Semicircular Canal Dehiscence

DENVER, Oct. 15, 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 the presentation of new analyses of clinical data further supporting the immunomodulating effect of the Selective Cytopheretic Device (SCD) at the American Society of Nephrology (ASN) 2024 Kidney Week to be held October 24-27 in San Diego. Abstracts for the meeting are available here. “We are excited to showcase these analyses at the world’s premier nephrology meeting that further describe how the SCD significantly lowered biomarkers related to inflammation in this critically ill population of patients with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT),” said Sai Prasad N. Iyer, PhD, SeaStar Medical Senior Vice President of Medical Affairs and Research. “These data further explain mechanistically how the SCD is addressing hyperinflammation and helps restore immune balance in these critically ill patients.” In a poster presentation, titled Immunomodulatory Effect of Selective Cytopheretic Device (SCD) on Neutrophil: Lymphocyte Ratio (NLR) and Hematologic Parameters from Multiple Acute Kidney Injury (AKI) Trials, the authors explain that NLR is a powerful biomarker with elevated levels linked to poor outcomes across a wide range of diseases. An analysis of multiple AKI clinical studies showed that SCD treatment significantly reduced NLR, providing further mechanistic clinical evidence of leukocyte immunomodulation in hyperinflammatory conditions such as AKI and sepsis with potential applicability to other diseases. “NLRs are easy to calculate and can be done using a patient’s complete blood count without need for any additional tests,” said Kevin Chung, MD, SeaStar Medical Chief Medical Officer. “This is one of several abstracts featuring the SCD that will be presented at ASN 2024 Kidney Week. We plan to have a significant presence at the meeting.” The Company’s pediatric SCD was approved by the U.S. Food and Drug Administration (FDA) as a Humanitarian Use Device (HDE) in February of this year, and the Company continues to enroll patients with its adult NEUTRALIZE-AKI pivotal trial, as well as advance other indications like cardiorenal syndrome. 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-Pediatric device, QUELIMMUNE™, 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, 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 does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact: LHA Investor Relations Jody Cain (310) 691-7100 Jcain@lhai.com # # #

Pictured: Panelists on stage at ASGCT (L to R: NHLBI’s Gary Gibbons, NCATS’ Joni Rutter, Amy Jenkins of Advanced Research Projects Agency for Health, NINDS’ Amir Tamiz and ASGCT President Jeffrey Chamberlain)/Photo by Greg Slabodkin Advancing translational research of novel therapies is a priority for both the scientific community and the National Institutes of Health, according to stakeholders at the 2024 American Society of Gene & Cell Therapy (ASGCT) annual meeting. In a Friday fireside chat with officials from the National Institute of Health (NIH) at ASGCT 2024, ASGCT President Jeffrey Chamberlain described translational research as the “critical nexus” between basic science and clinical investigation. “This is an area where we’re trying to bridge the gap between fundamental new discoveries and their applications to improve human health,” Chamberlain said. The session’s agenda highlighted some of the pivotal basic science and translational studies, as well as the researchers who are making breakthroughs when it comes to transformative genetic therapies. Gary Gibbons, director of the National Heart, Lung, and Blood Institute (NHLBI) at NIH, touted his organization’s launch of the Cure Sickle Cell Initiative in 2018 as a collaborative research effort to accelerate the development of gene therapies to cure sickle cell disease (SCD). Gibbons said that new FDA-approved curative gene therapies for SCD— Vertex Pharmaceuticals’ CRISPR-based Casgevy and bluebird bio’s gene therapy Lyfgenia—are a case study in the value of translational research for creating transformative treatments for patients. “We had folks from Vertex and bluebird bio at the table from the beginning, as well as our colleagues at FDA,” Gibbons commented. “Because we knew at that stage we were defining a regulatory pathway toward that end.” Chamberlain called Casgevy and Lyfgenia “possibly the most exciting development ever” in the field of gene therapies. Joni Rutter, director of the National Center for Advancing Translational Sciences (NCATS) at NIH, said that one of her organization’s primary missions is to re-engineer the translational research process so new treatments and cures for diseases can reach patients faster. “Our mission is essentially to understand how to traverse that pipeline better, faster, more effectively and efficiently,” Rutter said. NCATS has taken credit for enabling a path to market for ReveraGen BioPharma’s Duchenne muscular dystrophy therapy, which was approved by the FDA in late 2023. Another NCATS-led program Rutter pointed to is the Platform Vector Gene Therapy (PaVe-GT) pilot project. Launched in 2019, the PaVe-GT pilot aims to test the hypothesis of whether a platform vector approach will increase efficiency in preclinical testing and clinical trial start-up. Rutter also pointed to the NCATS-led Bespoke Gene Therapy Consortium (BGTC), a public-private collaboration involving NIH, FDA, industry and patient groups intended to help accelerate the delivery of AAV-based gene therapies for rare diseases. With BGTC, “we’re establishing how to optimize the biology and the studies behind developing the AAV vectors and then we’re also optimizing the manufacturing,” Rutter said. Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.

