ESRD

Healthy.io Announces Collaboration with Boehringer Ingelheim to Increase Access to Testing for Kidney Disease

Retrieved on: 
Wednesday, May 10, 2023

Through this collaboration, Boehringer Ingelheim will work with Healthy.io's Minuteful Kidney™ test kit to explore the operational aspects of an at-home UACR (urine albumin-to-creatinine ratio) test kit – the first and only FDA-cleared, smartphone powered at-home ACR test – to at-risk, previously untested patients.

Key Points: 
  • Through this collaboration, Boehringer Ingelheim will work with Healthy.io's Minuteful Kidney™ test kit to explore the operational aspects of an at-home UACR (urine albumin-to-creatinine ratio) test kit – the first and only FDA-cleared, smartphone powered at-home ACR test – to at-risk, previously untested patients.
  • This will help engage these patients in their kidney health by conducting a smartphone-powered test at the time and place of their choosing as a step-in screening for earlier identification of CKD.
  • "Minuteful Kidney is a catalyst to increase ACR testing at scale and support early detection of CKD," said Paula LeClair, U.S. General Manager at Healthy.io.
  • Yet most don't know they have the condition until it progresses to end-stage renal disease (ESRD), eventually requiring dialysis and/or a kidney transplant.

Reata Pharmaceuticals, Inc. Announces First Quarter 2023 Financial Results and Provides an Update on Operational Progress and Clinical Development Programs

Retrieved on: 
Wednesday, May 10, 2023

The FDA is reviewing the supplement as a Prior Approval Supplement under Priority Review with an approval target action date in mid-August 2023.

Key Points: 
  • The FDA is reviewing the supplement as a Prior Approval Supplement under Priority Review with an approval target action date in mid-August 2023.
  • As a result of discontinuation of bardoxolone development, we have amended the development and commercialization funding agreement with Blackstone Life Sciences.
  • The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations.
  • These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures.

Aloha: National Nephrology Alliance Expands to Hawaii through Strategic Partnership with Hawaii Kidney Specialists

Retrieved on: 
Monday, April 24, 2023

National Nephrology Alliance (NNA), a management services organization that partners with nephrology practices to enhance practice growth and align practice groups for value-based care, announced today its strategic alliance with Hawaii Kidney Specialists (HKS), the largest nephrology practice in Hawaii.

Key Points: 
  • National Nephrology Alliance (NNA), a management services organization that partners with nephrology practices to enhance practice growth and align practice groups for value-based care, announced today its strategic alliance with Hawaii Kidney Specialists (HKS), the largest nephrology practice in Hawaii.
  • NNA’s partnership with HKS follows NNA’s recent collaboration with Nephrology Associates Medical Group (NAMG), a prominent provider of nephrology care with the largest nephrology clinical practice, serving Riverside and San Bernardino counties in California.
  • “Hawaii Kidney Specialists is a premier nephrology practice that is similarly dedicated to providing superior care to chronic kidney disease (CKD) and end stage renal disease (ESRD) patients,” said Ravin Bisla, National Nephrology Alliance President and Chief Development Officer.
  • “Hawaii experiences some of the highest rates of CKD and ESRD in the nation.

Devyser enters agreement with Thermo Fisher Scientific for commercialization of Devyser's post-transplant NGS products

Retrieved on: 
Monday, April 24, 2023

STOCKHOLM, April 24, 2023 /PRNewswire/ -- Devyser Diagnostics AB (publ) today announced that the company has signed an exclusive collaboration and distribution agreement with Thermo Fisher Scientific.

Key Points: 
  • STOCKHOLM, April 24, 2023 /PRNewswire/ -- Devyser Diagnostics AB (publ) today announced that the company has signed an exclusive collaboration and distribution agreement with Thermo Fisher Scientific.
  • The agreement gives Thermo Fisher exclusive rights to commercialize, under combined brands, Devyser's post-transplant portfolio of NGS products in North America and Europe.
  • "Partnering with Thermo Fisher, the leading innovator in the HLA industry, is a great opportunity for Devyser and a significant milestone for our company.
  • The agreement is also a quality stamp of our company and our products," says Fredrik Alpsten, CEO of Devyser.

Devyser enters agreement with Thermo Fisher Scientific for commercialization of Devyser's post-transplant NGS products

Retrieved on: 
Monday, April 24, 2023

STOCKHOLM, April 24, 2023 /PRNewswire/ -- Devyser Diagnostics AB (publ) today announced that the company has signed an exclusive collaboration and distribution agreement with Thermo Fisher Scientific.

Key Points: 
  • STOCKHOLM, April 24, 2023 /PRNewswire/ -- Devyser Diagnostics AB (publ) today announced that the company has signed an exclusive collaboration and distribution agreement with Thermo Fisher Scientific.
  • The agreement gives Thermo Fisher exclusive rights to commercialize, under combined brands, Devyser's post-transplant portfolio of NGS products in North America and Europe.
  • "Partnering with Thermo Fisher, the leading innovator in the HLA industry, is a great opportunity for Devyser and a significant milestone for our company.
  • The agreement is also a quality stamp of our company and our products," says Fredrik Alpsten, CEO of Devyser.

Humacyte Completes Enrollment in Phase 3 Trial of Human Acellular Vessel™ (HAV™) for Hemodialysis Access in End-Stage Renal Disease Patients

Retrieved on: 
Tuesday, April 11, 2023

The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) as compared to autogenous arteriovenous (AV) fistulas.

Key Points: 
  • The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) as compared to autogenous arteriovenous (AV) fistulas.
  • The Phase 3 trial, labeled V007, is a prospective, multi-center, randomized, comparative study in 240 hemodialysis patients suffering from ESRD in the United States.
  • Enrolled individuals were randomly assigned to either the ​​HAV, or an AV fistula for hemodialysis.
  • The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Outset Medical to Present Research Highlighting Home Hemodialysis Success for Underserved Populations at National Kidney Foundation Spring Clinical Meetings

Retrieved on: 
Wednesday, April 12, 2023

“Kidney disease is debilitating and takes away the freedom of choice for patients,” said Leslie Trigg, Chair and Chief Executive Officer of Outset.

Key Points: 
  • “Kidney disease is debilitating and takes away the freedom of choice for patients,” said Leslie Trigg, Chair and Chief Executive Officer of Outset.
  • This research solidifies that all patients deserve access to options such as home hemodialysis regardless of health disparities and environmental conditions.”
    The research will be presented at the National Kidney Foundation (NKF) Spring Clinical Meetings (SCM23) in Austin, TX, which run from April 11-15.
  • Kidney professionals from around the world will attend this event to learn about new developments in nephrology.
  • The abstracts can be read in their entirety on the Outset Medical clinical evidence page .

Dialysis Patient Citizens Applauds Kentucky Legislation Expanding Medigap Access

Retrieved on: 
Friday, April 7, 2023

WASHINGTON, April 6, 2023 /PRNewswire/ -- Dialysis Patient Citizens (DPC) today applauds the signing of Kentucky bill HB 345, which will ensure access to Medicare Supplement – also called Medigap -- coverage for Kentuckians under 65 living with End-Stage Renal Disease (ESRD) or Amyotrophic Lateral Sclerosis (ALS).

Key Points: 
  • WASHINGTON, April 6, 2023 /PRNewswire/ -- Dialysis Patient Citizens (DPC) today applauds the signing of Kentucky bill HB 345, which will ensure access to Medicare Supplement – also called Medigap -- coverage for Kentuckians under 65 living with End-Stage Renal Disease (ESRD) or Amyotrophic Lateral Sclerosis (ALS).
  • "This legislation is a significant win not only for ESRD and ALS patients across Kentucky, but for their families as well," said Representative Moser.
  • "Kentucky now joins 15 other states that have enacted Medigap access and affordability laws, and 12 others which have an annual open enrollment period for Medigap enrollees to make changes to their coverage," said DPC Board President Andrew Conkling.
  • Previously, Kentucky ESRD patients under 65 did not have access to affordable supplemental "Medigap" coverage to pay the remaining 20 percent.

Dialysis Patient Citizens Celebrates Virginia Legislation Guaranteeing Medigap Access

Retrieved on: 
Friday, March 24, 2023

WASHINGTON, March 24, 2023 /PRNewswire/ -- Dialysis Patient Citizens (DPC) today celebrates Governor Glenn Youngkin's (R) signing of Virginia bills SB 1409 and HB 1640 into law, guaranteeing access to affordable Medigap coverage for thousands of Virginians under 65 living with end-stage renal disease (ESRD).

Key Points: 
  • WASHINGTON, March 24, 2023 /PRNewswire/ -- Dialysis Patient Citizens (DPC) today celebrates Governor Glenn Youngkin's (R) signing of Virginia bills SB 1409 and HB 1640 into law, guaranteeing access to affordable Medigap coverage for thousands of Virginians under 65 living with end-stage renal disease (ESRD).
  • "Today makes an important milestone for every dialysis patient across Virginia," said House Majority Leader Kilgore.
  • Moving forward, no dialysis patient in the Commonwealth will have to worry about paying unaffordable rates for the treatments that keep them alive.
  • The previous law in Virginia did not guarantee ESRD patients under 65 with access to supplemental "Medigap" coverage to pay the remaining 20 percent.

Dialysis Market Global Market Report 2023: Sector to Reach $148.8 Billion by 2028 at a CAGR of 5.1%

Retrieved on: 
Wednesday, March 15, 2023

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.

Key Points: 
  • 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.
  • Furthermore, the shifting patient preferences from kidney transplantation towards dialysis to reduce health complications and improve quality care are positively influencing the global market.
  • What are the key regions in the global dialysis market?
  • 9. Who are the key players/companies in the global dialysis market?