Acute respiratory distress syndrome

SeaStar Medical’s Selective Cytopheretic Device to be Featured at the 5th Chronic Kidney Disease Drug Development Summit

Retrieved on: 
Friday, February 24, 2023
Death, Acute respiratory distress syndrome, Safety, White, Chronic kidney disease, System, Department of Defense Serum Repository, Monocyte, Hospice and palliative medicine, Nursing care plan, Research, FDA, Homeostasis, Patient, Organ dysfunction, CKD5, Burns, Pelvic floor dysfunction, SCD, CKD, Neutrophil, Resuscitation, CKRT, COVID-19, Extracorporeal, Pharmaceutical industry, AKI

In his presentation, “The Selective Cytopheretic Device: A Novel Host Response Targeting Cell-Directed Extracorporeal Therapy in AKI (Acute Kidney Disease),” Dr. Chung will discuss the impact of systemic inflammation as a key driver of organ dysfunction and damage in the setting of acute and chronic diseases such as AKI and chronic kidney disease (CKD).

Key Points: 
  • In his presentation, “The Selective Cytopheretic Device: A Novel Host Response Targeting Cell-Directed Extracorporeal Therapy in AKI (Acute Kidney Disease),” Dr. Chung will discuss the impact of systemic inflammation as a key driver of organ dysfunction and damage in the setting of acute and chronic diseases such as AKI and chronic kidney disease (CKD).
  • He will detail the advantages of targeting leukocytes (neutrophils and monocytes) — the main function of the SCD — over targeting downstream byproducts of hyperinflammation.
  • Dr. Chung will also review the clinical data from studies with the SCD in adult and pediatric patients with AKI and COVID-19.
  • The therapy currently is delivered through continuous kidney replacement therapy (CKRT) to target and neutralize pro-inflammatory neutrophils and monocytes allowing the body to return to homeostasis.

SeaStar Medical Announces Details of the Selective Cytopheretic Device Pivotal Study in Critically ill Adults with Acute Kidney Injury

Retrieved on: 
Wednesday, February 15, 2023
Acute kidney injury, AKI, Acute respiratory distress syndrome, Pelvic floor dysfunction, Monocyte, ICU, Safety, Sepsis, Patient, Randomness, CKRT, Mortality, Death, Neutrophil, Dialysis, FDA, SCD, COVID-19, Homeostasis, MD, Pharmaceutical industry

DENVER, Feb. 15, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces details of its pivotal NEUTRALIZE-AKI study evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). The recently approved study will be initiated in March and is expected to enroll up to 200 patients at up to 30 U.S. clinical trial sites.

Key Points: 
  • DENVER, Feb. 15, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces details of its pivotal NEUTRALIZE-AKI study evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).
  • The recently approved study will be initiated in March and is expected to enroll up to 200 patients at up to 30 U.S. clinical trial sites.
  • The study will also include subgroups to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome (ARDS).
  • The SCD has demonstrated success in critically ill patients with AKI requiring CKRT in previous clinical studies.

Enlivex Announces Issuance of Israeli Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS) Resulting from CAR T-Cell Therapy, Infectious Diseases or Any Non-Infectious Source of CRS

Retrieved on: 
Wednesday, February 15, 2023
Well, Patent, SARS, Collection, Gram, Infection, Tocilizumab, Acute respiratory distress syndrome, CAR, Immunotherapy, CAPS, De novo, HLH, LPS, Smallpox, Acute pancreatitis, Cancer, NLRP3, CINCA, MAS, Sepsis, Patient, Macrophage activation syndrome, Muckle–Wells syndrome, Inhalation, GPI, Therapy, FCAS, FDA, Hemophagocytic lymphohistiocytosis, Trauma, Severe acute respiratory syndrome outbreak, MWS, Cytokine release syndrome, Malaria, FCU, Vaccine

Nes-Ziona, Israel, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of an Israeli patent, numbered 284985, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.” The patent provides added intellectual property protection in Israel into at least 2037, with claims covering the use of for Allocetra™ for prevention or amelioration of cytokine storms in cancer patients receiving CAR-T therapy, as well as in patients whose cytokine storms result from infectious diseases or non-infectious sources.

Key Points: 
  • Nes-Ziona, Israel, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of an Israeli patent, numbered 284985, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.” The patent provides added intellectual property protection in Israel into at least 2037, with claims covering the use of for Allocetra™ for prevention or amelioration of cytokine storms in cancer patients receiving CAR-T therapy, as well as in patients whose cytokine storms result from infectious diseases or non-infectious sources.
  • CAR T-cells are T-cells that have been genetically modified to include a receptor that allows them to specifically target and destroy cancer cells.
  • While certain CAR T-cell treatments were recently approved by the FDA in several cancer indications, such treatments have been associated in many patients with a side effect named cytokine release syndrome, which describes a collection of potentially severe or life-threatening symptoms that stem from over-activation of immune pathways.
  • Preclinical data indicate that Allocetra™ has the potential to prevent or ameliorate cytokine release syndrome associated with CAR T-cell therapies.

