PART II AND III

THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION (“SEC”) DOES NOT PASS UPON THE MERITS OF OR GIVE ITS APPROVAL TO ANY SECURITIES OFFERED OR THE TERMS OF THE OFFERING, NOR DOES IT PASS UPON THE ACCURACY OR COMPLETENESS OF ANY OFFERING CIRCULAR OR OTHER SELLING LITERATURE. THESE SECURITIES ARE OFFERED PURSUANT TO AN EXEMPTION FROM REGISTRATION WITH THE COMMISSION; HOWEVER, THE COMMISSION HAS NOT MADE AN INDEPENDENT DETERMINATION THAT THIS INVESTMENT INVOLVES A DEGREE OF RISK THAT MAY NOT BE SUITABLE FOR ALL PERSONS. ONLY THOSE INVESTORS WHO CAN BEAR THE LOSS OF A SIGNIFICANT PORTION OF THEIR INVESTMENT SHOULD PARTICIPATE IN THE INVESTMENT. (SEE “RISK FACTORS” BELOW.)

AN OFFERING STATEMENT PURSUANT TO REGULATION A RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION CONTAINED IN THIS PRELIMINARY OFFERING CIRCULAR IS SUBJECT TO COMPLETION OR AMENDMENT. THESE SECURITIES MAY NOT BE SOLD NOR MAY OFFERS TO BUY BE ACCEPTED BEFORE THE OFFERING STATEMENT FILED WITH THE COMMISSION IS QUALIFIED. THIS PRELIMINARY OFFERING CIRCULAR SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY NOR MAY THERE BE ANY SALES OF THESE SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL BEFORE REGISTRATION OR QUALIFICATION UNDER THE LAWS OF ANY SUCH STATE. THE COMPANY MAY ELECT TO SATISFY ITS OBLIGATION TO DELIVER A FINAL OFFERING CIRCULAR BY SENDING YOU A NOTICE WITHIN TWO BUSINESS DAYS AFTER THE COMPLETION OF THE SALE THAT CONTAINS THE URL WHERE THE FINAL OFFERING CIRCULAR OR THE OFFERING STATEMENT IN WHICH SUCH FINAL OFFERING CIRCULAR WAS FILED MAY BE OBTAINED.

THE SECURITIES OFFERED HAVE NOT BEEN APPROVED OR DISAPPROVED BY ANY STATE REGULATORY AUTHORITY NOR HAS ANY STATE REGULATORY AUTHORITY PASSED UPON OR ENDORSED THE MERITS OF THE OFFERING OR THE ACCURACY OR ADEQUACY OF THIS OFFERING CIRCULAR. ANY REPRESENTATION TO THE CONTRARY IS UNLAWFUL.

Preliminary Offering Circular

For

Medical 21, Inc.

A Minnesota Corporation

March 10, 2022

SECURITIES OFFERED : Equity in the form of Shares of common stock

PRICE PER SHARE : $5.80 per Share of Common Stock

MAXIMUM OFFERING AMOUNT : $40,000,000.00

MINIMUM OFFERING AMOUNT : Not Applicable (No Minimum Offering Amount)

MINIMUM INVESTMENT : $116.00

CONTACT INFORMATION :

Medical 21, Inc.

15070 23^rd Avenue North

Minneapolis, MN 55447

(952) 221-3104

Generally, no sale may be made to you in this Offering if the aggregate purchase price you pay is more than ten (10%) percent of the greater of your annual income or net worth. Different rules apply to accredited investors and non-natural persons. Before making any representation that your investment does not exceed applicable thresholds, Investors are encouraged to review rule 251(d)(2)(i)(C) of Regulation A. For general information on investing, Investors are encouraged to refer to www.investor.gov.

Medical 21, Inc. (the “Company” or “Medical 21” or the “Issuer”) is a Minnesota corporation, originally formed on February 12, 2016 by filing Articles of Incorporation with the Secretary of the State of Minnesota. (see Exhibit 2 “Articles of Amendment to Articles of Incorporation of Medical 21, Inc.”). The Company is offering (the “Offering”) by means of this offering circular (the “Offering Circular”) Company equity in the form of common stock denominated in shares (the “Shares”) on a “best efforts” and ongoing basis to investors who meet the Investor Suitability standards as set forth herein. (See “Investor Suitability” below.) The Company will offer Shares through medical21.com (“Platform”), and through Rialto Markets, a FINRA-registered broker-dealer entitled to commissions upon the sale of the Shares. (See the “Terms of the Offering” below.) Persons who purchase Shares will be shareholders of the Company (“Shareholders” or “Investors”). The Company intends to use the Proceeds of this Offering (“Proceeds”) to research, develop, test, and manufacture an artificial, nitinol-supported thin wall tubular graft, the MAVERICS Graft (the “Graft”) for use in heart bypass CABG surgeries.

The minimum investment amount per Investor is One Hundred Sixteen dollars ($116.00), representing Twenty (20) Shares at Five Dollars and Eighty Cents ($5.80) per Share. Although the Company does not intend to list the Shares for trading on any exchange or other trading market, the Company has adopted a redemption plan designed to provide Investors with limited liquidity for their investment in the Company. (See “Description of the Securities” below)

The Company is a run by a board of directors, comprised of one (1) director (the “Board” collectively, “Director” when referring to a director). The day-to-day management and investment decisions of the Company are vested in the Board and in the Officer. The Board is advised by an Advisory Board, comprised of various industry leader and vocational experts. The Company intends to use the Proceeds of this Offering to (1) commence and execute human clinical trials of the MAVERICS Graft; (2) obtain regulatory approval from national health agencies in key global markets; (3) increase the Company’s capacity for manufacturing of the MAVERICS Graft; (4) expand the marketing and sales activities of the Company.

Sales of the Shares pursuant to the Offering will commence immediately upon qualification of the Offering by the Securities and Exchange Commission (the “Effective Date”) and will terminate at the discretion of the Board or twelve (12) months following the Effective Date, whichever is earlier. The maximum amount of the Offering shall not exceed Forty Million Dollars ($40,000,000) in any twelve (12) month period (“Maximum Offering Amount”) in accordance with Tier II of Regulation A as set forth under the Securities Act of 1933, as amended, (“Reg A Tier II” or “Tier II”). The Company intends to offer the Shares described herein on a continuous and ongoing basis pursuant to Rule 251(d)(3)(i)(f). Further, the acceptance of Investor subscriptions, may be briefly paused at times to allow the Company to effectively and accurately process and settle subscriptions that have been received. (See “Terms of the Offering” below.) The Company may increase the Maximum Offering Amount at its sole and absolute discretion, subject to qualification by the SEC of a post-qualification amendment.

Prior to this Offering, there has been no public market for the Shares, and none is expected to develop. The Offering price is arbitrary and does not bear any relationship to the value of the assets of the Company. The Company does not currently have plans to list any Shares on any securities market, however it reserves the right to do so in the future. Investing in the Company through the purchase of Shares involves risks, some of which are set forth below. See the section titled “Risk Factors” to read about the factors an Investor should consider prior to purchasing Shares.

Investors who purchase Shares will become Shareholders of the Company (“Investors” or “Shareholders” subject to the terms of the Articles of Incorporation and the Bylaws of the Company (see Exhibit 2, the “Articles of Amendment to Articles of Incorporation of Medical 21, Inc.”) once the Company deposits the Investor’s investment into the Company’s main operating account.

The Officers will receive compensation from the Company as employees. (See “Risk Factors”, “Compensation of Directors and Officers” below.) Investing in the Shares is speculative and involves substantial risks, including risk of complete loss. Prospective Investors should purchase these securities only if they can afford a complete loss of their investment. (See “Risk Factors” below starting on Page 4.)

As of the date of this Offering Circular, the Company has engaged KoreConX as transfer agent in relation to this Offering.

NO PERSON HAS BEEN AUTHORIZED IN CONNECTION WITH THIS OFFERING TO GIVE ANY INFORMATION OR TO MAKE ANY REPRESENTATIONS OTHER THAN THAT INFORMATION AND THOSE REPRESENTATIONS SPECIFICALLY CONTAINED IN THIS OFFERING CIRCULAR; ANY OTHER INFORMATION OR REPRESENTATIONS SHOULD NOT BE RELIED UPON. ANY PROSPECTIVE PURCHASER OF THE SECURITIES WHO RECEIVES ANY OTHER INFORMATION OR REPRESENTATIONS SHOULD CONTACT THE COMPANY IMMEDIATELY TO DETERMINE THE ACCURACY OF SUCH INFORMATION AND REPRESENTATIONS. NEITHER THE DELIVERY OF THIS OFFERING CIRCULAR NOR ANY SALES HEREUNDER SHALL, UNDER ANY CIRCUMSTANCES, CREATE AN IMPLICATION THAT THERE HAS BEEN NO CHANGE IN THE AFFAIRS OF THE COMPANY OR IN THE INFORMATION SET FORTH HEREIN SINCE THE DATE OF THIS OFFERING CIRCULAR SET FORTH ABOVE.

THE INFORMATION CONTAINED IN THIS OFFERING CIRCULAR HAS BEEN SUPPLIED BY THE COMPANY. THIS OFFERING CIRCULAR CONTAINS SUMMARIES OF DOCUMENTS NOT CONTAINED IN THIS OFFERING CIRCULAR, BUT ALL SUCH SUMMARIES ARE QUALIFIED IN THEIR ENTIRETY BY REFERENCES TO THE ACTUAL DOCUMENTS. COPIES OF DOCUMENTS REFERRED TO IN THIS OFFERING CIRCULAR, BUT NOT INCLUDED AS AN EXHIBIT, WILL BE MADE AVAILABLE TO QUALIFIED PROSPECTIVE INVESTORS UPON REQUEST.

RULE 251(D)(3)(I)(F) DISCLOSURE. RULE 251(D)(3)(I)((F) PERMITS REGULATION A OFFERINGS TO CONDUCT ONGOING CONTINUOUS OFFERINGS OF SECURITIES FOR MORE THAN THIRTY (30) DAYS AFTER THE QUALIFICATION DATE IF: (1) THE OFFERING WILL COMMENCE WITHIN TWO (2) DAYS AFTER THE QUALIFICATION DATE; (2) THE OFFERING WILL BE MADE ON A CONTINUOUS AND ONGOING BASIS FOR A PERIOD THAT MAY BE IN EXCESS OF THIRTY (30) DAYS OF THE INITIAL QUALIFICATION DATE; (3) THE OFFERING WILL BE IN AN AMOUNT THAT, AT THE TIME THE OFFERING CIRCULAR IS QUALIFIED, IS REASONABLY EXPECTED TO BE OFFERED AND SOLD WITHIN ONE (1) YEARS FROM THE INITIAL QUALIFICATION DATE; AND (4) THE SECURITIES MAY BE OFFERED AND SOLD ONLY IF NOT MORE THAN THREE (3) YEARS HAVE ELAPSED SINCE THE INITIAL QUALIFICATION DATE OF THE OFFERING, UNLESS A NEW OFFERING CIRCULAR IS SUBMITTED AND FILED BY THE COMPANY PURSUANT TO RULE 251(D) (3)(I)((F) WITH THE SEC COVERING THE REMAINING SECURITIES OFFERED UNDER THE PREVIOUS OFFERING; THEN THE SECURITIES MAY CONTINUE TO BE OFFERED AND SOLD UNTIL THE EARLIER OF THE QUALIFICATION DATE OF THE NEW OFFERING CIRCULAR OR THE ONE HUNDRED EIGHTY (180) CALENDAR DAYS AFTER THE THIRD ANNIVERSARY OF THE INITIAL QUALIFICATION DATE OF THE PRIOR OFFERING CIRCULAR. THE COMPANY INTENDS TO OFFER THE SHARES DESCRIBED HEREIN ON A CONTINUOUS AND ONGOING BASIS PURSUANT TO RULE 251(D)(3)(I)(F). THE COMPANY INTENDS TO COMMENCE THE OFFERING IMMEDIATELY AND NO LATER THAN TWO (2) DAYS FROM THE INITIAL QUALIFICATION DATE. THE COMPANY REASONABLY EXPECTS TO OFFER AND SELL THE SECURITIES STATED IN THIS OFFERING CIRCULAR WITHIN ONE (1) YEAR FROM THE INITIAL QUALIFICATION DATE.

The Company will commence sales of the Shares immediately upon qualification of the Offering by the SEC. The Company approximates sales will commence at during Q2 - 2022

	Price to Public*		Commissions**		Proceeds to the Company
Amount to be Raised per Share	$	5.80	$	0.174	$	5.626
Minimum Investment Amount	$	116	$	3.48	$	112.52
Minimum Offering Amount		N/A		N/A		N/A
Maximum Offering Amount	$	40,000,000	$	1,200,000	$	38,000,000

*The Offering price to Investors was arbitrarily determined by the Board.

** The Company is not using an underwriter for the sale of Shares. These commissions listed are those for Rialto Markets, a FINRA broker-dealer. Rialto Markets is entitled to 3% on all sales of securities as placement agent. If securities are sold through the efforts of Rialto Markets an additional 8% will be due to Rialto Markets up to a maximum of $800,000. The commissions due to Rialto Markets are conditional on the services provided by Rialto Markets with respect to any one sale. See “Plan of Distribution “ below.

FORWARD LOOKING STATEMENTS

Investors should not rely on forward-looking statements because they are inherently uncertain. Investors should not rely on forward-looking statements in this Offering Circular. This Offering Circular contains forward-looking statements that involve risks and uncertainties. The use of words such as “anticipated”, “projected”, “forecasted”, “estimated”, “prospective”, “believes”, “expects,” “plans”, “future”, “intends”, “should”, “can”, “could”, “might”, “potential”, “continue”, “may”, “will”, and similar expressions identify these forward-looking statements. Investors should not place undue reliance on these forward-looking statements, which may apply only as of the date of this Offering Circular.

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TABLE OF CONTENTS

	PAGE
SUMMARY OF THE OFFERING	3
RISK FACTORS	4
DILUTION	5
PLAN OF DISTRIBUTION	5
USE OF PROCEEDS	6
DESCRIPTION OF THE BUSINESS	7
DESCRIPTION OF PROPERTY	9
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION	9
DIRECTORS, OFFICERS, SIGNIFICANT EMPLOYEES	10
COMPENSATION OF DIRECTORS/OFFICERS	11
SECURITY OWNERSHIP OF MANAGEMENT AND CERTAIN SECURITY HOLDERS	11
INTEREST OF MANAGEMENT AND CERTAIN OTHER TRANSACTIONS	12
DESCRIPTION OF THE SECURITIES	12
PART F/S	13
EXHIBIT INDEX	21
SIGNATURE PAGE	22

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SUMMARY OF THE OFFERING

The following information is only a brief summary of, and is qualified in its entirety by, the detailed information appearing elsewhere in this Offering. This Offering Circular, together with the exhibits attached including, but not limited to, the Articles of Amendment to Articles of Incorporation of Medical 21, Inc., a copy of which are attached hereto as Exhibit 2, and should be carefully read in their entirety before any investment decision is made. If there is a conflict between the terms contained in this Offering Circular and these documents, Articles of Incorporation and Bylaws shall prevail and control, and no Investor should rely on any reference herein to the Articles of Incorporation or Bylaws without consulting the actual underlying documents.

COMPANY INFORMATION AND BUSINESS	Medical 21, Inc. is a Minnesota corporation with a principal place of business located at 15070 23rd Avenue North, Minneapolis, MN 55447.
MANAGEMENT	The Company is managed by a Board of Directors. The Board is comprised of one (1) Director, Dr. Manny Villafaña, Ph.D.Sc., the founder, an owner, and the Chief Executive Officer of the Company.
THE OFFERING	This Offering is the second capital raise by the Company in its history. The Company has previously raised money under Rule 506(c) of Regulation D. The Company is selling Company equity in the form of Common Stock (the “Common Stock” or the “Shares”) through this Offering. The Company will use the Proceeds of this Offering to scale up its operations. See “Use of Proceeds” below
SECURITIES BEING OFFERED	The Shares are being offered at a purchase price of $5.80 per Share. The Minimum Offering Amount for any Investor is $116.00. Upon purchase of the Shares, a Shareholder is granted (i) the right to vote on all matters subject to a Common Stock vote; and (ii) the right to receive dividends or disbursements, when the Board declares such dividends or disbursements. For a complete summary of the rights granted to Shareholders, see “Description of the Securities” below.
COMPENSATION TO DIRECTORS	The Company pays Dr. Manny Villafaña, Ph.D.Sc. a salary for his role as Director and Officer. For more information on his compensation, see “Compensation of the Directors and Officers” section below. The Director, Officers, and employees of the Company will not be compensated through commissions for the sale of the Shares through this Offering.
PRIOR EXPERIENCE OF COMPANY MANAGEMENT	Dr. Manny Villafaña, Ph.D.Sc., Founder, Director, and CEO, has extensive experience as a business manager, financier and entrepreneur. Dr. Manny Villafaña, Ph.D.Sc. has founded many companies including Cardiac Pacemakers, Inc., St. Jude Medical, Inc., ATS Medical, Inc., and Kips Bay Medical, Inc. For a complete description of his background, see “Directors, Officers, Significant Employees” below.
INVESTOR SUITABILITY STANDARDS	The Shares will not be sold to any person unless they are a “Qualified Purchaser”. A Qualified Purchaser includes: (1) an “Accredited Investor” as that term is defined in Rule 501(a) of Regulation D promulgated under the Securities Act of 1933 (the “Securities Act”); or (2) all other Investors who meet the investment limitations set forth in Rule 251(d)(2)(C) of Regulation A. Such persons as stated in (2) above must conform with the “Limitations on Investment Amount” as described in the next below.   Each person acquiring Shares may be required to represent that he, she, or it is purchasing the Shares for his, her, or its own account for investment purposes and not with a view to resell or distribute the securities.   Each prospective purchaser of Shares may be required to furnish such information or certification as the Company may require determining whether any person or entity purchasing Shares is an Accredited Investor if such is claimed by the Investor.
LIMITATIONS ON INVESTMENT AMOUNT	For Qualified Purchasers who are Accredited Investors, there is no limitation as to the amount invested through the purchase of Shares. For non-Accredited Investors, the aggregate purchase price paid to the Company for the purchase of the Shares cannot be more than 10% of the greater of the purchaser’s (1) annual income or net worth if purchaser is a natural person; or (2) revenue or net assets for the purchaser’s most recently completed fiscal year if purchaser is a non-natural person.   Different rules apply to Accredited Investors and non-natural persons. Each Investor should review to review Rule 251(d)(2)(i)(C) of Regulation A before purchasing the Shares.
COMMISSIONS FOR SELLING Shares	The Shares will be offered and sold directly by the Company, the Board, the Officers, and Company’s employees. No commissions for selling the Shares will be paid to the Company, the Board, the Officer, or the Company’s employees.   The Company has engaged Rialto Markets, a registered independent FINRA broker-dealer, as placement agent for this Offering. Rialto Markets is entitled to 3% on all sales of securities as placement agent. If securities are sold through the efforts of Rialto Markets an additional 8% will be due to Rialto Markets up to a maximum of $800,000. The commissions due to Rialto Markets are conditional on the services provided by Rialto Markets with respect to any one sale. See “Plan of Distribution “ below.
NO LIQUIDITY	There is no public market for the Shares, and none is expected to develop in the near future. Additionally, the Shares will be transferable, in accordance with Minnesota law. However, the shares will not be listed for trading on any exchange or automated quotation system. (See “Description of the Securities” below.) Prospective Investors are urged to consult their own legal advisors with respect to secondary trading of the Shares. (See “Risk Factors” below.)
SELLING SECURITYHOLDERS	There are no selling security holders in this Offering.
COMPANY EXPENSES	Except as otherwise provided herein, the Company shall bear all costs and expenses associated with the Offering, the operation of the Company, including, but not limited to, the annual tax preparation of the Company's tax returns, any state and federal income tax due, accounting fees, filing fees, independent audit reports, costs and expenses associated with the acquisition, rehabilitation, holding and management of real estate and costs and expenses associated with the disposition of real estate or other Company assets.

