What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2023-02-14 compared with 2022-02-14 · 94 added, 224 removed, 27 unchanged (92% of the section changed)

Management’s Discussion and

Analysis of Financial Condition and Results of Operations.

You 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 “ Item 1A.

Risk Factors ”.

and elsewhere in this report.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You 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 Item 1A.

Risk Factors and elsewhere in this report.

COVID-19 Impact on Economy and Business Environment

The adverse public health developments and economic

effects of the ongoing COVID-19 outbreak in the United States have adversely affected the demand for our products and services by our

customers and from patients of our customers as a result of quarantines, facility closures and social distancing measures put into effect.

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.

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

(b) has secured and is continuing to seek 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.

Results of Operations

Fiscal year ended

October 31, 2021 as compared to fiscal year ended October 31, 2020

Fiscal year ended October 31, 2022 as compared to fiscal year ended October 31, 2021

Our revenues for the year ended October 31, 2022 were $6,491,008, compared to revenues of $5,597,487 for the year ended October 31, 2021.

The increase in revenues during the year ended October 31, 2021 of $2,541,711 (83.2%) was primarily the result of the Company being able

to realize an increase of approximately 103.7% (approximately $2,849,000) in unit sales of its products during the year ended October

31, 2021 compared with the year ended October 31, 2020, partially offset from a decrease of approximately 10.0% (approximately $308,000)

in the average sales prices for the products sold during the year ended October 31, 2021 compared with the average sales prices realized

on products sold during the year ended October 31, 2020.

The increase in the units sold was partly attributable to favorable responses

to the Company’s sales and marketing efforts establishing greater market awareness, 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, 2021 compared with the year ended October 31, 2020 was due to volume pricing

discounts for large orders of the Company’s medical grade product offerings and the 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.

The increase in revenues during the year ended October 31, 2022 of $893,521 or 16.0% was primarily the result of the Company being able to realize an increase of approximately 14.7% (approximately $793,000) in the average sales prices for the products sold during the year ended October 31, 2022 compared with the average sales prices realized on products sold during the year ended October 31, 2021, partially offset by a decrease of approximately 0.4% (approximately $27,000) in the overall unit sales of its products during the year ended October 31, 2022 compared with the year ended October 31, 2021, and the Company’s ability to generate approximately $100,400 of increased revenues associated with units processed in connection with its recently launched PPX ™ service platform during the year ended October 31, 2022 compared to the year ended October 31, 2021.

The increase in the average sales prices realized on products sold during the year ended October 31, 2022 compared with the year ended October 31, 2021 was due to increases in sales of higher priced medical grade product and the reduction in volume pricing discounts granted to distributors for large orders of the Company’s medical grade product offerings and the reduction 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 .

Our cost of revenues for the year ended October 31, 2021 were $547,881, compared with cost of revenues of $398,606 for the year ended

October 31, 2020.

The increase in the cost of revenues during the year ended October 31, 2021 of $149,275 (37.4%) compared with the year

ended October 31, 2020 was due to an increase in the amount of units sold of 103.7% (approximately $278,886) during the year ended October

31, 2021 compared with the year ended October 31, 2020, partially offset from the reduction in the cost of units sold of 32.5% (approximately

($129,611) during the year ended October 31, 2021 compared to costs of units sold during the year ended October 31, 2020, 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, 2021 compared to the year ended October 31, 2020 which have a lower cost of revenue than the Company’s

medical grade product offerings.

Our cost of revenues for the year ended October 31, 2022 were $753,534 compared with cost of revenues of $547,881 for the year ended October 31, 2021.

The increase in the cost of revenues during the year ended October 31, 2022 of $205,653 or 37.5% compared with the year ended October 31, 2021 was due to an increase in the cost of units sold of 24.2% (approximately ($132,600) during the year ended October 31, 2022, compared to costs of units sold during the year ended October 31, 2021 and the Company’s increase in costs associated with units processed in connection with the recently launched PPX ™ service platform of approximately $76,000 during the year ended October 31, 2022 compared to the year ended October 31, 2021.

The increase in the cost of units sold was primarily the result of the Company’s sales of higher cost medical grade product offerings, and the reduction of lower cost aesthetic product offerings.

Gross Profit .

Our gross profit for the year ended October 31, 2021 was $5,049,606 (90.1% of revenues), compared with gross profit of $2,657,170 (87.0%

of revenues) for the year ended October 31, 2020.

