Berlin – Fresenius SE & Co. KGaA reported that its global division, Fresenius Medical Care, and its Frenova Renal Research division have enrolled the first subjects in its new initiative to develop the largest genomic registry in the world to focus on kidney disease. At the same time, the German firm also announced that Ali Gharavi, chief of the division of nephrology at Columbia University Irving Medical Center, will lead the project and provide scientific guidance as principal investigator.
PERTH, Australia – About seven years ago, Australia’s George Institute for Global Health conducted a study to find out how many people require dialysis for end-stage kidney failure compared to how many people receive treatment.
Patensee Ltd. initiated a first-in-human trial of its machine vision-based surveillance system for stenosis in hemodialysis patients. The trial will evaluate the imaging system's ability to perform contact-free surveillance of the access points or fistulas essential for dialysis, which nearly all narrow or become blocked over time. The surveillance system aims to mimic the central components of a dialysis nurse's exam using technology.
Diagnostics innovator Renalytix AI plc and dialysis giant Davita Inc. partnered to develop a program to identify individuals with early-stage kidney disease and improve outcomes for the 37 million Americans with chronic kidney disease (CKD). The companies plan to launch the collaborative effort in three cities in 2021 to build a diverse, real-world evidence dataset as a base for moving forward.
Critically ill infants in need of continuous renal replacement therapy (CRRT) are often treated using machines intended for adults, leading to a number of challenges and a high risk of complications and death. Now, Medtronic plc has launched a pediatric and neonatal acute dialysis machine in the U.S. that is specifically designed for patients weighing between 2.5 and 10 kilograms. The Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine, the first of its kind in the U.S., received U.S. FDA clearance in April via the de novo pathway and is classified as a class II device.
PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.
Medtronic plc has unveiled its latest buy this year with the planned acquisition of Avenu Medical Inc., which focuses on the endovascular creation of arteriovenous (AV) fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis. The two did not disclose the terms of the transaction.
Outset Medical Inc. closed its Nasdaq IPO Thursday with gross proceeds of approximately of $277.9 million. The IPO, which launched Tuesday, included nearly 10.3 million shares of common stock at $27 per share and the full exercise of underwriters’ option to purchase more than 1.3 million additional shares. Shares of the San Jose, Calif.-based company’s stock, which is trading under the ticker OM, soared to more than $60 on the first day of trading amid enthusiasm for its portable dialysis machine.
Baxter International Inc. has scored a win from the U.S. FDA, which has granted the de novo application for Theranova, the company’s novel dialysis membrane. For his part, Cowen’s Josh Jennings noted that de novo designations are rare in the dialysis space, echoing a company statement. “We think the de novo classification strengthens any argument for the uniqueness of the technology, which should help its commercial experience,” he added. “BAX had expected an FDA clearance in [second half of] '20, so this action falls on the early end of that range.”
PERTH, Australia – With 1 in 3 patients with type 2 diabetes likely to develop diabetic kidney disease (DKD), Perth-based Proteomics International Laboratories Ltd. has developed a blood-based diagnostic test that can predict the onset of DKD, enabling patients to get treatment sooner to prevent the onset of the disease.