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RISK FACTORS

The SEC requires the Company to identify risks that are specific to its business and its financial condition. The Company is still subject to all the same risks that all companies in its business, and all companies in the economy, are exposed to. These include risks relating to economic downturns, political and economic events and technological developments (such as hacking and the ability to prevent hacking). Additionally, early-stage companies are inherently riskier than more developed companies. You should consider general risks as well as specific risks when deciding whether to invest.

RISKS RELATED TO THE COMPANY AND ITS BUSINESS

The Company is brand new and has no operating history.

The Company has no established business operations, and it is unclear at this point which, if any, of the Company’s current and intended plans may come into fruition and, if they do, which ones will be a success. The Company has incurred a net loss and has recorded no revenues since inception. There is no assurance that the Company will ever be able to establish successful business operations, become profitable or generate sufficient revenues to operate business or pay dividends.

The Company may not be able to develop a commercially viable Graft on the timetable they anticipate, or at all.

The Company’s Graft may be difficult to scale to a commercially viable level since it must meet expectations that it is equivalent or superior to traditional cardiac grafts in terms of efficacy, safety, and cost efficiency. The Company still needs to develop and refine the Graft and the Graft manufacturing process to ensure that the product meets performance goals and cost targets. The Company needs to perform additional laboratory and clinical trials and may encounter problems and delays. If the clinical trials reveal technical defects or reveal that the Company’s products do not meet performance goals and cost targets, the Company’s commercialization schedule could be delayed as the Company attempts to devise solutions to the defects or problems. If the Company is unable to find solutions, the Company’s business may not be viable.

The Company may not be able to successfully execute the business plan.

In addition to the requirement to successfully develop the Graft’s technology for commercial success, the Company must also raise significant amounts of capital, foster relationships with key suppliers and attract customers. There is no guarantee that the Company will be able to achieve or sustain any of the foregoing within the anticipated timeframe or at all – even though the Company’s principals are long-time industry professionals, who have been working for decades building relationship in the cardiac surgery industry. The Company may exceed the budget, encounter obstacles in research and development activities, or be hindered or delayed in implementing the Company’s commercialization plans, any of which could imperil the Company’s ability to secure customer contracts and begin generating revenues. In addition, any such delays or problems would require the Company to secure additional funding over and above what the Company currently anticipates they require to sustain business, which the Company may not be able to raise.

The Company relies on a single product line.

The Company’s primary product line is the Graft. The Company’s survival in near term depends on being able to sell Grafts to a sufficient number of customers to make a profit. The Company’s current customer base is still small, and the Company will only succeed if it can attract more customers for its primary product and maintain those customers.

The Company has not yet generated revenue or profit and it may take a long time for the Company to become profitable.

This is a pre-revenue Company and has not yet generated any revenue or profit. The Company does not yet have customers, since the gaining of customers is conditional upon regulatory approval of the device (see “Description of the Business” below). The Company hopes to obtain a CE Mark (allowing for sales in the EU, EEA, and EFTA) and also to obtain approval of the Graft by the U.S. Food and Drug Administration (“FDA”). The Company is working towards having sales of products, but the Company anticipates that it will take three (3) years to reach a breakeven point and at least for (4) to five (5) years achieve profitability, if at all.

The Company has not yet generated revenue or profit and it may take a long time for the Company to become profitable.

The Company is new and has not yet generated any revenue or profit. The Company does not yet have customers. The Company will work towards having sales of products in 2024, but the Company anticipates that it will take at least forty-eight (48) months until the Company reaches profitability. The Company’s ability to raise capital and to commercialize the Graft may be materially impacted by the COVID-19 pandemic. The full impact on the economy and the capital markets in the U.S. and the rest of the world from the COVID-19 pandemic are uncertain, in terms of both scale and duration. The high level of volatility in the capital markets may make it difficult to raise funds, especially for early stage companies that involve higher risk. If the Company raises sufficient funds to begin the work of commercializing Company products, the Company may have difficulty securing supplies needed or manufacturing and distribution partners. The impact of social distancing measures and related workforce reductions may negatively impact the ability of suppliers to deliver the Company to the components the Company needs for manufacture or the ability of any of the Company’s potential partners to operate effectively to meet Company requirements. In addition, many of the third parties that the Company would rely on for production and distribution are likely to be highly engaged in manufacturing products aimed at combatting the pandemic by manufacturing testing supplies and equipment, medical equipment and/or potential treatments. The Company cannot assure an investor that, should they raise sufficient funds, they will be able to contract with suppliers, manufacturing partners or distribution partners at a level that would allow the Company to achieve profitability, or at all.

The Company’s products may not achieve market acceptance thereby reducing the chance for success.

The Company is only in the early stages of selling first products. It is unclear whether these products and their features or other unanticipated events may result in lower sales than anticipated, which could force the Company to limit expenditures on research and development, advertising, and general Company requirements for improving and expanding product offerings. The Company cannot guarantee consumer demand or interest in current or future product offerings, which could have a material adverse effect on business, results of operations, and overall financial condition.

If the market chooses to buy competitive products and services, the Company may fail.

Although the Company believes that its Graft will be commercially viable, there is no verification by the marketplace that the Graft will be accepted by or purchased by customers at the scale desired by the Company. If the market chooses to continue to use competing products/procedures, it may be more difficult for the Company to ever become profitable which would be substantially harm the business and, possibly, cause it to fail whereby the Investors could lose their entire investment. In addition to Company dependency on their continued services, Company future success will also depend on the ability to attract and retain additional future key personnel. The Company may face intense competition for such qualified individuals from well-established and better financed competitors. The Company may not be able to attract qualified new employees or retain existing employees, which may have a material adverse effect on the Company’s results of operations and financial condition.

The Company will require additional funding to develop and commercialize the Graft. If the Company is unable to secure additional financing on acceptable terms, or at all, the Company may be forced to modify its current business plan or to curtail Company planned operations.

The Company anticipates incurring significant operating losses and using significant funds for the execution of the clinical trials and manufacturing capability scaling. The Company’s existing cash resources are insufficient to finance these operations. Accordingly, the Company will need to secure additional sources of capital to develop their business and Graft, as planned. The Company intends to seek substantial additional financing through public and/or private financing, which may include equity and/or debt financings, and through other arrangements, including collaborative arrangements. As part of such efforts, the Company may seek loans from certain of their executive officers, directors and/or current shareholders.

If the Company is unable to secure additional financing in the near term, the Company may be forced to: (1) Curtail or abandon the Company’s existing business plans; (2) Default on any debt obligations; (3) File for bankruptcy; (4) Seek to sell some or all of Company assets; and/or (4) Cease business operations.

If the Company is forced to take any of these steps, the Company’s common stock may lose significant value or become worthless.

Any future financing may result in ownership dilution to the Company’s existing Shareholders and may grant rights to future investors more favorable than the rights currently held by the Company’s existing Shareholders.

If the Company raises additional capital by issuing equity, equity-related, or convertible securities, the economic, voting and other rights of the Company’s existing shareholders may be diluted, and those newly-issued securities may be issued at prices that are at a significant discount to current and/or then fair market value of the Shares. In addition, any such newly issued securities may have rights superior to those of the Company’s common stock as offered through this Offering. If the Company obtains additional capital through collaborative arrangements, they may be required to relinquish greater rights to technologies or product candidates than the Company might otherwise have or become subject to restrictive covenants that may affect business.

Revenue derived from large orders could adversely affect the Company’s gross margin and could lead to greater variability in the Company’s quarterly, semi-annual, and annual results.

Large orders may be more sensitive to changes in the global industrial economy, may be subject to greater discount variability, lower gross margins, and may contract at a faster pace during an economic downturn compared to smaller orders. To the extent that the amount of Company net sales derived from large orders increases in future periods, either in absolute dollars or as a percentage of overall business, the Company’s gross margins could decline, and the Company could experience greater volatility and see a greater negative impact from future downturns in the global industrial economy.

Defects or errors in the clinical trial stage could set back the success of candidates, requiring further investment without a guaranteed outcome.

Although the Company has conducted significant animal testing, the Company’s Graft design may contain undetected defects or errors when placed into human clinical trials, which could materially and adversely affect the Company’s reputation, result in significant costs to the Company and impair their ability to sell their products in the future. The costs incurred in correcting any defects or errors may be substantial and could adversely affect operating results. Furthermore, the Graft may contain undetected defects or errors when first introduced to the market or as new versions are released, which could materially and adversely affect the Company’s reputation, result in significant costs to the Company and impair their ability to sell Company products in the future. The costs incurred in correcting any defects or errors may be substantial and could adversely affect operating results.

The FDA, other regulatory bodies and other comparable foreign regulatory authorities each have substantial discretion in the approval process and may either refuse to consider the company application for review or may form the opinion after review of the data that the Company’s application is insufficient to grant approval for commercial use.

Commercialization of the Graft will require FDA and other regulatory approval in the future. The FDA, Swissmedic/Council of the European Union (“COUNCIL”), and other comparable foreign regulatory authorities each have substantial discretion in the approval process and may either refuse to consider the business’s application for human clinical trials or may form the opinion after review of the Company’s clinical trial data that the application for the Graft is insufficient to allow approval of the Graft for human health applications. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in United States. Moreover, any approvals that the Company obtains may not cover all of the clinical indications for which the Company will seek approval, or could contain significant limitations in the form of narrow indications, warnings, precautions or contraindications with respect to conditions of use. In such an event, the Company’s ability to generate revenues from such products would be greatly reduced and its business would be harmed.

Failure to obtain approval to market the Company product for human health applications may limit Company prospects for growth.

The Company will require approval from the FDA and similar agencies in other countries prior to marketing Company products for human use. The Company will need to establish, to the satisfaction of those organizations, that their products are safe and effective for use. Because the Company’s Graft is novel and represents a great departure from the status quo, the Company cannot refer to existing technology to support their application and, as a result, cannot assure Investors that the Company will receive approval. In addition, the Company believes that the resources of the FDA are heavily engaged in monitoring, reviewing and approving testing solutions for COVID-19 and the underlying virus, SARS-CoV-2, and they may not have sufficient staffing or other resources to review the Company’s application in a timely manner. As a result, the Company may not be in a position to pursue human health applications for a significant period of time.

The regulatory approval process of the FDA, the COUNCIL and other comparable domestic and foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if the Company is unable to obtain timely regulatory approval for product candidates, the business will be substantially harmed.

The Company is not permitted to market product candidates in the US or the EU until approval from the FDA and the COUNCIL, respectively, or in any foreign countries until the Company receives the requisite approval from such countries. Prior to submitting for FDA and COUNCIL for approval of the Graft for human health application, the Company will need to initiate and complete multiple clinical trials. Successfully completing the company’s clinical program and obtaining approval is a complex, lengthy, expensive and uncertain process, and the FDA or COUNCIL may delay, limit or deny approval of the company’s product candidates for many reasons, including, among others, because:

(1) The Company may not be able to demonstrate that their product candidates are safe and effective in treating patients to the satisfaction of the FDA, COUNCIL, or other applicable foreign regulatory agencies;

(2) The results of the Company’s clinical trials may not meet the level of statistical or clinical significance required by the FDA, COUNCIL, or other applicable foreign regulatory agencies for marketing approval;

(3) The FDA, COUNCIL, or other applicable foreign regulatory agencies may disagree with the number, design, size, conduct or implementation of the Company’s clinical trials;

(4) The FDA, COUNCIL, or other applicable foreign regulatory agencies may require that the Company conduct additional clinical trials;

(5) The FDA, COUNCIL, or other applicable foreign regulatory authorities may not approve the labeling or specifications of the Company’s product candidates;

(6) The contract research organizations (CROs) and other contractors that the Company may retain to conduct clinical trials may take actions outside of Company control that materially adversely impact the clinical trials;

(7) The FDA, COUNCIL, or other applicable foreign regulatory agencies may find the data from preclinical studies and clinical trials insufficient to demonstrate that the Graft is safe and effective for its proposed indications;

(8) The FDA, COUNCIL, or other applicable foreign regulatory agencies may disagree with the Company’s interpretation of data from their preclinical studies and clinical trials;

(9) The FDA, COUNCIL, or other applicable foreign regulatory agencies may not accept data generated at the Company’s clinical trial sites or may disagree with the Company over whether to accept efficacy results from clinical trial sites outside the US, outside the EU, or outside a specific country, as applicable, where the standard of care is potentially different from that in the US or in the EU, as applicable;

(10) If and when the applications for regulatory approval are submitted to the FDA, COUNCIL, or other foreign regulatory agencies, as applicable, the regulatory authorities may have difficulties scheduling the necessary review meetings in a timely manner, may recommend against approval of the Company’s application or may recommend or require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;

(11) The FDA, COUNCIL or other applicable foreign regulatory agencies may change their approval policies or adopt new regulations.

Any of these factors, many of which are beyond Company control, could increase development costs, jeopardize the Company’s ability to obtain regulatory approval for and successfully market the Graft and generate product revenue. Moreover, because their business is entirely dependent on the approval of the Graft by the respective agencies, any such setback in the Company’s pursuit of regulatory approval would have a material adverse effect on business and prospects.

The Company’s ability to raise capital and commercialize their medical device products may be materially affected by the COVID-19 pandemic.

In December 2019, the 2019 novel coronavirus (“COVID-19”) surfaced in Wuhan, China. The World Health Organization declared a global emergency on January 30, 2020, with respect to the outbreak and several countries, including the United States, have initiated travel restrictions. The final impacts of the outbreak, and economic consequences, are unknown and still evolving.

The Company’s ability to raise capital and to commercialize the Company’s Graft may be materially impacted by the COVID-19 pandemic. The full impact on the economy and the capital markets in the U.S. and the rest of the world from the COVID-19 pandemic are uncertain, in terms of both scale and duration. The high level of volatility in the capital markets may make it difficult to raise funds, especially for early stage companies that involve higher risk. If the Company raises sufficient funds to begin the work of commercializing the Graft, the Company may have difficulty securing supplies needed or manufacturing and distribution partners at a level that would allow the Company to achieve profitability, or at all.

Risks Related to Development and Regulatory Approval of The Company’s Product

There may be a high rate of failure for Graft candidates proceeding through clinical trials.

There may be a high rate of failure for Graft candidates proceeding through clinical trials. The Company may suffer significant setbacks in their clinical trials, similar to the experience of a number of other companies in medical device industry, even after receiving promising results in earlier trials. Further, even if the Company views the results of a clinical trial to be positive, the FDA or other regulatory authorities may disagree with their interpretation of the data. For instance, because a large percentage of subjects in the Company’s pivotal trials for the Graft may be enrolled at sites outside the U.S., differences in efficacy results between U.S. and non-U.S. sites could cause the FDA to require additional trials.

Clinical trials for the Graft are expensive, time consuming, uncertain and susceptible to change, delay or termination.

Clinical trials are expensive, time consuming and difficult to design and implement. The result of a clinical trial may be undesirable and can result in a clinical trial cancellation or the need for re-evaluation and supplementation. Even if the results of the clinical trials are favorable, the clinical trials for the Graft are expected to continue for several years and may even take significantly longer to complete. In addition, the Company, the FDA, the COUNCIL, the various IRBs, or other regulatory authorities, may suspend, delay or terminate the Company’s clinical trials at any time, for various reasons.

