What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2021-02-08 compared with 2020-10-16 · 686 added, 918 removed, 57 unchanged (97% of the section changed)

We are engaged in the health care industry,

principally focusing on supplying products and services related to the growing field of regenerative anti-aging medicine (“RAAM”).

Our focus is the processing, distribution and supply of biologically processed cellular and tissue-based products developed from

internally-based research and development activities and/or from other state-of-the-art RAAM-related products developed by third

parties under exclusive and/or favorable supply arrangements and to provide other related services used in the regenerative medicine

field (“RAAM Products”).

Organicell distributes and supplies the RAAM Products and market RAAM-related services to

the health care industry through a doctors and clinics (collectively, the “Providers”).

From November 2016 to February 2018, we

operated our own laboratory facilities to process and distribute RAAM Products developed through trade secrets acquired in connection

with the employment of newly hired executives during November 2016 and March 2017.

During this time, we also implemented an in-house

sales force and made arrangements with newly identified independent distributors to sell our RAAM Products.

In February 2018, we sold or transferred

our laboratory facilities and all related assets (“Sale”), including intellectual property rights, to Vera Acquisition

LLC, a Utah limited liability company (“Vera”).

From the date of the Sale until the Company’s new laboratory

facility became operational, as described below, the Company relied on short-term supply agreements with third party manufacturers

to provide it with the products it sold and distributed to its customers.

Commencing in February 2019, the Company

began taking steps to once again operate a placental tissue bank processing laboratory in Miami, Florida for the purpose of performing

research and development and the manufacturing and processing of anti-aging and cellular therapy derived products.

This new laboratory

facility became operational in May 2019 and thereupon, the Company began producing products that are now being sold and distributed

to its customers.

The Company has actively taken steps to

meet compliance with current and anticipated United States Food and Drug Administration (“FDA”) regulations expected

to be enforced beginning in May 2021 requiring that the sale of products that fall under Section 351 of the Public Health Services

Act pertaining to marketing traditional biologics and human cells, tissues and cellular and tissue based products (“HCT/Ps”)

can only be sold pursuant to an approved biologics license application (“BLA”).

To date, the Company has obtained approximately

14 Investigation New Drug (“IND”), emergency IND (“eIND”) and/or non-emergency IND (“non-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 the Company’s products and related treatment protocols.

The Company is aggressively pursuing efforts to commence and complete the clinical studies 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.

COVID-19 Impact To Economy And Business

The current outbreak of the novel coronavirus

(“COVID-19”) and resulting impact to the United States economic environments began to take hold during March 2020.

The adverse public health developments and economic effects of the COVID-19 outbreak in the United States, have adversely affected

the demand for our products and services by our customers and from patients of our customers as a result of quarantines, facility

closures and social distancing measures put into effect in connection with the COVID-19 outbreak and which currently still continue

to have a negative impact to our business and the economy.

These restrictions have adversely affected the Company’s sales,

results of operations and financial condition.

In response to the COVID-19 outbreak, the Company (a) has accelerated its research

and development activities, particularly in regards to potential health benefits of the Company’s products in addressing

various health concerns associated with COVID-19 and (b) is aggressively seeking to raise additional debt and/or equity financing

to support working capital requirements until sale for its products to providers resumes to levels pre COVID-19.

There is no assurance as to when the adverse

impact to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether

any new or recurring pandemic outbreaks will occur again in the future causing similar or worse devastating impact to the United

States and worldwide economies and to our business.

Developments During Fiscal 2018 and

After the completion of the Sale of our

laboratory facilities and all related assets, including intellectual property rights, to Vera in February 2018, the Company remained

in the business of selling and distributing regenerative biologic therapies based on amnion placental tissue derived products to

doctors and hospitals but was required to depend on third party supply agreements, rather than from products manufactured internally

by ANU, for the supply of these advanced biologically processed cellular and tissue based products.

Since the Sale was completed, including

the departure of several key executives in connection therewith, the Company had difficulty in generating sufficient revenues and,

as a result, continued to have a lack of working capital to meet current operating costs, hiring of additional sales personnel,

pay past due accounts payable obligations to its vendors, pay past due and/or current salaries to its remaining management or fund

potential growth opportunities.

On April 23, 2018, the Company and Management

and Business Associates, LLC, a Florida limited liability company (“MBA”), executed a Plan and Agreement of Reorganization

(“Reorganization”) whereby the Company agreed to issue to MBA an aggregate of 222,425,073 shares of its common stock

of the Company, representing at the time 51% of the outstanding shares of common stock of the Company on fully-diluted basis, for

$0.001 per share (or an aggregate of $222,425), in consideration for Mr.

Manuel Iglesias’

agreement to serve as the Company’s

Chief Executive Officer and a member of the Board of the Company.

Iglesias is the sole Manager of MBA and thus may be

deemed to control MBA.

The Reorganization was effective as of April 13, 2018 (“Effective Date”).

On May 21, 2018, the Company filed a Certificate

of Amendment with the Secretary of State of Nevada to change the Company’s name from Biotech Products Services and Research,

to Organicell Regenerative Medicine, Inc., effective June 20, 2018 in order to express more clearly the Company’s focus

in the stem cell business (the “Name Change”).

However, due to the Company’s failing to have the required Exchange

Act reports filed with the SEC at the time of the filing, FINRA did not announce or effectuate the Name Change in the marketplace.

If the Company intends to proceed with the Name Change, the Company will be required to submit a new Issuer Company-Related Notification

Form for approval upon the Company becoming current in its Exchange Act filings.

