ImpediMed (ASX:IPD) - MD and CEO, Richard Carreon
MD and CEO, Richard Carreon
Source: ImpediMed
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  • ImpediMed’s (IPD) SOZO platform is granted Food and Drug Administration (FDA) breakthrough device designation for renal failure
  • ImpediMed’s SOZO device can provide an exact measure of fluid volume to remove during a dialysis session, unlike the current process which can’t account for body composition changes
  • Following the program acceptance, ImpediMed will be granted timely communication with the FDA, along with priority reviews
  • The company says the designation positions it to expand its SOZO platform into the renal space and will allow it to expedite the device’s development
  • ImpediMed is trading 4.55 per cent up at 11.5 cents at 10:50 am AEST

ImpediMed’s (IPD) SOZO platform has been granted Food and Drug Administration (FDA) breakthrough device designation for renal failure.

A breakthrough device designation is granted when a device is shown to provide a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition. To be granted this designation, the device must represent breakthrough technology and offer significant advances over existing approved alternatives, while being in the best interest of patients.

ImpediMed’s SOZO bioimpedance spectroscopy platform aims to do just that.

The company’s device can provide an exact measure of fluid volume to remove during a dialysis session. This differs from the current process, which cannot account for changes in body composition, with muscle loss being prevalent in end-stage renal disease patients.  

ImpediMed says the potential for SOZO to address this deficiency was the key aspect of meeting the criteria for breakthrough designation.

“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,” explained Mark Boiskin, from the Balboa Nephrology Medical Group & California Institute of Renal Research.

“Such a device may significantly improve quality of care and improve patient outcomes,” Dr Boiskin said.

By being accepted into the breakthrough program, ImpediMed will be granted interactive and timely communication with the FDA, along with priority reviews and provisions for obtaining binding agreements on clinical protocols.

Impedimed said the designation positioned it to expand its SOZO platform into the renal space. It intends to partner with the FDA to expediate the development and clearance of SOZO.

“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 commercialisation.”  

IPD was trading 4.55 per cent up at 11.5 cents at 10:50 am AEST.

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