SeaStar Medical Holding Corp

Seastar Medical Holding Corp. operates as a holding company whose subsidiaries manufacture and supply medical devices. The company is headquartered in Denver, CO.

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Seastar Medical Holding Corp. operates as a holding company whose subsidiaries manufacture and supply medical devices. The company was founded on June 6, 2007 and is headquartered in Denver, CO.

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 SCD in adult AKI patients.

SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients

March 13 webcast showcasing Quelimmune ™ scientific background and clinical data for pediatric AKI due to sepsis or a septic condition will be available on seastarmedical.com

SeaStar Medical-Sponsored Symposium Featuring Experts Discussing Pediatric Acute Kidney Injury and the Selective Cytopheretic Device to be Webcast Live at AKI & CRRT 2024

Interest continues to grow in developing new strategies to reduce systemic inflammation as a means of improving outcomes in heart failure patients

Manuscript Discussing the Benefit of SeaStar Medical's Selective Cytopheretic Device in Patients with Heart Failure and Hyperinflammation Published in European Journal of Heart Failure

SCD-PED (Pediatric) is the first FDA-approved product in the Company's Quelimmune™ product family

FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical's Selective Cytopheretic Device for Pediatric Acute Kidney Injury

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Despite a recent decline in the leading economic index, the U.S. economy is positioned for a positive future in 2024. Strong employment and robust stock levels contribute to the optimistic outlook.

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SeaStar Medical Holding (NASDAQ: ICU) stock price has done well this year even as the company continued diluting its shareholders. The stock is about to hit $1, meaning that it has surged by more than 177% from the lowest point in December and by 495% from its 2023 low.

ICU stock price: Here's why SeaStar Medical shares have surged

DENVER, Feb. 01, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the issuance by the Canadian Intellectual Property Office of Canadian Patent No. 2814586. This new patent has broad claims covering the Company's Selective Cytopheretic Device (SCD) technology. Its issuance expands SeaStar Medical's international patent rights and complements existing U.S. patent rights.

SeaStar Medical Granted Canadian Patent with Broad Claims Covering the Selective Cytopheretic Device Technology

DENVER, Jan. 26, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (the “Company”), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announced today that it has entered into a securities purchase agreement with a single institutional investor to purchase 10,840,761 shares of common stock (or pre-funded warrants in lieu thereof) in a registered direct offering. In a concurrent private placement, the Company also agreed to issue and sell to the investor Series A warrants to purchase up to an aggregate 10,840,761 shares of common stock, and Series B warrants to purchase up to an aggregate 5,420,381 shares of common stock. The combined effective offering price for each share of common stock (or pre-funded warrant in lieu thereof), accompanying Series A warrants and Series B warrants is $0.8302. The Series A warrants will have an exercise price of $0.8302 per share, expire five years from the date of stockholder approval, and will become exercisable upon the date of stockholder approval. The Series B warrants will have an exercise price of $0.8302 per share, expire one year from the date of stockholder approval, and will become exercisable upon the date of stockholder approval. The Company expects to receive gross proceeds in the amount of approximately $9.0 million from the offering.

SeaStar Medical Announces Pricing of $9.0 Million Registered Direct Offering Priced At-the-Market

DENVER, Jan. 11, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the appointment of healthcare industry veteran David A. Green as Chief Financial Officer, effective January 10, 2024. Caryl Baron, who has served as Interim CFO since October 2022, will continue with SeaStar Medical as Vice President of Finance.

SeaStar Medical Appoints David A. Green as Chief Financial Officer

DENVER, Jan. 09, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the issuance of U.S. Patent No. 11,866,730 with broad claims directed to methods of using the Selective Cytopheretic Device (SCD) to treat subjects with inflammatory conditions and to process activated leukocytes and platelets. The SCD is a first-in-class, cell-directed extracorporeal therapy that selectively targets highly active inflammatory cells to quell the inflammatory response.

SeaStar Medical Issued U.S. Patent with Broad Claims Covering Use of the Selective Cytopheretic Device for Multiple Clinical Indications

DENVER, Dec. 28, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).

SeaStar Medical Updates Subject Enrollment in its Pivotal Trial with the Selective Cytopheretic Device in Adults with Acute Kidney Injury

DENVER, Dec. 13, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs, announces the formation of the SeaStar Medical Scientific Advisory Board (SAB).

SeaStar Medical Forms Scientific Advisory Board of World-Renowned Pediatric and Adult Clinical Experts

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.

SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update

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DENVER, Oct. 30, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has issued an Approvable Letter for the company's proprietary Selective Cytopheretic Device Pediatric (SCD-PED) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in the hospital intensive care unit (ICU). As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.

FDA Issues Approvable Letter for SeaStar Medical's Selective Cytopheretic Device for Pediatric Patients

Shares of SeaStar Medical Holding Corp. ICU, +70.05% rocketed 45.3% on heavy volume in premarket trading Thursday, to take them back above the $1 mark for the first time in five months. Trading volume spiked to 21.4 million shares ahead of the open, to already match the full-day average.

SeaStar Medical's stock more than doubles in 2 days to get back above the $1 level

DENVER, Oct. 18, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive care unit (ICU) with acute kidney injury (AKI) and acute on chronic liver failure. This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device, and is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.

FDA Grants SeaStar Medical's Selective Cytopheretic Device Breakthrough Device Designation for Hepatorenal Syndrome

DENVER, Oct. 05, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that Eric Schlorff, CEO, will present a company overview at the 8th Annual Dawson James Small Cap Growth Conference on Thursday, October 12 at 2:30 p.m. Eastern time (11:30 a.m. Pacific time). The conference is being held at the Wyndham Grand Harborside Hotel in Jupiter, Fla.

SeaStar Medical to Present at the Dawson James Small Cap Growth Conference on October 12, 2023

Com pany to finalize labeling with FDA Approv able Letter expected within a month

SeaStar Medical Provides Regulatory Update Regarding Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption

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Underlying prices exhibited a notable cooling trend, providing the Federal Reserve shows evidence of softer inflation. While Americans did indeed spend more on costly gasoline and services during the month, this moderation in other price components underscores the nature of inflationary pressures.

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DENVER, Sept. 29, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug Administration (FDA) B reakthrough Device D esignation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive care unit (ICU) with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device (LVAD). The Breakthrough Device Designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population. This is only the ninth Breakthrough Device Designation granted by the FDA's Center for Biologics Evaluation and Research (CBER) since the program's inception in 2015.

FDA Grants Breakthrough Device Designation to SeaStar Medical's Selective Cytopheretic Device for Cardiorenal Syndrome

DENVER, Aug. 22, 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 management will hold a business update conference call today at 4:00 p.m. Eastern time (1:00 p.m. Pacific time). During the call, management will provide a clinical and regulatory update and review the Company's value proposition, including the commercial opportunity.

SeaStar Medical to Hold Business Update Conference Call Today at 4:00 p.m. Eastern Time

Management to hold a b usiness u pdate c onference c all on August 2 2 beginning at 4 :00 p.m. Eastern time

SeaStar Medical Reports Second Quarter 2023 Financial Results and Provides a Business Update

DENVER, June 30, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces its primary sponsorship of the first season of the Critical Care Time podcast series. These 24 weekly podcasts will delve into vital medical issues facing healthcare professionals who care for critically ill patients. The first podcast in the series, “Undifferentiated Shock: I,” will broadcast during the week of July 3rd and will be available here.

SeaStar Medical to Sponsor the Critical Care Time Podcast Series Covering Vital Medical Issues for Healthcare Professionals Who Care for Critically Ill Patients

News for SeaStar Medical Holding Corp Stock (ICU)