The increase in gross profit during the year ended October 31, 2021 was the result of

higher amount of units sold and lower cost of units sold during the year ended October 31, 2021 compared to the year ended October 31,

The increase in the units sold was partly 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,

2021 compared to the year ended October 31, 2020 which have a lower cost of revenue than the Company’s medical grade product offerings.

Our gross profit for the year ended October 31, 2022 was $5,737,474 (88.4% of revenues), compared with gross profit of $5,049,606 (90.2% of revenues) for the year ended October 31, 2021.

The increase in gross profit during the year ended October 31, 2022 of $687,868 was the result of the Company being able to realize an increases in the average sales prices for the products sold during the year ended October 31, 2022 and the new revenues associated with its recently launched PPX ™ service platform during the year ended October 31, 2022, partially offset from increases in costs of units sold during the year ended October 31, 2022 compared to the year ended October 31, 2021.

General and Administrative Expenses .

General and administrative expenses for the year ended October 31, 2021 were $17,793,709, compared with $15,095,111 for the year ended

October 31, 2020, an increase of $2,698,598 (17.9%).

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

31, 2021 compared with the year ended October 31, 2020 was primarily the result of increased research and development costs of approximately

$886,000, increased commissions due from sales of the Company’s products of approximately $915,000, increased payroll and consulting

costs of approximately $1,400,000, increased professional fees of approximately $384,000, increased office related costs of approximately

$141,000 and approximately $209,000 of increased laboratory related expenses, partially offset by a decrease in stock-based compensation

costs to advisors, consultants and administrative staff totaling approximately $1,262,000.

The increase in research and development costs,

payroll and consulting costs, professional fees 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 and public company compliance related costs during the year ended October 31, 2021 compared with the year ended 2020.

in commissions was the result in the increase in revenues sales during the year ended October 31, 2021 compared with the year ended 2020.

The decrease in stock-based compensation costs was the result of a reduction in the amount of shares issued as stock compensation during

the year ended October 31, 2021 compared with the year ended 2020, partially offset from the increase in the costs attributable to the

shares issued as stock compensation based on increases in the Company’s share price during periods that the stock compensation was

granted (average cost of shares granted during the year ended October 31, 2021 was $0.062 versus average cost of shares granted during

the year ended October 31, 2020 of $0.029).

Other Income (Expense) Other

expense, net, for the year ended October 31, 2021 was $12,457, compared with other expense, net, of $145,027 for the year ended October

The decrease in other expense, net, of $132,570 was principally the result of reduced interest costs during the year ended October

31, 2021 of approximately $118,350 in connection with the amount of the discount to the fair value of common stock associated with the

conversion of a funding facility into equity and the reduction in interest expense of approximately $25,000 associated with such funding

These costs occurred during the year ended October 31, 2020 and did not occur during the year ended October 31, 2021.

General and administrative expenses for the year ended October 31, 2022 were $14,580,434, compared with $17,793,709 for the year ended October 31, 2021, a decrease of $3,213,275 or 18.1%.

The decrease in the general and administrative expenses for the year ended October 31, 2022 compared with the year ended October 31, 2021, was primarily the result of a decrease in stock-based compensation costs to advisors, consultants and administrative staff totaling approximately $4,735,719, reduced research and development costs of approximately $329,000, partially offset by increases in payroll and consulting fees of approximately $332,700, increases in commissions due from sales of the Company’s products of approximately $430,000, increased professional fees of approximately $561,400 and increased laboratory and office related expenses of approximately $559,000.

The decrease in stock-based compensation costs was the result of a reduction in the amount of shares issued as stock-based compensation during the year ended October 31, 2022 compared with the year ended October 31, 2021, partially offset from increases in the average costs attributable to the shares issued as stock-based compensation based on the Company’s share price at the time that the stock-based compensation was granted (average cost of shares granted during the year ended October 31, 2022 was $0.074 versus average cost of shares granted during the year ended October 31, 2021 of $0.062).

Other Income (Expense).

Other (expense), net, for the year ended October 31, 2022 was $53,598, compared with other (expense), net, of $12,457 for the year ended October 31, 2021.

