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Nanotechnology is a game changer for modern medicine and Organicell Regenerative Medicine, Inc. (OCEL) has a unique product offering for an enormous untapped market.

Nanotechnologies are showing significant potential in the field of medicine. It is essentially the ability to write software for your cells. 

Nanotechnology has the potential to transform drug delivery, wound treatment, gene therapy, diagnostics, and almost every branch of medicine.

With an expected huge impact that could play an increasingly important role in medicine in the coming years, Organicell Regenerative Medicine, Inc. (OCEL) is a publicly traded, clinical-stage, biopharmaceutical company to pay very close attention to right now.

Unlike Stem Cells, Organicell’s nanotechnology utilizes Extracellular Vesicles such as Exosomes. They are acellular and naturally derived. 

Organicell sources these nano-particles from amniotic fluid, which every human has been exposed to and benefited from – it’s the fluid we grow in as a fetus. 

What’s especially exciting is that we have an opportunity to bear witness to this transformation at its forefront as nanomedicine is still in its infant stages. 

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    Organicell Regenerative Medicine, Inc. is a client of Tradigital IR, an investor relations and communications firm. Please see our disclosures in the research report as well as on our website www.Tradigitalir.com.

    OVERVIEW: UNDERSTANDING ORGANICELL

    Organicell Regenerative Medicine, Inc. (OCEL) is committed to the research, development, and manufacturing of new technologies in biologic medicine and therapeutics. 

    The company is comprised of two arms: Clinical Research and Commercial.

    Their flagship product, Zofin™, is currently undergoing research collaborations and Phase I/II clinical trials.

    Zofin utilizes perinatal-derived extracellular vesicles and nanoparticles that represent the technological revolution of regenerative biologic drug treatments. 

    OCEL has a Research and Development (R&D) partnership with the Center for Disease Control and Prevention (CDC) to assess Zofin’s anti-inflammatory and anti-infective efficacy in experimental models of influenza infection. 

    The company also has a R&D agreement with Oklahoma State University to assess Zofin’s suitability for treating respiratory illnesses brought on by potential pandemic causing viruses.

    Organicell (OCEL) is also conducting Phase I/II clinical trials for Zofin in COVID-19, LONG COVID, and COPD. Zofin’s preclinical research has shown that it is a hyper infused anti-inflammatory, so it can be utilized for most inflammatory ailments. 

    Long COVID

    “Long-haulers,” or patients with Long Covid, are COVID-19 survivors who have persistent symptoms such as shortness of breath, fatigue, headaches, heart palpitations, and impairments in mental health and cognition. 

    These lingering symptoms can last for weeks or months and can detrimentally affect the lives of many people.

    • Overall, 1 in 13 adults in the U.S. (7.5%) have “Long COVID” symptoms, defined as symptoms lasting three or more months after first contracting the virus, and that they didn’t have prior to their COVID-19 infection.
    • Studies indicate that about 10% of people infected with COVID-19 will experience long-haul symptoms. It can affect anyone – old and young, otherwise healthy people and those battling other conditions.

    "If it works the way we hope it does, this could be a birth of hope in the fog after COVID."

    Dr. Ryan Klein of NewportNativeMD in Newport Beach, California

    Dr. Klein is the clinical site manager and principal investigator who is conducting OCEL’s “Phase I/II Multicenter, Randomized, Double-Blinded Placebo Trial to Evaluate the Safety and Potential Efficacy of Zofin Infusing Intravenous in Patients Experiencing Prolonged COVID-19 Symptoms vs. the Placebo.”

    TOP PRODUCT CANDIDATE

    OCEL’s top product candidate is Zofin™, an acellular biologic derived from perinatal sources. Zofin is manufactured to retain naturally occurring exosomes, hyaluronic acid, proteins, and microRNAs, without the addition or combination of any other substance or diluent. It contains over 300 growth factors, cytokines, and chemokines as well as extracellular vesicles and nanoparticles.

    MicroRNAs are thought to be the key to Zofin's therapeutic effect. They are packaged into exosomes, which are cell messengers that carry proteins and molecular mediators, that bind and deliver their cargo to other cells which may direct them to repair themselves.

