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    Nasal Spray (1222)

    Uploaded by

    Kapital Senturi
    Covixyl Nasal Spray creates a protective barrier in the nasal passage to block viruses like COVID-19, flu, and common cold from entering the body. It has been shown to reduce various respiratory viruses by over 99% in clinical trials. The active ingredient, ELAH, is FDA-approved as safe. Covixyl Nasal Spray provides convenient protection against respiratory illnesses anywhere and anytime.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Nasal Spray (1222)

    Uploaded by

    Kapital Senturi
    215 views11 pages
    Covixyl Nasal Spray creates a protective barrier in the nasal passage to block viruses like COVID-19, flu, and common cold from entering the body. It has been shown to reduce various respiratory viruses by over 99% in clinical trials. The active ingredient, ELAH, is FDA-approved as safe. Covixyl Nasal Spray provides convenient protection against respiratory illnesses anywhere and anytime.

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    Covixyl Nasal Spray creates a protective barrier in the nasal passage to block viruses like COVID-19, flu, and common cold from entering the body. It has been shown to reduce various respiratory viruses by over 99% in clinical trials. The active ingredient, ELAH, is FDA-approved as safe. Covixyl Nasal Spray provides convenient protection against respiratory illnesses anywhere and anytime.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    215 views11 pages

    Nasal Spray (1222)

    Uploaded by

    Kapital Senturi
    Covixyl Nasal Spray creates a protective barrier in the nasal passage to block viruses like COVID-19, flu, and common cold from entering the body. It has been shown to reduce various respiratory viruses by over 99% in clinical trials. The active ingredient, ELAH, is FDA-approved as safe. Covixyl Nasal Spray provides convenient protection against respiratory illnesses anywhere and anytime.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 11

    Nasal Spray

    (COVID-19, Flu & Common Cold)

    December 2022 Confidential Information


    Mechanism

    Covixyl Nasal Spray creates protective barriers by coating the entire nasal passage.
    This barrier blocks the coronavirus spike from binding to the ACE2 receptors on
    the cell and the virus can’t gain a foothold in the nasal passage.

    Coronavirus
    Nasopharynx cells Spikes
    (entry point of virus)

    AC2 Receptor
    Respiratory viruses

    Covixyl Nasal Spray effectively inhibits most of respiratory viruses over 99% by
    unique blocking mode of action.

    Log Virus
    Disease Virus Type
    Reduction (10) Reduction (%)

    COVID-19 Delta 3.20 over 99.9%

    COVID-19 Omicron 2.10 over 99%

    Flu Influenza A (H1N1) 5.04 over 99.999%

    Common cold Human coronavirus 3.37 over 99.9%

    Common cold,
    Human RS virus 2.75 over 99%
    Pneumonia

    Diarrhea, Fever Rotavirus A 2.13 over 99%


    Coronavirus variants

    Covixyl Nasal Spray effectively neutralizes Delta and Omicron variants over 99%
    based on live viruses test at BSL-3 laboratory.

    Covixyl vs. Delta Covixyl vs. Omicron


    8
    10 10
    10

    9
    10
    7
    10
    8
    10

    TCID50/ml
    TCID50/ml

    6
    10
    7 10

    6
    10 5
    10
    5
    10
    4
    10
    4
    10 200µg/ml 250µg/ml
    0
    0 100µg/ml 200µg/ml
    TCID50 Assay in Vero-TMPRSS2 cells with Delta variant TCID50 Assay in TMPRSS2 cells with Omicron variant
    Control group Control group

    treated with Covixyl (dilution of 100~200µg/ml) treated with Covixyl (dilution of 200~250µg/ml)
    Safety

    Covixyl Nasal Spray has passed all standard safety testing protocol without harmful
    effect to nasal passage and all ingredients formulated are listed in GRAS of FDA.
    Safety Tests

    Tests Test Method Outcomes Food Preservatives

    Cytotoxicity ISO 10993-05 No cytotoxic with grade zero

    Skin Irritation ISO 10993-10 No irritation with grade zero

    Skin Sensation ISO 10993-10 No sensation with grade zero

    Skin Sensitization ISO 10993-10 No sensitization with grade zero

    Eye Irritation (BCOP) OECD guideline No irritation within IVIS

    Endotoxin NCI guideline Below the limit of detection <0.5 (53)

    β-Glucans NCI guideline Undetectable <5 (87)

    * Active: ELAH 0.1% (Ethyl Lauroyl Arginate Hydrochloride)


    Clinical Trial

    Human clinical trial proves the safety and efficacy of Covixyl Nasal Spray against
    COVID-19.

    Pre-clinical Clinical Trial

    ➢ No adverse events or
    side effects found

    ➢ CRO: Global Clinical Trial (USA) √


    . Period: May ~ October 2021
    ➢ No adverse interaction . Phase of study: Pivotal
    . Location: Miami, FL ➢ 400% more infection-free
    ➢ No body weight change
    . No. of Infected Patients: 30 subject were observed in
    ➢ 99.9% virus neutralization . Use: 2 times/day x 6 days Covixyl group vs. placebo
    Global Recognition

    Cascade Assay Award to Covixyl Nasal Spray and funded joint research with NCI /
    Research paper published in WHO global open access & peer-review in SCI journal
    / 5th Int’l Virology & Infectious Diseases as keynote speaker

    ➢ Prophylactic and Therapeutic Effects of ELAH on


    SARS-CoV-2 Infections (April 2022; global open
    access)
    Regulatory

    The device is approved in UK while CE & FDA are on-going process along with
    global patents and 3 qualified manufacturing sites.

    ➢ Regulatory

    ➢ Patent & Trademark ➢ Manufacturing (USA, UK, Korea)


    Sales

    Covixyl Nasal Spray is available at Walmart and Amazon in the US and it has been
    marketed as licensed brand of BioSure in UK.

    www.walmart.com www.amazon.com www.sprayprotectgo.com


    Application

    Covixyl Nasal Spray is preventative measures against COVID-19, Flu & Common Cold.
    It is designed to work alongside vaccines and masks.

    ➢ Anywhere & Anytime : before going out,


    work or school, when commuting, in the
    crowded areas, or public places.

    ➢ 2 times per day


    Reapply at anytime to maintain protection.

    ➢ Clinically proven to safely and effectively


    provide protection against COVID-19, Flu,
    and common colds
    Summary

    Covixyl Nasal Spray protects from COVID-19, Flu and Common Colds anywhere
    and anytime.

    Summary of Product

    ➢ Brand: COVIXYL Nasal Spray

    ➢ Size: 400 sprays (=20ml)

    ➢ Use period: 50 days (2 times/day)

    ➢ MSRP: U$18.99 / Bottle ($0.38/day)

    ➢ Claims
    Protect against respiratory
    viruses causing COVID-19 & Flu

    ➢ Regulatory: Approved by medical


    device in UK, Korea, and South
    America (pending FDA & CE)

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