Because we are a development stage company, we have limited revenues to sustain our operations.

Our recent efforts and financial resources have primarily been directed toward commercialization of the Kush™ products for the treatment of dogs and horses suffering from osteoarthritis. Accordingly, our business operationsprospects rely heavily on the successful launch and follow-up marketing of this products. In addition to establishing effective production, marketing, sales, distribution and training for the use of Kush™, we believe its successful commercialization will depend uponon other material factors including our ability to obtain customerseducate and provideconvince veterinarians and pet owners about the benefits, safety and effectiveness of our Kush™ products, the occurrence and severity of any side effects to pets from use of our products, maintaining regulatory compliance and effective quality control for our products, our ability to those customers.maintain and enforce our patents and other intellectual property rights, any increased manufacturing costs from third-party contractors or suppliers, and the availability, cost and effectiveness of treatments offered by competitors.

If we fail to attract and retain qualified management and key scientific personnel, we may be unable to successfully commercialize our current products or develop new products effectively.

Our success will significantly be dependent upon our current management and key scientific technicians, and also on our ability to attract, retain and motivate future management and employees. We are not able to predict whether we will be able to develophighly dependent upon our businesscurrent management and generate revenues.  If we are not able to completetechnology personnel, and the loss of the services of any of them could delay or prevent the successful commercialization or development of our business plan, generate revenues and attain sustainable operations, then our business will fail.

Our operations will rely on third parties to produce our raw materials to produce our products.

We will rely on independent third parties to produce the raw materials (e.g. collagen, elastin and heparin) that we use to produce our Kush™ products. As such, we will be dependent upon their services and will not be in a position to control their operations as we might if we directly produced these raw materials. While we believe the raw materials used to manufacture our Kush products are readily available and can be obtained from multiple reliable sources on a timely basis, circumstances outside our control may impair our ability to have an adequate supply of raw materials to produce our Kush products.

If we experience the rapid commercial growth we anticipate, we may not be able to manage such growth effectively.

We contemplate rapid growth for our business as we bring our Kush™ products to market and anticipate that will place significant new demands on our management and our operational and financial resources. Our organizational structure will become more complex as we add additional personnel, and we would likely require more financial and staff resources to support and continue our growth. If we are unable to manage our growth effectively, our business, financial condition and results of operations may be materially harmed.

We have a limited marketing and sales organization, and if our current marketing and sales personnel are insufficient or inadequate to support the current introduction of our Kush products, we may not be able to sell these products in quantities to become commercially successful.

We have a limited marketing and sales organization, and we have minimal prior experience in the marketing, sale and distribution of pet care products. There are significant risks involved in our building and managing an effective sales organization, including our ability to hire, adequately train, maintain and motivate qualified individuals, generate sufficient revenuessales leads and other contacts, and establish effective product distribution channels. Any failure or substantial delay in the development of our internal sales, marketing and distribution capabilities would adversely impact our business and financial condition.

Our business will depend significantly on the sufficiency and effectiveness of our marketing and product promotional programs and incentives.

Due to achieve profitable operations.

Failure to protect our intellectual property could harm our competitive position or cause us to incur significant expenses and personnel resources to enforce our rights.

Our success will depend significantly upon our ability to protect our intellectual property (“IP”) rights, including patents, trademarks, trade secrets, and process know-how, which valuable assets support our brand and the perception of our products. We rely on patent, trademark, trade secret and other intellectual property laws, as well as non-disclosure and confidentiality agreements to protect our intellectual property. Our non-disclosure and confidentiality agreements may not fundalways effectively prevent disclosure of our activities forproprietary IP rights, and may not provide an adequate remedy in the next twelve months.event of an unauthorized disclosure of such information, which could harm our competitive position. We also may need to engage in costly litigation to enforce or protect our patent or other proprietary IP rights, or to determine the validity and scope of proprietary rights of others. Any such litigation could require us to expend significant financial resources and also divert the efforts and attention of our management and other personnel from our ongoing business operations. If we fail to raise additional funds, investorsprotect our intellectual property, our business, brand, financial condition and results of operations may lose their entire cash investment.

Based on our financial and business objectives as potential investors may not want to invest in a company whose management has limited public company experience. The interruption of the services of our management could significantly hinder our operations, profits and future development, if suitable replacements are not promptly obtained.  We do not currently have any executive compensation agreements. We cannot guarantydetermination that our management will remain with us.

Moreover, at such future time that we commence business internationally, our products will need to obtain regulatory approval for labeling, marketing and sale in foreign countries from authorities such as the investorsEuropean Commission (“EU”) or the European Medicine Agency (“EMA”). Any substantial delay or inability to obtain any necessary foreign regulatory approvals for our products could harm our business and prospects materially.

Our products will face significant competition in our industry, and our failure to compete effectively may prevent us from achieving any significant market penetration.

The development and commercialization of animal care products is highly competitive, including significant competition from major pharmaceutical, biotechnology, and specialty animal health medical companies. Our competitors include Zoetis, Inc.; Merck Animal Health, the animal health division of Merck & Co., Inc.; Merial, the animal health division of Sanofi, S.A.; Elanco, the animal health division of Eli Lilly and Company; Bayer Animal Health, the animal health division of Bayer AG; Novartis Animal Health, the animal health division of Novartis AG; Boehringer Ingelheim Animal Health; Virbac Group; Ceva Animal Health; Vetaquinol; and Dechra Pharmaceuticals PLC. There also are several smaller stage animal health companies which have reduced visibilityrecently emerged in our industry and are developing therapeutics products that may compete with our products, including Kindred Bio, Aratana Therapeutics, Next Vet, and VetDC.

Since we are an early-stage company with limited operations and financing, virtually all our competitors have substantially more financial, technical and personnel resources than us. Most of them also have established brands and substantial experience in the development, production, regulation and commercialization of animal health care products. Regarding our development of any new products or technology, we also compete with academic institutions, governmental agencies and private organizations that conduct research in the field of animal health medicines. We expect that competition in our industry is based on several factors including primarily product reliability and effectiveness, product pricing, product branding, adequate patent and other IP protection, safety of use, and product availability.

Although for the foreseeable future, our efforts and financial resources will continue to focus on successfully commercializing our Kush™ products, our future business strategy plan includes the identification of additional animal care products we may license, acquire or develop, and then commercializing such products into a branded product portfolio along with our Kush™ products. Even if we successfully license, acquire or develop such animal care products from our proprietary technology, or acquire any such new products, we may still fail to commercialize them successfully for various reasons, including competitors offering alternative products which are more effective than ours, our discovery of third-party IP rights already covering the products, harmful side effects caused to animals by the products, inability to produce products in commercial quantities at an acceptable cost, or the products not being accepted by veterinarians and pet owners as being safe or effective. If we fail to successfully obtain and commercialize future new animal care products, our business and prospects may be harmed substantially.

We will rely on third-parties to conduct studies of our current and new products, and if these third parties do not successfully perform their contracted commitments effectively or substantially fail to meet expected study deadlines, we could be delayed significantly or even prevented from obtaining regulatory approval for and/or effectively commercializing our future products.

We intend to engage one or more educational institutions with a veterinary medical curriculum to conduct studies of Kush™ and other products to be introduced by us. We expect to have limited control over the timing and resources that such third parties will devote to the companystudies. Although we must rely on the third parties to conduct our studies, we remain responsible for ensuring any of our studies are conducted in compliance with protocols, regulations and our financial condition, whichstandards set by industry regulatory authorities and commonly referred to as current good clinical practices (“cGCPs”) and good laboratory practices (“GLPs”). These required clinical and laboratory practices include many items regarding the conducting, monitoring, recording and reporting the results of target animal studies to ensure that the data and results of these studies are objective and scientifically credible and accurate.

A failure of one or more key information technology systems, networks or processes may negatively impact our shareholders’ ability to evaluate our prospects.

Risks Related to this Offering, our Common Stock and Warrants

Ownership and control of Section 404 of the Sarbanes-Oxley Act of 2002. Section 404 requires management to establish and maintain a system of internal control over financial reporting and annual reports on Form 10-K filed under the Exchange Act to contain a report from management assessing the effectiveness of a company's internal control over financial reporting. our Company is concentrated in our management.

As of the date of this prospectus, we have not assessed the effectiveness ofProspectus, our disclosure controls and procedures or our internal controls over financial reporting.

Due to this ownership concentration, our officers and directors canmanagement has the ability to control all matters requiring stockholder approval by our security holders, including the election of directors.

The market price of our common stock and warrants is likely to be highly volatile because of several factors, including a limited public float.

The market price of our common stock has been volatile in the past and the market price of our common stock and our warrants is likely to be highly volatile in the future. You may not attainbe able to resell shares of our common stock or our warrants following periods of volatility because of the market’s adverse reaction to volatility.

Other factors that could cause such volatility may include, among other things:

Any of these factors could have a significant and adverse impact on the market values commensurate withprice of our common stock and/or warrants. In addition, the offering price.

Our common stock has in the foreseeable future.  Consequently, any economic return will initially be derived, if at all, from appreciation in the fair market value ofpast been a “penny stock” under SEC rules, and our stock, and not as a result of dividend payments.

In the past (including immediately prior to this offering), our common stock rules adopted by thewas a “penny stock” under applicable Securities and Exchange Commission. Penny stocks, like shares ofCommission (“SEC”) rules (generally defined as non-exchange traded stock with a per-share price below $5.00). While our common stock generally(and trading warrants) will not be considered “penny stocks” following this offering since they will be listed on the Exchange, if we are equity securities withunable to maintain that listing and our common stock and warrants are no longer listed on the Exchange, unless we maintain a per-share price above $5.00, our common stock and warrants will become “penny stocks.” These rules impose additional sales practice requirements on broker-dealers that recommend the purchase or sale of less than $5.00,penny stocks to persons other than securities registered on certain national securities exchangesthose who qualify as “established customers” or quoted on NASDAQ. The“accredited investors.” For example, broker-dealers must determine the appropriateness for non-qualifying persons of investments in penny stock rules require a broker-dealer,stocks. Broker-dealers must also provide, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, disclose the compensation of the broker-dealer and its salesperson in the transaction, and, if the broker-dealer is the sole market maker, the broker-dealer must disclose this fact and the broker-dealer’s presumed control over the market, andfurnish monthly account statements showing the market value of each penny stock held in the customer’s account. In addition, broker-dealers who sell these securities to persons other than established customers and “accredited investors” must makeaccount, provide a special written determination that the penny stock is a suitable investment for the purchaser, and receive the purchaser’s written agreement to the transaction. Consequently, these

Legal remedies available to an investor in “penny stocks” may include the following:

These requirements may have the effect of reducing the level of trading activity, if any, in the secondary market for a security that becomes subject to the penny stock rules,rules. The additional burdens imposed upon broker-dealers by such requirements may discourage broker-dealers from effecting transactions in our securities, which could severely limit the market price and investors inliquidity of our securities. These requirements may restrict the ability of broker-dealers to sell our common stock or our warrants and may findaffect your ability to resell our common stock and our warrants.

Many brokerage firms will discourage or refrain from recommending investments in penny stocks. Most institutional investors will not invest in penny stocks. In addition, many individual investors will not invest in penny stocks due, among other reasons, to the increased financial risk generally associated with these investments. For these reasons, penny stocks may have a limited market and, consequently, limited liquidity. We can give no assurance at what time, if ever, our common stock or our warrants will not be classified as a “penny stock” in the future.

If we fail to maintain effective internal control over financial reporting, the price of our securities may be adversely affected.

Our internal controls over financial reporting have weaknesses and conditions that require correction or remediation. For the year ended March 31, 2020 and the quarter ended June 30, 2020, we identified three material weakness in our assessment of the effectiveness of disclosure controls and procedures. We have (i) deficiencies in the segregation of duties, (ii) deficiencies in the staffing of our financial accounting department and (iii) limited checks and balances in processing cash and other transactions. We are committed to improving our financial reporting processes and plan on increasing the size of our accounting staff at the appropriate time for our business and its size to ameliorate our concern that we do not effectively segregate certain accounting duties or have adequate staffing, which we believe would resolve these material weakness in disclosure controls and procedures. However, there can be no assurances as to the timing of any such action or that we will be able to do so. Any failure by us to implement the changes necessary to maintain an effective system of internal controls could harm our operating results materially and cause investors and financial analysts to lose confidence in our reported financial information. Any such loss of confidence in the investment community would have a negative effect on the trading and price of our common stock and warrants.

We are required to comply with certain provisions of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”) and if we fail to continue to comply, our business could be harmed, and the price of our securities could decline.

Rules adopted by the SEC pursuant to Section 404 of the Sarbanes-Oxley Act require an annual assessment of internal controls over financial reporting, and for certain issuers, an attestation of this assessment by the issuer’s independent registered public accounting firm. The standards that must be met for management to assess the internal controls over financial reporting as effective are evolving and complex, and require significant documentation, testing, and possible remediation to meet the detailed standards. We expect to incur significant expenses and to devote resources to Section 404 compliance on an ongoing basis. It is difficult for us to predict how long it will take or costly it will be to complete the assessment of the effectiveness of our internal controls over financial reporting for each year and to remediate any deficiencies in our internal control over financial reporting. As a result, we may not be able to complete the assessment and remediation process on a timely basis. In the event that our Chief Executive Officer or Chief Financial Officer determines that our internal controls over financial reporting are not effective as defined under Section 404, we cannot predict how regulators will react or how the market prices of our securities will be affected; however, we believe that there is a risk that investor confidence and the market value of our securities may be negatively affected.

Our management has broad discretion over the use of proceeds received by us from this offering and may apply these proceeds in ways that do not improve our operating results or increase the value of your investment.

Our management will retain broad discretion as to the use and allocation of the net proceeds received by us in this offering. Accordingly, our investors will not have any opportunity to evaluate the economic, financial and other relevant information considered by us regarding the application of the net proceeds. Management could apply the proceeds in ways that you would not approve of, and which do not improve our business or increase the value of your investment.

You will experience immediate and substantial dilution in the value of any Units that you purchase from us in this offering.

The price per common share in this public offering is substantially higher than the net tangible book value of each outstanding share of our common stock, and accordingly purchasers of Units in this offering will experience immediate and substantial dilution. See “Dilution.���

Assuming we obtain an Exchange listing, we will incur material increased costs and become subject to additional regulations and requirements.

As a newly Exchange-listed public company, we will incur material additional legal, accounting and other expenses including recruiting and retaining qualified independent directors, payment of annual Exchange fees, and satisfying Exchange standards for companies listed with it. If we are unable to satisfy our obligations and responsibilities as an Exchange-listed company, we could be subject to delisting of our common stock and warrants from the Exchange and other regulatory action, and potentially even civil litigation. 

