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Saturday, November 26, 2022

Organicell Regenerative Medicine Inc (OTCMKTS: OCEL) Heating Up as Biotech Prepares for its Phase I/II Randomized, Double Blinded, Placebo Trial for Zofin

Organicell Regenerative Medicine Inc (OTCMKTS: OCEL) is making an explosive move up the charts after the Company announced the Mayo Clinic will be the site for clinical trials on Chronic Obstructive Pulmonary Disease (COPD). Mayo Clinic in Phoenix, Arizona will be the clinical trial site for Organicell’s Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). 

Earlier this year the Company closed on an additional $1 million private stock purchase at $0.04 per share and secured a $10 Million Equity Line of Credit with Tysadco Partners, LLC. This capital raise brings the total amount of new funding deals to $16.5 Million. The Company has also been busy expanding its BOD and management team recently recruiting Ryan Likes as new Chief Operating Officer, David Aciego as Chief Information Officer, and Jacqueline (Jackie) Domenechas Director of Finance. 

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Organicell Regenerative Medicine Inc (OTCMKTS: OCEL) is a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and to provide other related services. 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. Organicell RAAM Products and related services are principally used in the health care industry administered through doctors and clinics. 

Since May 2019, Organicell has operated a placental tissue bank processing laboratory in Miami, Florida for the purpose of performing research and development and the manufacturing and processing of the anti-aging and cellular therapy derived products that we sell and distribute to our customers. 

The Company’s leading product, Zofin™ (also known as OrganicellTM Flow), is an acellular, biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other exosomes/nanoparticles derived from perinatal tissues. 

To date, the Company has obtained certain Investigation New Drug (“IND”), and eighteen emergency IND (“eIND”) approvals from the FDA, including applicable Institutional Review Board (“IRB”) approvals which authorized the Company to commence clinical trials or treatments in connection with the use of Zofin™ and related treatment protocols. The Company is pursuing efforts to complete its already approved clinical studies (see below) as well as obtaining approval to commence additional studies for other specific indications it has identified that the use of its products will provide more favorable and desired health related benefits for patients seeking alternative treatment options than are currently available. The ability of the Company to succeed in these efforts is subject to among other things, the Company having sufficient available working capital to fund the substantial costs of completing clinical trials, which the Company currently does not have, and ultimately, obtaining approval from the FDA. 

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OCEL

On November 15 OCEL announced the Mayo Clinic will be the site for clinical trials on Chronic Obstructive Pulmonary Disease (COPD). Mayo Clinic in Phoenix, Arizona will be the clinical trial site for Organicell’s Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). 

Organicell completed the site activation and is ready to begin enrollments. Organicell aims to demonstrate the safety of Organicell’s lead extracellular vesicle biologic, Zofin, while concurrently investigating the drug’s potential long-term benefits for improved pulmonary function and quality of life measures in chronically ill COPD patients. Extracellular vesicle and exosome-based drugs, like Zofin, are becoming increasingly popular due to the number of anti-inflammatory and immune-modulatory effects. In chronic illnesses where inflammation is high, such as COPD, extracellular vesicles and exosomes offer an innovative solution for patients with unmet medical needs. 

COPD including emphysema and chronic bronchitis – a common airway disease that affects approximately 10% of individuals over 45 years of age, is a concern in patients who are infected with the Sars-Cov-2 viruses causing covid-19 disease. It is well known that COPD patients are prone to viral exacerbations and current evidence shows that COPD patients have increased pulmonary expression of ACE2, the SARS-CoV-2 receptor, providing a mechanism by which COPD patients may be more susceptible to COVID-19. COPD patients also demonstrate features of endothelial cell dysfunction and increased coagulopathy, which may predispose to increased risk of worse outcomes from COVID-19. 

Organicell’s Chief Medical Officer, Dr. George Shapiro said, “The association between COPD patients and Covid-19 is now clear. Based on the results I have seen in the numerous Emergency Investigative New Drug treatments we’ve conducted; this COPD trial was a natural progression of Organicell’s science. COPD patients who have Covid-19 are two and half times more likely to experience ICU admissions, invasive mechanical ventilation, or death. Clinical outcomes including requirement for mechanical ventilation and mortality appear to be worse in COPD patients resulting in a three-fold greater risk of mortality. If people with this underlying condition do get COVID-19, they are at high risk for complications and poorer outcomes. There is likely another round of COVID bound to hit this flu season. The timing of this trial couldn’t be more relevant to those suffering with COPD.” 

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Currently trading at $40 million market valuation OCEL OS is 1,479,126,390 with 535,327,372 shares in the public float. While the Company does carry $7 million in liabilities on the books, they have raised $16.5 million in new funding deals. OCEL has fast growing revenues recently reporting$1,713,214 in revenues for the 3 months ended July 31, 2021 up from $1,367,895 for the same period last year. Right now, is a very exciting time for OCEL as the Company begins its Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) at the Mayo Clinic in Phoenix, Arizona. OCEL has a long history of explosive moves skyrocketing to over $0.50 in 2020 and to over $0.60 in 2021. We will be updating on OCEL when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with OCEL.

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Disclosure: we hold no position in OCEL either long or short and we have not been compensated for this article.

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