What changed in this filing

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Item 1A. Risk Factors

2022-02-14 compared with 2021-02-08 · 1099 added, 982 removed, 24 unchanged (99% of the section changed)

RISK FACTORS.

INVESTMENT IN OUR SECURITIES IS HIGHLY SPECULATIVE AND INVOLVES A HIGH DEGREE OF RISK.

WE FACE A VARIETY OF RISKS THAT MAY AFFECT

OUR OPERATIONS OR FINANCIAL RESULTS AND MANY OF THOSE RISKS ARE DRIVEN BY FACTORS THAT WE CANNOT CONTROL OR PREDICT.

BEFORE INVESTING

IN THE SECURITIES YOU SHOULD CAREFULLY CONSIDER THE FOLLOWING RISKS, TOGETHER WITH THE FINANCIAL AND OTHER INFORMATION CONTAINED

IN THIS REPORT.

IF ANY OF THE FOLLOWING RISKS ACTUALLY OCCURS, OUR BUSINESS, PROSPECTS, FINANCIAL CONDITION AND RESULTS OF OPERATIONS

COULD BE MATERIALLY ADVERSELY AFFECTED.

IN THAT CASE, THE TRADING PRICE OF OUR COMMON STOCK WOULD LIKELY DECLINE AND YOU MAY LOSE

ALL OR A PART OF YOUR INVESTMENT.

ONLY THOSE INVESTORS WHO CAN BEAR THE RISK OF LOSS OF THEIR ENTIRE INVESTMENT SHOULD CONSIDER

AN INVESTMENT IN OUR SECURITIES.

Annual Report contains certain statements relating to future events or the future financial performance of our Company.

investors are cautioned that such statements are only predictions and involve risks and uncertainties, and that actual events

or results may differ materially.

In evaluating such statements, prospective investors should specifically consider the various

factors identified in this Annual Report, including the matters set forth below, which could cause actual results to differ materially

from those indicated by such forward-looking statements.

any of the following or other risks materialize, the Company’s business, financial condition, and results of operations

could be materially adversely affected which, in turn, could adversely impact the value of our securities.

In such a case, investors

in our securities could lose all or part of their investment.

investors should consider carefully whether an investment in the Company is suitable for them in light of the information contained

in this Report and the financial resources available to them.

The risks described below do not purport to be all the risks to

which the Company could be exposed.

This section is a summary of certain risks and is not set out in any particular order of priority.

They are the risks that we presently believe are material to the operations of the Company.

Additional risks of which we are not

presently aware or which we presently deem immaterial may also impair the Company’s business, financial condition or results

of operations.

Related to Our Business

ongoing COVID-19 outbreak and economic crisis has caused a significant disruption to the overall economy and there is no certainty

as to when or how the situation will evolve, including whether or not the virus will be controlled and/or the state of our economy

and business environment upon emerging from the crisis.

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 our business.

is no assurance that the COVID-19 crisis will be fully resolved or if resolved, that the overall economy will resume in a manner

that allows the Company to resume operations as planned.

We may not be able to generate revenues or achieve profitability in the

Our failure to achieve or maintain profitability could negatively impact the value of our common stock.

have limited cash on hand and there is substantial doubt as to our ability to continue as a going concern .

Company incurred operating losses of $12,437,941 for the year ended October 31, 2020.

In addition, the Company had an accumulated

deficit of $28,868,189 at October 31, 2020.

The Company had a negative working capital position of $1,693,741 at October 31, 2020.

In their report for the fiscal year ended October 31, 2020, our auditors have expressed that there is substantial doubt as to

our ability to continue as a going concern.

We have incurred operating losses since our formation and expect to incur substantial

losses and negative operating cash flows for the foreseeable future and may never become profitable.

We also expect to continue

to incur significant operating and capital expenditures for the next several years and anticipate that our expenses will increase

substantially in the foreseeable future.

We also expect to experience negative cash flow for the foreseeable future as we fund

our operating losses and capital expenditures.

As a result, we will need to generate significant revenues in order to achieve

and maintain profitability.

This Annual Report contains certain statements

relating to future events or the future financial performance of our Company.

Prospective investors are cautioned that such statements

are only predictions and involve risks and uncertainties, and that actual events or results may differ materially.

In evaluating such

statements, prospective investors should specifically consider the various factors identified in this Annual Report, including the matters

set forth below, which could cause actual results to differ materially from those indicated by such forward-looking statements.

If any of the following or other risks materialize,

the Company’s business, financial condition, and results of operations could be materially adversely affected which, in turn, could

adversely impact the value of our securities.

In such a case, investors in our securities could lose all or part of their investment.

Prospective investors should consider carefully

whether an investment in the Company is suitable for them in light of the information contained in this Report and the financial resources

available to them.

The risks described below do not purport to be all the risks to which the Company could be exposed.

This section is

a summary of certain risks and is not set out in any particular order of priority.

They are the risks that we presently believe are material

to the operations of the Company.

Additional risks of which we are not presently aware or which we presently deem immaterial may also

impair the Company’s business, financial condition or results of operations.

Risks Related to Our Business

We have incurred significant losses, have

limited cash on hand and there is substantial doubt as to our ability to continue as a going concern .

The Company incurred operating losses of $12,744,103

and $12,437,941 for the years ended October 31, 2021 and October 31, 2020, respectively.

In addition, the Company had accumulated deficits

of $41,624,749 and $28,868,189 at October 31, 2021 and October 31, 2020, respectively, and negative working capital positions of $3,609,174

and $1,693,741 at October 31, 2021 and October 31, 2020, respectively.

In their report for the fiscal year ended October 31, 2021, our

auditors have expressed that there is substantial doubt as to our ability to continue as a going concern.

We have incurred operating losses

since our formation and expect to incur substantial losses and negative operating cash flows for the foreseeable future and may never

become profitable.

We also expect to continue to incur significant operating and capital expenditures for the next several years and anticipate

that our expenses will increase substantially in the foreseeable future.

We also expect to experience negative cash flow for the foreseeable

future as we fund our operating losses and capital expenditures.

As a result, we will need to generate significant revenues in order to

achieve and maintain profitability.

We may not be able to generate these revenues or achieve profitability in the future.

to achieve or maintain profitability could negatively impact the value of our common stock.

have a limited operating history upon which investors can evaluate our future prospects.

connection with the change in control of our Company in June 2015, there was a change in the Company’s management, board

of directors and line of business.

Our current processing facility only began operations in May 2019.

Therefore, we have limited

operating history upon which an evaluation of our current business plan or performance and prospects can be made.

and prospects of the Company must be considered in the light of the potential problems, delays, uncertainties and complications

encountered in connection with a newly established business.

The risks include, but are not limited to, the possibility that we

will not be able to develop or identify functional and scalable products and services, or that although functional and scalable,

our products and services will not be economical to market;

that our competitors hold proprietary rights that preclude us from

marketing such products;

We have a limited operating history in our

current business upon which investors can evaluate our future prospects.

Our current business operations, including our

laboratory and processing facility only began operations in May 2019.

Therefore, we have limited operating history upon which an evaluation

of our current business plan or performance and prospects can be made.

The business and prospects of the Company must be considered in

the light of the potential problems, delays, uncertainties and complications encountered in connection with a newly established business.

The risks include, but are not limited to, the possibility that we will not be able to develop or identify functional and scalable products

and services, or that although functional and scalable, our products and services will not be economical to market;

that our competitors

hold proprietary rights that preclude us from marketing such products;

that our competitors market a superior or equivalent product;

that we are not able to upgrade and enhance

our technologies and products to accommodate new features and expanded service offerings;

or the failure to receive necessary

regulatory clearances for our products.

To successfully introduce and market our products at a profit, we must establish brand

name recognition and competitive advantages for our products.

There are no assurances that the Company can successfully address

these challenges.

we are not able to upgrade and enhance our technologies and products to accommodate new features and expanded service offerings;

failure to receive necessary regulatory clearances for our products.

To successfully introduce and market our products at a profit, we

must establish brand name recognition and competitive advantages for our products.

There are no assurances that the Company can successfully

address these challenges.

If it is unsuccessful, the Company and its business, financial condition and operating results could be materially

and adversely affected.

the limited operating history, management has little basis on which to forecast future demand for our products from our existing

customer base, much less new customers.

The current and future expense levels of the Company are based largely on estimates of

planned operations and future revenues rather than experience.

It is difficult to accurately forecast future revenues because

the business of the Company is new and its market has not been developed.

If the forecasts for the Company prove incorrect, the

business, operating results and financial condition of the Company will be materially and adversely affected.

Moreover, the Company

may be unable to adjust its spending in a timely manner to compensate for any unanticipated reduction in revenue.

any significant reduction in revenues would immediately and adversely affect the business, financial condition and operating results

of the Company.

depend upon our officers and key personnel, the loss of which could seriously harm our business.

operating performance is substantially dependent on the continued services of our executive officers and key employees, in particular,

Albert Mitrani, our Chief Executive Officer and President;

Given the limited operating

history, management has little basis on which to forecast future demand for our products from our existing customer base, much less new

The current and future expense levels of the Company are based largely on estimates of planned operations and future revenues

rather than experience.

It is difficult to accurately forecast future revenues because the business of the Company is new, and its market

has not been developed.

If the forecasts for the Company prove incorrect, the business, operating results and financial condition of the

Company will be materially and adversely affected.

Moreover, the Company may be unable to adjust its spending in a timely manner to compensate

for any unanticipated reduction in revenue.

As a result, any significant reduction in revenues would immediately and adversely affect

the business, financial condition and operating results of the Company.

The ongoing COVID-19 outbreak and economic

crisis has caused a significant disruption to the overall economy and there is no certainty as to when or how the situation will evolve,

including whether or not the virus will be controlled and/or the state of our economy and business environment upon emerging from the

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.

There is no assurance that the COVID-19 crisis

will be fully resolved or if resolved, that the overall economy will resume in a manner that allows the Company to resume operations as

We may not be able to generate revenues or achieve profitability in the future.

Our failure to achieve or maintain profitability

could negatively impact the value of our common stock.

We recently received

a subpoena from the Atlanta Regional Office of the SEC and while we are complying with the subpoena, there can be no assurances as to

the final outcome of the SEC’s investigation, 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.

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.

We depend upon

our officers and key personnel, the loss of which could seriously harm our business.

Our operating performance

is substantially dependent on the continued services of our executive officers and key employees, in particular, Albert Mitrani, our Chief

Executive Officer and President;

Bothwell, our Chief Financial Officer.

The unexpected loss

of the services of any of them could have a material adverse effect on our business, operations, financial condition and operating

results, as well as the value of our common stock.

may not be able to compete successfully with current and future competitors.

have many potential competitors in the regenerative medicine industry.

We will compete, in our current and proposed businesses,

with other established companies, most of which have far greater marketing and financial resources and experience than we do.

We cannot guarantee that we will be able to penetrate our intended markets and be able to compete profitably, if at all.

to established competitors, there are moderate obstacles for competitors to enter this market, but they are not insurmountable

if they have the financial resources and intellectual team.

Effective competition could result in price reductions, reduced margins

or have other negative implications, any of which could adversely affect our business and chances for success.

Competition is

likely to increase significantly as new companies enter the market and current competitors expand their services.

Many of these

potential competitors are likely to enjoy substantial competitive advantages, including, but not limited to, larger staffs, greater

name recognition, larger and established customer bases and substantially greater financial, marketing, technical and other resources.

To be competitive, we must respond promptly and effectively to industry dynamics, evolving standards and competitors’

by continuing to enhance our services and sales and marketing channels.

Any pricing pressures, reduced margins or loss of market

share resulting from increased competition, or our failure to compete effectively, could fatally damage our business and chances

currently rely on non-exclusive supply arrangements with birth tissue recovery companies for obtaining the raw material used in

manufacturing the products we sell.

Also, during the periods that we did not operate our own manufacturing facility, we have relied

on non-exclusive supply arrangements from other third-party manufacturers or distributors of products from third party manufacturers

to obtain the supply of products we sold.

our current supply arrangements under supply agreements with birth tissue recovery companies or third party manufacturers or distributors

of products from third party manufacturers are disrupted for any reason, we may not be able to provide products to our customers,

or if other supply arrangements can be made, the products and terms may not be as favorable, and that will adversely impact our

operations and profitability.

we do not continually update our products and/or services, they may become obsolete and we may not be able to compete with other

cannot assure you that we will be able to keep pace with technological advances, or that our current suppliers will be able to

keep pace with technological advances and as such, our products and/or services may become obsolete.

We cannot assure you that

competitors will not develop related or similar services and offer them before we do, or do so more successfully, or that they

will not develop services and products more effective than any that we and/or our suppliers have or are intending to develop.

In addition, although we may be able to identify new suppliers that can provide more effective services and products to be more

competitive, we may not be able to arrange satisfactory arrangements in a timely manner, if at all.

If that happens, our business,

prospects, results of operations and financial condition will be materially adversely affected.

enter into supply agreements for the raw materials and/or products we sell, which make us vulnerable to the ability of such suppliers

to remain current and innovative in their product offerings, to timely process and supply the products we desire to purchase,

and to remain compliant with the current and changing regulatory environment.

If our raw material and/or product suppliers are

not successful in managing these responsibilities, it will have an adverse effect on our operations and profitability.

current birth tissue supply arrangements for manufacturing the products we sell and our third-party supply arrangements for the

supply of products we sell provide for the supply and pricing for those products.

There can be no assurance that our suppliers

will continue to produce the products that we currently purchase under our existing arrangements, that our suppliers will be able

to comply with the required FDA regulations for the manufacturing of such products, that our suppliers will continue to develop

technology associated with their manufactured products to remain competitive with other companies, or that our suppliers will

remain a going concern in the future.

If any of our suppliers were to cause a disruption in our ability to obtain products as

desired and expected and/or we are not provided advance notice of such potential disruption, we may not be able to timely identify

and replace our current suppliers, if at all, and as a result, we may not be able to provide products to our customers, which

will have an adverse impact to our operations.

the event of default under our outstanding indebtedness, or we are unable to pay other obligations and accounts payable when due,

our creditors may file a creditors petition or force us into involuntary bankruptcy which may have an adverse impact on our business.

Company had a negative working capital position of $1,693,741 at October 31, 2020.

In addition, the outbreak of the novel coronavirus

(“COVID-19”) during March 2020 and the resulting adverse public health developments and economic effects to the United

States business environments 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.

