SeaStar

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of SeaStar Medical Holding Corporation - ICU

Retrieved on: 
Tuesday, April 16, 2024
LLP, News, Pomerantz, Special-purpose acquisition company, Classification, Judgement, SeaStar

NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of SeaStar Medical Holding Corporation (“SeaStar” or the “Company”) (NASDAQ: ICU).

Key Points: 
  • NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of SeaStar Medical Holding Corporation (“SeaStar” or the “Company”) (NASDAQ: ICU).
  • The investigation concerns whether SeaStar and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of SeaStar Medical Holding Corporation – ICU

Retrieved on: 
Monday, April 8, 2024
SeaStar, Classification, News, LLP, Judgement, Special-purpose acquisition company, Pomerantz

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of SeaStar Medical Holding Corporation (“SeaStar” or the “Company”) (NASDAQ: ICU).

Key Points: 
  • NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of SeaStar Medical Holding Corporation (“SeaStar” or the “Company”) (NASDAQ: ICU).
  • The investigation concerns whether SeaStar and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

SeaStar Medical to Restate Financials, Sets Business Update Call for April 17

Retrieved on: 
Wednesday, March 27, 2024
PIN, Sepsis, AKI, SeaStar, Classification, Security (finance), Judgement, Bank statement, Acute kidney injury, Special-purpose acquisition company, Annual report

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.

Key Points: 
  • The restatement will impact the accounting treatment and classification of certain outstanding warrants and the prepaid forward purchase arrangement that was terminated in June 2023.
  • “The restatement is not expected to have a material impact on our business operations or our cash position, but rather is related to the reporting of non-cash accounting items,” said Eric Schlorff, Chief Executive Officer of SeaStar Medical.
  • “We look forward to providing a more detailed update on our progress and outlook during our business update conference call.”
    SeaStar Medical’s management will hold a business update conference call on Wednesday, April 17 at 4:00 p.m. Eastern time (1:00 p.m. Pacific time).
  • Stockholders and other interested parties may also participate in the conference call by dialing 866-777-2509 from within the U.S. or 412-317-5413 from outside the U.S., and requesting the SeaStar Medical call.

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

Retrieved on: 
Monday, March 11, 2024
Chronic kidney disease, FAAP, Multiple organ dysfunction syndrome, Medical director, Critical care, FDA, CKRT, SCD, Hospital, Risk, Conference, University, SeaStar, Acute kidney injury, AKI, CRRT, Nephrology, Pharmaceutical industry

DENVER, March 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 its sponsorship of an Industry Symposium titled “New Therapies in Pediatric Acute Kidney Injury” on March 13, 2024 at the 29th International Conference on Advances in Critical Care Nephrology – Updates in ICU Medicine: Controversies, Challenges and Solutions (AKI & CRRT 2024). The hybrid in-person and virtual conference is being held March 12-15 in San Diego.

Key Points: 
  • The hybrid in-person and virtual conference is being held March 12-15 in San Diego.
  • “Despite advancements in kidney replacement therapy, mortality rates in children with acute kidney injury (AKI) and multi-organ failure requiring continuous kidney replacement therapy (CKRT) remain at about 50%, and children who survive an AKI episode are at elevated risk of chronic kidney disease.
  • “It’s exciting to have recognized leaders in AKI and nephrology who serve on the SeaStar Medical Scientific Advisory Board participate in this symposium.
  • The discussion will highlight our technology, clinical data and the recent FDA approval of the SCD-PED, the first therapeutic device in our Quelimmune product family,” said Kevin Chung, MD, SeaStar Medical’s Chief Medical Officer.

Nuwellis, Inc. Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024
Diuretic, Operating cost, Absorption, FDA, Growth, SCD, Cirrhosis, IDE, SeaStar, Nephrology, Webcast, Patient, Pediatrics, CRRT, CRRC, THT, Research, PIK, Pharmaceutical industry

Fourth quarter pediatric revenue grew 35% year over year; 28% increase in utilization and a 49% increase in console sales.

Key Points: 
  • Fourth quarter pediatric revenue grew 35% year over year; 28% increase in utilization and a 49% increase in console sales.
  • Gross margin was 54.4% for the fourth quarter of 2023, compared to 56.9% in the prior-year period, a decrease of 250 basis points.
  • Selling, general and administrative expenses for the fourth quarter of 2023 were $3.6 million, compared to $4.7 million in the prior-year period.
  • Total operating expenses for the fourth quarter of 2023 were $5.0 million, a 15% decrease compared to $5.9 million in the prior-year period.