We do not anticipate paying any dividends on our common stock for the foreseeable future.

We have not paid any dividends on our common stock to date, and we do not anticipate paying any such dividends in the foreseeable future. We anticipate that any earnings experienced by us will be retained to finance the implementation of our operational business plan and expected future growth.

The elimination of monetary liability against our directors and executive officers under Nevada law and the existence of indemnification rights held by them granted by our bylaws could result in substantial expenditures by us.

Our Articles of Incorporation eliminate the personal liability of our directors and officers to the Company and its stockholders for damages for breach of fiduciary duty to the maximum extent permissible under Nevada law. In addition, our Bylaws provide that we are obligated to indemnify our directors or officers to the fullest extent authorized by Nevada law for costs or damages incurred by them involving legal proceedings brought against them relating to their positions with the Company. These indemnification obligations could result in our incurring substantial expenditures to cover the cost of settlement or damage awards against our directors or officers.

Our Articles of Incorporation, Bylaws, and Nevada law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

Our Articles of Incorporation, Bylaws, and Nevada law could make it more difficult for a third party to acquire us, even if closing such a transaction would be beneficial to our stockholders. We are authorized to issue up to 1,000,000 shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our board of directors without further action by stockholders. The terms of any series of preferred stock may include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions. None of our preferred stock will be outstanding at the closing of this offering. The issuance of any preferred stock could materially adversely affect the rights of the holders of our common stock, and therefore, reduce the value of our common stock. In particular, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve control by the present management.

Provisions of our Articles of Incorporation, Bylaws and Nevada law also could have the effect of discouraging potential acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable. Such provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular, our certificate of incorporation and by-laws and Delaware law, as applicable, among other things:

Warrants are speculative in nature.

The warrants offered in this offering do not confer any rights of common stock ownership on their shares.

Holders of the warrants will have no rights as a common stockholder until they acquire our common stock.

Until holders of the warrants acquire shares of our common stock. We cannot guaranty that an active public marketstock upon exercise of the warrants, the holders will develop or be sustained. Therefore, investors may not be ablehave no rights with respect to find purchasers for their shares of our common stock. Should there developstock issuable upon exercise of the warrants. Upon exercise of the warrants, the holder will be entitled to exercise the rights of a significantcommon stockholder as to the security exercised only as to matters for which the record date occurs after the exercise.

There is no established market for the warrants to purchase shares of our shares,common stock being offered in this offering.

There is no established trading market for the warrants and we do not expect a market price for those shares may be significantly affected by such factors as our financial results and introduction of new products and services.  Factors such as announcements of new services by us or our competitors and quarter-to-quarter variations in our results of operations, as well as market conditions in our sector mayto develop. Although we have a significant impactapplied to list the warrants on the Exchange there can be no assurance that there will be an active trading market pricefor the warrants. Without an active trading market, the liquidity of the warrants will be limited.

Provisions of the warrants offered by this prospectus could discourage an acquisition of us by a third party.

In addition to the discussion of the provisions of our shares. Further,Articles of Incorporation and our Bylaws, certain provisions of the stockwarrants offered by this prospectus could make it more difficult or expensive for a third party to acquire us. The warrants prohibit us from engaging in certain transactions constituting “fundamental transactions” unless, among other things, the surviving entity assumes our obligations under the warrants. These and other provisions of the warrants offered by this prospectus could prevent or deter a third party from acquiring us even where the acquisition could be beneficial to you.

MARKET AND INDUSTRY DATA

This prospectus contains estimates, projections and other information concerning our industry, our business and the markets for our drug candidates, including data regarding the estimated size of such markets and the incidence of certain medical conditions. We obtained the industry, market has experienced extreme volatility that has particularly affected the market prices of stock of many companies and that often has been unrelated or disproportionate to the operating performance of those companies.

USE OF PROCEEDS

Based on the public offering price of $           per Unit, we estimate that the net proceeds to us from this public offering will be approximately $           after deducting the underwriting discounts and commissions and other estimated offering expenses. Based on our current projections, we expect such net proceeds will satisfy our operational and working capital needs for the next twelve months. We intend to use these net proceeds as follows:

We currently intend to use the net proceeds from this offering for general corporate purposes including marketing of our Kush™ products, debt repayment, research and development of our current product pipeline, purchase of manufacturing equipment and working capital. Our total planned debt repayment of $440,000 consists of (i) $360,000 in a Convertible Note due to RedDiamond Partners, LLC and maturing on March 15, 2021, consisting of approximately $353,000 in principal and $7,000 in interest, which accrues interest at a rate of 12.5%, is automatically converted into common stock at $0.72 per share if an uplisting to the Exchange occurs and the price per share in the uplisting is at least $0.864; (ii) $40,000 in accrued expenses relating to a past employee’s accrued salary; (iii) $40,000 in a note payable that accrues interest payable on a monthly basis at a rate of 6.5% interest and matures on May 3, 2026. We also plan to repay $130,000 in a notes payable to a related party, as follows: (i) payment in full of the remaining balance, on the Amendment (“Amendment”) to the Promissory Note dated September 1, 2020, which is $60,000 and (ii) a partial payment of $70,000 on the promissory note dated September 1, 2020 (“Note”) in the principal amount of $195,000 due to the related party. The Amendment bears interest at the rate of 3% per annum, has accrued interest due of $400 and has a maturity date of August 31, 2022. The Note bears interest at the rate of 8% per annum, has accrued interest due of $6,000, and a maturity date of June 30, 2022. Management plans to use net proceeds from this offering to repay debt including but not limited to: a bridge note used for working capital purposes, a note payable to a related party and accrued interest entered into for working capital purposes, accounts payable relating to general operating expenses and accrued expenses and accrued expenses – related party, both due to general operating expenses. See “Risk Factors” for a discussion of certain risks that may affect our intended use of the net proceeds from this offering.

We anticipate expending approximately $800,000 to fund independent studies for the use of our products in dogs and horses as part of the $3,000,000 for marketing support. We have had discussions with several universities that have veterinary studies in their curriculum regarding conducting such studies for us. We also anticipate expending approximately $130,000 for research and development relating to advancing products within our muco-adhesion technology included within our product pipeline.

These anticipated expenditures represent our current estimates and intentions based upon our present plans and assumptions regarding our anticipated future revenues and expenses. As of the date of this prospectus, we cannot predict accurately all of the particular uses for these net proceeds, and accordingly our management will have broad discretion regarding our use of net proceeds from this offering. Moreover, the amounts and timing of our actual expenditures will depend upon numerous factors, including the future results of our marketing and other commercialization efforts for our initial Kush System products. Pending our use of proceeds as above, we expect to invest them in investment-grade, short-term interest-bearing deposit certificates or similar securities.

MARKET FOR OUR STOCK AND RELATED STOCKHOLDER MATTERS

Market Information

During the fiscal years ended March 31, 2019 and 2020, our common stock was listed for quotation on the OTC Pink Sheets and OTCQB markets under the symbol “PETV.” The following table sets forth the high and low bid prices relating to our common stock on a quarterly basis for the periods indicated as quoted by the OTC Pink Sheets and OTCQB markets. These quotations reflect inter-dealer prices without retail mark-up, mark-down, or commissions. There can be no assurance that an active public market for our common stock will develop or be sustained.

Number of Stockholders

At September 30, 2020, there were approximately 287 stockholders of record. The number of stockholders of record does not include certain beneficial owners of our common stock, whose shares are held in the names of various dealers, clearing agencies, banks, brokers and other fiduciaries.

Dividends

We have never declared or paid any cash dividends on our common stock and do not anticipate paying any cash dividends on our common stock at any time in the foreseeable future. We currently intend to retain all available funds and any future earnings for use in the operation of our business and do not anticipate paying any dividends on our common stock in the foreseeable future. Any future determination to declare dividends will be made at the discretion of our Board and will depend on, among other factors, our financial condition, operating results, capital requirements, general business conditions, the terms of any future credit agreements and other factors that our Board may deem relevant.

Warrants and Stock Options

As of September 30, 2020, we have options and warrants outstanding for the purchase of 5,763,610 shares of our common stock. This does not include the underwriters’ warrants and warrants offered by us in this offering as part of the Units.

Restricted Stock Units

As of September 30, 2020, we have not granted any restricted stock units to any employees, consultants or other third parties.

DETERMINATION OF OFFERING PRICE

The offering price for the Units offered by this prospectus will be based upon negotiations between the Company and the Underwriters as described in “UNDERWRITING.”

CAPITALIZATION

The following table is illustrative only, and our capitalization following the completion of the offering will be adjusted based on the actual offering price the Units and other terms of our offering determined on such pricing. You should read the following table in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations and our financial statements and notes appearing elsewhere in this prospectus.

The table sets forth our cash and cash equivalents and our capitalization, as of June 30, 2020:

The number of shares of common stock to be outstanding after this offering is based on 24,876,189 shares outstanding as of September 30, 2020, ________ shares issued between October 1, 2020 through and immediately prior to the date of this prospectus and _________ Units to be issued in this Offering; and does not include _________ shares reserved for exercise of outstanding warrants, underwriters warrants for ________ shares and up to _________ Units for the over-allotment option.

DILUTION

If you invest in the Units offered pursuant to this prospectus, your interest will be diluted to the extent of the difference between the public offering price you pay and the adjusted net tangible book value per common share of our stock. Net tangible book value as of June 30, 2020 was ($0.05) per common share of our common stock. Net tangible book value per share is the difference between our total assets less our intangible assets and total liabilities, divided by the number of shares of common stock outstanding.

Dilution per share represents the difference between the amount per share paid by new investors who purchase Units in this offering and the adjusted net tangible book value per share of our common stock immediately after completion of this offering as of June 30, 2020, after giving effect to the sale by us of ________ Units at the public offering price of $__ per Unit.

The number of shares of common stock to be outstanding after this offering is based on 24,876,189 shares outstanding as of September 30, 2020, ________ shares issued between October 1, 2020 through and immediately prior to the date of this prospectus and _________ Units to be issued in this Offering; and does not include _________ shares reserved for exercise of outstanding warrants, underwriters warrants for ________ shares and up to _________ Units for the over-allotment option.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements and related notes that appear elsewhere in this prospectus. In addition to historical consolidated financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those discussed in the forward looking statements. Factors that could cause or contribute to those differences include those discussed below and elsewhere in this prospectus, particularly in “RISK FACTORS.” We caution the reader not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this prospectus.

General Overview

We are a smaller reporting company and have not generated any material revenues to date and have incurred substantial losses in connection with our limited operations. We need substantial capital to pursue our current plans to bring our first products to market. The first of such products is a proprietary gel-like protein-based biomedical material for injection into the afflicted body parts of animals suffering from osteoarthritis or other impairments to be marketed under the trade name Kush™. It will provide to veterinarians an innovative treatment for dogs and horses suffering from osteoarthritis.

Going Concern

The independent auditor’s report accompanying our March 31, 2020 financial statements contains an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The financial statements have been prepared “assuming that we will continue as a going concern,” which contemplates that we will realize our assets and satisfy our liabilities and commitments in the ordinary course of business. We have suffered recurring losses from operations, have a substantial working capital deficit and are currently in default of the payment terms of certain note agreements. These factors raise substantial doubt about our ability to continue as a going concern.

RESULTS OF OPERATION

For Fiscal Year Ended March 31, 2020 (“fiscal 2020”) Compared to Fiscal Year Ended March 31, 2019 (“fiscal 2019”)

Total Revenues. For fiscal 2020, we earned $3,588 in revenue compared to earning no revenue during fiscal 2019. Our sales in fiscal 2020 represented sample product sales, with no commercial sales in fiscal 2019.

Total Cost of Sales. For fiscal 2020, we incurred $19,710 in expenses compared to $77,936 in fiscal 2019. Cost of sales during fiscal 2020 was made up of costs during the year and subsequent reserve for obsolete inventory. Cost of sales during fiscal 2019 was made up of a reserve for obsolete inventory taken due to an analysis that included the product status, shelf life, and lack of material sales.

Operating Expenses. Operating expenses for fiscal 2020 were $2,000,010 compared to $4,594,872 for fiscal 2019, a decrease of $2,594,862. Operating expenses consisted of: (i) research and development expenses, (ii) sales and marketing, (iii) general and administrative expenses and (iv) intangible impairment expenses. General and administrative expenses generally include corporate overhead, financial and administrative contracted services, marketing, and consulting costs.

Sales and marketing expenses increased significantly to $171,509 in fiscal 2020 compared to $38,348 in fiscal 2019; this increase was due to increased sales and marketing expenses relating to promoting Kush™ to veterinarians.

Research and development expenses (“R&D”) decreased to $12,672 in fiscal 2020 compared to $200,982 in fiscal 2019. We completed most of our R&D for Kush™ in fiscal 2019 and therefore did not incur significant R&D expense in fiscal 2020. Sales and marketing expenses decreased to $38,348 in fiscal 2020 compared to $171,509 in fiscal 2019. General administrative (“G&A”) expenses were $1,784,557 in fiscal 2020 compared to $4,251,742 in fiscal 2019. In fiscal 2019, we had significant G&A expenses attributable to a charge in the amount of $861,592 attributable to common stock issued to our CEO to replace shares he surrendered pursuant to an escrow agreement, and $584,501 in common stock issued to our CEO to replace shares he gave up to secure funding for the Company in 2015. Our intangible impairment expense was $31,272 in fiscal 2020 compared to $103,800 in fiscal 2019.

Operating Loss. As a result of the foregoing, our operating loss for fiscal 2020 was $2,016,132 compared to an operating loss of $4,672,808 for fiscal 2019.

Other Income (Expense). Other expense for fiscal 2020 was $66,602 compared to other expense of $84,950 for fiscal 2019 in fiscal 2019, our only expense was interest expense of $84,950. In fiscal 2020, interest expense decreased significantly to $32,180 due to the retirement of certain outstanding debt. In addition, we have other expense in fiscal 2020 consisting of (i) a $47,710 gain on settlement, (ii) a loss on sale of assets of ($389) and (iii) a loss on debt extinguishment of ($81,738).

Net Loss before Taxes and Net Loss. Our net loss before taxes for fiscal year ended March 31, 2020 was ($2,082,734) or ($0.10) per share as compared to ($4,757,758) or ($0.26) per share for fiscal year ended March 31, 2019. Net loss generally decreased primarily due to the following differences in fiscal year ended March 31, 2019: increased expense related to sales and marketing of $133,161, a decrease in expense related to research and development of $188,310, a decrease in intangible impairment of $72,528, and a decrease in general and administrative expenses of $2,467,185. The weighted average number of shares outstanding during fiscal 2020 was 21,222,359 compared to 18,451,797 for fiscal 2019.

