Organicell Reports Positive Results from Compassionate Use of Organicell Flow in Severely Ill COVID-19 Patients

MIAMI, May 27, 2020 (GLOBE NEWSWIRE) -- Organicell Regenerative Medicine, Inc. (OTCBB:BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today a health update for two critically ill COVID-19 patients who were treated at Landmark Hospital in Athens, GA with the Company’s Organicell Flow product. These patients were treated under the two recently approved Emergency Compassionate Use Investigational New Drug applications (eINDs) by the U.S. Food and Drug Administration (FDA). 

Upon receiving FDA approval of the eIND on May 11, 2020, the Company and Landmark Hospital immediately treated the two critically ill COVID-19 patients, in their mid to late 70s, with Organicell Flow. Treatment with Organicell Flow resulted in a remarkable improvement in their clinical status, lung and renal function confirmed by follow up chest X-rays and lab data. These patients are no longer intubated, are alert and oriented with stable vital signs and oxygenation. Other organs such as the brain, heart and liver commonly affected in patients who had the SARS-CoV-2 virus have all shown progressive improvement in their function.

Dr. George Shapiro, Chief Medical Officer of Organicell stated, “We are very pleased that Organicell Flow, administered intravenously, has to date met all of the primary objectives of safety and secondary clinical objectives of improved ICU status and reduction in the sequential organ failure assessment (SOFA) score.”

Dr. Anthony Sagel, Chief of Medical Staff at Landmark hospital and treating physician for both patients said, “The first patient has improved considerably and is now off the ventilator with normal appearing lungs on their chest X-ray. In addition, their mental status continues to improve along with normal kidney function. The second patient has also been systemically improving, including their kidney and respiratory function. Their acute delirium has improved, and is communicating well with family. Both patients are ready to be discharged from the ICU.”

Worldwide clinical experiences have shown that the progressive decline in lung function is the main cause of death in patients infected with COVID-19 disease, and patients who are admitted to the ICU requiring mechanical ventilation (Intubation) has revealed high mortality rates. Both patients in the current study were severely ill with underlying health conditions and severe multi-organ failure. Under the defined protocols of the clinical trials, each of the above patients will continue to be monitored on their health vitals for a total period of 60 days. Based upon the continued favorable results, Organicell may seek other approvals to treat other severely ill patients.