Shares of Angion Biomedica Corp. tumbled more than 50% Oct. 27 on disappointing top-line data from its phase III study testing ANG-3777’s ability to improve organ function in patients receiving deceased donor kidney transplants. The company’s management, however, remained cautiously optimistic that the safety results and signals of biological activity could bode well for an exploratory phase II study testing the drug in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass, which is expected to read out later this quarter.
DUBLIN – With more than six months to go before an initial interim readout from its phase III pivotal trial of ilofotase alfa (recombinant human alkaline phosphatase) in sepsis-associated acute kidney injury (SA-AKI), AM-Pharma BV has already found a buyer for Japanese rights to the product. Kyowa Kirin Co. Ltd. is paying €20 million up front and could pay up to €225 million more in milestones attached to the progress of the program.
LONDON – The message that COVID-19 is a disease of the elderly needs to change, according to U.K. researchers who have analyzed complications suffered by 73,197 patients admitted to 302 hospitals in the first wave of the pandemic last year.
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.
Data from a newly published case series underscores the effectiveness of Cytosorbents Corp.’s blood purification technology in treating critically ill COVID-19 patients.
The U.S. FDA has granted emergency use authorizations (EUAs) to Baxter International Inc. for its HF20 Set and ST Set used in continuous renal replacement therapy (CRRT) during the COVID-19 pandemic. The two sets are intended for use with the company’s Prismaflex or Prismax CRRT monitors.
PERTH, Australia – Osprey Medical Inc. signed a deal with GE Healthcare that will see the company expand its global footprint for its Dyevert contrast minimization devices across Europe, Russia, the Middle East, Africa, Central Asia and Turkey. GE Healthcare will be the exclusive distributor in those markets, allowing Osprey to grow its commercial presence beyond the U.S. and Australia.
Machine learning-based diagnostics startup Dascena Inc. has won the U.S. FDA’s breakthrough device designation for its Previse algorithm, which is designed to predict acute kidney injury (AKI) before clinical symptoms. In early validation tests, Previse detected AKI more than a day before patients exhibited kidney damage or impaired function.
LONDON – AM-Pharma BV raised a further $52 million for the phase III trial of its recombinant alkaline phosphatase product, Recap, in treating sepsis-associated acute kidney injury (AKI), but now faces a delay in starting the study, as the COVID-19 crisis takes up more and more clinical resources.
HONG KONG – Yokneam, Israel-based Serenno Medical Ltd. has unveiled a device for automatic monitoring and detection of kidney damage in patients. Known as Sentinel, the device is a continuous urine output (UO) monitor that measures urine flow rate and volume in real time.