The Company’s

efforts to establish a stabilized source of sufficient revenues to cover operating costs has yet to be achieved and ultimately

may prove to be unsuccessful unless additional sources of working capital through operations or debt and/or equity financings

are realized.

The Company has not repaid its outstanding indebtedness on the required due dates and the loans remain still outstanding.

Management anticipates that the Company will remain dependent, for the near future, on additional investment capital to fund ongoing

operating expenses.

The Company does not have significant fixed and/or intangible assets to pledge for the purpose of borrowing

additional capital.

In addition, the Company relies on short term supply agreements to obtain the supply of raw materials used

in manufacturing the products it currently sells and distributes to its customers.

The Company’s current market capitalization

and common stock liquidity will hinder its ability to raise equity proceeds to implement its business plan and could adversely

affect the value of our securities, including the common stock.

may be required to borrow funds in the future.

the Company incurs indebtedness, a portion of its cash flow will have to be dedicated to the payment of principal and interest

on such indebtedness.

Typical loan agreements also might contain restrictive covenants, which may impair the Company’s operating

Such loan agreements would also provide for default under certain circumstances, such as failure to meet certain

financial covenants.

A default under a loan agreement could result in the loan becoming immediately due and payable and, if unpaid,

a judgment in favor of such lender which would be senior to the rights of the Company’s stockholders.

A judgment creditor

would have the right to foreclose on any of the Company’s assets resulting in a material adverse effect on the Company’s

business, operating results or financial condition.

the Company has limited assets which could be used as collateral in obtaining future borrowings.

Because of the Company’s

inability to provide lenders with collateral and a limited history of successful operations, the Company may not be successful

in its efforts to obtain additional funds though borrowings and as a result may not be able to fund required costs of operations.

growth depends on external sources of capital, which may not be available on favorable terms or at all.

access to capital will depend upon a number of factors over which we have little or no control, including general market conditions,

government regulations and the market’s perception of our current and potential future earnings.

If general economic instability

or downturn leads to an inability to borrow at attractive rates or at all, our ability to obtain capital to finance working capital

requirements could be negatively impacted.

we are unable to obtain capital on terms and conditions that we find acceptable, we likely will have to scale back our business

In addition, our ability to refinance all or any debt we may incur in the future, on acceptable terms or at all, is

subject to all of the above factors, and will also be affected by our future financial position, results of operations and cash

flows, which additional factors are also subject to significant uncertainties, and therefore we may be unable to refinance any

debt we may incur in the future, as it matures, on acceptable terms or at all.

All of these events would have a material adverse

effect on our business, financial condition, liquidity and results of operations.

to establish or enhance our brand recognition could have a material adverse effect on our business and results of operations.

believe we will need to expend significant time, effort and resources to enhance the recognition of our brands.

We believe developing

our brand will be important to our sales and marketing efforts.

If we fail to establish or enhance the recognition of our brands,

it could have a material adverse effect on our ability to sell our products and adversely affect our business and results of operations.

If we fail to develop a positive public image and reputation, our business with our existing customers could decline and we may

fail to develop additional business, which could adversely affect our results of operations.

in the products we sell or failures in quality control related to our distribution of products could impair our ability to sell

our products or could result in product liability claims, litigation and other significant events involving substantial costs.

of any significant defects in our products that we sell or failure in our quality control procedures or the quality control procedures

of our suppliers may result in, among other things, delay in time-to-market, loss of sales and market acceptance of our products,

diversion of development resources, injury to our reputation and restrictions imposed by governmental agencies.

The costs we may

incur in correcting any product defects may be substantial and we may not be able to identify adequate remedies, if required.

Additionally, errors, defects or other performance problems could result in financial or other damages to our customers, which

could result in litigation.

Product liability litigation, even if we prevail and/or our suppliers, would be time consuming and

costly to defend, and if we and/or our product suppliers do not prevail, could result in the imposition of a damages award.

presently maintain product liability insurance and we are named insured on our suppliers’

insurance policy;

may not be adequate to cover any claims.

can be no assurances of protection for proprietary rights or reliance on trade secrets.

certain cases, the Company may rely on trade secrets to protect intellectual property, proprietary technology and processes, which

the Company has acquired, developed or may develop in the future.

There can be no assurances that secrecy obligations will be

honored or that others will not independently develop similar or superior products or technology.

The protection of intellectual

property and/or proprietary technology through claims of trade secret status has been the subject of increasing claims and litigation

by various companies both in order to protect proprietary rights as well as for competitive reasons even where proprietary claims

are unsubstantiated.

The prosecution of proprietary claims or the defense of such claims is costly and uncertain given the uncertainty

and rapid development of the principles of law pertaining to this area.

The Company, in common with other firms, may also be subject

to claims by other parties with regard to the use of intellectual property, technology information and data, which may be deemed

proprietary to others.

ability to become profitable and continue as a going concern will be dependent on our ability to attract, employ and retain highly

skilled individuals to serve our clients.

nature of our business requires that we employ skilled persons to perform highly skilled and specialized tasks for our Company.

Our failure to retain such personnel could have a material adverse effect on our ability to offer services to clientele, and could

potentially have a negative effect on our business.

There is no guarantee that skilled persons will be available and willing to

work for us in the future, nor is there any guarantee that we could afford to retain them if they are available at a future time.

ability to commence and complete clinical studies and other research and development objectives that are required by the FDA,

including possible deadlines for certain products as early as May 2021 will require that we are properly funded to assure that

we can commence and proceed with the required research activities promptly and that the results are favorable.

Company is pursuing efforts to commence and complete 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 timely and 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

projections and forward-looking information may prove to be incorrect.

has prepared projections regarding the Company’s anticipated financial performance.

The Company’s projections are

hypothetical and based upon a presumed financial performance of the Company, the addition of a sophisticated and well-funded marketing

plan, and other factors influencing the business of the Company.

The projections are based on Management’s best estimate

of the probable results of operations of the Company, based on present circumstances, and have not been reviewed by the Company’s

independent accountants.

These projections are based on several assumptions, set forth therein, which Management believes are

Some assumptions upon which the projections are based, however, invariably will not materialize due to the inevitable

occurrence of unanticipated events and circumstances beyond Management’s control.

Therefore, actual results of operations

will vary from the projections, and such variances may be material.

Assumptions regarding future changes in sales and revenues

are necessarily speculative in nature.

In addition, projections do not and cannot take into account such factors as general economic

conditions, unforeseen regulatory changes, the entry into the Company’s market of additional competitors, the terms and

conditions of future capitalization, and other risks inherent to the Company’s business.

While Management believes that

the projections accurately reflect possible future results of the Company’s operations, those results cannot be guaranteed.

may not be able to manage our growth effectively.

must continually implement and improve our products and/or services, operations, operating procedures and quality controls on

a timely basis, as well as expand, train, motivate and manage our work force in order to accommodate anticipated growth and compete

effectively in our market segment.

Successful implementation of our strategy also requires that we establish and manage a competent,

dedicated work force and employ additional key employees in corporate management, product development, client service and sales.

We can give no assurance that our personnel, systems, procedures and controls will be adequate to support our existing and future

If we fail to implement and improve these operations, there could be a material, adverse effect on our business, operating

results and financial condition.

we make any acquisitions or enter into a merger or similar transaction, our business may be negatively impacted.

have no present plans for any specific acquisition.

However, in the event that we make acquisitions in the future, we could have

difficulty integrating the acquired companies’

personnel and operations with our own.

In addition, the key personnel of

the acquired business may not be willing to work for us.

We cannot predict the effect expansion may have on our core business.

Regardless of whether we are successful in making an acquisition, the negotiations could disrupt our ongoing business, distract

our management and employees and increase our expenses.

In addition to the risks described above, acquisitions, mergers and other

similar transactions are accompanied by a number of inherent risks, including, without limitation, the following:

difficulty of integrating acquired products, services or operations;

the potential disruption

of the ongoing businesses and distraction of our Management and the management of acquired companies;

the difficulty of

incorporating acquired rights or products into our existing business;

difficulties in

disposing of the excess or idle facilities of an acquired company or business and expenses in maintaining such facilities;

difficulties in

maintaining uniform standards, controls, procedures and policies;

the potential impairment

of relationships with employees and customers as a result of any integration of new management personnel;

the potential inability

or failure to achieve additional sales and enhance our customer base through cross-marketing of the products to new and existing

the effect of any

government regulations which relate to the business acquired;

potential unknown

liabilities associated with acquired businesses or product lines, or the need to spend significant amounts to retool, reposition

or modify the marketing and sales of acquired products or the defense of any litigation, whether or not successful, resulting

from actions of the acquired company prior to our acquisition.

business could be severely impaired if and to the extent that we are unable to succeed in addressing any of these risks or other

problems encountered in connection with these acquisitions, many of which cannot be presently identified, these risks and problems

could disrupt our ongoing business, distract our management and employees, increase our expenses and adversely affect our results

of operations.

might be unanticipated obstacles to the execution of our business plan.

Company’s business plans may change significantly.

The Company’s potential business endeavors are capital intensive.

Management believes that the Company’s chosen activities and strategies are achievable in light of current economic and

legal conditions with the skills, background, and knowledge of the Company’s principals and advisors.

Management reserves

the right to make significant modifications to the Company’s stated strategies depending on future events.

may engage in transactions that present conflicts of interest.

Company’s officers and directors may enter into agreements with the Company from time to time which may not be equivalent

to similar transactions entered into with an independent third party.

A conflict of interest arises whenever a person has an interest

on both sides of a transaction.

While we believe that it will take prudent steps to ensure that all transactions between the Company

and any officer or director is fair, reasonable, and no more than the amount it would otherwise pay to a third party in an “arms-length”

transaction, there can be no assurance that any transaction will meet these requirements in every instance.

have agreed to indemnify our officers and directors against lawsuits to the fullest extent of the law.

is a Nevada corporation.

Nevada law permits the indemnification of officers and directors against expenses incurred in successfully

defending against a claim.

Nevada law also authorizes Nevada corporations to indemnify their officers and directors against expenses

and liabilities incurred because of their being or having been an officer or director.

Our organizational documents provide for

this indemnification to the fullest extent permitted by law.

currently do not maintain any directors & officers insurance coverage.

The commercial insurance policies we do have in place

contain policy limits and exclusions for certain coverages and losses.

In the event that we are found liable for damage or other

losses, and such amounts are not covered under our existing insurance policies, we would incur substantial and protracted losses

in paying any such claims or judgments.

Although we intend to acquire coverage immediately upon resources becoming available,

there is no guarantee that we can secure such coverage or that any insurance coverage would protect us from any damages or loss

claims filed against it.

operating results may fluctuate significantly as a result of a variety of factors, many of which are outside of our control.

are subject to the following factors, among others, that may negatively affect our operating results:

announcement or introduction of new products by our competitors;

of Government and private health plans to adequately and timely reimburse the users of

our products;

ability to upgrade and develop our systems and infrastructure to accommodate growth;

ability to attract and retain key personnel in a timely and cost effective manner;

amount and timing of operating costs and capital expenditures relating to the expansion

of our business, operations and infrastructure;

by Federal, State or Local Governments;

economic conditions (including fallout from current and future pandemics) as well as

economic conditions specific to the healthcare industry.

have based our current and future expense levels largely on our investment plans and estimates of future events, although certain

of our expense levels are, to a large extent, fixed.

We may be unable to adjust spending in a timely manner to compensate for

any unexpected revenue shortfall.

Accordingly, any significant shortfall in revenue relative to our planned expenditures would

have an immediate adverse effect on our business, results of operations and financial condition.

Further, as a strategic

response to changes in the competitive environment, we may from time to time make certain pricing, service or marketing decisions

that could have a material and adverse effect on our business, results of operations and financial condition.

the foregoing factors, our revenue and operating results are and will remain difficult to forecast.

are in a highly competitive and evolving field and face competition from well-established tissue processors and medical device

manufacturers, as well as new market entrants.

business is in a very competitive and evolving field.

Competition from other tissue processors, medical device companies and from

research and academic institutions is intense, expected to increase, subject to rapid change, and could be significantly affected

by new product introductions.

The presence of this competition in our market may lead to pricing pressure, which would make it

more difficult to sell our products at a price that will make us profitable or prevent us from selling our products at all.

success will depend on our ability and/or the ability of our suppliers to perfect and protect their intellectual property rights

related to their technologies as well as to develop new technologies and new applications for our technologies.

Our failure to

compete effectively would have a material and adverse effect on our business, results of operations and financial condition.

technological change could cause our products to become obsolete.

technologies underlying the products we sell and intend to sell are subject to rapid and profound technological change.

intensifies as technical advances in each field are made and become more widely known.

We can give no assurance that our suppliers

will be able to develop services, products, or processes with significant advantages over the competing products, services, and

Any such occurrence could have a material and adverse effect on our business, results of operations and financial condition.

products are dependent on the availability of sufficient quantities of tissue from human donors, and any disruption in supply

could adversely affect our business.

success of the human tissue products we sell depends upon, among other factors, the availability of sufficient quantities of tissue

from human donors.

The availability of donated tissue could be adversely impacted by regulatory changes, public opinion

of the donor process as well as our and our suppliers’

The unexpected loss of the services of any of them

could have a material adverse effect on our business, operations, financial condition and operating results, as well as the value of our

common stock.

We may not be able to compete successfully

with current and future competitors.

We have many potential competitors in the regenerative

medicine industry.

We will compete, in our current and proposed businesses, with other established companies, most of which have far greater

marketing and financial resources and experience than we do.

We cannot guarantee that we will be able to penetrate our intended markets

and be able to compete profitably, if at all.

In addition to established competitors, there are moderate obstacles for competitors to

enter this market, but they are not insurmountable if they have the financial resources and intellectual team.

Effective competition could

result in price reductions, reduced margins or have other negative implications, any of which could adversely affect our business and

chances for success.

Competition is likely to increase significantly as new companies enter the market and current competitors expand

their services.

Many of these potential competitors are likely to enjoy substantial competitive advantages, including, but not limited

to, larger staffs, greater name recognition, larger and established customer bases and substantially greater financial, marketing, technical

and other resources.

To be competitive, we must respond promptly and effectively to industry dynamics, evolving standards and competitors’

innovations by continuing to enhance our services and sales and marketing channels.

