MIAMI--(BUSINESS WIRE)--Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that the U.S. Food and Drug Administration (FDA) granted emergency, expanded access approval to treat one “long-hauler” patient on August 1, 2020, and two additional patient approvals on August 17, 2020.
In the first approval, prior to treatment with Zofin, the patient was hospitalized for seven weeks. At the time of discharge, the patient was physically limited due to severe deconditioning and having shortness of breath while performing limited activities of daily living (eating meals, showering and short distance walking). After receiving three doses of Zofin, he is now free of post-COVID-19 complications and plans to return to work on September 1, 2020.
Organicell is the first reported company to treat outpatient COVID-19 long-haulers. In a July 24, 2020 report, the U.S. Centers for Disease Control and Prevention (CDC), found that of about 300 non-hospitalized but symptomatic COVID-19 patients, 35% were still experiencing symptoms like coughing, shortness of breath and fatigue up to three weeks after diagnosis. (By contrast, less than 10% of non-hospitalized influenza patients are not fully recovered within two weeks.) Recovery from COVID-19 can be a drawn-out process for patients of all ages, genders and prior levels of health, “potentially leading to prolonged absence from work, studies, or other activities,” the report noted.1
George Shapiro, M.D., Chief Medical Officer of Organicell said, “Organicell believes that ‘long-haulers” are a population of COVID-19 patients that need immediate help to return to normalcy, and as per Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease recently noted, it will take months to a year or more to know whether lingering COVID-19 symptoms in young people could become chronic illnesses2.”
Recently, Organicell broadened its focus to treat mild to moderate COVID-19 patients, as well as those patients that are more severely affected. Previously, three severely ill COVID-19 patients were treated with Zofrin at Landmark Hospital in Athens, GA, and two mild to moderate acute respiratory syndrome (SARS) patients were treated under an emergency investigational new drug expanded access program, with all patients reporting excellent results.
“Organicell believes that there is hope for the thousands of people suffering with post-COVID symptoms that can’t return to work, school or their daily lives. These long-haulers will not be forgotten,” said Albert Mitrani, Chief Executive Officer of Organicell.
Organicell is preparing to submit additional phase I/II INDs to treat COVID-19 long-haulers.
About Organicell Regenerative Medicine, Inc.:
Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of nanoparticles 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 microRNAs, 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. Maria Ines Mitrani, Chief Science Officer. To learn more, please visit https://organicell.com/.
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