FDA Approves Two Emergency INDs for COVID-19 Outpatient Therapy
Organicell Regenerative Medicine, Inc. recently announced the US 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 7 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 4, 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.
Expanded access trials that can treat early stage COVID-19 symptoms could potentially prevent permanent lung, kidney, and neurological damage. In addition, outpatient treatment could lower the number of hospitalizations and help curb the economic strain on the US healthcare system. As of August 5, 2020, 38 states have reported over 323,000 total hospitalized Covid-19 patients, with around 53,000 currently still hospitalized. On average, hospitalizations for COVID-19 can cost $50,000 per patient, according to a recent analysis by independent nonprofit FAIR Health.
“We are very pleased to announce the first reported FDA outpatient emergency approvals in the US for the treatment of mild-to-moderate respiratory distress due to COVID-19. Organicell Flow may serve to not only improve clinical outcomes, but also reduce the inpatient capacity strain and save the healthcare ecosystem billions of dollars by treating patients before they get into the hospital system,” said Albert Mitrani, Chief Executive Officer at Organicell.
Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Mari Mitrani, Chief Scientific Officer. For more information, visit https://organicell.com/.
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