Any pricing pressures, reduced margins or loss of

market share resulting from increased competition, or our failure to compete effectively, could fatally damage our business and chances

We currently rely on non-exclusive supply

arrangements with birth tissue recovery companies for obtaining the raw material used in manufacturing the products we sell.

If our current supply arrangements with birth

tissue recovery companies or third party manufacturers or distributors of products from third party manufacturers are disrupted for any

reason, we may not be able to provide products to our customers, or if other supply arrangements can be made, the products and terms may

not be as favorable, and that will adversely impact our operations and profitability.

If we do not continually update our products

and/or services, they may become obsolete and we may not be able to compete with other companies.

We cannot assure you that we will be able to keep

pace with technological advances, or that our current suppliers will be able to keep pace with technological advances and as such, our

products and/or services may become obsolete.

We cannot assure you that competitors will not develop related or similar services and offer

them before we do, or do so more successfully, or that they will not develop services and products more effective than any that we and/or

our suppliers have or are intending to develop.

In addition, although we may be able to identify new suppliers that can provide more effective

services and products to be more competitive, we may not be able to arrange satisfactory arrangements in a timely manner, if at all.

that happens, our business, prospects, results of operations and financial condition will be materially adversely affected.

We enter into supply arrangements for the

raw materials and/or products we sell, which make us vulnerable to the ability of such suppliers to remain current and innovative in their

product offerings, to timely process and supply the products we desire to purchase, and to remain compliant with the current and changing

regulatory environment.

If our raw material and/or product suppliers are not successful in managing these responsibilities, it will have

an adverse effect on our operations and profitability.

Our current birth tissue supply arrangements for

manufacturing the products we sell and our third-party supply arrangements for the supply of products we sell provide for the supply and

pricing for those products.

There can be no assurance that our suppliers will continue to produce the products that we currently purchase

under our existing arrangements, that our suppliers will be able to comply with the required FDA regulations for the manufacturing of

such products, that our suppliers will continue to develop technology associated with their manufactured products to remain competitive

with other companies, or that our suppliers will remain a going concern in the future.

If any of our suppliers were to cause a disruption

in our ability to obtain products as desired and expected and/or we are not provided advance notice of such potential disruption, we may

not be able to timely identify and replace our current suppliers, if at all, and as a result, we may not be able to provide products to

our customers, which will have an adverse impact to our operations.

In the event of default under our outstanding

indebtedness, or we are unable to pay other obligations and accounts payable when due, our creditors may file a creditors petition or

force us into involuntary bankruptcy which may have an adverse impact on our business.

The Company had a negative working capital positions

of $3,609,174 and $1,693,741 at October 31, 2021 and October 31, 2020, respectively.

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.

The Company’s

efforts to establish a stabilized source of sufficient revenues to cover operating costs has yet to be achieved and ultimately may prove

to be unsuccessful unless additional sources of working capital through operations or debt and/or equity financings are realized.

Company has not repaid certain outstanding indebtedness on the required due dates and the loans remain still outstanding.

Management anticipates

that the Company will remain dependent, for the near future, on additional investment capital to fund ongoing operating expenses.

Company does not have significant fixed and/or intangible assets to pledge for the purpose of borrowing additional capital.

the Company relies on short term supply agreements to obtain the supply of raw materials used in manufacturing the products it currently

sells and distributes to its customers.

The Company’s current market capitalization and common stock liquidity will hinder its ability

to raise equity proceeds to implement its business plan and could adversely affect the value of our securities, including the common stock.

We have borrowed and may be required to

borrow funds in the future.

If the Company incurs indebtedness, such as the

transaction described in “ Item 1.

– Business – Recent Development ” above, a portion of its cash flow will

have to be dedicated to the payment of principal and interest on such indebtedness.

Typical loan agreements also might contain restrictive

covenants, which may impair the Company’s operating flexibility.

Such loan agreements would also provide for default under certain

circumstances, such as failure to meet certain financial covenants.

A default under a loan agreement could result in the loan becoming

immediately due and payable and, if unpaid, a judgment in favor of such lender which would be senior to the rights of the Company’s

stockholders.

A judgment creditor would have the right to foreclose on any of the Company’s assets resulting in a material adverse

effect on the Company’s business, operating results or financial condition.

Currently the Company has limited assets which

could be used as collateral in obtaining future borrowings.

Because of the Company’s inability to provide lenders with collateral

and a limited history of successful operations, the Company may not be successful in its efforts to obtain additional funds though borrowings

and as a result may not be able to fund required costs of operations.

These loans are or may be convertible into common

stock under certain circumstances which may result in significant dilution to current stockholders.

Our growth depends on external sources of

capital, which may not be available on favorable terms or at all.

Our access to capital will depend upon a number

of factors over which we have little or no control, including general market conditions, government regulations and the market’s

perception of our current and potential future earnings.

If general economic instability or downturn leads to an inability to borrow at

attractive rates or at all, our ability to obtain capital to finance working capital requirements could be negatively impacted.

If we are unable to obtain capital on terms and

conditions that we find acceptable, we likely will have to scale back our business operations.

In addition, our ability to refinance all

or any debt we may incur in the future, on acceptable terms or at all, is subject to all of the above factors, and will also be affected

by our future financial position, results of operations and cash flows, which additional factors are also subject to significant uncertainties,

and therefore we may be unable to refinance any debt we may incur in the future, as it matures, on acceptable terms or at all.

these events would have a material adverse effect on our business, financial condition, liquidity and results of operations.

Failure to establish or enhance our brand

recognition could have a material adverse effect on our business and results of operations.

We believe we will need to expend significant

time, effort and resources to enhance the recognition of our brands.

We believe developing our brand will be important to our sales and

marketing efforts.

If we fail to establish or enhance the recognition of our brands, it could have a material adverse effect on our ability

to sell our products and adversely affect our business and results of operations.

If we fail to develop a positive public image and reputation,

our business with our existing customers could decline and we may fail to develop additional business, which could adversely affect our

results of operations.

Defects in the products we sell or failures

in quality control related to our distribution of products could impair our ability to sell our products or could result in product liability

claims, litigation and other significant events involving substantial costs.

Detection of any significant defects in our products

that we sell or failure in our quality control procedures or the quality control procedures of our suppliers may result in, among other

things, delay in time-to-market, loss of sales and market acceptance of our products, diversion of development resources, injury to our

reputation and restrictions imposed by governmental agencies.

The costs we may incur in correcting any product defects may be substantial

and we may not be able to identify adequate remedies, if required.

Additionally, errors, defects or other performance problems could result

in financial or other damages to our customers, which could result in litigation.

Product liability litigation, even if we prevail and/or

our suppliers, would be time consuming and costly to defend, and if we and/or our product suppliers do not prevail, could result in the

imposition of a damages award.

We presently maintain product liability insurance and we are named insured on our suppliers’ insurance

however, it may not be adequate to cover any claims.

Our ability to become profitable and continue

as a going concern will be dependent on our ability to attract, employ and retain highly skilled individuals to serve our clients.

The nature of our business requires that we employ

skilled persons to perform highly skilled and specialized tasks for our Company.

Our failure to retain such personnel could have a material

adverse effect on our ability to offer services to clientele and could potentially have a negative effect on our business.

guarantee that skilled persons will be available and willing to work for us in the future, nor is there any guarantee that we could afford

to retain them if they are available at a future time.

Our ability to commence and complete

clinical studies and other research and development objectives that are required by the FDA will require that we are properly funded to

assure that we can commence and proceed with the required research activities promptly and that the results are favorable.

The Company is pursuing efforts to commence and

complete 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 timely and 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.

Our projections and forward-looking

information may prove to be incorrect.

Management has prepared projections regarding

the Company’s anticipated financial performance and overall financial requirements.

The Company’s projections are hypothetical

and based upon a presumed financial performance of the Company, the addition of a sophisticated and well-funded marketing plan, and other

factors influencing the business of the Company.

The projections are based on Management’s best estimate of the probable results

of operations of the Company, based on present circumstances, and have not been reviewed by the Company’s independent accountants.

These projections are based on several assumptions, set forth therein, which Management believes are reasonable.

Some assumptions upon

which the projections are based, however, invariably will not materialize due to the inevitable occurrence of unanticipated events and

circumstances beyond Management’s control.

Therefore, actual results of operations will vary from the projections, and such variances

may be material.

Assumptions regarding our future clinical trials, including overall costs and outcomes as well as future changes in sales

and revenues are necessarily speculative in nature.

In addition, projections do not and cannot take into account such factors as general

economic conditions, unforeseen regulatory changes, the entry into the Company’s market of additional competitors, the terms and

conditions of future capitalization, and other risks inherent to the Company’s business.

While Management believes that the projections

accurately reflect possible future results of the Company’s operations, those results cannot be guaranteed.

We may not be able to manage our growth

We must continually implement and improve our

products and/or services, operations, operating procedures and quality controls on a timely basis, as well as expand, train, motivate

and manage our work force in order to accommodate anticipated growth and compete effectively in our market segment.

Successful implementation

of our strategy also requires that we establish and manage a competent, dedicated work force and employ additional key employees in corporate

management, product development, client service and sales.

We can give no assurance that our personnel, systems, procedures and controls

will be adequate to support our existing and future operations.

If we fail to implement and improve these operations, there could be a

material, adverse effect on our business, operating results and financial condition.

If we make any acquisitions or enter into

a merger or similar transaction, our business may be negatively impacted.

We have no present plans for any specific acquisition.

However, in the event that we make acquisitions in the future, we could have difficulty integrating the acquired companies’ personnel

and operations with our own.

In addition, the key personnel of the acquired business may not be willing to work for us.

We cannot predict

the effect expansion may have on our core business.

Regardless of whether we are successful in making an acquisition, the negotiations

could disrupt our ongoing business, distract our management and employees and increase our expenses.

In addition to the risks described

above, acquisitions, mergers and other similar transactions are accompanied by a number of inherent risks, including, without limitation,

the following:

the difficulty of integrating acquired products, services or operations;

the potential disruption of the ongoing businesses and distraction of our Management and the management of acquired companies;

the difficulty of incorporating acquired rights or products into our existing business;

difficulties in disposing of the excess or idle facilities of an acquired company or business and expenses in maintaining such facilities;

difficulties in maintaining uniform standards, controls, procedures and policies;

the potential impairment of relationships with employees and customers as a result of any integration of new management personnel;

the potential inability or failure to achieve additional sales and enhance our customer base through cross-marketing of the products to new and existing customers;

the effect of any government regulations which relate to the business acquired;

potential unknown liabilities associated with acquired businesses or product lines, or the need to spend significant amounts to retool, reposition or modify the marketing and sales of acquired products or the defense of any litigation, whether or not successful, resulting from actions of the acquired company prior to our acquisition.

Our business could be severely impaired if and

to the extent that we are unable to succeed in addressing any of these risks or other problems encountered in connection with these acquisitions,

many of which cannot be presently identified, these risks and problems could disrupt our ongoing business, distract our management and

employees, increase our expenses and adversely affect our results of operations.

There might be unanticipated obstacles to

the execution of our business plan.

The Company’s business plans may change

significantly.

The Company’s potential business endeavors are capital intensive.

Management believes that the Company’s chosen

activities and strategies are achievable in light of current economic and legal conditions with the skills, background, and knowledge

of the Company’s principals and advisors.

Management reserves the right to make significant modifications to the Company’s

stated strategies depending on future events.

We may engage in transactions that present

conflicts of interest.

The Company’s officers and directors may

enter into agreements with the Company from time to time which may not be equivalent to similar transactions entered into with an independent

A conflict of interest arises whenever a person has an interest on both sides of a transaction.

While we believe that it

will take prudent steps to ensure that all transactions between the Company and any officer or director is fair, reasonable, and no more

than the amount it would otherwise pay to a third party in an “arms-length” transaction, there can be no assurance that any

transaction will meet these requirements in every instance.

Our operating results may fluctuate

significantly as a result of a variety of factors, many of which are outside of our control.

We are subject to the following factors, among

others, that may negatively affect our operating results:

● The announcement or introduction of new products by our competitors;

● Failure of Government and private health plans to adequately and timely reimburse the users of our products;

● Our ability to upgrade and develop our systems and infrastructure to accommodate growth;

● Our ability to attract and retain key personnel in a timely and cost effective manner;

● The amount and timing of operating costs and capital expenditures relating to the expansion of our business,

operations and infrastructure;

● Regulation by Federal, State or Local Governments;

● General economic conditions (including fallout from current and future pandemics) as well as economic

conditions specific to the healthcare industry.

We have based our current and future expense levels

largely on our investment plans and estimates of future events, although certain of our expense levels are, to a large extent, fixed.

We may be unable to adjust spending in a timely manner to compensate for any unexpected revenue shortfall.

Accordingly, any significant

shortfall in revenue relative to our planned expenditures would have an immediate adverse effect on our business, results of operations

and financial condition.

Further, as a strategic response to changes in the competitive environment, we may from time to time make certain

pricing, service or marketing decisions that could have a material and adverse effect on our business, results of operations and financial

Due to the foregoing factors, our revenue and operating results are and will remain difficult to forecast.

We are in a highly competitive and evolving

field and face competition from well-established tissue processors and medical device manufacturers, as well as new market entrants.

Our business is in a very competitive and evolving

Competition from other tissue processors, medical device companies and from research and academic institutions is intense, expected

to increase, subject to rapid change, and could be significantly affected by new product introductions.

The presence of this competition

in our market may lead to pricing pressure, which would make it more difficult to sell our products at a price that will make us profitable

or prevent us from selling our products at all.

Our success will depend on our ability and/or the ability of our suppliers to perfect

and protect their intellectual property rights related to their technologies as well as to develop new technologies and new applications

for our technologies.

Our failure to compete effectively would have a material and adverse effect on our business, results of operations

and financial condition.

Rapid technological change could cause our

products to become obsolete.

The technologies underlying the products we sell

and intend to sell are subject to rapid and profound technological change.

Competition intensifies as technical advances in each field

are made and become more widely known.

We can give no assurance that our suppliers will be able to develop services, products, or processes

with significant advantages over the competing products, services, and processes.

Any such occurrence could have a material and adverse

effect on our business, results of operations and financial condition.

Our products are dependent on the availability

of sufficient quantities of tissue from human donors, and any disruption in supply could adversely affect our business.