On June 14, 2018, the Company filed a Certificate

of Withdrawal with the Secretary of State of Nevada thereby withdrawing and terminating all previously issued designations of the

Company’s Series A Preferred Stock and Series B Preferred Stock.

On June 1, 2018, the Company submitted an Issuer Company-Related

Notification Form (“June 1 Notification Form”) with the Financial Industry Regulatory Agency (“FINRA”)

pursuant to Rule 10b-17 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), regarding the Name

Change and Reverse Split.

During February 2019, the Company began

arranging to once again operate a new laboratory facility in Miami, Florida for the purpose of performing research and development,

production and manufacturing of anti-aging and cellular therapy products.

This new laboratory facility became operational in May

2019 and during the same period, the Company began producing and distributing the products that are being sold and distributed

to its customers.

The Company believes that this strategy will provide the Company with competitive advantages and greater assurances

that it can continue to comply with expected future FDA regulations.

On September 24, 2019, due to the Company’s

limited success since the Reorganization in stabilizing revenues and the growing urgency for the Company to remain compliant and

meet the anticipated new and more stringent regulatory deadlines to be imposed by the FDA in connection with the Company’s

products and operations that were previously announced to go into effect in May 2021, the Board determined that it would require

the services of a full-time CEO with the requisite expertise and experience to lead the Company as it (a) moves forward with its

strategy to expand its research and development efforts and submit IND applications for FDA approval to commence clinical trials

for its products to assure that the Company, its operations and its products remain compliant with FDA regulations and (b) implements

additional strategies to minimize the potential impact in the future on sales of its products as a result of future changes in

FDA regulations and/or restrictions associated with clinical trials that are utilizing the products that are currently being sold

by the Company.

Accordingly, the Board voted to remove Manuel Iglesias from his position as CEO of the Company.

The Board has since

appointed Albert Mitrani to serve as the Company’s CEO.

In connection with the Company’s

ongoing research and development efforts and the Company’s efforts to meet compliance with current and anticipated United

States Food and Drug Administration (“FDA”) regulations expected to be enforced beginning in May 2021 requiring that

the sale of products that fall under Section 351 of the Public Health Services Act pertaining to marketing traditional biologics

and human cells, tissues and cellular and tissue based products (“HCT/Ps”) can only be sold pursuant to an approved

biologics license application (“BLA”), the Company has obtained certain Investigation New Drug (“IND”),

emergency IND (“eIND”) and/or non-emergency IND (“non-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 the Company’s products and related treatment protocols.

The status of the Company’s current

IND’s, eIND’s, non-eIND’s submitted and approved for past or planned treatments and/or clinical trials are described

Company’s FDA approved

phase I/II IND, eIND’s and non-eIND’s:

IND # 19881 approved on 04/30/2020 - A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate

the Safety and Potential Efficacy of Intravenous Infusion of OrganicellTM Flow for the Treatment of Moderate to Severe Acute Respiratory

Syndrome (SARS) Related to COVID-19 Infection vs Placebo.

IRB was approved by the Institute of Regenerative and Cellular Medicine

(“IRCM”) on 06/04/2020 (approval number:

are 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.

Our 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 (“RAAM Products”).

Our RAAM Products and related services are principally used in the health care industry

administered through doctors and clinics (collectively, the “Providers”).

November 2016 to February 2018, we operated our own laboratory facilities to process and distribute RAAM Products developed through

trade secrets acquired in connection with the employment of newly hired executives during November 2016 and March 2017.

this time, we also implemented an in-house sales force and made arrangements with newly identified independent distributors to

sell our RAAM Products.

February 2018, we sold or transferred our laboratory facilities and all related assets (“Sale”), including intellectual

property rights, to Vera Acquisition LLC, a Utah limited liability company (“Vera”).

From the date of the Sale until

the Company’s new laboratory facility became operational, as described below, the Company relied on short-term supply agreements

with third party manufacturers to provide it with the products it sold and distributed to its customers.

in February 2019, the Company began taking steps to once again operate a placental tissue bank processing laboratory in Miami,

Florida for the purpose of performing research and development and the manufacturing and processing of anti-aging and cellular

therapy derived products.

This new laboratory facility became operational in May 2019 and thereupon, the Company began producing

products that are now being sold and distributed to its customers.

Company’s leading product, Zofin™

(Organicell TM 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.

Company has actively taken steps to meet compliance with current and anticipated United States Food and Drug Administration

(“FDA”) regulations expected to be effective beginning in May 2021 that will require that the sale of products

that fall under Section 351 of the Public Health Services Act pertaining to marketing traditional biologics and human cells,

tissues and cellular and tissue based products (“HCT/Ps”) can only be sold pursuant to an approved biologics

license application (“BLA”).

To date, the Company has obtained certain Investigation New Drug

(“IND”), and 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™

(Organicell TM Flow) and related treatment protocols.

The Company is pursuing efforts to

commence and complete the clinical studies 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.

November 2020, the Company formed Livin Again Inc., a wholly owned subsidiary of the Company for the purpose of among other things,

providing independent education, advertising and marketing services, (“Marketing Services”) to providers that provide

medical and other healthcare, anti-aging and regenerative services (“Regenerative Services”) including FDA-approved

IV vitamin and mineral liquid infusions (“IV Drip Therapies”).

The Company intends to initially market such services

by coordinating turnkey opportunities for Providers to provide IV Drip Therapies at select properties and locations.

