Michael Barbella, Managing Editor01.26.24
Diality Inc. could soon begin a clinical trial to support a home use indication for its Moda-flx Hemodialysis System.
Diality filed an investigational device exemption (IDE) application with the U.S. Food and 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; first patient enrollments are expected this quarter.
“The planned execution of our home clinical study is a testament to our organization’s growth and readiness to support clinical and commercial expansion,” DIality CEO Osman Khawar, M.D., said. “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.”
Headquartered in Irvine, Calif., Diality is developing a user-friendly, mobile, and connected hemodialysis system.
Diality filed an investigational device exemption (IDE) application with the U.S. Food and 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; first patient enrollments are expected this quarter.
“The planned execution of our home clinical study is a testament to our organization’s growth and readiness to support clinical and commercial expansion,” DIality CEO Osman Khawar, M.D., said. “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.”
Headquartered in Irvine, Calif., Diality is developing a user-friendly, mobile, and connected hemodialysis system.