The success of the human tissue products we sell

depends upon, among other factors, the availability of sufficient quantities of tissue from human donors.

The availability of donated

tissue could be adversely impacted by regulatory changes, public opinion of the donor process as well as our and our suppliers’

reputations in the industry.

Any disruption in the supply

of donated human tissue could restrict our growth and could have a material adverse impact on our business and financial condition.

cannot be sure that the supply of human tissue will continue to be available at current levels or will be sufficient to meet our

future needs.

products we offer are derived from human tissue and therefore have the potential for disease transmission.

utilization of human tissue creates the potential for transmission of communicable disease, including, but not limited to, HIV,

viral hepatitis, syphilis and other viral, fungal or bacterial pathogens.

Our suppliers are required to comply with

federal and state regulations intended to prevent communicable disease transmission.

we believe that our suppliers maintain strict quality controls over the procurement and processing of the human tissue used to

make the products we sell, there is no assurance that these quality controls are or will continue to be adequate.

addition, negative publicity concerning disease transmission from other companies improperly processed donated tissue could have

a negative impact on the demand for our products.

order to grow revenues from certain of our products, we must expand our relationships with distributors and independent sales

representatives.

derive significant revenues through our relationships with distributors and independent sales representatives.

During the year

ended October 31, 2020, one distributor was affiliated with revenues received from customers comprising approximately 6.0% of

our revenues.

If such relationships were terminated for any reason, it could materially and adversely affect our ability

to generate revenues and profits.

We intend to obtain the assistance of additional distributors and independent sales

representatives to continue our sales growth with respect to certain of our products.

We may not be able to find additional

distributors and independent sales representatives who will agree to market and/or distribute those products on commercially reasonable

terms, if at all.

In addition, adding new distributors and independent sales representatives require additional administrative

and accounting efforts for which the Company may not have sufficient resources to manage effectively.

If we are unable to

establish new distribution and independent sales representative relationships or renew current distribution and sales agency agreements

on commercially acceptable terms or manage the growth effectively, our business, financial condition and results of operations

could be materially and adversely affected.

continue to invest significant capital in expanding our internal sales force, and there can be no assurance that these efforts

will continue to result in significant increases in sales.

are engaged in a major initiative to build and further expand our internal sales and marketing capabilities which has contributed

to our increased sales.

As a result, we continue to invest in a direct sales force for certain of our products to allow

us to reach new customers.

These expenses impact our operating results, and there can be no assurance that we will

continue to be successful in significantly expanding the sales of our products.

revenues may need to depend on adequate reimbursement from public and private insurers and health systems.

a significant number of public and private insurers and health systems currently do not provide reimbursement for our products.

Our success and extent of our growth depends on the extent to which reimbursement for the costs of our products and related treatments

will be available from third party payers, such as public and private insurers and health systems.

Government and other

third-party payers attempt to contain healthcare costs by limiting both coverage and the level of reimbursement of new products.

significant uncertainty usually exists as to the reimbursement status of new healthcare products.

If we are not successful

in obtaining adequate reimbursement for our products from these third-party payers, the market's acceptance of our products could

be adversely affected.

Inadequate reimbursement levels also likely would create downward price pressure on our products.

if we do succeed in obtaining widespread reimbursement for our products, future changes in reimbursement policies could have a

negative impact on our business, financial condition and results of operations.

be commercially successful, we must convince physicians that our products are compliant with regulations, safe and effective

alternatives to existing treatments and that our products should be used in their procedures.

believe physicians will only adopt our products if they determine, based on experience, clinical data and published peer reviewed

journal articles, that the use of our products in a particular procedure is a favorable alternative to conventional methods.

may be slow to change their medical treatment practices for the following reasons, among others:

lack of experience with prior procedures in the field using our products;

of evidence supporting additional patient benefits and our products over conventional

liability risks generally associated with the use of new products and procedures;

exposure from regulatory agencies that monitor the use of our products;

availability of reimbursement from third party payers;

time that must be dedicated to training.

addition, we believe recommendations for and support of our products by influential physicians are essential for market acceptance

and adoption.

If we do not receive this support or if we are unable to demonstrate favorable long-term clinical data,

physicians and hospitals may not use our products, which would significantly reduce our ability to achieve expected revenue and

would prevent us from sustaining profitability.

will need to expand our organization and managing growth may be more difficult than expected.

our growth may be more difficult than we expect.

We anticipate that a period of significant expansion will be required

to penetrate and service the market for our existing and anticipated future products and to continue to develop new products.

expansion will place a significant strain on management, operational and financial resources.

To manage the expected

growth of our operations and personnel, we must both modify our existing operational and financial systems, procedures and controls

and implement new systems, procedures and controls.

We must also expand our finance, administrative, and operations

Any disruption in the supply of donated human tissue could restrict our growth and could have a material

adverse impact on our business and financial condition.

We cannot be sure that the supply of human tissue will continue to be available

at current levels or will be sufficient to meet our future needs.

The products we offer are derived from human

tissue and therefore have the potential for disease transmission.

The utilization of human tissue creates the potential

for transmission of communicable disease, including, but not limited to, HIV, viral hepatitis, syphilis and other viral, fungal or bacterial

Our suppliers are required to comply with federal and state regulations intended to prevent communicable disease transmission.

Although we believe that our suppliers maintain

strict quality controls over the procurement and processing of the human tissue used to make the products we sell, there is no assurance

that these quality controls are or will continue to be adequate.

In addition, negative publicity concerning disease transmission from

other companies improperly processed donated tissue could have a negative impact on the demand for our products.

In order to grow revenues from certain of

our products, we must expand our relationships with distributors and independent sales representatives.

We derive significant revenues through our relationships

with distributors and independent sales representatives.

If such relationships were terminated for any reason, it could materially

and adversely affect our ability to generate revenues and profits.

We intend to obtain the assistance of additional distributors and independent

sales representatives to continue our sales growth with respect to certain of our products.

We may not be able to find additional distributors

and independent sales representatives who will agree to market and/or distribute those products on commercially reasonable terms, if at

In addition, adding new distributors and independent sales representatives require additional administrative and accounting efforts

for which the Company may not have sufficient resources to manage effectively.

If we are unable to establish new distribution and independent

sales representative relationships or renew current distribution and sales agency agreements on commercially acceptable terms or manage

the growth effectively, our business, financial condition and results of operations could be materially and adversely affected.

We continue to invest significant capital

in expanding our internal sales force, and there can be no assurance that these efforts will continue to result in significant increases

We are engaged in a major initiative to build

and further expand our internal sales and marketing capabilities which has contributed to our increased sales.

As a result, we continue

to invest in a direct sales force for certain of our products to allow us to reach new customers.

These expenses impact our operating

results, and there can be no assurance that we will continue to be successful in significantly expanding the sales of our products.

Our revenues may need to depend on adequate

reimbursement from public and private insurers and health systems.

Currently, a significant number of public and

private insurers and health systems do not provide reimbursement for our products.

Our success and extent of our growth depends on the

extent to which reimbursement for the costs of our products and related treatments will be available from third party payers, such as

public and private insurers and health systems.

Government and other third-party payers attempt to contain healthcare costs by limiting

both coverage and the level of reimbursement of new products.

Therefore, significant uncertainty usually exists as to the reimbursement

status of new healthcare products.

If we are not successful in obtaining adequate reimbursement for our products from these third-party

payers, the market’s acceptance of our products could be adversely affected.

Inadequate reimbursement levels also likely would create

downward price pressure on our products.

Even if we do succeed in obtaining widespread reimbursement for our products, future changes

in reimbursement policies could have a negative impact on our business, financial condition and results of operations.

To be commercially successful, we must convince

physicians that our products are compliant with regulations, safe and effective alternatives to existing treatments and that our products

should be used in their procedures.

We believe physicians will only adopt our products

if they determine, based on experience, clinical data and published peer reviewed journal articles, that the use of our products in a

particular procedure is a favorable alternative to conventional methods.

Physicians may be slow to change their medical treatment practices

for the following reasons, among others:

● Their lack of experience with prior procedures in the field using our products;

● Lack of evidence supporting additional patient benefits and our products over conventional methods;

● Perceived liability risks generally associated with the use of new products and procedures;

● Perceived exposure from regulatory agencies that monitor the use of our products;

● Limited availability of reimbursement from third party payers;

● The time that must be dedicated to training.

In addition, we believe recommendations for and

support of our products by influential physicians are essential for market acceptance and adoption.

If we do not receive this support

or if we are unable to demonstrate favorable long-term clinical data, physicians and hospitals may not use our products, which would significantly

reduce our ability to achieve expected revenue and would prevent us from sustaining profitability.

We will need to expand our organization

and managing growth may be more difficult than expected.

Managing our growth may be more difficult than

We anticipate that a period of significant expansion will be required to penetrate and service the market for our existing

and anticipated future products and to continue to develop new products.

This expansion will place a significant strain on management,

operational and financial resources.

To manage the expected growth of our operations and personnel, we must both modify our existing operational

and financial systems, procedures and controls and implement new systems, procedures and controls.

We must also expand our finance, administrative,

and operations staff.

Management may be unable to hire, train, retain, motivate and manage necessary personnel or to identify, manage

and exploit existing and potential strategic relationships and market opportunities.

face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance .

business exposes us to the risk of product liability claims that are inherent in the manufacturing, processing and marketing of

human tissue products.

We may be subject to such claims if the products we sell cause, or appear to have caused, an

Claims may be made by patients, healthcare providers or others selling our products.

maintain product liability insurance that contain limits of coverage for the insured.

Defending a lawsuit, regardless of merit,

could be costly, divert management attention and result in adverse publicity, which could result in the withdrawal of, or reduced

acceptance of, our products in the market.

There can be no assurance that adequate insurance will be available in the event of

a lawsuit, if at all.

We may be unable to obtain or maintain

adequate product liability insurance .

Our business exposes us to the risk of product

liability claims that are inherent in the manufacturing, processing and marketing of human tissue products.

We may be subject to such

claims if the products we sell cause, or appear to have caused, an injury.

Claims may be made by patients, healthcare providers or others

selling our products.

We currently maintain product liability insurance that contain limits of coverage for the insured.

Defending a lawsuit,

regardless of merit, could be costly, divert management attention and result in adverse publicity, which could result in the withdrawal

of, or reduced acceptance of, our products in the market.

There can be no assurance that adequate insurance will be available in the event

of a lawsuit, if at all.

A product liability claim could result in significant costs and significant harm to our business.

may implement a product recall or voluntary market withdrawal, which could significantly increase our costs, damage our reputation

and disrupt our business.

manufacturing, marketing and processing of the tissue products we sell or intend to sell involve an inherent risk that they do

not meet applicable quality standards and requirements.

In that event, there may be recall or market withdrawal required

by a regulatory authority.

A recall or market withdrawal of one of our products would be costly and would divert management

A recall or withdrawal of one of the products we sell, or a similar product processed, also could impair

sales of our products as a result of confusion concerning the scope of the recall or withdrawal, or as a result of the damage

to our reputation for quality and safety.

disruptions of information technology systems or breaches of information security could adversely affect our business.

rely to a large extent upon sophisticated information technology systems to operate our business.

In the ordinary course of business,

we collect, store and transmit large amounts of confidential information (including, but not limited to, personal information

and intellectual property).

We also have outsourced significant elements of our operations to third parties, including significant

elements of our information technology infrastructure and, as a result, we are managing many independent vendor relationships

with third parties who may or could have access to our confidential information.

The size and complexity of our information technology

and information security systems, and those of our third-party vendors with whom we contract (and the large amounts of confidential

information that is present on them), make such systems potentially vulnerable to service interruptions or to security breaches

from inadvertent or intentional actions by our employees or vendors, or from malicious attacks by third parties.

are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including,

We may implement a product recall or voluntary

market withdrawal, which could significantly increase our costs, damage our reputation and disrupt our business.

The manufacturing, marketing and processing of

the tissue products we sell or intend to sell involve an inherent risk that they do not meet applicable quality standards and requirements.

In that event, there may be recall or market withdrawal required by a regulatory authority.

A recall or market withdrawal of one of our

products would be costly and would divert management resources.

A recall or withdrawal of one of the products we sell, or a similar product

processed, also could impair sales of our products as a result of confusion concerning the scope of the recall or withdrawal, or as a

result of the damage to our reputation for quality and safety.

Significant disruptions of information technology

systems or breaches of information security could adversely affect our business.

We rely to a large extent upon sophisticated information

technology systems to operate our business.

In the ordinary course of business, we collect, store and transmit large amounts of confidential

information (including, but not limited to, personal information and intellectual property).

We also have outsourced significant elements

of our operations to third parties, including significant elements of our information technology infrastructure and, as a result, we are

managing many independent vendor relationships with third parties who may or could have access to our confidential information.

and complexity of our information technology and information security systems, and those of our third-party vendors with whom we contract

(and the large amounts of confidential information that is present on them), make such systems potentially vulnerable to service interruptions

or to security breaches from inadvertent or intentional actions by our employees or vendors, or from malicious attacks by third parties.

Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including,

but not limited to, industrial espionage and market manipulation) and expertise.

While we have invested significantly in the protection

of data and information technology, there can be no assurance that our efforts will prevent service interruptions or security

Although we may obtain cyber-insurance coverage that may cover certain events described above, this insurance is

subject to deductibles and coverage limitations and we may not be able to maintain this insurance.

Also, it is possible that

claims could exceed the limits of our coverage.

Any interruption or breach in our systems could adversely affect our business

operations and/or result in the loss of critical or sensitive confidential information or intellectual property, and could result

in financial, legal, business and reputational harm to us or allow third parties to gain material, inside information that they

use to trade in our securities.

lines of business or new products and services may subject us to additional risks.

time to time, we may implement or may acquire new lines of business or offer new products and services within existing lines of

There are risks and uncertainties associated with these efforts, particularly in instances where the markets are not

fully developed or are evolving.

In developing and marketing new lines of business and new products and services, we may invest

significant time and resources.

External factors, such as regulatory compliance obligations, competitive alternatives, and shifting

market preferences, may also impact the successful implementation of a new line of business or a new product or service.

to successfully manage these risks in the development and implementation of new lines of business or new products or services

could have a material adverse effect on our business, results of operations and financial condition.

Related to Our Intellectual Property

can be no assurances of protection for proprietary rights or reliance on trade secrets.

certain cases, the Company may rely on trade secrets to protect intellectual property, proprietary technology and processes, which

the Company has acquired, developed or may develop in the future.