Impact To Economy And Business Environment

current outbreak of the novel coronavirus (“COVID-19”) and resulting impact to the United States economic environments

began to take hold during March 2020.

The adverse public health developments and economic effects of the COVID-19 outbreak in

the United States, have adversely affected the demand for our products and services by our customers and from patients of our

customers as a result of quarantines, facility closures and social distancing measures put into effect in connection with the

COVID-19 outbreak and which currently still continue to have a negative impact to our business and the economy.

These restrictions

have adversely affected the Company’s sales, results of operations and financial condition.

In response to the COVID-19

outbreak, the Company (a) has accelerated its research and development activities, particularly in regards to potential health

benefits of the Company’s products in addressing various health concerns associated with COVID-19 and (b) is seeking to

raise additional debt and/or equity financing to support working capital requirements until sale for its products to providers

resumes to levels pre COVID-19.

is no assurance as to when the adverse impact to the United States and worldwide economies resulting from the COVID-19 outbreak

will be eliminated, if at all, and whether any new or recurring pandemic outbreaks will occur again in the future causing similar

or worse devastating impact to the United States and worldwide economies and to our business.

Compliance Steps

connection with the Company’s ongoing research and development efforts and the Company’s efforts to meet

compliance with current and anticipated United States Food and Drug Administration (“FDA”) regulations expected

to be enforced beginning in May 2021 requiring that the sale of products that fall under Section 351 of the Public Health

Services Act pertaining to marketing traditional biologics and human cells, tissues and cellular and tissue based products

(“HCT/Ps”) can only be sold pursuant to an approved biologics license application (“BLA”), the

Company has obtained certain Investigation New Drug (“IND”) and 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 the Company’s products and related treatment protocols.

The status of the Company’s current IND’s

and eIND’s submitted and approved for past or planned treatments and/or clinical trials are described

Company’s FDA submitted and/or approved phase I/II IND’s and eIND’s:

# 19881 approved on 04/30/2020 - A Phase I/II Randomized, Double Blinded, Placebo Trial

to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of OrganicellTM

Flow for the Treatment of Moderate to Severe Acute Respiratory Syndrome (SARS) Related

to COVID-19 Infection vs Placebo.

IRB was approved by the Institute of Regenerative and

Cellular Medicine (“IRCM”) on 06/04/2020 (approval number:

IRCM-2020-254).

Clinical trial is currently in process.

eIND#22370 approved on 05/11/2020 - Treatment for Acute hypoxic respiratory failure with ARDS secondary

The clinical trial is currently in process.

A total of nine patients have been enrolled

to the study thus far.

approved on 05/11/2020 - Treatment for Acute hypoxic respiratory failure with ARDS secondary

to COVID-19 infection for single patient.

eIND#22371 approved on 05/11/2020 - Treatment for Acute hypoxic respiratory secondary to bilateral pneumonia

approved on 05/11/2020 - Treatment for Acute hypoxic respiratory secondary to bilateral

pneumonia secondary to COVID-19 with ARDS for single patient.

approved on 05/29/2020 –

Treatment for Acute respiratory failure with hypoxia,

secondary to COVID-19 with ARDS for single patient.

eIND#22897 approved on 05/29/2020 –

Treatment for Acute respiratory

failure with hypoxia, secondary to COVID-19 with ARDS for single patient.

eIND#25426 approved on 07/24/2020 - Treatment of COVID-19 positive

for single patient.

eIND#25888 approved on 8/01/2020 - Treatment of post COVID-19 complication for single patient

eIND#26560 approved on 8/17/2020 - Treatment of post-COVID-19 complications for single patient.

eIND#26561 approved on 8/17/2020 - Treatment of post-COVID-19 complications for single patient.

eIND#26676 approved on 8/20/2020 - Treatment of respiratory failure due to COVID-19 infection for single

eIND#26700 approved on 8/21/2020 - Treatment for ARDS associated with COVID-19 for single patient.

eIND#26776 approved on 8/25/2020 - Treatment of COVID-19 positive for single patient.

eIND#26777 approved on 8/25/2020 - Treatment of COVID-19 positive for single patient.

eIND#26864 approved on 9/05/2020 - Treatment of COVID-19 positive for single patient.

Non-eIND#26821 approved on 9/22/2020 - Treatment of post COVID-19 complications for single patient.

Expanded Access to Zofin TM (Organicell TM Flow) approved on 09/24/2020 - Treatment

of Patients with COVID-19 Outpatient and Inpatient Population.

A Phase II Multicenter, Randomized, Double Blinded, Placebo Trial to Evaluate the Efficacy and

Safety of Intramuscular Injections of ZofinTM Comparing with Intravenous Infusions for the Treatment of Post COVID-19 Complications

and Severe Sequelae vs Placebo.

IND submitted on 09/28/2020.

approved on 07/24/2020 - Treatment of COVID-19 positive for single patient.

approved on 8/01/2020 - Treatment of post COVID-19 complication for single patient.

approved on 8/17/2020 - Treatment of post-COVID-19 complications for single patient.

approved on 8/20/2020 - Treatment of respiratory failure due to COVID-19 infection for

single patient.

approved on 8/21/2020 - Treatment for ARDS associated with COVID-19 for single patient.

approved on 8/25/2020 - Treatment of COVID-19 positive for single patient.

approved on 9/05/2020 - Treatment of COVID-19 positive for single patient.

approved on 9/22/2020 - Treatment of post COVID-19 complications for single patient.

approved on 10/10/2020 - Treatment for ARDS associated with COVID-19 for single patient.

approved on 10/14/2020 - Treatment for ARDS associated with COVID-19 for single patient.

approved on 10/16/2020 - Treatment for ARDS associated with COVID-19 for single patient.

approved on 12/04/2020 - Treatment of mild to moderate symptoms of COVID-19 for a single

approved on 12/04/2020 - Treatment of COVID-19 pneumonia and respiratory failure with

ARDS for a single patient.