Risks Related to the Securities and the Offering

The Company is controlled by its Chairman/Board of Directors, and only Common Stock Shareholders have voting rights.

The Company’s founder, Dr. Manny Villafaña, Ph.D.Sc, is the beneficial owner of or has a right to acquire a majority of the Company’s Shares as of the date of this Offering Circular, but upon a successful Offering (where the Maximum Offering Amount is raised) will not own a majority of the Company’s voting stock. Investors in this Offering will not have a majority of voting Shares and therefore will not have the have the ability to control a vote of the Shareholders without consensus from other Common Stock Shareholders.

Dr. Manny Villafaña, Ph.D.Sc is the sole Director on the Board of Directors as of the date of this Offering Circular. Dr. Manny Villafaña, Ph.D.Sc has the majority of the voting power of the Shares, and as the sole Director, Dr. Manny Villafaña, Ph.D.Sc has complete control as to the direction of the Company. There is a disproportionate reliance on Dr. Manny Villafaña, Ph.D.Sc for the operation of the Company, and therefore a risk that the direction of the Company may change if Dr. Manny Villafaña, Ph.D.Sc is unable to perform his duties as Director and Officer.

There is no current market for the Shares.

There is no formal marketplace for the resale of Company Shares and none is expected to arise for the foreseeable future. Investors should assume that they may not be able to liquidate their investment.

The Offering price of the Company’s Shares was not established on an independent basis; the actual value of an investment may be substantially less than what Investor pays for the securities.

The Company’s Board of Directors established the Offering price of the Company’s Shares on an arbitrary basis. The selling price of the Shares bears no relationship to the book or asset values or to any other established criteria for valuing Shares. Because the Offering price is not based upon any independent valuation, the Offering price may not be indicative of the proceeds that an Investor would receive upon liquidation. Further, the Offering price may be significantly more than the price at which the Shares would trade if they were to be listed on an exchange or actively traded by broker-dealers.

4 

DILUTION

On January 1, 2022 the Board passed a resolution approving a 2 to 1 stock split for all shareholders of record as of January 17, 2022. As of January 1, 2021 the Company only had one Director and Officer, Dr. Manny Villafaña, Ph.D.Sc. – who has owned his Shares since founding the Company in 2016. Before the stock split, Dr. Manny Villafaña, Ph.D.Sc. owned 4,360,000 Shares. After the stock split, he owns 8,720,000 Shares. Dr. Manny Villafaña, Ph.D.Sc. purchased these Shares more than one (1) year prior to the date of this Offering Circular.

PLAN OF DISTRIBUTION

The Offering will be made through general solicitation, direct solicitation, and marketing efforts whereby Investors will be directed to the Portal (medical21.com) to invest. The Company has engaged Rialto Markets, an independent FINRA broker-dealer to assist with the Share sales in exchange for a 3% commission fee on the aggregate sales. The Offering is conducted on a best-efforts basis. No Commissions or any other renumeration for the Share sales will be provided to the Company, the Directors, any Officer, or any employee of the Company, relying on the safe harbor from broker-dealer registration set forth in Rule 3a4-1 under the Securities Exchange Act of 1934, as amended.

The Company will not limit or restrict the sale of the Shares during this 12-month Offering. No market exists for the Shares and no market is anticipated or intended to exist in the near future, therefore there is no plan to stabilize the market for any of the securities to be offered.

Directors, Officers, and employees of the Company are primarily engaged in the Company’s business of developing and manufacturing medical devices, and none of them are, or have ever been, brokers nor dealers of securities. The Directors, Officers, and employees will not be compensated in connection with the sale of securities through this Offering. The Company believes that the Directors, Officers, and employees are associated persons of the Company not deemed to be brokers under Exchange Act Rule 3a4-1 because: (1) no Director, Officer, or employee is subject to a statutory disqualification, as that term is defined in section 3(a)(39) of the Exchange Act at the time of their participation; (2) no Director, Officer, or employee will be compensated in connection with his participation by the payment of commissions or by other remuneration based either directly or indirectly on transactions in connection with the sale of securities through this Offering; (3) no Director, Officer, or employee is an associated person of a broker or dealer; (4) the Directors, Officers, and employees primarily perform substantial duties for the Company other than the sale or promotion of securities; (5) no Director, Officer, or employee has acted as a broker or dealer within the preceding twelve months of the date of this Offering Circular; (6) no Director, Officer, or employee will participate in selling this Offering after more than twelve months from the Effective Date of the Offering.

Rialto Markets LLC (“Rialto”) has agreed to act as placement agent to assist in connection with this Offering. Rialto is not purchasing or selling any securities offered by this Offering Circular, nor is it required to arrange the purchase or sale of any specific number or dollar amount of securities. However, Rialto has agreed to use their best efforts to arrange for the sale of the Shares offered through this Offering Circular. In addition, Rialto may engage other brokers to sell the securities on their behalf. Rialto will receive compensation for sales of the Shares offered and sold through pursuant to this Offering at a rate of 3% of the Gross Proceeds for a maximum of $1,200,000. In addition, the Company may pay Rialto 8% of the Gross Proceeds from the sale of up to $10,000,000 in Common Stock resulting from the direct selling efforts of Rialto not to exceed $800,000.

The Company will also publicly market the Offering using general solicitation through methods that include e-mails to potential Investors, the internet, social media, and any other means of widespread communication.

This Offering Circular will be furnished to prospective investors via download 24 hours per day, 7 days per week on the Company’s website at medical21.com and via of the EDGAR filing system.

The following table shows the total discounts and commissions payable to Rialto in connection with this Offering by the Company:

In the event that Rialto’s targeted selling efforts lead to sales of up to $10,000,000 in Shares of Common Stock, Rialto will be entitled to 8.0% of the Gross Proceeds from the sale of such shares of Common Stock not to exceed $800,000.

	Price Per Share		Total Offering
Public Offering Price	$	5.80	$	40,000,000
Placement Agent Commissions	$	0.174	$	1,200,000
Proceeds, Before Expenses	$	5.626	$	38,000,000

Other Terms

Rialto has also agreed to perform the following services in exchange for the compensation discussed above: 

- Act as lead broker for the Offering, coordinating efforts of parties involved and providing regulatory guidance; 

- Manage the back-end process of the Offering Platform technology, Investors use to invest in the Offering;

- Reviewing marketing materials if requested;

- Performing AML/KYC checks on all Investors, and; 

- Providing other financial advisory services normal and customary for Regulation A offerings and coordinate with the Company’s registered transfer agent and legal representatives. 

In addition to the commissions described above, the Company will also pay $5,000 to Rialto for out-of-pocket accountable expenses paid prior to commencing the Offering. This fee will be used for the purpose of coordinating filings with FINRA (Form 5110). In addition, the Company will pay Rialto $6,500 consulting fee upon the issuance of the FINRA No Objection Letter and a $5,000 Blue Sky filing service fee for managing the filings required for Blue Sky regulations. The Company will forward the fees required for state notice filing fees, estimated to be approximately $13,000. Assuming the full amount of the offering is raised, and that Rialto's targeted selling efforts lead to sales of $10,000,000, the Company estimates that the total fees and expenses of the Offering payable by the Company to Rialto will be approximately $1,200,000. Maximum expected out of pocket expenses total $18,750.

Selling Securityholders

There are no selling securityholders in this Offering.

5 

USE OF PROCEEDS

	25	%	50	%	75	%	100	%
1. Marketing	1,000,000 (10%)		1,500,000	(%)	3,500,000 (11.67%)		5,500,000 (13.75%)
2. Scaling Manufacturing Capacity/Add’l Applications	2,000,000 (20%)		2,000,000	(%)	2,000,000 (6.67%)		15,000,000 (37.5%)
3. Clinical Studies	5,000,000 (50%)		10,000,000	(%)	10,000,000 (33.33%)		15,000,000 (37.5%)
4. Working/Reserve Capital	2,000,000 (20%)		6,500,000	(%)	14,500,000 (48.33%)		4,500,000 (11.25%)
Total	10,000,000		20,000,000		30,000,000		40,000,000

1. Marketing

The Company intends to spend upwards of $5,500,000 worldwide on marketing for the Company’s products. The Company intends to market the Graft through the use of independent representatives. To expand the representative base, the Company will need to expand educational infrastructure including hiring training employees and the creation of media for training and sales purposes. Additional uses include costs for travel, marketing materials, and advertising.

2. Scaling Manufacturing Capacity

The Company intends to spend approximately $15,000,000 on scaling manufacturing capacity. The Company is currently in the process of developing a manufacturing facility in Plymouth, MN. Upon a successful offering the Company intends to develop an additional 2 facilities. Each of these facilities will be redeveloped by the Company to conform to the requirements of Good Manufacturing Practices as required by the FDA. In addition to redevelopment of the facility(ies), the Company must purchase a significant amount of specialized manufacturing and testing equipment. The Company intends to use these Proceeds to increase the manufacturing employee base.

3. Clinical Studies

The Company intends to use approximately $15,000,000 of the Proceeds to engage in FDA and OUS (“Outside United States”) Clinical studies. The Company estimates each clinical study subject will cost the approximately $10,000 - $20,000 per patient. For more information on the nature of these clinical studies, please see Description of the Business below.

4. Working/Reserve Capital

The Company intends to use $4,500,000 of the Proceeds for working capital. Included in this use is payment of salaries, benefits, legal and other professional services, and other administrative costs.

6 

DESCRIPTION OF THE BUSINESS

Corporate History

Medical 21, Inc. was founded as a Minnesota C- Corp on February 12, 2016 with the authority to issue 50,000,000 Shares – 40,000,000 Common Shares and 10,000,000 undesignated shares. The Company has executed two stock splits during its lifetime. The first stock split was executed on October 15, 2018. In this first stock split all Shares of outstanding stock (as of 10/5/18) two for one (2:1). The second stock split was executed on January 1, 2022. In this second stock split all Shares of outstanding stock (as of 01/17/22) two for one (2:1).

Introduction to the Company

Medical 21 is a development stage medical device Company founded by Dr. Manny Villafaña, Ph.D.Sc., in 2016 to significantly improve the quality of life for cardiac bypass patients by eliminating the need to harvest vessels from the legs and other parts of the body through the creation and development of an artificial graft. The Company has developed and intends to commercialize and market an artificial, nitinol-supported thin wall tubular graft, the MAVERICS Graft, (“Graft”) to bypass lesions in the heart and other parts of the body.

The Company intends to use the Proceeds of this Offering to (1) commence and execute human clinical trials of the MAVERICS Graft; (2) obtain regulatory approval from national health agencies in key global markets; (3) increase the Company’s capacity for manufacturing of the MAVERICS Graft; (4) expand the marketing and sales activities of the Company.

 

The MAVERICS Graft

The MAVERICS Graft is a thin walled cylindrical device fitted with a clinically tested nitinol support, reinforcing the artificial tubular construct against internal physiologic blood pressure. Over the previous year, The Company has successfully implanted their device into ovine animals with outcomes that warrant human clinical trials as regulated by various national agencies. As of the date of this offering Circular, the Company is: (1) completing the remaining pre-clinical testing required for regulatory submissions; (2) implementing quality and manufacturing systems to comply with regulatory agencies; and, (3) developing clinical strategies and regulatory documentation to obtain EU, FDA, and other relevant government approvals.

Intended Clinical Trials

The Company is using some of the Proceeds of this Offering to execute human clinical trials for the Graft in Switzerland and the United States, then in other jurisdictions.

Swissmedic - Switzerland

In Switzerland, research projects involving one or more human subjects, undertaken to systematically assess the safety or performance of medical devices are deemed to be clinical trials of medical devices. The Human Research Act (HRA) and Ordinance on Clinical Trials with Medical Devices (ClinO-MD) define the corresponding requirements for clinical trials with medical devices and devices without a medical purpose listed in Article 1 of the Medical Devices Ordinance (MedDO). They transpose the provisions of the European medical device regulation into Swiss law and define national requirements and procedures.

Clinical trials fall under category C if the medical device carries a CE-mark but will not be used in accordance with the CE-marked instructions for use (off-label use, Category C1), or is not CE-marked (C2), or when its placing on the market or use is prohibited in Switzerland (C3). 

These “pre-market” trials require the authorization of Swissmedic and the cantonal ethics committee.

As the Company has not yet gained a CE mark for the Graft, the Graft would be categorized as a C2 Medical Device. The Company has already contacted medical practitioners in Switzerland to conduct the study after Proceeds have been raised through this offering to execute the study. Presuming a successful human clinical study, the Company expects to have a CE mark issued within 18 to 24 months.

The Food and Drug Administration - (United States)

The Company is using some of the Proceeds of this offering to execute human clinical trials for the Graft initially in Switzerland and the United States. The Graft is designated as an “Implant” by the FDA meaning that the Graft “is a device that is placed into a surgically or naturally formed cavity of the human body and is intended to remain there for a period of 30 days or more. In order to protect public health, FDA may determine that devices placed in subjects for shorter periods are also implants.” The Company intends to submit the clinical trial with the FDA under an “Investigational Device Exemption” (an “IDE”). An IDE refers to the regulations under 21 CFR 812. An approved IDE means that the Institutional Review Board (“IRB”) (and FDA for significant risk devices) has approved the sponsor’s study application and all the requirements under 21 CFR 812 are met. As stated by the FDA:

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights, safety and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights, safety and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents). The IRB must monitor and review an investigation throughout the clinical study.

If an IRB determines that an investigation involves a significant risk device, it must notify the investigator and, if appropriate, the sponsor. The sponsor may not begin the investigation until approved by FDA.

Company Intellectual Property

Patents

The Company currently owns multiple issued United States Patent and Trademark Office (“USPTO”) Utility Patent and an issued USPTO and Patent Cooperation Treaty (“PCT”) Patent. The Company was assigned these patents from the University of Iowa Research Foundation.

The Company has acquired licensing rights to intellectual property from the University of Iowa Research Foundation These patents are related to implantable medical devices, including membranes for use in artificial blood vessel grafts, heart valves, etc. See Exhibit 6 “Amendment to the License Agreement between University of Iowa Research Foundation and Medical 21, Inc.”

Market for the Graft

Currently, to perform coronary artery bypass graft surgery, the surgeons must harvest arteries from the patient’s limbs. This is a dangerous, painful, expensive, and inefficient procedure in addition to the coronary bypass surgery.

The Company expects that the use of the Graft will improve quality of life for cardiac bypass patients by eliminating the need to harvest vessels from the legs and other parts of the body, which will also reduce overall healthcare costs in the cardiac bypass market. Based on discussions with cardiologists and cardiovascular surgeons around the world, the Company believes that the MAVERICS Graft would be a welcome addition to the techniques, products, and tools of heart specialists who treat blocked arteries in their patients. Recent publications have indicated superior long-term outcomes in coronary bypass procedures as compared to procedures involving drug-eluting coronary stents.

The Company’s initial entry into the global market for coronary bypass grafts will be into a market, which in 2017 was estimated (by Life Science Intelligence Global Procedure Volumes Database 2018) to have been comprised of approximately 800,000 bypass operations worldwide per year. On average, each coronary bypass operation uses 3-4 grafts per procedure. Although this market had been shrinking in recent years, it is currently seeing growth due to issues concerning late thrombosis in drug-eluting coronary stents.

Medical 21’s management team collectively possess decades of experience in the successful development, manufacturing, sales, and marketing of medical products to the domestic and international healthcare markets.

The Company believes that the first product developed by Medical 21, its MAVERICS Graft, will fulfill a current need in the coronary artery bypass market. The Company intends to price its product to appeal to a managed-care market that stresses the lowest total cost for all treatment parameters.

7 

Plan of Distribution

After approval by the relevant authorities, the Company intends to initially distribute the Graft in the United States and Europe. Within the United States, the Company will engage in direct sales to customers. The customers in the United States primarily consist of hospitals and hospital systems. Generally speaking, the cardiac surgeons have the discretion on whether to use a device and/or engage in a procedure. Once the decision has been made to use a certain device, the surgeon will direct the hospital administration to purchase the product. Initially, the Company expects to receive orders for approximately 10 – 30 units at a time, until the Graft is adopted more regularly by cardiac surgeons – after which the Company expects to sell in bulk and at much higher quantities.

The Company intends to utilize distributors to affect international sales. The Company’s officers have longstanding relationships with many international medical device distributors. These distributors will be responsible for maintaining sales and regulatory compliance within each international market. Additionally, the Company intends on using some of the Proceeds for international marketing efforts.

Total Number of Employees

As of the Date of this offering Circular, the Company has seven full time employees and no part-time employees.

Legal Proceedings

The Company is not presently a party to any material litigation, nor is any litigation known to be threatened against the Company. Furthermore, the Company has no bankruptcies, investigations, or criminal proceedings to disclose.

Licensing for Graft Technology

As a condition of obtaining all rights to the material technology underlying the Graft, the Company has entered into a royalty payment agreement with University of Iowa, Iowa City, Iowa. In return, the Company has agreed to pay a customary and market-rate royalty on the net revenue (billed/invoiced sales less discounts, commissions, credits, returns and sales tariffs) received from sales of the Graft at the end of each calendar year after. The Company has provided a redacted copy of the licensing agreement as Exhibit 6 “Amendment to the License Agreement between University of Iowa Research Foundation and Medical 21, Inc.”

Special Characteristics of the Company’s Operations and Competing Products/Procedures

The Company is subject to stringent regulation both before, during, and after approval by the FDA and other global regulatory agencies.

