Renal replacement therapy

Nuwellis Receives USPTO Notice of Patent Allowance for Innovative Pediatric CRRT Technology

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목요일, 5월 2, 2024

CRRT, Bangladesh Technical Education Board, NIH, Hemofiltration, Renal replacement therapy, Patent, Patient, Hospice and palliative medicine, Health, KBT, Pharmaceutical industry

This patent strengthens Nuwellis' intellectual property portfolio and paves the way for the development of novel technology designed to improve treatment options for critically ill children.

Key Points:

This patent strengthens Nuwellis' intellectual property portfolio and paves the way for the development of novel technology designed to improve treatment options for critically ill children.
This innovative feature offers unmatched flexibility, allowing clinicians to tailor treatment plans to the specific needs of each young patient.
"We are thrilled to receive this patent allowance from the USPTO," said Nestor Jaramillo, Jr., President and Chief Executive Officer of Nuwellis.
This patent allowance represents a significant advancement in the company's mission to revolutionize pediatric fluid management.

The National Kidney Foundation Urges Passage of New Home Dialysis Bill

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화요일, 4월 23, 2024

WASHINGTON, April 23, 2024 /PRNewswire/ -- The National Kidney Foundation is applauding a move by Congress to increase access to care and improve outcomes for some patients on dialysis. The Improving Access to Home Dialysis Act (HR-8075) was introduced today in the U.S. House of Representatives by Reps. Carol Miller (R-WV), Marilyn Strickland (D-WA), Earl Blumenauer (D-OR), and Mariannette Miller-Meeks (R-IA). A companion bill is expected to be introduced soon in the Senate.

Key Points:

WASHINGTON, April 23, 2024 /PRNewswire/ -- The National Kidney Foundation is applauding a move by Congress to increase access to care and improve outcomes for some patients on dialysis.
Home dialysis is a form of renal (kidney) replacement therapy (aka, dialysis) that can be done at home by the patient alone or with the help of a care partner.
"Patients deserve to know about all options for dialysis so they can make an educated choice for themselves," said Kevin Longino, Chief Executive Officer of the National Kidney Foundation and a kidney transplant recipient.
"Policies like this make me increasingly optimistic that more kidney patients struggling with dialysis can have a chance to get some of their life back."

Alebund's Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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금요일, 3월 29, 2024

ODD, Diagnosis, Kidney disease, Prevalence, Kidney, Renal replacement therapy, Patient, Orphan, ESKD, FDA, Pharmaceutical industry

"We are very excited that AP303 has been granted Orphan Drug Designation by the FDA", Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented.

Key Points:

"We are very excited that AP303 has been granted Orphan Drug Designation by the FDA", Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented.
"It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with ADPKD.
AP303, a novel drug candidate developed in-house by Alebund, has demonstrated a meaningful improvement of renal survival in an ADPKD mice model.
This Orphan Drug Designation reflects the need for more new treatment options and the potential for AP303 to address the pressing needs of people living with ADPKD.

CMUH(Taiwan) Using AI to Monitor Home Hemodialysis

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월요일, 3월 18, 2024

TAICHUNG, March 18, 2024 /PRNewswire/ -- Chronic Kidney Disease has become a new "national disease" in Taiwan, and the number of patients requiring hemodialysis is increasing. Traditionally, hemodialysis patients and accompanies require at least an hour spent on commuting, and that maybe even more time consuming for those who live in suburbs. Moreover, patients almost feel tired or fatigue and need rest half a day following hemodialysis. Since 2019 in Taiwan, China Medical University Hospital (CMUH) has initiated and implemented AI monitoring system for hemodialysis patients. The unique AI system receives the messages sent by the dialysis machine to keep track of any risk message with incorporated AI system, ensuring patient safety and collecting information for prescription adaptation. Accredited with CMUH's AI technology, those who require hemodialysis are not necessary to visit a healthcare facility for this routine. Dr. Huey-Liang Kuo, Director of Hemodialysis Center at CMUH, stated that patients have been heathier and safer to do hemodialysis at home.

Key Points:

Since 2019 in Taiwan, China Medical University Hospital (CMUH) has initiated and implemented AI monitoring system for hemodialysis patients.
The unique AI system receives the messages sent by the dialysis machine to keep track of any risk message with incorporated AI system, ensuring patient safety and collecting information for prescription adaptation.
Accredited with CMUH's AI technology, those who require hemodialysis are not necessary to visit a healthcare facility for this routine.
Dr. Huey-Liang Kuo, Director of Hemodialysis Center at CMUH, stated that patients have been heathier and safer to do hemodialysis at home.

AM-Pharma Initiates Phase 2 Trial of Ilofotase Alfa for Cardiac Surgery-Associated Renal Damage

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화요일, 1월 16, 2024

CSA-RD is defined as the long-term loss of renal function in cardiac surgery patients and arises from acute kidney injury (AKI) immediately following the surgery.

Key Points:

CSA-RD is defined as the long-term loss of renal function in cardiac surgery patients and arises from acute kidney injury (AKI) immediately following the surgery.
Ilofotase alfa has a proven safety and tolerability profile and a strong record of renal protective effects as observed in previous clinical studies.
Notably, prior Phase 2 and Phase 3 trials with ilofotase alfa demonstrated significant improvements in Major Adverse Kidney Events by day 90 (MAKE90) in sepsis-associated AKI.
Ilofotase alfa was recently evaluated in a Phase 1b pilot study as enzyme replacement therapy in hypophosphatasia (HPP) patients.

AcelRx Announces Rebranding With Name Change to Talphera, Inc.

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화요일, 1월 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

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금요일, 1월 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?

Arch Biopartners Receives Approval from Ethics Committee in Turkey to Proceed with Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

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목요일, 12월 21, 2023

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points:

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
The ethics committee approval of the trial will be followed by a final regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-January.
Once the trial is approved by the MoH, activation of clinical sites in Turkey will take place and patient enrollment can begin in February.
Quote from Richard Muruve, CEO of Arch Biopartners Inc:
“We look forward to a positive decision from the MoH, which will permit enrollment of Turkish cardiac surgery patients into the trial.

Arch Biopartners Submits Application to Health Canada to Conduct the Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Retrieved on:

수요일, 12월 13, 2023

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points:

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
The FDA granted the Company permission to proceed with a Phase II trial in late June .
Quote from Richard Muruve, CEO of Arch Biopartners Inc:
“The clinical trial application submitted to Health Canada is the result of clinical interest in Canada to support our Phase II trial targeting CS-AKI.
LSALT peptide has been shown to prevent ischemia reperfusion injury (IRI) to the kidneys in pre-clinical models , providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT®) for Diabetic CKD and Provides Corporate Updates

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월요일, 11월 13, 2023

Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients.

Key Points:

Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients.
Updated interim REACT RMCL-002 study data support continued investigation of REACT’s potential to benefit patients with moderate and high-risk diabetic CKD.
The ongoing Phase 2 clinical study assessed adverse events and changes in kidney function as measured by estimated glomerular filtration rate (eGFR), as primary study endpoints.
Further, you may listen to the presentation by dialing 1-877-407-0784 (US) or 1-201-689-8560 (International) and entering the Conference ID: 13742672.