Access to Zofin TM (Organicell TM Flow) approved on 09/24/2020 -

Treatment of Patients with COVID-19 Outpatient and Inpatient Population.

Expected to start trial during fiscal year ended October 31, 2021.

Phase I/II Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy

of Intravenous Infusion of Zofin™

(Organicell TM Flow) for the Treatment

of patients diagnosed with chronic obstructive pulmonary disease (COPD).

on January 27, 2021.

Expected to start trial during fiscal year ended October 31, 2021.

Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential

Efficacy of Intravenous Infusion of Zofin TM (Organicell TM Flow)

for the Treatment of Post COVID-19 Complications “Long Haulers”

Pending IND and IRB approval.

The Company is aggressively pursuing efforts

to commence and complete the above described clinical studies 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 the approval from the FDA.

Industry Overview

Health Care Industry Overview:

The traditional health care industry in

the United States is predominantly controlled by the rules of the Centers for Medicare & Medicaid Services (“CMS”)

(wwws.cms.gov) and commercial health insurance companies.

Company is pursuing efforts to commence and complete the above-described clinical studies 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.

Care Industry Overview

traditional health care industry in the United States is predominantly controlled by the rules of the Centers for Medicare &

Medicaid Services (“CMS”) (wwws.cms.gov) and commercial health insurance companies.

This control limits patients’

access to alternative medical therapies,

that recent medical literature demonstrates highly beneficial outcomes in the field of anti-aging and regenerative medicine.

allopathic medicine of health care provided to patients in the United States relies on government and commercial health insurance

for payment of the costs associated with their day-to-day health care.

Because of this close relationship, physicians must follow

government and commercial insurers guidelines in order to stay in the plans and receive reimbursement.

Physicians are restricted

in their ability to expand the nature of the treatments provided beyond industry practices because of legal ramifications and/or

lack of knowledge concerning protocol of cutting-edge anti-aging and regenerative medical treatments.

Despite the above, anecdotal and medical

literature has shown an increased demand by patients for access to alternative medical therapies and treatments.

Patients are seeking

these alternatives to traditional allopathic medicine, due to the adverse events associated with traditional pharmaceuticals, risks

associated with surgeries, and that traditional medicine and insurers are not addressing wellness or preventive medicine sufficiently.

To address a wide variety of aging issues, safe alternatives to pathologies, including access to other treatments and pharmaceuticals

and to achieve beneficial “elective”

health treatments, we intend utilize the latest regenerative technologies.

alternative pathways to date have had significant restrictions because of regulations imposed by the FDA, other regulatory bodies

and insurers due to lack of randomized controlled studies, yet many published case series demonstrate safety and efficacy.

and consumers are looking to safe alternatives compared more traditional medicine, including the following:

Cellular/ Tissue based therapies

o Adipose-derived stromal vascular fraction

o Bone marrow-derived stem cell therapies

o Peripheral blood derived therapies ( i.e., platelet rich plasma);

o Placental-based therapies

Technology documented since 1910 for safety and efficacy, tissue processed from human amniotic

membrane and fluid, donated by consenting mothers delivering a full-term healthy baby by scheduled Caesarean section, avoiding

any ethical or moral concerns, proven safety record, case series documented success in a multitude of systemic and local pathologies

o Growth factor, cytokine therapies

o Supplements

Medical foods

o Weight control

o Topical lotions and creams for the largest organ the skin

Nontraditional medical alternatives

o Acupuncture

o Naturopathic

o Chiropractic

access to alternative medical therapies, that recent medical literature demonstrates highly beneficial outcomes in the field of

anti-aging and regenerative medicine.

Traditional allopathic medicine of health care provided to patients in the United States

relies on government and commercial health insurance for payment of the costs associated with their day-to-day health care.

of this close relationship, physicians must follow government and commercial insurers guidelines in order to stay in the plans

and receive reimbursement.

Physicians are restricted in their ability to expand the nature of the treatments provided beyond industry

practices because of legal ramifications and/or lack of knowledge concerning protocol of cutting-edge anti-aging and regenerative

medical treatments.

the above, anecdotal and medical literature has shown an increased demand by patients for access to alternative medical therapies

and treatments.

Patients are seeking these alternatives to traditional allopathic medicine, due to the adverse events associated

with traditional pharmaceuticals, risks associated with surgeries, and that traditional medicine and insurers are not addressing

wellness or preventive medicine sufficiently.

To address a wide variety of aging issues, safe alternatives to pathologies, including

access to other treatments and pharmaceuticals and to achieve beneficial “elective”

health treatments, we intend utilize

the latest regenerative technologies.

These alternative pathways to date have had significant restrictions because of regulations

imposed by the FDA, other regulatory bodies and insurers due to lack of randomized controlled studies, yet many published case

series demonstrate safety and efficacy.