FDA Approval

The Company believes that the Graft will be regulated in the United States as a Class III medical device by the FDA under the Federal Food, Drug and Cosmetic Act. The FDA classifies medical devices into one of three classes based upon controls the FDA considers necessary to reasonably ensure their safety and effectiveness. Class I devices are subject to general controls such as labeling, adherence to good manufacturing practices and maintenance of product complaint records, but are usually exempt from premarket notification requirements. Class II devices are subject to the same general controls and also are subject to special controls such as performance standards and may also require clinical testing prior to approval. Class III devices are subject to the highest level of controls because they are life-sustaining or life-supporting devices. Class III devices require rigorous preclinical and clinical testing prior to their approval and generally require a pre-market approval, or PMA by the FDA prior to their sale.

Manufacturers must file an Investigational Device Exemption, or IDE, application if human clinical studies of a device are required and if the FDA considers investigational use of the device to represent significant risk to the patient. The IDE application must be supported by data, typically including the results of animal and nonclinical laboratory testing of the device. The animal and nonclinical laboratory testing must meet the FDA’s good laboratory practice requirements. If the IDE application is approved by the FDA, human clinical studies may begin at a specific number of investigational sites with a maximum number of patients, as approved by the FDA. The clinical studies must be conducted under the review of an independent institutional review board to ensure the protection of patients’ rights.

Generally, upon completion of these human clinical studies, a manufacturer seeks approval of a Class III medical device from the FDA by submitting a PMA application. A PMA application must be supported by extensive data, including the results of the clinical studies, as well as testing and literature to establish the safety and effectiveness of the device. PMA approval may be conditional upon the conduct of certain post-approval studies, such as long-term follow-up studies.

FDA regulations will require the Company to register as a medical device manufacturer with the FDA. Because of this, the FDA will most likely inspect the Company on a routine basis for compliance with the Quality System Regulation, or QSR. These regulations require that the Company manufactures its products and maintains related documentation in a prescribed manner with respect to manufacturing, testing and control activities. The Company expects to undergo regular QSR inspections in connection with the manufacture of the Graft at the Company’s facility(ies). Further, the FDA most likely will require the Company to comply with various FDA regulations regarding labeling. Failure by the Company or by the Company’s suppliers to comply with applicable regulatory requirements can result in enforcement action, which may include any of the following sanctions:

- warning letters, fines, injunctions, consent decrees and civil penalties;

- customer notifications, recall or seizure of the Company’s products;

- operating restrictions, partial suspension or total shutdown of production;

- delay in processing applications for new products or modifications to existing products;

- mandatory product recalls;

- withdrawing approvals that have already been granted; and

- criminal prosecution.

The medical device reporting laws and regulations require the Company to provide information to the FDA on deaths or serious injuries alleged to have been associated with the use of the Company’s devices, as well as product malfunctions that likely would cause or contribute to death or serious injury if the malfunction were to recur. In addition, the FDA prohibits an approved device from being marketed for off-label use. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a Company that is found to have improperly promoted off-label uses may be subject to significant liability, including substantial monetary penalties and criminal prosecution.

The Company will also subject to other federal, state and local laws, regulations, and recommendations relating to safe working conditions, laboratory, and manufacturing practices.

FDA Early Feasibility Studies Program – The Company has decided to apply for an Early Feasibility Study for the Graft with the FDA, as stated by the FDA on its website:

An early feasibility study (“EFS”) is a limited clinical investigation of a device early in development. It typically:

-enrolls a small number of subjects;

-is used to evaluate the device design concept with respect to initial clinical safety and device -functionality; and

-may guide device modifications.

CDRH's EFS Program facilitates the conduct of early feasibility studies in the United States to increase access for patients to potentially beneficial technologies and to support device innovation. EFS concepts are described in the FDA guidance document, Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical studies, Including Certain First in Human (FIH) Studies.  

The EFS Program provides a mechanism for innovators to work directly with, sponsors, FDA review teams, and clinicians to work together early so they can increase the efficiency of their device development. Early clinical experience obtained from an EFS can provide insights for sponsors and FDA review teams into device proof of concept, patient characteristics that may impact performance, operator technique refinements, device safety, necessary device modifications, and human factors.

Components of the EFS Program include:

- Opportunities for interactive review

- Assistance in submission preparation from an EFS Program representative

- Potential for less non-clinical data to support study initiation relative to the data needed for larger clinical studies based on use of clinical mitigation strategies

- New mechanisms for timely device and clinical protocol modifications

Plan of Operations

1. Apply for and Submit the Graft for Human Clinical Testing in European Jurisdiction and with the FDA;
2. Conduct Human Clinical Trials; (approx. $10,000 – $20,000 per patient in the clinical trial)
3. Scale manufacturing capability of the Company, improve internal processes by optimizing the MAVERICS Graft handling and developing consistency in manufacturing;
4. Receive Regulatory Approvals. The Company anticipates EU approval for the device for commercial use in 2024. The Company anticipates the FDA will approve the device for commercial use in 2026.

The Company anticipates this Plan of Operations will take approximately $15,000,000-$25,000,000 to execute. The Company is not reasonably able determine the costs of each step at this time due to the conditionality of the human clinical trial process(es).

8 

DESCRIPTION OF PROPERTY

As of the Date of this offering Circular, the Company does not own real property or business personal property of material significance.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF THE FINANCIAL CONDITION OF THE COMPANY

Medical 21, Inc. is a privately-held entity organized in February 2016 in the State of Minnesota.

Components of Results of Operations 

The following discussion of our financial conditions and results of operations should be read in conjunction with the financial statements and the related notes included elsewhere in this Offering Statement. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. The Company’s actual results could differ significantly from those discussed in the forward-looking statements. Unless otherwise indicated, the latest results discussed below are as of December 31, 2021.

Revenue/Net Loss from Operating Activities

The Company is, and has been, solely focused on further development of its Graft through research and testing. As of the date of this Offering Circular, the Company has never been profitable. In FY2021 the Company had a Net loss of $3,860,264. In FY2020 the Company had a Net loss of $1,822,522. This represents an increase in Net loss of $2,037,724 or 112%. The reason for this increase is an increase in Company expenditures (materials, equipment, professional fees, employee costs) in support of research and development activities.

Operating Expenses

The Company classifies its Operating Expenses as salaries & benefits, research and development, general and administrative expenses, and other operating expenses (professional fees, travel and entertainment and rent). In FY2021 the Company had Operating Expenses totaling $3,860,545. In FY2020 the Company had Operating Expenses totaling of $1,824,341. This represents an increase in Operating Expenses of $2,036,204 or 111.6%. The reason for this increase is an increase in Company expenditures for research and development.

Research and Development Expense

The Company’s research and development efforts are focused on the continued development of the Graft, including animal testing in preparation of human clinical trials. Research and development expenses consist primarily of materials, equipment, and manufacturing costs to design, develop, and test the Graft in clinical settings. Also included are parts, tools and equipment acquired to produce prototypes for testing.

In FY2021, the Company spent $870,248 on research and development expenses. In FY2020, the Company spent $478,221 on research and development expenses. This represents an increase of $392,027 or 81.9%. The reason for this increase is increased research and development activities by the Company in FY 2021.

The Company anticipates that the Company will increase these expenses significantly upon a successful Offering as the Company will begin human clinical trials. (see “Use of Proceeds”) above.

Salaries and benefits

In FY2021, the Company spent $2,380,301 on salary and benefit expenses. In FY2020, the Company spent $885,777 on salary and benefit expenses. This represents an increase of $1,494,524 or 168.7%. The reason for this increase is the hiring of new employees and increased use of professionals in the Company’s research lab.

Due to Shareholders

On December 31, 2019 15,778,228 Shares of Common Stock were outstanding, with a total balance Due to Shareholders of $1,852,109.

On December 31, 2020 16,602,228 Shares of Common Stock were outstanding, with a total balance Due to Shareholders of $2,451,410. This represents an increase of $599,301 or 32.3%. The reason for this increase was due to the sale of common stock to investors under regulation D 506(c) exemption from registration.

On December 31, 2021 18,065,830 Shares of Common Stock were outstanding, with a total balance Due to Shareholders of $4,490,248. This represents an increase of $2,038,838 or 83.1%. The reason for this increase was due to the sale of common stock to investors under regulation D 506(c) exemption from registration.

Liquidity and Capital Resources

As of December 31, 2021, the Company had cash of $3,514,121, total assets of $3,689,736. On December 31, 2020, the Company had cash of $1,339,050, total assets of $2,451,410. This represents an increase in $2,175,071 (or 162%) in cash and $2,189,144 (or 89.3%) in total assets.

The Company has financed its operations primarily through the sale of common stock.

The Company will have additional capital requirements during fiscal year 2022 to conduct the human clinical testing and execute the other anticipated uses of the Proceeds (see “Use of Proceeds” above. Therefore, the Company will attempt to raise additional capital through the sale of its securities in this Regulation A+ offering. The Company’s initial offering is for a maximum of 6,896,552 Shares of its Common Stock at price of $5.80 per share, with potential aggregate gross Proceeds of $40,000,000.

There can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its future capital requirements. If the Company is unable to raise additional capital in sufficient amounts or on terms acceptable to it, the Company may have to significantly reduce, delay, scale back or discontinue the development of its technologies and patents or discontinue operations completely.

9 

DIRECTORS, OFFICERS, & SIGNIFICANT EMPLOYEES

Directors/Officers

Name	Position	Age		Term of Office		Approximate Hours per week
Dr. Manny Villafaña, Ph.D.Sc	Director/Chief Executive Officer of Company (“C.E.O.”)/Chief Financial Officer		81		June 2016 – Present	Full Time

Significant Employees

Name	Position	Age		Term of Office		Approximate Hours per week
Eric Solien	Senior Research Scientist		62		November 2021 – Present	Full Time
Chaid Schwarz, Ph.D.	Head of Research and Development		38		June 2016 – Present	Full Time
Jeff Vreeman	Head of Manufacturing		47		October 2018 – Present	Full Time

Directors/Officers

Dr. Manny Villafaña, Ph.D.Sc.: Founder, Chairman of the Board, CFO and CEO

Manny started his career with Medtronic, Inc. as the Company's first international sales administrator. Manny went on to found Cardiac Pacemakers, Inc. (CPI), a CRM Company that revolutionized the pacemaker industry by introducing a long-life lithium iodine pacemaker, a technology still utilized today by 100% of the market. CPI was ultimately acquired by Eli Lilly & Company, which spun out CPI as Guidant, which in turn was acquired by Boston Scientific, Inc. for $27 billion. After CPI, Manny founded St. Jude Medical, Inc. Manny led St. Jude Medical's development of a novel heart valve that still dominates the mechanical valve replacement market. St. Jude Medical was acquired by Abbott for $30 billion in 2016.

Manny has also founded and led the public offering for medical technology companies such ATS Medical, Inc., acquired by Medtronic, which developed the latest generation of open-pivot mechanical heart valves, and Kips Bay Medical, Inc.

Manny has received numerous awards and honors for his accomplishments, including: the “Living Legend of Medicine” award from the World Society of Cardio Thoracic Surgeons; the Ellis Island Medal of Honor; the Grand Prize Recipient - Mediterranean Institute of Cardiology; the Ernst & Young LLP National Master Entrepreneur of the Year; the 2016 MDEA Lifetime Achievement Award; the Boys and Girls Club of America Hall of Fame; and inductions into both the Minnesota Business Hall of Fame and the Science and Technology Hall of Fame. Manny, a native of the South Bronx of New York, attended Cardinal Hayes High School, Bronx, New York and in 2014, received an honorary Doctor of Science degree in Biomedical Engineering from the University of Iowa, Iowa City.

Significant Employees

Eric Solien: Senior Research Scientist

Eric has over 30 years of experience in pre-clinical cardiovascular research. Eric began his career with the University of Minnesota's Cardiovascular Research Laboratory (known today as Experimental Surgical Services) and held several positions there before leaving as the Associate Program Director. Eric served as Study Director and Senior Research Surgeon at Surpass Incorporated (previously River Valley Farms and Charles River Labs, Interventional and Surgical Services) and was a member of the research teams developing novel devices for coronary artery bypass at HeartStent Corporation and Kips Bay Medical, Inc. Eric is a certified Surgical Research Specialist and has a Bachelor of Science degree in Biology from the University of Minnesota.

Duties:

Management and oversight of the Company’s preclinical research;

Performing experimental device implantation;

Device development support;

Clinical trial activities;

Physician training and facility expansion.

Chaid Schwarz, Ph.D.: Head of Research and Development

Chaid received his Ph.D., in Biomedical Engineering from the University of Iowa. His research interests encircle notions of ‘thin’ tissued engineered constructs and biological membranes. These interests have intersected in the fields of cardiovascular biomechanics, biomaterials, and the mechanical assessment of soft tissues. While at the University of Iowa, he designed, developed and tested materials for transcatheter deliverable heart valves, stents and computationally modeled endovascular grafts for the treatment of abdominal aortic aneurysms. Additionally, he investigated the mechanical effects of severe diabetes on Descemet’s membrane, a thin membrane on the back of the cornea which impacts our vision. At Medical 21, he is leading research and development efforts including the technical design, testing and preliminary manufacturing of our tissue engineered arterial bypass graft.

Duties:

Head of Medical 21 research and development;

Lead technical design and testing of medical devices;

Set timelines for research and development;

Identification and sourcing of test and manufacturing equipment;

Negotiate supplier and research related contracts;

Manage intellectual property;

Lead technical presentations;

Support preclinical implant efforts and manage research and development personnel;

Oversee lab chemicals and safety.

Jeff Vreeman: Head of Manufacturing.

Jeff has over 20 years of experience in medical device engineering, having held positions in manufacturing/operations, process development, product development/R&D, and Quality. Much of Jeff’s career has been with small companies and startups, including Kips Bay Medical where he helped develop and manufacture the nitinol knit. He has extensive experience with nitinol and nitinol processing, lean manufacturing, and quality systems. Jeff has a BS in Mechanical Engineering from the University of North Dakota.

Duties include (but are not limited to): 

Identifying, procuring and properly qualifying/training equipment;

Facilities and personnel required to accurately and repeatably manufacture devices to required standards;

Lead quality systems and documentation and supporting personnel;

Lead receiving, incoming inspection, sterilization and finished goods storage and shipments and related personnel;

Support R&D development tasks and builds;

Lead plant meetings and necessary organizational updated meetings; set timelines, budgets and resources for process development and manufacturing.

Family Relationship Disclosure

There is no familial relationship between any of the persons named above.

Legal Proceedings Disclosure

There are no legal proceedings to disclose on behalf of the Company, its Directors, or Officers, including but not limited to bankruptcy, civil, or criminal proceedings.

10 

COMPENSATION OF THE MANAGEMENT

Name	Capacity for Compensation	Cash Compensation		Other Compensation	Total Compensation
Dr. Manny Villafaña, Ph.D.Sc.	Director/Chief Executive Officer of Company (“CEO”)/Chief Financial Officer	$	275,000	$1,391,650* (Stock Options)		$1,666,650

*Using the Black-Scholes model for valuation. This number represents the total number of options issued Dr. Manny Villafaña, Ph.D.Sc. since January 2016.

Aggregate Compensation to Directors

The Company has one (1) Director, Dr. Manny Villafaña, Ph.D.Sc. Total Compensation to all Directors is $275,000.

Stock Options

Dr. Manny Villafaña received multiple option grants beginning in January 2016, for a total of 3,600,000 Shares. 1,325,000 of those Shares are vested as of February 1, 2022.

Each grant has a 10-year term and an exercise price equal to the fair market value of the Company’s common stock on the date of grant. The vesting schedule for all these options is not based on performance of the option holders, and vesting of the options occurs automatically, conditional upon an option-holder’s continued business relationship with the Company and an employee, consultant, or advisor.

Increases in Compensation/Bonuses

The Company may disburse bonuses to employees of the Company. The amount of any such bonus cannot be determined at this time, and the issuance of any bonus is at the sole discretion of Dr. Manny Villafaña.

SECURITY OWNERSHIP OF MANAGEMENT AND CERTAIN SECURITYHOLDERS

Title of Class	Name and Address of Beneficial Owner	Amount and nature of beneficial ownership		Amount and nature of beneficial ownership acquirable	Percent of Class
Common Stock	Dr. Manny Villafaña1		8,720,000	1,325,000 Common Stock Shares (Pursuant to Stock Options)		51.8	%

(1) Manuel A. Villafaña Revocable Trust Agreement:

Mailing Address: P.O. Box 47946, Minneapolis, MN 55447

11 

INTEREST OF MANAGEMENT AND OTHERS IN CERTAIN TRANSACTIONS

There have not been any transactions by management or other persons within the past two fiscal years that require disclosure under this section. Furthermore, there are no contingency fees of other persons.

DESCRIPTION OF THE SECURITIES

Summary of Company Equity

The Company has two authorized classes of equity stock, Common Stock and undesignated shares. As of the date of this Offering Circular, no undesignated Shares are outstanding.

Description of the Common Stock Offered through this Offering

The voting, dividend, and liquidation rights of the holders of the Common Stock are set by the Articles of Amendment to Articles of Incorporation of Medical 21, Inc. (see Exhibit 2) and the relevant Minnesota Statutes.

Dividends

Minn. Stat. Section 302A.551 - DISTRIBUTIONS

Subdivision 1. When permitted.

(a) The board may authorize and cause the corporation to make a distribution only if the board determines, in accordance with subdivision 2, that the corporation will be able to pay its debts in the ordinary course of business after making the distribution and the board does not know before the distribution is made that the determination was or has become erroneous.

(b) The corporation may make the distribution if it is able to pay its debts in the ordinary course of business after making the distribution.

(c) The effect of a distribution on the ability of the corporation to pay its debts in the ordinary course of business after making the distribution shall be measured in accordance with subdivision 3.

(d) The right of the board to authorize, and the corporation to make, distributions may be prohibited, limited, or restricted by, or the rights and priorities of persons to receive distributions may be established by, the articles or bylaws or an agreement.