    EXTRACELLULAR VESICLES

    Extracellular Vesicles (EVs) are a type of cell-membrane derived lipid bubbles comprising of exosomes and microvesicles originating from the endosomal system and plasma membrane, respectively. EVs are present in biological fluids and are instrumental in multiple physiological and pathological processes. 

    In recent years, EVs have been found to be a key component in cell-to-cell communication. Depending on their origin, EVs carry specific cargo which allows cells to exchange proteins, lipids, and genetic material. Exchanging cargo can alter the recipient cells behavior, including immune signaling, angiogenesis, stress response, senescence, proliferation, and cell differentiation. 

    EVs are involved in restoring tissue and repairing organ damage and may partially explain the effects observed in other stem cell-based therapies.

    The function and content of EVs may also provide information that can be used in tissue engineering, in which cell signaling is employed to modulate cell recruitment, differentiation, and proliferation.

    OTHER PRODUCTS

    PPX™ is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood. 

    Similar to the origin of growth factors present in platelet-rich plasma (PRP), nanoparticles derived from platelets and peripheral blood mononuclear cells may carry signaling molecules to deliver a regenerative response.

    Factor X™ is an acellular non HCT-P biologic derived from full-term human amniotic fluid, which is manufactured to retain the naturally occurring nanoparticles, diluted in Normal Sterile Saline (dilution is 1 to 4 with Sterile Saline).

    This proprietary therapeutic contains over 300 soluble proteins as growth factors, cytokines, and chemokines; extracellular matrix proteins as fibronectin and collagen; structural molecules as hyaluronic acid, nanoparticles as extracellular vesicles, exosomes, and surfactants.

    Clinical research has identified 102 unique microRNAs contained in these extracellular vesicles which contain approximately 100 billion extracellular vesicles per ml.

    XoTin™ is an acellular non HCT-P biologic derived from full-term Human Amniotic Fluid and is manufactured to only contain the extracellular vesicle fraction, diluted in Normal Sterile Salines.

    It contains approximately 200 Billion extracellular vesicles (exosomes) per ml.

    OCEL’s clinical research team has identified 102 unique microRNAs contained in these extracellular vesicles.

    A CRITICAL MISSION

    Organicell (OCEL)’s mission is to be the first company to prove the efficacy of extracellular vesicles for inflammatory conditions in clinical trials. The company generates revenue by extracting and delivering potent formulas of EVs for various applications.

    REVENUES CLIMBING

    With revenue of $5.6MM in FY 2021 and revenue of $5.8MM YTD FY 2022, this early-stage biotech company is producing big numbers. Many startups have little to no revenue in comparison.

    OCEL also had $4M+ in cash on hand in September to help the company accelerate drug development by funding their clinical trials. The company has two (2) FDA-approved trials being enrolled!

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      SIGNIFICANT HIGHLIGHTS

      • The company was recapitalized and appointed new management in August 2022. The team has relevant domain expertise.
      • The company is generating revenue and is approved for Phase I/II clinical trials for COVID Long Hauler, COPD, and Osteoarthritis.
      • Current accessible capital is now $10MM.
      • Five (5) Investigational New Drugs (IND’s)
      • Eighteen (18) Emergency Investigational New Drugs (eIND’s)
      • Has diversified clinical trials and a unique product offering to disrupt an enormous untapped market.
      • The company is expanding potential market in research with The Beauty Health Company (NASDAQ: SKIN)
      • Attractive valuation relative to market size.

      TRANSLATIONAL PLAN

      INTELLECTUAL PROPERTY  PATENT TIMELINE

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        WHAT MAKES ORGANICELL SPECIAL?

        Supercharged Anti-Inflammatory

        • Patent pending process enable the company to concentrate up to 600 billion EVs per milliliter, which contain over 300 cytokines, chemokines and growth factors.

        Clinical Data, eIND's, IND's

        • 18 Emergency Investigative New Drugs (eIND's) issued - FDA Approved
        • 5 IND's - Investigative New Drug Filing - FDA-Approved first step to clinical trials.
        • 2 Clinical trials - currently enrolling - FDA-Approved

        Potential of EV's efficacy for other applications

        • Hair transplant procedures to expedite healing and reduce swelling.
        • Micro Needling to increase elastin and collagen
        • Dermatological Creams and Serums for commercial sale

        HEALTH AND BEAUTY OPPORTUNITY

        On September 14, 2022 BeautyHealth's Hydrafacial (NASDAQ:SKIN) announced its new partnership with Organicell (OCEL) to create the first-to-market exosome booster for their patented Hydrafacial device. 