There can be no assurances that secrecy obligations will be

honored or that others will not independently develop similar or superior products or technology.

The protection of intellectual

property and/or proprietary technology through claims of trade secret status has been the subject of increasing claims and litigation

by various companies both in order to protect proprietary rights as well as for competitive reasons even where proprietary claims

are unsubstantiated.

The prosecution of proprietary claims or the defense of such claims is costly and uncertain given the uncertainty

and rapid development of the principles of law pertaining to this area.

The Company, in common with other firms, may also be subject

to claims by other parties with regard to the use of intellectual property, technology information and data, which may be deemed

proprietary to others.

suppliers’

ability to protect their intellectual property and proprietary technology through patents and other means

is uncertain and may be inadequate, which could have a material and adverse effect on us.

depend significantly on our suppliers’

ability to protect their proprietary rights to the technologies used in the products

we purchase from them and resell.

Traditional legal means afford only limited protection and may not adequately protect

their rights or permit them to gain or keep any competitive advantage.

To the extent that they are unable to protect

their intellectual property against infringement by others or by claims of infringement by such suppliers, our business could

be materially adversely affected.

may be subject to damages resulting from claims that we, our employees, or our independent contractors have wrongfully used

or disclosed alleged trade secrets of others.

of our employees were previously employed at other medical device or tissue companies.

We may also hire additional employees who

are currently employed at other medical device or tissue companies, including our competitors.

Additionally, consultants or other

independent agents with which we may contract may be or have been in a contractual arrangement with one or more of our competitors.

no claims against us are currently pending, we may be subject to claims that these employees or independent contractors have used

or disclosed any party's trade secrets or other proprietary information.

of data and information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches.

we may obtain cyber-insurance coverage that may cover certain events described above, this insurance is subject to deductibles and coverage

limitations and we may not be able to maintain this insurance.

Also, it is possible that claims could exceed the limits of our coverage.

Any interruption or breach in our systems could adversely affect our business operations and/or result in the loss of critical or sensitive

confidential information or intellectual property, and could result in financial, legal, business and reputational harm to us or allow

third parties to gain material, inside information that they use to trade in our securities.

New lines of business or new products and

services may subject us to additional risks.

From time to time, we may implement or may acquire

new lines of business or offer new products and services within existing lines of business.

There are risks and uncertainties associated

with these efforts, particularly in instances where the markets are not fully developed or are evolving.

In developing and marketing new

lines of business and new products and services, we may invest significant time and resources.

External factors, such as regulatory compliance

obligations, competitive alternatives, and shifting market preferences, may also impact the successful implementation of a new line of

business or a new product or service.

Failure to successfully manage these risks in the development and implementation of new lines of

business or new products or services could have a material adverse effect on our business, results of operations and financial condition.

Risks Related to Our Intellectual Property

If we are unable to adequately protect our

intellectual property, our ability to compete in the market will be harmed.

Our commercial success will depend in part on

patents and other intellectual property protection.

To date we have applied for two patent applications and one provisional patent and

plan to file for additional patents with respect to our products and we intend to defend our patents and other intellectual property against

third party challenges.

However, there can be no assurance that any patents applied for will be issued, that scope of protection afforded

by any patents issued will be as broad as claimed or if challenged, patents may be found to be invalid or unenforceable.

Moreover, there

can be no assurance that we will have the financial resources to protect our intellectual property.

There can be no assurances of protection

for proprietary rights or reliance on trade secrets.

In certain cases, the Company may rely on trade

secrets to protect intellectual property, proprietary technology and processes, which the Company has acquired, developed or may develop

in the future.

There can be no assurances that secrecy obligations will be honored or that others will not independently develop similar

or superior products or technology.

The protection of intellectual property and/or proprietary technology through claims of trade secret

status has been the subject of increasing claims and litigation by various companies both in order to protect proprietary rights as well

as for competitive reasons even where proprietary claims are unsubstantiated.

The prosecution of proprietary claims or the defense of

such claims is costly and uncertain given the uncertainty and rapid development of the principles of law pertaining to this area.

Company, in common with other firms, may also be subject to claims by other parties with regard to the use of intellectual property, technology

information and data, which may be deemed proprietary to others.

Our suppliers’ ability to protect

their intellectual property and proprietary technology through patents and other means is uncertain and may be inadequate, which

could have a material and adverse effect on us.

We depend significantly on our suppliers’

ability to protect their proprietary rights to the technologies used in the products we purchase from them and resell.

Traditional legal

means afford only limited protection and may not adequately protect their rights or permit them to gain or keep any competitive advantage.

To the extent that they are unable to protect their intellectual property against infringement by others or by claims of infringement

by such suppliers, our business could be materially adversely affected.

We may be subject to damages resulting from

claims that we, our employees, or our independent contractors have wrongfully used or disclosed alleged trade secrets of others.

Some of our employees were previously employed

at other medical device or tissue companies.

We may also hire additional employees who are currently employed at other medical device

or tissue companies, including our competitors.

Additionally, consultants or other independent agents with which we may contract may be

or have been in a contractual arrangement with one or more of our competitors.

Although no claims against us are currently pending, we

may be subject to claims that these employees or independent contractors have used or disclosed any party’s trade secrets or other

proprietary information.

Litigation may be necessary to defend against these claims.

if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

we fail to defend such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

loss of key personnel or their work product could hamper or prevent our ability to market existing or new products, which could

severely harm our business.

we are unable to protect our trademarks from infringement, our business prospects may be harmed.

currently have applied for a registered trademark for the use of Organicell and the suite of our family of biologic products offered

in the United States.

Although we may take steps to monitor the possible infringement or misuse of our Organicell or other trademarks

once they are obtained, it is possible that third parties may infringe, dilute or otherwise violate our trademark rights.

unauthorized use of our trademarks could harm our reputation or commercial interests.

In addition, our enforcement against third-party

infringers or violators may be unduly expensive and time-consuming, and any remedy obtained may constitute insufficient redress

relative to the damages we may suffer.

Our business may be materially adversely affected in the event we are unable to protect

our trademarks.

Related to Regulatory Approval of Our Products and Other Government Regulations

the extent our products do not qualify for regulation as human cells, tissues and cellular and tissue-based products under Section

361 of the Public Health Service Act, this could result in removal of the applicable products from the market, would make the

introduction of new tissue products more expensive and significantly delay the expansion of our tissue product offerings and subject

us to additional post-market regulatory requirements.

products we offer are derived from human tissue.

The FDA has specific regulations governing human cells, tissues and

cellular and tissue-based products, or HCT/Ps.

An HCT/P is a product containing or consisting of human cells or tissue intended

for transplantation into a human patient.

HCT/Ps that meet the criteria for regulation solely under Section 361 of

the Public Health Service Act (so-called “361 HCT/Ps”) are not subject to any premarket clearance or approval requirements

and are subject to less stringent post-market regulatory requirements.

a product is deemed not to be a 361 HCT/P, FDA regulations will require premarket clearance or approval requirements that will

involve significant time and cost investments by the Company.

Further, there can be no assurance that the FDA will not, at some

future point, change its position on current or future products' 361 HCT/P status, and any regulatory reclassification could have

adverse consequences for us and make it more difficult or expensive for us to conduct our business by requiring premarket clearance

or approval and compliance with additional post-market regulatory requirements with respect to those products.

Moreover, increased

regulatory scrutiny within the industry in which we operate could lead to increased regulation of HCT/Ps, including 361 HCT/Ps.

also cannot assure you that the FDA will not impose more stringent definitions with respect to products that qualify as 361 HCT/Ps.

“Government Regulation”

in Item 1 for a discussion of 361 HCT/Ps and the FDA's position on our products.

does allow the Company to continue to market those products that fall under the proposed regulations without a biologics license

either prior to or after finalization of the draft guidance documents, it may impose conditions, such as labeling restrictions

and compliance with cGMP.

Although the Company is preparing for these requirements in connection with its pursuit of a BLA for

certain of its products, earlier compliance with these conditions would require significant additional time and cost investments

by the Company.

It is also possible that the FDA will not allow the Company to market any form of it’s products without

a biologics license even prior to finalization of the draft guidance documents and could even require the Company to recall it’s

FDA has recently announced that it intends to begin enforcement of regulations to manufacturers of certain biologics tissue products,

including the products that we may purchase through supply agreements with those identified manufacturers.

If the FDA were to

take enforcement action against those suppliers, it would have a material adverse impact to our operations.

November 2017, the FDA issued guidance documents to clarify the FDA’s interpretation of the risk-based criteria manufacturers

used to determine which manufactured tissue products are subject to the FDA’s premarket review and in order to be lawfully

marketed in the United States, require an FDA-approved BLA.

FDA intends to exercise enforcement discretion through May 2021 with regard to allowing manufacturers for certain products that

are subject to the FDA’s premarket review under the existing regulations, but are not currently meeting these requirements.

Company believes that the current products it distributes are not specifically identified within the scope of these regulations

and that the new regulatory restrictions being implemented by the FDA are intended to assure that all parties involved in the

chain of gathering, processing, distributing and/or administrating RAAM related products have met the required standards to assure

that the manufacturing, marketing the administration of the RAAM regulated products are not misleading and are performed in a

safe and ethical manner and in accordance with the “objective intent”

of the manufacturer.

is no assurance that the FDA will not take enforcement action against us or our suppliers in connection with the products we manufacture

and/or purchase from suppliers and sell to our customers.

Furthermore, our supply agreements provide that we comply with all FDA

requirements for in the use of the products we purchase from our suppliers, including the way we market the products to our customers,

including our representatives and sub-distributors, and any activities that we take that might be inconsistent with the “manufacturers

objective intent”, including potential significant safety concerns on how the products are being administered as well as

the diseases and conditions for which they are being used.

If the FDA were to take any adverse action against ourselves and/or

our suppliers and/or representatives and distributors and/or it is determined that any of our activities are the basis for FDA

enforcement, it will have a significant adverse effect on our operations.

business is subject to continuing regulatory compliance by the FDA and other authorities, which is costly and our failure to comply

could result in negative effects on our business.

discussed above, the FDA has specific regulations governing our tissue-based products, or HCT/Ps.

The FDA has broad post-market

and regulatory and enforcement powers.

The FDA's regulation of HCT/Ps includes requirements for registration and listing

of products, donor screening and testing, processing and distribution (“Current Good Tissue Practices”), labeling,

record keeping and adverse-reaction reporting, and inspection and enforcement.

and medical devices are subject to even more stringent regulation by the FDA.

Even if pre-market clearance or approval is

obtained, the approval or clearance may place substantial restrictions on the indications for which the product may be marketed

or to whom it may be marketed, may require warnings to accompany the product or impose additional restrictions on the sale and/or

use of the product.

In addition, regulatory approval is subject to continuing compliance with regulatory standards,

including the FDA's quality system regulations.

we fail to comply with the FDA regulations regarding our tissue products or medical devices, the FDA could take enforcement action,

including, without limitation, any of the following sanctions and the manufacture of our products or processing of our tissue

could be delayed or terminated:

letters, warning letters, fines, injunctions, and civil penalties;

or seizure of our products;

restrictions, partial suspension or total shutdown of production;

our requests for clearance or approval of new products;

● Withdrawing

or suspending current applications for approval or approvals already granted;

to grant export approval for our products;

is likely that the FDA's regulation of HCT/Ps will continue to evolve in the future.

Complying with any such new regulatory

requirements may entail significant time delays and expense, which could have a material adverse effect on our business.

has issued operating standards for tissue banking.

Compliance with these standards is a requirement in order to become

an accredited tissue bank.

In addition, some states have their own tissue banking regulations.

November 2017, the FDA released four guidance documents (two final, two draft) in an effort to implement a “comprehensive

policy framework”

for existing laws and regulations governing regenerative medicine products, including human cells, tissues,

and cellular and tissue-based products (“HCT/Ps”).

These guidance documents build upon the previous regulatory

framework for these products, which was completed in 2005.

The Comprehensive regenerative medicine policy framework intends

to spur innovation, efficient access to potentially transformative products, while ensuring safety & efficacy.

framework builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated

as drugs, devices, and/or biological products.

Further, two of the guidance documents propose an efficient, science-based process

for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area.

guidance documents also defines a risk-based framework for how the FDA intends to focus its enforcement actions against those

products that raise potential significant safety concerns.

This modern framework is intended to balance the agency’s commitment

to safety with mechanisms to drive further advances in regenerative medicine so innovators can bring new, effective therapies

to patients as quickly and safely as possible.

The policy also delivers on important provisions of the Act.

the FDA has not changed its basic approach to regulating HCT/Ps, the agency intends to exercise enforcement discretion until May

2021 with regard to 351 HCT/Ps requiring premarket approval.

The guidance states that, in order to “give manufacturers time

to determine if they need to submit an IND or marketing application in light of this guidance,”

the FDA intends to exercise

enforcement discretion (i.e., the agency may permit marketing without an approved marketing application) if the HCT/P “is

intended for autologous use and its use does not raise reported safety concerns or potential significant safety concerns.”

Company believes that the new regulatory restrictions being implemented by the FDA are intended to assure that all parties involved

in the chain of gathering, processing, distributing and/or administrating RAAM related products have met the required standards

to assure that the manufacturing, marketing the administration of the RAAM regulated products are not misleading and are performed

in a safe, ethical and in accordance with “objective intent”.

addition, procurement of certain human organs and tissue for transplantation is subject to the restrictions of the National Organ

Transplant Act (“NOTA”), which prohibits the transfer of certain human organs, including skin and related tissue for

valuable consideration, but permits the reasonable payment associated with the removal, transportation, implantation, processing,

preservation, quality control and storage of human tissue and skin.

We reimburse tissue banks, hospitals and physicians

for their services associated with the recovery, storage and transportation of donated human tissue.

Although we have

independent third party appraisals that confirm that reasonableness of the service fees we pay, if we were to be found to have

violated NOTA's prohibition on the sale or transfer of human tissue for valuable consideration, we would potentially be subject

to criminal enforcement sanctions, which could materially and adversely affect our results of operations.

as discussed above, we and other manufacturers of skin substitutes are required to provide ASP information to CMS on a quarterly

The Medicare payment rates are updated quarterly based on this ASP information.

