Acute kidney injury

KidneyIntelX Clinical Utility and Health Economics Validated in Multiple Data Releases at American Society of Nephrology

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Monday, October 17, 2022
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The new model with plasma sTNFR1, sTNFR2, and KIM-1 combined with clinical variables accurately risk-stratified AAs with and without APOL1 risk genotype for kidney outcomes.

Key Points: 
  • The new model with plasma sTNFR1, sTNFR2, and KIM-1 combined with clinical variables accurately risk-stratified AAs with and without APOL1 risk genotype for kidney outcomes.
  • Thursday, November 3, 2022 from 10:00 AM to 12:00 PM at the Exhibit Hall, Orange County Convention Center.
  • Initial results suggest that despite similar median eGFR and median UACR levels, African American patients tested with KidneyIntelX were three times more likely to be scored as high risk.
  • KidneyIntelX has received Breakthrough Device Designation from the U.S. Food and Drug Administration and Renalytix has submitted for De Novo marketing authorization.

EQS-News: Mighty Mitochondria: This Company is Developing A Novel Drug for Kidney Disease By Targeting The Powerhouse Of Human Cells

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Wednesday, October 12, 2022
Disease, Risk, Chronic kidney disease, Therapy, Life, NYSE, NASDAQ, Ischemia, Biotechnology, AKBA, Research, Cell, Acute kidney injury, Mortality, Food and Drug Administration, AKI, Kidney, Food, Kidney disease, Cell death, Human, Health, Mitochondrial disease, Mitochondrion, Hyperphosphatemia, Swelling, Philippine Council of Evangelical Churches, Liver, Advertising, MPT, ATP, CKD, Death, Apoptosis, FDA, Conditional sentence, Solution, Pharmaceutical industry

While kidney cells make up only 1% of our body weight, they consume over 10% of our daily energy supply.

Key Points: 
  • While kidney cells make up only 1% of our body weight, they consume over 10% of our daily energy supply.
  • When either acute or chronic disease strikes these vital organs, the health of the mitochondria can literally be the difference between life and death.
  • The company is now beginning its next milestone, filing to begin Phase 1 human trials of the drug.
  • Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases.

Eligo Bioscience Receives FDA Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation for EB003 for the Prevention of Hemolytic Uremic Syndrome with First-in-class CRISPR-based medicine

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Tuesday, October 11, 2022
RPD, Shiga toxin, Disease, Technology, IND, Royal commission, Escherichia coli, Genetically modified bacteria, World Economic Forum, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Synthetic biology, Gene editing, DNA repair, Genetic engineering, Rockefeller University, Platelet, ODD, Acute kidney injury, Dysentery, Food, Anemia, GlaxoSmithKline, Khosla Ventures, Microdeletion syndrome, MIT, STEC, CRISPR, PRV, Bacteria, BLA, DNA, HUS, Death, FDA, Gene, Solution, European Commission, Biologics license application, Pharmaceutical industry, Vaccine, Antibiotics, Shiga Prefecture

Children under 5 years of age are particularly sensitive to the expression of Shiga toxins from E. coli (STEC) bacteria after their ingestion from contaminated foods.

Key Points: 
  • Children under 5 years of age are particularly sensitive to the expression of Shiga toxins from E. coli (STEC) bacteria after their ingestion from contaminated foods.
  • EB003 is IND-enabled with a robust manufacturing process at the 100L-scale, full preclinical package and a clear regulatory path-to-clinic.
  • The FDA grants Orphan Drug Designation to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the U.S.
  • The FDA grants Rare Pediatric Disease designation for serious and life-threatening diseases primarily affecting individuals ages 18 or younger and fewer than 200,000 individuals in the United States.

Fresenius Kabi Expands Contrast Agent Portfolio with Launch of Gadoterate Meglumine Injection, USP

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Tuesday, October 4, 2022
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Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem.

Key Points: 
  • Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem.
  • View the full release here: https://www.businesswire.com/news/home/20221004005162/en/
    Fresenius Kabi Gadoterate Meglumine Injection, USP is an FDA-approved generic for MRI procedures that is fully substitutable for Dotarem.
  • Fresenius Kabi is pleased to expand our contrast agent portfolio and our support for the radiology community with the launch of Gadoterate Meglumine Injection, USP, said John Ducker, president and CEO of Fresenius Kabi USA.
  • Contrast agents are vital to patient diagnosis, and the addition of Fresenius Kabi Gadoterate Meglumine will provide hospitals and clinics across the U.S. with more high-quality choices to support patient care.

Unicycive Therapeutics to Present at Roth Inaugural Healthcare Opportunities Conference

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Thursday, September 29, 2022
Hyperphosphatemia, Biotechnology, GLOBE, Conference, Kidney disease, Kidney, LOS, Nasdaq, Acute kidney injury, Therapy, Patient, Pharmaceutical industry

LOS ALTOS, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chairman and Chief Executive Officer of Unicycive, will present a corporate overview and meet with investors at the upcoming Roth Inaugural Healthcare Opportunities Conference taking place October 6, 2022 in New York City.

Key Points: 
  • LOS ALTOS, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chairman and Chief Executive Officer of Unicycive, will present a corporate overview and meet with investors at the upcoming Roth Inaugural Healthcare Opportunities Conference taking place October 6, 2022 in New York City.
  • For investors interested in scheduling a one-on-one meeting with Unicycive management, please contact your Roth representative.
  • For questions or further information about Unicycive, please contact Anne Marie Fields of Stern IR at 212-362-1200 or submit your request to [email protected] .
  • Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases.

EQS-News: How One Company Plans To Help Battle A Silent Killer Globally Through Its New Kidney Disease Medication

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Friday, September 23, 2022
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Most people are surprised to learn that chronic kidney disease (CKD) is the fastest growing, non-communicable disease in the United States.

Key Points: 
  • Most people are surprised to learn that chronic kidney disease (CKD) is the fastest growing, non-communicable disease in the United States.
  • In fact, each year, more people die from this silent killer than from breast or prostate cancer.
  • Hyperphosphatemia (elevated phosphorus levels in the blood) is a common complication of CKD affecting over 80% of dialysis patients.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.

Global Dialysis Market Report 2022: Growing Number of Diabetic and Hypertension Patients Fueling Sector - ResearchAndMarkets.com

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Friday, September 16, 2022
Medical Devices, Health, Dialysis, Diabetes, Health, Chronic kidney disease, COVID-19, ESRD, Prevalence, Acute kidney injury, CKD, Hypertension, Renal replacement therapy, Patient, Kidney transplantation, Awareness, CAGR, Pharmaceutical industry, Growth

The "Dialysis Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Dialysis Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.
  • The global dialysis market reached a value of US$ 104.13 Billion in 2021.
  • The growing number of diabetic and hypertension patients along with the increasing incidences of end-stage renal disease (ESRD) are primarily driving the global dialysis market.
  • Additionally, the introduction of sorbent-based regenerative technology that enables the delivery of high-dose dialysis with a low volume of dialysis solution while removing toxins is expected to drive the global dialysis market in the coming years.

Potrero Medical Receives FDA Breakthrough Device Designation for Accuryn AKI Predict Algorithm

Retrieved on: 
Tuesday, September 13, 2022
Disease, Intelligence, Technology, Health, AKI, Kidney, Acute kidney injury, Diagnosis, FDA, IAH, Medicine, Patient, Medical imaging, Medical device

HAYWARD, Calif., Sept. 13, 2022 /PRNewswire/ -- Potrero Medical announced today that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients.

Key Points: 
  • HAYWARD, Calif., Sept. 13, 2022 /PRNewswire/ -- Potrero Medical announced today that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients.
  • Combining Accuryn technology with a predictive AKI algorithm will enhance the clinical decision support we provide at the bedside."
  • To receive breakthrough designation from the FDA, there are several criteria that must be met.
  • First, the device must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

BioPorto to Participate in H.C. Wainwright’s 24th Annual Global Investment Conference

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Thursday, September 8, 2022
Mortality, Disease, AKI, Risk assessment, Acute kidney injury, CPH, Nasdaq Copenhagen, Physician, Quality of life, Antibody, GLOBE, Conference, Company, Biomarker, Risk, CE, Patient, Pharmaceutical industry

COPENHAGEN, Denmark and BOSTON, Sept. 08, 2022 (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto) (CPH:BIOPOR) today announced plans to participate in the H.C. Wainwright 24th Annual Global Investment Conference taking place September 12-14, 2022 in New York City.

Key Points: 
  • COPENHAGEN, Denmark and BOSTON, Sept. 08, 2022 (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto) (CPH:BIOPOR) today announced plans to participate in the H.C. Wainwright 24th Annual Global Investment Conference taking place September 12-14, 2022 in New York City.
  • Following are details for managements presentation:
    Management will also be available for 1x1 meetings.
  • Following the conference, the presentation video will be available for three months on BioPortos website at www.bioporto.com .
  • The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange.

Unicycive Reports Key Findings of UNI-494 Efficacy in Preclinical Animal Model of Acute Kidney Injury (AKI)

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Wednesday, September 7, 2022
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LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.

Key Points: 
  • LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.
  • The Company evaluated the effect of UNI-494 on ischemia-reperfusion induced acute kidney injury (IR-AKI) in rats.
  • We are excited to report this key finding from the IR-AKI model showing treatment with UNI-494 significantly reduced this key biomarker of kidney injury that is a well-accepted biomarker of proximal renal tubule damage.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.For more information, please visit www.unicycive.com .