First Patient Treated in Moda-flx Home IDE PRESCRIBE Diality Trial

Diality Inc. has enlisted begun the first patient treatment in its PRESCRIBE Diality Home Hemodialysis trial in partnership with aQua Research Institute and aQua Dialysis in Houston, Texas.

Diality is conducting the PRESCRIBE Diality trial under an Investigational Device Exemption (IDE) to evaluate a home use indication for the Moda-flx Hemodialysis System. The product earned U.S. Food and Drug Administration (FDA) clearance for use in professional care settings in August 2024.

”Diality’s Moda-flx Hemodialysis System is unique in its ability to offer an integrated reverse osmosis (RO) system combined with dialysis flow rates (Qd) up to 600 mL/min. Moda-flx addresses the gaps that exist between conventional in-center dialysis and current home hemodialysis systems. Those gaps often force clinicians to compromise elements of dialysis care due to the limitations of their technology,” Diality CEO Dr. Osman Khawar stated. “We are fortunate to work with clinical partners like aQua Dialysis who are committed to supporting clinical research and home hemodialysis, and improving the dialysis experience for both patients and clinicians.”

The Moda-flx Hemodialysis System is designed to empower kidney care professionals with numerous variable flow rates, integrated reverse osmosis water filtration, and an intuitive, easy-to-use graphical user interface. It gives clinicians the flexibility to easily customize each hemodialysis experience according to patient needs in one integrated system. The platform’s compact footprint and mobility also enable seamless integration and transportation between dialysis care settings.

“We are excited to partner with Diality in this clinical trial with the objective of providing clinicians, patients and their caregivers improved technology options to positively impact their day to day lives,” aQua Research Institute and Dialysis CEO Ivan Ramirez said.

Diality develops solutions to improve lives impacted by kidney disease. The Moda-flx Hemodialysis System is a user-friendly, mobile, and connected hemodialysis platform designed to maximize clinical flexibility by combining prescription capabilities of in-center systems with the ease-of-use of next generation hemodialysis devices.