FDA Grants Breakthrough Device Designation for ImpediMed’s SOZO® Digital Health Platform for Renal Failure
FDA Recognizes Potential of SOZO® Digital Health Platform to Assist Clinicians in Measuring Exact Fluid Volume of Patients Undergoing Dialysis
CARLSBAD, Calif., Aug. 30, 2021 /PRNewswire/ — ImpediMed Limited (ASX:IPD), a global medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to improve patient health, today announced that the SOZO® Digital Health Platform was designated a Breakthrough Device by the Food and Drug Administration (FDA) for a proposed indication in renal failure.
Using bioimpedance spectroscopy, the SOZO® Digital Health Platform aims to provide clinicians with a more precise measure of fluid volume to be removed from a renal failure patient during dialysis. The current standard-of-care method to measure the accumulation of fluid in kidney failure patients utilizes weight scales. These scales cannot account for changes in body composition, with muscle loss being a common side effect of end-stage renal disease patients. The potential for SOZO® to address this deficiency was paramount in the FDA awarding its Breakthrough Designation to the SOZO® Digital Health Platform.
The Breakthrough Device Designation is granted when a device meets several criteria, including providing for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
“Dry weight assessment and appropriate fluid removal during dialysis remains a significant challenge for nephrologists. Clinical assessment alone appears to be inadequate in many dialysis patients, especially those with multiple coexisting illnesses including cardiovascular disease and diabetes. Both inadequate fluid removal and excessive fluid removal resulting in hypotension may adversely affect quality of life, increase hospitalizations and increase mortality,” noted Dr. Mark M. Boiskin, MD FACP, of the Balboa Nephrology Medical Group and California Institute of Renal Research. “A device that can quickly and easily be used in the dialysis setting to accurately measure fluid volume is currently not FDA approved and readily available. Such a device may significantly improve quality of care and improve patient outcomes.”
“We are extremely pleased to be moving forward with the renal opportunity through the FDA Breakthrough Device Program. There is a clear need for an innovative device to help clinicians more effectively manage end-stage renal disease patients. The mortality rate of these patients remains persistently high, with many dying from fluid related heart failure. We believe SOZO® can provide a significant improvement to the dialysis process by better quantifying the volume of fluid needed to be removed,” said Richard Carreon, Managing Director and CEO of ImpediMed. “It also allows us to advance the discussions with both potential clinical and commercial partners, with a goal of moving quickly to clinical trials and subsequently to commercialization.”
Founded in Brisbane, Australia, with U.S. headquarters and European operations, ImpediMed is a global medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to maximize patient health. ImpediMed produces a family of FDA cleared and CE Marked medical devices, including SOZO® for multiple indications, including heart failure, lymphedema, and protein calorie malnutrition sold in select markets globally. Visit www.impedimed.com.
About SOZO Digital Health Platform
SOZO, the world’s most advanced, noninvasive bioimpedance spectroscopy (BIS) device, delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds. Using ImpediMed’s BIS technology, SOZO measures 256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz. Results are available immediately online for easy data access and sharing across an entire healthcare system. The FDA-cleared, CE-marked and ARTG-listed digital health platform aids in the early detection of secondary lymphedema, provides fluid status for patients living with heart failure, and can be used to monitor and maintain overall health – all on a single device.
Visit ImpediMed’s website for more information about the SOZO Digital Health Platform.
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