        Organicell's science team will work with Hydrafacial to prove the efficacy of how this new booster application may reduce inflammation, increase collagen, and increase elastin while extending the benefits of a traditional Hydrafacial.

        Hydrafacial™ is available in over 90 countries with an install base of nearly 23,000 Delivery Systems providing millions of experiences to consumers each year. 

        Extracellular Vesicles (EVs) are anti-inflammatory in nature. OCEL’s patent pending process allows them to concentrate up to 600 billion EVs per milliliter which contain over 300 cytokines, chemokines, and growth factors.

        OCEL’s science team will be looking into how our products can possibly take the place of a Platelet-Rich Plasma (PRP) procedure for hair restoration. The global hair restoration market size was estimated at US$4.2 billion in 2020!

        This partnership is a great first step into the skincare space. Revenue in the Skin Care segment amounts to US$19.42bn in 2022!

        OCEL’s clinical research team will gather data to see how their EVs may help reduce wrinkles and the early signs of aging. Anti-aging is a monstrous space. According to Precedence Research, the global anti-aging market size is expected to be worth around US$ 119.6 billion by 2030!

        “This partnership is the first of many we are working on in the aesthetic and hair space. Hydrafacial is its own market, and we have given them exclusivity for their applications, however, this partnership paves the way for our science team to start collecting data that may help prove the efficacy of our products on hair restoration and in various topical skincare and aftercare products.”

        Organicell's CEO, Matt Sinnreich

         

        RESEARCH FACILITY

        Organicell Research & Manufacturing facilities are located at the Nova Southeastern University Center for Collaborative Research. The company also maintains a commercial production lab space in Basalt, CO.

        Both facilities are registered with the FDA as a Human Cell and Tissue Establishment compliant with Title 21 of the Code of Federal Regulations, Part 1271 issued by the FDA’s Center for Biologics Evaluation and Research.

        All product manufacturing is performed in a designated clean room space certified to maintain the air quality of ISO-Class 7 with cGMP standards to control the potency and purity of products.

        The company specializes in perinatal tissue-derived products focused on regulatory compliance and data to support the overall efficacy and safety of its products.

        EXECUTIVE LEADERSHIP

        Organicell’s world-class management team combines a proven track record in big business with science and regulatory expertise.

        Management is dedicated to finishing its clinical trials in the near future, especially with respect to Zofin™, as it wants to create an FDA-approved COVID-19 therapy option. 

        "At this stage of growth, it is necessary to invest in people that can handle specific tasks and responsibilities. I am a believer in creating systems for every facet of a business that can be taught, duplicated, and scaled. I made these strategic hires to surround myself with talent with specific core-competencies in the areas of the company that needed enhancement.”

        CEO Matt Sinnreich

        IN SUMMARY

        Biotech has not been this hot since early 2021, when the industry was thrust into the pandemic limelight as Pfizer and its partner BioNTech, Moderna, and Johnson & Johnson launched a trio of Covid vaccines.

        After hitting a six-year low in mid-June, biotech stocks seem to have regained their footing. Shares rose 40% from that point through mid-August, before tapering slightly down.

        Priced at under $1, Organicell (OCEL) is a promising prospect in the blazing biotech arena. The company’s pipeline could be successfully commercialized and may be a game-changer in the medical community.

        OCEL believes that its ground-breaking research in the field of nanotechnology, specifically extracellular vesicles, and perinatal-derived nanoparticles, has created a DRUG CANDIDATE that is the next frontier of regenerative biologic drug therapeutics.

        Learn More about Organicell Regenerative Medicine, Inc. by gaining access to the latest research report

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        Organicell Regenerative Medicine, Inc. is a client of Tradigital IR, an investor relations and communications firm. Please see our disclosures in the research report as well as on our website www.Tradigitalir.com.
        Organicell Regenerative Medicine, Inc. is a client of Tradigital IR, an investor relations and communications firm. Please see our disclosures in the research report as well as on our website www.Tradigitalir.com.

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