What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2022-02-14 compared with 2021-02-08 · 1103 added, 684 removed, 59 unchanged (97% of the section changed)

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:

We 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 (“Providers”).

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 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

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.

New FDA guidance which was announced in November

2017 and which became effective in May 2021 (postponed from November 2020 due to the COVID-19 pandemic) requires 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”).

We have not obtained any opinion or ruling regarding

the Company’s operations and whether the processing, sales and distribution of the products we currently produce would be subject

to the FDA’s previously announced intended enforcement policies regarding HCT/P’s.

However, we do not believe that our products

fall within these guidelines and intend to vigorously defend against any adverse interpretation by the FDA on the classification of our

products that may be deemed as falling under this defined regulation, if any.

Notwithstanding the foregoing, we are undertaking efforts

on an ongoing basis to mitigate any potential risks associated with an adverse ruling by the FDA and the subsequent limitations on our

ability to continue to generate revenues from the sale of our products in the United States until the Company obtains the required licenses.

The efforts include continuing with clinical trials, expanding sales internationally and developing new product offerings and/or designations

of products that would not fall under these regulations.

During November 2020, the Company formed Livin’

Again Inc., a wholly owned subsidiary, for the purpose of among other things, providing independent education, advertising and marketing

services, to Providers that provide medical and other healthcare, anti-aging and regenerative services.

including FDA-approved IV vitamin

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

To date, there has been no significant activity and the Company has no

timetable, if any, as to when IV Drip Therapies revenues will commence.

Developments During the Fiscal Year ended October

In April 2020, the FDA approved an IND application

for the Company’s lead product, Zofin™, (IND # 19881) for 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.

The IRB was approved by the Institute of Regenerative and Cellular Medicine

(“IRCM”) during June 2020 (approval number:

IRCM-2020-254).

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.

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.

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.

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.

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

Enrollment for the clinical trial began in September 2020.

of ten patients have been enrolled to the study thus far and currently the clinical trial is not enrolling subjects due to the challenges

of enrolling the remaining study population.

In March 2021, Organicell entered into a Material

Cooperative Research and Development Agreement with the Centers for Disease Control and Prevention (the “CDC”) to determine

the anti-inflammatory and anti-infective effectiveness of Zofin™ in experimental models of influenza infection.

Pursuant to the

agreement, Organicell will supply the CDC with Zofin™ and using well established in vitro and in vivo experimental models of influenza

infection, the CDC will test the anti-infective and anti-inflammatory properties of Zofin™.

All the proposed experiments will be

performed in the appropriate biosafety levels and approved protocols at the Immunology and Pathogenesis Branch / Influenza Division of

In April 2021, the Company entered into a similar

agreement with Oklahoma State University to evaluate Zofin TM for the treatment of respiratory diseases caused by virus infections

of pandemic potential and the FDA approved an Investigational New Drug (“IND”) application for Zofin™, in the treatment

of knee osteoarthritis.

In June 2021, Organicell announced the results

of its expanded access (EA) intermediate size patient population trial (NCT04657406) for treatment of COVID-19 patients with Zofin™,

which EA trial had been authorized by the FDA in September 2020.

The results of the EA trial indicated that treatment of participants

met endpoints for safety and efficacy in patients with mild to moderate COVID-19;

mitigated mild and moderate symptoms;

improved pulmonary opacities detected in chest X-rays;

improved inflammatory biomarkers.

The trial was conducted at United Memorial Medical

Center in Houston, Texas.

The study enrolled a total of 11 subjects:

adults between the age of 35 to 69 who were fighting COVID-19 infection

and presented respiratory fatigue with and without exertion, cough, and shortness of breath and met all inclusion/exclusion criteria.

One patient withdrew before receiving any doses of Zofin TM .

Two subjects withdrew at day 14 post treatment with Zofin TM .

As a result, eight subjects completed the day 30 follow-up and are included in the data analysis.

The administration of Zofin TM in

the trial was well tolerated in all enrolled subjects, with no adverse events.

Chest X-ray data demonstrated that 75% of subjects had

bilateral opacities caused by COVID-19 infection at day 0 (baseline), prior to treatment with Zofin TM and thirty (30)

days after Zofin TM treatment, chest X-ray data showed 83% of treated subjects had normal lung imaging, indicating complete

Upon such time that Organicell enrolls and submits additional patient data from the above-mentioned study, Organicell intends

to submit the updated results of the trial to the FDA for approval of an amendment to the Company’s previously approved IND (NCT04384445)

to perform a placebo-controlled Phase II clinical trial to confirm safety and efficacy in a randomized fashion.

The Company is currently in the process of pursuing

the implementation of three other previously approved clinical trials:

In January 2021, the Company announced that the FDA had approved an IND application for its lead product, Zofin™, in the treatment of patients diagnosed with chronic obstructive pulmonary disease (“COPD”).

