- ImpediMed (IPD) has welcomed a second contract extension and expansion of its SOZO Digital Health Platform for use in clinical trials being conducted for AstraZeneca
- The phase two trial will use the SOZO devices to track patient fluid volume in an upcoming pharmaceutical study focused on chronic kidney disease
- The total contracts are expected to generate over $5.5 million in revenue across the trials
- The company says the endorsement is timely as it begins enrolment for its renal failure trial and progresses towards an FDA clearance
- ImpediMed is up 1.72 per cent, trading at 14.8 cents at 12:40 pm AEDT
ImpediMed (IPD) has announced a second contract extension and expansion of its SOZO Digital Health Platform for use in clinical trials being conducted for AstraZeneca.
The phase two trial will use the SOZO devices to track patient fluid volume in an upcoming pharmaceutical study focused on chronic kidney disease.
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.
The study has been extended from 18 months to 21 months, with the number of SOZO devices increased from 200 to 223.
Richard Carreon, Managing Director and CEO of ImpediMed, said the feedback to date 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.”
“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 total contracts are expected to generate over $5.5 million in revenue across the trials – $3.5 million of which was recognised in revenue under these contracts through December 31, 2021.
The remainder of the revenue will be recognised throughout the second half of FY22 and first half of FY23.
Under the terms of the agreement, 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
The company said the endorsement is timely, as the company starts enrolment for its renal failure trial and progresses towards an FDA clearance in Renal through the Breakthrough Device Designation Program.
ImpediMed was up 1.72 per cent, trading at 14.8 cents at 12:40 pm AEDT.