If a manufacturer is found to have made

a misrepresentation in the reporting of ASP, such manufacturer is subject to civil monetary penalties of up to $10,000 for each

misrepresentation for each day in which the misrepresentation was applied.

and our sales representatives, whether employees or independent contractors, must comply with various federal and state anti-kickback,

self-referral, false claims and similar laws, any breach of which could cause a material adverse effect on our business, financial

condition and results of operations.

relationships with physicians, hospitals and other healthcare providers are subject to scrutiny under various federal anti-kickback,

self-referral, false claims and similar laws, often referred to collectively as healthcare fraud and abuse laws.

fraud and abuse laws are complex, and even minor, inadvertent violations can give rise to claims that the relevant law has been

Possible sanctions for violation of these fraud and abuse laws include monetary fines, civil and criminal

penalties, exclusion from federal and state healthcare programs, including Medicare, Medicaid, Veterans Administration health

programs, workers' compensation programs and TRICARE (the healthcare system administered by or on behalf of the U.S.

of Defense for uniformed services beneficiaries, including active duty and their dependents, retirees and their dependents), and

forfeiture of amounts collected in violation of such prohibitions.

Certain states have similar fraud and abuse laws,

imposing substantial penalties for violations.

Any Government investigation or a finding of a violation of these laws

would likely result in a material adverse effect on the market price of our common stock, as well as our business, financial condition

and results of operations.

Anti-kickback

laws and regulations prohibit any knowing and willful offer, payment, solicitation or receipt of any form of remuneration in return

for the referral of an individual or the ordering or recommending of the use of a product or service for which payment may be

made by Medicare, Medicaid or other Government-sponsored healthcare programs.

We will enter into consulting agreements,

speaker agreements, research agreements and product development agreements with physicians, including some who may order our products

or make decisions to use them.

In addition, some of these physicians own our stock, which they purchased in arm's length

transactions on terms identical to those offered to non-physicians, or received stock awards from us as consideration for services

performed by them.

While these transactions were structured with the intention of complying with all applicable laws,

including state anti-referral laws and other applicable anti-kickback laws, it is possible that regulatory or enforcement agencies

or courts may in the future view these transactions as prohibited arrangements that must be restructured or for which we would

be subject to other significant civil or criminal penalties.

As discussed above, we have incorporated the AdvaMed code

principles into our relationships with healthcare professionals under our consulting agreements, and our policies regarding payment

of travel and lodging expenses, research and educational grant procedures and sponsorship of third-party conferences.

Even if we are successful in defending against these

claims, litigation could result in substantial costs and be a distraction to management.

If we fail to defend such claims, in addition

to paying monetary damages, we may lose valuable intellectual property rights or personnel.

A loss of key personnel or their work product

could hamper or prevent our ability to market existing or new products, which could severely harm our business.

If we are unable to protect our patents

and trademarks from infringement, our business prospects may be harmed.

We currently have applied for various patents

and received registered trademarks for the use of Organicell and the suite of our family of biologic products offered in the United States.

Although we may take steps to monitor the possible infringement or misuse of our patents and trademarks once they are obtained, it is

possible that third parties may infringe, dilute or otherwise violate our intellectual property rights.

Any unauthorized use of our intellectual

property could harm our reputation or commercial interests.

In addition, our enforcement against third-party infringers or violators may

be unduly expensive and time-consuming, and any remedy obtained may constitute insufficient redress relative to the damages we may suffer.

Our business may be materially adversely affected in the event we are unable to protect our intellectual property.

Risks Related to Regulatory Approval of Our

Products and Other Government Regulations

Our business is subject to continuing

regulatory compliance by the FDA and other authorities, which is costly and our failure to comply could result in negative effects on

our business.

The FDA has specific regulations governing our

tissue-based products, or HCT/Ps.

The FDA has broad post-market and regulatory and enforcement powers.

The FDA’s regulation

of HCT/Ps includes requirements for registration and listing of products, donor screening and testing, processing and distribution (“Current

Good Tissue Practices”), labeling, record keeping and adverse-reaction reporting, and inspection and enforcement.

Biologics and medical devices are subject to even

more stringent regulation by the FDA.

Even if pre-market clearance or approval is obtained, the approval or clearance may place substantial

restrictions on the indications for which the product may be marketed or to whom it may be marketed, may require warnings to accompany

the product or impose additional restrictions on the sale and/or use of the product.

In addition, regulatory approval is subject

to continuing compliance with regulatory standards, including the FDA’s quality system regulations.

If we fail to comply with the FDA regulations

regarding our tissue products or medical devices, the FDA could take enforcement action, including, without limitation, any of the following

sanctions and the manufacture of our products or processing of our tissue could be delayed or terminated:

● Untitled letters, warning letters, fines, injunctions, and civil penalties;

● Recall or seizure of our products;

● Operating restrictions, partial suspension or total shutdown of production;

● Refusing our requests for clearance or approval of new products;

● Withdrawing or suspending current applications for approval or approvals already granted;

● Refusal to grant export approval for our products;

● Criminal prosecution.

It is likely that the FDA’s regulation of HCT/Ps

will continue to evolve in the future.

Complying with any such new regulatory requirements may entail significant time delays

and expense, which could have a material adverse effect on our business.

The AATB has issued operating standards for tissue banking.

with these standards is a requirement in order to become an accredited tissue bank.

In addition, some states have their own tissue banking

In November 2017, the FDA released four guidance

documents (two final, two draft) in an effort to implement a “comprehensive policy framework” for existing laws and regulations

governing regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (“HCT/Ps”).

These guidance documents build upon the previous regulatory framework for these products, which was completed in 2005.

The Comprehensive

regenerative medicine policy framework intends to spur innovation, efficient access to potentially transformative products, while ensuring

safety & efficacy.

The framework builds upon the FDA’s existing

risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products.

two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these

therapies, while supporting development in this area.

The suite of guidance documents also defines a risk-based framework for how the

FDA intends to focus its enforcement actions against those products that raise potential significant safety concerns.

This modern framework

is intended to balance the agency’s commitment to safety with mechanisms to drive further advances in regenerative medicine so innovators

can bring new, effective therapies to patients as quickly and safely as possible.

The policy also delivers on important provisions of

The FDA guidance with regard to 351 HCT/Ps requiring

premarket approval became effective in May 2021 (extended from November 2020 due to the COVID-19 pandemic).

The guidance states that,

in order to “give manufacturers time to determine if they need to submit an IND or marketing application in light of this guidance,”

the FDA intends to exercise enforcement discretion (i.e., the agency may permit marketing without an approved marketing application) if

the HCT/P “is intended for autologous use and its use does not raise reported safety concerns or potential significant safety concerns.”

As of the date of this prospectus, we are not aware of whether any further extension of effectiveness and enforcement of these regulations

is or will be issued by the FDA.

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.

However, if our products are deemed by the FDA to fall

within the new guidelines and we are unable to successfully challenge any such determination, our business, results of operations and

financial condition may be significantly harmed.

In addition, procurement of certain human organs

and tissue for transplantation is subject to the restrictions of the National Organ Transplant Act (“NOTA”), which prohibits

the transfer of certain human organs, including skin and related tissue for valuable consideration, but permits the reasonable payment

associated with the removal, transportation, implantation, processing, preservation, quality control and storage of human tissue and skin.

reimburse tissue banks, hospitals and physicians for their services associated with the recovery, storage and transportation of donated

human tissue.

Although we have independent third party appraisals that confirm that reasonableness of the service fees we pay,

if we were to be found to have violated NOTA’s prohibition on the sale or transfer of human tissue for valuable consideration, we would

potentially be subject to criminal enforcement sanctions, which could materially and adversely affect our results of operations.

Finally, as discussed above, we and other manufacturers

of skin substitutes are required to provide ASP information to CMS on a quarterly basis.

The Medicare payment rates are updated quarterly

based on this ASP information.

If a manufacturer is found to have made a misrepresentation in the reporting of ASP, such manufacturer

is subject to civil monetary penalties of up to $10,000 for each misrepresentation for each day in which the misrepresentation was applied.

To the extent our products do not

qualify for regulation as human cells, tissues and cellular and tissue-based products under Section 361 of the Public Health Service Act,

this could result in removal of the applicable products from the market, would make the introduction of new tissue products more expensive

and significantly delay the expansion of our tissue product offerings and subject us to additional post-market regulatory requirements.

The products we offer are derived from human tissue.

FDA has specific regulations governing human cells, tissues and cellular and tissue-based products, or HCT/Ps.

An HCT/P is a product containing

or consisting of human cells or tissue intended for transplantation into a human patient.

HCT/Ps that meet the criteria for

regulation solely under Section 361 of the Public Health Service Act (so-called “361 HCT/Ps”) are not subject to any premarket

clearance or approval requirements and are subject to less stringent post-market regulatory requirements.

If a product is deemed not to be a 361 HCT/P,

FDA regulations will require premarket clearance or approval requirements that will involve significant time and cost investments by the

Further, there can be no assurance that the FDA will not, at some future point, change its position on current or future products’

361 HCT/P status, and any regulatory reclassification could have adverse consequences for us and make it more difficult or expensive for

us to conduct our business by requiring premarket clearance or approval and compliance with additional post-market regulatory requirements

with respect to those products.

Moreover, increased regulatory scrutiny within the industry in which we operate could lead to increased

regulation of HCT/Ps, including 361 HCT/Ps.

We also cannot assure you that the FDA will not impose more stringent definitions

with respect to products that qualify as 361 HCT/Ps.

If the FDA does allow the Company to continue

to market those products that fall under the new regulations without a biologics license either prior to or after finalization of the

draft guidance documents, it may impose conditions, such as labeling restrictions and compliance with cGMP.

Although the Company is preparing

for these requirements in connection with its pursuit of a BLA for certain of its products, compliance with these conditions would require

significant additional time and cost investments by the Company.

It is also possible that the FDA will not allow the Company to market

any form of its products without a biologics license even prior to finalization of the draft guidance documents and could even require

the Company to recall its products, which would likely result in significant harm to our business, results of operations and financial

The FDA has recently announced that it intends

to begin enforcement of regulations to manufacturers of certain biologics tissue products, including the products that we may purchase

through supply agreements with those identified manufacturers.

If the FDA were to take enforcement action against those suppliers, it

would have a material adverse impact to our operations.

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.

However, if our products are deemed by the FDA to fall within the new guidelines

and we are unable to successfully challenge any such determination, our business, results of operations and financial condition may be

significantly harmed.

There is no assurance that the FDA will not take

enforcement action against us or our suppliers in connection with the products we manufacture and/or purchase from suppliers and sell

to our customers.

Furthermore, our supply agreements provide that we comply with all FDA requirements for in the use of the products we

purchase from our suppliers, including the way we market the products to our customers, including our representatives and sub-distributors,

and any activities that we take that might be inconsistent with the “manufacturers objective intent”, including potential

significant safety concerns on how the products are being administered as well as the diseases and conditions for which they are being

If the FDA were to take any adverse action against ourselves and/or our suppliers and/or representatives and distributors and/or

it is determined that any of our activities are the basis for FDA enforcement, it will have a significant adverse effect on our operations.

Our ability to commence and complete clinical

studies and other research and development objectives that are required by the FDA, will require that we are properly funded to assure

that we can commence and proceed with the required research activities promptly and that the results are favorable.

The Company is pursuing efforts to commence and

complete 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 timely and sufficient available working capital to fund the substantial costs of completing clinical trials, and ultimately the

approval from the FDA.

We and our sales representatives,

whether employees or independent contractors, must comply with various federal and state anti-kickback, self-referral, false claims and

similar laws, any breach of which could cause a material adverse effect on our business, financial condition and results of operations.

Our relationships with physicians, hospitals and

other healthcare providers are subject to scrutiny under various federal anti-kickback, self-referral, false claims and similar laws,

often referred to collectively as healthcare fraud and abuse laws.

Healthcare fraud and abuse laws are complex, and even minor,

inadvertent violations can give rise to claims that the relevant law has been violated.

Possible sanctions for violation of

these fraud and abuse laws include monetary fines, civil and criminal penalties, exclusion from federal and state healthcare programs,

including Medicare, Medicaid, Veterans Administration health programs, workers’ compensation programs and TRICARE (the healthcare system

administered by or on behalf of the U.S.

Department of Defense for uniformed services beneficiaries, including active duty and their dependents,

retirees and their dependents), and forfeiture of amounts collected in violation of such prohibitions.

Certain states have

similar fraud and abuse laws, imposing substantial penalties for violations.

Any Government investigation or a finding of a

violation of these laws would likely result in a material adverse effect on the market price of our common stock, as well as our business,

financial condition and results of operations.

Anti-kickback laws and regulations prohibit any

knowing and willful offer, payment, solicitation or receipt of any form of remuneration in return for the referral of an individual or

the ordering or recommending of the use of a product or service for which payment may be made by Medicare, Medicaid or other Government-sponsored

healthcare programs.

We will enter into consulting agreements, speaker agreements, research agreements and product development

agreements with physicians, including some who may order our products or make decisions to use them.

In addition, some of these

physicians own our stock, which they purchased in arm’s length transactions on terms identical to those offered to non-physicians, or

received stock awards from us as consideration for services performed by them.

While these transactions were structured with

the intention of complying with all applicable laws, including state anti-referral laws and other applicable anti-kickback laws, it is

possible that regulatory or enforcement agencies or courts may in the future view these transactions as prohibited arrangements that must

be restructured or for which we would be subject to other significant civil or criminal penalties.

As discussed above, we have

incorporated the AdvaMed code principles into our relationships with healthcare professionals under our consulting agreements, and our

policies regarding payment of travel and lodging expenses, research and educational grant procedures and sponsorship of third-party conferences.

addition, we have conducted training sessions on these principles.

However, there can be no assurance that regulatory or enforcement

authorities will view these arrangements as being in compliance with applicable laws or that one or more of our employees or agents

will not disregard the rules we have established.

Because our strategy relies on the involvement of physicians who consult with

us on the design of our products, perform clinical research on our behalf or educate the market about the efficacy and uses of

our products, we could be materially impacted if regulatory or enforcement agencies or courts interpret our financial relationships

with physicians who refer or order our products to be in violation of applicable laws and determine that we would be unable to

achieve compliance with such applicable laws.

This could harm our reputation and the reputations of the physicians

we engage to provide services on our behalf.