(Subdivisions 2 and 3 not provided)

Subdivision. 4. Restrictions.

(a) A distribution may be made to the holders of a class or series of shares only if:

(1) All amounts payable to the holders of shares having a preference for the payment of that kind of distribution, other than those holders who give notice to the corporation of their agreement to waive their rights to that payment, are paid; and

(2) The payment of the distribution does not reduce the remaining net assets of the corporation below the aggregate preferential amount payable in the event of liquidation to the holders of shares having preferential rights, unless the distribution is made to those shareholders in the order and to the extent of their respective priorities or the holders of shares who do not receive distributions in that order give notice to the corporation of their agreement to waive their rights to that distribution.

A determination that the payment of the distribution does not reduce the remaining net assets of the corporation below the aggregate preferential amount payable in the event of liquidation to the holders of shares having preferential rights is presumed to be proper if the determination is made in compliance with the standard of conduct provided in section 302A.251 on the basis of financial information prepared in accordance with accounting methods, or a fair valuation, or other methods, reasonable in the circumstances. Liability under section 302A.251 or 302A.559 will not arise if the requirements of this paragraph are met.

(b) If the money or property available for distribution is insufficient to satisfy all preferences, the distributions shall be made pro rata according to the order of priority of preferences by classes and by series within those classes unless those holders who do not receive distributions in that order give notice to the corporation of their agreement to waive their rights to that distribution.

Voting

The holders of the Common Stock are entitled to one vote for each share of Common Stock held at all meetings of stockholders (and written actions in lieu of meetings). There is no cumulative voting for Common Stock.

Redemption Provisions

Common Stock does not have any redemption rights.

Sinking Fund Provisions

The Amended Certificate of Incorporation does not contain any Sinking Fund Provisions.

Liability to Further Calls

The Amended Certificate of Incorporation does not contain any provisions regarding liability to further calls.

Restrictions on Alienability

The Shares have no restrictions on alienability for Shares of Common Stock.

12 

Part F/S

 Financial Statements and Independent Auditor’s Report

for

Medical 21, Inc.

December 31, 2021 and 2020

INDEPENDENT AUDITOR’S REPORT

To the Stockholders of Medical 21, Inc.

Opinion

We have audited the accompanying financial statements of Medical 21, Inc. (the “Company”), which comprise of the balance sheets as of December 31, 2021 and 2020, and the related statements of operations, changes in stockholders’ equity, and cash flows for the years then ended, and the related notes to the financial statements.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and cash flows for the years then ended in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP’).

Basis of Opinion

We conducted our audits in accordance with auditing standards generally accepted in the United States of America (“U.S. GAAS”). Our responsibilities under those standards are further described in the Auditor’s Responsibilities for the Audit of the Financial Statements section of our report. We are required to be independent of the Company and to meet our other ethical requirements relating to our audits. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

Responsibilities of Management for the Financial Statements

Management is responsible for the preparation and fair presentation of the financial statements in accordance with U.S. GAAP, and for the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error.

In preparing the financial statements, management is required to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are available to be issued.

Auditor’s Responsibilities for the Audit of the Financial Statements

Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue and auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance but is not absolute assurance and therefore is not a guarantee that an audit conducted in accordance with U.S. GAAS will always detect material misstatement when it exists. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control. Misstatements are considered material if there is a substantial likelihood that, individually or in the aggregate, they would influence the judgement made by a reasonable user based on the financial statements.

In performing an audit in accordance with U.S. GAAS, we:

Exercise professional judgement and maintain professional skepticism throughout the audit.

Identify and assess the risks of material misstatement of the financial statements, whether due to fraud or error, and design and perform audit procedures responsive to those risks. Such procedures include examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.

Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control. Accordingly, no such opinion is expressed.

Evaluate the appropriate of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluate the overall presentation of the financial statements.

Conclude whether, in our judgement, there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time.

We are required to communicate with those charged with governance regarding, among others matters, the planned scope and timing of the audit, significant audit findings, and certain internal control related matters that we identified during the audit.

s/ Assurance Dimensions

Jacksonville, Florida

January 31, 2022

13 

ASSETS

Current assets:	2021		2020
Cash	$	3,514,121	$	1,339,050
Prepaid expenses		175,615		4,561
Total current assets		3,689,736		1,343,611
Intangible assets, net		152,412		169,079
Property and equipment, net		798,406		938,720
Total assets		4,640,554	$	2,451,410

LIABILITIES AND STOCKHOLDER’S EQUITY

Current liabilities:	2021		2020
Accounts payable and accrued liabilities	$	150,306	$	—
Total Liabilities		150,306		—
Shareholders’ equity:
Common stock, $0.01 par value, 100,000,000 shares authorized; 18,065,830 and 16,602,228 shares issued and outstanding for 2021 and 2020, respectively		180,658		166,022
Additional paid-in capital		13,570,249		7,658,801
Accumulated deficit		(9,260,659)		(5,400,413)
Total Stockholders’ equity		4,490,248		2,451,410
Total liabilities and stockholders’ equity	$	4,640,554	$	2,451,410

Medical 21, Inc.

Statements of Operations

For the Years Ended December 31, 2021 and 2020

Operating revenue	2021		2020
Operating expenses:	$		$
Salaries & benefits		2,380,301		885,777
Research & development expanses		870,248		478,221
Professional fees		129,522		103,455
Depreciation and amortization		182,622		143,580
Insurance		105,916		95,190
Rent expense		80,866		79,148
Travel expense		51,876		16,469
Office expense		28,955		18,637
Bank charges		24,352		360
Other expenses		5,887		3,504
Total operating expenses		3,860,545		1,824,341
Operating loss		(3,860,545)		(1,824,341)
Other income:
Interest income		299		1,819
Total other income		299		1,819
Net loss	$	(3,860,246)	$	(1,822,522)

Medical 21, Inc.

Statements of Changes in Stockholders’ Equity

For the Years Ended December 31, 2021 and 2020

	Common		Stock
	Shares		Amount		Additional Paid-In capital		Accumulated deficit		Total
Balance at December 31, 2019		15,778,228	$	157,782	$	5,272,218	$	(3,577,891)	$	1,852,109
Issuance of common stock		824,000		8,240		2,051,760		—		2,060,000
Stock-based compensation expense		—		—		361,823		—		361,823
Net loss		—		—		—		(1,822,522)		(1,822,522)
Balance at December 31, 2020		16,602,228		166,022		7,685,801		(5,400,413)		2,451,410
Issuance of common stock		1,463,602		14,636		4,331,864		—		4,346,500
Stock-based compensation expense		—		—		1,552,584		—		1,552,584
Net loss		—		—		—		(3,860,246)		(3,860,246)
Balance at December 31, 2021		18,065,830	$	180,658	$	13,570,249	$	(9,260,659)	$	4,490,248

Medical 21, Inc.

Statements of Cash Flows

For the Years Ended December 31, 2021 and 2020

Cash flows from operating activities:	2021		2020
Net loss	$	(3,860,246	$	(1,822,522)
Adjustments to reconcile net loss to net cash used by operating activities:
Depreciation and amortization		182,622		143,580
Stock-based compensation expense		1,552,584		361,823
Changes in assets and liabilities:
Prepaid expenses		(54)		12,763
Accounts payable and accrued liabilities		150,306		—
Net cash used by operating activities		(1,974,788)		(1,304,356)
Cash flows from investing activities:
Purchase of property and equipment		(25,641)		(74,776)
Net cash used by investing activities		(25,641)		(74,776)
Cash flows from financing activities:
Prepaid equity raise costs		(171,000)		—
Proceeds from common stock issued		4,346,500		2,060,000
Net cash provided by financing activities		4,175,500		2,060,000
Net change in cash		2,175,071		680,868
Cash at beginning of period				658,182
Cash at end of period	$	3,514,121	$	1,339,050
Supplemental and non-cash disclosures
Cash paid for income taxes	$	—	$	—
Cash paid for interest	$	—	$	—

The accompanying notes are an integral part of these financial statements.

14 

Notes to the Financial Statements

December 31, 2021 and 2020

Note A – Nature of Business

Medical 21, Inc. (the “Company”) is a Minnesota corporation organized in February 2016 to produce artificial grafts that eliminate the harvesting of vessels for cardiac bypass surgery, which improves the quality of life for patients and reduces costs for the healthcare system. The Company is currently in the developmental stages. The Company has its office in Plymouth, Minnesota.

Note B – Summary of Significant Accounting Policies

Basis of Accounting

The financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Such estimates include inventory reserves for obsolescence, allowance for uncollectible loans, depreciable lives of property and equipment and stock based compensation. Actual results could differ from those estimates.

Recent Accounting Pronouncements Not Yet Adopted

The Company periodically reviews new accounting standards that issued as Accounting Standards Updates (“ASU”) by the Financial Accounting Standard Board (“FASB”). The Company carefully considers all new pronouncements that alter previous U.S. GAAP, and has identified the following new accounting standards that it believes merits further discussion. Other accounting standards that have been issued or proposed by FASB that do not require adoption until a future date are not expected to have material impact on the financial statements upon adoption.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This Guidance amends the existing accounting standards for lease accounting, including requiring lessees to recognize most leases on their balance sheet. Under ASU 2020-05, ASU 2016-02 is effective for years beginning on or after December 15, 2021. Management is evaluating the impact of this ASU on the Company’s financial reporting.

In August 2020, the FASB issued ASU 2020-06, Debt- Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) – Accounting for Convertible Instruments and Contracts on an Entity’s Own Equity. The ASU simplifies accounting for convertible instruments by removing major separation models required under current U.S. GAAP. Consequently, more convertible debt instruments will be reported as a single liability instrument with no separate accounting for embedded conversion features. The ASU removes certain settlement conditions that are required for equity contracts to quality for the derivative scope exception, which will permit more equity contracts to qualify for the exceptions. The ASU also simplifies the diluted net income per share calculation in certain areas. The new guidance is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, and early adoption is permitted. The Company is currently evaluating the impact of the adoption of the standard on the financial statements.

15 

Note B – Summary of Significant Accounting Policies (continued)

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40).The new ASU addresses issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options. This amendment is effective for all entities, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact this new guidance will have its financial statements.

Cash

The Company deposits cash and cash equivalents with financial institutions which management believes is of high credit quality. The Company does not believe it is exposed to significant risk. At December 31, 2021 and 2020, there were no cash equivalents.

Prepaid Equity Raise Costs

The Company capitalizes all costs directly related to a specific equity raise and offsets them against proceeds of the raise when the raise is completed. The Company had a balance of approximately $171,000 in prepaid equity raise costs that are included in prepaid expenses on the accompanying balance sheet as of December 31, 2021. Management has reviewed the costs and has determined they are realizable.

Property and Equipment

Property and equipment are recorded at cost. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. Maintenance and repairs are charged to expense as incurred. Betterments and renewals are capitalized. When property and equipment are sold or otherwise disposed of, the asset account and related accumulated depreciation account are relieved, and any gain or loss is included in operations. The straight-line method of depreciation is used over the following estimated useful lives:

Lab equipment 7 Years

Leasehold improvements Lease Term

Computers & software 3-5 Years

Additions and improvements are capitalized, while replacements, maintenance, and repairs, which do not improve or extend the life of the respective assets, are expensed as incurred. Gains and losses from the disposition of assets are recorded in the year of disposition.

Intangible Assets

Intangible assets consist of patents and patents pending. Patents and patents pending are being amortized on the straight-line method over fifteen years, but not exceeding the initial expiration date of the patent.

Impairment of Long-Lived Assets

Long-lived assets such as property and equipment, and intangible assets subject to amortization are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If this review reveals an indicator of impairment, as determined based on estimated undiscounted cash flows, the carrying amounts of the related long-lived assets are adjusted to fair value. Management has determined that there has been no impairment in the carrying value of its long-lived assets as of December 31, 2021 and 2020.

16 

Note B – Summary of Significant Accounting Policies (continued)

Revenue Recognition

The Company is in the development stage. There were no revenues generated in 2021 or 2020.

Stock-Based Compensation

For stock-based compensation awards, the Company measures compensation costs for these awards to employees based upon the fair value of the award on the date of grant. The compensation cost is recognized over the requisite service period, which is generally the vesting period. The Company considers expected award forfeitures when determining the compensation cost to be recognized. The Company estimates the fair value of stock options using the Black-Scholes valuation model.

Product Testing and Research

The Company expenses product testing and research & development costs as incurred.

Income Taxes

The Company utilizes an asset and liability approach to financial accounting and reporting for income taxes. Deferred income tax assets and liabilities are computed annually for differences between the financial statement and tax basis of assets and liabilities that will result in taxable deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

The Company’s income tax returns are subject to review and examination by federal and state authorities in accordance with prescribed statutes. When accrued, interest and penalties related to unpaid taxes are included in income tax expense.

The Company adopted the income tax standard for uncertain tax positions. As a result of this implementation, the Company evaluated its tax positions and determined that it has no uncertain tax positions as of December 31, 2021 and 2020. The Company’s 2018-2021 tax years are open for examination for federal and state taxing authorities.

Note C – Intangible Assets

Intangible assets consisted of the following as of December 31:

	2021			2020			Useful Life (years)
Intellectual property	$	252,413		$	252,413			15
Less: accumulated amortization		(100,001	)		(83,334	)
Intangible assets, net	$	152,412		$	169,079

Amortization expense charged to operations for the years ended December 31, 2021 and 2020 was approximately $17,000.

17 

Note C – Intangible Assets (continued)

The following is a schedule of the estimated amortization expense for intangible assets over the remaining useful life:

Years ending December 31,
	2022	$	16,667
	2023		16,667
	2024		16,667
	2025		16,667
	2026		16,667
	Thereafter		16,667
			69,077
		$	152,412

Note D – Property and Equipment

Property and equipment consisted of the following as of December 31:

	2021			2020
Lab equipment	$	934,298		$	917,047
Leasehold improvements		257,621			257,621
Computers & software		16,886			8,496
Total property and equipment		1,208,805			1,183,164
Less: accumulated depreciation		(410,399	)		(2444,444	)
Property and equipment, net		&798,406		$	938,720

For the years ended December 31, 2021 and 2020, the depreciation expense was approximately $166,000 and $127,000, respectively.

Note E – Stockholder’s Equity

In January 2022, the board of directors authorized a 2:1 stock split effective for all outstanding shares as of December 31, 2021. The authorized and the issued shares on the balance sheets and the financial statements reflect the completion of the split.

Note F – Income Taxes

No provision or benefit for federal or state income taxes has been reflected for the years ended December 31, 2021 and 2020 since the Company reported losses and has established a valuation allowance against the total net deferred tax asset.

18 

Note F – Income Taxes (continued)

Significant components of the Company’s deferred tax assets and liabilities are as follows as of December 31:

	2021			2020
Net operating loss carryfoward	$	1,770,080		$	1,248,846
Property and equipment		(38,868	)		(27,494	)
Valuation allowance		(1,731,212	)		(1,221,352	)
Net deferred tax asset		$			$

The entire balance of the deferred tax asset has been offset by a valuation allowance since there may be limitations on the amount of net operating loss carryforwards which can be used in future years, and utilization of net operating loss carryforwards cannot be sufficiently assured at December 31, 2021 and 2020.

At December 31, 2021 and 2020, the Company had federal net operating loss carryforwards of approximately $6,200,000 and $4,300,000, respectively. Approximately $660,000 of the federal net operating loss will expire between 2036 and 2037. Net operating loss beginning in 2018 may be carried forward indefinitely but are limited to 80% of the taxable income in any one tax period. The utilization of the net operating loss carryforwards may be limited in the case of certain events including significant changes in ownership interests. The Company’s federal and state blended tax rate was 28.74% for the years ended December 31, 2021 and 2020.

Note G – Stock Option Plan

In January 2016, the Company established the 2016 Equity Incentive Plan (the “2016 Plan”). The purpose of the plan is to provide a method whereby directors, executive officers, key employees and outside consultants of the Company who are presently making and are expected to make substantial contributions to the Company’s future management and growth, may be forced incentives, and may be motivated by increased personal involvement in the fortunes and success of the Company to continue in its service thereby advancing the interests of the Company and its shareholders. The Company reserved 20,000,000 shares of common stock under the 2016 plan.

The fair value of each option award is estimated on the date of grant using the Black-Scholes option valuation model that uses the assumptions noted in the following table. Expected volatility of an industry sector index. The expected life of options granted is derived from the termination date related to the option. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.

The following assumptions were used to determine the fair value of the stock options for the years ended December 31, 2021 and 2020:

	2021			2020
Estimated fair value of underlying stock at grant date	$0.16 - $0.60			$0.16 - $0.60
Expected price		$2.50 - $3.75		$	2.50
Expected life		10 years			10 years
Risk-free interest rates		0.34% - 3.09%			0.34% - 3.09%
Volatility		0	%		0	%

19 

Note G – Stock Option Plan (continued)

Total stock-based compensation charged to operations for option-based arrangements amounted to approximately $1,553,000 and $362,000, respectively, for the years ended December 31, 2021 and 2020. At December 31, 2021, there was approximately $3,912,000 of unrecognized stock-based compensation expense.

