What changed in this filing

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Item 5. Market for Registrant’s Common Equity

2022-02-14 compared with 2021-02-08 · 99 added, 364 removed, 20 unchanged (96% of the section changed)

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

symbol for our common stock is BPSR.

Due to the late filing of this Form 10-K and other Exchange Act Reports, our common stock

is currently quoted on the OTCPink tier of the over-the counter market operated by OTC Markets Group, Inc.

of January 28, 2021, 992,207,783 shares of our common stock were outstanding.

Market for Registrant’s Common

Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Market Information

Our common stock is traded on the OTCQB tier of

the over-the-counter market operated by OTC Markets Group, Inc.

under the symbol “ OCEL ”.

The trading market for our

common stock is limited and sporadic.

We can provide no assurance that our shares of common stock will continue to be traded on the over-the

counter market or another national securities exchange, or if traded, that any public market for our common stock will be active and sustained.

The SEC has adopted rules that regulate broker-dealer

practices in connection with transactions in penny stocks.

Penny stocks are generally equity securities with a price of less than $5.00,

other than securities registered on certain national securities exchanges or quoted on the Nasdaq system, provided that current price

and volume information with respect to transactions in such securities is provided by the exchange or system.

The penny stock rules require

a broker-dealer, prior to a transaction in a penny stock, to deliver a standardized risk disclosure document prepared by the SEC, that:

(a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading;

(b) contains a description of the broker’s or dealer’s duties to the customer and of the rights and remedies available to

the customer with respect to a violation to such duties or other requirements of securities laws;

description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask

(d) contains a toll-free telephone number for inquiries on disciplinary actions;

(e) defines significant terms in the disclosure

document or in the conduct of trading in penny stocks;

and (f) contains such other information and is in such form, including language,

type, size and format, as the SEC shall require by rule or regulation.

The broker-dealer also must provide, prior to

effecting any transaction in a penny stock, the customer with (a) bid and offer quotations for the penny stock;

(b) the compensation of

the broker-dealer and its salesperson in the transaction;

information relating to the depth and liquidity of the market for such stock;

and (d) monthly account statements showing the market value

of each penny stock held in the customer’s account.

In addition, the penny stock rules require that

prior to a transaction in a penny stock not otherwise exempt from those rules the broker-dealer must make a special written determination

that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written acknowledgment of the receipt

of a risk disclosure statement, a written agreement to transactions involving penny stocks, and a signed and dated copy of a written suitability

These disclosure requirements may have the effect

of reducing the trading activity in the secondary market for our stock if it becomes subject to these penny stock rules.

Therefore, because

our common stock is subject to the penny stock rules, shareholders may have difficulty selling those securities.

As of January 28, 2022, 1,149,204,595 shares of

our common stock were outstanding.

of Our Common Stock

of January 28, 2021, we had approximately 200 record holders of our common stock.

One of these holders is CEDE and Company which

is the mechanism used for brokerage firms to hold securities in book entry form on behalf of their clients and as of January 28,

2021, they held 51,733,743 shares of common stock for these shareholders.

Accordingly, we believe that we have significantly in

excess of 1,000 beneficial shareholders as of the date of this report.

have never paid or declared dividends on our securities.

The payment of cash dividends, if any, in the future is within the discretion

of our Board and will depend upon our earnings, our capital requirements, financial condition and other relevant factors.

not expect to pay dividends for the foreseeable future, and intend to retain future earnings, if any, towards the use in our business

and growth strategies.

As of January 28, 2022, we had approximately 200

holders of record of our common stock.

One of these holders is CEDE and Company which is the mechanism used for brokerage firms to hold

securities in book entry form on behalf of their clients and as of January 28, 2022, they held approximately 271,200,000 shares of common

stock for these shareholders.

Based on a recent industry report obtained detailing the number of non-objecting holders of our common stock

held through brokerage firms, we believe that the Company has significantly in excess of 6,000 beneficial stockholders as of the date

of this report.

Dividend Policy

We have never paid or declared dividends on our

The payment of cash dividends, if any, in the future is within the discretion of our Board and will depend upon our earnings,

our capital requirements, financial condition and other relevant factors.

We do not expect to pay dividends for the foreseeable future,

and intend to retain future earnings, if any, towards the use in our business and growth strategies.

