SeaStar Medical’s Selective Cytopheretic Device to be Featured at the 5th Chronic Kidney Disease Drug Development Summit
SeaStar Medical (Nasdaq: ICU) announces that Dr. Kevin Chung will present the company's Selective Cytopheretic Device (SCD) at the 5th Chronic Kidney Disease Drug Development Summit on March 7, 2023. The presentation will focus on the SCD's role in addressing systemic inflammation, a key factor in organ dysfunction, particularly in Acute Kidney Injury (AKI) and COVID-19 cases. The SCD offers a novel approach by targeting activated pro-inflammatory cells, helping restore homeostasis in critically ill patients. SeaStar Medical has received FDA approval for a pivotal study evaluating the SCD's safety and efficacy in adults with AKI requiring continuous kidney replacement therapy.
- FDA approval granted for a pivotal study of the SCD in adults with AKI.
- SCD targets activated pro-inflammatory neutrophils and monocytes, potentially improving patient outcomes.
- Presentation at CKD5 summit indicates engagement with industry professionals and potential market expansion.
- Reliance on FDA approval and successful study outcomes presents uncertainty in product commercialization.
- High competition in the medical device industry may impact growth and market entry.
DENVER, Feb. 24, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that Kevin Chung, M.D., Chief Medical Officer, will discuss the Company’s Selective Cytopheretic Device (SCD) in a presentation at the 5th Chronic Kidney Disease Drug Development Summit (CKD5) in Boston on March 7, 2023 at 10 a.m. Eastern Time.
In his presentation, “The Selective Cytopheretic Device: A Novel Host Response Targeting Cell-Directed Extracorporeal Therapy in AKI (Acute Kidney Disease),” Dr. Chung will discuss the impact of systemic inflammation as a key driver of organ dysfunction and damage in the setting of acute and chronic diseases such as AKI and chronic kidney disease (CKD). He will detail the advantages of targeting leukocytes (neutrophils and monocytes) — the main function of the SCD — over targeting downstream byproducts of hyperinflammation. Dr. Chung will also review the clinical data from studies with the SCD in adult and pediatric patients with AKI and COVID-19.
The SCD is a patented cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that causes organ failure and possible death in critically ill patients. The therapy currently is delivered through continuous kidney replacement therapy (CKRT) to target and neutralize pro-inflammatory neutrophils and monocytes allowing the body to return to homeostasis. SeaStar Medical recently announced FDA approval to begin a pivotal study evaluating the safety and efficacy of its SCD in adults with AKI requiring CKRT and subsequently provided details of the planned study. The SCD received the FDA’s Breakthrough Device Designation in 2022.
“The SCD represents a major innovation in the treatment of life-threatening hyperinflammation in the setting of critical illness. An estimated six million American adults and children are diagnosed with AKI every year, and more than 200,000 require continuous kidney replacement therapy as part of their care,” said Dr. Chung. “I am excited to engage with and learn from my industry and academic colleagues at CKD5 to explore ways we can bring life-saving therapies like SCD more rapidly to the market.”
Dr. Chung is an accomplished critical care physician with expertise in extracorporeal life support therapies and extensive research in critical care and organ support. He has authored more than 300 scientific papers, reviews, editorials and book chapters related to burns, resuscitation, AKI, acute respiratory distress syndrome and organ support. He has led multiple clinical trials and was responsible for overseeing the PURIFY Program, a series of multicenter studies sponsored by the Department of Defense to study blood purification in life-threatening illness.
About the 5th Chronic Kidney Disease Drug Development Summit (CKD5)
CKD5 is the definitive industry forum sharing cross-industry insight to bring effective therapies to patients faster by uniting industry experts dedicated to accelerating the frontier of pioneering research beyond the new standard of care and breaking new ground with redefined patient inclusion criteria.
About SeaStar Medical
SeaStar Medical is a medical technology company focusing on 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 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 Twitter.
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 timing of regulatory approval of its products, the expected timing on enrollment, generation of study results, submission of PMA and other corporate milestones, the ability of SCD to treat patients with AKI, and the potential benefits of SCD to treat other diseases. 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 inability to recognize the anticipated benefits of the business combination with LMAO, which may be affected by, among other things, competition and the ability of the post-combination company to grow and manage growth profitability and retain its key employees, (ii) costs related to the business combination, (iii) the outcome of any legal proceedings that may be instituted against SeaStar Medical following the business combination, (iv) the ability to maintain the listing of its securities on NASDAQ, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns and the possibility of rapid change in the highly competitive industry in which SeaStar Medical operates, (vii) 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, (viii) the risk that SeaStar Medical may never achieve or sustain profitability; (ix) the risk that SeaStar Medical may need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (xi) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (xii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (xiii) other risks and uncertainties indicated from time to time in SeaStar Medical’s registration statement on Form S-4, as amended (File No. 333-264993), 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.
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