Results of Operations for the Three Months Ended June 30, 2020 (“first quarter 2020”) and June 30, 2019 (“first quarter 2019”)

Total Revenues. In the first quarter of 2020, revenue was $2,006 which consisted of Kush™ product sales to veterinary clinics, compared to no revenues in the first quarter 2019.

Total Cost of Sales. We did not incur any costs of sales in the first quarter of 2020 or first quarter of 2019 because we were not manufacturing any new Kush™ products.

Gross Profit. Our gross profit was $2,006 for the first quarter of 2020, compared to $0 in the first quarter of 2019.

Operating Expenses. Operating expenses for the first quarter of 2020 were $444,074, compared to $493,721 for the first quarter of 2019. The decrease of $49,647 was due primarily to a decrease in depreciation and amortization of $92,285 since several of our patents have become fully-amortized. The decrease in depreciation and amortization was partially offset by an increase in sales and marketing expense of $43,886 due to various stock-based agreements being relieved from prepaids to expense.

The majority of our operating expenses in both of these quarters was general and administrative expenses. During the three-month period ended June 30, 2020, operating expenses were primarily made up of $51,805 (compared to $144,090 for the comparable quarter in 2019) in depreciation and amortization and $183,244 (compared to $190,801 for the comparable quarter in 2019) in stock-based compensation.

Other Expense. Other Expense for the three months ended June 30, 2020 of $371,940 is primarily due to derivative expense in the amount of $324,200 related to the setup of a derivative liability as described in Note 8 to these financial statements. Other Expense for the three months ended June 30, 2019 of $7,166 was primarily made up of interest accrued on outstanding notes payable, notes payable – related party, and convertible notes payable in the amount of $7,616, which was partially offset by a $450 gain on sale of asset that was fully depreciated at the time of the sale.

Net Loss before Taxes and Net Loss – Our net loss for the three months ended June 30, 2020 was $814,008, or $0.04 per share, compared to $500,887, or $0.03 per share for the three months ended June 30, 2019. The increased loss of $313,121 was attributable primarily to derivative expense of $342,200 recognized during the three months ended June 30, 2020. The weighted average number of shares outstanding during the three-month periods ended June 30, 2020 and June 30, 2019 were 22,938,231 and 19,867,200, respectively.

LIQUIDITY AND CAPITAL RESOURCES

Our financial position and future prospects depend significantly on our access to financing to fund our operations during our commercialization stage. Much of our current cost structure is based on costs related to personnel and facilities, and not subject to material variability. In order to fund our operations and working capital needs, we historically have utilized loans from accredited investors and others, equity sales of common stock to accredited investors and others with whom we have pre-existing relationships, and substantial issuances of stock-based compensation to satisfy outstanding debt and pay for development, management, financial, professional and other services.

As of June 30, 2020, our current assets were $268,434 and our current liabilities were $2,013,558, which resulted in a working capital deficiency of $1,745,124. As of June 30, 2020, we had approximately $128,564 in cash, $2,000 in accounts receivable, $1,500 in investment – equity securities, and $136,370 in prepaid expenses. In comparison, our current liabilities as of that date were $2,013,558, consisting of $780,835 of accounts payable and accrued expenses, $239,372 of accrued expenses – related party, $548,200 in derivative liability, $301,446 in convertible notes and accrued interest payable, net of debt discount, $25,197 in convertible notes and accrued interest – related party, $15,947 in PPP loan – short term, $15,325 in notes payable, $62,445 in notes payable and accrued interest – related party, and $24,791 in operating lease liability – short term.

We currently have little cash to support our operations and projected commercial growth. We will need to raise substantial additional capital through private or public offerings of our equity or debt securities, or a combination thereof, and we may have to use a material portion of any capital raised to repay past due debt obligations. To the extent any capital raised is insufficient to both satisfy operational working capital needs and meet any required debt payments, we will most likely need to either extend, refinance or convert to equity our outstanding indebtedness.

If we complete this offering, we believe the net proceeds will be sufficient to fund our operational working capital for at least the next 12 months. In the event we cannot complete this offering or obtain any such financing when needed on terms acceptable to us, if at all, our business would suffer substantially.

Liquidity represents the ability of a company to generate sufficient cash to provide for its immediate cash needs, which our continued losses have made it difficult for us to accomplish. Over the past several years, we have continued to incur substantial losses without any source of material revenues or liquid assets, which has caused a serious and harmful effect to our liquidity and a substantial strain on our ongoing business operations.

We have not receivegenerated any operating cash flows since we are a development stage company which has not yet realized any significant commercial revenues.

Net Cash Used in Operating Activities

We used $235,331 of net cash in operating activities for the three months ended June 30, 2020 compared to $173,797 of net cash for the three months ended June 30, 2019. This increase in cash used in operating activities was primarily attributable to a decrease in the amount of depreciation and amortization recognized of $92,285.

We used $496,598 and $736,445 of net cash in operating activities in fiscal 2020 and fiscal 2019, respectively. Net cash flows used in operating activities during fiscal 2020 consisted primarily of a net loss of $2,082,734, which was offset by: (i) $863,012 of stock-based compensation and (ii) $559,544 in depreciation and amortization expenses. Net cash used in operating activities during fiscal 2019 consisted primarily of a net loss of $4,757,758, which was offset by: (i) $1,642,869 in in stock based compensation, (ii) $1,446,093 for shares issued to our CEO to replace shares given up in escrow and (iii) $646,921 in depreciation and amortization. The stock-based compensation expenses, including warrant and common stock issuances, helped us to operate the business with minimal amounts of cash on hand at any given time during the year.

Net Cash Used in Investing Activities

We used $45,890 of net cash in investing activities in the three months ended June 30, 2020, consisting of $5,136 of costs capitalized to intangible assets, $482 in sale of equipment, and $41,236 of costs capitalized to property and equipment. This is compared to $21,260 of net cash used in investing activities in the three months ended June 30, 2019, which was primarily due to $19,760 of costs capitalized to intangible assets.

We used $65,196 and $103,807 of net cash in investing activities in fiscal 2020 and 2019, respectively. Our use in fiscal 2020 consisting primarily of the purchase of equipment for $32,791 and an increase of patents and trademarks for $43,386, which were offset by proceeds from the sale of equipment in the sharesamount of common stock offered under this prospectus$12,481.

Net Cash Provided by Financing Activities

During the selling shareholders.  Rather,three months ended June 30, 2020, we were provided with net cash of $399,203 from financing activities consisting of $322,500 from entering into various convertible notes payable, $38,665 from the selling shareholders will receive those proceeds directly.

We are indebted to certain related parties with respect to accrued salaries. At June 30, 2020, we considered several factors including the following:

Notes and Convertible Notes Payable

As of the 39,150,000 shares of common stock being offered by the selling shareholders has no relationship to any established criteria of value, such as book value or earnings per share. Additionally, becauseJune 30, 2020, we have no significant operating history and have only generated limited revenues to date, the price of the shares of common stock is not based on past earnings, nor is the price of the shares indicative of current market valuewere obligated for the assets owned by us. No valuation or appraisal has been prepared for our business and potential business expansion.

As of up toSeptember 30, 2020, an aggregate of 39,150,000 shares$25,197 of common stock.  the principal and interest on a convertible note payable to a related party was converted into equity.

OFF-BALANCE SHEET ARRANGEMENTS

We do not have during the periods presented, and we do not currently have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

GOING CONCERN

The independent auditors’ report accompanying our March 31, 2020 financial statements contains an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The financial statements have been prepared assuming that we will continue as a going concern, which contemplates that we will realize our assets and satisfy our liabilities and commitments in the ordinary course of business. We have suffered recurring losses from operations and have a working capital deficit. These factors raise substantial doubt about our ability to continue as a going concern.

Critical AccountING Policies

We prepare our consolidated financial statements in accordance with generally accepted accounting standards in the United States of America. Our significant accounting policies are described in Note 3 to our consolidated financial statements attached hereto. We believe the following critical accounting policies involve the most significant judgments and estimates used in the preparation of the consolidated financial statements.

RECENTLY ISSUED ACCOUNTING STANDARDS

The following table sets forth,describes the recently issued accounting standards used in reporting our financial condition and results of operations. In some cases, accounting standards allow more than one alternative accounting method for reporting. In those cases, our reported results of operations would be different should we employ an alternative accounting method.

The FASB issued ASC 606 as guidance on the recognition of revenue from contracts with customers in May 2014 with amendments in 2015 and 2016. Revenue recognition will depict the transfer of promised goods or services to our knowledge, certain information aboutcustomers in an amount that reflects the selling shareholders asconsideration to which the entity expects to be entitled in exchange for those goods or services. The guidance also requires disclosures regarding the nature, amount, timing and uncertainty of August 11, 2011 ,revenue and cash flows arising from contracts with customers. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented, or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the cumulative catch-up transition method). The company adopted the table, basedguidance on information furnished to us byApril 1, 2018 and applied the selling shareholders.  

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) to increase transparency and includes votingcomparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. Topic 842 affects any entity that enters into a lease, with some specified scope exemptions. The guidance in this ASU supersedes Topic 840, Leases. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use (“ROU”) asset representing its right to use the underlying asset for the lease term. The Company adopted Topic 842 on April 1, 2019 and resulted in a right of use asset and liability of $154,917.

All newly issued accounting pronouncements but not yet effective have been deemed either immaterial or investment power with respect tonot applicable.

JOBS Act

On April 5, 2012, the securities. The shares offered for sale constitute allJumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the shares known to us to be beneficially owned by the selling shareholder. EachJOBS Act provides that an “emerging growth company” can take advantage of the selling shareholders is not a broker-dealer or an affiliate of a broker-dealer to our knowledge. Except as indicatedextended transition period provided in the footnotes or description of the private placement transactions following the table, each selling security holder has indicated to us that it is acting individually, not as a member of a group, and none of the selling security holders or their affiliates has held any position or office or had any other material relationship with us in the past three years.  

We have chosen to opt out of the extended transition periods available to emerging growth companies under the JOBS Act for complying with new or revised accounting standards. Section 107 of the JOBS Act provides that our decision to opt out of the extended transition periods for complying with new or revised accounting standards is irrevocable.

We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which exemptionwe have total annual gross revenues of $1.0 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of this offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

BUSINESS

PetVivo is specifieda veterinary biotech and biomedical device company headquartered in suburban Minneapolis, Minnesota that is primarily engaged in the business of commercializing and licensing products in the veterinary market to treat companion animals such as dogs and horses. Most of our technology was developed for human biomedical applications, and we intend to leverage the investments already expended in their development to commercialize treatments for pets in a capital and time-efficient way.

Many of the Company’s products are derived from proprietary biomaterials that simulate a body’s cellular tissue by virtue of their reliance upon natural protein compositions which incorporate such “tissue building blocks” as collagen, elastin and heparin. Since these are naturally-occurring in the body, we believe they have an enhanced biocompatibility with living tissues compared to synthetic biomaterials such as those based upon alpha-hydroxy polymers (PLA, PLGA and the like) and other “natural” biomaterials that may lack the multiple proteins incorporated into our biomaterials. These proprietary protein-based biomaterials appear to mimic the body’s tissue thus allowing integration and tissue repair in long-term implantation in certain applications.

Our initial product, Kush™, is a veterinary device designed to help reinforce articular cartilage tissue for the treatment and prevention of osteoarthritis and other joint related afflictions in companion animals. Kush™ uses an intra-articular injection of non-dissolving, cartilage-like, patented particles that are slippery, wet-permeable, durable and resilient to enhance the force cushioning function of the synovial fluid. The particles mimic natural cartilage in composition, structure and hydration. Multiple joints can be treated simultaneously. Our particles are comprised of collagen, elastin and heparin, the same components found in natural cartilage. These particles show an effectiveness to augment the cartilage and enhance the functionality of the joint (e.g. provide cushion or shock-absorbing features to the joint and to provide joint lubricity).

Osteoarthritis, the most common inflammatory joint disease in both dogs and horses, is a chronic, progressive, degenerative joint disease that is caused by a loss of synovial fluid and/or the deterioration of joint cartilage. Osteoarthritis affects 1 out of 4 dogs and over half of all horses. It is estimated that there are over 20 million dogs with osteoarthritis in the United States and the European Union with a market size of $2.6 billion and over 1 million lame horses in the US for a $600 million United States and the European market. See Johnston, Spencer A. “Osteoarthritis. Joint anatomy, physiology, and pathobiology.” The Veterinary Clinics of North (1997):699-723.

Despite the market size, veterinary clinics and hospitals have very few treatments and/or drugs for use in treating osteoarthritis in dogs, horses and other pets. As there is no cure for osteoarthritis, the various treatment methods are focused on managing the related symptoms of pain and inflammation. The current treatment for osteoarthritis in dogs generally consists of the use of nonsteroidal anti-inflammatory drugs (or “NSAIDs”) which present the potential for side effects relating to gastrointestinal, kidney and liver damage. In contrast, the Company’s treatment using Kush™, to our knowledge, has not elicited any adverse side effects in dogs. Remarkably, Kush™-treated dogs have shown an increase in activity even after they no longer are receiving pain medication. Other treatments for osteoarthritis include steroid and/or hyaluronic acid injections, which are often slow acting and/or short lasting.

We believe Kush™ is superior to existing treatments to safely improve joint function in animals for several reasons:

Historically, drug sales represent up to 30% of revenues at a typical veterinary practice (Veterinary Practice News). Revenues and margins at veterinary practices are being eroded because online, big-box and traditional pharmacies have recently started filling veterinary prescriptions. Veterinary practices are looking for ways to replace lost prescription revenues with safe and effective products. Kush™ is veterinarian-administered and should expand practice revenues and margins. We believe that the increased revenues and margins provided by Kush™ will accelerate its adoption rate and propel it forward as the standard of care for canine and equine lameness related to or due to synovial joint issues

Kush™ is classified as an animal device under the FDA rules and pre-market approval is not required by the FDA. Kush™ has completed a safety and efficacy study in rabbits in 2007. Since that time, more than 100 horses and dogs have been successfully treated with Kush™. We are in the process of preparing a protocol to conduct a pilot study with a major university or another academic institute. We anticipate this study will be a 12-month study that will be primarily used to expand our distribution outlets since the large international and national distributors generally require a third-party university study to include a product in their catalog of products.

