Cardiorenal syndrome

Strong data from DSR® proof-of-concept studies in heart failure published in European Journal of Heart Failure

Retrieved on: 
Wednesday, April 3, 2024
Cardiorenal syndrome, Congestion, DSR, Brussels Stock Exchange, Liver disease, Associate, RED, Patient, NYHA, Mortality, Cancer, Fluid, Heart failure, European Journal, Diuretic, Overload, Syndrome, Yale University, Pharmaceutical industry

The publication can be accessed here .

Key Points: 
  • The publication can be accessed here .
  • Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the publication commented: “Cardiorenal syndrome is a major clinical challenge in heart failure with a clear unmet need for therapies to effectively and durably address congestion and cardio-renal dysfunction.
  • Currently the mainstay of therapy for sodium avidity and congestion are the loop diuretics, which actually worsen sodium avidity and cardiorenal syndrome.
  • Diuretic-resistant heart failure and cardiorneal syndrome are large and growing markets both in the US and rest of world, with the clear need for novel treatments that can improve clinical outcomes beyond loop diuretics.

Sequana Medical announces 2023 Full Year Results and 2024 Outlook

Retrieved on: 
Thursday, March 28, 2024
Cardiorenal syndrome, Cirrhosis, Partner, Congestion, American Medical Association, Ascites, DSR, Brussels Stock Exchange, Liver disease, RED, Patient, Peritoneal dialysis, 2.0, Mouse, Sheep, Cancer, Heart, Heart failure, PMA, US FDA, Safety, File, CPT9, Overload, Catheter, ISO, THT, FDA, Animal, Pharmaceutical industry

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.

Key Points: 
  • Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.
  • Furthermore, the alfapump can benefit from attractive pricing and leverage its FDA breakthrough device designation to enhance its reimbursement position.
  • Following this equity placement, the €3.0 million convertible loan agreement entered in February 2024 by Partners in Equity and Rosetta Capital will be mandatorily converted into new shares.
  • A day-100 meeting is scheduled with the FDA on April 9th 2024.

Sequana Medical announces three month follow-up data from MOJAVE non-randomized cohort confirming dramatic improvement in diuretic response and virtual elimination of loop diuretics following DSR® therapy

Retrieved on: 
Monday, March 25, 2024
Cardiorenal syndrome, Congestion, Myocardial infarction, DSR, Brussels Stock Exchange, Liver disease, Partnership, RED, Patient, 2.0, Blood urea nitrogen, Cancer, Fluid, Heart, Heart failure, Furosemide, EGFR, Safety, DSMB, Overload, Hyponatremia, Hypertension, Pharmaceutical industry

These final data support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome.

Key Points: 
  • These final data support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome.
  • Unlike loop diuretics which, on average, have a negative impact on renal function and diuretic response, DSR has again demonstrated its potential to restore renal health and control of volume status.
  • Dramatic improvement in diuretic response and stable kidney function: During the four-week DSR treatment period, all three patients maintained euvolemia without the need of loop diuretics.
  • In January 2024, the independent DSMB approved the start of the randomized MOJAVE cohort following review of the safety data reported from the non-randomized cohort.

SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 11.5 MILLION IN AN EQUITY PLACEMENT

Retrieved on: 
Thursday, March 21, 2024
Cardiorenal syndrome, EUR, Partner, DSR, Offering, Liver disease, Ketel One, KBC, Patient, 2.0, Cancer, Quality management system, AMERICA, Prospectus, Heart failure, EQT, LSP, PMA, US FDA, NASH, Overload, THT, USD, FDA, Security (finance)

This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.

Key Points: 
  • This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.
  • We look forward to continuing our track record of meeting our corporate milestones and driving Sequana Medical forward."
  • (ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.
  • As announced in February 2024, the Company entered into an unsecured and subordinated convertible loan agreement with Partners in Equity and Rosetta Capital for an aggregate principal amount of EUR 3.0 million.

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.”

Sequana Medical announces DSMB approval to start randomized MOJAVE cohort – US Phase 1/2a study of DSR® 2.0 for treatment of heart failure

Retrieved on: 
Tuesday, January 23, 2024
Patient, DSMB, Overload, Heart failure, Cancer, Data monitoring committee, DSR, Brussels Stock Exchange, Cardiorenal syndrome, Safety, 2.0, Liver disease, Heart, Pharmacotherapy, Furosemide, Fluid, RED, Pharmaceutical industry

After the last DSR treatment, patients will be followed for a three-month safety follow-up period.

Key Points: 
  • After the last DSR treatment, patients will be followed for a three-month safety follow-up period.
  • The first patient is expected to be enrolled in Q1 2024 and interim data are planned for H2 2024.
  • Dr. Oliver Gödje, Chief Medical Officer of Sequana Medical, commented: “We are delighted to announce the ongoing progress of our US MOJAVE study and look forward to enrol the first patient in the randomized cohort later this quarter.
  • Their diuretic responseiii nearly normalized with a mean increase of 324% in their six-hour urinary sodium excretion post-treatment vs baseline.

Sequana Medical announces positive data from non-randomized cohort in US Phase 1/2a MOJAVE study of DSR® 2.0 for treatment of heart failure

Retrieved on: 
Wednesday, November 29, 2023
DSMB, Cardiorenal syndrome, Brussels Stock Exchange, Overload, Furosemide, DSR, Cancer, Fluid, Congestion, Patient, Liver disease, Heart failure, Pharmaceutical industry

Data from the third patient show similar beneficial effects of DSR therapy as reported previously in the first two patientsii.

Key Points: 
  • Data from the third patient show similar beneficial effects of DSR therapy as reported previously in the first two patientsii.
  • Dr. Oliver Gödje, Chief Medical Officer of Sequana Medical, commented: “We are delighted to see the timely execution of the non-randomized cohort and the encouraging outcomes of our DSR therapy in these first three US patients with diuretic-resistant heart failure.
  • At the start of the study treatment period, loop diuretics were withheld, and patients were treated with DSR 2.0 up to daily for four weeks.
  • During the four-week DSR treatment period, all three patients maintained euvolemia without the need of loop diuretics and showed improved cardiorenal status post-treatment.

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.

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.

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

Retrieved on: 
Wednesday, October 18, 2023
FDA, Center for Biologics Evaluation and Research, Food, SCD, Mortality, MD, Liver transplantation, Liver, Acute kidney injury, University, AKI, Society, Hepatorenal syndrome, Cardiorenal syndrome, NASH, COVID-19, Fatty liver disease, Immunomodulation, Kidney, Cirrhosis, Hospital, Sepsis, Patient, Food and Drug Administration, Prognosis, ICU, Pharmaceutical industry, Research

This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device, and is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.

Key Points: 
  • This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device, and is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.
  • An investigator-initiated pilot study conducted at the University of Michigan assessed treatment with the SCD in two patients with type 1 hepatorenal syndrome.
  • “We are grateful for FDA’s decision to award Breakthrough Device Designation to the SCD in hepatorenal syndrome, which follows similar awards for adult AKI in 2022 and for cardiorenal syndrome last month,” said Eric Schlorff, SeaStar Medical CEO.
  • “The SCD now has three Breakthrough Device Designations in total granted by the FDA’s Center for Biologics Evaluation and Research (CBER).