Manifest and latent functions and dysfunctions

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.

Miromatrix Provides Update on miroliverELAP

Retrieved on: 
Wednesday, February 1, 2023
MIRO, Food, IND, CMC, EDEN, Manifest and latent functions and dysfunctions, Patient, Clinical trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Chemistry, Letter, Pharmaceutical industry

EDEN PRAIRIE, Minn., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Miromatrix Medical Inc. (NASDAQ: MIRO), a life sciences company pioneering a novel technology for bioengineering fully transplantable organs to help save and improve patients' lives, today provided a program update on miroliverELAP™.

Key Points: 
  • EDEN PRAIRIE, Minn., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Miromatrix Medical Inc. (NASDAQ: MIRO), a life sciences company pioneering a novel technology for bioengineering fully transplantable organs to help save and improve patients' lives, today provided a program update on miroliverELAP™.
  • Miromatrix previously announced the submission of its miroliverELAP Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in November 2022.
  • "Miromatrix is bioengineering organs with the goal of providing organ failure patients with treatment alternatives that do not exist today," said Dr. Jeff Ross, Chief Executive Officer of Miromatrix.
  • "miroliverELAP is a novel first-in-class therapeutic and the clinical hold letter provides us with a defined path forward from the FDA as we strive to solve one of the greatest unmet medical needs facing the world today.

eGenesis Announces Knut Niss as Chief Technology Officer

Retrieved on: 
Tuesday, January 24, 2023
Cell, Mustang, Molecular biology, Regenerative medicine, Biotechnology, CMC, Hospital, Biogen, Organ transplantation, Manifest and latent functions and dysfunctions, Humboldt University of Berlin, Patient, Cell therapy, Dana–Farber Cancer Institute, University of Göttingen, Doctor of Philosophy, Merck Millipore, Pharmaceutical industry, Operation, Biology, Pfizer

CAMBRIDGE, Mass., Jan. 24, 2023 (GLOBE NEWSWIRE) -- eGenesis, a biotechnology company developing human-compatible organs and cells for the treatment of organ failure, today announced that Knut Niss, Ph.D., has joined the company as Chief Technology Officer.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 24, 2023 (GLOBE NEWSWIRE) -- eGenesis, a biotechnology company developing human-compatible organs and cells for the treatment of organ failure, today announced that Knut Niss, Ph.D., has joined the company as Chief Technology Officer.
  • “We are pleased to welcome Knut to the team and are confident he will help us advance our goal of transforming the treatment paradigm for organ failure,” said Michael Curtis, Ph.D., Chief Executive Officer of eGenesis.
  • “Synthetic biology and gene engineering are core components of our approach to developing high-quality, transplantable organs that ultimately save lives.
  • “Powered by a strong technological platform, eGenesis is well-positioned to address the hurdles that have hindered the field of xenotransplantation to date,” Dr. Niss said.

FDA Clears Cytovale’s® IntelliSep® Sepsis Test, First in a New Class of Emergency Department-Focused Diagnostic Tools

Retrieved on: 
Wednesday, January 18, 2023
Pharmaceutical, Finance, Medical Devices, Infectious Diseases, Hospitals, Data Management, Professional Services, Technology, Practice Management, Nursing, Clinical Trials, Managed Care, Medical Supplies, General Health, FDA, Biotechnology, Health, Health Technology, Cell, Our Lady of the Lake Regional Medical Center, Hospital, Prostate cancer, Infection, Critical care, LSU Health Sciences Center New Orleans, Heart, Septic, Pressure, CMS, Death, Centers for Medicare & Medicaid Services, Manifest and latent functions and dysfunctions, MD, Risk, Band, Food and Drug Administration, Research, United, Sepsis Alliance, Medicare, Band I, Sepsis, Food, Diagnosis, Patient, Band 3 anion transport protein, Breast cancer, Probability, Joe Byrd (Cherokee Nation Principal Chief), Medical device, Medical imaging

IntelliSep is a groundbreaking diagnostic tool that helps clinicians recognize sepsis and supports critical time-sensitive clinical decisions, providing test results in under 10 minutes.

Key Points: 
  • IntelliSep is a groundbreaking diagnostic tool that helps clinicians recognize sepsis and supports critical time-sensitive clinical decisions, providing test results in under 10 minutes.
  • The first in a new class of ED-focused diagnostic tools that assess host response, the test is a simple, fast, and intuitive solution that provides actionable answers directly from a standard blood draw.
  • IntelliSep categorizes patients into three bands according to their probability of sepsis, with Band 1 indicating low probability of sepsis and Band 3 indicating high probability of sepsis.
  • "Every minute is crucial in identifying sepsis, and IntelliSep has the potential to transform clinical approaches to sepsis triage and diagnosis and save countless lives."

