Dialysis

Data Supportive of KidneyIntelX Utility in Minorities and Veterans to Be Presented at the National Kidney Foundation Spring Clinical Meeting

Retrieved on: 
Wednesday, April 12, 2023

LONDON and SALT LAKE CITY, April 12, 2023 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced that two scientific presentations have been accepted at the upcoming National Kidney Foundation Spring Clinicals Conference taking place in Austin, Texas (April 11-15). The studies entitled the “Impact of KidneyIntelX testing on novel medication prescription in a diverse patient population” and “Diabetic kidney disease epidemiology in US veterans” show the importance of using KidneyIntelX bioprognosis in early stage kidney disease and diabetes patients to blunt the effects of health inequity, help guide proper drug prescription to patients in need, and support established clinical guidelines to slow or stop unnecessary progression to late stage kidney disease, kidney failure and dialysis.

Key Points: 
  • The webinar is now on-demand and available on www.kidneyintelx.com or via this link .
  • National Kidney Foundation Clinical Spring Conference Data Presentations Include:
    KidneyIntelX was recently introduced into the Wake Forest-Atrium Health System to predict progressive decline in kidney function.
  • The KidneyIntelX risk score identified those patients at highest risk which resulted in appropriately selecting SGLT2-inhibitors for the right patients.
  • The data will be showcased from April 12-14 in the Poster Hall at the Austin Convention Center and the abstract is now online at the NKF website.

Calliditas Announces Publication of Cost-Effectiveness Analysis of Nefecon versus Best Supportive Care for People with IgA Nephropathy in the United States

Retrieved on: 
Tuesday, April 11, 2023

NEW YORK, April 11, 2023 (GLOBE NEWSWIRE) -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), announced the publication of a cost-effective analysis of Nefecon (marketed in the United States as TARPEYO® (budesonide) delayed release capsules) versus standard of care (SOC) for people with Primary IgA Nephropathy (IgAN) in the United States (US).

Key Points: 
  • NEW YORK, April 11, 2023 (GLOBE NEWSWIRE) -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), announced the publication of a cost-effective analysis of Nefecon (marketed in the United States as TARPEYO® (budesonide) delayed release capsules) versus standard of care (SOC) for people with Primary IgA Nephropathy (IgAN) in the United States (US).
  • Health-state occupancy probabilities and key model inputs were based on the individual patient-level data from NefIgArd, the Phase 3 randomized controlled trial evaluating Nefecon.
  • Andrew Udell, president, North America at Calliditas stated: “These findings are timely and relevant in light of the 2-year eGFR results from the NefIgArd trial we recently announced.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

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.

GeoVax Announces Presentation of Preliminary Data from Clinical Trial of Next-Generation COVID-19 Vaccine Candidate

Retrieved on: 
Thursday, April 6, 2023

Atlanta, GA, April 06, 2023 (GLOBE NEWSWIRE) --  via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, presented an update on the development of its SARS-CoV-2 vaccine, GEO-CM04S1, including preliminary data from an ongoing Phase 2 clinical trial, during the 23rd Annual World Vaccine Congress taking place in Washington, DC.

Key Points: 
  • CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose.
  • These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines.
  • Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.
  • GeoVax is focusing on the clinical development of this vaccine for use in patients with special medical limitations or needs, specifically the immunocompromised populations.

Disc Medicine Reports Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Friday, March 31, 2023

In August 2022, Disc initiated BEACON, an open-label Phase 2 clinical study of bitopertin in patients with EPP and X-linked protoporphyria (XLP).

Key Points: 
  • In August 2022, Disc initiated BEACON, an open-label Phase 2 clinical study of bitopertin in patients with EPP and X-linked protoporphyria (XLP).
  • In October 2022, Disc initiated AURORA, a Phase 2 randomized, placebo-controlled clinical study of bitopertin in adults with EPP.
  • Disc completed a reverse merger with Gemini Therapeutics in December 2022, which resulted in Disc becoming publicly listed on NASDAQ, and raised approximately $90 million in operating capital.
  • Full Year 2022 Financial Results:
    Cash Position: Cash and cash equivalents were $194.6 million as of December 31, 2022 compared to $88.0 million as of December 31, 2021.