Patients and consumers are looking to safe alternatives compared more traditional medicine,

including the following:

Tissue based therapies

○ Adipose-derived

stromal vascular fraction

marrow-derived stem cell therapies

blood derived therapies ( i.e., platelet rich plasma);

○ Placental-based

documented since 1910 for safety and efficacy, tissue processed from human amniotic membrane

and fluid, donated by consenting mothers delivering a full-term healthy baby by scheduled

Caesarean section, avoiding any ethical or moral concerns, proven safety record, case

series documented success in a multitude of systemic and local pathologies

factor, cytokine therapies

○ Supplements

lotions and creams for the largest organ the skin

● Nontraditional

medical alternatives

○ Acupuncture

○ Naturopathic

○ Chiropractic

● Self-directed

Currently, patients who desire alternative

treatments rely on the following options:

n Medical Tourism

o In United States

o Off-shore United States

Central and South America

n Consulting directly with physicians knowledgeable in providing regenerative medical services

n Unlicensed life coaches

Business Strategy

patients who desire alternative treatments rely on the following options:

United States

and South America

directly with physicians knowledgeable in providing regenerative medical services

Business Strategy :

Our current business strategy is to achieve

the following goals and milestones:

Develop and expand operations

to provide for growth of our revenues for the sales and distribution of RAAM related products;

o Increase revenues for RAAM related products;

Hiring of additional in-house sales personnel

Selectively engaging independent distributors

Marketing private label products to distributors

Increasing market recognition for our Organicell brand from:

marketing and participating in industry trade shows

o Expand our sales market outside of the United States

o Increase the number of RAAM product offerings for various modalities using proprietary processing,

current business strategy is to achieve the following goals and milestones:

on current strategy to commence and complete clinical studies as well as obtaining approval

to commence additional studies for other specific indications that we identify that the

use of our products will provide more favorable and desired health related benefits for

patients seeking alternative treatment options than are currently available.

clinical based studies associated with the use of our products (independently and/or

in conjunction with Providers and/or Manufacturers) and seek accelerated approval for

each product application in accordance with the 21st Century Cures Act (“Cures

Act”) and/or through the granting of an FDA-approved biologics application (BLA)

to allow products to be lawfully marketed and/or sold in the United States;

the Company’s maintains compliance with existing and the anticipated changes to

FDA regulations, including the use and sale of tissue-based products (HCT/Ps) published

in November 2017 and expected to take effect by May 2021, as well as readiness to respond

to ongoing future changes to regulations impacting our products;

to build out our lab facilities to meet expected production and research requirements;

high profile and industry recognized medical advisors, researchers and/or scientists

to help identify and develop new and emerging technologies concerning biologics and to

assure our Products remain cutting edge and competitive to products offered by other

alternative products and services to (a) offset any potential decline in revenues resulting

from FDA limitations on the sales and distribution of our existing products currently

being sold and distributed as a result of our commencement of clinical trials using such

products and/or future expected FDA restrictions on RAAM products and (b) provide our

Providers with alternative product and treatment options to remain competitive with the

market and our Providers to meet the needs and demands of their patients;

our sales market and network of Providers outside of the United States

sources of exclusive and superior suppliers of RAAM products;

strategic relationships to acquire existing Providers and/or suppliers or owners of IP

associated with additional desired RAAM products;

and expand operations to provide for growth of our revenues;

revenues for RAAM related products;

of additional in-house sales personnel

● Selectively

engaging independent distributors

private label products to distributors

market recognition for our Organicell brand from:

and participating in industry trade shows

our sales market outside of the United States

the number of RAAM product offerings for various modalities using proprietary processing,

formulas and administration techniques

o Extending our referral network of Providers based on:

Superior product offerings

Demonstrating a realistic and executable regulatory roadmap to assure Company and product compliance

additional revenues from IV Drip Therapies to be conducted through Livin Again

our referral network of Providers based on:

product offerings

● Demonstrating

a realistic and executable regulatory roadmap to assure Company and product compliance

with current and anticipated FDA regulations

Developing and providing educational support to Providers regarding our products and regulatory

Execute on current strategy

to assure the Company’s ability to maintain compliance with existing and the anticipated changes to FDA regulations regarding

the use and sale of our current products published in November 2017 and expected to take effect by May 2021, as well as readiness

to respond to ongoing future changes to those regulations:

o Perform clinical based studies associated with the use of our products (independently and/or in

conjunction with Providers and/or Manufacturers) and seek accelerated approval for each product application in accordance with

the 21st Century Cures Act (“Cures Act”) and/or through the granting of an FDA-approved biologics application (BLA)

to allow products to be lawfully marketed and/or sold in the United States in accordance with newly established FDA guidelines

outlined in November 2017 expected to take effect by May 2021;

o Continue to build out our lab facilities to meet expected production and research requirements;

o Engage high profile and industry recognized medical advisors and scientists to help identify new

and emerging technologies concerning biologics and to assure our Products remain cutting edge and competitive to products offered

by other companies;

o Identify alternative products and services to (a) offset any potential decline in revenues resulting

from FDA limitations on the sales and distribution of our existing products currently being sold and distributed as a result of

our commencement of clinical trials using such products and/or future expected FDA restrictions on RAAM products and (b) provide

our Providers with alternative product and treatment options to remain competitive with the market and our Providers to meet the

needs and demands of their patients;

o Expand our sales market and network of Providers outside of the United States

o Identify sources of exclusive and superior suppliers of RAAM products;

o Identify strategic relationships to acquire existing Providers and/or suppliers or owners of IP

associated with additional desired RAAM products;

o Engage new researchers that bring additional expertise and capacity to develop ongoing research

and development and growth opportunities for additional RAAM-related products.

