SEASTAR MEDICAL HOLDING CORPORATION


Associated tags: Inflammation, Human, SeaStar, Transplant, Medical imaging, Pharmaceutical industry, SCD, AKI, Patient, Acute kidney injury, FDA, CKRT, Neutrophil, Monocyte, Mortality, HDE, ICU, Safety, MD, Dialysis

Locations: EDEN PRAIRIE, MN, DENVER, COLORADO, US, ARDS

SeaStar Medical Reports 2023 Financial Results and Provides a Business Update

Retrieved on: 
Wednesday, April 17, 2024
Mortality, FDA, Nephrology, Risk, Nephron, Partnership, Hepatorenal syndrome, Acute kidney injury, ICU, White, AKI, Chronic kidney disease, Monocyte, Heart failure, SCD, Dialysis, CRRT, CKRT, KRT, Inflammation, Safety, Insurance, Clinical study design, Therapy, Clinical trial, G&A, Sepsis, University, HDE, Survival rate, Neutrophil, Acute respiratory distress syndrome, Patent, Cardiorenal syndrome, European Journal, Physician, Manuscript, Bank statement, Standard of care, Pharmaceutical industry

DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.

Key Points: 
  • DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.
  • “Lastly, I’m pleased that we have filed our Form 10-K for 2023, which includes restated 2022 financial statements,” said Mr. Schlorff.
  • Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
  • The Company reported cash of $176,000 as of December 31, 2023, compared with $47,000 as of December 31, 2022.

SeaStar Medical to Present at the Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference

Retrieved on: 
Thursday, April 11, 2024
Noble, Conference

DENVER, April 11, 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 management will present at the Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on Thursday, April 18 at 9:30 a.m. Eastern time.

Key Points: 
  • DENVER, April 11, 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 management will present at the Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on Thursday, April 18 at 9:30 a.m. Eastern time.
  • The formal presentation will be followed by a hosted question-and-answer session.
  • Investors interested in viewing the live presentation can register for this event here: Virtual Healthcare Equity Conference Registration .
  • An archived replay will be available on the Company’s website approximately 48 hours after the live event and will be archived for 90 days.

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 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.

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.

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

Retrieved on: 
Friday, January 26, 2024
Prospectus, Form, Regulation D, Sale, The Act, S-3, Exercise, Security (finance), Venture round

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.

Key Points: 
  • 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 Company expects to receive gross proceeds in the amount of approximately $9.0 million from the offering.
  • Maxim Group LLC is acting as the sole placement agent for the offering.
  • The offering is expected to close on or about January 30, 2024, subject to the satisfaction of customary closing conditions.

SeaStar Medical Appoints David A. Green as Chief Financial Officer

Retrieved on: 
Thursday, January 11, 2024
Bard (company), Death, Duff, Duff & Phelps, Therapy, State university system, Intarcia Therapeutics, State, CFO, Certified Public Accountant, University, Interim management, MBA, Interim, Growth, Pharmaceutical industry

Green as Chief Financial Officer, effective January 10, 2024.

Key Points: 
  • 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.
  • “We welcome David to our executive team at this critical time as we prepare for our first commercial launch for the Selected Cytopheretic Device Pediatric (SCD-PED) later this quarter,” said Eric Schlorff, CEO of SeaStar Medical.
  • Earlier, he was Chief Accounting Officer at Intarcia Therapeutics, a commercial-stage biopharmaceutical company; CFO of Catheter Connections, a commercial-stage medical device company acquired by Merit Medical; and CFO of Specialized Health Products International, a publicly traded medical device company acquired by C.R.