Authorized for Issuance under Equity Compensation Plans

of securities to

Plan category

Number of securities to

be issued upon exercise of

5 unchanged sentences

warrants and rights

of securities remaining

Number of securities remaining

available for future issuance under

1 unchanged sentence

(excluding securities reflected in

2020 Plan (a)

Board Stock Compensation Plan

Management And Consultants Performance Stock Plan

Management And Consultants Performance Stock Plan (a)

2021 Equity Incentive Plan

(a) No awards were issued under the 2020 Plan and the 2020 Plan was terminated in connection with the adoption

of the Company’s 2021 Equity Incentive Plan.

Following the adoption of the 2021 Equity Incentive Plan and consummation of the Share

Exchange Agreement described in “ Item 11.

Executive Compensation ” in October 2021, the Management And Consultants Performance

Stock Plan, but not unexchanged shares awarded under the Management And Consultants Performance Stock Plan ,was terminated.

Sales of Unregistered Securities

October 10, 2019, the Company and an investor (“Noteholder”) agreed to a

funding facility arrangement (“Funding Facility”) whereby the Noteholder

was required to fund the Company an initial tranche of $100,000 on October 15, 2019 (“Initial

Funding Date”) and had the option to fund the Company up to an aggregate of $500,000

(“Funding Facility Limit”) in minimum $100,000 monthly tranches by no later

than February 15, 2020 (“Funding Expiration Date”).

The Funding Facility

matures on February 15, 2021 (“Maturity Date”) and accrues interest at 6.0%

The Funding Facility, plus all accrued interest, automatically converts into

40,000,000 shares of newly issued common stock of the Company if the Noteholder funds

the full $500,000 by the Funding Expiration Date.

The Noteholder fully funded the Funding

Facility as prescribed on February 12, 2020 and the Company converted the Funding Facility

into 40,000,000 shares of common stock of the Company that were issued to the Noteholders

designated entity, Republic Asset Holdings LLC.

April 27, 2020, the Company sold 5,000,000 shares of common stock to Republic Asset Holdings LLC., a Company controlled by Michael

Carbonara, a director of the Company, at $0.02 per share for an aggregate purchase price of $100,000.

The proceeds were used for

working capital.

November 2019 through January 2020, the Company sold 3,250,000 shares of common stock

to three “accredited investors”

at $0.02 per share for an aggregate purchase

price of $65,000.

The proceeds were used for working capital.

February 2020 through April 2020, the Company sold 11,050,000 shares of common stock

to five “accredited investors”

at $0.02 per share for an aggregate purchase

price of $221,000.

The proceeds were used for working capital.

April 2020 through May 2020, the Company sold 11,000,000 shares of common stock to Dr.

Allen Meglin, a director of the Company at $0.02 per share for an aggregate purchase

price of $220,000.

During July, August and October 2020, the Company sold an additional

1,166,666 shares, 422,514 shares, and 625,000 shares of common stock to Dr.

at $0.03 per share, $0.10 per share and $0.08 per share, respectively, for an aggregate

purchase price of $127,251.

The proceeds from all of the above sales were used for working

May 2020, the Company sold 3,000,000 shares of common stock to two “accredited

investors”

During November 2020, the Company sold 800,000 shares of common stock to an “accredited investor”,

at $0.05 per share, for an aggregate purchase price of $40,000.

were used for working capital.

July and August 2020, the Company completed the private placement to 19 accredited investors

for the sale of 13,499,992 shares of Common stock of the Company at a selling price of

$0.03 per share for an aggregate amount of $405,000 (“Sale”).

are being used to fund the Company’s public company financial reporting requirements.

July 2020, the Company sold 1,000,000 shares of common stock to two “accredited

investors”, at $0.02 per share and $0.03 per share, respectively for an aggregate

purchase price of $25,000.

The proceeds were used for working capital.

August 2020, the Company sold 8,606,665 shares of common stock to nine “accredited

investors”, at prices ranging from $0.03 per share and $0.06 per share, for an

aggregate purchase price of $392,100.

The proceeds were used for working capital.

September 2020, the Company sold 4,800,000 shares of common stock to five “accredited

investors”, at prices ranging from $0.06 per share and $0.10 per share, for an

aggregate purchase price of $410,000.

The proceeds were used for working capital.

October 2020, the Company sold 2,033,333 shares of common stock to five “accredited

investors”, at prices ranging from $0.06 per share and $0.10 per share, for an

aggregate purchase price of $170,000.

The proceeds were used for working capital.

