Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), today announced that its wholly owned subsidiary, Dialco Medical Inc. (“Dialco”) has been granted 510(k) clearance by the United States Food and Drug Administration (“FDA”) for DIMI to treat patients with acute and/or chronic renal failure with or without fluid overload using hemodialysis (“HD”), hemodiafiltration (“HDF”), hemofiltration (“HF”) and/or ultrafiltration (“UF”) in hospital or clinical settings. As previously communicated, this is the first major step of the full regulatory development of DIMI. Further advances will be clearance for home and peritoneal dialysis (“PD”) use.
DIMI is an innovative renal replacement system that shares the same patented platform as Dialco’s FDA cleared SAMI system, which is indicated for continuous renal replacement therapy (“CRRT”) in the intensive care unit (“ICU”) setting. Based on a fully integrated cassette technology, the set-up, operation and management of a dialysis session is significantly simplified compared to other instruments currently available on the market. Moreover, DIMI (similarly to SAMI) is specifically designed to avoid all contact between the console and a patient’s biological fluids, helping to reducing the risk of cross infection when it is used to treat multiple patients.
“The overall 510(k) clearance process was completed in less than nine months including review, and time to address and resolve deficiencies, despite the COVID-19 pandemic,” said Dr. Gualtiero Guadagni, President of Dialco Medical Inc. “This FDA 510(k) clearance is significant for Spectral. Not only is it an important first step in the full regulatory development of DIMI, but it also opens up significant commercial markets and opportunities which we expect would result in significant revenue growth for the Company. We look forward to working with our SAMI early adopters and other clinical teams to evaluate DIMI and run the usability trial to pursue the home market designation.”
Source: Company Press Release