Applied UV – PURONet UV Air and Surface Disinfection System to be Installed at Leading Medical School - University of Texas San Antonio

Retrieved on: 
Thursday, April 13, 2023

The Company’s PURONet UV Disinfection Control System + PURO Protect System (Far UV-C 222) is scheduled to be installed in 16 operating rooms at the University of Texas, San Antonio hospital.

Key Points: 
  • The Company’s PURONet UV Disinfection Control System + PURO Protect System (Far UV-C 222) is scheduled to be installed in 16 operating rooms at the University of Texas, San Antonio hospital.
  • With years of research and development, the installation of the PURONet UV Disinfection Control System PURO Protect at University of Texas, San Antonio, further validates the clinically proven effectiveness in eliminating dangerous pathogens from hospital operating rooms where the highest quality of air and cleanliness of surfaces is paramount.
  • Hospitals currently utilizing the PURONet system include Massachusetts General Hospital, University of Chicago Medicine, Children’s Mercy - Kansas City, and now UT San Antonio.
  • Additionally, according to CDC, losses due to HAI’s have exceeded $28 billion, with losses due to absenteeism of $225 billion, and $25 billion in student/teacher absenteeism.

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 .

Outset Medical to Report First Quarter 2023 Financial Results on Wednesday, May 3, 2023

Retrieved on: 
Wednesday, April 12, 2023

Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced that it will release financial results for the first quarter of 2023 after the close of trading on Wednesday, May 3, 2023.

Key Points: 
  • Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced that it will release financial results for the first quarter of 2023 after the close of trading on Wednesday, May 3, 2023.
  • On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Leslie Trigg, Chief Executive Officer, and Nabeel Ahmed, Chief Financial Officer, will host a conference call to discuss financial and operating results.
  • The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Wednesday, May 3, 2023.
  • A live and archived webcast of the event will be available on the “Investors” section of the Outset website at https://investors.outsetmedical.com/ .

Genexine’s Long-acting Anemia Treatment GX-E4 Phase 3 Clinical Trial Interim Result Is Presented at WCN2023, Confirmed Non-inferiority Compared to Mircera

Retrieved on: 
Tuesday, April 11, 2023

Its non-inferiority results compared to Mircera (Methoxy Polyethylene Glycol-epoetin beta) were presented at the World Congress of Nephrology (WCN2023).

Key Points: 
  • Its non-inferiority results compared to Mircera (Methoxy Polyethylene Glycol-epoetin beta) were presented at the World Congress of Nephrology (WCN2023).
  • Kidneys are responsible for 90% of the EPO produced in our bodies.
  • CKD-induced anemia is caused by the failure to produce EPO (erythropoietin) due to long-term decreased kidney function.
  • It is aimed to confirm non-inferiority by administering and comparing with Roche's Mircera, a third-generation long-acting anemia treatment.

Rockwell Medical to Exhibit at the National Kidney Foundation SCM23

Retrieved on: 
Tuesday, April 11, 2023

Rockwell's hemodialysis concentrates portfolio includes:

Key Points: 
  • Rockwell's hemodialysis concentrates portfolio includes:
    CitraPure® Citric Acid Concentrate — Rockwell Medical's CitraPure Concentrate is citric acid-based and 100% acetate-free.
  • CitraPure is packaged as a liquid and as a dry powder acid concentrate for use with Rockwell Medical's Dry Acid Concentrate Mixer.
  • Dri-Sate® Dry Acid Concentrate — Rockwell Medical's Dri-Sate Concentrate is the Company's acetic acid-based product.
  • Dry Acid Concentrate Mixer — Rockwell Medical's Dry Acid Concentrate Mixer is designed for the Company's CitraPure and Dri-Sate Dry Acid products and enables the clinic to mix acid concentrate on-site.