney professionals from across the globe expected to attend the 2024 event. ASN Kidney Week provides participants exciting and challenging opportunities to exchange knowledge, learn the latest scientific and medical advances, and listen to engaging and provocative discussions with leading experts in the field. 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 COVID-19, sepsis, severe trauma and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from 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 chronic kidney disease or end-stage renal disease requiring dialysis, among other complications. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. Selective Cytopheretic Device The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT hemofiltration systems 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 and eliminate the need for future KRT, including dialysis. The SCD has been awarded U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation in three indications: Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD)Adult Acute Kidney Injury (AKI)Hepatorenal Syndrome (HRS) QUELIMMUNE, the SCD-Pediatric device, is being commercialized following FDA approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with KRT. QUELIMMUNE was approved in February 2024 under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options. About 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 www.seastarmedical.com or visit us on LinkedIn or X. 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, the amount and timing of future QUELIMMUNE commercial sales; the ability of SeaStar Medical to meet the demand for and the revenue recognition on 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 does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact: Alliance Advisors IRJody Cain(310) 691-7100Jcain@allianceadvisors.com # # #

Data illustrate the potential of QUELIMMUNE ™️ with cost neutrality starting at 6 days of therapy and a significant reduction in total hospitalization costs in children with acute kidney injury SeaStar Medical’s SCD was featured in four Company presentations at the premier nephrology conference DENVER, Oct. 25, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that for the first time new data highlighting the cost savings of its first-in-class, cell-directed Selective Cytopheretic Device (SCD) Pediatric therapeutic device, QUELIMMUNE, were presented yesterday at the American Society of Nephrology’s (ASN) Kidney Week 2024, underway in San Diego. “We are thrilled to present a high-quality analysis highlighting the significant potential cost-saving benefits of QUELIMMUNE to the healthcare system in treating critically ill children with acute kidney injury (AKI) at this renowned nephrology conference,” said Eric Schlorff, CEO of SeaStar Medical. “QUELIMMUNE is another tool in the arsenal for hospitals to defeat pediatric AKI with sepsis. Sepsis is a big challenge, which is why the Centers for Medicare & Medicaid Services (CMS) developed the SEP-1 protocol and quality metric for hospital systems to perform against. “Importantly, our findings underscore the opportunity for widespread adoption by hospitals to generate significant cost while also saving lives,” he added. “Utilization of QUELIMMUNE is also operationally efficient. It fits directly into existing continual renal replacement therapy (CRRT) circuits.” The poster, titled Cost Impact of An Immunomodulatory Selective Cytopheretic Device in Pediatrics (SCD-PED) in AKI due to Sepsis (AKI-S) , presents an analysis of the Kids’ Inpatient Database (KID) revealing that the hospitalization cost of pediatric patients with AKI requiring CRRT, a majority of whom were septic, was $461,736 per hospitalization, highlighting an exceptionally high financial burden on institutions and the healthcare system. Data from KID and SeaStar Medical’s SCD-PED studies indicate that hospitalization costs were significantly lower for critically ill children with AKI on CRRT who were treated with QUELIMMUNE, a majority of whom were septic, compared with historical average hospital costs for children not treated with QUELIMMUNE. Treatment with QUELIMMUNE results in a projected cost savings of approximately $30,000 per hospitalization principally driven by the lower expected death rate and shorter length of stay versus standard of care. Additional benefits of QUELIMMUNE included a cost-effective solution for institutions starting at 6 days of QUELIMMUNE therapy, which produced cost neutrality for QUELIMMUNE afforded by the high survival rate of 77% in children ≥10 kg and age ≤22 years with AKI requiring CRRT treated with QUELIMMUNE, versus the control survival rate of approximately 50%. Further, the combined observed outcomes of 0% dialysis dependence at day 60 from the SCD PED-01 and SCD-PED-02 studies illustrate the durability of QUELIMMUNE therapy. The SeaStar Medical team has a significant presence at Kidney Week 2024, with a total of four posters being presented by the Company. A second poster describes the mechanistic effects of reducing hyperinflammatory markers in patients with AKI . Additional SeaStar Medical posters that highlight the design of the ongoing NEUTRALIZE-AKI pivotal trial and the upcoming NEUTRALIZE-CRS trial are summarized below: NEUTRALIZE-AKI: A Multicenter, Randomized, Controlled Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with AKI Requiring Continuous Kidney Replacement Therapy (L. Yessayan, et al.) The ongoing NEUTRALIZE-AKI trial aims to evaluate the safety and efficacy of the SCD in adults with AKI requiring CKRT. NEUTRALIZE-CRS: A Multicenter, Single-Arm, Open-Label Study to Assess a Selective Cytopheretic Device in Bridging Severe Heart Failure Patients to Left Ventricular Assist Device (LVAD) Implantation (L. Yessayan, et al.). This study is designed to evaluate SCD treatment in cardiorenal syndrome (CRS) patients and its effectiveness in bridging them to LVAD. The study aims to enroll 20 ICU patients with acute or chronic systolic heart failure and worsening renal function due to CRS who are awaiting LVAD implantation. Key outcomes include safety of the SCD, reversal of cardiac and renal dysfunction and the number of patients successfully transitioned to LVAD. ASN Kidney Week ASN Kidney Week is the world’s premier nephrology meeting with more than 12,000 kidney professionals from across the globe expected to attend the 2024 event. ASN Kidney Week provides participants exciting and challenging opportunities to exchange knowledge, learn the latest scientific and medical advances, and listen to engaging and provocative discussions with leading experts in the field. 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 COVID-19, sepsis, severe trauma and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from 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 chronic kidney disease or end-stage renal disease requiring dialysis, among other complications. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. Selective Cytopheretic Device The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT hemofiltration systems 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 and eliminate the need for future KRT, including dialysis. The SCD has been awarded U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation in three indications: Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD) Adult Acute Kidney Injury (AKI) Hepatorenal Syndrome (HRS) QUELIMMUNE, the SCD-Pediatric device, is being commercialized following FDA approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with KRT. QUELIMMUNE was approved in February 2024 under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options. About 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 . 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, the amount and timing of future QUELIMMUNE commercial sales; the ability of SeaStar Medical to meet the demand for and the revenue recognition on 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 does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact: Alliance Advisors IR Jody Cain (310) 691-7100 Jcain@allianceadvisors.com # # #