Medical technology company ImpediMed (ASX: IPD) unveiled a timely contract valued at over $2 million for its SOZO digital health platform, which paves the way for it to be used in a clinical trial by global biopharmaceutical giant AstraZeneca.
The company said around 175 of its SOZO devices will be used in a phase II trial to track patient fluid volume focused on heart failure and chronic kidney disease. The study is set to commence in November and expected to run for approximately 18 months.
ImpediMed’s SOZO platform has been certified in the by the Food and Drug Administration in the US for heart failure, as well as being CE-Marked for heart failure and renal failure in Europe.
The company’s bioimpedance spectroscopy (BIS) devices noninvasively measure a patient’s total body water and extracellular and intracellular fluid volumes to aid in the assessment and interventions for chronic diseases.
According to ImpediMed, SOZO is the world’s most advanced, non-invasive BIS device that gives healthcare professionals a precise snapshot of fluid status and tissue composition “in less than 30 seconds”.
The AstraZeneca study will evaluate the efficacy, safety, and tolerability of a combination of two AstraZeneca drugs in heart failure patients with chronic kidney disease. To complete the study, the biopharma giant selected SOZO as its preferred equipment supplier.
Under the terms of the agreement, each device will have a monthly licence fee for the duration of the study with ImpediMed retaining ownership of the devices after the trials.
“AstraZeneca has used ImpediMed’s BIS technology for a number of years to measure subjects’ fluid volumes in their clinical studies,” said Dennis Schlaht, senior vice president of ImpediMed.
“With SOZO, they will be able to achieve the fluid measurement accuracy of gold standard dilution methods in a test that takes 30 seconds instead of up to 24 hours. Add in the fact that it offers real-time data review globally, and it’s clear why the SOZO Digital Health Platform was chosen for this new research,” Mr Schlaht added.
ImpediMed cardiology launch
As part of its overarching plan to insert its products into the cardiology market, ImpediMed said the upcoming trial will provide a significant number of cardiologists, both in the US and globally, firsthand experience with its devices and coincides with its launch into the cardiology market.
The latest research shows that cardiovascular disease is the leading cause of death among patients with kidney disease.
Moreover, researchers discovered that among hospitalisations for primary heart failure, chronic kidney disease was a comorbid diagnosis 47% of the time.
“Heart failure and chronic kidney disease are two of our three strategic focus areas, and this agreement provides further validation of the applicability of our technology in both patient populations. This endorsement of our technology is timely as the Company begins the launch of SOZO into the cardiology market,” ImpediMed managing director and chief executive officer Richard Carreon said.