The increase in other (expense), net, of $41,141 during the year ended October 31, 2022 compared to the year ended October 31, 2021 was principally the result of increased costs of approximately $323,100 from the amortization of discounts in connection with the with the Note issued and sold by the Company to AJB in January 2022, the increase of $37,200 of interest costs principally the result of $52,000 in interest costs associated with the Note during the year ended October 31, 2022 offset by a reduction of interest costs from other interest bearing obligations totally approximately $14,000, and the increase in the Commitment Fee Shortfall Obligation of approximately $30,700 under our SPA during the year ended October 31, 2022 compared with the year ended 2021, partially offset from increases of approximately $224,000 from gains from settlements and write-offs on outstanding payables and the gain from the write-off of liabilities attributable to discontinued operations that had exceeded the “statute of limitations” of $125,851during the year ended October 31, 2022 compared with the year ended October 31, 2021.

and Capital Resources

Cash and Cash

The following table summarizes the sources and

uses of cash for the periods stated.

Cash and Cash Equivalents

The 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

Fiscal Year Ended

Cash, beginning of year

3 unchanged sentences

Cash, end of year

During the year ended October 31, 2021, the Company

used cash in operating activities of $2,609,085, compared to $1,812,499 for the year ended October 31, 2020, an increase in cash used

The increase in cash used in operating activities was due to the increase in the general and administrative expenses during

the year ended October 31, 2021 after adjusting for non-cash charges (mostly related to stock-based compensation), 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, 2021, partially offset from the increase in revenues and gross profit during the year ended

October 31, 2021.

During the year ended October 31, 2021, the Company

had cash used in investing activities of $496,011, compared to cash used in investing activities of $138,694 for the year ended October

The increase in cash used in investing activities of $357,317 was due primarily due the Company’s leasehold improvements

associated with the new lab facility in Basalt, CO of $406,709, partially offset from lower capital expenditures for the acquisition of

additional fixed assets required in connection with the Company’s laboratory operations during the year ended October 31, 2021 as

compared to the year ended October 31, 2020.

During the year ended October 31, 2021, the Company

had cash provided by financing activities of $2,622,869 compared to cash provided by financing activities of $2,409,433 for the year ended

October 31, 2020.

The increase in cash provided by financing activities of $213,436 was due to increases in proceeds from the sale of

equity securities and convertible notes of approximately $512,000, decreases in repayments of outstanding debt obligations of approximately

$96,900, and reduced payments on finance leases of approximately $9,000, partially offset from reduced proceeds received from the issuance

of notes payable of $400,000 during the year ended October 31, 2021 as compared to the year ended October 31, 2020.

During the year ended October 31, 2022, the Company used cash in operating activities of $3,165,840, compared to $2,680,354 for the year ended October 31, 2021, an increase in cash used of $485,486.

The increase in cash used in operating activities was due to the increase in cash to pay increasing operating expenses on a current basis associated with professional fees, payroll, consulting costs and laboratory related expenses in connection with the Company’s expansion of its research and development activities as well as increases in payments of past due accounts payable and accrued expenses during the year ended October 31, 2022 as compared to the year ended October 31, 2021, partially offset from the increase in revenues and gross profit during the year ended October 31, 2022 as compared to the year ended October 31, 2021.

During the year ended October 31, 2022, the Company had cash used in investing activities of $824,743, compared to cash used in investing activities of $424,742 for the year ended October 31, 2021 an increase in cash used of $400,001.

The increase in cash used in investing activities was due primarily due to $690,704 of payments made in connection with the Company’s leasehold improvements associated with the new lab facility in Basalt, CO during the year ended October 31, 2022 as compared to the year ended October 31, 2021 and an decrease of $290,703 in laboratory equipment purchased for the Company’s Basalt, CO laboratory facilities during the year ended October 31, 2022 as compared to the year ended October 31, 2021.

During the year ended October 31, 2022, the Company had cash provided by financing activities of $7,635,110 compared to cash provided by financing activities of $2,622,869 for the year ended October 31, 2021.

The increase in cash provided by financing activities of $5,012,241 was due to increases in proceeds of $540,000 from the issuance of the Note to AJB, increases in capital contributed by executive of $250,000 and increases in proceeds from the sale of equity securities in connection with the Restructuring of $4,000,0000 and the sale of equity securities in other transactions of $562,730, partially offset from increases in repayments of outstanding debt obligations of approximately $331,400 and increase in payments on capital leases of approximately $9,000 during the year ended October 31, 2022 as compared to the year ended October 31, 2021.

