ImpediMed Limited (ASX.IPD), today announced the second contract extension and expansion of its SOZO Digital Health Platform used in clinical trials being conducted for AstraZeneca. 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 has been extended from 18 months to 21 months and the number of SOZO devices increased from 200 to 223.
In total, the contracts are expected to generate over $5.5 million in revenue across the trials. The Company recognised approximately $3.5 million in revenue under these contracts through 31 December 2021. The remainder of the revenue will be recognised throughout the second half of FY’22 and first half of FY’23.
The Company previously announced AstraZeneca is using SOZO to track patient fluid volume in two separate clinical trials. The first is focused on heart failure and chronic kidney disease and the second only on chronic kidney disease. A combined 434 SOZO devices have been leased across over 28 countries for both trials.
The Company anticipates a range of 250-350 SOZO devices will remain under active contracts over the balance of the trials, as sites begin to complete their portion of testing.
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 began in January 2021 and is now scheduled to be completed in August 2022. 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. The contract does not contain any material termination
provisions.
“To date, the feedback on SOZO has been very positive. The trial is providing a significant number of cardiologists and nephrologists, both in the US and globally, firsthand experience with SOZO, “commented Richard Carreon, Managing Director and CEO of ImpediMed. “Heart failure and chronic kidney disease are two of our three strategic focus areas, and this contract addition provides continued validation of the applicability of our technology in both patient populations.
The endorsement is timely, as the Company starts enrollment for its renal failure trial and progresses towards an FDA clearance in Renal through the Breakthrough Device Designation Program,” he added.
Approved for release by the Managing Director and CEO, Mr Richard Carreon.