This approved trial design will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of intravenous infusion (IV) of Zofin™ for the treatment of COPD.

The Company and the clinical research organization (“CRO”) are currently working to initiate the trial which the Company expects enrollment to begin during the quarter ending April 30, 2022, subject to the successful negotiation and execution of definitive agreements with the site facility where the study patients will be treated and the Company raising sufficient working capital to finance the trial, as to all of which no assurance can be given.

In April 2021, the Company announced that the FDA had approved the IND application for its lead product, Zofin™, in the treatment of knee osteoarthritis.

This approved trial design, will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of Zofin™ for patients suffering with knee osteoarthritis.

The Company and the CRO are currently working to initiate the trial which the Company expects enrollment to begin during the quarter ending July 31, 2022, subject to the successful negotiation and execution of definitive agreements with the site facility where the study patients will be treated and the Company raising sufficient working capital to finance the trial, as to all of which no assurance can be given.

In July 2021, the Company announced that the FDA had approved an IND application for its lead product, Zofin™, for the treatment of ‘Prolonged COVID-19 Symptoms’ (“Long Haulers”).

This approved trial design consists of a double blinded, placebo-controlled, randomized phase I/II trial designed to investigate the safety and potential efficacy of Zofin™ in treating COVID-19 Long Haulers.

The Company and the CRO are currently working to initiate the trial which the Company expects enrollment to begin during February 2022, subject to the successful negotiation and execution of definitive agreements with the site facility where the study patients will be treated and the Company raising sufficient working capital to finance the trial, as to all of which no assurance can be given.

In June 2021, the Company announced that it was

launching a service platform for their first autologous product called Patient Pure X TM (PPX TM ).

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

The Company began

to accept minimal orders for this service during October 2021.

The Company expects that once capacity for providing the service is adequate

(either from processing capacity available or to become available at the Company’s existing facilities or through third party arrangements)

as well as continued favorable response from health care providers and patients from the use of PPX TM , the Company will seek

to expand this service on a larger scale.

In April 2021, we announced that an initial trial

of ten COVID -19 patients in India conducted by CWI India, our Indian partner, generated positive results.

The trial had been conducted

by CWI India, our Indian partner with whom we had entered a product testing and distribution agreement in February 2021, to collaborate

on a study or studies to evaluate the effects of Zofin™ on moderate to severe COVID-19 patients in India.

The ten patients in the

initial trial were treated at hospitals in Bangalore, Kozhikode and Chennai, and all ten patients recovered from their symptoms and were

discharged from the hospital.

Based on the initial results of this trial, CWI India has since been seeking to obtain government approval

to conduct an expanded trial of up to sixty-five patients with moderate to severe COVID-19, who were to be treated at these hospitals.

To date, CWI India has not obtained the required approval and it is uncertain if they will ultimately be successful in doing so.

is eventually obtained, we anticipate that CWI India will conduct the trials in a timely manner.

If the results of the expanded trial

prove to be positive, Organicell and CWI India intend to file with the ICMR (Indian Council for Medical Research) for Emergency Use Approval

to use Zofin™ in India as a therapeutic for treating COVID-19.

In May 2021, the Company announced that its Zofin TM therapy

has been approved by Pakistani regulators to be used for a treatment of a named COVID-19 patient hospitalized at the Pakistan Institute

of Medical Sciences on compassionate grounds.

In addition to this compassionate grounds authorization, Organicell received further indications

from the Pakistani regulators to begin a broader trial of Zofin TM with up to 60 additional patients suffering from moderate

to severe COVID-19.

The Company has already shared data with Pakistani regulatory authorities in the country in support of this effort.

To date, the Company and the Company’s Pakistani partner for the proposed study have not obtained the required approval and the

Company is uncertain if they will ultimately be successful in doing so.

If approval is eventually obtained, we anticipate that the trial

will be conducted in a timely manner.

In addition, in May 2021, Organicell also entered into a one-year exclusive distribution agreement

with Apex Services Pakistan to import and distribute Zofin TM to hospitals and clinics in the country, subject to the issuance

of all necessary approvals and licenses by the Drug Regulatory Authority of Pakistan, which as previously stated, have not yet been obtained.

On June 17, 2021, Organicell received a subpoena

dated June 14, 2021, from the Atlanta Regional Office of the SEC requiring the production of certain documents and communications in connection

with the treatment and results of various COVID-19 patients, as discussed in the Company’s Current Reports on Form 8-K filed with

the SEC during the period from May 27, 2020 through May 11, 2021.

The Company is fully cooperating with the SEC’s investigation

and believes that it will be able to provide all of the information requested by the SEC.