A summary of the status of the Company’s outstanding stock options as of December 31, 2021 and 2020, and changes during the two years is as follows:

	Shares			Weighted Average Exercise Price
Outstanding at December 31, 2019		10,260,000		$	1.025
Granted		744,000			2.50
Exercised		—			—
Forfeited		(1,400,000	)		0.04
Outstanding at December 31, 2020		9,604,000			0.97
Granted		9,108,280			3.63
Exercised		—			—
Forfeited		—			—
Outstanding at December 31, 2021		18,712,280			2.27

A summary of the status of the Company’s outstanding stock options as of December 31, 2021 and 2020 is as follows:

		December 31, 2021						December 31, 2020
Exercise Prices		Shares		Contractual Life (Days)		Exercise Prices		Shares		Contractual Life (Days)
$	0.013		2,400,000		1,472	$	0.013		2,400,000		1,837
	0.25		400,000		1,472		0.25		400,000		1,837
	0.125		1,600,000		1,472		0.125		1,600,000		1,837
	0.50		600,000		1,711		0.50		600,000		2,076
	0.75		560,000		2,164		0.75		560,000		2,529
	1.125		1,300,000		2,466		1.125		1,300,000		2,831
	2.50		3,502,280		3,182		2.50		2,744,000		3,317
	3.75		8,350,000		3,608
	Total		18,712,280				Total		9,604,000

Note H – Commitments and Contingencies

Operating Leases

The Company leases its office space under a non-cancellable operating lease which expires in December 2022. Rent expense is recognized on a straight-line basis over the term of the lease. Total rent expense associated with the operating leases amounted to approximately $81,000 and $79,000 for the years ended December 31, 2021 and 2020, respectively.

Future minimum rental payments under non-cancellable operating leases (with initial or remaining lease terms in excess of one year) for each of the five years subsequent to December 31, 2021 are:

2022 $49,622

COVID-19

In March 2020, Congress established the Paycheck Protection Program (“PPP”) to provide relief to small businesses during the coronavirus pandemic (“COVID-19”) as part of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. The legislation authorized Treasury to use the Small Business Association’s 7(a) small business lending program to fund forgivable loans that qualifying businesses could spend to cover payroll, mortgage interest, rent, and utilities during the “Covered Period” defined as the 24-week period starting on the date the PPP loan proceeds are received. The Company received a PPP loan of $83,400. Upon meeting certain criteria as specified in the PPP program, the loan was eligible for partial or total forgiveness.

In June 2020, the AICPA issued Technical Question and Answer (“TQA”) 3200.18, Borrower Accounting for a Forgivable Loan Received Under the Small Business Administration Paycheck Protection Program. The TQA addresses accounting for not-for-profit entities that believe the PPP loan represents, in substance, a grant that is expected to be forgiven, it may account for the loan as revenue. The TQA further states that if such an entity expected to be forgiven, it may account for the loan as revenue. The TQA further states that if such entity expects to meet the PPP’s eligibility criteria and concludes that the PPP loan represents in substance, a grant that is expected to be forgiven, it may analogize to International Accounting Standard (“IAS”) 20 to account for the PPP loan. IAS 20 provides a model for the accounting of different forms of government assistance, which includes forgivable loans. Under this model, government assistance is not recognized until there is reasonable assurance (similar to the probable threshold in U.S. GAAP) that any conditions attached to the assistance will be met and the assistance will be received.

The Company applied for and received proceeds of $83,400 through the PPP program in April 2020, and used all of the funds for covered eligible expenses from April 2020 to June 2020. The loan was forgiven in January 2021. In analogizing to IAS 20, the Company considers the PPP loan a grant in 2020, and it is recorded as a reduction to related payroll expenses in salaries & benefits on the statements of operations.

Due to the COVID-19 outbreak in 2020, the Company was not closed at any point. Additionally, there were no staff furloughed or terminated due to COVID-19. Overall, the Company was not significantly affected by COVID-19.

Due to the level of risk this virus may have on the global economy, it is at least reasonably possible that it could have an impact on the operations of the Company in the near term that could materially impact the Company’s financial statements, however, management does not believe there will be any future impact. In addition, with vaccines and therapeutics coming to market, these will also help to mitigate any potential future losses.

Note I – Subsequent Events

In preparing the accompanying financial statements, the Company has evaluated events and transactions for potential recognition or disclosure through January 31, 2022, the date the financial statements were available to be issued. Management has determined that all subsequent events have been properly disclosed.

20 

PART III - EXHIBITS

Exhibit Index

Exhibit 2. Articles of Amendment to Articles of Incorporation of Medical 21, Inc.

Exhibit 4. Subscription Agreement

Exhibit 6. Amendment to the License Agreement between University of Iowa Research Foundation and Medical 21, Inc.

Exhibit 8. Escrow Agreement

Exhibit 11. Written Expert Consent Letter of Assurance Dimensions

Exhibit 12. Legal Opinion of Trae O’Neil High

21 

Signature Page

Pursuant to the requirements of Regulation A, the issuer certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form 1-A and has duly caused this Offering Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Minneapolis, MN, on March 10, 2022.

(Exact name of the Issuer as specified in its Charter)

Medical 21, Inc.

15070 23^rd Avenue North

Minneapolis, MN 55447

(952) 221-3104

By:

s/Dr. Manny Villafaña, Ph.D.Sc

Director, CEO of Medical 21, Inc.

(Date): March 10, 2022

Location Signed: Minneapolis, MN

This Offering Statement has been signed by the following Officers in the capacities and on the dates indicated.

s/Dr. Manny Villafaña, Ph.D.Sc

CEO, Medical 21, Inc.

(Date): March 10, 2022

Location Signed: Minneapolis, MN

This Offering Statement has been signed by the following Directors in the capacities and on the dates indicated.

s/Dr. Manny Villafaña, Ph.D.Sc

Director of Medical 21, Inc.

(Date): March 10, 2022

Location Signed: Minneapolis, MN

22 

EX1A-2A CHARTER

ARTICLES OF AMENDMENT

TO

ARTICLES OF INCORPORATION

OF

MEDICAL 21, INC.

Medical 21, Inc., a corporation organized and existing under and by the virtue of the Minnesota Business Corporation Act, hereby certifies as follows:

1.The name of the corporation is Medical 21, Inc. The original Articles of Incorporation were filed with the Minnesota Secretary of State on February 12, 2016.

2.These Articles of Amendment have been duly adopted pursuant to Minnesota Statutes, Chapter 302A.

3.That section 3.1 of Article 3 of the Articles of Incorporation is hereby amended by deleting the section entirely and replacing it with the following:

"3.1) Authorized Shares: Establishment of Classes and Series. The aggregate number of shares the corporation has authority to issue shall be 100,000,000 shares, which shall have a par value of $.01 per share solely for the purpose of a statute or regulation imposing a tax or fee based upon the capitalization of the corporation, and which shall consist of 80,000,000 common shares and 20,000,000 undesignated shares. The Board of Directors of the corporation is authorized to establish from the undesignated shares, by resolution adopted and filed in the manner provided by law, one or more classes or series of shares, to designate each such class or series (which may include but is not limited to designation as additional common shares), and to fix the relative rights and preferences of each such class or series."

4.The undersigned certifies that the foregoing is true and accurate and that the undersigned has the authority to sign this document on behalf of the corporation. I further certify that I have completed all required fields, and that the information in this document is true and correct and in compliance with the applicable chapter of Minnesota Statutes. I understand that by signing this document I am subject to the penalties of perjury as set forth in Section 609.48 as if had signed this document under oath.

[Signature page follows

1

IN WITNESS WHEREOF, this document has been executed as of the 11th day of October,

2021.

MEDICAL 21, INC.

s://Manny Villafana

By: Manny Villafana

Its: Chief executive Officer and

Chairman of the Board

[Signature Page to the Articles of Amendment to Articles of Incorporation of Medical 21, Inc.]

2

Work Item 1263172600045

Original File Number 872647900040

STATE OF MINNESOTA OFFICE OF THE SECRETARY OF STATE

FILED

10/12/2021 11:59 PM

s:// Steve Simon

Steve Simon

Secretary of State

3

Office of the Minnesota Secretary of State

Certificate of Incorporation

I, Steve Simon, Secretary of State of Minnesota, do certify that: The following business entity has duly complied with the relevant provisions of Minnesota Statutes listed below, and is formed or authorized to do business in Minnesota on and after this date with all the powers, rights and privileges, and subject to the limitations, duties and restrictions, set forth in that chapter.

The business entity is now legally registered under the laws of Minnesota.

Name: Medical 21, Inc.

File Number: 872647900040

Minnesota Statutes, Chapter: 302A

This certificate has been issued on: 02/12/2016

s:// Steve Simon

Steve Simon

Secretary of State

State of Minnesota

4

ARTICLES OF INCORPORATION OF

MEDICAL 21, INC.

The undersigned individual, being of full age, for the purpose of forming a corporation under and pursuant to Chapter 302A of the Minnesota Statutes, as amended, hereby adopts the following Articles of Incorporation:

ARTICLE 1 - NAME

1.1)       The name of the corporation is Medical 21, Inc.

ARTICLE 2 - REGISTERED OFFICE

2.1)       The registered office of the corporation is located at 1482 Hunter Drive, Wayzata, Minnesota 55391.

ARTICLE 3 - CAPITAL STOCK

3.1)Authorized Shares; Establishment of Classes and Series. The aggregate number of shares the corporation has authority to issue shall be 50,000,000 shares, which shall have a par value of $.01 per share solely for the purpose of a statute or regulation imposing a tax or fee based upon the capitalization of the corporation, and which shall consist of 40,000,000 common shares and 10,000,000 undesignated shares. The Board of Directors of the corporation is authorized to establish from the undesignated shares, by resolution adopted and filed in the manner provided by law, one or more classes or series of shares, to designate each such class or series (which may include but is not limited to designation as additional common shares), and to fix the relative rights and preferences of each such class or series.

3.2)Issuance of Shares. The Board of Directors of the corporation is authorized from time to time to accept subscriptions for, issue, sell and deliver shares of any class or series of the corporation to such persons, at such times and upon such terms and conditions as the Board shall determine, establishing a price in money or other consideration, or a minimum price, or a general formula or method by which the price will be determined.

3.3)Issuance of Rights to Purchase Shares. The Board of Directors is further authorized from time to time to grant and issue rights to subscribe for, purchase, exchange securities for, or convert securities into, shares of the corporation of any class or series, and to fix the terms, provisions, and conditions of such rights, including the exchange or conversion basis or the price at which such shares may be purchased or subscribed for.

3.4)Issuance of Shares to Holders of Another Class or Series. The Board is further authorized to issue shares of one class or series to holders of that class or series or to holders of another class or series to effectuate share dividends or splits.

5

ARTICLE 4 - RIGHTS OF SHAREHOLDERS

4.1)No Preemptive Rights. No shares of any class or series of the corporation shall entitle the holders to any preemptive rights to subscribe for or purchase additional shares of that class or series or any other class or series of the corporation now or hereafter authorized or

issued.

4.2)No Cumulative Voting Rights. There shall be no cumulative voting by the shareholders of the corporation.

4.3)Written Action by Shareholders. An action required or permitted to be taken at a meeting of the shareholders may be taken without a meeting by written action signed, or consented to by authenticated electronic communication, by shareholders having voting power equal to the voting power that would be required to take the same action at a meeting of the shareholders at which all shareholders were present. The written action is effective when it has been signed, or consented to by authenticated electronic communication, by the required shareholders, unless a different effective time is provided in the written action. When written action is permitted to be taken by less than all shareholders, all shareholders must be notified of its text and effective time no later than five (5) days after the effective time of the action. Failure to provide the notice does not invalidate the written action. A shareholder who does not sign or consent to the written action has no liability for any action authorized by the written action.

ARTICLE 5 - WRITTEN ACTION BY DIRECTORS

5.1) Written Action by Directors. Any action required or permitted to be taken at a Board meeting may be taken by written action signed, or consented to by authenticated electronic communication, by all of the directors or, in cases where the action need not be approved by the shareholders, by written action signed by the number of directors that would be required to take the same action at a meeting of the Board at which all directors were present.

ARTICLE 6 - MERGER, EXCHANGE, SALE OF ASSETS, CONVERSION AND DISSOLUTION

6.1) Where approval of shareholders is required by law, the affirmative vote of the holders of a majority of the voting power of all shares entitled to vote shall be required to authorize the corporation (i) to merge into or with one or more other corporations, (ii) to exchange its shares for shares of one or more other corporations, (iii) to sell, lease, transfer or otherwise dispose of all or substantially all of its property and assets, including its good will, (iv) to convert into a domestic limited liability company, or (v) to commence voluntary dissolution.

ARTICLE 7 - AMENDMENT OF ARTICLES OF INCORPORATION

7.1)       After the issuance of shares by the corporation, any provision contained in these Articles of Incorporation may be amended, altered, changed, or repealed by the affirmative vote of the holders of a majority of the voting power of all shares entitled to vote or such greater percentage as may be otherwise prescribed by the laws of the State of Minnesota.

6

ARTICLE 8 - LIMITATION OF DIRECTOR LIABILITY

8.1) To the fullest extent permitted by Chapter 302A, Minnesota Statutes, as the same exists or may hereafter be amended, a director of this corporation shall not be personally liable to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director.

ARTICLE 9 - INCORPORATOR

9.1)       The name and mailing address of the incorporator are as follows:

Julie A. Taylor

c/o Fredrikson & Byron P.A.

200 South 6^th Street, Suite 4000

Minneapolis, MN 55402

[Signature page follows]

7

IN WITNESS WHEREOF, the undersigned incorporator has hereunto set her hand this

l2th day of February 2016.

s:// Julie A. Taylor

Julie A. Taylor

8

Work Item 872647900040 Original File Number 872647900040

STATE OF MINNESOTA

OFFICE OF THE SECRETARY OF STATE FILED

02/12/2016 11:59 PM

s:// Steve Simon

Steve Simon

Secretary of State

EX1A-4 SUBS AGMT

MEDICAL 21, INC., A MINNESOTA CORPORATION

COMMON STOCK SHARES

REGULATION A+ SUBSCRIPTION AGREEMENT

Investing in securities represented by shares of common stock (“Shares”) of Medical 21, Inc. (the “Company”) involves significant risks. This investment is suitable only for persons who can afford to lose their entire investment and such investment could be illiquid for an indefinite period of time. No public market currently exists for the Shares, and if a public market develops following this offering, it may not continue.

The Shares have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities or blue-sky laws and are being offered and sold in reliance on exemptions from the registration requirements of the Securities Act and state securities or blue-sky laws. Although an offering statement has been filed with the Securities and Exchange Commission (the “SEC”), that offering statement does not include the same information that would be included in a registration statement under the Securities Act. The Shares have not been approved or disapproved by the SEC, any state securities commission or other regulatory authority, nor have any of the foregoing authorities passed upon the merits of this offering or the adequacy or accuracy of the offering circular or any other materials or information made available to subscriber in connection with this offering, through the online website platform https://www.medical21.com, (the “Platform” or “Portal”) or the SEC’s EDGAR website at www.sec.gov.

No sale may be made to persons in this offering who are not “accredited investors” if the aggregate purchase price is more than 10% of the greater of such investors’ annual income or net worth. The Company is relying on the representations and warranties set forth by each subscriber in this Subscription Agreement and the other information provided by subscriber in connection with this offering to determine compliance with this requirement.

Prospective investors may not treat the contents of the Subscription Agreement, the offering circular or any of the other materials available (collectively, the “Offering Materials”) or any prior or subsequent communications from the Company or any of its affiliates, officers, employees or agents as investment, legal or tax advice. In making an investment decision, investors must rely on their own examination of the Company and the terms of this offering, including the merits and the risks involved. Each prospective investor should consult the investor’s own counsel, accountant and other professional advisor as to investment, legal, tax and other related matters concerning the investor’s proposed investment.

The Company reserves the right in its sole discretion and for any reason whatsoever to modify, amend and/or withdraw all or a portion of the offering and/or accept or reject in whole or in part any prospective investment in the Shares or to allot to any prospective investor less than the amount of Shares such investor desires to purchase.

Except as otherwise indicated, the Offering Materials speak as of their date. Neither the delivery nor the purchase of the Shares shall, under any circumstances, create any implication that there has been no change in the affairs of the Company since that date.

This agreement (“Subscription Agreement,” or “Agreement”) is made as of the date set forth below by and between the undersigned (“Subscriber”) the Company and is intended to set forth certain representations, covenants and agreements between Subscriber and the Company with respect to the offering (the “Offering”) for sale by the Company of the Shares as described in the Company’s Offering Circular dated , 2022 (the “Offering Circular”), a copy of which has been delivered to Subscriber. The Shares are also referred to herein as the “Securities.”

SUBSCRIPTION

1.Subscription. Subject to the terms and conditions hereof, Subscriber hereby irrevocably subscribes for and agrees to purchase from the Company the number of Shares set forth on the Subscription Agreement Signature Page, and the Company agrees to sell such Shares to Subscriber at a purchase price of $5.80 per Share for the total amount set forth on the Subscription Agreement Signature Page (the “Purchase Price”), subject to the Company’s right to sell to Subscriber such lesser number of Shares as the Company may, in its sole discretion, deem necessary or desirable.

2.Delivery of Subscription Amount; Acceptance of Subscription; Delivery of Securities. Subscriber understands and agrees that this Subscription is made subject to the following terms and conditions:

a.Contemporaneously with the execution and delivery of this Agreement through the Platform, Subscriber shall pay the Purchase Price for the Shares in the form of ACH debit transfer, wire transfer, or credit card. Your subscription is irrevocable. The escrow agent (the “Escrow Agent”) appointed by the Company will maintain all such funds for Subscriber’s benefit until the earliest to occur of: (i) the Closing (as defined below), (ii) the rejection of such subscription or (iii) the termination of the Offering by the Company in its sole discretion;

b.Payment of the Purchase Price shall be made by Subscriber via the Portal, and shall be held in escrow by the Escrow Agent until Closing, after which time, the funds tendered by Subscriber will be available to the Company;

c.This subscription shall be deemed to be accepted only when this Agreement has been signed by an authorized officer or agent of the Company (the “Closing”), and the deposit of the payment of the Purchase Price for clearance will not be deemed an acceptance of this Agreement;

d.The Company shall have the right to reject this subscription, in whole or in part;

e.The payment of the Purchase Price (or, in the case of rejection of a portion of the Subscriber’s subscription, the part of the payment relating to such rejected portion) will be

returned promptly, without interest or deduction, if Subscriber’s subscription is rejected in whole or in part or if the Offering is withdrawn or canceled;

f.Subscriber shall receive notice and evidence of the digital entry (or other manner of record) of the number of the Shares owned by Subscriber reflected on the books and records of the Company and verified by the company’s transfer agent (the “Transfer Agent”), which books and records shall bear a notation that the Shares were sold in reliance upon Regulation A;

g.The Offering is described in the Offering Circular, that is available through the online website platform https://www.medical21.com, or the SEC’s EDGAR website at www.sec.gov. Please read this Agreement, the Offering Circular, and the Articles of Amendment to Articles of Incorporation of Medical 21, Inc. (the “Articles of Incorporation”). While they are subject to change, as described below, the Company advises you to print and retain a copy of these documents for your records.

