Medical technology company Diality has unveiled plans to commence a clinical study of the Moda-flx Hemodialysis System for home use.
The company intends to file an investigational device exemption (IDE) application with the US Food and Drug Administration for the study, which will be carried out by contract research organisation Fortrea.
Diality chose the initial clinical sites for the trial and plans to include more sites during the fourth quarter of this year.
Diality CEO Osman Khawar said: “The planned execution of our home clinical study is a testament to our organisation’s growth and readiness to support clinical and commercial expansion.
“This represents another significant milestone for our team, made possible by our success in validating and building production-quality devices for use in the clinical study and targeted commercialisation of our device in 2024.”
The patient-inspired haemodialysis system has been designed to provide healthcare professionals with the flexibility to make the best choices for both their patients and their clinical practice.
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The Diality system is not currently approved for sale in any location and has been developed to enable healthcare professionals to select the appropriate haemodialysis prescription in any care environment.
It offers the water/dialysate-generation option to meet individual requirements along with a user-friendly interface that is accessible for both specialists and non-nephrology clinicians.