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

Retrieved on: 
Tuesday, February 27, 2024
Cardiorenal syndrome, Division, Inflammation, FDA, Food, SCD, Emeritus, Manuscript, Hospital, Heart failure, European Journal, University, SeaStar, Internal medicine, Glucocorticoid, Acute kidney injury, Michigan Medicine, Drug, Monocyte, FACC, Acute respiratory distress syndrome, LVAD, Mortality, Heart, Pharmaceutical industry

DENVER, Feb. 27, 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 publication of a manuscript discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the adult Selective Cytopheretic Device, part of the Quelimmune™ product family, in enabling previously ineligible patients with severe disease to receive a left ventricular assist device (LVAD) or heart transplant in the peer-reviewed European Journal of Heart Failure February 2024, Pitt, B., Iyer, S.P.N. and Humes, H.D. (2024), Eur J Heart Fail. https://doi.org/10.1002/ejhf.3177.

Key Points: 
  • The manuscript, titled “New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation” cites increasing evidence of the role of chronic systemic inflammation in patients with heart failure and discusses the Adult SCD’s potential to improve hypertensive heart failure and mortality following hospitalization for acute or worsening heart failure.
  • Following treatment with the Adult SCD, this patient was effectively bridged to LVAD three days after discontinuing treatment and was subsequently discharged without further complications.
  • “Prior attempts targeting singular proinflammatory factors as well as systemic immunosuppression with glucocorticoids in patients with acute heart failure have yielded unclear results, raising the need to identify new strategies.
  • “While our manuscript discusses a positive outcome in one patient following treatment for six hours daily over six consecutive days, the results suggest that more study with Adult SCD is warranted for patients with heart failure and hyperinflammation.”

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

Retrieved on: 
Thursday, February 22, 2024
Chronic kidney disease, Sepsis, ICU, Traction, FDA, Food, Dialysis, CKRT, SCD, HUD, Risk, Safety, SeaStar, HDE, Acute kidney injury, Patient, KRT, AKI, Mortality, Nephrology, Pharmaceutical industry

DENVER, Feb. 22, 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 that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) Approval Order to the Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy (KRT). This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).

Key Points: 
  • This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).
  • In clinical studies, Quelimmune for pediatric AKI has been shown to reduce mortality rates and dialysis dependency in clinical studies.
  • “We appreciate the FDA’s willingness to work collaboratively with SeaStar Medical and our advisors to grant HDE approval to Quelimmune for pediatric use,” Mr. Schlorff added.
  • SeaStar Medical is currently focused on its NEUTRALIZE-AKI pivotal clinical trial to evaluate Quelimmune therapy in the larger adult AKI population, while exploring other applications for this device.

Nuwellis’ Distribution Partner, SeaStar Medical, Receives FDA Humanitarian Device Exemption for Pediatric Selective Cytopheretic Device Quelimmune™

Retrieved on: 
Thursday, February 22, 2024
Sepsis, Humanitarian Device Exemption, Failure, Traction, Physician, FDA, Food, Dialysis, CKRT, Hospice and palliative medicine, Nephrology, Nursing care plan, SeaStar, HDE, Acute kidney injury, Patient, AKI, Mortality, Immune system

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.
  • Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical to distribute Quelimmune and will market and distribute the device to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
  • “The pediatric segment of our business has gained significant traction since the 2020 FDA clearance of our Aquadex device for pediatric patients weighing 20kg or more – growing at a compound annual growth rate (CAGR) of over 30%.
  • Clinical studies have demonstrated Quelimmune’s potential to eliminate dialysis dependency, shorten intensive care unit time, and restore the lives of critically ill pediatric patients.

Honda Marine and Scout Boats Launch New Brand Partnership Program Integrates Legendary Brands, Technologies, Quality and Reliability

Retrieved on: 
Thursday, February 8, 2024
Shift, Center console, Partnership, Marine, SeaStar, Pleasure, USB, Motorcycle, Honda Vision, VTEC, Honda Marine, Car, Scout, Head

Honda Marine , a business division of Honda Power Sports & Products , announces a new brand partnership with Scout Boats —bringing together two legendary and complementary brands known for advanced technologies and exceptional product quality and reliability.

Key Points: 
  • Honda Marine , a business division of Honda Power Sports & Products , announces a new brand partnership with Scout Boats —bringing together two legendary and complementary brands known for advanced technologies and exceptional product quality and reliability.
  • Honda Marine targets the core of the boating market with the highest-quality outboards derived from Honda legendary automotive platforms and exclusive technologies and advantages.
  • The new brand partnership, a program being launched with participating Honda Marine dealers, will offer the Honda Seabrook Series Boats : all-new, high-performing boats built exclusively for Honda by Scout and powered by Honda Marine BF150 iST® outboards .
  • The new brand partnership, a program being launched with participating Honda Marine dealers, will offer the Honda Seabrook Series Boats : all-new, high-performing boats built exclusively for Honda by Scout and powered by Honda Marine BF150 iST® outboards .

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

Retrieved on: 
Thursday, February 1, 2024
SCD, Patent, Death, White, SeaStar, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • 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.
  • This newly issued Canadian patent, titled Cytopheretic Cartridge and Use Thereof, provides coverage of SCD cartridges for treating activated leukocytes and activated platelets, as well as their use in processing activated leukocytes and platelets.