REPRESENTATIONS AND WARRANTIES OF SUBSCRIBER

By executing this Subscription Agreement, Subscriber (and, if Subscriber is purchasing the Securities subscribed for hereby in a fiduciary capacity, the person or persons for whom Subscriber is so purchasing) represents and warrants, which representations and warranties are true and complete in all material respects as of the date of the Closing:

3.Requisite Power and Authority. Such Subscriber has all necessary power and authority under all applicable provisions of law to execute and deliver this Subscription Agreement. All action on Subscriber’s part required for the lawful execution and delivery of this Subscription Agreement has been or will be effectively taken prior to the Closing. Upon execution and delivery, this Subscription Agreement will be a valid and binding obligation of Subscriber, enforceable in accordance with its terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors’ rights and (b) as limited by general principles of equity that restrict the availability of equitable remedies.

4.Investment Representations. Subscriber understands that the Securities have not been registered under the Securities Act. Subscriber also understands that the Securities are being offered and sold pursuant to an exemption from registration contained in the Securities Act based in part upon Subscriber’s representations contained in this Agreement. Subscriber is purchasing the Shares for Subscriber’s own account. Subscriber has received and reviewed this Agreement, The Offering Circular and the Articles of Incorporation. Subscriber and/or Subscriber’s advisors, who are not affiliated with and not compensated directly or indirectly by the Company or an affiliate thereof, have such knowledge and experience in business and financial matters as will enable them to utilize the information which they have received in connection with the Offering to evaluate the merits and risks of an investment, to make an informed investment decision and to protect Subscriber’s own interest in connection with an investment in the Shares.

5. Illiquidity and Continued Economic Risk. Subscriber acknowledges and agrees that there is no ready public market for the Securities and that there is no guarantee that a market for their resale will ever exist. Subscriber must bear the economic risk of this investment indefinitely and the Company has no obligation to list the Securities on any market or take any steps (including registration under the Securities Act or the Securities Exchange Act of 1934, as amended) with respect to facilitating trading or resale of the Securities. Subscriber acknowledges that Subscriber is able to bear the economic risk of losing Subscriber’s entire investment in the Securities. Subscriber also understands that an investment in the Company involves significant risks and has taken full cognizance of and understands all of the risk factors relating to the purchase of Securities.

6.Accredited Investor Status or Investment Limits. Subscriber represents that either:

a.Subscriber is an “accredited investor” within the meaning of Rule 501 of Regulation D under the Securities Act; or

b.The Purchase Price set out below, on the signature page of this Agreement, together with any other amounts previously used to purchase Securities in this Offering, does not exceed 10% of the greater of the Subscriber’s annual income or net worth. Subscriber represents that to the extent it has any questions with respect to its status as an accredited investor, or the application of the investment limits, it has sought professional advice.

7.Additional Subscriber Information; Payment Information. Subscriber agrees to provide any additional documentation the Company may reasonably request, including documentation as may be required by the Company to form a reasonable basis that the Subscriber qualifies as an “accredited investor” as that term is defined in Rule 501 under Regulation D promulgated under the Act, or otherwise as a “qualified purchaser” as that term is defined in Regulation A promulgated under the Act, or as may be required by the securities administrators or regulators of any state, to confirm that the Subscriber meets any applicable minimum financial suitability standards and has satisfied any applicable maximum investment limits. Subscriber acknowledges that Subscriber’s responses to questions on the Platform are true, complete and accurate in all respects. Payment information provided by Subscriber through the Platform is true, accurate and correct and such payment information shall be deemed to be a part of this Agreement as if and to the same extent that such information was set forth herein.

8.Company Information. Subscriber has read the Offering Circular filed with the SEC, including the section titled “Risk Factors.” Subscriber understands that the Company is subject to all the risks that apply to early-stage companies, whether or not those risks are explicitly set out in the Offering Circular. Subscriber acknowledges that no representations or warranties have been made to Subscriber, or to Subscriber’s advisors or representative, by the Company or others with respect to the business or prospects of the Company or its financial condition.

9.Neither the Company nor the Platform is an Investment Advisor. Subscriber understands that neither the Company nor the Platform is registered under the Investment Company Act of 1940 or the Investment Advisers Act of 1940.

10. Valuation. Subscriber acknowledges that the price of the Securities was set by the Company on the basis of the Company’s internal valuation and no warranties are made as to value. Subscriber further acknowledges that future offerings of Securities may be made at lower valuations, with the result that the Subscriber’s investment will bear a lower valuation.

11.Domicile. Subscriber maintains Subscriber’s domicile (and is not a transient or temporary resident) at the address shown on the signature page and provided on the Platform.

12.Power of Attorney. Any power of attorney of the Subscriber granted in favor of the Company has been executed by the Subscriber in compliance with the laws of the state, province or jurisdiction in which such agreements were executed.

13.No Brokerage Fees. Other than commissions payable to Rialto Markets, a licensed broker-dealer, as placement agent, there are no claims for brokerage commission, finders’ fees or similar compensation in connection with the transactions contemplated by this Subscription Agreement or related documents based on any arrangement or agreement binding upon Subscriber. Subscriber will indemnify and hold the Company harmless against any liability, loss or expense (including, without limitation, reasonable attorneys’ fees and out-of-pocket expenses) arising in connection with any such claim.

14.Foreign Investors. If Subscriber is not a United States person (as defined by Section 7701(a)(30) of the Internal Revenue Code of 1986, as amended), Subscriber hereby represents that it has satisfied itself as to the full observance of the laws of its jurisdiction in connection with any invitation to subscribe for the Securities or any use of this Subscription Agreement, including (a) the legal requirements within its jurisdiction for the purchase of the Securities, (b) any foreign exchange restrictions applicable to such purchase, (c) any governmental or other consents that may need to be obtained, and (d) the income tax and other tax consequences, if any, that may be relevant to the purchase, holding, redemption, sale, or transfer of the Securities. Subscriber’s subscription and payment for and continued beneficial ownership of the Securities will not violate any applicable securities or other laws of the Subscriber’s jurisdiction.

15.Terms and Conditions of the Platform. Subscriber acknowledges that it has read, understands and agrees to the terms and conditions, privacy policy and disclaimers on the Platform.

16.Transfer Restrictions. Subscriber acknowledges and agrees that the Shares may be subject to restrictions on transfer pursuant to applicable federal and state laws, the Company’s Articles of Incorporation, and this Agreement. The Shares may not be sold, offered for sale, pledged or hypothecated in the absence of a registration statement in effect with respect to the Shares under the Securities Act or an opinion of legal counsel satisfactory to the Company that such registration is not required or unless the Shares are sold pursuant to Rule 144 or Rule 144A of the Securities Act. The Shares shall bear a digital or physical restrictive legend in substantially the following form (and a stop transfer order may be placed against transfer of such certificates or instruments):

THE SECURITIES EVIDENCED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITES ACT OF 1933 AND THEY ARE SUBJECT TO SIGNIFICANT

RESTRICTIONS ON TRANSFER PURSUANT TO APPLICABLE FEDERAL AND STATE LAWS, THE COMPANY’S ARTICLES OF INCORPORATION AND THE SUBSCRIPTION AGREEMENT PURSUANT TO WHICH THESE SECURITIES WERE ORIGINALLY SOLD. THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED OR HYPOTHECATED IN THE ABSENCE OF A REGISTRATION STATEMENT IN EFFECT WITH RESPECT TO THE SECURITIES UNDER SUCH ACT OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED OR UNLESS SOLD PURSUANT TO RULE 144 OR RULE 144A OF SUCH ACT.

ANY PURPORTED TRANSFER IN VIOLATION OF SUCH PROVISIONS SHALL BE VOID, AB INITIO.

SURVIVAL; INDEMNIFICATION

17.Survival; Indemnification. All representations, warranties and covenants contained in this Agreement and the indemnification contained herein shall survive (a) the acceptance of this Agreement by the Company, (b) changes in the transactions, documents and instruments described herein which are not material or which are to the benefit of Subscriber, and (c) the death or disability of Subscriber. Subscriber acknowledges the meaning and legal consequences of the representations, warranties and covenants herein, and that the Company has relied upon such representations, warranties and covenants in determining Subscriber’s qualification and suitability to purchase the Securities. Subscriber hereby agrees to indemnify, defend and hold harmless the Company, its officers, directors, employees, agents and controlling persons, from and against any and all losses, claims, damages, liabilities, expenses (including attorneys’ fees and disbursements), judgments or amounts paid in settlement of actions arising out of or resulting from the untruth of any representation of Subscriber herein or the breach of any warranty or covenant herein by Subscriber. Notwithstanding the foregoing, however, no representation, warranty, covenant or acknowledgment made herein by Subscriber shall in any manner be deemed to constitute a waiver of any rights granted to it under the Securities Act or state securities laws.

MISCELLANEOUS PROVISIONS

18.Caption and Headings. The Article and Section headings throughout this Agreement are for convenience of reference only and shall in no way be deemed to define, limit or add to any provision of this Agreement.

19.Notification of Changes. Subscriber agrees and covenants to notify the Company immediately upon the occurrence of any event prior to the consummation of this Offering that would cause any representation, warranty, covenant or other statement contained in this Agreement to be false or incorrect or of any change in any statement made herein occurring prior to the consummation of this Offering.

20.Assignability. This Agreement is not assignable by Subscriber, and may not be modified, waived or terminated except by an instrument in writing signed by the party against whom enforcement of such modification, waiver or termination is sought.

21. Binding Effect. Except as otherwise provided herein, this Agreement shall be binding upon and inure to the benefit of the parties and their heirs, executors, administrators, successors, legal representatives and assigns, and the agreements, representations, warranties and acknowledgments contained herein shall be deemed to be made by and be binding upon such heirs, executors, administrators, successors, legal representatives and assigns.

22.Obligations Irrevocable. The obligations of Subscriber shall be irrevocable, except with the consent of the Company, until the consummation or termination of the Offering.

23.Entire Agreement; Amendment. This Agreement states the entire agreement and understanding of the parties relating to the matters contained herein, superseding all prior contracts or agreements, whether oral or written. No amendment of the Agreement shall be made without the express written consent of the parties.

24.Severability. The invalidity or unenforceability of any particular provision of this Agreement shall not affect any other provision hereof, which shall be construed in all respects as if such invalid or unenforceable provision were omitted.

25.Notices. All notices and communications to be given or otherwise made to the Subscriber shall be deemed to be sufficient if sent by electronic mail to such address as set forth for the Subscriber at the records of the Company (or that you submitted to us via the Platform). You shall send all notices or other communications required to be given hereunder to the Company via email at (with a copy to be sent concurrently via prepaid certified mail to: Medical 21, Inc., 15070 23rd Avenue North, Minneapolis, Minnesota 55447, Attention: Investor Relations. Any such notice or communication shall be deemed to have been delivered and received on the first business day following that on which the electronic mail has been sent (assuming that there is no error in delivery). As used in this Section, “business day” shall mean any day other than a day on which banking institutions in the State of Minnesota are legally closed for business.

26.Counterparts. This Agreement may be executed in any number of counterparts, each of which when so executed and delivered shall be deemed to be an original and all of which together shall be deemed to be one and the same agreement.

27.Digital Signatures. Digital (“electronic”) signatures, often referred to as an “e-signature”, enable paperless contracts and help speed up business transactions. The 2001 E-Sign Act was meant to ease the adoption of electronic signatures. The mechanics of this Subscription Agreement’s electronic signature include your signing this Agreement below by typing in your name, with the underlying software recording your IP address, your browser identification, the timestamp, and a securities hash within an SSL encrypted environment. This electronically signed Subscription Agreement will be available to both you and the Company, as well as any associated brokers, so they can store and access it at any time, and it will be stored and accessible on the Platform and hosting provider, including backups. You and the Company each hereby consents and agrees that electronically signing this Agreement constitutes your signature, acceptance and agreement as if actually signed by you in writing. Further, all parties agree that no certification authority or other third-party verification is necessary to validate any electronic signature; and that

the lack of such certification or third-party verification will not in any way affect the enforceability of your signature or resulting contract between you and the Company. You understand and agree that your e-signature executed in conjunction with the electronic submission of this Subscription Agreement shall be legally binding and such transaction shall be considered authorized by you. By signing electronically below, you agree your electronic signature is the legal equivalent of your manual signature on this Subscription Agreement and you consent to be legally bound by this Subscription Agreement’s terms and conditions. Alternatively, you may opt-out of this provision by printing a copy of this Agreement, signing it manually and returning it to the Company and, if your subscription is accepted, the Company will manually countersign it and return a countersigned copy to you via email.

28.Consent to Electronic Delivery of Tax Documents. Please read this disclosure about how the Company will provide certain documents that it is required by the Internal Revenue Service (the “IRS”) to send to you (“Tax Documents”) in connection with your Shares. A Tax Document provides important information you need to complete your tax returns. Tax Documents include Form 1099 and/or Form K-1. Occasionally, the Company is required to send you CORRECTED Tax Documents. Additionally, the Company may include inserts with your Tax Documents. The Company is required to send Tax Documents to you in writing, which means in paper form. When you consent to electronic delivery of your Tax Documents, you will be consenting to delivery of Tax Documents, including these corrected Tax Documents and inserts, electronically instead of in paper form. By executing this Agreement on the Platform, you are consenting in the affirmative that the Company may send Tax Documents to you electronically and acknowledging that you are able to access Tax Documents from the site. If you subsequently withdraw consent to receive Tax Documents electronically, a paper copy will be provided. Your consent to receive the Tax Documents electronically continues for every tax year until you withdraw your consent. You can withdraw your consent before the Tax Document is furnished by mailing a letter including your name, mailing address, effective tax year, and indicating your intent to withdraw consent to the electronic delivery of Tax Documents to: Medical 21, Inc., 15070 23rd Avenue North, Minneapolis, Minnesota 55447, Attention: Investor Relations. If you withdraw consent to receive Tax Documents electronically, a paper copy will be provided. You Must Keep Your E-mail Address Current with the Company. You must promptly notify the Company of a change of your email address. If your mailing address, email address, telephone number or other contact information changes, you may also provide updated information by contacting the Company at: Medical 21, Inc., 15070 23rd Avenue North, Minneapolis, Minnesota 55447, Attention: Investor Relations, Phone or @medical21.com.

29.Electronic Delivery of Information. Subscriber and the Company each hereby agrees that all current and future notices, confirmations and other communications regarding this Agreement and future communications in general between the parties, may be made by email, sent to the email address of record as set forth in this Agreement or as otherwise from time to time changed or updated and disclosed to the other party, without necessity of confirmation of receipt, delivery or reading, and such form of electronic communication is sufficient for all matters regarding the relationship between the parties. If any such electronically sent communication fails to be received for any reason, including but not limited to such communications being diverted to the recipients spam filters by the recipients email service provider, or due to a recipient’s change of address, or due to technology issues by the recipients service provider, the parties agree that the

burden of such failure to receive is on the recipient and not the sender, and that the sender is under no obligation to resend communications via any other means, including but not limited to postal service or overnight courier, and that such communications shall for all purposes, including legal and regulatory, be deemed to have been delivered and received. No physical, paper documents will be sent to you, and if you desire physical documents then you agree to be satisfied by directly and personally printing, at your own expense, the electronically sent communication(s) and maintaining such physical records in any manner or form that you desire.

[SIGNATURE APPEARS ONLINE]

EX1A-6 MAT CTRCT

EX1A-8 ESCW AGMT

ESCROW AGREEMENT

This ESCROW AGREEMENT (this “Agreement”) dated as of this 4th day of January 2022 by and among Company, a Delaware corporation (the “Company”), having an address at ______; Rialto Markets, LLC, having an address at 42 Broadway, Ste 12-129, NY, NY 10004 (“Placement Agent”), and WILMINGTON TRUST, NATIONAL ASSOCIATION (the “Escrow Agent”), with its principal corporate trust office at 99 Wood Avenue South, 10^th Floor, Iselin, NJ 08830. The Company and the Placement Agent, each a “Party,” are collectively referred to as “Parties” and individually, a “Party.”

All capitalized terms not herein defined shall have the meaning ascribed to them in that certain Subscription Agreement, dated as of or about January 18, 2022, as amended or supplemented from time-to-time, including all attachments, schedules and exhibits thereto (the “Subscription Agreement”).

