Jean-Louis Vincent

SeaStar Medical Submits Investigational Device Exemption (IDE) Application to FDA to Study a Novel Therapy to Reduce Hyperinflammation in Adult Acute Kidney Injury Patients

Retrieved on: 
Monday, January 9, 2023
AKI, Acute respiratory distress syndrome, COVID-19, Nephrology, Dialysis, Trial of the century, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, Safety, Manifest and latent functions and dysfunctions, Neutrophil, IDE, FDA, SCD, MD, HDE, Critical care, Economics, Homeostasis, Food, Patient, Monocyte, Mortality, Acute kidney injury, PMA, Jean-Louis Vincent, CKRT, SeaStar, Pharmaceutical industry

DENVER, Jan. 09, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical (Nasdaq: ICU), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, has submitted an investigational device exemption (IDE) application to the U.S. Food and Drug Administration (FDA) requesting approval to initiate a pivotal study to evaluate the effectiveness of the Company’s Selective Cytopheretic Device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).

Key Points: 
  • Details of the study design will be provided upon IDE approval by the FDA.
  • “We are pleased to take this important step in our journey towards creating the new standard of care in reducing harmful hyperinflammation.
  • The FDA has demonstrated continued support in the SCD in granting breakthrough therapy status in adults and a substantive review of a Humanitarian Device Exemption (HDE) for pediatric AKI patients,” said Eric Schlorff, Chief Executive Officer of SeaStar Medical.
  • The SCD has demonstrated success in critically ill adult patients with AKI requiring CKRT, a condition with a high mortality rate.

InflaRx Provides Update on Planned Phase III Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of its EUA Application in Critically Ill COVID-19 Patients

Retrieved on: 
Thursday, January 5, 2023
Neutrophil, PGA, PG, OD, European Medicines Agency, COVID-19, Jean-Louis Vincent, C5a, Patient, Plasma, EUA, Particle-size distribution, Ulcer, FDA, Therapy, Dentistry, Observation, EMA, Nightclub, Pharmaceutical industry, Dermatology

The planned Phase III study is designed to enroll patients in the US, Europe and selected countries in other regions.

Key Points: 
  • The planned Phase III study is designed to enroll patients in the US, Europe and selected countries in other regions.
  • Treatment will be discontinued for patients whose disease progresses or fails to improve at defined time points during the study.
  • In September 2022, the Company submitted its application for emergency use authorization (EUA) of vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients with the FDA.
  • The Company will continue to interact closely with the FDA and will provide a timely update when appropriate.

SeaStar Medical and Nuwellis Enter into a U.S. License and Distribution Agreement for SeaStar Medical’s Selective Cytopheretic Device (SCD) for Pediatric Acute Kidney Injury (AKI)

Retrieved on: 
Thursday, December 29, 2022
Chronic kidney disease, Nephrology, Hypervolemia, SCD, HDE, Dialysis, Food, AKI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SeaStar, Acute kidney injury, Death, Jean-Louis Vincent, Critical care, ICU, Risk, CKD, Patient, Mortality, Neutrophil, Physician, Monocyte, Manifest and latent functions and dysfunctions, Homeostasis, FDA, CKRT, Pharmaceutical industry

DENVER and MINNEAPOLIS, Dec. 29, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) and Nuwellis, Inc. (Nasdaq: NUWE) (Nuwellis) announce an exclusive U.S. license and distribution agreement by Nuwellis of SeaStar Medical’s Selective Cytopheretic Device (SCD) for the treatment of acute kidney injury (AKI) in children.

Key Points: 
  • DENVER and MINNEAPOLIS, Dec. 29, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) and Nuwellis, Inc. (Nasdaq: NUWE) (Nuwellis) announce an exclusive U.S. license and distribution agreement by Nuwellis of SeaStar Medical’s Selective Cytopheretic Device (SCD) for the treatment of acute kidney injury (AKI) in children.
  • Nuwellis will market and distribute the SCD through its direct salesforce to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
  • SeaStar Medical expects the U.S. Food and Drug Administration (FDA) to complete a substantive review of a Humanitarian Device Exemption (HDE) for the use of SCD in children (>20 kg.)
  • Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD).1