We plan to commercialize Kush™ and other products developed by us in the United States through the use of in-house marketing personnel who will oversee the efforts of independent distributors we engage on a regional or national basis. We plan to support our distributors with use of social media and other methods to educate and inform to key opinion leaders and decision makers at the top distributors and high prescriber veterinarians for companion animals of the availability and benefits of Kush^TM . We have developed a commercialization strategy, which provides for our (i) initial launch in key regional markets (Colorado, Minnesota and Texas) by internal sales representatives, (ii) development of alliances with 3 to 4 of the top national distributors and (iii) development of a full national roll-out strategy to deliver our products to customers commencing in July of 2021.

We have established an ISO 7 certified clean room manufacturing facility located in our Minneapolis facility using a patented and scalable self-assembly production process, which reduces the infrastructure requirements and manufacturing risks to deliver a consistent, high-quality product while being responsive to volume requirements. While we are not currently manufacturing commercial quantities, we have built out an ISO 7 certified facility that will be able to handle projected production in units for at least the next five years.

In addition to Kush™, we have engaged a strategic partner, Emerald Organic Products, Inc. (“Emerald”), through an exclusive license agreement dated July 31, 2019 to allow Emerald to bring our mucoadhesive drug delivery technology to the human nutraceutical market for the delivery of various active nutraceuticals including cannabidiol (“CBD”), caffeine, and citicoline. Since such products tout up to a 10-times increase in bioavailability of active agents, we believe that we have an advantage over other delivery methods in the CBD and nutritional supplement markets. We have agreed that the license to Emerald will include use PetVivo’s proprietary technology in the formulation, manufacture and sale of Emerald’s nutritional supplements including its hemp-based CBD wellness products.

We also have a pipeline which includes 17 therapeutic devices for both veterinary and human clinical applications. Some such devices may be regulated by the FDA or other equivalent regulatory agencies, including but not limited to the CVM. We anticipate growing our product pipeline through the acquisition or in-licensing of additional proprietary products from human medical device companies specifically for use in pets. In addition to commercializing our own products in strategic market sectors and in view of the Company’s vast proprietary product pipeline, the Company may establish strategic out-licensing partnerships to provide secondary revenues.

Product Pipeline

Possible Future Use In Humans

Dr. David Masters’ and Gel-Del’s efforts in the development of the gel-like substance used in Kush™, was intended for use in humans. Such efforts included pursuit of premarket approval for use of the material for injection as a dermal filler for cosmetic wrinkle treatment. Details regarding the FDA clinical trial may be found at the FDA’s website for clinical trails https://www.clinicaltrials.gov/ct2/show/NCT00414544?spons=Gel+Del&rank=1. In 2006, the technology was licensed for such purposes on an exclusive basis to a California-based marketer of facial rejuvenation products; however, the arrangement was terminated after approximately eighteen months largely due to economic conditions in 2007.

While we currently have no immediate plans to pursue marketing Kush™ for use in treatment of humans or to license it to third parties for such marketing, we believe there are significant opportunities for such use in the future. We have no intention to devote proceeds from this offering or current efforts in the near term towards such opportunities in treatment of humans.

Dermal Filler

Our biomaterials are constructed from purified water, protein, and carbohydrate, tailored to simulate different body tissues that biologically integrate (bio-integration). Our biomaterials can be manufactured and used as a dermal filler for wrinkle treatment by injection. These formed, gel particles fill, integrate and rejuvenate dermal skin tissue to remove the wrinkle. This product was taken through an FDA clinical trial under the name CosmetaLife®, the results of which can be found at www.clinicaltrials.gov (NCT00414544).

Cardiovascular Device

Our blood-compatible biomaterial, which allows blood contact and bio-integrative processes to occur without clotting, platelet attachment, or thrombogenesis, is used to repair cardiovascular tissue. VasoGraft®, a blood vessel graft made from VasoCover™ material, is designed to mimic natural blood vessel tissue in almost every respect, including the components used.

Drug Delivery

Unique fabrication techniques allow us to homogeneously distribute drug in milligram to nanogram amounts, resulting in optimum performance and manufacturing capabilities for a variety of delivery methods, such as coatings, injectables, implantables or transmucosal delivery. The first planned transmucosal product has been optimized and tested with peptide drugs with better efficacy than oral dosing via swallowing.

Orthopedic Devices

Another of our materials can be used in a variety of shapes for orthopedic and dental applications. The first products, OrthoGelic™ and OrthoMetic™, will be aimed at difficult-to-heal, non-union broken bones, by using particles to fill the empty space. The orthopedic biomaterial, made to mimic the structural components of bone, can allow integration and healing in the break and exclude non-bone tissue infiltration.

Overview of the Animal Health Market

Over the last several decades, we believe the animal health market and industry has been a strong component in the overall U.S. economy and is more resistant to economic cycles. The veterinary sector is as an attractive area to participate in the growth of the broader healthcare industry without reimbursement risk. According to the American Pet Products Association (“APPA”) 2019-2020 National Pet Owners Survey, in 2019, U.S. pet spending was $95.7 billion, with veterinary care and products accounting for $29.3 billion of these sales, followed by supplies, live animals and OTC medicines at $19.2 billion and other services at $10.3 billion. The APAA projects that pet spending will increase to $99 billion, a 3.5% increase in 2020.

Management expects growth in the companion animal market to continue for several years. Factors influence the growth in demand for veterinarian care and pet therapeutics include: (i) increased pet ownership globally, (ii) pets living longer, and (iii) increased pet spending as pets are viewed as members of the family. The APPA projects that the global veterinary medicine market is expected to grow from $22.9 billion in 2019 to $29.7 billion by 2027, registered a compound annual growth rate of 4.6% from 2020 to 2027.¹

According to the APPA, U.S. pet ownership reached record levels in 2019. Specifically, 68% of all U.S. households (approximately 84.9 million households) owned a pet in 2019. The APPA also reported that there were 63.4 million dogs, 42.7 million cats and 1.6 million horses held by U.S. households in 2019. According to the APPA, pet ownership increased at a 1.58% annual compound growth rate in the United States while the human population in the United States increased at a 0.83% compound annual growth rate over the last 15 years.

Pets are living longer, with the average lifespan for dogs increasing by half a year to 11 years between 2002 and 2012 according to a study by Banfield Pet Hospital. With pets living longer, consumers are spending more disposable income to give their “family member” a healthier, more comfortable life. Most veterinary expenditures are paid out of pocket. Even in times of recession, pet owners are less sensitive to the overall price of pet care than to other aspects of their lifestyle. As new innovations emerge, pet owners now have a greater ability to extend the life of their pet by treating chronic diseases and ailments associated with old age.

¹Allied Market Research, July 2020 report titled: “Veterinarian Medicine Market by Product (Drugs, Vaccines, and Medicated Feed Additives), Routes of Administration (Oral Route, Parenteral Route and Topical Route), Animal Type (Companion Animals and Livestock Animals), and Distribution Channel (Veterinary Hospitals Pharmacies, and Retail Veterinary Pharmacies): Global Opportunity Analysis and Industry Forecast, 2020-2027 – July 2020. 

Osteoarthritis Market Size

Osteoarthritis, the most common inflammatory joint disease in both dogs and horses, is a progressive condition that is caused by a deterioration of joint cartilage. Over time, the joint cartilage deterioration creates joint stiffness from mechanical stress resulting in inflammation, pain and loss of range of motion, which may be referred to as lameness. Osteoarthritis joint stiffness and lameness worsens with time from gradual cartilage degeneration and an ongoing loss of protective cushion and lubricity (i.e., loss of slippery padding).

Canine Osteoarthritis

The prevalence of companion animal osteoarthritis is estimated through a variety of methods. In looking at the incidence of osteoarthritis in dogs, Spencer Johnston’s article “Osteoarthritis. Joint anatomy, physiology, and pathobiology” is often cited, which reports that 20% of all dogs over the age of one year suffer from osteoarthritis. Using the following simple methodology and management’s estimate that 20% of the total dog population is under the age of one, we estimate that 14.4 million dogs in the U.S. suffer from osteoarthritis.

89.7 million dogs in the U.S. x 80% = 71.8 million total dogs x 20% with osteoarthritis = 14.4 million dogs with osteoarthritis in the U.S.

Craig-Hallum’s July 22, 2013 institutional research report on Aratana Therapeutics estimates the U.S. dog osteoarthritis market at 16.6 million dogs. William Blair & Company, L.L.C. released a July 25, 2013 Equity Research report by Aratana Therapeutics that concluded that roughly 10% of dogs and cats suffer from osteoarthritis (89.7 million dogs x 10% = 9 million dogs with OA). Stifel issued a report on Aratana Therapeutics dated July 22, 2013 that estimated the osteoarthritis market to be 55% of dogs over the age of 10. This equates to a US market in 2014 of 7.1 million dogs with osteoarthritis.

Horse Osteoarthritis (Lameness)

Equine osteoarthritis is the most common cause of lameness in horses. The annual average costs for diagnosis and treatment of equine lameness is $3,000 per horse, with downtime & homecare costs being much higher (Oke and McIlwraith, 2010). “The USDA National Economic Cost of Equine Lameness… in the United States” published by 1978 places the annual incidence of lameness at 8.5 to 13.7 lameness events per 100 horses.

As noted previously, the APPA reported the total number of horses owned by U.S. households was 7.6 million in 2018. A 2007 publication by Emily Kilby “The Demographics of the U.S. Equine Population” concludes the U.S. horse population to be 9.5 million in 2006 with racehorses being 9% of that population or 846,000 horses. The article “The Occurrence and Causes of Lameness and Laminitis in the U.S. Horse Population” estimates that 17% of racehorses and 5.4% of the rest of the horse population go lame annually. Based on the above assumptions we calculate that there are approximately 500,000 new lame horses each year.

Treatments for Osteoarthritis

Despite the market size, veterinary clinics and hospitals have very few treatments and/or drugs for use in treating osteoarthritis, one of the most common inflammatory joint diseases in both dogs and horses. As there is no cure for osteoarthritis, the various treatment methods are focused on managing the related symptoms of pain and inflammation. Veterinarians recommend several treatments depending on the severity of the disease, including a combination of rest, weight loss, physical rehabilitation, and a regimen of pain and NSAIDs. Non-steroidal anti-inflammatory drugs (NSAIDs and hyaluronic (“HA”) injections in the joints) are used to alleviate the pain and inflammation caused by osteoarthritis.

NSAID’s are administered once or twice per day in a pill form. Many NSAID’s, including Rimadyl and Elanco’s Galliprant, present the potential for gastrointestinal, kidney and liver side effects in the animal and do not treat the underlying condition. Use of NSAID’s in dogs may have serious side effects in dogs that limit their long-term use and may require ongoing monitoring by veterinarians. Furthermore, NSAID’s do not halt or slow joint degeneration. In addition, the owner may need to pay for toxicity monitoring. We estimate the annual cost of treatment with NSAIDs to be from $350 to $700 (exclusive of toxicity monitoring which may be implemented).

Another palliative treatment for osteoarthritis is the injection of HA into the joint, which avoids risks of the side effects associated with NSAIDs. However, the HA injections are often slow-acting and/or short lasting. The duration of the treatment may be limited to thirty days or less. Generally, an animal will receive HA injections once a month at the vet. We estimate the cost to be from $150 to $250 per HA injection. On an annual basis, the cost is $1,800 to $3,000.

Joint replacement is a more extreme treatment and is limited to larger or specialty surgical veterinary practices. While both administration of Kush™ and HA injections may involve sedation of the animal, joint replacement involves invasive surgery and rehabilitation. As such there are risks of surgical complications and higher cost, which we estimate to be between $2,000 and $4,000.

There are other treatments which may have a more regenerative effect, including stem cell and platelet rich plasma therapy. These treatments require painful tissue harvesting and are time-sensitive, time-consuming and expensive. Furthermore, the long-term effects of these treatments are not well known at this time.

Use of Kush™ to Treat Osteoarthritis

Overview

Kush™ is veterinary device designed to help reinforce articular cartilage tissue for the treatment and prevention of osteoarthritis and other joint related afflictions in companion animals. Kush™ uses an intra-articular injection of non-dissolving, cartilage like patented particles to enhance the force cushioning function of the synovial fluid. No special training is required for the administration of Kush™ to treat osteoarthritis, degenerative disk disease or hip dysplasia. The veterinarian simply injects the material into the synovial joint space using standard intra-articular injection techniques. Many veterinarians, especially in canines, will choose to sedate the animal in connection with the injection. Multiple joints can be treated simultaneously. There are no special post-injection treatment requirements

The particles in Kush™ are comprised of collagen, elastin and heparin, the same components found in natural cartilage. These particles show an effectiveness to augment the cartilage and enhance the functionality of the joint (e.g. provide cushion or shock-absorbing features to the joint and to provide joint lubricity) based on experiences reported by our customers.

Once injected, the extent of bone-on-bone contact is lessened immediately, and results are typically seen within days. In-vivo studies indicate that Kush™ can easily be combined with synovial fluid in a rabbit knee to form a joint cushion, buffering the adjacent bones and cartilage; in this rabbit study it was shown that no damage was caused to the cartilage from replacing the synovial fluid. The particles show an effectiveness to augment the cartilage and enhance the functionality of the joint (e.g. provide cushion or shock-absorbing features to the joint and to provide joint lubricity).

Kush is the Superior Solution

We believe Kush™ is superior to existing treatments to safely improve joint function in companion animals for several reasons.

Address the Underlying Cause. Kush™ addresses the underlying cause of the pain and discomfort (not enough synovial fluid) with no known side effects. Kush provides a biocompatible lubricious cushion to the join, which establishes a barrier between the bones, thereby protecting the remaining cartilage and bone. Upon injection into the afflicted joint the spongy Kush™ gel-like substance provides long-lasting lubrication and cushioning which mimic the composition and protective function of the synovial membrane and cartilage (i.e., providing both a slippery cushion and healing scaffolding). Essentially, the injected particles function in a way that may protect the joint as an artificial cartilage. NSAID’s and HA mask the symptoms and do not treat the underlying condition.

Easy Delivery. Kush™ is easily administered with the standard intra-articular injection technique. Multiple joints can be treated simultaneously Veterinarians do not need any special training to make a Kush™ injection. There are no special post treatment requirements. In contrast, animals who receive NSAID’s must receive pills every day and may need to undergo toxicity monitoring. HA injections require follow up treatments every month.

No Known Side Effects. We are not aware of any adverse side effects when treating dogs or horses with Kush™. When dogs are treated with NSAID’s, there are many possible side effects including gastric, kidney or liver problems.

Superior Outcomes. Veterinarians have used Kush™ to treat osteoarthritis and lameness successfully in both dogs and horses for many years beginning in 2014. Case studies indicate long-lasting multi-month improvement in lameness. Furthermore, many animals have multi-year post treatment records.