VERU DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Veru Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, February 2, 2023
Class Action Lawsuit, Professional Services, Legal, NDA, Acute respiratory distress syndrome, Standard of care, Trial of the century, Form 10-Q, Breast, Tiberius Claudius Verus, Safety, P.C, Patient, Telephone, Jeanne Eagels, News, Fast track (FDA), Prostate cancer, Mortality, Aerospace, Person, Death, Prostate Cancer Foundation, FDA, Court, Steiner, COVID-19, Fast Track, Infection, EUA, Pharmaceutical industry

Investors have until February 3, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until February 3, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Veru is primarily an oncology-based biopharmaceutical company that develops drugs for the management of breast and prostate cancers.
  • Veru also develops medicines for COVID-19 and other diseases related to viral and acute respiratory distress syndrome (“ARDS”), and has two FDA-approved products for sexual health.
  • Veru had originally developed sabizabulin with the intention of using it as a treatment for prostate cancer.

SeaStar Medical Receives FDA Approval to Begin Study with Selective Cytopheretic Device to Reduce Hyperinflammation in Adults with Acute Kidney Injury

Retrieved on: 
Thursday, February 9, 2023
Standard of care, Acute kidney injury, Homeostasis, Food, Safety, MD, AKI, COVID-19, Acute respiratory distress syndrome, SCD, PMA, Manifest and latent functions and dysfunctions, IDE, Monocyte, Patient, Dialysis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Nephrology, CKRT, ICU, Neutrophil, Mortality, Death, Pharmaceutical industry

DENVER, Feb. 09, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces today that the U.S. Food and Drug Administration (FDA) approved the Company’s investigational device exemption (IDE) application to conduct a pivotal study evaluating the effectiveness of its Selective Cytopheretic Device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).

Key Points: 
  • The Company plans to begin enrollment in this 200-patient randomized, controlled trial in March 2023.
  • We currently expect to generate interim study results during the fourth quarter of 2023 and topline study results and submission of a Pre-market Approval (PMA) application in the second half of 2024.
  • “We are excited about the potential of SCD to treat life-threatening hyperinflammation in severely ill patients with AKI requiring CKRT.
  • The SCD has previously demonstrated success in critically ill adults with AKI requiring CKRT, a condition with a high mortality rate.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Veru Inc. - VERU

Retrieved on: 
Saturday, February 4, 2023
Food, COVID-19, Acute respiratory distress syndrome, Advisory Committee, Patient, Defense Department Advisory Committee on Women in the Services, News, Pharmaceutical industry

NEW YORK, Feb. 04, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).

Key Points: 
  • NEW YORK, Feb. 04, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Veru and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Veru Inc. - VERU

Retrieved on: 
Sunday, January 29, 2023
Food, COVID-19, Acute respiratory distress syndrome, Advisory Committee, Patient, Defense Department Advisory Committee on Women in the Services, News, Pharmaceutical industry

NEW YORK, Jan. 29, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).

Key Points: 
  • NEW YORK, Jan. 29, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Veru and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

BioAegis Therapeutics Announces FDA Clearance of IND for its ‘Inflammation Regulator Protein,’ Gelsolin, for the Treatment of ARDS

Retrieved on: 
Thursday, January 26, 2023
Administration, Infection, Food, Inflammation, IND, ASPR, Acute respiratory distress syndrome, Drive, Gelsolin (cellular), Respiratory distress syndrome, BARDA, Lung, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, ICU, Saipan, Mortality, Death, Plasma, Therapy, Pharmaceutical industry, Management, Vaccine

ARDS is a serious inflammatory condition for which there are severe consequences with no current therapies other than supportive care.

Key Points: 
  • ARDS is a serious inflammatory condition for which there are severe consequences with no current therapies other than supportive care.
  • Its genesis can be from various etiologies, with severe infection being a frequent cause.
  • BioAegis is collaborating with the BARDA DRIVe Solving Sepsis program, to further develop plasma gelsolin for ARDS.
  • Plasma gelsolin is critically depleted in ARDS patients and has been shown to address both injurious and infectious inflammation in multiple studies.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Veru Inc. - VERU

Retrieved on: 
Saturday, January 21, 2023
Defense Department Advisory Committee on Women in the Services, News, Acute respiratory distress syndrome, Advisory Committee, COVID-19, Food, Patient, Pharmaceutical industry

NEW YORK, Jan. 21, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).

Key Points: 
  • NEW YORK, Jan. 21, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Veru and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

SQI installs two RALI-DX systems in Toronto hospitals to fight the growing respiratory health crisis in Emergency Departments

Retrieved on: 
Wednesday, January 18, 2023
Hospital, Acute respiratory distress syndrome, Degenerative disease, COVID-19, Severe acute respiratory syndrome coronavirus 2, Intubation, UHN, Risk, Patient, Emergency department, Science, University Health Network, Innovation, EDS, Physician, IL-6, Triage, Medical device, Pharmaceutical industry

"This is a timely response to the continuing challenge of COVID-19 and other respiratory diseases," said Andrew Morris, President and CEO of SQI Diagnostics.

Key Points: 
  • "This is a timely response to the continuing challenge of COVID-19 and other respiratory diseases," said Andrew Morris, President and CEO of SQI Diagnostics.
  • "We believe a respiratory triage test will be a vital tool enabling physicians to manage the ongoing respiratory health crisis in our EDs."
  • The number of laboratory confirmed cases of COVID-19 in Ontario began to rise at the beginning of this year according to provincial data.
  • The test was designed by a team of physicians at University Health Network (UHN) and was licensed and further developed by SQI Diagnostics.