Organicell Regenerative Medicine Inc (OTCMKTS: BPSR) is going into beast mode and skyrocketing up the charts and transforming into a volume leader and serious mover and shaker in small caps. The stock has attracted legions of shareholders who continue to bid BPSR higher.
BPSR is running northbound as its Zofin (Organcell™ Flow) gains serious traction and shows real promise in the fight against covid-19. On August 20, 2020, Organicell issued a press release in which it 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.
Organicell Regenerative Medicine Inc (OTCMKTS: BPSR) 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.
The big story on Organicell is Zofin (Organcell™ Flow); a natural and acellular product derived from amniotic fluid and is manufactured to retain the naturally occurring hyaluronic acid, proteins, and exosomes present in perinatal fluid without the addition or combination of a substance or diluent. Organicell products are manufactured in cGMP compliant labs and are tested for sterility, endotoxin levels, hyaluronic acid, protein analysis, and exosomes composition. Exosomes are nano-sized extracellular vesicles that mediate cell-to-cell communication and affect cell function and behavior. Organicell has received Emergency Compassionate Use Investigational New Drug applications (eINDs) by the FDA which allows for the immediate use of the experimental biologic.
Last week BPSR announced it has partnered with Alternative Research Associates, LLC and Larkin Hospital in Miami, FL to initiate a randomized, double-blinded, placebo-controlled phase I/II clinical trial against COVID-19 of its lead therapeutic candidate, which has been rebranded as Zofin. To date, a total of five patients have been treated with Zofin under the U.S. Food and Drug Administration’s (FDA) emergency Investigational New Drug (eIND) Program. Three of these COVID-19 patients were hospitalized in critical condition and, following treatment, regained complete recovery of lung and renal function. The other two patients were treated as outpatients and both have shown significant improvements in all symptoms and will continue to be monitored. The objective of the FDA phase I/II study is to investigate the safety and potential efficacy of perinatal sourced components for COVID-19. The study will enroll 20 patients and is expected to commence within the next two weeks. In addition to the rebranding of its therapeutic candidate, Organicell will be unveiling a new corporate logo, tagline and website. The new brand reflects the company’s renewed focus on building and advancing a portfolio of biologics.
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On August 20 BPSR reported the 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.
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 is the first reported company to treat outpatient COVID-19 long-haulers. 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 illnesses.”
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Currently moving northbound in a hurry BPSR is an excitng story developing in small caps; Organicell Flow continues to gain traction and shows real promise in the fight against covid-19. Treatment with Zofin (Organcell™ 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. Organicell is collaborating with physicians at Landmark Hospital, a network of six hospitals located throughout the Southeast United States, to treat these patients for advanced complications associated with COVID-19. BPSR is running northbound as its Zofin (Organcell™ Flow) gains serious traction and shows real promise in the fight against covid-19. On August 20, 2020, Organicell issued a press release in which it 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. We will be updating on BPSR as events unfold so make sure you are subscribed to Microcapdaily so you know what is going on with BPSR.
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Disclosure: we hold no position in BPSR either long or short and we have not been compensated for this article.