Economic Solution. Kush is an effective and economical solution for treating OA. The cost for one treatment is $400 to $600 per joint. The cost for other treatments is generally higher, with less effective results.

Composition

Kush’s proprietary biomaterials simulate a body’s cellular tissue by virtue of their reliance upon natural protein compositions which incorporate such “tissue building blocks” as collagen, elastin and heparin. Since these are naturally-occurring in the body, we believe they have an enhanced biocompatibility with living tissues compared to synthetic biomaterials such as those based upon alpha-hydroxy polymers (PLA, PLGA and the like) and other “natural” biomaterials that may lack the multiple proteins incorporated into our biomaterials. These proprietary protein-based biomaterials appear to mimic the body’s tissue thus allowing integration and tissue repair in long-term implantation in certain applications.

Mechanism of Action

The Kush™ components self-assemble to form an insoluble matrix which is slippery, wet permeable, durable and resilient. The components mimic natural cartilage in composition, structure and hydration. These biocompatible particles are lubricious, “cushioning” and reside in joint synovial space. These spongy augmentation particles mimic the protective function of cartilage – providing both a slippery cushion and a protective barrier between bones. Kush™ augments the synovial membrane function, without pharmacologic, chemical or metabolic action.

Figure 1 - Kush Particles mimic cartilage

Use of Kush™ to Treat Lameness due to Navicular Disease and/or Digital Cushion Impairment

We believe Kush™ to be superior to existing treatments to safely treat lameness due to navicular disease and/or other deficiencies in the digital cushion of hoofed animals. Navicular syndrome, often called navicular disease, is a syndrome of lameness problems in horses. It most commonly describes an inflammation or degeneration of the navicular bone and its surrounding tissues, usually on the front feet. It can lead to significant and even disabling lameness. The digital cushion is a major component of the circulation and shock dissipation apparatus of the animal’s hoof. It is an elastic, wedge-shaped mass composed of fibrous fatty tissue located in the animal’s hoof that has varying consistencies depending on the animal’s health.

The structure of the hoof differs from species to species; however, the basic anatomy is very similar between species. Cattle, sheep, goats and pigs are cloven-footed animals while a horse has a single hoof at the end of each of its legs. The exterior of the hoof is a hard surface, structurally similar to the human fingernail, but functionally like human skin with the exterior being formed by the tissue directly beneath it. Underneath the hoof is a slightly softer area called the sole. Within the hoof are located bones that serve to shape the hoof and provide a supporting structure. The digital cushion is located above the sole and separated from it by the corium (which acts much like the quick of a human fingernail).

Horses may experience compression of the navicular bone, loss of cartilage and/or a reduction and/or compression of the digital cushion due to excessive walking, trotting or running over a short period of time and/or normal work over a longer period of time. Such use can cause the occurrence of Navicular Disease and/or other lameness that may be attributed to compression of the navicular bone, cartilage degeneration and/or a reduction in digital cushion thickness. Kush™ may be used to treat such afflictions by simply injecting Kush into the digital cushion to increase its thickness.

The images to the left and right are of cross sections of hoofs and display the location of the digital cushion.

Kush™ Manufacturing and Product Information

The Company manufactures Kush™ in a two-phased approach. In Phase One, the sterile Kush™ particles are produced by the Company. The Company uses a proprietary coacervation and particle production process. In Phase Two, the Company’s personnel or strategic partner will perform aseptic syringe filling, packaging, analytics and quality assurance of Kush™ particles for final sale and distribution.

Once produced, Kush™ is packaged in sterile syringes containing approximately 2 cc of the product and delivered to veterinary clinics and/or veterinarians in protective boxes. Kush™ is generally stored under room temperature (approximately 60° to 80° F) and has been shown to be stable in a 25-month stability study.

The Company is currently in the process of completing the build-out of its manufacturing facility located in suburban Minneapolis, Minnesota. The manufacturing facility is ISO 7 and ISO 8 certified with ISO 5 environments totaling approximately 500 square feet for the production of the Company’s Kush™ product. The Company anticipates completion of our facility and initial production of the Kush™ product in the third quarter of 2020 pending successful funding. The initial batch runs will be for 500 syringes and are planned to increase to runs of approximately 5,000 syringes in 12 months. The Company believes that this facility will handle capacity of approximately 500,000 units per year. Additionally, the Company may engage strategic partners to perform syringe filling, packaging, analytics and quality assurance prior to final sale and distribution.

Sales and Marketing

We are currently focusing on marketing Kush™ to veterinarians for use in the treatment of osteoarthritis in dogs and horses. We plan to commercialize Kush™ for use in the United States through use of in-house marketing personnel who will oversee the efforts of independent distributors we engage on a regional or national basis.

Most U.S. veterinarians buy a majority of their equipment and supplies from a preferred distributor. More than 75% of veterinarians name Covetrus, Patterson, MWI Animal Health (a division of AmerisourceBergen), Midwest Veterinary Supply, Inc. or Victor Medical Company as their preferred distributor. We believe, these top tier distributors sell a substantial majority by revenue, of the products sold to companion animal veterinarians in the U.S. Covetrus, Patterson and MWI are recognized by manufacturers, distributors and veterinarians as the pre-eminent national companion animal veterinary supply distributors in the US. There are no other distributors that provide equivalent levels of service to manufacturers and regularly visit veterinarians in as wide a geographic area as Covetrus, Patterson or MWI. Midwest and Victor are large, regional distributors, also with strong reputations for high-quality service.

We have developed a commercialization strategy, which provides for our (i) initial launch in key regional markets (Colorado, Minnesota and Texas) in the third and fourth quarter of fiscal 2020 (ii) developing alliances with 3 to 4 of the top national distributors in the first and second quarter of 2021 and (iii) a developing a full national roll-out to deliver our products to customers in the third quarter of 2021.

Our product distribution will leverage the existing supply chain, veterinary clinic and clinician relationships already established by these large distributors. We intend to support and supplement this distribution channel with regional business development & training representatives. Our business development staff will provide product training to distribution representatives, veterinarians and other veterinary staff. In addition, we will exhibit at key veterinary conferences in addition to supporting ongoing case studies. All of these sales, distribution, marketing and education efforts will also be supported by both veterinarian and pet owner product education and treatment awareness campaigns that will be conducted utilizing a variety of advertising and social media tools. The unique nature and the anticipated benefits provided by our initial Kush™ products are expected to generate significant consumer response.

Particle Devices

Orthopedic Joint Treatments

Kush is a treatment for joint pain, which is made of injected, protein-based, gel-like particles. In vivo studies indicate that the gel particle device can easily be combined with synovial fluid in a rabbit knee to form a joint cushion, buffering the adjacent bones/cartilage where no damage was caused to the cartilage from replacing the synovial fluid. The particles show an effectiveness to repair, reconstitute or remodel the tissue, cartilage, ligaments and/or bone and/or enhance the functionality of the joint (e.g. repair deteriorated components present in the joint to provide cushion or shock-absorbing features to the joint and to provide joint lubricity).

AppTec Laboratories accomplished a gel-particle rabbit study in which six New Zealand white rabbits were injected in both stifle joints (knees) to fill but not extend the synovial space (~0.5 cc GDP/site). Rabbits were tested every other day for abnormal clinical signs including range of motion and joint observations until sacrifice. Behavioral testing revealed no abnormal scores for range of motion, withdrawal response, or joint observations (all animals were 100% normal). At one week and at four weeks the animals were sacrificed. AppTec pathologists evaluated knee joint histology. The reported cartilage surfaces of the femoral and tibia condyles and the menisci were grossly and histologically 100% normal for all animals and test sites.

Clinical Studies

The particle devices for joint injections have been extensively studied for a broad range of applications including the treatment of wrinkles as dermal filler. Described below is an overview of the pre-clinical and clinical studies completed for CosmetaLife, which is the name used for the particle device when it was used as a dermal filler.

Particle Integration after 12 Weeks

Particle Integration after 12 Weeks The image at left shows collagen in blue, fibroblasts in red and CosmetaLife in gray. Note the typical cellularization and integration of collagen within the CosmetaLife matrix perimeter. Also notice the fibroblasts (collagen producers) are integrated throughout the injection site. Microvascularization, indicated by arrowheads, is also present in several locations. There is little to no sign of inflammation. Trichrome Stain - 20x Objective

CosmetaLife Particles

CosmetaLife is an easy-to-inject, water-protein-based dermal filler that not only fills nasolabial wrinkle depressions but also helps rejuvenate the dermal tissues, counteracting damage that causes wrinkles. The dermal cells are attracted to the CosmetaLife gel-particles, attach to them, and then slowly replace them with natural dermal material (extracellular matrix). The natural biological replacement process of CosmetaLife to collagen is estimated to take 6 to 12 months. CosmetaLife clinical trial on nasolabial folds supports this estimate.

CosmetaLife injections allow the body to create more natural dermal structure in and around every particle. Enhancing the natural process of dermal tissue construction with CosmetaLife allows for long-term dermal contouring, corrections, and rejuvenation with little to no adverse side effects noted in clinical trials.

Particle Device Clinical Studies

The Company has conducted several biocompatibility animal studies. In the implantation study, no abnormal clinical signs were noted for any of the rabbits. The results of the sensitization study in guinea pigs showed a sensitization response equivalent to the negative controls. The results of the histological report on the rabbit skin biopsies clearly demonstrate structural integration of the particles into the host tissues by week 12. Evaluators observed the particle material integration with normal tissue, remodeled and/or new collagen, and fibroblasts throughout the injected particles, mild to no inflammation, and new collagen-matrix production.

An FDA/IDE approved pivotal human clinical trial began with CosmetaLife late in 2006. The clinical trial was a randomized, double-blind, parallel assignment, multi-center comparison of the safety and efficacy of CosmetaLife versus Restylane® (Control) for the correction of nasolabial folds. One hundred seventy-one patients were skin tested and 145 were treated at six trial sites. The number of study exits after treatment totaled four subjects. This clinical trial was reported and published at www.clinicaltrials.gov (NCT00414544).

The feedback from physician investigators has been positive with respect to CosmetaLife injection qualities, cosmetic appearance, and its feel to the touch. During the first three to four months of the study, CosmetaLife showed no decrease in efficacy, as compared to Restylane that showed an 11 percent decrease in efficacy. The FDA/IDE approved human clinical trial for the CosmetaLife product through twelve months was found to be the same as compared to control hyaluronic acid product, Restylane (for each interval the consensus of the blinded subjects tested preferred CosmetaLife or showed no preference at 3, 6, 9 and 12 months).

CosmetaLife particles, shown in figure to the left, were photographed from a light microscope under high magnification and immersed in a saline solution to help disperse them for better viewing. These particles are approximately 100 microns in size (0.1 mm in diameter).

We use existing, scalable processes to reduce the infrastructure requirements and manufacturing risks to deliver a consistent, high-quality product while being responsive to volume requirements.

Particles Safety Study

Patients injected with CosmetaLife were found to have no or mild inflammatory, irritation, or immunogenic responses. These results suggest the particles are biocompatible because it closely matches the skin structure, composition, and moisture content. The no-to-low immunogenic responses are attributed to the tight cross-linking of the CosmetaLife matrix, which prevents immunogenic progenitor cells from producing antibodies to the matrix.

In the clinical trial, the incidence of possible reaction to a skin test was 2.55 percent, with only one subject showing a reaction to a second test or 0.6%, (1 out of 171). We also have a study report by AppTec, Inc., our Contract Research Organization, that indicates CosmetaLife did not produce an antibody response during the clinical trial further supporting our belief that it is safe to use. CosmetaLife is composed of materials that approximately meet the Generally Regarded As Safe (“GRAS”) requirements of the FDA. CosmetaLife contains materials from certified bovine and porcine tissue sources that do not harbor prion disease or BSE. Additionally, steps in the manufacturing process have been validated for deactivating viruses.

Extrusion force testing and the Clinical Trial usage both demonstrate the consistent and easy injection of CosmetaLife. Twenty-five month stability testing shows that CosmetaLife is stable at room temperature conditions. Moreover, CosmetaLife has been shown to be stable at 40 °C (104 °F) conditions for at least 3 months.

Muco-Adhesion Technology Overview

Our muco-adhesion technology is an active agent delivery platform that is based on an eroding mucoadhesive protein matrix, is well patented and uses only materials that satisfy the FD’s GRAS requirements. In wafer form, it sticks very strongly and comfortably to buccal mucosal tissue, which covers the roof of mouth, cheeks and gums. Other active agent delivery applications include particle and pill forms for nasal and oral routes. The fabrication steps are reproducible and economical, including an aqueous active agent solution and protein mixture to form a dried protein matrix from which mucoadhesive particles are made at any exact active agent dose (milligrams to nanograms), and then pill pressed into wafers.

Wafer eroding characteristics are quite adjustable (up to 15 minutes before the wafer dissolves), allowing drug to release and absorb into mucosal tissue and the blood stream, thereby avoiding alimentary canal deactivation and first pass liver elimination. Since our muco-adhesion particles contain exact doses of homogenously and reversibly bound active agent as protein-encased molecules, their nasal applications work well by controlling active agent delivery and irritation in the sinus passages, allowing for active agent penetration into the brain via olfactory bulb transport paths. Alternatively, our buccal wafers instantly attach to buccal mucosa tissue and the roof of the mouth, soften from mucus wetting absorption and dissolve at the mucosal surface to release active agent into the mucus membrane. The protein matrix tastes good and can include substances to mask active agent taste and enhance active agent tissue absorption.

In clinical tests, our wafers were used for buccal delivery of the peptide drug, desmopressin, which were reportedly about 10 times more effective in inhibiting urination urge than a swallowed pill. Moreover, these wafers can be very effective in the veterinary market, especially because of their strong non-friable ability to bind mucosal tissue so strongly that while it dissolves away completely it cannot be removed by the animal’s tongue.

Since this novel delivery technology allows for very low doses, reduces active agent irritation, enhances bioavailability, and can use alimentary canal sensitive active agents, it expands the ability to develop active agents (e.g., highly potent actives, neuropeptides, others).

Exclusive License Agreement

On July 31, 2019, the Company entered into an exclusive license agreement with Emerald Organic Products, Inc. (“Emerald”; OTCPink: EMOR) whereby we licensed our muco-adhesion technology for use of cannabidiol (“CBD”), caffeine, and citicoline in the human nutraceutical market. Emerald touts a strong management team with a pedigree in commercializing products within the human nutraceutical market. It is our belief that Emerald is a great partner for us because of their expertise in commercializing similar product to our muco-adhesion technologies and their relationships established within distribution channels we believe can generate significant licensing revenues to us if utilized effectively.

