SeaStar

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.

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

Retrieved on: 
Wednesday, December 13, 2023
SCD, Associate, Hospital, Baylor College of Medicine, Food, AKI, Letter, FDA, Medical director, HDE, Nephrology, MD, Doctor of Philosophy, SAB, SeaStar, University, Acute kidney injury, Patient, Pharmaceutical industry

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).

Key Points: 
  • 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).
  • The SAB is comprised of world-renowned international pediatric and adult clinical experts including nephrologists, critical care intensivists and translational scientists who will advise on the Company’s technology capabilities, share insights on emerging trends in healthcare, and advise on the Company’s critical care and acute kidney injury (AKI) clinical development programs.
  • “Science and innovation are the foundational pillars of SeaStar Medical and key to our competitive advantage,” said Eric Schlorff, CEO of SeaStar Medical.
  • “The advisory board also advised on design elements of our ongoing, pivotal NEUTRALIZE-AKI Phase 3 study with the SCD in adult patients with AKI.

Nuwellis, Inc. Announces Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
FDA, Diuretic, Heart failure, CRRT, Research, Critical care, Pediatrics, IDE, DaVita Inc., Growth, Webcast, SeaStar, Collaboration, Letter, Patient, Video game, Pharmaceutical industry, Q3

MINNEAPOLIS, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of people with fluid overload, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • MINNEAPOLIS, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of people with fluid overload, today reported financial results for the third quarter ended September 30, 2023.
  • Revenue of $2.4 million for the third quarter 2023, increased 16% over the prior quarter and increased 17% over the prior-year period.
  • By customer category, third quarter 2023 revenue in Heart Failure increased 27% over the same period last year, Critical Care and Pediatrics increased 16% and 9%, respectively.
  • In the third quarter, we sold 20 consoles, an increase of 11 units vs prior quarter.

Nuwellis’ Strategic Partner, SeaStar Medical, Receives FDA Approvable Letter for Its Pediatric Selective Cytopheretic Device

Retrieved on: 
Tuesday, October 31, 2023
FDA, HDE, Food, SCD, MD, Acute kidney injury, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, AKI, Dialysis, Immune system, SeaStar, Intensive care medicine, CKRT, Letter, Hospice and palliative medicine, Sepsis, End organ damage, Patient, Label, Failure, Pharmaceutical industry

MINNEAPOLIS, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its strategic partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its pediatric Selective Cytopheretic Device (SCD-PED).

Key Points: 
  • MINNEAPOLIS, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its strategic partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its pediatric Selective Cytopheretic Device (SCD-PED).
  • The Approvable Letter indicates that SeaStar Medical’s Humanitarian Device Exemption (HDE) application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization.
  • For the SCD-PED, these include revisions to product labeling and minor modifications to the post-approval study plan.
  • Nuwellis and SeaStar Medical previously announced an exclusive U.S. license and distribution agreement for Nuwellis to distribute the SCD-PED.

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

Retrieved on: 
Monday, October 30, 2023
FDA, Standard of care, Center for Biologics Evaluation and Research, HDE, Humanitarian Device Exemption, Food, SCD, Mortality, MD, Acute kidney injury, Inflammation, AKI, Hepatorenal syndrome, Dialysis, Cardiorenal syndrome, SeaStar, Intensive care medicine, CKRT, Letter, Neutrophil, Hospice and palliative medicine, Monocyte, Sepsis, Patient, Label, Infection, ICU, Pharmaceutical industry, Medical device, Research

As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.

Key Points: 
  • As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.
  • The issuance by the FDA of an Approvable Letter is a standard step in the approval process of a Humanitarian Device Exemption (HDE) application.
  • The Approvable Letter indicates that SeaStar Medical’s HDE application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization.
  • The SCD-PED-01 (weight range ≥15 kg) and PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively.

Nuwellis Provides Regulatory Update on SeaStar Medical’s Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption

Retrieved on: 
Tuesday, October 10, 2023
Humanitarian Device Exemption, Language, Food, SCD, Acute kidney injury, AKI, Sepsis, Risk, CKD, Center for Biologics Evaluation and Research, Mortality, Safety, FDA, SeaStar, Chronic kidney disease, CKRT, Marketing, Letter, ICU, Agency, HDE, Physician, Pharmaceutical industry, Nursing, Research

The correspondence indicates that an Approvable Letter is expected to be issued within a month.

