From the cochlear implant to pacemakers, medical devices have changed the way we treat and manage numerous conditions. Medtech company ImpediMed (ASX: IPD) saw a need in dialysis patients and sought to offer a better solution.
Dialysis is the process of removal of water and waste products from the body to filter out toxins, and extra fluid from those who have kidney failure. Dialysis machines take on the role of an external kidney but do not restore kidney function. Life expectancy on dialysis varies with the average being 5-10 years.
ImpediMed’s SOZO bioimpedance spectroscopy platform aims to improve and fine tune the dialysis process by determining exact measures of patient fluid volume to remove during dialysis sessions. In less than 30 seconds, the FDA cleared and CE marked device provides a clear snapshot of fluid status and tissue composition.
Currently, weight scales are used to determine how much fluid has accumulated however, these fail to take into account any changes in body composition such as muscle loss, common in those with end stage kidney disease.
“Dry weight assessment and appropriate fluid removal during dialysis remains a significant challenge for nephrologists”, says Dr Mark M Boiskin, a nephrologist at the Balboa Nephrology Medical Group and California Institute of Renal Research. “Clinical assessment alone appears to be inadequate in many dialysis patients, especially those with multiple coexisting illnesses (cardiovascular disease, diabetes, etc). Both inadequate fluid removal and excessive fluid removal resulting in hypotension may adversely affect quality of life, increase hospitalisations and increase mortality.”
The mortality rate of dialysis patients remains persistently high. ImpediMed hopes that by improving the delivery of dialysis they can reduce mortality and associated morbidities. Dr. Boiskin highlighted the need for such a device saying: “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.”
Recognising the need and applications of this device, the FDA has granted ImpediMed with Breakthrough Device Designation, a designation that only exists for medical devices that represent breakthrough technology in an area where no approved or cleared alternatives exist. The designation will offer the Company support through the approval process as well as help in expediting the development of the device through access to priority review and other resources from the FDA.
Richard Carreon, Managing Director and CEO of ImpediMed said: “ 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. 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 commercialisation.”
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