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

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IRVINE, Calif.--(BUSINESS WIRE)--Sep 11, 2025--

Diality Inc., a medical device company that has developed the Moda- flx™ Hemodialysis System, today announced the first patient treatment in its PRESCRIBE Diality Home Hemodialysis Clinical 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 Moda-flx Hemodialysis System received 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,” said Diality CEO Dr. Osman Khawar. “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 a wide range of variable flow rates, integrated reverse osmosis water filtration, and an intuitive, easy-to-use graphical user interface. It provides 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,” said Ivan Ramirez, CEO of aQua Research Institute and Dialysis.

About Diality

Diality is a medical device company focused on developing 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. Please visit www.diality.com or find us on LinkedIn to learn more about Diality and The Moda -flx Hemodialysis System.

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CONTACT: MEDIA CONTACT:

Sam Choinski

Pazanga Health Communications

schoinski@pazangahealth.com

(860) 301-5058

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: SOFTWARE HEALTH DIABETES MEDICAL DEVICES HEALTH TECHNOLOGY TECHNOLOGY CLINICAL TRIALS MOBILE/WIRELESS

SOURCE: Diality Inc.

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PUB: 09/11/2025 07:05 AM/DISC: 09/11/2025 07:04 AM

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