Key Points: 
  • The correspondence indicates that an Approvable Letter is expected to be issued within a month.
  • In December of 2022, Nuwellis and SeaStar entered into a U.S. license and distribution agreement for SeaStar Medical’s SCD for pediatric AKI.
  • Under this agreement, Nuwellis will market and distribute the SCD through its direct salesforce to nephologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
  • Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD).1

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

Retrieved on: 
Friday, September 29, 2023
Partnership, University, Heart failure, Heart, SCD, Food and Drug Administration, Center for Biologics Evaluation and Research, National Institutes of Health, Bangladesh Technical Education Board, AKI, Trial of the century, Șaeș, Acute kidney injury, PMA, MD, Patient, Multiple organ dysfunction syndrome, Cardiorenal syndrome, Breakthrough, Heart transplantation, LVAD, SeaStar, ICU, FDA, NIH, Food, Pharmaceutical industry, Research

The Breakthrough Device Designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.

Key Points: 
  • 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.
  • “Cardiorenal syndrome is seen in the most severe cases of heart failure and is associated with a very poor prognosis,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We believe the SCD represents a novel, innovative and transformative approach to treating hyperinflammation in severely ill patients with chronic heart failure.

Case Series of Three Critically Ill Children with Acute Kidney Injury Safely Treated with SeaStar Medical’s Selective Cytopheretic Device Published in the Journal Blood Purification

Retrieved on: 
Tuesday, August 29, 2023
STEC, Neutrophil, Multiple organ dysfunction syndrome, SCD, Systemic, AKI, STEC-HUS, Acute kidney injury, CKRT, Hospital, MD, Immunomodulation, Observation, Paper, SeaStar, ICU, Cincinnati, Karger Publishers, Pharmaceutical industry

All three children were in the ICU at two different hospitals and treated with continuous kidney replacement therapy (CKRT).

Key Points: 
  • All three children were in the ICU at two different hospitals and treated with continuous kidney replacement therapy (CKRT).
  • Each show gradual improvement following treatment with the SCD-PED and normalization or near normalization of kidney function at 60-day follow up.
  • The article, “Hemolytic Uremic Syndrome-Induced Acute Kidney Injury Treated via Immunomodulation with the Selective Cytopheretic Device: Cases of STEC-HUS Treated with Immunomodulation via SCD CRRT Filter,” (H. Rhodes Hambrick, et al.)
  • was published in the peer-reviewed journal Blood Purification.

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

Retrieved on: 
Friday, June 30, 2023
Hospice and palliative medicine, Critical care, Shock, SCD, Medicine, MD, Physician, Patient, SeaStar, Nursing care plan, Pharmaceutical industry, Nursing

These 24 weekly podcasts will delve into vital medical issues facing healthcare professionals who care for critically ill patients.

Key Points: 
  • 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 .
  • “We are excited to partner with Critical Care Time as the primary sponsor of its inaugural season.
  • “Our sponsorship allows SeaStar Medical to connect with the healthcare professionals we are working to support with our novel, patented Selective Cytopheretic Device .

SeaStar Medical Announces Activation of First Clinical Site in Pivotal Trial with Selective Cytopheretic Device in Critically Ill Adults with Acute Kidney Injury

Retrieved on: 
Wednesday, April 19, 2023
Good Samaritan Hospital, Neutrophil, SCD, Randomness, AKI, Dialysis, Sepsis, Acute kidney injury, CKRT, MD, Patient, Standard of care, FACEP, Acute respiratory distress syndrome, Mortality, SeaStar, FDA, Monocyte, Safety, Critical Care Medicine (journal), Pharmaceutical industry, Nursing

This trial, expected to include up to 30 U.S. sites, is evaluating the safety and efficacy of SeaStar Medical’s 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).

Key Points: 
  • This trial, expected to include up to 30 U.S. sites, is evaluating the safety and efficacy of SeaStar Medical’s 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).
  • “We recently received FDA approval to begin this pivotal trial and activated the first clinical site in record time, with many more sites expected to come onboard in the near term,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective CytopheretIic Device - a randomiZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 patients.
  • Breakthrough therapies receive many benefits, including a commitment by the FDA to expedite development and review.