| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | August 27, 2024 4:30 P.M. |
| Form: | S-3 | ||||||
| |||||||
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SC 13G - SeaStar Medical Holding Corp (0001831868) (Subject)
SeaStar Medical Holding Corporation (NASDAQ:ICU) (SeaStar Medical) reports treatment of the first patient in a commercial setting with QUELIMMUNE™, its U.S. Food and Drug Administration (FDA)-approved, patented cell-directed extracorporeal therapy to treat acute kidney injury (AKI) in pediatric patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy (KRT). With this development, the Company has now met the August 20, 2024 FDA deadline to begin patient treatments, which is designated in the FDA's approval of QUELIMMUNE.
Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company dedicated to transforming the lives of patients suffering from fluid overload, is proud to announce its first commercial sale of QUELIMMUNE™, a novel therapy developed by SeaStar Medical Holding Corporation for pediatric patients suffering from an uncontrolled inflammatory response triggered by their immune systems, to Cincinnati Children's. We believe this milestone marks a significant advancement in pediatric critical care and underscores Nuwellis' commitment to revolutionizing pediatric patient outcomes. QUELIMMUNE, or Selective Cytopheretic Device for pediatrics, represents a transformative solution for pediatric patients sufferi
Reimbursement expected to accelerate medical site activations and cover a portion of the Company's NEUTRALIZE-AKI trial costsDENVER, July 16, 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 receipt of a Category B Coverage Letter from the U.S. Centers for Medicare & Medicaid Services (CMS) for the NEUTRALIZE-AKI pivotal trial evaluating the Company's Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). CMS will pay for certain expenses incurred by medical centers treating patients covered by M
4 - SeaStar Medical Holding Corp (0001831868) (Issuer)
4 - SeaStar Medical Holding Corp (0001831868) (Issuer)
Restatement of non-cash items is not expected to materially impact cash position or operations DENVER, March 27, 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 it will restate its financial statements for the fiscal year ended December 31, 2022 and for the interim periods ended March 31, 2023, June 30, 2023 and September 30, 2023. The restatement will impact the accounting treatment and classification of certain outstanding warrants and the prepaid forward purchase arrangement that was terminated in
Company plans to hold a business update conference call in April DENVER, March 12, 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, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI. "We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our
DENVER, Nov. 14, 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, reports financial results for the three and nine months ended September 30, 2023 and provides a business update. "Recent clinical and regulatory successes have significantly improved and strengthened our company's prospects," said Eric Schlorff, SeaStar Medical CEO. "We are addressing the remaining administrative steps outlined by the U.S. Food and Drug Administration (FDA) for approval of the Selective Cytopheretic Device Pediatric (SCD-P
4 - SeaStar Medical Holding Corp (0001831868) (Issuer)
4 - SeaStar Medical Holding Corp (0001831868) (Issuer)
4 - SeaStar Medical Holding Corp (0001831868) (Issuer)
10-Q - SeaStar Medical Holding Corp (0001831868) (Filer)
8-K - SeaStar Medical Holding Corp (0001831868) (Filer)
DEF 14A - SeaStar Medical Holding Corp (0001831868) (Filer)
DENVER, Nov. 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, has begun shipping QUELIMMUNE™ to a third hospital customer. QUELIMMUNE is the Company's Selective Cytopheretic Device (SCD) for treating critically ill children in the intensive care unit (ICU) with acute kidney injury (AKI) and sepsis. "Within weeks of implementing our direct sales model we have added two commercial customers, underscoring our team's ability to assist hospitals with the Humanitarian Use Device (HUD) requirements and seamlessly fulfill their o
DENVER, Nov. 13, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU) ("SeaStar Medical" or the "Company"), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2024, and provides a business update. "We are delighted to report market demand and our first commercial sales of QUELIMMUNE™, our pediatric SCD that was cleared for sale by FDA in February 2024," said Eric Schlorff, SeaStar Medical CEO. "During the third quarter, we recognized $67,500 of revenue from shipping QUELIMMUNE directly to one
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 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 receipt of a Breakthrough Device Designation from the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) for the Company's patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodial