Aethlon Announces FDA Approval of IDE Supplement for COVID-19 Patients
(FDA) has approved a supplement to the Company's existing Investigational Device Exemption (IDE) for the Company's Hemopurifier® in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19 in a new feasibility study.
The feasibility study, which is the device equivalent of a phase 1 trial, will enroll up to 40 subjects at up to 20 centers in the U.S. Subjects will have established laboratory diagnosis of COVID-19, be admitted to an intensive care unit (ICU) and will have acute lung injury and/or severe or life threatening disease among other criteria.
"We believe that the Hemopurifier may have the potential to help severely affected patients with COVID-19. We believe that clearing circulating virus in these patients, in combination with other supportive measures, could improve outcomes in this deadly disease."
The Hemopurifier is an FDA designated "Breakthrough Device" for the treatment of life-threatening viruses that are not addressed with approved therapies. The Hemopurifier also holds a Breakthrough Device designation
finance.yahoo.com/ne...l-ide-131900535.html
www.bloomberg.com/ne...er-speculation-began
(FDA) has approved a supplement to the Company's existing Investigational Device Exemption (IDE) for the Company's Hemopurifier® in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19 in a new feasibility study.
The feasibility study, which is the device equivalent of a phase 1 trial, will enroll up to 40 subjects at up to 20 centers in the U.S. Subjects will have established laboratory diagnosis of COVID-19, be admitted to an intensive care unit (ICU) and will have acute lung injury and/or severe or life threatening disease among other criteria.
"We believe that the Hemopurifier may have the potential to help severely affected patients with COVID-19. We believe that clearing circulating virus in these patients, in combination with other supportive measures, could improve outcomes in this deadly disease."
The Hemopurifier is an FDA designated "Breakthrough Device" for the treatment of life-threatening viruses that are not addressed with approved therapies. The Hemopurifier also holds a Breakthrough Device designation
finance.yahoo.com/ne...l-ide-131900535.html
www.bloomberg.com/ne...er-speculation-began