- Spectral Medical Inc.’s (EDT) subsidiary receives FDA approval of a protocol amendment to its DIMI usability trial
- The protocol amendment allows for both improved patient and clinical logistics flow when conducting the DIMI trial
- DIMI is a kidney replacement system
- The DIMI usability trial is designed to evaluate the safety and efficacy of DIMI in the home setting
- Spectral Medicine is progressing with contracting clinical trial sites
- Spectral Medical Inc. (EDT) is up 1.88 per cent and is trading at $0.27 per share as of 1:35 p.m. EST
Spectral Medical Inc.’s (EDT) subsidiary, Dialco Medical Inc., receives FDA approval of a protocol amendment to its DIMI usability trial.
The protocol amendment allows for both improved patient and clinical logistics flow when conducting the DIMI trial.
DIMI is a kidney replacement system that is designed to avoid all contact between a robotically-assisted surgery operator and biological fluids to reduce the risk of infection when used to treat multiple patients.
The DIMI usability trial is designed to evaluate the safety and efficacy of DIMI in the home setting.
It does so by analyzing delivered dialysis doses and potential adverse events during six weeks of use.
It will contrast the results versus ones observed in a hospital.
Dr. John Kellum, Chief Medical Officer of Spectral, commented,
“We worked closely with our clinical trial partners and vetted the modifications to our DIMI protocol with potential clinical trial sites… We now believe we have an exceptional approved protocol for the DIMI trial and look forward to onboarding the clinical sites.”
Spectral Medicine is progressing with contracting clinical trial sites and the trial will include 35 patients in the United States.
DIMI recently received its FDA 510k clearance for use in hospital and clinical settings.
It also obtained its Health Canada license for use within Canadian hospitals, clinics and in-home.
Spectral Medical Inc. (EDT) is up 1.88 per cent and is trading at $0.27 per share as of 1:35 p.m. EST.