Secure additional working capital;

o Fund shortfalls in working capital to fund ongoing expenses and required payments to vendors and

creditors until revenues are stabilized;

o Fund ongoing costs to pursue clinical trials;

o Fund capital expenditures associated with maintaining compliance of our facilities and products;

o Fund our strategy to develop and expand our revenues for the sales and distribution of RAAM related

products described above;

o Hire additional personnel to support our growth and planned expansion;

o Enhance our CRM, e-commerce and ERP capabilities to facilitate marketing,

sales and distribution functionality and accounting for our operations.

Enhance Company Corporate Governance;

o Revisit previously announced plans to complete a reverse split, and a reduction in the authorized

and providing educational support to Providers regarding our products and regulatory

additional working capital;

shortfalls in working capital to fund ongoing expenses and required payments to vendors

and creditors until revenues are stabilized;

ongoing costs to pursue clinical trials;

capital expenditures associated with maintaining compliance of our facilities and products;

our strategy to develop and expand our revenues for the sales and distribution of RAAM

related products described above;

additional personnel to support our growth and planned expansion;

our CRM, e-commerce and ERP capabilities to facilitate marketing, sales and distribution

functionality and accounting for our operations.

Company Corporate Governance;

previously announced plans to complete a reverse split, and a reduction in the authorized

shares outstanding.

The Company believes a reverse split will bring value to the issued and outstanding shares of the Company by

limiting dilution of operating results by an excessive number of shares overhanging the market;

o Appoint additional independent members to the Board of Directors that will provide overall industry

expertise and fulfill audit committee and independent director requirements to meet listing requirements for the national stock

o Continue to develop and expand the Company’s internal control policies

Potential Effects of COVID-19 Pandemic

The current outbreak of the novel coronavirus

(“COVID-19”) and resulting impact to the United States economic environments began to take hold during March 2020.

The adverse public health developments and economic effects of the COVID-19 outbreak in the United States, have adversely affected

the demand for our products and services by our customers and from patients of our customers as a result of quarantines, facility

closures and social distancing measures put into effect in connection with the COVID-19 outbreak and which currently still continue

to have a negative impact to our business and the economy.

These restrictions have adversely affected the Company’s sales,

results of operations and financial condition.

In response to the COVID-19 outbreak, the Company (a) has accelerated its research

and development activities, particularly in regards to potential health benefits of the Company’s products in addressing

various health concerns associated with COVID-19 and (b) is aggressively seeking to raise additional debt and/or equity financing

to support working capital requirements until sale for its products to providers resumes to levels pre COVID-19.

There is no assurance as to when the adverse

impact to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether

any new or recurring pandemic outbreaks will occur again in the future causing similar or worse devastating impact to the United

States and worldwide economies.

Market Overview

The population of the United States and

the developed world is getting older and living longer.

According to a United States Consensus Bureau’s report, “An

America’s 65-and-over population is projected to nearly double over the next three decades, ballooning

from 48 million to 88 million by 2050 and that worldwide, the 65-and-over population will more than double to 1.6 billion by 2050.

The Company believes a reverse split will bring value to the issued

and outstanding shares of the Company by limiting dilution of operating results by an

excessive number of shares overhanging the market;

additional independent members to the Board of Directors that will provide overall industry

expertise and fulfill audit committee and independent director requirements to meet listing

requirements for the national stock exchanges;

to develop and expand the Company’s internal control policies

population of the United States and the developed world is getting older and living longer.

According to a United States Consensus

Bureau’s report, “An Aging World:

America’s 65-and-over population is projected to nearly double

over the next three decades, ballooning from 48 million to 88 million by 2050 and that worldwide, the 65-and-over population will

more than double to 1.6 billion by 2050.

According to the report, in 2015, 14.9% of the U.S.

population was 65 or over and the United States was the 48th oldest country

out of 228 countries and areas in the world in 2015.

Baby boomers began reaching age 65 in 2011 and by 2050 the older share of

population was 65 or over and the

United States was the 48th oldest country out of 228 countries and areas in the world in 2015.

Baby boomers began reaching age

65 in 2011 and by 2050 the older share of the U.S.

population will increase to 22.1%.

The world average age of death has increased

by 35 years since 1970, with declines in death rates in all age groups, including those aged 60 and older (Source:

Institute for

Health Metrics and Evaluation, 2013;

world average age of death has increased by 35 years since 1970, with declines in death rates in all age groups, including those

aged 60 and older (Source:

Institute for Health Metrics and Evaluation, 2013;

Mathers et al., 2015).

The leading causes of death are shifting, in part because of increasing

Between 1990 and 2013, the number of deaths from non-communicable diseases (“NCDs”) has increased by 42%;

and the largest increases in the proportion of global deaths took place among the population aged 80 and over.

An estimated 42.8%

of deaths worldwide occur in the population aged 70 and over, with 22.9% in the population aged 80 and over.

Also, according to the Center for Disease

Control (“CDC”), “Medical Tourism”

(a term commonly used to describe people traveling outside their home

country for medical treatment) is a worldwide, multibillion-dollar phenomenon that is expected to grow substantially in the next

5–10 years.

Studies have estimated that hundreds of thousands of medical tourists travel from the United States annually

and that p atients pursue medical care abroad for a variety of reasons, including a

desire to receive a procedure or therapy not available in their country of residence.

The leading causes of death

are shifting, in part because of increasing longevity.

