On Aug. 6, 2020, Organicell Regenerative Medicine, a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that the U.S. Food and Drug Administration (FDA) approved two outpatient Emergency Investigational New Drug Applications (eINDs) for treating mild to moderate respiratory distress due to COVID-19.

Organicell’s first patient approved for the eIND experienced moderate chest discomfort accentuated when taking deep breaths, persistent non-productive cough and fatigue upon exertion. After receiving three doses of Organicell Flow, the patient has shown a reduction in cough and ability to breathe without pain. The second outpatient previously spent seven weeks in the hospital, was admitted to the ICU twice, received Bi-Level Positive Airway Pressure (BiPAP) treatment and continued to experienced shortness of breath after hospital discharge. Now, being treated as an outpatient, he was administered the first dose of Organicell Flow on August 4th, 2020, and to date, has reported improvements in all his symptoms.

In May, Organicell previously announced it had successfully treated two critically ill COVID-19 inpatients at Landmark Hospital in Athens, Georgia. Since then, a third approved eIND inpatient with COVID-19 related respiratory impairment and acute kidney injury, was treated by Organicell, and the patient had a complete recovery of lung and renal function and was discharged 26 days after initiation of treatment.