Acute kidney injury

Grant Awarded to Newcastle University to Research Athersys’ MultiStem® in Machine Perfusion Prior to Kidney Transplantation

Retrieved on: 
Wednesday, September 6, 2023
Education, Health, Stem Cells, Surgery, Pharmaceutical, University, Biotechnology, Perfusion, Stroke, Splenic infarction, Research, Inflammation, Cell, Doctor of Philosophy, Regenerative medicine, Transplant, Acute kidney injury, Ischemia, UK Research and Innovation, Publication, Patient, Kidney transplantation, Kidney, Newcastle University, Trauma, Pharmaceutical industry

Machine perfusion refers to a technology used for limiting the damaging effects of removing and transporting kidneys prior to transplantation.

Key Points: 
  • Machine perfusion refers to a technology used for limiting the damaging effects of removing and transporting kidneys prior to transplantation.
  • It involves a machine that pumps fluid around the organ while it is outside the body, allowing for the potential therapeutic treatments to the kidney after donation.
  • Athersys and Newcastle University researchers previously demonstrated that administration of MAPC cells to donor human kidneys during machine perfusion resulted in healthier organs more suitable for transplantation.
  • “This planned study builds upon the foundation of several publications and early clinical work in solid organ transplant with collaborators.

EQS-News: International Experts Highlight Demand for Diagnostic Innovations as PenKid's Research and Real-World Data Fuels Quest for Improved RRT Liberation Tools

Retrieved on: 
Wednesday, September 6, 2023
Royal Surrey County Hospital, Hospice and palliative medicine, University, Consultant, E pluribus unum, RRT, Critical Care (journal), Overalls, Renal replacement therapy, Biomarker, AKI, Intensive care medicine, Acute kidney injury, CRRT, Professor, University Hospital Heidelberg, Patient, School, RICH, Mortality, University of Surrey, Intensive care unit, Health, Southern Illinois University School of Medicine, Pharmaceutical industry, Medical imaging, Nursing

Recently published scientific data affirms that penKid remains informative under acute renal replacement therapy (RRT) and can identify patients for successful liberation.

Key Points: 
  • Recently published scientific data affirms that penKid remains informative under acute renal replacement therapy (RRT) and can identify patients for successful liberation.
  • RRT, a common practice in Intensive Care Units (ICUs), has long relied on clinical observations for stop decisions.
  • However, the lack of a dependable biomarker poses challenges in accurately assessing when to discontinue RRT.
  • Considering this, leading experts from the field have discussed in a recent advisory board the importance of identifying the right tools to improve the outcomes in AKI.

EQS-News: Boditech Med and SphingoTec close Market Development Agreement to Boost Commercialization of Kidney Function Biomarker PenKid

Retrieved on: 
Thursday, August 31, 2023
Partnership, PMID, Acute kidney injury, Critical Care (journal), Hollinger, Septic shock, Risk, AKI, Kidney, Korea, Patient, Developed country, Renal replacement therapy, INT, Diagnosis, MDA, Medical device, Dietary supplement, Sepsis

In 2022, Boditech Med and SphingoTec closed a global licensing agreement to develop and offer the Proenkephalin A 119-159 (penKid) test on Boditech's automated immunoassay systems.

Key Points: 
  • In 2022, Boditech Med and SphingoTec closed a global licensing agreement to develop and offer the Proenkephalin A 119-159 (penKid) test on Boditech's automated immunoassay systems.
  • The current market development agreement aims at enhancing the commercialization of the upcoming assay for penKid and ultimately advancing AKI diagnostics.
  • Gangwon-do, Republic of Korea and Hennigsdorf/Berlin, Germany, August 31, 2023 - Boditech Med Inc. (“Boditech”) and SphingoTec GmbH (“SphingoTec”) today announced they have entered into a market development agreement (MDA), building on their previous licensing collaboration for the kidney function biomarker penKid.
  • The MDA solidifies the partnership between Boditech and SphingoTec, aiming to support the successful commercialization of the assay for the biomarker penKid on the AFIAS platforms.

LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark

Retrieved on: 
Wednesday, August 30, 2023
Cardiology, Software, Health, FDA, Medical Devices, Health Technology, Technology, Other Health, Partnership, PLC, ILBM, LIVN, Perfusion, Hematocrit, Oxygen, CE marking, Food and Drug Administration, LivaNova, CPB, Multimedia, Temperature, Cardiopulmonary bypass, Sale, United Arab Emirates, CLIA, Journal, Acute kidney injury, GDP, Patient, Risk, Stazione Sperimentale per le Industrie delle Essenze e dei Derivati dagli Agrumi, Clinical Laboratory Improvement Amendments, Perfusionist, HLM, Partial pressure, Food, Monitoring (medicine), Medical device, Medical imaging

LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark for its Essenz™ In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures.

Key Points: 
  • LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark for its Essenz™ In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures.
  • “Dynamic conditions can rapidly change a patient’s blood parameters during a cardiopulmonary bypass procedure,” said Marco Dolci, LivaNova President, Cardiopulmonary.
  • “The Essenz In-Line Blood Monitor provides continuous monitoring throughout a patient’s procedure.
  • It consists of a next-generation heart-lung machine (HLM), a patient monitor and accurate sensing technology that now includes the ILBM.

A.C. Camargo Cancer Center Harnesses the Power of DoseMe Precision Dosing Platform to Substantially Reduce Toxicity and Kidney Injuries

Retrieved on: 
Wednesday, August 30, 2023
Managed Care, Software, Research, Other Health, Pharmaceutical, Oncology, Technology, Infectious Diseases, Hospitals, Health Technology, Clinical Trials, Science, Health, BCPS, PM, Doctor of Pharmacy, University, Education, Evidence-based medicine, Post, Serum, Acute kidney injury, Survival, Infection, Cancer, International Association, Rehabilitation, Clinical endpoint, Doctor of Philosophy, ECCMID, Vancomycin, Patient, Collection, Nursing, Therapeutic drug monitoring, Diagnosis, Hospital, Yale Cancer Center, TDM, Pharmaceutical industry, Dosem

DoseMe , a leading provider of precision dosing software for therapeutic drug monitoring (TDM) and creators of DoseMeRx and DoseMe Analytics, today announced AC Camargo Cancer Center continues to recognize improved patient care with real world data dosing results.

Key Points: 
  • DoseMe , a leading provider of precision dosing software for therapeutic drug monitoring (TDM) and creators of DoseMeRx and DoseMe Analytics, today announced AC Camargo Cancer Center continues to recognize improved patient care with real world data dosing results.
  • A.C. Camargo is an integrated Cancer Center for diagnosis, treatment, education and research.
  • Since its inception in 1953, A.C. Camargo has made significant and ongoing contributions to the fight against cancer and it is recognized internationally as a reference institution.
  • "DoseMe is critical to our team's ability to access real-time data and continue to deliver on our promise of customized care for every single patient."

Case Series of Three Critically Ill Children with Acute Kidney Injury Safely Treated with SeaStar Medical’s Selective Cytopheretic Device Published in the Journal Blood Purification

Retrieved on: 
Tuesday, August 29, 2023
STEC, Neutrophil, Multiple organ dysfunction syndrome, SCD, Systemic, AKI, STEC-HUS, Acute kidney injury, CKRT, Hospital, MD, Immunomodulation, Observation, Paper, SeaStar, ICU, Cincinnati, Karger Publishers, Pharmaceutical industry

All three children were in the ICU at two different hospitals and treated with continuous kidney replacement therapy (CKRT).

Key Points: 
  • All three children were in the ICU at two different hospitals and treated with continuous kidney replacement therapy (CKRT).
  • Each show gradual improvement following treatment with the SCD-PED and normalization or near normalization of kidney function at 60-day follow up.
  • The article, “Hemolytic Uremic Syndrome-Induced Acute Kidney Injury Treated via Immunomodulation with the Selective Cytopheretic Device: Cases of STEC-HUS Treated with Immunomodulation via SCD CRRT Filter,” (H. Rhodes Hambrick, et al.)
  • was published in the peer-reviewed journal Blood Purification.

XORTX Submits Orphan Drug Designation Application to the European Medicines Agency (EMA) to Treat Progressive Kidney Disease

Retrieved on: 
Tuesday, August 29, 2023
Marketing, ODD, European Medicines Agency, Acute kidney injury, COMP, Oxipurinol, Research, Science, Committee, EMA, Polycystic kidney disease, Patient, Hyperuricemia, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Kidney disease, Autosome, Pharmaceutical industry, ADPKD

CALGARY, Alberta, Aug. 29, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, announces that it has submitted an Orphan Drug Designation application for XORLO™ to the European Medicines Agency (the “EMA”). The “orphan-drug designation request is for the use of XORTX’s patented unique proprietary formulation of oxypurinol – XORLO™ – for the treatment of autosomal dominant polycystic kidney disease (ADPKD)”.