October 2020, the Company and the holder of the $20,000 debenture agreed to convert the

principal amount of the $20,000 debenture plus interest accrued and unpaid through the

date of the conversion totaling approximately $20,300 into 160,000 shares of common stock

of the Company.

November 2020, the Company sold 800,000 shares of common stock to an “accredited

investor”, at $0.05 per share, for an aggregate purchase price of $40,000.

proceeds were used for working capital.

of the above issuances involved any underwriters, underwriting discounts or commissions, or any public offering and we believe

were exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”) by

virtue of Section 4(a)(2) and Regulation D promulgated thereunder due to the fact that there was no solicitation or advertising

and the did not involve a public offering of securities.

SELECTED FINANCIAL DATA.

a “smaller reporting company,”

as defined by Item 10 of Regulation S-K, we are not required to provide the information

required by this item of Form 10-K.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

should read the following discussion together with our consolidated financial statements and the related notes included elsewhere

in this report.

This discussion contains forward-looking statements, which involve risks and uncertainties.

Our actual results

may differ materially from those we currently anticipate as a result of many factors, including the factors we describe under

“Risk Factors”

and elsewhere in this report.

Looking Statements

of the information in this section contains forward-looking statements that involve substantial risks and uncertainties.

identify these statements by forward-looking words such as “may,”

“will,”

“expect,”

“anticipate,”

“believe,”

“estimate”

and “continue,”

or similar words.

You should read statements that contain

these words carefully because they:

our future expectations;

contain projections

of our future results of operations or of our financial condition;

state other “forward-looking”

believe it is important to communicate our expectations.

However, there may be events in the future that we are not able to accurately

predict or over which we have no control.

Our actual results and the timing of certain events could differ materially from those

anticipated in these forward-looking statements as a result of certain factors, including those set forth under “Item 1.

Business,”

“Item 1A Risk Factors,”

“Business”

and elsewhere in this report.

Impact To Economy And Business Environment

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

began to take hold during March 2020.

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

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

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

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

These restrictions

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

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.

of Operations

year ended October 31, 2020 as compared to fiscal year ended October 31, 2019

revenues for the year ended October 31, 2020 were $3,055,776, compared with revenues of $1,702,271 for the year ended October

The increase in revenues during the year ended October 31, 2020 of $1,353,505 (79.5%) was primarily the result of the

Company’s ability to increase unit sales of its products by 125.0% (approximately $1,697,898) during the year ended October

31, 2020 compared with the year ended October 31, 2019, partially offset from the reduction of approximately 20.2% (approximately

$344,393) in the average sales prices for the products sold during the year ended October 31, 2020 compared with the average sales

prices realized on products sold during the year ended October 31, 2019.

The increase in the units sold was partly attributable

to favorable responses to the Company’s sales and marketing efforts establishing greater market awareness, less discounting

of product prices to new customers, the introduction of new and more advanced product offerings and increased research and development

efforts which provided customers with greater comfort in the Company’s products and ability to better address potential

market uncertainty regarding anticipated FDA regulations.

The decrease in the average sales prices realized on products sold during

the year ended October 31, 2020 compared with the year ended October 31, 2019 was due to an increase in the sales of the Company’s

aesthetic product offerings which are sold at lower prices than the Company’s medical grade product offerings.

cost of revenues for the year ended October 31, 2020 were $398,606, compared with cost of revenues of $300,837 for the year ended

October 31, 2019.

The increase in the cost of revenues during the year ended October 31, 2020 compared with the year ended October

31, 2019 was due to an increase in the amount of units sold of 125.0% (approximately $221,480) during the year ended October 31,

2020 compared with the year ended October 31, 2019, partially offset from the reduction in the cost of units sold of 40.7% (approximately

($123,711) during the year ended October 31, 2020 compared to costs of units sold during the year ended October 31, 2019, which

as described above was primarily the result of the Company’s increase in the sales of the Company’s aesthetic product

offerings during the year ended October 31, 2020 compared to the year ended October 31, 2019 which have a lower cost of revenue

than the Company’s medical grade product offerings and also from the Company’s ability to supply inventory through

lower costing inventory manufactured by the Company beginning in May 2019 rather than from more costly third party manufacturers

for the six months ended April 30, 2019.

gross profit for the year ended October 31, 2020 was $2,657,170, compared with gross profit of $1,401,434 for the year ended October

The increase in gross profit during the year ended October 31, 2020 of $1,255,736 (89.6%) was the result of the increase

in the amount of units sold during the year ended October 31, 2020 compared to the year ended October 31, 2019 and the lower costs

of units sold during the year ended October 31, 2020 compared to the year ended October 31, 2019.

