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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

DENVER, Nov. 01, 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, reports setting a new monthly enrollment record with 10 critically ill acute kidney injury (AKI) patients added to the NEUTRALIZE-AKI pivotal trial during the past month, bringing total enrollment to 56. This trial is evaluating the safety and efficacy of the Company's proprietary therapeutic Selective Cytopheretic Device (SCD) in adults with AKI in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT). "The pace of enrollment in o

DENVER, Oct. 31, 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 shipped QUELIMMUNE™ directly to a second 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. QUELIMMUNE was granted U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE). "We are excited to add a second hospital customer, which is our first since we transitioned to a direct sal

DENVER, Oct. 23, 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 Stanford Medicine is cleared to actively enroll subjects in the NEUTRALIZE-AKI pivotal trial. With the recent addition of two Department of Defense medical centers, 12 sites are now activated to enroll subjects in the trial with enrollment at 52. "It goes without saying that Stanford is an incredibly important site," said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. "The recent decision by the U.S. Centers for Medicare and Medicai

DENVER, Oct. 22, 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 has assumed all responsibility for direct sales, marketing and distribution of QUELIMMUNE™ to hospital customers. QUELIMMUNE is SeaStar Medical's therapeutic device approved for the treatment of pediatric acute kidney injury (AKI) due to sepsis or a septic-like condition. "The SeaStar Medical team is focused on a successful commercial rollout with this game-changing therapy, QUELIMMUNE, to treat severely ill children. We have the infrastruct

The pace of patient enrollment has significantly accelerated following a summertime slowdown DENVER, Oct. 18, 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 51 subjects have been enrolled in its NEUTRALIZE-AKI pivotal trial, passing the halfway point toward the target of 100 subjects for performing an interim analysis on the trial's 90-day primary endpoint. The trial is evaluating the safety and efficacy of SeaStar Medical's proprietary therapeutic Selective Cytopheretic Device (SCD) in adults with acute kidn

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 inflam

DENVER, Oct. 09, 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 management will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit hosted by M-Vest on Wednesday, October 16, at 12:00 p.m. Eastern time (9:00 a.m. Pacific time). The fireside chat will be hosted by Maxim Group analyst Anthony Vendetti. Registration for the M-Vest platform to access to the live and archived presentation webcast will be posted to Events & Presentations section of the SeaStar Medical website. About SeaS

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

SeaStar Medical Holding's (NYSE:ICU) short percent of float has risen 97.61% since its last report. The company recently reported that it has 231 thousand shares sold short, which is 8.26% of all regular shares that are available for trading. Based on its trading volume, it would take traders 1.0 days to cover their short positions on average. Why Short Interest Matters Short interest is the number of shares that have been sold short but have not yet been covered or closed out. Short selling is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises. Short

U.S. stocks traded higher toward the end of trading, with the Nasdaq Composite gaining around 1% on Wednesday. The Dow traded up 0.50% to 39,488.59 while the NASDAQ rose 1.01% to 18,615.28. The S&P 500 also rose, gaining, 0.70% to 5,616.11. Check This Out: Nvidia, Amazon And 2 Other Stocks Insiders Are Selling Leading and Lagging SectorsMaterials shares jumped by 1.2% on Wednesday. In trading on Wednesday, financials shares fell by 0.1%. Top Headline The EIA said U.S. crude oil inventories declined by 3.444 million barrels in the week ended July 5, compared to market estimates of a 3.0 million decline. Equities Trading UP                        Virpax Pharmaceuticals

Shares of SeaStar Medical Holding Corporation (NASDAQ:ICU) fell sharply during Wednesday's session after the company entered into a $10 million registered direct offering of 947,868 shares at $10.55 per share. SeaStar Medical shares dipped 34% to $8.55 on Wednesday. Here are some other stocks moving in today’s mid-day session. Gainers Virpax Pharmaceuticals, Inc. (NASDAQ:VRPX) shares jumped 139% to $2.78 after the company announced results for a Swine Model pilot study for Probudur. Kazia Therapeutics Limited (NASDAQ:KZIA) gained 129% to $0.4325 after the company announced results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of

U.S. stocks traded higher midway through trading, with the Nasdaq Composite gaining more than 50 points on Wednesday. The Dow traded up 0.10% to 39,329.75 while the NASDAQ rose 0.34% to 18,491.35. The S&P 500 also rose, gaining, 0.24% to 5,590.26. Check This Out: Nvidia, Amazon And 2 Other Stocks Insiders Are Selling Leading and Lagging SectorsMaterials shares jumped by 0.7% on Wednesday. In trading on Wednesday, consumer discretionary shares fell by 0.2%. Top Headline The EIA said U.S. crude oil inventories declined by 3.444 million barrels in the week ended July 5, compared to market estimates of a 3.0 million decline. Equities Trading UP                        Vir

U.S. stocks traded mostly higher this morning, with the Nasdaq Composite gaining around 100 points on Wednesday. The Dow traded up 0.02% to 39,298.72 while the NASDAQ rose 0.53% to 18,526.10. The S&P 500 also rose, gaining, 0.28% to 5,592.62. Check This Out: Nvidia, Amazon And 2 Other Stocks Insiders Are Selling Leading and Lagging SectorsInformation technology shares jumped by 0.7% on Wednesday. In trading on Wednesday, financials shares fell by 0.3%. Top Headline Shares of Manchester United plc (NYSE:MANU) gained around 4% on Wednesday after the company reported results for the third quarter. The company reported quarterly loss of 31 cents per share which missed the a

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