Hemodialysis News
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Stanford Surgeon Venita Chandra Joins Alucent Biomedical Scientific Advisory Board as Company Enters Arteriovenous Fistula Market
Alucent Biomedical, a privately held medical technology company founded to transform the way vascular disease is treated, today announced Venita Chandra, M.D., will join the company’s scientific advisory board. Dr. Chandra is board certified in both general and vascular surgery. She is a clinical associate professor of surgery in the Division of Vascular Surgery at Stanford University ...
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Alnylam Announces FDA Approval of Supplemental New Drug Application for OXLUMO® (lumasiran) in Advanced Primary Hyperoxaluria Type 1
- OXLUMO Now Indicated for the Treatment of Primary Hyperoxaluria Type 1 (PH1) to Lower Urinary and Plasma Oxalate Levels in Pediatric and Adult Patients - - Approval is Based on Positive Efficacy and Safety Results of the ILLUMINATE-C Phase 3 Study of OXLUMO in PH1 Patients with Severe Renal Impairment, Including Those on Hemodialysis - CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 6, 2022-- Alnylam ...
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Quanta Announces CEO Transition
Quanta Dialysis Technologies Inc (“Quanta or “The Company”), a medical technology company committed to making kidney care more accessible with its SC+ hemodialysis system, announced today that CEO John E. Milad will leave the company effective July 15, 2022. The company has begun the search for a new CEO. Upon Milad’s departure and until the appointment of a new CEO, ...
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Aurinia Presents Data Demonstrating LUPKYNIS (voclosporin) is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, presented data demonstrating the efficacy of LUPKYNIS® (voclosporin) for the treatment of people with lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), in achieving the proteinuria ...
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Bluegrass Vascular Announces Featured Paper in the Journal of Vascular Surgery Reporting on the Use of the Surfacer System
Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a paper featured on the cover of the June 2022 issue of the Journal of Vascular Surgery (JVS) which reports on the use the Surfacer System to perform an Inside-Out® procedure to obtain central venous ...
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Cara Therapeutics to Present at Upcoming Investor Conferences
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will present at the following investor conferences: H.C. Wainwright Global Investment Conference Wednesday, May 25, 2022, at 10:30 a.m. ...
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Major Biomedical Catalyst grant win
£1 million grant will support first-in-human clinical trials of H-Guard Invizius Limited ("Invizius"), a biotechnology company developing treatments to suppress unwanted innate immune responses, today announces that it has been awarded a £1 million grant to bring H-Guard, its proprietary priming solution, designed to reduce the life-threatening inflammatory effects of ...
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Bluegrass Vascular Announces New Paper Reporting Use of the Surfacer System via Transcollateral Approach
Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a paper reporting on the use of the Surfacer® System to perform the Inside-Out® procedure via transcollateral approach. “The Surfacer Inside-out system represents a new approach to restore ...
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FDA grants new QIDP Designation Status for BTX 1801
Botanix is pleased to announce that the US Food and Drug Administration (FDA) Office of Antimicrobial Products has granted new Qualified Infectious Disease Product (QIDP) status for our antibacterial product, BTX 1801. This QDIP designation applies to the use of BTX 1901 to potentially ‘reduce the risk of Staph. aureus bloodstream infections in colonised patients dependent on central ...
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Kapruvia® approved by European Commission for the treatment of moderate-to-severe pruritus in hemodialysis patients
First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients First launches in Europe expected in H2 2022 Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Commission has granted marketing authorization to Kapruvia® (difelikefalin) for the ...
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Second grant win to research Peritoneal Dialysis indication
Invizius Limited (“Invizius”), a biotechnology company developing treatments to suppress unwanted immune responses in haemodialysis, today announces that it has been awarded a second Biomedical Catalyst grant (Feasibility & Primer Award) by Innovate UK to research a new field of application for its H-Guard technology. Globally there are 3.5 million patients who are ...
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Cara Therapeutics to Present at the 21st Annual Needham Virtual Healthcare Conference
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on Monday, April 11, 2022, at 1:30 p.m. ET. ...
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Cara Therapeutics Announces Biomarker Data from KALM-1 and KALM-2 Trials of KORSUVA (difelikefalin) Injection Selected for Presentation at National Kidney Foundation Spring Clinical Meetings 2022
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced biomarker data from the KALM-1 and KALM-2 clinical trials evaluating KORSUVA™ (difelikefalin) injection for the treatment of chronic kidney disease-associated pruritus in patients undergoing ...
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Home Dialysis Patients Face Postcode Lottery of Care, New Report Finds
QUANTA Dialysis Technologies Ltd (“QUANTA” or the “Company”), a medical technology company committed to making kidney care more accessible with its SC+ haemodialysis system, has released a new report that suggests people with kidney failure who wish to do home dialysis face unequal access across the UK. The Bridging the Gap report finds that failure to offer such treatment ...
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Cara Therapeutics Announces Oral KORSUVA (difelikefalin) Improves Itch and Inflammatory Biomarkers in Atopic Dermatitis Patients with Moderate-To-Severe Pruritus
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced data from a sub-study of the KARE Phase 2 clinical trial demonstrated Oral KORSUVA™ (difelikefalin) improved itch and inflammatory biomarkers in atopic dermatitis (AD) patients with ...
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Vertex Advances VX-147 Into Pivotal Clinical Development for People With APOL1-Mediated Kidney Disease
Single pivotal trial to initiate later this month targets the broad patient population with two APOL1 mutations and proteinuric kidney disease Pathway for accelerated approval using an interim analysis at Week 48 of eGFR slope, supported by reduction in proteinuria Final analysis evaluating eGFR slope at approximately two years serves as basis for U.S. approval Vertex Pharmaceuticals ...
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FDA clears Sonavex’s ultrasound blood flow monitor
Sonavex scored FDA clearance for its technology that uses ultrasound imaging and deep learning to deliver blood flow data on demand. The EchoSure system is cleared for use with the company’s EchoMark bioresorbable tissue markers, which got the agency’s nod in June. “The key goal is to be able to detect the problems associated with microvascular and vascular surgeries with ...
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Cara Therapeutics Announces Oral KORSUVA (difelikefalin) Data Selected for Late-Breaking Presentation at 2022 American Academy of Dermatology Annual Meeting
Oral presentation will include biomarker data from KARE Phase 2 clinical trial of Oral KORSUVA™ (difelikefalin) for the treatment of moderate-to-severe pruritus in atopic dermatitis patients Oral KORSUVA (difelikefalin) Phase 3 pruritus programs in non-dialysis dependent advanced chronic kidney disease and atopic dermatitis, respectively, to be discussed during Company’s virtual ...
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Cara Therapeutics to Present at May Investor Conferences
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will present at the following investor conferences in May: BofA Securities 2022 Healthcare Conference Tuesday, May 10, 2022, at 2 p.m. ...
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Bluegrass Vascular Closes $5 Million Convertible Debt Financing
Privately held Bluegrass Vascular Technologies, a leading innovator and global manufacturer of lifesaving devices and methods based on the Inside-Out® vascular access procedure, today announced the closing of a $5.0 million financing in convertible promissory notes to a group of qualified investors, including new investors and existing shareholders who participated in previous capital raises. ...
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