The increase in the units sold

was attributable to favorable responses to the Company’s sales and marketing efforts establishing greater market awareness

and the introduction of new and more advanced product offerings.

The lower cost of units sold was due to the Company’s increase

in the sales of the Company’s aesthetic product offerings during the year ended October 31, 2020 compared to the year ended

October 31, 2019 which have a lower cost of revenue than the Company’s medical grade product offerings and also from the

Company’s ability to supply inventory through lower costing inventory manufactured by the Company beginning in May 2019

rather than from more costly third party manufacturers for the six months ended April 30, 2019.

and Administrative Expenses

and administrative expenses for the year ended October 31, 2020 were $15,095,111, compared with $3,177,924 for the year ended

October 31, 2019, an increase of $11,917,187.

The increase in the general and administrative expenses for the year ended October

31, 2020 compared to the year ended October 31, 2019 was primarily the result of increased stock-based compensation costs to advisors,

consultants and administrative staff totaling $9,187,087, increased payroll and consulting costs of approximately $2,171,000,

approximately $308,000 of increased laboratory related expenses and approximately $260,000 of increased professional fees and

administrative expenses.

The increase in payroll and consulting costs and laboratory related expenses was the result of the Company’s

expansion of its research and development activities primarily relating to the filing and approval of IND applications and the

performance of clinical trials.

Income (Expense)

(expense), net, for the year ended October 31, 2020 was ($145,027), compared with other income, net, of $38,191 for the year ended

October 31, 2019, a decrease of $183,218.

The net decrease in the other income was the result of reduced income realized from

the settlement of obligations of $52,074 and increased interest costs associated with interest-bearing obligations totaling $13,394

and $118,350 in connection with the amount of the discount to the fair value of the Converted Stock associated with the conversion

and Capital Resources

the fiscal year ended October 31, 2020 and through the date of the filing of this Form 10-K, the Company has relied on the sale

of debt or equity securities, the restructuring of debt obligations and/or the issuance and/or exchange of equity securities to

meet the shortfall in cash to fund its operations.

October 10, 2019, the Company and an investor (“Noteholder”) agreed to a

funding facility arrangement (“Funding Facility”) whereby the Noteholder

was required to fund the Company an initial tranche of $100,000 on October 15, 2019 (“Initial

Funding Date”) and had the option to fund the Company up to an aggregate of $500,000

(“Funding Facility Limit”) in minimum $100,000 monthly tranches by no later

than February 15, 2020 (“Funding Expiration Date”).

The Funding Facility

matures on February 15, 2021 (“Maturity Date”) and accrues interest at 6.0%

The Funding Facility, plus all accrued interest, automatically converts into

40,000,000 shares of newly issued common stock of the Company if the Noteholder funds

the full $500,000 by the Funding Expiration Date.

The Noteholder fully funded the Funding

Facility as prescribed on February 12, 2020 and the Company converted the Funding Facility

into 40,000,000 shares of common stock of the Company that were issued to the Noteholders

designated entity, Republic Asset Holdings LLC.

April 27, 2020, the Company sold 5,000,000 shares of common stock to Republic Asset Holdings LLC., a Company controlled by Michael

Carbonara, a director of the Company, at $0.02 per share for an aggregate purchase price of $100,000.

The proceeds were used for

working capital.

November 2019 through January 2020, the Company sold 3,250,000 shares of common stock

to three “accredited investors”

at $0.02 per share for an aggregate purchase

price of $65,000.

The proceeds were used for working capital.

February 2020 through April 2020, the Company sold 11,050,000 shares of common stock

to five “accredited investors”

at $0.02 per share for an aggregate purchase

price of $221,000.

The proceeds were used for working capital.

April 2020 through May 2020, the Company sold 11,000,000 shares of common stock to Dr.

Allen Meglin, a director of the Company at $0.02 per share for an aggregate purchase

price of $220,000.

During July, August and October 2020, the Company sold an additional

1,166,666 shares, 422,514 shares, and 625,000 shares of common stock to Dr.

at $0.03 per share, $0.10 per share and $0.08 per share, respectively, for an aggregate

purchase price of $127,251.