In addition, the cost of noncompliance with these laws could be substantial

since we could be subject to monetary fines and civil or criminal penalties, and we could also be excluded from federally-funded

healthcare programs, including Medicare and Medicaid, for non-compliance.

Federal False Claims Act (“FCA”) imposes civil liability on any person or entity that submits, or causes the submission

of, a false or fraudulent claim to the U.S.

Damages under the FCA can be significant and consist of the imposition

of fines and penalties.

The FCA also allows a private individual or entity with knowledge of past or present fraud

against the Federal Government to sue on behalf of the Government to recover the civil penalties and treble damages.

Department of Justice (“DOJ”) on behalf of the Government has previously alleged that the marketing and promotional

practices of pharmaceutical and medical device manufacturers, including the off-label promotion of products or the payment of

prohibited kickbacks to doctors, violated the FCA, resulting in the submission of improper claims to federal and state healthcare

entitlement programs such as Medicaid.

In certain cases, manufacturers have entered into criminal and civil settlements

with the federal government under which they entered into plea agreements, paid substantial monetary amounts and entered into

corporate integrity agreements that require, among other things, substantial reporting and remedial actions going forward.

scope and enforcement of all of these laws is uncertain and subject to rapid change, especially in light of the lack of applicable

precedent and regulations.

There can be no assurance that federal or state regulatory or enforcement authorities will

not investigate or challenge our current or future activities under these laws.

Any investigation or challenge could

have a material adverse effect on our business, financial condition and results of operations.

Any state or federal

regulatory or enforcement review of us, regardless of the outcome, would be costly and time consuming.

Additionally,

we cannot predict the impact of any changes in these laws, whether these changes are retroactive or will have effect on a going-forward

face significant uncertainty in the industry due to Government healthcare reform.

have been and continue to be proposals by the Federal Government, State Governments, regulators and third-party payers to control

healthcare costs, and generally, to reform the healthcare system in the United States.

There are many programs and

requirements for which the details have not yet been fully established or the consequences are not fully understood.

proposals may affect aspects of our business.

We also cannot predict what further reform proposals, if any, will be

adopted, when they will be adopted, or what impact they may have on us.

Relating to Ownership of Our Common Stock

However, there can be no assurance that regulatory or enforcement authorities

will view these arrangements as being in compliance with applicable laws or that one or more of our employees or agents will not disregard

the rules we have established.

Because our strategy relies on the involvement of physicians who consult with us on the design of our products,

perform clinical research on our behalf or educate the market about the efficacy and uses of our products, we could be materially impacted

if regulatory or enforcement agencies or courts interpret our financial relationships with physicians who refer or order our products

to be in violation of applicable laws and determine that we would be unable to achieve compliance with such applicable laws.

could harm our reputation and the reputations of the physicians we engage to provide services on our behalf.

In addition, the

cost of noncompliance with these laws could be substantial since we could be subject to monetary fines and civil or criminal penalties,

and we could also be excluded from federally-funded healthcare programs, including Medicare and Medicaid, for non-compliance.

The Federal False Claims Act (“FCA”)

imposes civil liability on any person or entity that submits, or causes the submission of, a false or fraudulent claim to the U.S.

Damages under the FCA can be significant and consist of the imposition of fines and penalties.

The FCA also allows a private

individual or entity with knowledge of past or present fraud against the Federal Government to sue on behalf of the Government to recover

the civil penalties and treble damages.

Department of Justice (“DOJ”) on behalf of the Government has

previously alleged that the marketing and promotional practices of pharmaceutical and medical device manufacturers, including the off-label

promotion of products or the payment of prohibited kickbacks to doctors, violated the FCA, resulting in the submission of improper claims

to federal and state healthcare entitlement programs such as Medicaid.

In certain cases, manufacturers have entered into criminal

and civil settlements with the federal government under which they entered into plea agreements, paid substantial monetary amounts and

entered into corporate integrity agreements that require, among other things, substantial reporting and remedial actions going forward.

The scope and enforcement of all of these laws

is uncertain and subject to rapid change, especially in light of the lack of applicable precedent and regulations.

be no assurance that federal or state regulatory or enforcement authorities will not investigate or challenge our current or future activities

under these laws.

Any investigation or challenge could have a material adverse effect on our business, financial condition

and results of operations.

Any state or federal regulatory or enforcement review of us, regardless of the outcome, would be

costly and time consuming.

Additionally, we cannot predict the impact of any changes in these laws, whether these changes are

retroactive or will have effect on a going-forward basis only.

We face significant uncertainty in

the industry due to Government healthcare reform.

There have been and continue to be proposals by

the Federal Government, State Governments, regulators and third-party payers to control healthcare costs, and generally, to reform the

healthcare system in the United States.

There are many programs and requirements for which the details have not yet been fully established

or the consequences are not fully understood.

These proposals may affect aspects of our business.

We also cannot predict what further

reform proposals, if any, will be adopted, when they will be adopted, or what impact they may have on us.

Risks Related to our Status as a Public Company

We are subject to the periodic reporting

requirements of the Exchange Act that requires us to incur audit fees and legal fees in connection with the preparation of such reports.

These additional costs could reduce or eliminate our ability to earn a profit.

We are required to file periodic reports with

the SEC pursuant to the Exchange Act and the rules and regulations promulgated thereunder.

In order to comply with these requirements,

our independent registered public accounting firm has to review our financial statements on a quarterly basis and audit our financial

statements on an annual basis.

Moreover, our legal counsel has to review and assist in the preparation of such reports.

The incurrence

of such costs is an expense to our operations, may increase as the Company grows and therefore have a negative effect on our ability to

meet our overhead requirements and earn a profit.

If we cannot provide reliable financial reports or prevent fraud, our business and operating

results could be harmed, investors could lose confidence in our reported financial information, and the trading price of our common stock,

if an active trading market for our common stock ever develops or is sustained, could drop significantly.

Our internal controls are inadequate, which

could cause our financial reporting to be unreliable and lead to misinformation being disseminated to the public.

Our management is responsible for establishing

and maintaining adequate internal control over financial reporting.

As defined in Rule 13a-15(f) under the Exchange Act, internal control

over financial reporting is a process designed by, or under the supervision of, the principal executive and principal financial officer

and effected by the board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial

reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles

and includes those policies and procedures that:

● pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions

and dispositions of the assets of the Company;

● provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial

statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made

only in accordance with authorizations of management and/or directors of the Company;

● provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use

or disposition of the Company’s assets that could have a material effect on the financial statements.

Our Chief Executive Officer and Chief Financial

Officer noted the following material weaknesses that have caused management to conclude that, as of October 31, 2021, our disclosure controls

and procedures, and our internal control over financial reporting, were not effective at the reasonable assurance level in that:

● Due to our small number of employees and resources, we have limited segregation of duties, as a result

of which there is insufficient independent review of duties performed.

● Due to our small number of employees and resources, we have limited segregation of duties, as a result

of which do not have the ability to implement internal controls over the granting of access to our IT environment.

● As a result of the limited number of accounting personnel, we rely on inexperienced staff and outside

consultants for the preparation of our financial reports, including tax preparation, which could require adjustments and lead to overlooking

items requiring disclosure.

● The Company’s board of directors at October 31, 2021 did not have a majority of independent directors,

with a majority of the members of the board being employees.

The board does not have an audit committee or an independent audit committee

financial expert nor did it have either one at October 31, 2021.

While not being legally obligated to have an audit committee or independent

audit committee financial expert, it is the management’s view that to have an audit committee, comprised of independent board members,

and an independent audit committee financial expert, is an important entity-level control over the Company’s financial statements.

● As a result of the Company’s limited financial and personnel resources, there may be difficulties

in timely analyzing and identifying potential operational and disclosure transactions within management and to comply with financial reporting

We have taken and are continuing to take additional

steps to remedy these material weaknesses.

However, in doing so, we have incurred and expect to incur additional expenses and diversion

of management’s time in order to do so, which may adversely affect our business, results of operations and financial condition.

Further effective internal controls, particularly those related to receipts and expenditures as well as disclosures, are necessary for

us to produce reliable financial reports and are important to help prevent financial fraud.

There can be no assurance that our remedial

measures will be sufficient to address the material weaknesses or that our internal control over financial reporting will not be subject

to additional material weaknesses in the future.

If the remedial measures that we take are insufficient to address the material weaknesses

or if additional material weaknesses or significant deficiencies in our internal control are discovered or occur in the future, our consolidated

financial statements may contain material misstatements, and we could be required to restate our financial results.

Additionally, we may

encounter problems or delays in implementing any changes necessary for management to make a favorable assessment of our internal control

over financial reporting.

If we cannot provide reliable financial reports or prevent fraud, our business and operating results could be

harmed, investors could lose confidence in our reported financial information, and the trading price of our common stock, if a market

ever develops, could drop significantly.

Risks Relating to Ownership of Our Common Stock

articles of incorporation allow for our board to create a new series of preferred stock without further approval by our stockholders,

which could adversely affect the rights of the holders of our common stock.

Board of Directors has the authority to fix and determine the relative rights and preferences of preferred stock.

Directors have the authority to issue up to 10,000,000 shares of our preferred stock terms of which may be determined by the Board

without further stockholder approval.

As a result, our Board of Directors could authorize the issuance of a series of preferred

stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before

dividends are distributed to the holders of common stock and the right to the redemption of the shares, together with a premium,

prior to the redemption of our common stock.

In addition, our Board of Directors could authorize the issuance of a series of preferred

stock that has greater voting power than our common stock or that is convertible into our common stock, which could decrease the

relative voting power of our common stock or result in dilution to our existing stockholders.

Although we have no present intention

to issue any additional shares of preferred stock or to create any additional series of preferred stock, we may issue such shares

in the future.

of Directors has the authority to fix and determine the relative rights and preferences of preferred stock.

Our Board of Directors have

the authority to issue up to 10,000,000 shares of our preferred stock terms of which may be determined by the Board without further stockholder

As a result, our Board of Directors could authorize the issuance of a series of preferred stock that would grant to holders

the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders

of common stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock.

addition, our Board of Directors could authorize the issuance of a series of preferred stock that has greater voting power than our common

stock or that is convertible into our common stock, which could decrease the relative voting power of our common stock or result in dilution

to our existing stockholders.

Although we have no present intention to issue any additional shares of preferred stock or to create any

additional series of preferred stock, we may issue such shares in the future.

may experience dilution of your ownership interests because of the future issuance of additional shares of common stock.

the future, we may issue additional authorized but previously unissued equity securities, resulting in the dilution of the ownership

interests of our shareholders.

We may also issue additional shares of our securities that are convertible into or exercisable

for common stock, as the case may be, in connection with hiring or retaining employees, future acquisitions, future sales of its

securities for capital raising purposes, or for other business purposes.

The future issuance of any such additional shares of

common stock may create downward pressure on the value of our securities.

There can be no assurance that we will not be required

to issue additional shares of common stock, warrants or other convertible securities in the future in conjunction with any capital

raising efforts, including at a price (or exercise prices) below the price at which our shares may be valued or are trading in

a public market.

or availability for sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.

our stockholders sell substantial amounts of their shares of our common stock, or shares of our common stock underlying any outstanding

securities held by them, in the public market under Rule 144 or upon registration of such shares pursuant to an effective registration

statement, it could create a circumstance commonly referred to as an “overhang”

and in anticipation of which the market

price of our common stock could fall.

The existence of an overhang, whether or not sales have occurred or are occurring, also

could make more difficult our ability to raise additional financing through the sale of equity or equity-related securities in

the future at a time and price that we deem reasonable or appropriate.

can be no assurances that an active trading market may develop for our common stock, or if developed, be maintained.

average trading volume in our stock has been historically low, with little or no trading at all on some days.

As a result, an

investor may find it difficult to dispose of, or to obtain accurate quotations of the price of, our common stock.

investors must assume they may have to bear the economic risk of an investment in our common stock for an indefinite period of

There can be no assurance that a more active market for the common stock will develop, or if one should develop, there is

no assurance that it will be maintained.

This severely limits the liquidity of our common stock, and would likely have a material

adverse effect on the market price of our common stock and on our ability to raise additional capital.

common stock is subject to the “penny stock”

rules of the SEC and the trading market in the securities is limited,

which makes transactions in the stock cumbersome and may reduce the value of an investment in the stock.

SEC has adopted Rule 15g-9 which establishes the definition of a “penny stock,”

for the purposes relevant to us, as

any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share,

subject to certain exceptions.

For any transaction involving a penny stock, unless exempt, the rules require:

a broker or dealer approve a person’s account for transactions in penny stocks;

the broker or dealer

receives from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock

to be purchased.

order to approve a person’s account for transactions in penny stocks, the broker or dealer must:

financial information and investment experience objectives of the person;

make a reasonable

determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and

experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.

broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating

to the penny stock market, which, in highlight form sets forth:

basis on which the broker or dealer made the suitability determination;

that the broker

or dealer received a signed, written agreement from the investor prior to the transaction.

brokers may be less willing to execute transactions in securities subject to the “penny stock”

This may make

it more difficult for investors to dispose of common stock and cause a decline in the market value of stock.

also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the

commissions payable to both the broker-dealer and the registered representative, current quotations for the securities and the

rights and remedies available to an investor in cases of fraud in penny stock transactions.

Finally, monthly statements have to

be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny

price of our common stock may become volatile, which could lead to losses by investors and costly securities litigation.

trading price of our common stock is likely to be highly volatile and could fluctuate in response to factors such as:

or anticipated variations in our operating results;

announcements of

developments by us or our competitors;

announcements by

us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

adoption of new

accounting standards affecting our Company’s industry;

additions or departures

of key personnel;

sales of our common

stock or other securities in the open market;

other events or

factors, many of which are beyond our control.

stock market is subject to significant price and volume fluctuations.

In the past, following periods of volatility in the market

price of a company’s securities, securities class action litigation has often been initiated against the company.

initiated against us, whether or not successful, could result in substantial costs and diversion of our management’s attention

and resources, which could harm our business and financial condition.

do not anticipate dividends to be paid on our common stock, and investors may lose the entire amount of their investment.

dividends have never been declared or paid on the common stock, and we do not anticipate such a declaration or payment for the

foreseeable future.

We expect to use future earnings, if any, to fund business growth.

Therefore, stockholders will not receive

any funds absent a sale of their shares.

