Hemofiltration

CalciMedica Presents Data from Preclinical Studies of Auxora in Acute Kidney Injury at the 29th International AKI & CRRT Conference

Retrieved on: 
Wednesday, March 13, 2024
CRRT, Conference, Pneumonia, CRAC, Disease, Incidence, GFR, AKI, Patient, Physiology, COVID-19, Renal artery, Biomarker, Hemofiltration, T helper 17 cell, Mortality, Indiana University, Cell biology, Glomerular filtration rate, Respiratory failure, Doctor of Philosophy, Acute kidney injury, Ischemia, Kidney, Poster, Stage 2, Blood, Animal, Hospice and palliative medicine, Pharmaceutical industry

LA JOLLA, Calif., March 13, 2024 /PRNewswire/ -- CalciMedica Inc. (CalciMedica or the Company) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic diseases, last evening presented data from preclinical studies of Auxora™ in acute kidney injury (AKI) at the 29th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) in San Diego, CA. David Basile, Ph.D., Professor of Anatomy, Cell Biology and Physiology at Indiana University, gave an oral and poster presentation entitled "The Store-Operated Calcium Channel Inhibitor Auxora Improves Renal Function Following Ischemia-Induced Acute Kidney Injury in Rats."

Key Points: 
  • In rats with kidney injury akin to Stage 3 AKI, the rats treated with placebo died while those on Auxora survived and showed modest recovery of GFR.
  • We are excited as these studies support clinical observations of Auxora that suggest the drug may be beneficial for AKI patients."
  • The data presented at AKI & CRRT was from a series of studies referred to as Study 1 and Study 2.
  • These results indicate that Auxora has the ability to hasten the recovery of kidney function and improve survival in rat models of AKI.

CalciMedica Announces FDA Clearance of IND Application for Phase 2 Trial of Auxora™ for the Treatment of Severe Acute Kidney Injury

Retrieved on: 
Tuesday, February 13, 2024
Oxygen, International, Chronic kidney disease, Incidence, FDA, Food, Dialysis, Glomerular filtration rate, Pneumonia, Hemofiltration, IRI, Risk, Conference, IMV, Angiopoietin, CRAC, Survivor, COVID-19, Classification, Death, Acute kidney injury, EGFR, AHRF, Patient, Biomarker, AKI, Survival, Disease, Kidney disease, Medicine, GFR, Endothelium, IND, Mortality, Pharmaceutical industry

LA JOLLA, Calif., Feb. 13, 2024 /PRNewswire/ -- CalciMedica, Inc. (CalciMedica or the Company) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic diseases, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for the Company's lead product candidate, Auxora™, a potent and selective small molecule inhibitor of Orai1-containing CRAC channels, to be evaluated in a Phase 2 trial in acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024 and data expected in 2025.

Key Points: 
  • CalciMedica expects to initiate the trial, named KOURAGE, in the first half of 2024 and data expected in 2025.
  • "Through KOURAGE, we aim to determine how Auxora can benefit patients with severe AKI and potentially reduce the high mortality rate associated with this disease."
  • AKI is classified as stages 1, 2 and 3 depending on the degree of kidney injury.
  • A single dose of Auxora after IRI increased GFR by 61% and decreased mononuclear (inflammatory) cell infiltration by 30%.

Fresenius Medical Care Brings Industry-Leading Dialysis Therapy to Kidney Disease Patients in the U.S., demonstrating Global Leadership in Medical Device and Membrane Engineering Technologies

Retrieved on: 
Thursday, February 8, 2024
Health care, Dialysis, BAD, Hemofiltration, Kidney, Mortality, FDA, Food, Food and Drug Administration, Fresenius Medical Care, Convection, Diffusion, Engineering, Patient, Water, FME, Blood, Medical device

Fresenius Medical Care (FME) receives U.S. Food and Drug Administration (FDA) 510(k) clearance of the company's 5008X Hemodialysis System.