CBD Market

The CBD Market is projected to reach $20 billion with a compound annual growth rate of 49% by 2024². We believe our muco-adhesion technology is positioned uniquely to capture a significant portion of this market as it is projected to continually grow over the next several years. However, a major problem in the CBD industry is that CBD has exceptionally poor bioavailability, as low as 3%, because like other cannabinoids, it is not readily soluble in water and it faces extensive first-pass metabolism in the liver before it reaches circulation. An efficacious dose of CBD oil is upward of 5 milligrams per kilogram of body weight taken via tincture, which is s approximately a 500 milligram dose for a 220-pound person. In addition, as currently marketed, a typical 30-day supply of tinctured CBD is 500 milligrams at a price of approximately $60. This price becomes uneconomical for end users as they are typically spending $60 or more on a product that needs to be over 15-times stronger for an average 160-pound person to become efficacious. Since our product touts up to a 10-times increase in bioavailability of active agents, we believe that we have an advantage over other delivery methods in the CBD market and will become the premier CBD product in the market.

Muco-Adhesive Device Manufacturing

Most other biomaterials have difficulty incorporating low quantities of drugs homogeneously because all prior techniques require dry powder mixing. For example, one microgram of active drug in a 100 mg pill requires a mixing ratio of one gram of powder into 100,000 grams of powder, which cannot be reliably accomplished homogeneously. However, unique fabrication techniques will allow our muco-adhesion material to homogeneously distribute any drug in small or large quantities, resulting in what we believe will be optimum performance from an active-delivery standpoint and little to no risk of inhomogeneous dosages.

² BDS Analytics and Arcview Market Research press release dated May 9, 2019 at https://bdsa.com/u-s-cbd-market-anticipated-to-reach-20-billion-in-sales-by-2024/#:~:text=BDS%20Analytics’%20predicts%20US%20sales,annual%20growth%20rate%20of%2049%25.&text=CBD%20consumers%20are%20an%20average,to%20be%20employed%20full%20time

Our muco-adhesion technology uses only safe materials (FDA-GRAS). The fabrication steps are reproducible and economical, including an aqueous drug solution and protein mixture that we use to form a dried protein matrix from which mucoadhesive particles are made at any exact drug dose (milligrams to nanograms), and then pill pressed into wafers.

Competition

The development and commercialization of new animal health medicines and treatments is highly competitive, and we expect considerable competition from major pharmaceutical, biotechnology and specialty animal health medicines companies. As a result, there are, and likely will continue to be, extensive research and substantial financial resources invested in the discovery and development of new animal health medicines.

Our potential competitors include large animal health companies, such as Zoetis, Inc. Merck Animal Health (the animal health division of Merck & Co., Inc.), Merial (the animal health division of Sanofi S.A.), Elanco (the animal health division of Eli Lilly and Company), Bayer Animal Health (the animal health division of Bayer AG), NAH (the animal health division of Novartis AG), Boehringer Ingelheim Animal Health (the animal health division of Boehringer Ingelheim GmbH), Virbac Group, Ceva Animal Health, Vetoquinol and Dechra Pharmaceuticals PLC. We are also aware of several smaller, early-stage animal health companies, such as Kindred Bio, Aratana Therapeutics Inc., Parnell, Veterinary Sciences Inc., Luitpold Pharmaceuticals, NextVet and VetDC that are developing products for use in the pet therapeutics market.

The current standard for treatment of osteoarthritis is use of NSAIDs. NSAIDs may cause gastral tract bleeding and kidney damage. Another pitfall of NSAIDs treatment is the lack of pet-owner compliance when administering the treatment. Treatment of osteoarthritis using the Kush^TM has no known negative side effects, bypasses pet-owner compliance issues, and has shown increased duration of lameness improvement.

Intellectual Property

Our intellectual property portfolio is comprised of patents, patent applications, trademarks and trade secrets. We have one U.S. trademark application pending (for Kush™), nine issued United States Patents with an additional two U.S. patent applications currently being examined. In addition to our U.S. patent portfolio, we also have one EU trademark, nine non-U.S. patents issued or granted and one non-U.S. patent application currently pending in key markets around the world, including Australia (1), Canada (4), Germany (1), Europe (1), France (2) and Great Britain (1).

We believe we have developed a broad and deep patent portfolio around our biomaterials and manufacturing processes in addition to the application of these biomaterials for use as medical devices and pharmaceutical delivery devices. The Company relies on trade secret law to secure and protect other technological know-how and also possesses one trademark protected pursuant to trademark common law.

United States Patents:

To maximize the strength and value of our patent portfolio many of the claims use the transitional term “comprising”, which is synonymous with “including,” This use of transitional language is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Our patents also include method claims covering many of the applications and uses of the biomaterials as medical devices and drug delivery systems. With 10 issued or allowed United States Patents that contain over 300 claims, our intellectual property portfolio strongly protects our proprietary technology, including the composition of raw elements used to produce our formulations, the fabricated biomaterials and their application in end products, thereby making our material and devices much more attractive to industry partners.

We protect our products and technologies through a combination of patents, and proprietary know-how. Our goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods and other proprietary technologies, preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the United States and in other countries. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our current products and any future products in development. We also strenuously protect our proprietary information and proprietary technology through a combination of contractual arrangements, trade secrets and patents, both in the United States and abroad. However, even patent protection may not always afford us with complete protection against competitors who seek to circumvent our patents.

We depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our advisors, consultants and other contractors. To help protect our proprietary know-how which may not be patentable, or for which patents may be difficult to obtain or enforce, we rely on trade secret protection and confidentiality agreements. We generally require all of our employees, consultants, advisors and other contractors to enter into confidentiality agreements that prohibit disclosure of confidential information and, where applicable, require disclosure and assignment of ownership to us any of the ideas, developments, discoveries and inventions important to our business.

Government Regulation – Medical Device Veterinary Use

The FDA provides a general exception to the requirement of pre-market approval for the use of medical devices in veterinary medicine. Our Kush™ product has already been classified and referred to as a medical device in past correspondence issued by the FDA. Accordingly, we believe the veterinary application of this medical device, Kush™, falls under this FDA exception, which allows us to commercialize our Kush products without obtaining prior regulatory approval.

Government Regulation – Veterinary and/or Human Use

A number of the formulations and medical devices that we manufacture for veterinary applications, and plan to manufacture for human applications, are subject to regulation by numerous regulatory bodies, including the FDA and comparable international regulatory agencies. These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of medical devices. Medical devices are generally subject to varying levels of regulatory control, the most comprehensive of which requires that a clinical evaluation program be conducted before a device receives approval for commercial distribution.

In the EU, medical devices are required to comply with the Medical Devices Directive and obtain CE Mark certification in order to market medical devices. The CE Mark certification, granted following approval from an independent Notified Body, is an international symbol of adherence to quality assurance standards and compliance with applicable European Medical Devices Directives. Distributors of medical devices may also be required to comply with other foreign regulations such as Ministry of Health Labor and Welfare approval in Japan. The time required to obtain these foreign approvals to market our products may be longer or shorter than that required in the U.S., and requirements for those approvals may differ from those required by the FDA. In Europe, our devices are classified as Class IIa or IIb, and will need to conform to the Medical Devices Directive.

In the U.S., specific permission from the FDA to distribute a new device is usually required (that is, other than in the case of very low risk devices), and we expect that some form of marketing authorization will be necessary for our devices. Marketing authorization is generally sought and obtained in one of two ways. The first process requires that a pre-market notification (510(k) Submission) be made to the FDA to demonstrate that the device is as safe and effective as, or “substantially equivalent” to, a legally-marketed device that is not subject to pre-market approval (“PMA”). A legally-marketed device is a device that (i) was legally marketed prior to May 28, 1976, (ii) has been reclassified from Class III to Class II or I, or (iii) has been found to be substantially equivalent to another legally-marketed device following a 510(k) Submission. The legally-marketed device to which equivalence is drawn is known as the “predicate” device. Applicants must submit descriptive data and, when necessary, performance data to establish that the device is substantially equivalent to a predicate device. In some instances, data from human clinical studies must also be submitted in support of a 510(k) Submission. If so, these data must be collected in a manner that conforms with specific requirements in accordance with federal regulations including the Investigational Device Exemption (IDE) and human subjects protections or “Good Clinical Practice” regulations. After the 510(k) application is submitted, the applicant cannot market the device unless FDA issues “510(k) clearance” deeming the device substantially equivalent. After an applicant has obtained clearance, the changes to existing devices covered by a 510(k) Submission which do not significantly affect safety or effectiveness can generally be made without additional 510(k) Submissions, but evaluation of whether a new 510(k) is needed is a complex regulatory issue, and changes must be evaluated on an ongoing basis to determine whether a proposed change triggers the need for a new 510(k), or even PMA. The 510(k) clearance pathway is not available for all devices: whether it is a suitable path to market depends on several factors, including regulatory classifications, the intended use of the device, and technical and risk-related issues for the device.

The second, more rigorous, process requires that an application for PMA be made to the FDA to demonstrate that the device is safe and effective for its intended use as manufactured. This approval process applies to most Class III devices. A PMA submission includes data regarding design, materials, bench and animal testing, and human clinical data for the medical device. Again, clinical trials are subject to extensive FDA regulation. Following completion of clinical trials and submission of a PMA, the FDA will authorize commercial distribution if it determines there is reasonable assurance that the medical device is safe and effective for its intended purpose. This determination is based on the benefit outweighing the risk for the population intended to be treated with the device. This process is much more detailed, time-consuming, and expensive than the 510(k) process. Also, FDA may impose a variety of conditions on the approval of a PMA.

Both before and after a device for the U.S. market is commercially released, we would have ongoing responsibilities under FDA regulations. The FDA reviews design and manufacturing practices, labeling and record keeping, and manufacturers’ required reports of adverse experiences and other information to identify potential problems with marketed medical devices. We would also be subject to periodic inspection by the FDA for compliance with the FDA’s quality system regulations, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, and servicing of all finished medical devices intended for human use. In addition, the FDA and other U.S. regulatory bodies (including the Federal Trade Commission, the Office of the Inspector General of the Department of Health and Human Services, the Department of Justice (DOJ), and various state Attorneys General) monitor the manner in which we promote and advertise our products. Although physicians are permitted to use their medical judgment to employ medical devices for indications other than those cleared or approved by the FDA, we are prohibited from promoting products for such “off-label” uses and can only market our products for cleared or approved uses. If the FDA were to conclude that we are not in compliance with applicable laws or regulations, or that any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could require us to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health, order a recall, repair, replacement, or refund of such devices, detain or seize adulterated or misbranded medical devices, or ban such medical devices. The FDA may also impose operating restrictions, enjoin and/or restrain certain conduct resulting in violations of applicable law pertaining to medical devices, including a hold on approving new devices until issues are resolved to its satisfaction, and assess civil or criminal penalties against our officers, employees, or us. The FDA may also recommend prosecution to the DOJ. Conduct giving rise to civil or criminal penalties may also form the basis for private civil litigation by third-party payers or other persons allegedly harmed by our conduct.

The delivery of our devices in the U.S. market would be subject to regulation by the U.S. Department of Health and Human Services and comparable state agencies responsible for reimbursement and regulation of health care items and services. U.S. laws and regulations are imposed primarily in connection with the Medicare and Medicaid programs, as well as the government’s interest in regulating the quality and cost of health care.

Federal health care laws apply when we or customers submit claims for items or services that are reimbursed under Medicare, Medicaid, or other federally-funded health care programs. The principal federal laws include: (1) the False Claims Act which prohibits the submission of false or otherwise improper claims for payment to a federally-funded health care program; (2) the Anti-Kickback Statute which prohibits offers to pay or receive remuneration of any kind for the purpose of inducing or rewarding referrals of items or services reimbursable by a Federal health care program; (3) the Stark law which prohibits physicians from referring Medicare or Medicaid patients to a provider that bills these programs for the provision of certain designated health services if the physician (or a member of the physician’s immediate family) has a financial relationship with that provider; and (4) health care fraud statutes that prohibit false statements and improper claims to any third-party payer. There are often similar state false claims, anti-kickback, and anti-self-referral and insurance laws that apply to state-funded Medicaid and other health care programs and private third-party payers. In addition, the U.S. Foreign Corrupt Practices Act can be used to prosecute companies in the U.S. for arrangements with physicians, or other parties outside the U.S. if the physician or party is a government official of another country and the arrangement violates the law of that country.

The laws applicable to us are subject to change, and subject to evolving interpretations. If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and our officers and employees could be subject to severe criminal and civil penalties including substantial fines and damages, and exclusion from participation as a supplier of product to beneficiaries covered by Medicare or Medicaid.

The process of obtaining clearance to market products is costly and time-consuming in virtually all of the major markets in which we expect to sell products and may delay the marketing and sale of our products. Countries around the world have recently adopted more stringent regulatory requirements, which are expected to add to the delays and uncertainties associated with new product releases, as well as the clinical and regulatory costs of supporting those releases. No assurance can be given that any of our other medical devices will be approved on a timely basis, if at all. In addition, regulations regarding the development, manufacture and sale of medical devices are subject to future change. We cannot predict what impact, if any, those changes might have on our business. Failure to comply with regulatory requirements could have a material adverse effect on our business, financial condition and results of operations.

Exported devices are subject to the regulatory requirements of each country to which the device is exported. Some countries do not have medical device regulations, but in most foreign countries medical devices are regulated. Frequently, medical device companies may choose to seek and obtain regulatory approval of a device in a foreign country prior to application in the U.S. given the differing regulatory requirements. However, this does not ensure approval of a device in the U.S.

Research and Development

The Company is currently pursuing advancements in the composition, methods of manufacture and use for its proprietary biomaterials. It is anticipated that within the next twelve months the Company will pursue additional third-party studies related to the use of Kush™ for the treatment of osteoarthritis in canine and equine patients. The Company also anticipates that resources will be expended to advance and improve the manufacturing systems for Kush™ that will increase product volume and overall efficiency. Finally, the Company anticipates that research and testing will be conducted in the next eighteen months involving the existing Kush™ formulation and other variations to identify and determine the next commercial product(s) that may be administered to the digital cushion of horses for the treatment of navicular disease.

We intend to use a portion of the net proceeds from the offering to expand and scale our manufacturing capabilities to fill larger quantity orders should they be placed. We anticipate expending approximately $800,000 to engage independent studies of the use of our products in dogs and horses. We have had discussions with several universities that have veterinary studies in their curriculum regarding conducting such studies for us.