We cannot assure stockholders of a positive return on their investment when they sell

their shares, nor can we assure that stockholders will not lose the entire amount of their investment.

must obtain approval from FINRA if we wish to reduce our authorized shares of common stock and/or to effectuate a reverse split

of the issued and outstanding shares of the common stock, of which the impact to the trading price of our common stock and/or

the liquidity for trading our common stock may be adverse to current stockholders and may not result in desired benefits to the

Company currently has 1,500,000,000 authorized shares of common stock and 992,207,783 shares issued and outstanding.

9, 2021, the Company intends to file the Certificate of Amendment to the Company’s Articles of Incorporation with the Secretary

of State of Nevada to effectuate an increase in the amount of authorized shares to 2,500,000,000.

The Company expects that it

will continue to issue common stock in the future in connection with debt and/or equity financings, transactions with third parties,

performance incentives and as compensation to its employees and consultants.

The Company believes that a reverse split would 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.

Company’s ability to effectuate a reverse split will require approval from FINRA.

FINRA has previously informed the Company

that it will not approve and process announcements for company-related actions such as a reverse split if the Company is delinquent

in its Exchange Act reports with the SEC and until a Notification Form is submitted.

completed, and the reverse split does not bring value to the current shareholders and/or our ability to attract prospective investors,

including possible adverse impact to the trading price of our common stock and/or the liquidity for trading our common stock,

it would likely have a material adverse effect on the market price of our common stock and on our ability to raise additional

securities analysts do not initiate coverage or continue to cover our common stock or publish unfavorable research or reports

about our business, this may have a negative impact on the market price of our common stock.

trading market for the common stock will depend on the research and reports that securities analysts publish about our business

and the Company.

We do not have any control over these analysts.

There is no guarantee that securities analysts will cover the

common stock.

If securities analysts do not cover the common stock, the lack of research coverage may adversely affect its market

If we are covered by securities analysts, and our stock is the subject of an unfavorable report, our stock price and trading

volume would likely decline.

If one or more of these analysts ceases to cover the Company or fails to publish regular reports

on the Company, we could lose visibility in the financial markets, which could cause our stock price or trading volume to decline.

Approximately

53.55% of the outstanding shares of common stock is currently owned and/or controlled by our Board members and executive management

of the Company.

Our Board members and executive management currently have significant ability to influence the election of our

directors and the outcome of matters submitted to our stockholders.

of January 28, 2021, there are 992,207,783 shares of common stock outstanding, of which 531,344,370 shares of common stock (approximately

53.55% of the outstanding shares of common stock) are owned and/or controlled by our Board and executive officers, Albert Mitrani,

In the future,

we may issue additional authorized but previously unissued equity securities, resulting in the dilution of the ownership interests of

our shareholders.

We may also issue additional shares of our securities that are convertible into or exercisable for common stock, as

the case may be, in connection with hiring or retaining employees, future acquisitions, future sales of its securities for capital raising

purposes, or for other business purposes.

The future issuance of any such additional shares of common stock may create downward pressure

on the value of our securities.

There can be no assurance that we will not be required to issue additional shares of common stock, warrants

or other convertible securities in the future in conjunction with any capital raising efforts, including at a price (or exercise prices)

below the price at which our shares may be valued or are trading in a public market.

Offers or availability for sale of a substantial

number of shares of our common stock may cause the price of our common stock to decline.

If our stockholders sell substantial amounts of

their shares of our common stock, or shares of our common stock underlying any outstanding securities held by them, in the public market

under Rule 144 or upon registration of such shares pursuant to an effective registration statement, it could create a circumstance commonly

referred to as an “overhang” and in anticipation of which the market price of our common stock could fall.

The existence of

an overhang, whether or not sales have occurred or are occurring, also could make more difficult our ability to raise additional financing

through the sale of equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate.

There can be no assurances that an active

trading market may develop for our common stock, or if developed, be maintained.

The average trading volume in our stock has been

historically low, with little or no trading at all on some days.

As a result, an investor may find it difficult to dispose of, or to obtain

accurate quotations of the price of, our common stock.

Accordingly, investors must assume they may have to bear the economic risk of an

investment in our common stock for an indefinite period of time.

There can be no assurance that a more active market for the common stock

will develop, or if one should develop, there is no assurance that it will be maintained.

This severely limits the liquidity of our common

stock, and would likely have a material adverse effect on the market price of our common stock and on our ability to raise additional

Our common stock is subject to the “penny

stock” rules of the SEC and the trading market in the securities is limited, which makes transactions in the stock cumbersome and

may reduce the value of an investment in the stock.

The SEC has adopted Rule 15g-9 which establishes

the definition of a “penny stock,” for the purposes relevant to us, as any equity security that has a market price of less

than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain exceptions.

For any transaction involving

a penny stock, unless exempt, the rules require:

that a broker or dealer approve a person’s account for transactions in penny stocks;

the broker or dealer receives from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.

In order to approve a person’s account for

transactions in penny stocks, the broker or dealer must:

obtain financial information and investment experience objectives of the person;

make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.

The broker or dealer must also deliver, prior

to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market, which, in highlight

form sets forth:

the basis on which the broker or dealer made the suitability determination;

that the broker or dealer received a signed, written agreement from the investor prior to the transaction.

Generally, brokers may be less willing to execute

transactions in securities subject to the “penny stock” rules.

This may make it more difficult for investors to dispose of

common stock and cause a decline in the market value of stock.

Disclosure also has to be made about the risks

of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer

and the registered representative, current quotations for the securities and the rights and remedies available to an investor in cases

of fraud in penny stock transactions.

Finally, monthly statements have to be sent disclosing recent price information for the penny stock

held in the account and information on the limited market in penny stocks.

The Financial Industry Regulatory Authority

(“FINRA”) sales practice requirements may also limit a shareholder’s ability to buy and sell our common stock.

In addition to the “penny stock” rules

described above, FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable

grounds for believing that the investment is suitable for that customer.

Prior to recommending speculative low-priced securities to their

non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status,

tax status, investment objectives and other information.

Under interpretations of these rules, the FINRA believes that there is a high

probability that speculative low-priced securities will not be suitable for at least some customers.

The FINRA requirements make it more

difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buy and sell our

common stock and have an adverse effect on the market for shares of our common stock.

The price of our common stock may become

volatile, which could lead to losses by investors and costly securities litigation.

The trading price of our common stock is likely

to be highly volatile and could fluctuate in response to factors such as:

actual or anticipated variations in our operating results;

announcements of developments by us or our competitors;

announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

adoption of new accounting standards affecting our Company’s industry;

additions or departures of key personnel;

sales of our common stock or other securities in the open market;

other events or factors, many of which are beyond our control.

The stock market is subject to significant price

and volume fluctuations.

In the past, following periods of volatility in the market price of a company’s securities, securities

class action litigation has often been initiated against the company.

Litigation initiated against us, whether or not successful, could

result in substantial costs and diversion of our management’s attention and resources, which could harm our business and financial

We must obtain approval from FINRA if we

wish to reduce our authorized shares of common stock and/or to effectuate a reverse split of the issued and outstanding shares of the

common stock, of which the impact to the trading price of our common stock and/or the liquidity for trading our common stock may be adverse

to current stockholders and may not result in desired benefits to the Company.

The Company currently has 2,500,000,000 authorized

shares of common stock and 1,149,204,595 shares issued and outstanding.

The Company expects that it will continue to issue common stock

in the future in connection with debt and/or equity financings, transactions with third parties, performance incentives and as compensation

to its employees and consultants.

The Company believes that a reverse split would 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.

The Company’s ability to effectuate a reverse

split will require approval from FINRA.

FINRA has previously informed the Company that it will not approve and process announcements for

company-related actions such as a reverse split if the Company is delinquent in its Exchange Act reports with the SEC and until a Notification

Form is submitted.

If completed, and the reverse split does not bring

value to the current shareholders and/or our ability to attract prospective investors, including possible adverse impact to the trading

price of our common stock and/or the liquidity for trading our common stock, it would likely have a material adverse effect on the market

price of our common stock and on our ability to raise additional capital.

If securities analysts do not initiate coverage

or continue to cover our common stock or publish unfavorable research or reports about our business, this may have a negative impact on

the market price of our common stock.

The trading market for the common stock will depend

on the research and reports that securities analysts publish about our business and the Company.

We do not have any control over these

There is no guarantee that securities analysts will cover the common stock.

If securities analysts do not cover the common stock,

the lack of research coverage may adversely affect its market price.

If we are covered by securities analysts, and our stock is the subject

of an unfavorable report, our stock price and trading volume would likely decline.

If one or more of these analysts ceases to cover the

Company or fails to publish regular reports on the Company, we could lose visibility in the financial markets, which could cause our stock

price or trading volume to decline.

Approximately 46.00% of the outstanding

shares of common stock is currently owned and/or controlled by our Board members and executive management of the Company.

Our Board members

and executive management currently have significant ability to influence the election of our directors and the outcome of matters submitted

to our stockholders.

As of January 28, 2022, there are 1,149,204,595

shares of common stock issued and outstanding, of which 83,844,432 shares shall become fully vested during various future dates and ending

on December 31, 2023.

532,028,264 shares of common stock (excluding 50,000,000 shares that have been issued under our equity incentive

plans and have not yet vested) or approximately 46.00% of the outstanding shares of common stock are owned and/or controlled by our Board

and executive officers, Albert Mitrani, Ian T.

Bothwell, Dr.

1 unchanged sentence

George Shapiro, Michael Carbonara and Dr.

Allen Meglin, and two of the members of management

are spouses, Albert Mitrani and Dr.

Allen Meglin,

and two of the members of management are spouses, Albert Mitrani and Dr.

Maria Mitrani.

In addition, all four of our executive officers are also members of the Board

of Directors, which currently consists of six members.

In addition, our executive officers may receive additional stock grants

in the future based on the achievement of certain performance milestones and from the conversion of unpaid compensation into common

stock, which if fully issued would provide our Board and executive officers with additional shares of the common stock outstanding.

In addition, all four of our executive officers

are also members of the Board of Directors, which currently consists of six members.

In addition, our executive officers may receive additional

stock grants in the future based on the achievement of certain performance milestones and from the conversion of unpaid compensation into

common stock, which if fully issued would provide our Board and executive officers with additional shares of the common stock outstanding.

As a result, the foregoing persons have the ability to significantly influence the outcome of issues submitted to our stockholders.

Although our officers and directors have a fiduciary obligation to the Company stockholders, their interests may not always coincide

with our interests or the interests of other stockholders.

As a consequence, it may be difficult for the other stockholders to

remove our management.

The ownership of these officers/directors could also deter unsolicited takeovers, including transactions

in which stockholders might otherwise receive a premium for their shares over then current market prices.

identified material weaknesses in our internal controls over financial reporting that existed at October 31, 2020.

fail to properly identify or remediate any future weaknesses or deficiencies, or fail to achieve and maintain effective internal

control, our ability to produce accurate and timely financial statements could be impaired and investors could lose confidence

in our financial statements.

control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial

reporting and the preparation of financial statements in accordance with GAAP.

At October 31, 2020, our management determined

that our internal controls over financial reports were ineffective.

Although management intends to implement remedial actions

to correct these inefficiencies, there can be no assurance that our remedial measures will be sufficient to address the material

weaknesses or that our internal control over financial reporting will not be subject to additional material weaknesses in the

If the remedial measures that we take are insufficient to address the material weaknesses or if additional material weaknesses

or significant deficiencies in our internal control are discovered or occur in the future, our consolidated financial statements

may contain material misstatements, and we could be required to restate our financial results.

Additionally, we may encounter

problems or delays in implementing any changes necessary for management to make a favorable assessment of our internal control

over financial reporting.

If we cannot favorably assess the effectiveness of our internal control over financial reporting, investors

could lose confidence in our financial information and the price of our common stock could decline.

Financial Industry Regulatory Authority (“FINRA”) sales practice requirements may also limit a stockholder’s

ability to buy and sell our common stock.

addition to the “penny stock”

rules described above, the Financial Industry Regulatory Authority, which we refer to

as FINRA, has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable

grounds for believing that the investment is suitable for that customer.

Prior to recommending speculative low-priced securities

to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s

financial status, tax status, investment objectives and other information.

Under interpretations of these rules, the FINRA believes

that there is a high probability that speculative low-priced securities will not be suitable for at least some customers.

FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may

limit your ability to buy and sell our common stock and have an adverse effect on the market for shares of our common stock.

our officers and directors have a fiduciary obligation to the Company stockholders, their interests may not always coincide with our interests

or the interests of other stockholders.

As a consequence, it may be difficult for the other stockholders to remove our management.

ownership of these officers/directors could also deter unsolicited takeovers, including transactions in which stockholders might otherwise

receive a premium for their shares over then current market prices.

We have agreed to indemnify our officers

and directors against lawsuits to the fullest extent of the law.

Organicell is a Nevada corporation.

permits the indemnification of officers and directors against expenses incurred in successfully defending against a claim.

also authorizes Nevada corporations to indemnify their officers and directors against expenses and liabilities incurred because of their

being or having been an officer or director.

Our organizational documents provide for this indemnification to the fullest extent permitted

We currently do not maintain any directors &

officers insurance coverage.

The commercial insurance policies we do have in place contain policy limits and exclusions for certain coverages

In the event that we are found liable for damage or other losses, and such amounts are not covered under our existing insurance

policies, we would incur substantial and protracted losses in paying any such claims or judgments.

Although we intend to acquire coverage

immediately upon resources becoming available, there is no guarantee that we can secure such coverage or that any insurance coverage would

protect us from any damages or loss claims filed against it.

We do not anticipate dividends to be paid

on our common stock, and investors may lose the entire amount of their investment.

Cash dividends have never been declared or paid

on the common stock, and we do not anticipate such a declaration or payment for the foreseeable future.

We expect to use future earnings,

if any, to fund business growth.

Therefore, stockholders will not receive any funds absent a sale of their shares.

We cannot assure stockholders

of a positive return on their investment when they sell their shares, nor can we assure that stockholders will not lose the entire amount

of their investment.

The “market overhang” from options,

warrants and convertible securities could adversely impact the market price of our shares .

The “ market overhang ” from

options, warrants and convertible securities could adversely impact the market price of our shares as a result of the dilution which would

result if such securities were exercised for or converted into shares.

Unresolved Staff Comments.

Not applicable.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors