Spectral Medical Announces that its Wholly-Owned Subsidiary Dialco Medical has been Granted FDA IDE Authorization to Conduct a Trial of DIMI for Home Hemodialysis Use
TORONTO, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly-owned subsidiary, Dialco Medical
Inc. (“Dialco”), has been granted Investigational Device Exemption (IDE) authorization by the United States Food and Drug Administration (FDA) to conduct a usability
trial to demonstrate the safety and efficacy of DIMI for performing hemodialysis in the home environment.
DIMI is an innovative renal replacement system based on a fully integrated cassette technology, which simplifies set-up, operation, and management of a dialysis session when compared to other instruments currently available on the market. DIMI was recently cleared by the FDA to treat patients with acute and/or chronic renal failure with or without fluid overload using hemodialysis, hemodiafiltration, hemofiltration and/or ultrafiltration in hospital or clinical settings.
The approved IDE usability trial is expected to enroll 35 patients and is designed to evaluate the safety and efficacy of DIMI in the home setting by analyzing delivered dialysis dose and potential adverse events happening during six weeks of use at home compared to six weeks of use in the hospital setting on the same patients.
Dialco is in the process of selecting its contract research organization (“CRO”) partner to run the trial, as well as identifying and evaluating clinical sites that will participate in the trial.
“We look forward to working with our early adopters and other clinical teams to evaluate DIMI and run the usability trial to pursue the home market designation,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “The trial design is similar to the ones run recently by Outset Medical and previously by NxStage. The key measure of success will be demonstrating that DIMI can deliver the prescribed dialysis needs per session, both in hospital and in the home environment, while maintaining safeguards for the mitigation of safety risk.”
“We are very excited to announce that the FDA has granted IDE authorization to commence this landmark trial of DIMI for at home use,” said Chris Seto, COO and CFO of Spectral. “This latest authorization follows our recent FDA 510(k) Clearance of DIMI for use within hospitals, clinics and skilled nursing facilities. Assuming this trial is successful, we believe Dialco’s addressable home hemodialysis market alone will approach $3 billion by 2025, due to increasing pressure to transition hemodialysis to an at-home setting in the U.S. We are more excited than ever by the outlook for the business and look forward to announcing a number of important upcoming milestones.”