Nestor Jaramillo, President and CEO of Nuwellis, shared his thoughts on this milestone: "We are thrilled to introduce QUELIMMUNE to critically ill pediatric patients in need. This marks a significant step forward in Nuwellis' mission to execute our pediatric business development strategy. By partnering with SeaStar Medical, we are committed to bringing this groundbreaking therapy to U.S. healthcare providers, offering new hope to children suffering from severe immune system reactions." About Nuwellis Dr. St ...

NEW YORK, July 25, 2024 /PRNewswire/ -- So what: If you purchased SeaStar securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. Details of the case: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) SeaStar and/or Legacy SeaStar had deficient compliance controls and procedures related to the HDE Application; (2) ...

NEW YORK, July 23, 2024 (GLOBE NEWSWIRE) -- WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents inves ...

Company Overview - SeaStar Medical Holding Corporation has successfully treated its first patient with QUELIMMUNE™, an FDA-approved therapy for acute kidney injury (AKI) in pediatric patients [1][2] - The company aims to provide widespread access to QUELIMMUNE, which has shown potential to save lives and reduce dialysis dependency in severely ill children [2] Product Details - QUELIMMUNE is a patented cell-directed extracorporeal therapy that targets activated proinflammatory neutrophils and monocytes, restoring them to a reparative state [4] - The treatment process takes about 15 minutes and requires a full course of therapy lasting three to seven days, with the SCD-PED cartridge replaced every 24 hours [4] Clinical Impact - Approximately 4,000 children in the U.S. require continuous kidney replacement therapy annually, with a mortality rate of around 50% [2] - Clinical trials indicate that children treated with QUELIMMUNE had a 77% survival rate without dialysis dependency at 60 days, with no serious adverse events reported [2] Market Opportunity - The adult AKI population is significantly larger than the pediatric population, representing a multibillion-dollar market opportunity for SeaStar Medical [5] - The company is currently enrolling patients in the adult NEUTRALIZE-AKI pivotal clinical trial, expanding its therapeutic reach [5] Company Mission - SeaStar Medical is focused on redefining extracorporeal therapies to mitigate excessive inflammation's impact on vital organs, aiming to provide life-saving solutions for critically ill patients [6]

Core Viewpoint - SeaStar Medical has successfully treated its first patient with QUELIMMUNE, a therapy for acute kidney injury (AKI) in pediatric patients, meeting FDA requirements for timely treatment [5]. Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing cell-directed extracorporeal therapies to mitigate excessive inflammation in critically ill patients [8]. - The company’s first product, QUELIMMUNE, is a Selective Cytopheretic Device (SCD) that targets activated proinflammatory cells to restore them to a reparative state [7]. Product Details - QUELIMMUNE is FDA-approved for treating pediatric patients with AKI who weigh 10 kilograms or more and require kidney replacement therapy [5]. - The treatment process involves using a disposable SCD-PED cartridge connected to an existing hemodialysis system, with an average treatment duration of three to seven days [7]. - Clinical trials indicate that children treated with QUELIMMUNE have a 77% survival rate without dialysis dependency at 60 days post-treatment, with no serious device-related adverse events reported [10]. Market Opportunity - The adult AKI population is significantly larger than the pediatric population, representing a multibillion-dollar market opportunity for SeaStar Medical [3]. - Approximately 4,000 children in the U.S. require continuous kidney replacement therapy annually, with a high mortality rate of around 50% [10].

Core Viewpoint - SeaStar Medical Holding Corporation is facing legal challenges due to alleged misleading statements and deficiencies in compliance related to its Humanitarian Device Exemption application, leading to significant stock price declines and potential financial restatements [5][9]. Group 1: Legal and Financial Implications - A class action lawsuit has been filed on behalf of investors who purchased SeaStar securities between October 31, 2022, and March 26, 2024, with a deadline of September 6, 2024, to file a lead plaintiff motion [4]. - SeaStar's stock price fell by $0.04, or 4.8%, closing at $0.71 per share on March 27, 2024, following the announcement of the need to restate financial statements [2]. - The company announced on March 27, 2024, that it would restate financial statements for fiscal year 2022 and the first three quarters of fiscal year 2023 due to complex financial instruments requiring different accounting treatment [5]. Group 2: Regulatory Challenges - On May 9, 2023, SeaStar disclosed that the FDA rejected its Humanitarian Device Exemption application for its pediatric Selective Cytopheretic Device, citing that the application was not approvable in its current form [8]. - The complaint alleges that SeaStar had deficient compliance controls related to the HDE application and that the FDA was unlikely to approve it in its present form, which was not disclosed to investors [9]. Group 3: Stock Performance - Following the FDA rejection news, SeaStar's stock price dropped by $0.77, or 39.7%, closing at $1.17 per share on May 10, 2023, indicating significant investor injury [11].

QUELIMMUNE, or Selective Cytopheretic Device for pediatrics, represents a transformative solution for pediatric patients suffering from acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring kidney replacement therapy (KRT). Early clinical data suggest a 77% survival rate for patients treated with this new therapy1. Through Nuwellis' exclusive U.S. license and distribution agreement with SeaStar Medical (NASDAQ:ICU), the developer of QUELIMMUNE, this therapy is now ...

SAN DIEGO, July 15, 2024 (GLOBE NEWSWIRE) -- Robbins LLP reminds investors that a shareholder filed a class action on behalf of persons and entities that purchased or otherwise acquired SeaStar Medical Holding Corporation (NASDAQ: ICU, ICUCW) securities between October 31, 2022 and March 26, 2024. SeaStar was originally a special purpose acquisition company functioning under the name LMF Acquisition Opportunities, Inc. Legacy SeaStar was a medical technology company developing extracorporeal therapies to re ...

To be considered for a lead plaintiff role, a SeaStar investor must file a motion in the U.S. District Court for the District of Colorado, no later than September 6, 2024. Please contact Edelson Lechtzin LLP to discuss your investment losses, at 844-696-7492 or by e-mail at [email protected]. You can also submit your trading information online HERE. Headquartered in Denver, Colorado, SeaStar is a medical device company that develops Selective Cytopheretic Device (SCD) therapies to reduce hyperinflammation's ...

# # # DENVER, July 12, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) reports the initial commercial sale of QUELIMMUNE™-Pediatric to its U.S. license and distribution partner, Nuwellis, Inc. QUELIMMUNE is SeaStar Medical's Selective Cytopheretic DevicePediatric (SCD-PED), a patented cell-directed extracorporeal therapy that selectively targets the most highly activated neutrophils and monocytes responsible for hyperactive immune response. QUELIMMUNE is approved ...