Key Points: 
  • CALGARY, Alberta, Aug. 29, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, announces that it has submitted an Orphan Drug Designation application for XORLO™ to the European Medicines Agency (the “EMA”).
  • The “orphan-drug designation request is for the use of XORTX’s patented unique proprietary formulation of oxypurinol – XORLO™ – for the treatment of autosomal dominant polycystic kidney disease (ADPKD)”.
  • The orphan drug designation process (“ODD”) initiated with the submission of this application and is made to the EMA’s COMP (Committee for Orphan Medicinal Products) office.
  • It also follows on receipt of ODD status granted by the U.S. Food and Drug Administration in April 2023.

Alloksys reports interim results of its clinical phase IIb trial with Alkaline Phosphatase therapy RESCAP® in critical care patients

Retrieved on: 
Thursday, August 24, 2023
Extrapyramidal system, EEA, Trauma, Human, Probability, Therapy, Chronic kidney disease, Accident, Prevalence, New Drug Application, NDA, AP, Inflammation, Marketing, AKI, Sepsis, Intensive care medicine, Alkaline phosphatase, ITMS, Incidence, Acute kidney injury, Patient, Disease, Acute respiratory distress syndrome, Mortality, Nursing care plan, MAA, Burns, Intensive care unit, CKD, III, Calf, Dentistry, Pharmaceutical industry, Hospital, Vaccine

The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery.

Key Points: 
  • The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery.
  • These outcomes warrant a follow-up clinical phase III trial with a total of 400 patients, to commence Q3 2023.
  • Ruud Brands, Founder and CEO of Alloksys, comments on the interim results of the APPIRED-III study, which focuses on patients undergoing cardiothoracic surgery.
  • RESCAP® (RESCuing Alkaline Phosphatase), is a proprietary medication developed by Alloksys, based on the enzyme alkaline phosphatase (AP).

Alloksys reports interim results of its clinical phase IIb trial with Alkaline Phosphatase therapy RESCAP® in critical care patients

Retrieved on: 
Thursday, August 24, 2023
Extrapyramidal system, EEA, Trauma, Human, Probability, Therapy, Chronic kidney disease, Accident, Prevalence, New Drug Application, NDA, AP, Inflammation, Marketing, AKI, Sepsis, Intensive care medicine, Alkaline phosphatase, ITMS, Incidence, Acute kidney injury, Patient, Disease, Acute respiratory distress syndrome, Mortality, Nursing care plan, MAA, Burns, Intensive care unit, CKD, III, Calf, Dentistry, Pharmaceutical industry, Hospital, Vaccine

The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery.

Key Points: 
  • The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery.
  • These outcomes warrant a follow-up clinical phase III trial with a total of 400 patients, to commence Q3 2023.
  • Ruud Brands, Founder and CEO of Alloksys, comments on the interim results of the APPIRED-III study, which focuses on patients undergoing cardiothoracic surgery.
  • RESCAP® (RESCuing Alkaline Phosphatase), is a proprietary medication developed by Alloksys, based on the enzyme alkaline phosphatase (AP).

Unicycive Announces Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 14, 2023
USAN, Travel, Drug development, Chronic kidney disease, Falls in older adults, Quality of life, Medicine, G&A, LDC, Trial of the century, Research and development, Acute kidney injury, Nephrology, American Journal, Publication, OLC, Patient, Administration, Kidney, United Kingdom, LOS, R, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Labour, Food, Kidney disease, Pharmaceutical industry, Cryptocurrency

LOS ALTOS, Calif., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the second quarter ended June 30, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the second quarter ended June 30, 2023, and provided a business update.
  • Financial Results for the Second Quarter Ended June 30, 2023
    Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2023 were $2.3 million, compared to $1.9 million for the same period in 2022.
  • General and Administrative (G&A) Expenses: G&A for the quarter ended June 30, 2023 were $2.1 million, compared to $1.8 million for the same quarter of 2022.
  • Other Income (Expenses): Other income (expenses) for the quarter ended June 30, 2023 increased $0.5 million due primarily to the revaluation of the warrant liability.