Carlsbad, CA /PRNewswire/ - ImpediMed Limited (ASX: IPD) today announced the details of the third contract extension related to the use of its SOZO® Digital Health Platform in a clinical trial being conducted for AstraZeneca. The Phase IIb trial uses SOZO to track patient fluid volume in a pharmaceutical study focused on patients with chronic kidney disease. The trial, involving 210 SOZO devices, has been extended from 21 months to 29 months.
The Phase IIb trial is designed to evaluate the efficacy, safety and tolerability of a combination of two AstraZeneca drugs in patients with chronic kidney disease. This Phase IIb trial began in November 2020 and the use of SOZO within the trial is now scheduled to be completed in April 2023. The trial is being run by a contract research organization on behalf of AstraZeneca.
The Company previously announced AstraZeneca is using SOZO to track patient fluid volume in two separate clinical trials. A combined 434 SOZO devices have been leased across over 28 countries over the course of both trials. The first trial was focused on heart failure and chronic kidney disease and the second only on chronic kidney disease. The use of SOZO in the initial trial is now complete.
About SOZO Digital Health Platform
SOZO, the world's most advanced, noninvasive bioimpedance spectroscopy (BIS) device, delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds. Using ImpediMed's BIS technology, SOZO measures 256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz. Results are available immediately online for easy data access and sharing across an entire healthcare system. The FDA-cleared, CE-marked and ARTG-listed digital health platform aids in the early detection of secondary lymphedema, provides fluid status for patients living with heart failure, and can be used to monitor and maintain overall health – all on a single platform.
For more information, visit https://www.impedimed.com/products/sozo/
Founded and headquartered in Brisbane, Australia with US and European operations, ImpediMed is a medical software technology company that non-invasively measures, monitors, and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS). ImpediMed produces a family of FDA cleared and CE Marked medical devices, including the SOZO® Digital Health Platform for multiple indications including heart failure, protein calorie malnutrition and lymphedema, sold in select markets globally.
For more information, visit https://www.impedimed.com