Key Points: 
  • Fresenius Medical Care (FME) receives U.S. Food and Drug Administration (FDA) 510(k) clearance of the company's 5008X Hemodialysis System.
  • This will enable Fresenius Medical Care to offer the industry-leading, high-volume hemodiafiltration (Hv-HDF) dialysis therapy – already widely used in Europe – for people living with kidney diseases in the U.S.
  • The 510(k) clearance allows the start of clinical evaluations and user-studies in the U.S., with a planned broad commercial launch of the 5008X Hemodialysis System in 2025.
  • The 5008X Hemodialysis System and companion FX CorAL dialyzer demonstrate the company's global innovation leadership in medical device and membrane engineering technologies.

AcelRx Announces Rebranding With Name Change to Talphera, Inc.

Retrieved on: 
Tuesday, January 9, 2024
IDE, Dialysis, Patient, Hemofiltration, Talisman, SAN, Risk, Heparin, IRB, FDA, Renal replacement therapy, Bleeding, Pain, PMA, Pharmaceutical industry

SAN MATEO, Calif., Jan. 9, 2024 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the rebranding of the Company, with a name change to Talphera, Inc. ("Talphera"). The rebrand decision was made to reflect the Company's strategy of developing and commercializing products to support advancing care to optimize outcomes in medically supervised settings, moving beyond the original focus on acute pain.  The Company's lead nafamostat product candidate, Niyad, is expected to have a Premarket Approval (PMA) submission to the FDA in the second half of 2024.  

Key Points: 
  • The name Talphera was derived from "Talisman", meaning a strong leader, and reflects the new "pharmaceutical era" for the Company.
  • The company's new mission at Talphera is to support healthcare providers by developing and commercializing products in medically supervised settings that deliver advances in care to patients.
  • Talphera will commence trading on the Nasdaq Global Market under the ticker symbol "TLPH" effective January 10, 2024.
  • A PMA submission for Niyad is expected to be filed with the FDA in the second half of 2024.

Global Continuous Renal Replacement Therapy Market Analysis and Forecast Report 2024-2033 - ResearchAndMarkets.com

Retrieved on: 
Friday, January 5, 2024
Biotechnology, Pharmaceutical, Health, AKI, Prevalence, Competitive landscape, Incidence, Hemofiltration, Renal replacement therapy, Hospice and palliative medicine, Growth, Patient, CRRT, Sepsis, Pharmaceutical industry

The "Global Continuous Renal Replacement Therapy Market: Focus on Modality, Product, Region, and Competitive Landscape - Analysis and Forecast, 2024-2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Continuous Renal Replacement Therapy Market: Focus on Modality, Product, Region, and Competitive Landscape - Analysis and Forecast, 2024-2033" report has been added to ResearchAndMarkets.com's offering.
  • Key Questions Answered in this Report:
    What are the focus segments of the global continuous renal replacement therapy market in the upcoming years?
  • What are the major opportunities for existing market players and new entrants in the global continuous renal replacement therapy market?
  • What are the major opportunities for existing market players and new entrants in the global continuous renal replacement therapy market?

OrbusNeich Acquires 84% Stake in an Indonesian Distributor for Approximately US$15 Million

Retrieved on: 
Monday, November 27, 2023
World Bank, PCI, Sale, PTA, Acquisition, GDP, Bank statement, Death, Percutaneous coronary intervention, World Health Organization, Growth, Patient, OrbusNeich, Hemofiltration, Cardiac catheterization, Pharmaceutical industry

The consideration for the acquisition will be funded from the proceeds of the Group's global offering and cash generated from operations.

Key Points: 
  • The consideration for the acquisition will be funded from the proceeds of the Group's global offering and cash generated from operations.
  • PT Revass is an Indonesian company that specializes in the distribution and sale of cardiovascular intervention, neuro intervention, peripheral intervention and continuous renal replacement therapy products.
  • Its profit after tax in FY2022 amounted to IDR14.3 billion (equivalent to approximately US$920,000).
  • As of 30 June 2023, its unaudited net asset value was approximately IDR88.1 billion (equivalent to approximately US$5.7 million).