Employees and Services Performed by our Independent Contractors

We currently have two employees, consisting of our CEO and CFO, and have contracted with two independent contractors, who serve as our General Counsel and Director of Science and Technology. Our CEO is a full-time employee and our CFO is currently a part-time employee. With the proceeds received from this offering, we have identified and plan to add additional staff including a Director of Manufacturing, a Director of Quality Assurance and Studies, an Office Administrator, a Business Development Director and two manufacturing technicians.

We also engage outside consultants to assist with research and development, clinical development and regulatory matters, business development, operations and other functions from time to time.

Insurance

We currently maintain a “life science” commercial insurance policy with coverage in the amount of $1 million for our products and operations. The policy has been designed for those engaged in the life science business. We may face claims in excess of the limits of such insurance. As well, claims made against us may fall outside of our coverage. The policy is a “claims made” policy. Thus, our coverage must be maintained at the time a claim is made for us to be entitled to seek coverage from the issuer of the policy for such claims.

Corporate History and Structure

In 1999, Dr. David Masters, a biochemist, formed Gel-Del to pursue the development of biomaterials that could be used in connection with implantable therapeutic medical devices and treatments. Gel-Del’s efforts were principally funded by grants received from various federal governmental agencies. In connection with those efforts, Dr. Masters obtained United States Patents for methods of production and use of biomaterials that were assigned to Gel-Del. In August 2013, Gel-Del entered into a licensing agreement with PetVivo, Inc., a Minnesota Corporation (“PetVivo MN”) which had then been recently formed by John Lai and John Dolan to pursue the development and/or licensing of biomedical technology for application in the veterinary medicine markets.

The Company was incorporated in 2009 in Nevada under a former name and pursued a business unrelated to our current operations. In March 2014 the Company entered into a share exchange agreement with PetVivo MN and the five shareholders of PetVivo MN, whereby we acquired all of the common stock of PetVivo MN, resulting in PetVivo MN becoming our wholly-owned subsidiary, in exchange for the issuance to the shareholders of PetVivo MN of 4,159,692 shares of our common stock, as adjusted for a reverse stock split soon after this merger. In 2014 we changed our name to PetVivo Holdings, Inc., and our common stock’s trading symbol was changed to “PETV”.

In November 2014, the Boards of Directors of the Company and Gel-Del approved the terms of an agreement providing for a merger of the Company and Gel-Del. The merger was subject to approval by shareholders of both companies. The Gel-Del shareholders approved the merger in March 2015 and our shareholders approved it in April 2015; however, the required documents to effect the merger were not filed with the offices of the Secretary of State for Nevada or Minnesota. As we deemed ourselves to then be in control of Gel-Del, we combined its operations with ours and began to include its financial operating results in our financial statements as a “variable interest entity” where an investor has a controlling interest in a company, that is not based on ownership of a controlling equity interest.

Primarily due to an elongated delay to close the merger and a substantial decline in the prices for our shares, we found it necessary to adjust the terms of the original agreement between Gel-Del and the Company to complete the merger. In order provide compensation for such a delay and decline in our share price, in early 2017, we agreed to provide to the Gel-Del shareholders a larger number of our shares than was required in the initial merger agreement. The prior agreement was terminated and we entered into a new agreement among the Company, a newly established subsidiary of the Company and Gel-Del providing for Gel-Del to merge into that subsidiary with our issuing 4,905,000 shares upon the merger, then representing approximately 30% of our then outstanding shares. The shares were issued on the effective date for the Merger, which was April 10, 2017.

DESCRIPTION OF PROPERTIES

We rent our Edina, Minnesota office in suburban Minneapolis under the provisions of Regulation S promulgated pursuanta long-term lease. Our executive, administrative and operating offices are located at 5251 Edina Industrial Blvd., Edina, Minnesota 55439. We believe that our facility is adequate for our needs and that additional suitable space will be available on acceptable terms as required.

LEGAL PROCEEDINGS

From time to time, the Company is involved in various legal claims and actions arising in the ordinary course of business. While from time to time, claims are asserted that act.

MANAGEMENT

Board of Directors and Executive Officers

Our executive officers are appointed by and serve at the discretion of our board of directors. The following table includes the names, ages and positions held by our executive officers and directors as of September 30, 2020:

Each of our directors will be elected at our annual meeting of stockholders and hold office until the next annual meeting of stockholders, or until a successor is elected and qualified. If any director resigns, dies or is otherwise unable to serve out the director’s term, or if the Board increases the number of directors, the Board may fill the vacancy by the vote of a majority of the directors then in office. A director elected to fill a vacancy shall serve for the unexpired term of such director’s predecessor.

John Lai. Mr. Lai has been a director and senior executive officer since March 2014, serving in various capacities that include Principal Financial Officer, President and CEO; and serving as our Chief Executive Officer from March 2014 to May 2017 and June 2019 to present. From March 2012 to April 2016, Mr. Lai also was Chief Executive Officer and a director of Blue Earth Resources, Inc., a small public company which acquired and managed working interests in producing oil and gas leases in Louisiana. Mr. Lai has over thirty years of senior executive and operational management and financial experience while holding key executive positions with several public companies in various industries. In 1992, Mr. Lai founded, and until December 2012 was the principal owner and President of Genesis Capital Group, Inc., which provided significant consulting services to many public and private companies in powersports, technology and other industries, while advising its clients in corporate development, mergers and acquisitions, and private and public capital-raising through equity offerings. Mr. Lai’s role as a co-founder of the company and his many years of experience as a chief executive officer of many public or private companies are material factors regarding his qualifications to serve on our Board of Directors.

John Carruth. Mr. Carruth joined our Company as our Controller in April 2018, was promoted to serve as our Acting Chief Financial Officer in December 2018 and has served as our Chief Financial Officer since July 2019. He has spent several years in the accounting field with continually-progressing responsibilities. His areas of expertise include internal controls over financial reporting, SEC reporting, and GAAP compliance. He holds three degrees in accounting, including a Master of Accountancy degree from the University of Minnesota. Since April of 2020 he has provided services to Granicus, LLC as an Accounting Manager specializing in accounting systems administration and acquisitions for approximately 5 hours per week. He has previously been employed at Merrill Corporation, where he worked on SEC reporting from May 2015 until September 2015, at Prime Therapeutics from September 2015 to March 2016, where he worked on special projects; and most recently, from March 2016 until April 2018 at Supervalu focusing on GAAP compliance and emerging and special projects.

John F. Dolan. Mr. Dolan has been a director since March 2014, and he served as our Chief Financial Officer from March 2014 to November 2017. Since March 2013, Mr. Dolan also has served as corporate and intellectual property counsel for KILO, Inc. and TerraCOH, Inc., both alternative energy companies. Mr. Dolan has also served as general counsel for Traust IP Finance, LLC since June, 2019. From June 2000 to July 2012, Mr. Dolan was a shareholder in the intellectual property group of the Minneapolis law firm of Fredrikson & Byron, where he specialized in securing and protecting domestic and foreign patent and other IP rights for various clients including biomaterials technology and products. During the periodpast five years, Mr. Dolan also has provided consulting services to several early stage companies on all aspects of IP asset protection as well as new technology and corporate development. His extensive career in the intellectual property field includes serving as a patent examiner with the U.S. Patent and Trademark Office. Mr. Dolan’s role as a cofounder of the Company and his extensive experience in intellectual property, mergers and acquisitions, private equity, corporate governance and general corporate law are material factors which demonstrate his qualifications to serve on our Board of Directors.

Gregory Cash. Mr. Cash has served as a director of the Company since July 2019. He has more than 35 years senior management and/or key sales and marketing executive experience in the life sciences industry, including being Chief Executive Officer or Division President of publicly traded and privately held cardiovascular medical device companies. Since 2011, he has been the Chief Executive Officer and principal owner of Argent International LLC, Minneapolis, MN, a consulting firm he founded to provide management, marketing and financial consulting services to start-up and established companies in the life sciences industry. Prior to founding Argent, Mr. Cash served for over thirty years in senior executive management or marketing roles with leading medical device companies, including five years with Boston Scientific Corporation and over fourteen years with Medtronic, Incorporated. His many industry achievements also feature extensive and high-level overseas experience including being Chief Executive Officer or a senior marketing executive of both start-up and established international medical device companies in European countries including The United Kingdom, France and Italy, as well as serving for several years as the Marketing Manager in Asia for all Medtronic product lines. Mr. Cash’s many years of experience as an executive in the medical device industry are material factors regarding his qualification to serve on our Board of Directors.

James Martin. Mr. Martin has served as a director of the Company since July 2019. He is a retired Certified Public Accountant (“CPA”) and attorney whose career included his responsibility as Partner in Charge of KPMG’s tax practice for its Newport Beach, California office. In that role he provided and oversaw the rendition of tax services for numerous clients in varied industries including those for which KPMG provided a certified audit. He retains his AICPA membership and holds Accounting and Law Degrees from the University of Washington and, on a Fellowship, received a Master of Laws Degree from New York University. Mr. Martin’s extensive accounting expertise is a material factor which demonstrate his qualifications to serve on our Board of Directors.

Scott Johnson. Mr. Johnson has served as a director of the Company since July 2019. He is a licensed professional engineer with over 30 years experience providing life science engineering leadership, risk management, production engineering, quality control, auditing, and FDA compliance for numerous manufacturers. Since 2012 he has been the Chief Executive Officer and principal owner of Stratego, Inc., a life sciences consulting corporation he founded. Significant engagements of Stratego include risk management services for defibrillator products at Philips Healthcare, risk management and quality audit services for combination products at Hospira, a subsidiary of Pfizer and Baxter, quality remediation management for implantable medical devices at St. Jude Medical, a product regulatory roadmap for Varuna Biomedical and engineering PMA submissions content at Zimmer Biomet –Biologics. Mr. Johnson’s lengthy past employment and consulting include five years of employment with SciMed Life Systems, five years systems engineering, testing and compliance for PumpWorks, and being FDA compliance project manager at Boston Scientific. His engineering projects for the production of medical devices include substantial domestic and foreign facility experience. Mr. Johnson’s many years of experience as an executive in the life science industries and expertise with medical product design and regulatory issues are material factors which demonstrate his qualifications to serve on our Board of Directors.

David B. Masters, Ph.D. Dr. Masters has been a director since April 2015, and he served as our Chief Technical Officer from April 2015 to December 2017. Dr. Masters is the founder of and served as Chief Executive Officer and Chief Technology Officer of Gel-Del Technologies, Inc., from 1999 to December 2017, while for Gel-Del he developed and obtained significant patents for the proprietary biomaterial technology and product applications acquired by us from Gel-Del. Dr. Masters is recognized internationally as a leading expert in biomaterials and local drug delivery, and over the past twenty years he has developed and obtained patents for many novel biomaterials and drug delivery products, including implantable medical devices for neurologic, vascular, orthopedic, urologic and dermal applications. Dr. Masters’ former academic career included teaching courses and doing significant research at Harvard Medical School and The Mayo Clinic. He received a B.A. Degree in Biochemistry, a Master’s Degree in Chemistry, and a Ph.D. in Behavioral and Neural Sciences from Rutgers University. Dr. Master’s role as the founder of Gel-Del and his long professional career in developing and obtaining patents for many biomaterials and drug delivery products are material factors regarding his qualifications to serve on our Board of Directors.

Randall A. Meyer. Mr. Meyer has been a director since April 2015, and he served as our Chief Operating Officer from April 2015 to November 2017. From January 2009 to April 2015, Mr. Meyer served as Chief Operating Officer of Gel-Del Technologies, Inc. while being in charge of all operational and marketing activities of Gel-Del. Prior to joining Gel-Del, Mr. Meyer’s substantial medical device industry management experience included being Chief Operating Officer of Softscope Medical Technologies, Inc. and being Chief Executive Officer of Tactile Systems Technology, Inc. Mr. Meyer’s role as the senior operational officer of Gel-Del for many years and his long experience as an executive officer of several companies in the medical device industry are material factors regarding his qualifications to serve on our Board of Directors.

David Deming. Mr. Deming has been a director of the Company since September 2017. Mr. Deming has over 35 years of institutional investment management experience with pensions, endowments, family offices and high net worth investors in roles. He is currently serving as the Chief Investment Officer of Business Brokers Investment Company, a main street business brokerage firm, which he joined in January 2020. He served for over 19 years as the Director of Business Development at Arbor Capital Management, LLC from January 1997 until October 2016. Subsequent thereto, he served as the Director of Marketing and Investor Relations at BCCM Advisors, an alternative investment platform, from August 2018 to March 2020 and as the Director of Business Development, Chief Compliance Officer and Partner at Asymmetric Capital Management from October 2016 until August 2018. Prior thereto, he held positions with brokerage and trading firms, including, Merrill Lynch, Paine Webber and Leuthold Weeden Capital Management and was a floor trader at the Chicago Board of Trade. Mr. Deming’s extensive experience in the finance industry is a material factor which demonstrates his qualifications to serve on our Board of Directors.

Robert Rudelius. Mr. Rudelius has been a director of the Company since August 2018. Currently, he is the Chief Executive Officer and Managing Director of Noble Ventures, LLC, a company he founded in 2001 that provides advisory and consulting services to early and mid-stage companies in the information technology, communications, medical technology and social e-commerce industries. He is also the co-founder, President & CEO of MedicaMetrix, Inc., a company that is building a commercialization engine that will launch a stream of medical devices aimed at delivering transformative healthcare solutions for unmet medical needs. From April 1999 through May 2001, when it was acquired by StarNet L.P., Mr. Rudelius was the founder and CEO of Media DVX, Inc., a start-up business that provided a satellite-based, IP-multicasting alternative to transmitting television commercials via analog videotapes to television stations, networks and cable television operators throughout North America. From April 1998 to April 1999, Mr. Rudelius was the President and Chief Operating Officer of Control Data Systems, Inc., during which time Mr. Rudelius reorganized and re-positioned the software company as a professional technology services company, resulting in the successful sale of the company to British Telecom. From October 1995 through April 1998, Mr. Rudelius was the founding Managing Partner of AT&T Solutions, Inc., a subsidiary of AT&T Inc. (NYSE: T) and headed the Media, Entertainment & Communications industry practice. From January 1990 through September 1995, Mr. Rudelius was a partner in McKinsey & Company’s information, technology and systems practice, during which time he headed the practice in Japan and the United Kingdom. Mr. Rudelius began his career at Arthur Andersen & Co. where he was a leader in the firm’s financial accounting systems consulting practice. Mr. Rudelius served as a member of the Axogen, Inc. (NASDAQ: AXGN) Board of Directors for ten years from September 2010 through September 30, 2020, where he served on the audit committee and as a member of the compensation committee. Mr. Rudelius has an M.B.A. from the Kellogg School of Management at Northwestern University and a B.S. in mathematics and economics from Gustavus Adolphus College in St. Peter, Minnesota. Mr. Rudelius’ qualifications to serve on our Board of Directors include his extensive executive leadership and financial experience, particularly in connection with rapid growth technology businesses, and his experience as a director of publicly traded companies.