SeaStar Medical and Nuwellis Enter into a U.S. License and Distribution Agreement for SeaStar Medical’s Selective Cytopheretic Device (SCD) for Pediatric Acute Kidney Injury (AKI)

Retrieved on: 
Thursday, December 29, 2022
Chronic kidney disease, Nephrology, Hypervolemia, SCD, HDE, Dialysis, Food, AKI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SeaStar, Acute kidney injury, Death, Jean-Louis Vincent, Critical care, ICU, Risk, CKD, Patient, Mortality, Neutrophil, Physician, Monocyte, Manifest and latent functions and dysfunctions, Homeostasis, FDA, CKRT, Pharmaceutical industry

DENVER and MINNEAPOLIS , Dec. 29, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) and Nuwellis, Inc. announce an exclusive U.S. license and distribution agreement by Nuwellis of SeaStar Medical’s Selective Cytopheretic Device (SCD) for the treatment of acute kidney injury (AKI) in children. Nuwellis will market and distribute the SCD through its direct salesforce to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. SeaStar Medical expects the U.S. Food and Drug Administration (FDA) to complete a substantive review of a Humanitarian Device Exemption (HDE) for the use of SCD in children (>20 kg.) with AKI during the first quarter of 2023, with a potential commercial introduction in the second quarter of 2023.

Key Points: 
  • Nuwellis will market and distribute the SCD through its direct salesforce to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
  • SeaStar Medical expects the U.S. Food and Drug Administration (FDA) to complete a substantive review of a Humanitarian Device Exemption (HDE) for the use of SCD in children (>20 kg.)
  • with AKI during the first quarter of 2023, with a potential commercial introduction in the second quarter of 2023.
  • Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD).1

InflaRx Announces Amendment of Co-Development Agreement and Additional Equity Investment by Staidson in Connection with Regulatory Filing in China for Anti-C5a-Antibody for Treatment of COVID-19

Retrieved on: 
Wednesday, December 21, 2022
STS, Food, Pyoderma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, COVID-19, Inflammation, Jean-Louis Vincent, NMPA, USD, C5a, Patient, Immortalised cell line, FDA, Therapy, Sale, Pharmaceutical industry, Security (finance)

Through the amendment of the existing co-development agreement, InflaRx will receive royalties of 10% on net sales of BDB-001 for the treatment of COVID-19 in China.

Key Points: 
  • Through the amendment of the existing co-development agreement, InflaRx will receive royalties of 10% on net sales of BDB-001 for the treatment of COVID-19 in China.
  • The existing co-development agreement contains an exclusive license restricted to development and commercialization within the territory of China and was granted to STS by InflaRx in 2015.
  • STS is now planning to apply for regulatory approval in China of BDB-001 for the treatment of COVID-19.
  • The option for such subsequent purchase will expire on the twelve-month anniversary of STS receiving regulatory approval for BDB-001 in China.

Insights on the Renal Replacement Therapy Global Market to 2028 - Featuring Asahi Kasei, Baxter, CryoLife and DaVita Among Others - ResearchAndMarkets.com

Retrieved on: 
Friday, January 6, 2023
Health, General Health, Hemofiltration, CRRT, Septic shock, PD, Blood, Kidney, Dialysis, Food, AKI, Renal replacement therapy, Incidence, Geography, Peritoneal dialysis, COVID-19, Myasthenia gravis, Jean-Louis Vincent, News, Conditional sentence, Abdomen, Travel, Growth, Patient, ESRD, HD, Clifton Springs Hospital & Clinic, FDA, Hospital, Baxter International, Food and Drug Administration, Chronic kidney disease, Quality of life, EUA, Acute kidney injury, Prevalence, Survival, Pharmaceutical industry, Medical device, Marketing, Sepsis, ICU

Additionally, the increasing prevalence of chronic disease is expected to drive the growth of the renal replacement therapy market.

Key Points: 
  • Additionally, the increasing prevalence of chronic disease is expected to drive the growth of the renal replacement therapy market.
  • However, the high cost of renal replacement therapy procedures is expected to restrain the market growth in the forecasted period.
  • Additionally, Strict regulatory guidelines for continuous renal replacement therapy, and the Lack of skilled professionals to perform constant renal replacement therapy are hampering the growth of the renal replacement therapy market.
  • The global renal replacement therapy market is analyzed based on the geographical regions that are contributing significantly towards the growth of the market.

