SeaStar

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

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

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

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

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

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

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

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

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

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

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.