Joseph Jasper. Mr. Jasper has been a director of the Company since August 20, 2018. He is a CFA who since 2005 has been Chief Executive Officer of Vermillion Capital Management, an institutional investment firm. From 2002 to 2005, Mr. Jasper was Managing Director and Director of Fixed Income Strategy and Marketing for Piper Jaffray Company. Prior to 2002, he spent 20 years managing, structuring and selling fixed income and equity securities at several leading investment banking firms, including U.S. Bancorp Libra and UBS PaineWebber. Mr. Jasper also serves as Vice Chairman of the Board of Directors of MicroNet, Inc. and as a director of GroundCloud, Inc. both privately-held companies. He has previously served as a director or principal advisor to many operating and venture-stage companies across a broad range of industries. Mr. Jasper received a MBA degree from the University of St. Thomas, where he also has served as its Adjunct Professor of Finance. Mr. Jasper’s extensive financing and accounting expertise are material factors which demonstrate his qualifications to serve on our Board of Directors

Family Relationships

There are no family relationships between any of our executive officers and directors.

Board of Directors

Each of our directors will be elected at our annual meeting of stockholders and hold office until the next annual meeting of stockholders, or until a successor is elected and qualified. If any director resigns, dies or is otherwise unable to serve out the director’s term, or if the Board increases the number of directors, the Board may fill the vacancy by the vote of a majority of the directors then in office. A director elected to fill a vacancy shall serve for the unexpired term of such director’s predecessor.

Director Independence

We have applied to have our common stock and warrants listed on the Exchange, subject to notice of issuance under the trading symbols “PETV” and “PETVW,” respectively. The Exchange Listing Rules require that independent directors compose a majority of a listed company’s board of directors within one year of listing. In addition, the Exchange Listing Rules require that, subject to specified exceptions, each member of a listed company’s audit, compensation, and nominating and corporate governance committees be independent and that audit committee members also satisfy independence criteria set forth in Rule 10A-3 under the Exchange Act of 1934. Under the Exchange Listing Rules, a director will only qualify as an “independent director” if, in the opinion of our board of directors, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In order to be considered independent for purposes of Rule 10A-3 under the Exchange Act, a member of an audit committee of a listed company may not, other than in his or her capacity as a member of the audit committee, the board of directors, or any other board committee: (1) accept, directly or indirectly, any consulting, advisory, or other compensatory fee from the listed company or any of its subsidiaries; or (2) be an affiliated person of the listed company or any of its subsidiaries.

In addition members of the compensation committee must satisfy additional independence requirements set forth in the Exchange Listing Rules. In order to be considered independent for purposes of the Exchange Listing Rules, a member of a compensation committee of a listed company may not, other than in his or her capacity as a member of the compensation committee, the board of directors, or any other board committee, accept, directly or indirectly any consulting, advisory, or other compensatory fee from the listed company or any of its subsidiaries. Additionally, the board of directors of the listed company must consider whether the compensation committee member is an affiliated person of the listed company or any of its subsidiaries and if so, must determine whether such affiliation would impair the director’s judgment as a member of the compensation committee.

In July 2020, our board of directors undertook a review of its composition, the composition of its committees and the independence of each director. Based upon information requested from and provided by each director concerning his background, employment and affiliations, including family relationships, our board of directors determined that Messrs. Cash, Deming, Johnson, Jasper and Martin do not have any relationships that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and that each is considered an “independent” director as that term is defined under the applicable SEC rules and the Exchange Listing Rules. In making those determinations, our board of directors considered the current and prior relationships that each non-employee director has with our Company and all other facts and circumstances our board of directors deemed relevant in determining their independence, including the beneficial ownership of our capital stock by each non-employee director.

Committees of the Board of Directors

We have an Audit Committee, Compensation Committee, and Nominating Committee. Our Audit Committee consists of three independent directors who are David Deming, James Martin and Joseph Jasper, with Mr. Martin considered as an “audit committee financial expert” within the meaning of Regulation S-K of the SEC. Our Compensation Committee consists of three independent directors who are David Deming, Scott Johnson and Robert Rudelius. Our Nominating Committee consists of two independent directors who are Joseph Jasper and Robert Rudelius.

Code of Ethics

We have adopted a Code of Ethics which applies to our board of directors, executive officers and other employees. Our Code of Ethics outlines the broad principles of ethical business conduct we have adopted, including subject areas such as confidentiality, conflicts of interest, corporate opportunities, public disclosure reporting, protection of company assets, and compliance with applicable laws. A copy of our Code of Ethics is available without charge to any person by written request to us at our principal offices at 5251 Edina Industrial Blvd., Edina, MN 55439.

EXECUTIVE AND DIRECTOR COMPENSATION

The following is a discussion and analysis of the compensation arrangements for our named executive officers, or NEOs. For fiscal 2020 and 2019, our named executive officers were John Lai, our Chief Executive Officer and President, John Carruth, our Chief Financial Officer, John F. Dolan, our General Counsel and Secretary.

Summary Compensation Table

The following table sets forth information regarding the compensation paid to or earned by our named executive officers for the fiscal years ended DecemberMarch 31, 2010, we sold 34,650,0002019 and 2020.

In February of 2020, the Company issued John Lai 61,396 shares of common stock in exchange for $103,950, or $0.003 per share. The shares were issued in a transaction which we believe satisfies the requirements of that exemption from the registration and prospectus delivery requirements of the Securities Act of 1933, as amended, which exemption is specified by the provisions of Regulation S promulgated pursuant to that act.

Outstanding Equity Awards at a valueFiscal Year-End

The table below provides information regarding unexercised option and warrants awards held by each of $7,500 or $0.003 per share. The shares were issued in a transaction which we believe satisfiesour named executive officers as of our fiscal year-end, March 31, 2020. All share amounts and exercise prices reflect the requirements of that certain exemption from the registration and prospectus delivery requirementseffect of the Securities Actreverse split of 1933, as amended, which exemption is specifiedour common stock effected on ______________.

2020 Equity Incentive Plan

The PetVivo Holdings, Inc. 2020 Equity Incentive Plan (“Plan”) was adopted by the provisionsBoard of Section 4(2)Directors on July 10, 2020 and approved by our stockholders on September 22, 2020 The Plan permits the following types of that act.

Executive and Consultant Employment and Consulting Agreements

John Lai

On October 1, 2019, we entered into employment agreement with John Lai to permitserve as our Chief Executive Officer for a term of three years to expire on September 30, 2022. This agreement may be terminated by the resaleCompany without cause at any time upon 10 days’ notice or for Cause (as defined in Mr. Lai’s employment agreement). Mr. Lai’s annual base salary is a minimum of $100,000 or such higher annual salary, if approved by the Board. The Board may elect to pay Mr. Lai’s salary in cash or warrants to purchase shares of the Company’s common stock at 125% of the cash value calculated using the volume weight average price of the Company’s common stock in the last week of the quarter that the base salary is accrued but that conversion rate shall never be less than $0.35 per share. Mr. Lai is eligible to receive discretionary bonuses, as determined by the Board and is eligible for all employee benefits provided to executives of similar tenure.

On October 31, 2019, Mr. Lai was granted a warrant to purchase up to 540,000 shares of our common stock at an exercise price of $.56 per share. The warrants have a five-year term and 360,000 warrants vest quarterly over a three-year term and 180,000 warrants vest based on certain performance conditions; 90,000 of which vest if the Company completes a successful listing on the Exchange and sustaining a stock price of at least $4.00 for the thirty consecutive days of trading. Mr. Lai’s employment agreement contains customary confidentiality and non-competition provisions which survive for a period of one year after his employment with the Company is terminated.

During fiscal 2020, Mr. Lai received an aggregate grant of 177,490 warrants exercisable at prices ranging from $0.32 to $0.49 per share in lieu of his salary. These warrants expire five years after their respective grant date. In June 2020, he received a grant of 90,000 warrants exercisable at a price of $0.35 per share that will vest if the Company completes a successful listing on the Exchange and sustaining a stock price of at least $4.00 for the thirty consecutive days of trading. In June 2020, My Lai also received a warrant for 29,762 shares of common stock, vested immediately, at a price of $0.40 per share in lieu of his salary.

John Carruth

On October 1, 2019, we entered into an employment agreement with John Carruth to serve as our Chief Financial Officer for a term of three years, to expire on September 30, 2022. This agreement may be terminated by the selling shareholders, fromCompany at any time upon 10 days’ notice or for Cause (as defined in Mr. Carruth’s employment agreement). Under this agreement, Mr. Carruth’s annual base salary is a minimum of $100,000 or such higher annual salary, approved by the Board. The Board may elect to time afterpay Mr. Carruth’s salary in cash or warrants to purchase shares of the Company’s common stock at exercise price of $0.35 per share. Mr. Carruth is eligible to receive discretionary bonuses, as determined by the Board and is eligible for all employee benefits provided to executives of similar tenure.

On October 1, 2019, Mr. Carruth was granted a warrant to purchase up to 360,000 shares of our common stock at an exercise price of $0.56 per share. These warrants have a five-year term and vest quarterly over a three-year term. He also received a warrant to purchase up to 90,000 shares of the Company’s common stock at an exercise price of $0.56 per share that vest upon certain milestones, which includes vesting of 45,000 shares upon the Company’s filing and approval of an S-1 registration statement by the SEC and (ii) 45,000 shares on the date of completion of a successful uplisting to the Exchange or similar national exchange. Mr. Carruth’s employment agreement contains customary confidentiality and non-competition provisions which survive for a period of one year after his employment with the Company is terminated.

We amended our employment agreement with Mr. Carruth pursuant to an amendment (“Amendment”) dated June 15, 2020, with an effective date of April 14, 2020 to provide that Mr. Carruth’s employment would be part-time and to reduce his salary to a maximum of $33,000 per year. All other terms of the employment agreement remain the same.

John Dolan

We entered into an independent contractor agreement with John Dolan, our General Counsel and Secretary on November 20, 2019. This agreement has a term of three years and is set to expire on September 30, 2022. Mr. Dolan will receive compensation at the rate of $3,000 per month for the performance of general counsel services, which shall be provided for approximately 25% of his normal monthly time allocated to such services. The Company may pay the monthly compensation at its discretion in cash or warrants for common at 125% of the cash value calculated by using the volume weighted average price of the Company’s common stock in the last week of the quarter that compensation is accrued.

In connection with this prospectus.  agreement, Mr. Dolan received a warrant to purchase 220,500 shares of the Company’s common stock at an exercise price of $0.56 per share, of which 40,500 vested immediately, 90,000 warrants vest upon achieving certain performance milestones and 90,000 vest in equal installments of 7,500 warrants each quarter over the three years ended September 30, 2022. All of these 220,500 warrants expire on October 31, 2024.

In fiscal 2020, the Company did not pay any cash consulting fees to Mr. Dolan and paid Mr. Dolan’s consulting fee with the grant of an aggregate of 51,194 warrants at exercise prices of $0.32 to $0.49 per share. These warrants expire between December 31, 2024 and March 31, 2025.

Potential Payments Upon Termination of Employment or Change-in-Control

Termination and Change-in-Control Agreements or Arrangements

We willdo not have any contracts, agreements, or arrangements with any of our named executive officers providing for additional benefits or payments in connection with a termination of employment, change in job responsibility, or change-in-control. Upon termination of employment for any reason, all unvested restricted stock units expire.

Change in Control Provisions of the 2020 Plan

Subject to the terms of the applicable award agreement or an individual agreement between the Company and a participant, upon a change in control, the Board may, in its discretion, determine whether some or all outstanding options shall become exercisable in full or in part, whether the restriction period and performance period applicable to some or all outstanding restricted stock awards and restricted stock units, shall lapse in full or in part, and whether the performance measures applicable to some or all outstanding awards shall be deemed to be satisfied. The Board may further require that shares of stock of the Company resulting from such a change in control, thereof, be substituted for some or all of our shares of common stock subject to an outstanding award and that any outstanding awards, in whole or in part, be surrendered to us by the holder, to be immediately cancelled by us, in exchange for a cash payment, shares of capital stock of the corporation resulting from or succeeding us, or a combination of both cash and such shares of stock.

Director Compensation

Directors who are also executive officers do not receive any compensation regarding their role as a director. Currently, our policy for non-executive director compensation is as follows: i) independent directors receive a grant of 100,000 warrants to purchase shares of our common stock at the exercise price on the date of grant for a term of with a 5-year term for each 2 years of service, ii) directors who serve on committees are compensated in cash or warrants, at the Company’s discretion, at various pre-set amounts for different levels of service ranging from $1,500 to $5,000 per year per director. We also have a clawback provision which provides that if a director quits or is terminated for service prior to the end of the proceeds fromfiscal year, all warrant issued to that director are automatically cancelled.

The following table provides information on compensation paid to our current independent directors for their services as members of our board of directors during our fiscal year ended March 31, 2020:

Each of our three newly elected directors, Messrs. Johnson, Cash and Martin, were issued warrants with five-year terms to purchase 90,000 shares of our common stock in consideration for their agreements to serve as a director, which warrants are fully vested, exercisable at $0.33 per share, and include a cashless exercise provision, and each of these three directors also received similar warrants to serve as a director for a second year with the sale byexception that the selling shareholderssecond year warrants vest at a rate of such11,250 shares quarterly provided they continue to serve as a director.

Each of the independent directors, in consideration of their service as members of our Board of Directors, has been issued warrants for the purchase of 90,000 shares of our common stock. We will bear all fees and expenses incidentThe dollar value in the table above for warrant awards to independent directors for the fiscal year ended March 31, 2020 reflects valuations using the Black-Scholes model of grants that occurred during the fiscal year ended March 31, 2020. The amounts disclosed were determined in accordance with ASC Topic 718.

Securities authorized for issuance under equity compensation plans.

The following table sets forth securities authorized for issuance under any equity compensation plan approved by our obligation to register these sharesstockholders as well as any equity compensation plans not approved by our stockholders as of common stock.

PRINCIPAL SHAREHOLDERS

As of September 30, 2020 (the “Record Date”), we had 24,876,189 shares of our common stock under Rule 144 underissued and outstanding. The following table sets forth, as of the Securities Act, if available, rather than under this prospectus.

As used in this section, the term “beneficial ownership” with respect to whom they may sell as principal (which discounts, concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types of transactions involved).