CGTN: China's preparedness for adjusting its COVID-19 policies

Retrieved on: 
Wednesday, January 4, 2023
Arm, Bed, Chinese Center for Disease Control and Prevention, COVID-19, Pharmacy, National Health Commission, Jean-Louis Vincent, Critical care, ICU, City, Patient, Policy, Time-invariant system, Interview, Hospital, State Council, Nursing, Diagnosis, COVID, Community, Vaccine, Pharmaceutical industry

Preparedness can only be evaluated by the results to which it leads – in the case of COVID-19, the number of lives saved.

Key Points: 
  • Preparedness can only be evaluated by the results to which it leads – in the case of COVID-19, the number of lives saved.
  • The dynamic zero-COVID policy was put into place to buy time for the deadly original strain and the subsequent variants to become less deadly.
  • "And now, once the virus become much much less severe and mild, at this time, we want to ease our measures.
  • China has rapidly adapted to the current situation and making adjustments based on feedback from the public and medical community.

CGTN: China's preparedness for adjusting its COVID-19 policies

Retrieved on: 
Wednesday, January 4, 2023
Arm, Bed, Chinese Center for Disease Control and Prevention, COVID-19, Pharmacy, National Health Commission, Multimedia, Jean-Louis Vincent, Critical care, ICU, City, Patient, Policy, Time-invariant system, Interview, Hospital, State Council, Nursing, Diagnosis, COVID, Community, Vaccine, Pharmaceutical industry

Preparedness can only be evaluated by the results to which it leads – in the case of COVID-19, the number of lives saved.

Key Points: 
  • Preparedness can only be evaluated by the results to which it leads – in the case of COVID-19, the number of lives saved.
  • The dynamic zero-COVID policy was put into place to buy time for the deadly original strain and the subsequent variants to become less deadly.
  • "And now, once the virus become much much less severe and mild, at this time, we want to ease our measures.
  • And the policy change reflects the fact that China is ready to take on what comes next.

CGTN: Vitality under COVID-19: China gears up for medical supplies

Retrieved on: 
Tuesday, December 27, 2022
Patient, Jean-Louis Vincent, Transport, COVID-19, ICU, Medicine, Ministry, Ministry of Industry and Information Technology, China Media Group, N95, Media Group, Infection, City, Vaccine, Information technology, Bed, Hospital, Animal, Oil, Pharmaceutical industry, Healthcare

East China's Shandong Province is the largest production base of raw materials for antipyretic analgesic medicines in the country.

Key Points: 
  • East China's Shandong Province is the largest production base of raw materials for antipyretic analgesic medicines in the country.
  • Many companies in the province focus on export markets, but quickly adjusted their distribution channels and increased production capacity in order to secure domestic supplies.
  • Doctors in the makeshift clinics would diagnose patients and prescribe drugs, making it convenient for locals in urgent need of medical services.
  • Some medical institutions have set up special treatment channels for vulnerable groups of people such as the elderly, the pregnant and infants.

CGTN: Vitality under COVID-19: China gears up for medical supplies

Retrieved on: 
Tuesday, December 27, 2022
Patient, Jean-Louis Vincent, Transport, COVID-19, ICU, Medicine, Ministry, Ministry of Industry and Information Technology, China Media Group, N95, Media Group, Infection, City, Vaccine, Information technology, Bed, Hospital, Animal, Oil, Pharmaceutical industry, Healthcare

East China's Shandong Province is the largest production base of raw materials for antipyretic analgesic medicines in the country.

Key Points: 
  • East China's Shandong Province is the largest production base of raw materials for antipyretic analgesic medicines in the country.
  • Many companies in the province focus on export markets, but quickly adjusted their distribution channels and increased production capacity in order to secure domestic supplies.
  • Doctors in the makeshift clinics would diagnose patients and prescribe drugs, making it convenient for locals in urgent need of medical services.
  • Some medical institutions have set up special treatment channels for vulnerable groups of people such as the elderly, the pregnant and infants.