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First Pediatric Patient Treated in a Commercial Setting with SeaStar Medical's FDA-Approved QUELIMMUNE Therapeutic Device
Newsfilter· 2024-07-23 12:30
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].
First Pediatric Patient Treated in a Commercial Setting with SeaStar Medical's FDA-Approved QUELIMMUNE Therapeutic Device
GlobeNewswire News Room· 2024-07-23 12:30
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]
Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against SeaStar Medical Holding Corporation (ICU)
GlobeNewswire News Room· 2024-07-19 15:00
If you suffered a loss on your SeaStar investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at www.glancylaw.com/cases/SeaStar-Medical-Holding-Corporation/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at shareholders@glancylaw.com to learn more about your rights. On this news, SeaStar's stock price fell $0.04, or 4.8%, to close at $0.7 ...
Nuwellis Marks First Commercial Sale of QUELIMMUNE™ Therapy to Cincinnati Children's
Newsfilter· 2024-07-17 13:00
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 ...
ICU Class Action Notice: Robbins LLP Reminds Stockholders of the Lead Plaintiff Deadline in the Class Action Against SeaStar Medical Holding Corporation
GlobeNewswire News Room· 2024-07-15 19:01
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 ...
ICU SHAREHOLDER ALERT: Edelson Lechtzin LLP Urges SeaStar Medical Holding Corporation (NASDAQ: ICU, ICUCW) Shareholders to Consult Legal Counsel About the Pending Securities Fraud Class Action
Prnewswire· 2024-07-12 21:05
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 ...
SeaStar Medical Ships First QUELIMMUNE Product Order to U.S. Distribution Partner
Newsfilter· 2024-07-12 12:30
# # # 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 ...
SeaStar Medical Announces Closing of $10 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Newsfilter· 2024-07-11 20:05
DENVER, July 11, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) announces that it has closed its previously announced registered offering for the issuance and sale of an aggregate of 947,868 shares of its common stock at a purchase price of $10.55 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, SeaStar Medical has issued in a concurrent private placement unregistered warrants to purchase up to 947,8 ...
ICU Investors Have Opportunity to Lead SeaStar Medical Holding Corporation. Securities Fraud Lawsuit
Prnewswire· 2024-07-10 22:00
What to do next: To join the ICU class action, go to https://rosenlegal.com/submit-form/?case_id=27084 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 6, 2024. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Attorney Advertising. Prior results d ...
SeaStar Medical Announces $10 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Newsfilter· 2024-07-10 13:00
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 rang ...