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.

eGenesis and Eledon Pharmaceuticals Announce Collaboration for Use of Tegoprubart in Preclinical Xenotransplantation Studies

Retrieved on: 
Monday, January 9, 2023
IND, Cell, CD154, Kidney, Heart, Manifest and latent functions and dysfunctions, Immunomodulation, Immunosuppression, FDA, Drug development, Immune system, Patient, CD40, Immunoglobulin G, CD40L, Pharmaceutical industry, Eledone

CAMBRIDGE, Mass. and IRVINE, Calif., Jan. 09, 2023 (GLOBE NEWSWIRE) -- eGenesis, Inc. (“eGenesis”) and Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), today announced that they have entered into a collaborative research agreement under which eGenesis will gain access to Eledon’s anti-CD40L antibody candidate, tegoprubart, for eGenesis’ ongoing preclinical research and development studies of human-compatible organs and cells for the treatment of organ failure. The collaboration has the potential to span multiple eGenesis programs including kidney, heart and islet cell transplant.

Key Points: 
  • -Agreement leverages Eledon’s investigational anti-CD40L antibody, tegoprubart, as part of eGenesis’ immunosuppression regimen that prevents xenotransplant rejection in nonhuman primate recipients-
    -Establishes framework for use of tegoprubart for preclinical xenotransplantation studies in support of eGenesis’ kidney, heart and islet cell programs-
    CAMBRIDGE, Mass.
  • and IRVINE, Calif., Jan. 09, 2023 (GLOBE NEWSWIRE) -- eGenesis, Inc. (“eGenesis”) and Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), today announced that they have entered into a collaborative research agreement under which eGenesis will gain access to Eledon’s anti-CD40L antibody candidate, tegoprubart, for eGenesis’ ongoing preclinical research and development studies of human-compatible organs and cells for the treatment of organ failure.
  • The collaboration has the potential to span multiple eGenesis programs including kidney, heart and islet cell transplant.
  • “Despite significant recent progress and momentum in the field of xenotransplantation, improving organ compatibility to prevent rejection remains an ongoing challenge,” said Michael Curtis, Ph.D., Chief Executive Officer of eGenesis.

Opticyte Earns FDA Breakthrough Device Designation for the First Cell O2 Patient Monitor for Organ Failure

Retrieved on: 
Monday, January 9, 2023
Technology, FDA, Health, General Health, Health Technology, Other Science, Other Technology, Medical Devices, Research, Science, Hardware, News, Cell, Hospital, University of Washington Medical Center, University, Standard of care, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, Manifest and latent functions and dysfunctions, FDA, Risk, Korea Disease Control and Prevention Agency, Conference, History, Food, VC, Patient, Breakthrough, Sepsis, Observational study, Mortality, Harborview Medical Center, Pigment, Organ dysfunction, Myocardial infarction, Shock, CDC, Pharmaceutical industry, Trauma

Opticyte , a medical device start-up, announced today that its Cell O₂ Patient Monitor received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for real-time, continuous monitoring of patients at risk of organ failure.

Key Points: 
  • Opticyte , a medical device start-up, announced today that its Cell O₂ Patient Monitor received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for real-time, continuous monitoring of patients at risk of organ failure.
  • The Cell O₂ Patient Monitor uses noninvasive optical spectroscopy technology to measure and detect systemic low oxygen levels inside cells.
  • The Breakthrough Device Designation provides for timely interactions with the FDA and prioritized review of the regulatory submissions.
  • Fewer than 800 devices in the history of the FDA regulatory approval process have ever received Breakthrough Device Designation.

Enlivex Receives Authorizations from French and Belgian Regulatory Agencies To Expand Its Phase II Sepsis Clinical Trial Into France and Belgium

Retrieved on: 
Wednesday, January 4, 2023
Hospital, FAMHP, Food, Therapy, ANSES, Biophysical environment, SOFA, Immunotherapy, Occupational safety and health, Sepsis, Patient, Mortality, Medication, Safety, Manifest and latent functions and dysfunctions, Time-invariant system, Phase, Pharmaceutical industry

The Phase II trial is expected to include 80 to 160 patients across four cohorts, receiving varying doses of either AllocetraTM or a placebo, all in addition to standard-of-care therapy.

Key Points: 
  • The Phase II trial is expected to include 80 to 160 patients across four cohorts, receiving varying doses of either AllocetraTM or a placebo, all in addition to standard-of-care therapy.
  • The trial is supported by previously reported positive results from a Phase Ib investigator-initiated trial that showed vastly improved clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in AllocetraTM-treated sepsis patients, as compared to a group of matched historical controls who received standard-of-care therapy.
  • Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, “Expanding the study to France and Belgium with frozen formulation AllocetraTM is an important step in the execution of our ongoing Phase II sepsis trial.
  • We also believe that this is a notable regulatory achievement that provides additional validation for our amended study design and AllocetraTM frozen formulation.”

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