Capital Resources

The Company has historically 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.

During the fiscal year ended October 31, 2021 and through the date of this report, the Company

completed the following private sales of its securities:

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.

The Company has historically 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.

During the fiscal year ended October 31, 2022 and through the date of this Annual Report, the Company completed the following private sales of its securities:

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.

The proceeds were used for working capital.

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.

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.

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

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.

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.

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 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.

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.

In November 2021, the Company sold an aggregate of 8,000,000 shares of common stock to one “accredited

investor” at $0.05 per share for an aggregate purchase price of $400,000.

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 of $631,020.

The proceeds were used for working capital.

On January 11, 2022, the Company entered into a Securities Purchase Agreement with AJB Capital Investments,

LLC (the “Purchaser”) pursuant to which we sold a Promissory Note in the principal amount of $600,000 to the Purchaser in

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

– Recent Development” for further details regarding this transaction.

In February 2022, the Company sold an aggregate of 8,333,333

shares of common stock to one “accredited investor” at $0.03 per share for an aggregate purchase price of $250,000.

were used for working capital.

The 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.

Going Concern

Consideration

The accompanying consolidated financial statements

have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going

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.

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.

In November 2021, the Company sold an aggregate of 8,000,000 shares of common stock to one “accredited investor” at $0.05 per share for an aggregate purchase price of $400,000.

The proceeds were used for working capital.

On January 11, 2022, the Company entered into a Securities Purchase Agreement with AJB Capital Investments, LLC (the “Purchaser”) pursuant to which we sold a Promissory Note in the principal amount of $600,000 to the Purchaser in a private transaction to for a purchase price of $540,000 (giving effect to original issue discount of $60,000).

Business – Recent Development” for further details regarding this transaction.

In February 2022, the Company sold an aggregate of 8,333,333 shares of common stock to one “accredited investor” at $0.03 per share for an aggregate purchase price of $250,000.

The proceeds were used for working capital.

During August 2022, the Company sold an aggregate of 200,000,000 shares of common stock to four “accredited investors” at $0.02 per share for an aggregate purchase price of $4,000,000.

The proceeds are being used for working capital.

During August 2022 and September 2022, the Company sold an aggregate of 65,500,000 shares of common stock to four “accredited investors” at $0.04 per share for an aggregate purchase price of $2,620,000.

The proceeds are being used for working capital.

The 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.

Pursuant to the Purchase Agreement entered into with Tysadco Partners LLC, on December 2, 2022, the Company submitted a put request to Tysadco to purchase 4,456,326 registered shares at a purchase price (as calculated pursuant to the Purchase Agreement) of $0.02244, for a total of $100,000 (“Put Request”).

On December 5, 2022, Tysadco funded the Put Request and the Company issued 4,456,326 shares to Tysadco.

The proceeds from the share sale are being used for working capital and general corporate purposes.

Going Concern Consideration

The 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.

The Company incurred operating losses of $12,744,103 for the year ended

October 31, 2021.

The Company incurred net losses of $8,896,557 for the year ended October 31, 2022.

In addition, the Company had an accumulated deficit of $50,521,306 at October 31, 2022.

The Company had a negative working

capital position of $3,609,174 at October 31, 2021.

New United States Food and Drug Administration

(“FDA”) regulations which were announced in November 2017 and which became effective beginning in May 2021 (postponed from

November 2020 due to the COVID -19 pandemic) require that the sale of products that fall under Section 351 of the Public Health Services

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

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

The Company has not obtained any opinion or

ruling regarding the Company’s operations and whether the processing, sales and distribution of the products it currently produces

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

In addition to the above, the adverse public health

developments and economic effects of the ongoing COVID-19 pandemic 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.

As 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 Company’s ability to process, sell and distribute the products currently being produced or developed

in the future are not restricted, (b) the United States economy resumes to pre-COVID-19 conditions and/or (c) additional sources of working

capital through operations or debt and/or equity financings are realized.

These financial statements do not include any adjustments that

might be necessary if the Company is unable to continue as a going concern.

Management anticipates that the Company will remain

dependent, for the near future, on additional investment capital to fund ongoing operating expenses and research and development costs

related to development of new products and to perform required clinical studies in connection with the sale of its products.

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.

