CKRT

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

Retrieved on: 
Tuesday, March 12, 2024
CKRT, Randomness, Sepsis, Survival rate, Neutrophil, Monocyte, AKI, Humanitarian Device Exemption, Patient, Hospital, Acute respiratory distress syndrome, Mortality, Acute kidney injury, Standard of care, MD, HDE, KRT, Safety, Dialysis, Chronic kidney disease, SCD, FDA, Food, Pharmaceutical industry

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.

Key Points: 
  • “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.
  • Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We expect the pace of enrollment will accelerate as more medical centers come onboard.
  • With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.

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.

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.

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

Retrieved on: 
Thursday, December 28, 2023
SCD, Quality of life, AKI, FDA, HDE, MD, Clinical trial, Food and Drug Administration, Acute kidney injury, Patient, Safety, Dialysis, CKRT, Sepsis, Pharmaceutical industry

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).

Key Points: 
  • 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).
  • “Over the past six weeks we have enrolled five subjects in this clinical trial while also continuing progress in activating additional clinical sites,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We are grateful to the dedicated investigators and their research staff who are working diligently to help validate the efficacy and safety of the SCD in this vulnerable population.”
    “We look forward to providing periodic updates on patient enrollment and site activations as this important trial progresses,” said Eric Schlorff, CEO of SeaStar Medical.
  • “We believe the more than 200,000 U.S. adult patients each year with AKI who require CKRT deserve a better treatment option.

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

Retrieved on: 
Tuesday, November 14, 2023
Chronic kidney disease, Neutrophil, Acute respiratory distress syndrome, STEC-HUS, Cardiorenal syndrome, Safety, Food, Hepatorenal syndrome, University, AKI, HDE, Risk, ICU, Clinical trial, Monocyte, Mortality, CBER, Sepsis, Patient, Nephrology, Insurance, Research, Letter, Dialysis, Approvable letter, FDA, G&A, Child, Standard of care, Acute kidney injury, Partnership, Nephron, Clinical study design, R, Hospital, SCD, Physician, CKRT, Karger Publishers, PMA, HIV disease progression rates, Pharmaceutical industry, Nursing, Dietary supplement, Cryptocurrency

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.

Key Points: 
  • 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.
  • “Recent clinical and regulatory successes have significantly improved and strengthened our company’s prospects,” said Eric Schlorff, SeaStar Medical CEO.
  • SeaStar Medical expects regulatory approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The Company issued two convertible notes each for $0.5 million in August 2023 and a third convertible note for $0.5 million in September 2023.

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

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

Retrieved on: 
Tuesday, October 3, 2023
Letter, Chronic kidney disease, Neutrophil, Marketing, Infection, HDE, SCD, Center for Biologics Evaluation and Research, Language, AKI, Sepsis, Acute kidney injury, CKRT, Monocyte, Patient, Agency, Risk, Humanitarian Device Exemption, Mortality, ICU, Septic, FDA, Food, Safety, Pharmaceutical industry, Research

DENVER, Oct. 03, 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 receipt of a correspondence from the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) indicating that the Agency considers the Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) to be approvable under a Humanitarian Device Exemption (HDE) 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).

Key Points: 
  • The correspondence further indicates that an Approvable Letter, which is a standard part of CBER’s approval process, is expected to be issued within a month.
  • The Approvable Letter will outline conditions, including language for safety, probable benefit and labeling for intended use, which will be required for formal marketing approval.
  • “The correspondence provides a clear path forward in making this much needed therapy accessible to critically ill children suffering with AKI and sepsis,” said Eric Schlorff, SeaStar Medical CEO.
  • The SCD-PED-01 (weight range ≥15 kg) and PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively.