Kidney failure

ProKidney Announces Publication of Trial Design for Phase 2 Multicenter Clinical Trial of REACT for Late Stage 4 Diabetes-Related Chronic Kidney Disease

Retrieved on: 
Tuesday, January 10, 2023

WINSTON-SALEM, N.C., Jan. 10, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced the publication of the trial design and early data analysis from REGEN-003, a Phase 2 clinical study of Renal Autologous Cell Therapy (REACT®), in the Journal of Blood Purification. The paper, titled Renal Autologous Cell Therapy (REACT) in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis, was published online and will appear later this year in the print edition of the Journal (DOI: doi.org/10.1159/000527582).

Key Points: 
  • The paper, titled Renal Autologous Cell Therapy (REACT) in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis, was published online and will appear later this year in the print edition of the Journal (DOI: doi.org/10.1159/000527582 ).
  • “This is a high-risk patient population with seriously reduced kidney function.
  • At 15 months, two patients (20%) had preservation of their kidney function and had not advanced to renal replacement therapy.
  • We believe that REACT has the potential to have a significant, positive impact on patients’ health and quality of life.

National Kidney Foundation Journal Changes Name to Advances in Kidney Disease and Health

Retrieved on: 
Monday, January 9, 2023

NEW YORK, Jan. 9, 2023 /PRNewswire/ -- The National Kidney Foundation (NKF) is excited to announce a new name for its bimonthly journal, Advances in Kidney Disease and Health (AKDH).

Key Points: 
  • NEW YORK, Jan. 9, 2023 /PRNewswire/ -- The National Kidney Foundation (NKF) is excited to announce a new name for its bimonthly journal, Advances in Kidney Disease and Health (AKDH).
  • Formerly known as Advances in Chronic Kidney Disease, the previous title fit the focus of the journal at that time and included topics related to chronic kidney disease (CKD) or kidney failure.
  • The vision & mission of this journal is to offer practical tools and knowledge to improve the health of kidney patients.
  • For more information about kidney disease and to learn more about NKF's bimonthly journal, go to AKDH .

SoniVie Raises $60m in Round C Financing, and Appoints New Board Members

Retrieved on: 
Monday, January 9, 2023

TEL AVIV, Israel, Jan. 9, 2023 /PRNewswire/ -- SoniVie Ltd. ("SoniVie" or the "Company"), a medical device company developing a proprietary solution to treat hypertension, announced today the completion of a $60 million series C round financing. The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds. Current SoniVie shareholder TechWald also participated.

Key Points: 
  • In conjunction with the financing, the Company appointed two renowned medtech experts to its Board of Directors, Raymond W. Cohen and Zeev Zehavi, as independent directors.
  • The proceeds from SoniVie financing are envisioned to be used to reach clinical and regulatory milestones and to support TIVUS™ renal artery denervation program.
  • Raphaël Wisniewski of Andera Partners commented, "SoniVie TIVUS™ has the potential to provide patients and physicians with a safe, efficient and easy to use device.
  • We are thrilled to support this talented management together with our syndicate partners and our new board members".

SoniVie Raises $60m in Round C Financing, and Appoints New Board Members

Retrieved on: 
Monday, January 9, 2023

TEL AVIV, Israel, Jan. 9, 2023 /PRNewswire/ -- SoniVie Ltd. ("SoniVie" or the "Company"), a medical device company developing a proprietary solution to treat hypertension, announced today the completion of a $60 million series C round financing. The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds. Current SoniVie shareholder TechWald also participated.

Key Points: 
  • In conjunction with the financing, the Company appointed two renowned medtech experts to its Board of Directors, Raymond W. Cohen and Zeev Zehavi, as independent directors.
  • The proceeds from SoniVie financing are envisioned to be used to reach clinical and regulatory milestones and to support TIVUS™ renal artery denervation program.
  • Raphaël Wisniewski of Andera Partners commented, "SoniVie TIVUS™ has the potential to provide patients and physicians with a safe, efficient and easy to use device.
  • We are thrilled to support this talented management together with our syndicate partners and our new board members".

EQS-News: Andera Partners invests in SoniVie, a medtech company developing a promising device for the treatment of hypertension

Retrieved on: 
Sunday, January 22, 2023

TEL AVIV, ISRAEL, AND PARIS, FRANCE, JANUARY 10, 2023 -- SoniVie Ltd. ("SoniVie" or the "Company"), a medical device company developing a proprietary solution to treat hypertension, announced today the completion of a $60 million series C round financing. The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds. Current SoniVie shareholder TechWald also participated.

Key Points: 
  • Andera Partners invests in SoniVie, a medtech company developing a promising device for the treatment of hypertension
    The issuer is solely responsible for the content of this announcement.
  • The financing was led by Andera Partners, with participation from Supernova Invest and Omega Funds.
  • Raphaël Wisniewski of Andera Partners commented, "SoniVie TIVUS™ has the potential to provide patients and physicians with a safe, efficient and easy to use device.
  • We are thrilled to support this talented management together with our syndicate partners and our new board members".

liberDi Receives FDA Regulatory Clearance for its Digital Dialysis System

Retrieved on: 
Wednesday, January 4, 2023

MISGAV, Israel, Jan. 4, 2023 /PRNewswire/ -- liberDi Ltd., a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced today that it has received regulatory clearance from the United States Food and Drug Administration (FDA) for its Digital Dialysis Clinic, which allows patients to perform dialysis at home or at the workplace, by themselves, monitored by their physician using the advanced telemedicine capabilities of the system. 

Key Points: 
  • liberDi CEO, Hezkiah Tsoory remarked, "Receiving FDA clearance for our state of the art Digital Dialysis Clinic technology, is a huge achievement for liberDi.
  • liberDi frees people from spending half of their lives in dialysis centers, which is a disruptive technology in the dialysis market."
  • liberDi conducted two initial clinical studies to demonstrate the safety and effectiveness of the Portable Peritoneal Dialysis system on patients requiring dialysis.
  • liberDi provides mobility and freedom to people on dialysis, allowing them to continue with their normal private and professional activities while on dialysis.

Hansa Biopharma announces positive reimbursement decision for Idefirix® (imlifidase) in the Czech Republic

Retrieved on: 
Monday, January 2, 2023

"We are very pleased to see that Idefirix® is now reimbursed in the Czech Republic for the treatment of highly sensitized kidney patients.

Key Points: 
  • "We are very pleased to see that Idefirix® is now reimbursed in the Czech Republic for the treatment of highly sensitized kidney patients.
  • These patients have a serious disease burden and unmet needs and this decision is a significant milestone for them", says Søren Tulstrup, President and CEO, Hansa Biopharma.
  • "For Hansa, this decision is well aligned with  our vision: A world where patients with rare immunologic diseases can lead long and healthy lives."
  • Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S.

U.S. FDA Approves Clinical Trial Application for IASO Bio's BCMA CAR-T CT103A for Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Thursday, December 22, 2022

Multiple myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures.

Key Points: 
  • Multiple myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures.
  • In February 2022, CT103A was granted the "orphan drug designation (ODD)" by the FDA for the treatment of multiple myeloma.
  • In June 2022, CT103A was accepted by the NMPA for the NDA application for the treatment of relapsed/refractory multiple myeloma and included in the priority review.
  • The NMPA accepted the New Drug Application for equecabtagene autoleucel for the treatment of relapsed/refractory multiple myeloma (R/R MM).

MediGO is Latest Recipient of National Kidney Foundation Innovation Fund Investment

Retrieved on: 
Tuesday, December 20, 2022

NEW YORK, Dec. 20, 2022 /PRNewswire/ -- The National Kidney Foundation (NKF) Innovation Fund, the philanthropic impact investment program of NKF, has made its latest investment in MediGO Inc., a first-of-its-kind healthcare supply chain technology company focused on improving equity, access, and transparency in the organ donation and transplant industry. MediGO is digitally transforming kidney donation and transplant operations to increase access to lifesaving organs and tissue. NKF funding will assist MediGO in the development, implementation, and overhaul of the kidney transplantation supply chain through advances in technology.

Key Points: 
  • NEW YORK, Dec. 20, 2022 /PRNewswire/ -- The National Kidney Foundation (NKF) Innovation Fund , the philanthropic impact investment program of NKF, has made its latest investment in MediGO Inc. , a first-of-its-kind healthcare supply chain technology company focused on improving equity, access, and transparency in the organ donation and transplant industry.
  • We launched the NKF Innovation Fund because the kidney care landscape in this country is fundamentally broken.
  • "We launched the NKF Innovation Fund because the kidney care landscape in this country is fundamentally broken," he added.
  • The National Kidney Foundation (NKF ) is the largest, most comprehensive
    and longstanding patient-centric organization dedicated to the awareness, prevention

American Kidney Fund Thanks Amgen for its Champion Level 2022 Corporate Membership

Retrieved on: 
Tuesday, December 13, 2022

ROCKVILLE, Md., Dec. 13, 2022 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) today expressed its appreciation for Amgen’s participation in the 2022 class of its Corporate Membership Program as a Champion-level member.

Key Points: 
  • ROCKVILLE, Md., Dec. 13, 2022 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) today expressed its appreciation for Amgen’s participation in the 2022 class of its Corporate Membership Program as a Champion-level member.
  • “We are very grateful that Amgen has continued to be a Champion-level member in the AKF Corporate Membership Program,” said LaVarne A. Burton, AKF President and CEO.
  • Amgen’s membership also supports AKF’s programs for kidney health care professionals, such as AKF’s dietitian roundtable discussions about navigating healthy eating for kidney disease patients.
  • The American Kidney Fund (AKF) fights kidney disease on all fronts as the nation’s leading kidney nonprofit.