The Company can make no assurances as to the

time or resources that will need to be devoted to this investigation or its final outcome, or the impact, if any, of this investigation

or any proceedings on the Company’s current business, financial condition, results of operations, cash flows, or the Company’s

future operations.

Recent Development

On January 11, 2022, the Company entered into

a Securities Purchase Agreement (the “SPA”) with AJB Capital Investments, LLC (the “Purchaser”), pursuant to which

we sold a Promissory Note in the principal amount of $600,000 (the “Note”) to the Purchaser in a private transaction to for

a purchase price of $540,000 (giving effect to original issue discount of $60,000).

In connection with the sale of the Note, the Company

also paid the Purchaser’s legal fees and due diligence costs of $12,500 and brokerage fees of $9,000 to J.H.

Darbie & Co., a

registered broker-dealer.

After payment of the legal fees and brokerage fees, the net proceeds to the Company were $518,500, which will

be used for working capital and other general corporate purposes.

The Note matures on July 11, 2022, subject to

extension at the option of the Company for up to an additional six month period, bears interest at the a rate of 10% per annum for the

first six months and 12% per annum thereafter if extended, and only following an event of default (as defined in the Note), is convertible

into shares of the Company’s common stock at a conversion price equal to the lower of the “VWAP” (as hereinafter defined)

of the common stock during (i) the twenty (20) trading day period preceding the issuance date of the Note;

or (ii) the twenty (20) trading

day period preceding the date of conversion of the Note.

As used in the Note, “VWAP” means, for any date, the price of our

common stock as determined by the first of the following clauses that applies:

(i) if the common stock is then listed or quoted on one

or more established stock exchanges or national market systems, the daily volume weighted average price of the common stock for such date

on the trading market on which the common stock is then listed or quoted as reported by Bloomberg L.P.;

or (ii) if the common stock is

regularly quoted on an automated quotation system (including applicable tiers of the over-the-counter market maintained by OTC Market

Group, Inc.) or by a recognized securities dealer, the volume weighted average price of the common stock for such date on the applicable

OTC Markets Group, Inc.

tier or as quoted by such securities dealer.

In accordance with the terms of the SPA, as of January 11, 2022,

the Company has reserved 36,923,080 shares of its authorized but unissued common stock for issuance in the event the Purchaser exercises

its right to convert the Note following an event of default.

may be prepaid by the Company at any time without penalty.

The Note also contains covenants, events of defaults, penalties, default

interest and other terms and conditions customary in transactions of this nature.

Pursuant to the terms of the SPA, the Company

paid a commitment fee to the Purchaser in the amount of $200,000 (the “Initial Commitment Fee”) in the form of 3,076,921 shares

of the Company’s common stock (the “Initial Commitment Fee Shares”).

In addition, if the Company exercises the option

to extend the maturity date of the Note, the Company will pay an additional commitment fee to the Purchaser in the amount of $100,000

(the “Additional Commitment Fee,” and together with the Initial Commitment Fee, collectively, the “Commitment Fee”)

in the form of an additional 1,538,462 shares of its common stock (the “Additional Commitment Fee Shares,” and together with

the Initial Commitment Fee Shares, collectively, the “Commitment Fee Shares”).

In the event that by the first anniversary

of repayment of the Note by the Company, the Purchaser has not generated the amount of the Commitment Fee from public sales of the Commitment

Fee Shares, the Company shall either pay the amount of any such shortfall either (i) by issuing additional shares of our common stock

at a price equal to the VWAP for the common stock during the five (5) trading day period prior to such anniversary date;

or (ii) in cash,

in which case, the Company shall repurchase any unsold Commitment Fee Shares then held by the Purchaser for such shortfall amount.

The offer and sale of the Note to the Purchaser

was made in a private transaction exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities

Act”), in reliance on exemptions afforded by Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D promulgated thereunder.

COVID-19 Impact on Economy and Business Environment

The adverse public health developments and economic

effects of the ongoing 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.

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;

(b) is seeking to raise additional debt and/or

equity financing to support working capital requirements;

and (c) continues to take steps to stabilize and increase revenues from the

sale of its products.

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 a similar or worse devastating impact to the United States and worldwide

economies or our business.

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.

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.

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.

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.

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:

● Cellular/ Tissue based therapies

○ Adipose-derived stromal vascular fraction

○ Bone marrow-derived stem cell therapies

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

○ Placental-based therapies

Ø 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

○ Growth factor, cytokine therapies

○ Supplements

lotions and creams for the largest organ the skin

● Nontraditional

medical alternatives

Ø Medical foods

○ Weight control

○ Topical lotions and creams for the largest organ the skin

● Nontraditional medical alternatives

○ Acupuncture

2 unchanged sentences

● Self-directed

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 :

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

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

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

What changed 10-K

Item 1. Business