Interest continues to grow in developing new strategies to reduce systemic inflammation as a means of improving outcomes in heart failure patients DENVER, Feb. 27, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces publication of a manuscript discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the adult Selective Cytopheretic Device, part of the Quelimmune™ product family, in enabling previously ineligible patients with severe disease to receive a left ventricular assist device (LVAD) or heart transplant in the peer-reviewed European Journal of Heart Failure February 2024, Pitt, B., Iyer, S.P.N. and Humes, H.D. (2024), Eur J Heart Fail. https://doi-org.libproxy1.nus.edu.sg/10.1002/ejhf.3177. The manuscript, titled “New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation” cites increasing evidence of the role of chronic systemic inflammation in patients with heart failure and discusses the Adult SCD’s potential to improve hypertensive heart failure and mortality following hospitalization for acute or worsening heart failure. The manuscript reviews the positive effect of the Adult SCD in a previously announced first-in-human case report of a 71-year-old patient with cardiorenal syndrome who was deemed ineligible for cardiac transplantation or a LVAD due to worsening renal function and right ventricular dysfunction. Following treatment with the Adult SCD, this patient was effectively bridged to LVAD three days after discontinuing treatment and was subsequently discharged without further complications. This study was the basis for Adult SCD receiving a Breakthrough Device Designation in cardiorenal syndrome from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) in September 2023. “Systemic inflammation is one component in the multi-factorial pathophysiology of heart failure, and the use of anti-inflammatory strategies in patients with acute or worsening heart failure is not novel ,” said lead manuscript author and heart failure expert Bertram Pitt, MD, FACC, Division of Internal Medicine (Emeritus), University of Michigan School of Medicine. “Prior attempts targeting singular proinflammatory factors as well as systemic immunosuppression with glucocorticoids in patients with acute heart failure have yielded unclear results, raising the need to identify new strategies. An alternative strategy may be to target cellular sources of proinflammatory molecules such as activated leucocytes.” “Our novel extracorporeal device has shown significant promise in targeting active neutrophils and monocytes to quell systematic inflammation, leading to improved outcomes in hyperinflammatory acute conditions including acute kidney injury, acute respiratory distress syndrome and cardiorenal syndrome,” said manuscript co-author Sai Prasad N. Iyer, Ph.D., SeaStar Medical’s Vice President, Medical Affairs and Clinical Development. “While our manuscript discusses a positive outcome in one patient following treatment for six hours daily over six consecutive days, the results suggest that more study with Adult SCD is warranted for patients with heart failure and hyperinflammation.” On February 22, 2024 SeaStar Medical announced the Humanitarian Device Exemption (HDE) FDA Approval Order for the Pediatric SCD (SCD-PED now known as Quelimmune) for use in children weighing 10 kilograms or more with acute kidney injury due to sepsis or a septic condition requiring kidney replacement therapy (KRT). About Hyperinflammation Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm. About the Selective Cytopheretic Device (SCD)The 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 that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the device 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. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis. About SeaStar MedicalSeaStar Medical is a 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 StatementsThis 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 SCD’s ability to treat hyperinflammation and the expected results of clinical trials and studies. 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 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, including the equity line of credit and forward purchase 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 assume 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: LHA Investor Relations Jody Cain (310) 691-7100 Jcain@lhai.com # # #