Between 1990 and 2013, the number of deaths from non-communicable diseases

(“NCDs”) has increased by 42%;

and the largest increases in the proportion of global deaths took place among the population

aged 80 and over.

An estimated 42.8% of deaths worldwide occur in the population aged 70 and over, with 22.9% in the population

aged 80 and over.

according to the Center for Disease Control (“CDC”), “Medical Tourism”

(a term commonly used to describe

people traveling outside their home country for medical treatment) is a worldwide, multibillion-dollar phenomenon that is expected

to grow substantially in the next 5–10 years.

Studies have estimated that hundreds of thousands of medical tourists

travel from the United States annually and that patients pursue medical care abroad for a variety of reasons, including a desire

to receive a procedure or therapy not available in their country of residence.

Common categories of procedures that US travelers

2 unchanged sentences

Common destinations include Thailand, Mexico, Singapore, India, Malaysia, Cuba, Brazil, Argentina, and Costa Rica.

If we are able to implement our intended

business plan, we believe that we will be well situated to address this increased consumer demand for alternative medical treatments.

Marketing and Sales

Currently, we market our RAAM products

and services to a network of Providers through in-house, contracted sales personnel and/or from independent distributors.

October 31, 2019, we had two salespeople who marketed our RAAM products and services by using social media outlets, medical conferences

and seminars and from development of prior and newly identified Providers and related professional relationships.

we had arrangements with several independent distributors that were marketing and distributing our products.

we are able to implement our intended business plan, we believe that we will be well situated to address this increased consumer

demand for alternative medical treatments.

we market our RAAM products and services to a network of Providers through in-house, contracted sales personnel and/or from independent

distributors.

As of October 31, 2020, we had four salespeople who marketed our RAAM products and services.

In addition, we had

arrangements with several independent distributors that were marketing and distributing our products.

We intend in the future

to expand our in-house sales force and independent distributors as our working capital improves, our product line expands and as

volumes increase.

We also intend to develop and offer ongoing training seminars to provide the best possible information on the

latest advances on anti-aging, and regenerative medicine to Providers.

Sources and Availability of Raw

Materials and the Names of Principal Suppliers

From the completion of the Sale in February

2018 through April 2019, we purchased all of our RAAM Products through supply arrangements directly with third-party manufacturers

or indirectly from distributors of other third-party manufacturers.

Beginning May 2019, we once again began

to manufacture our own RAAM Products in our newly developed Miami, Florida laboratory facilities and acquired the required raw

materials and supplies for our RAAM research and development and the manufacturing of our RAAM placental-related products from

unaffiliated third-party laboratories pursuant Supply Arrangements.

In the event any one or more of our current

suppliers are unwilling or unable to sell us required raw materials and/or products, for any reason, we may not be able to provide

replacement products to our customers, or if other supply arrangements can be made, the replacement products and terms may not

be as favorable.

Dependence on One or a Few Major

During the year ended October 31, 2019,

one customer accounted for approximately 12.2% of our revenues.

Our RAAM business is not expected to be dependent on any one or

more customers, especially as our customer and distribution network expands.

We expect that our customer and consumers will be

broad based and throughout the United States and worldwide.

Patents, Trademarks, Licenses,

Franchises, Concessions, Royalty Agreements or Labor Contracts

The table below sets forth a summary of

our intellectual property rights.

Patent Applications:

to expand our in-house sales force and independent distributors as our working capital improves, our product line expands and

as volumes increase.

We also intend to develop and offer ongoing training seminars to provide the best possible information on

the latest advances on anti-aging, and regenerative medicine to Providers.

Materials and Sources of Supply

the completion of the Sale in February 2018 through April 2019, we purchased all of our RAAM Products through supply arrangements

directly with third-party manufacturers or indirectly from distributors of other third-party manufacturers.

May 2019, we once again began to manufacture our own RAAM Products in our newly developed Miami, Florida laboratory facilities

and acquired the required raw materials and supplies for our RAAM research and development and the manufacturing of our RAAM placental-related

products from unaffiliated third-party laboratories pursuant Supply Arrangements.

the event any one or more of our current suppliers are unwilling or unable to sell us required raw materials and/or products,

for any reason, we may not be able to provide replacement products to our customers, or if other supply arrangements can be made,

the replacement products and terms may not be as favorable.

RAAM business is not dependent on any one or more customers, especially as our customer and distribution network expands.

customer base is increasingly broad based and throughout the United States and worldwide.

table below sets forth a summary of our intellectual property rights.

Applications:

Organicell TM

1 unchanged sentence

of products and the proprietary techniques used in during processing perinatal fluid.

Provisional Patent Application

COMPOSITIONS COMPRISING

NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

Provisional Patent Application No.

COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

April 10, 2020

Maria Ines Mitrani

Organicell Regenerative

Medicine, Inc.

Conversion Filing Deadline :

MARIA INES MITRANI (Assignor),

Organicell Regenerative Medicine, Inc.

Filing Deadline :

April 10, 2021

MARIA INES MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.

April 15, 2020

052403 / 0365

Goods/Services :

Biologically derived

products developed from perinatal tissue material for medical, regenerative and aesthetic purposes

Serial Number :

Filing Date :

July 13, 2020

Organicell Regenerative Medicine,

Radiation sterilized biologically derived products developed from perinatal tissue material in the nature of cultured

biological tissue and non-cultured biological tissue, for aesthetic purposes, other than for medical or veterinary purposes

November 19, 2020

Organicell Regenerative Medicine, Inc.

