BRISBANE: ImpediMed Limited announced a second contract valued at over $2.0 million for its SOZO Digital Health Platform to be used in a clinical trial being conducted for AstraZeneca, a global pharmaceutical company.
The Phase II trial will use the SOZO devices to track patient fluid volume in an upcoming pharmaceutical study focused on chronic kidney disease. The study, which is scheduled to begin in January 2021 and run for approximately 18 months, will require approximately 200 additional devices globally.
The company previously announced in September 2020 that AstraZeneca will use SOZO to track patient fluid volume in a clinical trial focused on heart failure and chronic kidney disease. A combined 375 SOZO devices will now be leased across 31 countries for the two trials. Together, the trials are expected to generate in excess of $4.5 million in revenue.
“AstraZeneca’s selection of SOZO for a second clinical trial that is focused on patients with chronic kidney disease provides important validation for our technology and directly aligns with one of our three strategic focus areas,” commented Richard Carreon, Managing Director and CEO of ImpediMed.
“There are millions of people today living with chronic kidney disease, and we look forward to learning more about the impact this trial will have on improving patient care,” he continued.
The AstraZeneca study using SOZO will evaluate the efficacy, safety, and tolerability of a combination of two AstraZeneca drugs in patients with chronic kidney disease.
This Phase II trial is scheduled to begin in January 2021. The trial is being run by a contract research organisation, on behalf of AstraZeneca.
Under the terms of the agreement, and in alignment with the Company’s SaaS business model, each device will have a monthly license fee for the duration of the study. ImpediMed will retain ownership of the devices at the conclusion of the trials.
SOZO is CE-Marked for renal failure. Nearly 750,000 patients per year in the U.S. and an estimated 2 million patients worldwide are affected by end-stage renal disease (ESRD). Those who live with ESRD are 1% of the U.S. Medicare population but account for 7% of the Medicare budget, or approximately US$35 billion.