In 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 Company

is able to continue to produce products or obtain products under supply arrangements which are in compliance with current and future regulatory

guidelines, (2) the effects of the COVID-19 crisis resume to pre-COVID-19 market conditions, (3) the Company will be able to establish

a stabilized source of revenues, including efforts to expand sales internationally and the development of new product offerings and/or

designations of products, (4) obligations to the Company’s creditors are not accelerated, (5) the Company’s operating expenses

remain at current levels and/or the Company is successful in restructuring and/or deferring ongoing obligations, (6) the Company is able

to continue its research and development activities, particularly in regards to remaining compliant with the FDA and ongoing safety and

efficacy of its products, and/or (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.

There is no assurance as to when the adverse impact

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

recurring pandemic outbreaks will occur again in the future causing similar or worse devastating impact to the United States and worldwide

economies and our business.

In addition, there is no assurance that the products we currently produce will not be subject to the FDA’s

previously announced intended enforcement policies regarding HCT/P’s and/or the Company will be able to complete its revenue growth

There is no assurance that the Company’s research and development activities will be successful or that the Company will

be able to timely fund the required costs of those activities.

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, if the Company’s ability to process, sell and/or distribute the

products currently being produced or developed in the future are restricted, and/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 Company had a working capital position of $303,085 at October 31, 2022.

New United States Food and Drug Administration (“FDA”) regulations which were announced in November 2017 and which became effective beginning in May 2021 (postponed from November 2020 due to the COVID-19 pandemic) require that the sale of products that fall under Section 351 of the Public Health Services Act pertaining to marketing traditional biologics and human cells, tissues and cellular and tissue based products (“HCT/Ps”) can only be sold pursuant to an approved biologics license application (“BLA”).

The Company has not obtained any opinion or ruling regarding the Company’s operations and whether the processing, sales and distribution of the products it currently produces would be subject to the FDA’s previously announced intended enforcement policies regarding HCT/P’s.

In addition to the above, the adverse public health developments associated with the ongoing COVID-19 pandemic combined with the downturn in the overall United States and global economies have adversely affected the demand for our products and services by our customers and from patients of our customers and which currently still continue to have a negative impact to our business and the economy.

As 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 Company’s ability to process, sell and distribute the products currently being produced or developed in the future are not restricted;

(b) the United States economy returns to pre-COVID-19 conditions;

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

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

Management anticipates that the Company will remain dependent, for the near future, on additional investment capital to fund ongoing operating expenses and research and development costs related to development of new products and 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.

In view of the matters described in the preceding paragraphs, recoverability of the recorded asset amounts shown in the accompanying consolidated balance sheet assumes that (a) 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;

(b) the United States economy returns to pre-COVID-19 market conditions;

(c) the Company will be able to establish a stabilized source of revenues, including efforts to expand sales internationally and the development of new product offerings and/or designations of products;

(d) obligations to the Company’s creditors are not accelerated;

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

(f) the Company is able to continue its research and development activities, particularly in regards to remaining compliant with the FDA and ongoing safety and efficacy of its products;

and/or (g) the Company obtains additional working capital to meet its contractual commitments and maintain the current level of Company operations through debt or equity sources.

There is no assurance that the products we currently produce will not be subject to the FDA’s previously announced intended enforcement policies regarding HCT/P’s and/or the Company will be able to complete its revenue growth strategy.

There is no assurance that the Company’s research and development activities will be successful or that the Company will be able to timely fund the required costs of those activities.

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.

If revenues do not increase and stabilize, if the Company’s ability to process, sell and/or distribute the products currently being produced or developed in the future are restricted, and/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.

bankruptcy laws.

As of October 31, 2021, 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.

As of October 31, 2022, 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

Our 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, 2021 and through

the date of this report, we had no such arrangements.

Our 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, 2022 and through the date of this report, we had no such arrangements.

Recently Issued Financial Accounting Standards

There were no recently issued financial accounting

standards that would have an impact on the Company’s financial statements.

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

Critical Accounting Policies

Our audited consolidated financial statements

reflect the selection and application of accounting policies which require us to make significant estimates and judgments.

to our audited consolidated financial statements included in this report, “ Summary of Significant Accounting Policies ”.

Quantitative and Qualitative Disclosures

about Market Risk

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.

Our 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 report, “ Summary of Significant Accounting Policies ”.

Quantitative and Qualitative Disclosures about Market Risk.

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 7. Management’s Discussion and Analysis