Pending, awaiting examination

Goods/Services :

Biologically derived

products developed from perinatal tissue material for medical, regenerative and aesthetic purposes

Serial Number :

Filing Date :

Organicell Regenerative Medicine,

Office Action issued August

Radiation sterilized biologically derived products developed from perinatal tissue material for medical and medical regenerative

purposes, namely, biological tissue grafts, implants comprising living tissue, surgical implants comprising living tissue,

and biological implants for cushioning tissues and supporting tissue repair and homeostasis (IC 005)

November 19, 2020

Organicell Regenerative Medicine, Inc.

Pending, awaiting examination

Goods/Services :

Non-medicated anti-aging

Biologically derived nanoparticles, namely, exosomes and extracellular vesicles, developed from perinatal tissue material

for aesthetic purposes, other than for medical or veterinary purposes (IC 001)

September 9, 2020

Organicell Regenerative Medicine, Inc.

Notice of Allowance issued January 26, 2021

Goods/Services :

Biologically derived nanoparticles, namely, exosomes and extracellular vesicles, developed from perinatal tissue for medical

and medical regenerative purposes, namely, biological tissue grafts, implants comprising living tissue, surgical implants

comprising living tissue, and biological implants for cushioning tissues and supporting tissue repair and homeostasis

September 9, 2020

Organicell Regenerative Medicine, Inc.

Notice of Allowance issued January 26, 2021

Goods/Services :

Biologically derived products developed from perinatal tissue material in the nature of cultured biological tissue and

non-cultured biological tissue, for aesthetic purposes, other than for medical or veterinary purposes (IC 001);

derived products developed from perinatal tissue material for medical and medical regenerative purposes, namely, biological

tissue grafts, implants comprising living tissue, surgical implants comprising living tissue, and biological implants

for cushioning tissues and supporting tissue repair and homeostasis (IC 005)

July 13, 2020

Organicell Regenerative Medicine, Inc.

Pending, response to Office Action filed October 29, 2020

Goods/Services:

Biologically derived products developed from perinatal tissue material in the nature of cultured biological tissue

and non-cultured biological tissue, for aesthetic purposes, other than for medical or veterinary purposes (IC 001);

derived products developed from perinatal tissue material for medical and medical regenerative purposes, namely, biological

tissue grafts, implants comprising living tissue, surgical implants comprising living tissue, and biological implants

for cushioning tissues and supporting tissue repair and homeostasis (IC 005)

Organicell Regenerative Medicine, Inc.

Notice of Allowance issued December 22, 2020

Goods/Services :

Non-medicated anti-aging serum;

non-medicated skin serums;

all of the aforementioned goods are made in whole or in substantial part of organic ingredients

Serial Number :

Filing Date :

all of the aforementioned goods are made in whole or in substantial

part of organic ingredients (IC 003)

January 23, 2017

Organicell Regenerative Medicine,

Registration Number:

Registration Date:

Organicell Regenerative Medicine, Inc.

September 19, 2017

1 unchanged sentence

Goods/Services :

plasma extracts

for medical use, namely, plasma extract containing purified and concentrated exosomes derived from whole human blood

Serial Number :

Filing Date :

plasma extracts for medical use, namely, plasma extract containing purified and concentrated exosomes derived from whole

January 24, 2020

Organicell Regenerative Medicine,

Notice of Allowance issued

July 28, 2020

Organicell Regenerative Medicine, Inc.

Notice of Allowance issued July 28, 2020 –

1 st extension filed and approved

PATIENT PURE X - PPX

Goods/Services :

plasma processing

services for others, namely, extracting purified and concentrated exosomes based on whole blood harvested from patients for use

by hospitals, clinics, or other organizations or persons involved in delivering healthcare services to patients

Serial Number :

Filing Date :

plasma processing services for others, namely, extracting purified and concentrated exosomes based on whole blood harvested

from patients for use by hospitals, clinics, or other organizations or persons involved in delivering healthcare services

January 24, 2020

Organicell Regenerative Medicine,

Organicell Regenerative Medicine, Inc.

Notice of Allowance issued August 18, 2020

Registered Copyrights:

Domain Names:

www.organicell.com

The status of the Company’s

current IND’s, eIND’s, non-eIND’s submitted and approved for past or planned treatments and/or clinical trials

are described below:

Company’s FDA approved

phase I/II IND, eIND’s and non-eIND’s:

IND # 19881 approved on 04/30/2020 - A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate

the Safety and Potential Efficacy of Intravenous Infusion of OrganicellTM Flow for the Treatment of Moderate to Severe Acute Respiratory

Syndrome (SARS) Related to COVID-19 Infection vs Placebo.

IRB was approved by the Institute of Regenerative and Cellular Medicine

(“IRCM”) on 06/04/2020 (approval number:

IRCM-2020-254).

Clinical trial is currently in process.

eIND#22370 approved on 05/11/2020 - Treatment for Acute hypoxic respiratory failure with ARDS secondary

to COVID-19 infection for single patient.

eIND#22371 approved on 05/11/2020 - Treatment for Acute hypoxic respiratory secondary to bilateral pneumonia

secondary to COVID-19 with ARDS for single patient.

eIND#22897 approved on 05/29/2020 –

Treatment for Acute respiratory

failure with hypoxia, secondary to COVID-19 with ARDS for single patient.

eIND#25426 approved on 07/24/2020 - Treatment of COVID-19 positive

for single patient.

eIND#25888 approved on 8/01/2020 - Treatment of post COVID-19 complication for single patient.