Astrazeneca strikes deal with Impedimed for Sozo platform in heart failure, kidney disease trial
Impedimed bioimpedance spectroscopy device. Credit: Impedimed Ltd.
October 6, 2020
By Tamra Sami
PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.
That news is a major win for the Brisbane, Australia, and Carlsbad, Calif.-based company that noninvasively measures, monitors and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS).
“This means the technology is not only accepted by the surgical community but by the pharma community,” Impedimed CEO Rick Carreon told BioWorld.
“To bring the average drug to market is a $2.5 billion to $3 billion spend, and they’re not going to waste their dollars on technology that doesn’t work, because they have a lot of money riding on this.”
Rick Carreon, CEO of Impedimed
“Astrazeneca has been a customer of ours for more than a decade,” Carreon said. “We make devices not only for medical, which is lymphedema, heart failure, renal failure and malnutrition, but we also have a scientific device, which has been the gold standard since it was first introduced in the early 2000s. The amount of information it provides is enormous.”
The company produced a new method to measure fluid in the body that took just 30 minutes, changing the standard of care from a 24-hour test to a 30-minute test.
“Astrazeneca was an early adopter in the 2000s, and they’ve been using it ever since. Our new device gives you that new information, not in 30 minutes but in 30 seconds, and it is a connective platform.”
“The 30-second test is faster, more accurate, and it’s globally connected so that wherever the patient takes the test, all of that data is centrally located so you can look at this data in real time.”
That connectiveness was important for Cambridge, U.K.-based Astrazeneca, which is going to be running its trial in 20 countries with thousands of patients. Impedimed’s technology can detect fluid shifts as small as two-and-a-half tablespoons throughout the human body.
$2M in revenue for Impedimed
The Astrazeneca study using the Sozo platform will evaluate the efficacy, safety, and tolerability of a combination of two Astrazeneca drugs in heart failure patients with chronic kidney disease. The phase II trial is scheduled to begin in November 2020 and will run for about 18 months. It is expected to generate more than $2 million in revenue for Impedimed.
Under the terms of the agreement, each device will have a monthly license fee for the duration of the study, and Impedimed will retain ownership of the devices when the trials conclude.
Over the last three years, Impedimed has completely changed its business model and moved to a software as a service model (SAAS). It charges a monthly fee to lease the devices depending on the software used. As a SAAS model, the data goes to the cloud and then the results of the data are sent to customers.
The company recently released a new software package for the Sozo platform that adds functionality for new applications in heart failure and end-stage renal disease patients while building on its current use as the only rapid, noninvasive FDA-cleared tool to aid in the assessment of subclinical lymphedema.
The software package includes the separately licensed HF-Dex heart failure assessment, a monitoring tool for the assessment of fluid overload in HF patients for risk stratification and monitoring purposes. It also includes a separately licensed assessment module for patients with end-stage renal disease who are undergoing dialysis.
Sozo is FDA-cleared for heart failure and CE-marked for heart failure and renal failure. The trial will provide cardiologists firsthand experience with Sozo and coincides with Impedimed’s launch into the cardiology market. Cardiovascular disease is the leading cause of death among those with kidney disease. The company is working with the U.S. FDA to get clearances for hydration and bone density.
“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,” the CEO said.
“There are no FDA-cleared devices using bioimpedance spectroscopy that have heart failure, that have a CE mark for renal failure, that have protein-calorie malnutrition,” he said, noting that Impedimed uses in excess of 200 frequencies, which supplies the accuracy and the detailed data that companies want.
As the devices are used, more information is gleaned from the data, which is proving to be valuable for several uses. One such use is protocol adherence for companies running clinical trials.
Carreon said the company was able to see that one group was using the wrong diagnosis codes and were missing out on millions of dollars in reimbursement.
“We’re going to start introducing more population health metrics,” he said. “For example, in cancer patients, it can be very helpful to go back and see how many have fallen into protein-calorie malnutrition.”
It is the only device ever cleared for protein-calorie malnutrition, he said.
“Today, we have more than 150,000 patients in the cloud, and we’re using that data to improve the accuracy of our device.”
He noted that the FDA will allow real-time data to be used in lieu of clinical trials, so the company should be able to add on indications without having to run trials.
IPD Price at posting:
8.4¢ Sentiment: Buy Disclosure: Held