The proceeds from all of the above sales were used for working

May 2020, the Company sold 3,000,000 shares of common stock to two “accredited

investors”

at $0.02 per share for an aggregate purchase price of $60,000.

were used for working capital.

July and August 2020, the Company completed the private placement to 19 accredited investors

for the sale of 13,499,992 shares of Common stock of the Company at a selling price of

$0.03 per share for an aggregate amount of $405,000 (“Sale”).

are being used to fund the Company’s public company financial reporting requirements.

July 2020, the Company sold 1,000,000 shares of common stock to two “accredited

investors”, at $0.02 per share and $0.03 per share, respectively for an aggregate

purchase price of $25,000.

During February 2021, the Company sold an aggregate of 12,340,910 shares of common stock to five “accredited

investors” at prices ranging from $0.05 per share to $0.06 per share for an aggregate purchase price of $665,000.

The proceeds were

used for working capital.

On February 22, 2021, the Company sold 1,818,181 shares of common stock to Republic Asset Holdings LLC.,

a Company controlled by Michael Carbonara, a director of the Company, at $0.055 per share for an aggregate purchase price of $100,000.

The proceeds were used for working capital.

August 2020, the Company sold 8,606,665 shares of common stock to nine “accredited

investors”, at prices ranging from $0.03 per share and $0.06 per share, for an

aggregate purchase price of $392,100.

During April 2021, the Company sold an aggregate of 13,677,821 shares of common stock to seven “accredited

investors” at prices ranging from $0.03 per share to $0.25 per share for an aggregate purchase price of $535,000.

The proceeds were

used for working capital.

During May 2021, the Company sold an aggregate of 2,087,822 shares of common stock to eight “accredited

investors” at prices ranging from $0.13 per share to $0.15 per share for an aggregate purchase price of $286,250.

The proceeds were

used for working capital.

During the period June 2021 through July 2021, the Company sold an aggregate of 11,541,500 shares of common

stock to four “accredited investors” at prices ranging from $0.05 per share to $0.13 per share for an aggregate purchase price

The proceeds were used for working capital.

September 2020, the Company sold 4,800,000 shares of common stock to five “accredited

investors”, at prices ranging from $0.06 per share and $0.10 per share, for an

aggregate purchase price of $410,000.

During August 2021, the Company sold an aggregate of 3,000,000 shares of common stock to one “accredited

investor” at $0.05 per share for an aggregate purchase price of $150,000.

The proceeds were used for working capital.

October 2020, the Company sold 2,033,333 shares of common stock to five “accredited

investors”, at prices ranging from $0.06 per share and $0.10 per share, for an

aggregate purchase price of $170,000.

During October 2021, the Company sold an aggregate of 7,500,000 shares of common stock to four “accredited

investors” at $0.04 per share for an aggregate purchase price of $300,000.

The proceeds were used for working capital.

October 2020, the Company and the holder of the $20,000 debenture agreed to convert the

principal amount of the $20,000 debenture plus interest accrued and unpaid through the

date of the conversion totaling approximately $20,300 into 160,000 shares of common stock

of the Company.

November 2020, the Company sold 800,000 shares of common stock to an “accredited

investor”, at $0.05 per share, for an aggregate purchase price of $40,000.

proceeds were used for working capital.

Company issued the foregoing securities pursuant to the exemption from the registration requirements of the Securities Act afforded

by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

and Cash Equivalents

following table summarizes the sources and uses of cash for the periods stated.

The Company held no cash equivalents for any of

the periods presented:

For the Fiscal Year Ended

Cash, beginning of year

Net cash used in operating activities

Net cash used in investing activities

Net cash provided by financing activities

Cash, end of year

the year ended October 31, 2020, the Company used cash in operating activities of $1,812,499, compared to $565,454 for the year

ended October 31, 2019, an increase in cash used of $1,247,045.

The change in cash used in operating activities was due to the

increase in the general and administrative expenses during the year ended October 31, 2020 after adjusting for non-cash charges

(mostly related to stock-based compensation and interest expense on conversion of debt), resulting from increased payroll and

consulting costs and laboratory related expenses in connection with the Company’s expansion of its research and development

activities during the year ended October 31, 2020, partially offset from the increase in revenues and gross profit during the

year ended October 31, 2020.

the year ended October 31, 2020, the Company had cash used in investing activities of $138,694, compared to cash used in investing

activities of $32,736 for the year ended October 31, 2019.