Inspira™ Announces 95% Accuracy Results for HYLA™ Blood Sensor, Planning FDA Submission for Clearance in 2024

Retrieved on: 
Tuesday, December 26, 2023
Annual report, Extracorporeal membrane oxygenation, FDA, ART, Hospital, Health, HYLA, Risk, Blood, Patient, OXY, Hemofiltration, Dialysis, ICU, Medical device

This breakthrough, in achieving 95% accuracy compared to standard blood gas analyzers, brings continuous and real-time blood monitoring capabilities compared to traditional blood gas analyzer systems used in hospitals that typically require intermittent blood draws.

Key Points: 
  • This breakthrough, in achieving 95% accuracy compared to standard blood gas analyzers, brings continuous and real-time blood monitoring capabilities compared to traditional blood gas analyzer systems used in hospitals that typically require intermittent blood draws.
  • This sensor technology is designed to be integrated with the Company's INSPIRA ART100 and was submitted to the FDA in September 2023, with clearance anticipated in the first half of 2024.
  • The HYLA™ Blood Sensor line (the "Blood Sensor") is set to transform intensive care unit (ICU) operations, offering continuous, real-time blood data collection and analysis.
  • This approach has enabled to define the Blood Sensor's disposable materials and methods, with HYLA's planned razor blade business model.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Outset Medical, Inc. - OM

Retrieved on: 
Monday, November 13, 2023
Chronic kidney disease, LLP, Letter, FDA, Marketing, Hemofiltration, Health, Diabetes, News, Novo Nordisk, Pomerantz, CRRT

NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Outset Medical, Inc. (“Outset” or the “Company”) (NASDAQ: OM).

Key Points: 
  • NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Outset Medical, Inc. (“Outset” or the “Company”) (NASDAQ: OM).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Outset 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, Pomerantz pioneered the field of securities class actions.

AcelRx to Host KOL Panel Discussion on Current Anticoagulant Use in Dialysis and the Upcoming Niyad™ Clinical Study

Retrieved on: 
Tuesday, November 7, 2023
Ronald Reagan UCLA Medical Center, Hemofiltration, Anticoagulant, Dialysis, Nephrology, KOL, Emory University School of Medicine, Medication, Pharmaceutical industry

SAN MATEO, Calif., Nov. 7, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it will host a virtual Key Opinion Leader (KOL) panel discussion on its lead candidate Niyad™ (nafamostat) for use as an anticoagulant in dialysis circuits. The panel will feature two thought-leaders in the nephrology and critical care fields who are also co-authors on a recent market research manuscript reporting current issues with anticoagulants in the dialysis circuit. The panel will also discuss the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, a registrational study comparing Niyad with placebo for dialysis circuit anticoagulation, which is planned to start in the fourth quarter. Both panel members are principal investigators in the trial.

Key Points: 
  • The panel will feature two thought-leaders in the nephrology and critical care fields who are also co-authors on a recent market research manuscript reporting current issues with anticoagulants in the dialysis circuit.
  • The panel will also discuss the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, a registrational study comparing Niyad with placebo for dialysis circuit anticoagulation, which is planned to start in the fourth quarter.
  • The webcasted event will take place on Wednesday, December 6, 2023 at 11:00 a.m.
  • A live question and answer will follow the discussion.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Outset Medical, Inc. - OM

Retrieved on: 
Sunday, November 5, 2023
FDA, Novo Nordisk, News, Diabetes, CRRT, Hemofiltration, Chronic kidney disease, Pomerantz, LLP, Marketing, Health, Letter, Pharmaceutical industry

NEW YORK, Nov. 05, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Outset Medical, Inc. (“Outset” or the “Company”) (NASDAQ: OM).

Key Points: 
  • NEW YORK, Nov. 05, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Outset Medical, Inc. (“Outset” or the “Company”) (NASDAQ: OM).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Outset 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, Pomerantz pioneered the field of securities class actions.