Diality, Inc., a medical technology company developing a user-friendly, mobile, and connected hemodialysis system with a category-leading prescription range, today announced plans for a clinical trial to support a home use indication for its Moda-flx Hemodialysis System.
Diality plans to file for an investigational device exemption (IDE) from the U.S. Food & Drug Administration (FDA) for the trial, to be conducted by Fortrea, a leading global contract research organization (CRO) with more than 30 years of experience performing clinical trials, including in the dialysis space.
Initial clinical sites have already been selected, with additional sites to be added through the fourth quarter of 2023; first patient enrollments are expected during the first quarter of 2024.
“The planned execution of our home clinical study is a testament to our organization’s growth and readiness to support clinical and commercial expansion,” said Osman Khawar, M.D., CEO of Diality. “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 commercialization of our device in 2024.”
About Diality
Headquartered in Irvine, Calif., Diality is a medical technology company developing a user-friendly, mobile, and connected hemodialysis system. Diality’s hemodialysis system is currently not approved for sale in any region.
Source link : https://www.businesswire.com/