The increase in the cash used in investing activities was due primarily

due the acquisition of additional fixed assets required in connection with the expansion of the Company’s laboratory operations.

the year ended October 31, 2020, the Company had cash provided by financing activities of $2,409,433, compared to cash provided

by financing activities of $687,731 for the year ended October 31, 2019, an overall increase of $1,721,702.

The increase in cash

provided by financing activities was due to increases in proceeds from the sale of equity securities and notes payable of $1,735,821

and $145,000, respectively, partially offset from increased payments on outstanding debt obligations and finance and operating

Concern Consideration

accompanying consolidated financial statements have been prepared in conformity with generally accepted accounting principles,

which contemplate continuation of the Company as a going concern.

The Company has had limited revenues since its inception.

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.

addition to the above, 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.

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.

a result of the above, 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 (a) the United States economy resumes to pre-COVID-19

conditions and (b) additional sources of working capital through operations or debt and/or equity financings are realized.

financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

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

expenses and the costs to perform required clinical studies in connection with the sale of its products.

The Company does not

have any assets to pledge for the purpose of borrowing additional capital.

In addition, the Company relies on its ability to produce

and sell products it manufactures that are subject to changing technology and regulations that it currently sells and distributes

to its customers.

The Company’s current market capitalization, common stock liquidity and available authorized shares may

hinder its ability to raise equity proceeds.

The Company anticipates that future sources of funding, if any, will therefore be

costly and dilutive, if available at all.

view of the matters described in the preceding paragraphs, recoverability of the recorded asset amounts shown in the accompanying

consolidated balance sheet assumes that (1) the effects of the COVID-19 crisis resume to pre-COVID-19 market conditions, (2) the

Company will be able to establish a stabilized source of revenues, (3) obligations to the Company’s creditors are not accelerated,

(4) the Company’s operating expenses remain at current levels and/or the Company is successful in restructuring and/or deferring

ongoing obligations, (5) the Company is able to continue to produce products or obtain products under supply arrangements which

are in compliance with current and future regulatory guidelines, (6) the Company is able to continue its research and development

activities, particularly in regards to remaining compliant with the FDA and the safety and efficacy of its products, and (7) the

Company obtains additional working capital to meet its contractual commitments and maintain the current level of Company operations

through debt or equity sources.

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.

In addition, there is no assurance

that the Company will be able to complete its revenue growth strategy, its expected required research and development activities

or otherwise obtain sufficient working capital to cover ongoing cash requirements.

Without sufficient cash reserves, the Company’s

ability to pursue growth objectives will be adversely impacted.

Furthermore, despite significant effort since July 2015, the Company

has thus far been unsuccessful in achieving a stabilized source of revenues.

As described above, the COVID-19 crisis has significantly

impaired the Company and the overall Unites States and World economies.

If revenues do not increase and stabilize, if the COVID-19

crisis is not satisfactorily managed and/or resolved or if additional funds cannot otherwise be raised, the Company might be required

to seek other alternatives which could include the sale of assets, closure of operations and/or protection under the U.S.

As of October 31, 2020, based on the factors described above, the Company concluded that there was substantial doubt

about its ability to continue to operate as a going concern for the 12 months following the issuance of these financial statements.

Sheet Arrangements

liquidity is not dependent on the use of off-balance sheet financing arrangements (as that term is defined in Item 303(a) (4)

(ii) of Regulation S-K) and as of October 31, 2019 and through the date of this report, we had no such arrangements.

Issued Financial Accounting Standards

were no recently issued financial accounting standards that would have an impact on the Company’s financial statements.

Accounting Policies

audited consolidated financial statements reflect the selection and application of accounting policies which require us to make

significant estimates and judgments.

See Note 2 to our audited consolidated financial statements included in this Annual Report

on Form 10-K, “Summary of Significant Accounting Policies”.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

a “smaller reporting company,”

as defined by Item 10 of Regulation S-K, we are not required to provide the information

required by this item of Form 10-K.

None of the above issuances involved any underwriters,

underwriting discounts or commissions, or any public offering and we believe were exempt from the registration requirements of the Securities

Act of 1933, as amended (the “Securities Act”) by virtue of Section 4(a)(2) and Regulation D promulgated thereunder due to

the fact that there was no solicitation or advertising and the did not involve a public offering of securities.

Selected Financial Data.

As a “smaller reporting company,”

as defined by Item 10 of Regulation S-K, we are not required to provide the information required by this item of Form 10-K.

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 5. Market for Registrant’s Common Equity