W I T N E S S E T H:

WHEREAS, the Company proposes to sell (the “Financing Transaction”) a maximum of ____________shares of our common stock, par value __________(“Common Stock”), at an offering price of $____________ per share (the “Shares”) for an offering amount of $______; provided, a minimum of gross proceeds of $___________ raised, in a public offering (the “Offering”) to investors (each, an “Investor”); and

WHEREAS, subject to all conditions to closing being satisfied or waived, the closing(s) of the Offering shall take place from time to time until the earlier of (a) the date which is one year after this Offering being qualified by the U.S. Securities and Exchange Commission (the “SEC” or the “Commission”), or (b) the date on which this Offering is earlier terminated by the Company in its sole discretion (the “Termination Date”) (the earlier of (a) or (b), the “Final Termination Date”); and

WHEREAS, there is no minimum offering amount and all funds shall only be returned to the potential Investors in the event the Offering is not consummated or if the Company, in its sole discretion, rejects all or a part of a particular potential Investor’s subscription; and

WHEREAS, in connection with the Financing Transaction contemplated by the Subscription Agreement, the Company entered into a Placement Agent Agreement between the Company and the Placement Agent, and certain other agreements, documents, instruments and certificates necessary to carry out the purposes thereof, including without limitation the Subscription Agreement (collectively, the “Transaction Documents”); and

WHEREAS, the Company and Placement Agent desire to establish an escrow account with the Escrow Agent into which the Company and Placement Agent shall instruct the Investors to deposit checks or make a wire transfer for the payment of money made payable to the order of “WILMINGTON TRUST, N.A. as Escrow Agent for ____,” and the Escrow Agent is willing to accept said checks and other instruments for the payment of money in accordance with the terms hereinafter set forth; and

WHEREAS, the Company and Placement Agent represent and warrant to the Escrow Agent that they have not stated to any individual or entity that the Escrow Agent’s duties will include anything other than those duties stated in this Agreement; and

WHEREAS, THE ISSUER AND THE PLACEMENT AGENT UNDERSTAND THAT THE ESCROW AGENT, BY ACCEPTING THE APPOINMTMENT AND DESIGNATION AS ESCROW AGENT HEREUNDER, IN NO WAY ENDORSES THE MERITS OF THE OFFERING OF THE SECURITIES. THE ISSUER AND THE PLACEMENT AGENT AGREE TO NOTIFY ANY PERSON ACTING ON ITS BEHALF THAT THE ESCROW AGENT’S POSITION AS ESCROW AGENT DOES NOT CONSTITUTE SUCH AN ENDORSEMENT, AND TO PROHIBIT SAID PERSONS FROM THE USE OF THE ESCROW AGENT’S NAME AS AN ENDORSER OF SUCH OFFERING. The Issuer and the Placement Agent further agree to include with any sales literature, in which the Escrow Agent’s name appears and which is used in connection with such offering, a statement to the effect that the Escrow Agent in no way endorses the merits of the offering; and

WHEREAS, the Company and Placement Agent represent and warrant to the Escrow Agent that a copy of each document that has been delivered to the Investor and third parties that include Escrow Agent’s name and duties, has been attached hereto as Schedule I.

NOW, THEREFORE, IT IS AGREED as follows:

Article 1

ESCROW DEPOSIT

Section 1.1 Delivery of Escrow Funds.

(a)        Placement Agent and the Company shall instruct the Investor to deliver to Escrow Agent checks made payable to the order of “WILMINGTON TRUST, N.A. as Escrow Agent for ______ Escrow”, or wire transfer to:

Wilmington Trust Company

ABA #: 031100092

A/C #: TBD

A/C Name:

Attn: Boris Treyger

International Wires:

M&T

Buffalo, New York

ABA: 022000046

SWIFT: MANTUS33

Beneficiary Bank: Wilmington Trust

Beneficiary ABA: 031100092

A/C #: TBD

A/C Name:

All such checks and wire transfers remitted to the Escrow Agent shall be accompanied by information identifying each Investor, subscription, the Investor’s social security or taxpayer identification number and address. In the event the Investor’s address and/or social security number or taxpayer identification number are not provided to Escrow Agent by the Investor, then Placement Agent and/or the Company agree to promptly upon request provide Escrow Agent with such information in writing. The checks or wire transfers shall be deposited into a non-interest-bearing account at WILMINGTON TRUST, NATIONAL ASSOCIATION entitled “WILMINGTON TRUST, N.A. as Escrow Agent ______” (the “Escrow Account”).

Investors can also send funds using credit or debit card by utilizing the Invoice and Pay® service offered by M&T Bank by visiting the portal listed below:

https://www.sampleportal.mtb.com”

(b)       The collected funds deposited into the Escrow Account are referred to as the “Escrow Funds.”

(c)       The Escrow Agent shall have no duty or responsibility to enforce the collection or demand payment of any funds deposited into the Escrow Account. If, for any reason, any check deposited into the Escrow Account shall be returned unpaid to the Escrow Agent, the sole duty of the Escrow Agent shall be to return the check to the Investor and advise the Company and Placement Agent promptly thereof.

(d)       All funds received by the Escrow Agent shall be held only in non-interest-bearing bank accounts at WILMINGTON TRUST, NATIONAL ASSOCIATION.

(e) In the event that market conditions are such that negative interest applies to amounts deposited with the Escrow Agent, the Company and Placement Agent [jointly and severally] shall be responsible for the payment of such interest and the Escrow Agent shall be entitled to deduct from amounts on deposit with it an amount necessary to pay such negative interest. For the avoidance of doubt, the indemnification protections afforded to the Escrow Agent under Section 2.2 of this Agreement shall cover any interest-related expenses (including, but not limited to, negative interest) incurred by the Escrow Agent in the performance of its duties hereunder.

Section 1.2 Release of Escrow Funds. The Escrow Funds shall be paid by the Escrow Agent in accordance with the following:

(a)       In the event that the Company advises the Escrow Agent in writing that the Offering has been terminated (the “Termination Notice”), the Escrow Agent shall promptly return the funds paid by each Investor to such Investor without interest or offset.

(b)       At each Closing, the Company and the Placement Agent shall provide the Escrow Agent with written instructions regarding the disbursement of the Escrow Funds in accordance with Exhibit A attached hereto and made a part hereof and signed by the Company and the Placement Agent (the “Disbursement Instructions”).

(c)       If by 5:00 P.M. Eastern time on the Final Termination Date, the Escrow Agent has not received written Disbursement Instructions from the Company and Placement Agent regarding the disbursement of the Escrow Funds in the Escrow Account, if any, then the Escrow Agent shall promptly return such Escrow Funds, if any, to the Investors without interest or offset. The Escrow Funds returned to the Investors shall be free and clear of any and all claims of the Escrow Agent.

(d)       The Escrow Agent shall not be required to pay any uncollected funds or any funds that are not available for withdrawal.

(e)        The Placement Agent or the Company will provide the Escrow Agent with the payment instructions for each Investor, to whom the funds should be returned in accordance with this section.

(f)        In the event that Escrow Agent makes any payment to any other party pursuant to this Escrow Agreement and for any reason such payment (or any portion thereof) is required to be returned to the Escrow Account or another party or is subsequently invalidated, declared to be fraudulent or preferential, set aside and/or required to be repaid to a receiver, trustee or other party under any bankruptcy or insolvency law, other federal or state law, common law or equitable doctrine, then the recipient party shall repay to the Escrow Agent upon written request the amount so paid to it.

(g)       The Escrow Agent shall, in its sole discretion, comply with judgments or orders issued or process entered by any court with respect to the Escrow Amount, including without limitation any attachment, levy or garnishment, without any obligation to determine such court's jurisdiction in the matter and in accordance with its normal business practices. If the Escrow Agent complies with any such judgment, order or process, then it shall not be liable to any of the Parties or any other person by reason of such compliance, regardless of the final disposition of any such judgment, order or process.

(h)       Each Party understands and agrees that Escrow Agent shall have no obligation or duty to act upon a written direction delivered to Escrow Agent for the disbursement of all or part of the Escrow Amount under this Agreement (a “Written Direction”) if such Written Direction is not

(i) in writing,

(ii) signed by representatives of both Parties listed in Schedule II to this Agreement, in each case, each such individual an “Authorized Representative” of such Party), and

(iii) delivered to, and able to be authenticated by, Escrow Agent in accordance with Section 1.4 below.

(i)       Upon request by any Party, the Escrow Agent set up each Party with on-line access to the account(s) established pursuant to this Agreement, which each Party can use to view and verify transaction on such account(s).

(j)       A Party may specify in a Written Direction whether such Escrow Amount shall be disbursed by way of wire transfer or check. If the written notice for the disbursement of funds does not so specify the disbursement means, Escrow Agent may disburse the Escrow Amount by wire transfer.

Section 1.3 Written Direction and Other Instruction.

(a)With respect to any Written Direction or any other notice, direction or other instruction required to be delivered by a Party to Escrow Agent under this Agreement, Escrow Agent is authorized to follow and rely upon any and all such instructions given to it from time to time if the Escrow Agent believes, in good faith, that such instruction is genuine and to have been signed by an Authorized Representative of such Party. Escrow Agent shall have no duty or obligation to verify that the person who sent such instruction is, in fact, a person duly authorized to give instructions on behalf of a Party, other than to verify that the signature of the Authorized Representative on any such instruction appears to be the signature of such person. Each Party acknowledges and agrees that it is fully informed of the protections and risks associated with the various methods of transmitting instructions to Escrow Agent, and that there may be more secure methods of transmitting instructions other than the method selected by such Party. Escrow Agent shall have no responsibility or liability for any loss which may result from (i) any action taken or not taken by Escrow Agent in good faith reliance on any such signatures or instructions, (ii) as a result of a Party’s reliance upon or use of any particular method of delivering instructions to Escrow Agent, including the risk of interception of such instruction and misuse by third parties, or (iii) any officer or Authorized Representative of a Party named in Exhibit B delivered hereunder prior to actual receipt by Escrow Agent of a more current incumbency certificate or an updated Exhibit and a reasonable time for Escrow Agent to act upon such updated or more current certificate or Exhibit .

(b)       Each Party may, at any time, update Schedule II by signing and submitting to Escrow Agent an update of such Schedule. Any updated Schedule shall not be effective unless Escrow Agent countersigns a copy thereof. Escrow Agent shall be entitled to a reasonable time to act to implement any changes on an updated Schedule II.

Section 1.4 Delivery and Authentication of Written Direction.

(a)A Written Direction must be delivered to Escrow Agent by one of the delivery methods set forth in Section 4.3.

(b)Each Party and Escrow Agent hereby agree that the following security procedures will be used to verify the authenticity of a Written Direction delivered by any Party to Escrow Agent under this Agreement:

(i) The Written Direction must include the name and signature of the person delivering the disbursement request to Escrow Agent. Escrow Agent will check that the name and signature of the person identified on the Written Direction appears to be the same as the name and signature of an Authorized Representative of such Party;

(ii) Escrow Agent will make a telephone call to an Authorized Representative of the Party purporting to deliver the Written Direction (which Authorized Representative may be the same as the Authorized Representative who delivered the Written Direction) at any telephone number for such Authorized Representative as set forth on Exhibit A to obtain oral confirmation of delivery of the Written Direction. If the Written Direction is a joint written notice of the Parties, the Escrow Agent shall call back an Authorized Representative of both of those Parties; and

(iii) If the Written Direction is sent by email to Escrow Agent, Escrow Agent also shall review such email address to verify that it appears to have been sent from an email address for an Authorized Representative of one of the Parties as set forth on Schedule II, as applicable, or from an email address for a person authorized under Schedule II to email a Written Direction to Escrow Agent on behalf of the Authorized Representative).

(c)Each Party acknowledges and agrees that given its particular circumstances, including the nature of its business, the size, type and frequency of its instructions, transactions and files, internal procedures and systems, the alternative security procedures offered by Escrow Agent and the security procedures in general use by other customers and banks similarly situated, the security procedures set forth in this Section 1.4 are a commercially reasonable method of verifying the authenticity of a payment order in a Written Direction.

(d)Escrow Agent is authorized to execute, and each Party expressly agrees to be bound by any payment order in a Written Direction issued in its name (and associated funds transfer) (i) that is accepted by Escrow Agent in accordance with the security procedures set forth in this Section 1.4 , whether or not authorized by such Party and/or (ii) that is authorized by or on behalf of such Party or for which such Party is otherwise bound under the law of agency, whether or not the security procedures set forth in this Section 1.4 were followed, and to debit the Escrow Account for the amount of the payment order. Notwithstanding anything else, Escrow Agent shall be deemed to have acted in good faith and without negligence, gross negligence or misconduct if Escrow Agent is authorized to execute the payment order under this Section 1.4. Any action taken by Escrow Agent pursuant to this paragraph prior to Escrow Agent’s actual receipt and acknowledgement of a notice of revocation, cancellation or amendment of a Written Direction shall not be affected by such notice.

(e)The security procedures set forth in this Section 1.4 are intended to verify the authenticity of payment orders provided to Escrow Agent and are not designed to, and do not, detect errors in the transmission or content of any payment order. Escrow Agent is not responsible for detecting an error in the payment order, regardless of whether any of the Parties believes the error was apparent, and Escrow Agent is not liable for any damages arising from any failure to detect an error.

(f)When instructed to credit or pay a party by both name and a unique numeric or alpha-numeric identifier (e.g. ABA number or account number), Escrow Agent, and any other banks participating in the funds transfer, may rely solely on the unique identifier, even if it identifies a party different than the party named. Each Party agrees to be bound by the rules of any funds transfer network used in connection with any payment order accepted by Escrow Agent hereunder.

(g)       Escrow Agent shall not be obliged to make any payment requested under this Escrow Agreement if it is unable to validate the authenticity of the request by the security procedures set forth in this Section 1.4 . Escrow Agent’s inability to confirm a payment order may result in a delay or failure to act on that payment order. Notwithstanding anything else in this Agreement, Escrow Agent shall not be required to treat a payment order as having been received until Escrow Agent has authenticated it pursuant to the security procedures in this Section 2.3 and shall not be liable or responsible for any losses arising in relation to such delay or failure to act.

ARTICLE 2

PROVISIONS CONCERNING THE ESCROW AGENT

Section 2.1 Acceptance by Escrow Agent. The Escrow Agent hereby accepts and agrees to perform its obligations hereunder, provided that:

(a)       The Escrow Agent shall be entitled to rely upon any order, judgment, opinion, or other writing delivered to it in compliance with the provisions of this Agreement without being required to determine the authenticity or the correctness of any fact stated therein or the propriety or validity of service thereof.

(b)       The Escrow Agent shall be entitled to rely on and shall not be liable for any action taken or omitted to be taken by the Escrow Agent in accordance with the advice of counsel or other professionals retained or consulted by the Escrow Agent. The Escrow Agent shall be reimbursed as set forth in Section 2.2 for any and all compensation (fees, expenses and other costs) paid and/or reimbursed to such counsel and/or professionals. The Escrow Agent may perform any and all of its duties through its agents, representatives, attorneys, custodians, and/or nominees and shall not be responsible for the acts or omissions of such agents, representatives, attorneys, custodians or nominees appointed with due care.

(c)       In the event that the Escrow Agent shall be uncertain as to its duties or rights hereunder, the Escrow Agent shall be entitled to (i) refrain from taking any action other than to keep safely the Escrow Funds until it shall be directed otherwise by a court of competent jurisdiction, or (ii) deliver the Escrow Funds to a court of competent jurisdiction.

(d)       The Escrow Agent shall have no duty, responsibility or obligation to interpret or enforce the terms of any agreement other than Escrow Agent’s obligations hereunder, and the Escrow Agent shall not be required to make a request that any monies be delivered to the Escrow Account The Escrow Agent makes no representation as to the validity, value, genuineness or collectability of any security or other document or instrument held by or delivered to it.

(e)       The Escrow Agent shall be obligated to perform only such duties as are expressly set forth in this Agreement. No implied covenants or obligations shall be inferred from this Agreement against the Escrow Agent, nor shall the Escrow Agent be bound by the provisions of any agreement by the Company beyond the specific terms hereof. Without limiting the foregoing, the Escrow Agent shall dispose of the Escrow Funds in accordance with the express provisions of this Agreement, and has not reviewed and shall not make, be required to make or be liable in any manner for its failure to make, any determination under any other document, or any other agreement.

(f)       No term or provision of this Agreement is intended to create, nor shall any such term or provision be deemed to have created, any trust, joint venture, partnership, between or among the Escrow Agent and any of the Parties.

Section 2.2. Indemnification. Placement Agent and the Company agree, jointly and severally, to indemnify and hold the Escrow Agent and its employees, officers, directors and agents (the “Indemnified Parties”) the “Indemnified Parties”) harmless from any and against all liabilities, losses, actions, suits or proceedings at law or in equity, and any other expenses, fees or charges of any character or nature, (including, without limitation, negative interest, attorney's fees and expenses and the costs of enforcement of this Escrow Agreement or any provision thereof), which an Indemnified Party may incur or with which it may be threatened by reason of acting as or on behalf of the Escrow Agent under this Escrow Agreement or arising out of the existence of the Escrow Account, except to the extent the same shall be have been finally adjudicated to have been directly caused by the Escrow Agent's gross negligence or willful misconduct. Placement Agent and the Company agree, jointly and severally, to pay or reimburse the Escrow Agent upon request for any transfer taxes or other taxes relating to the Escrow Funds incurred in connection herewith and shall indemnify and hold harmless the Escrow Agent with respect to any amounts that it is obligated to pay in the way of such taxes. The terms of this paragraph shall survive termination of this Agreement.

Section 2.3. Limitation of Liability. the escrow agent SHALL NOT be liable, directly or indirectly, for any (i) damages, Losses or expenses arising out of the services provided hereunder, other than damages, losses or expenses which have been finally adjudicated to have DIRECTLY resulted from the escrow agent’s gross negligence or willful misconduct, or (ii) special, Indirect, PUNITIVE or consequential damages or LOSSES OF ANY KIND WHATSOEVER (INCLUDING WITHOUT LIMITATION LOST PROFITS), even if the escrow agent has been advised of the possibility of such LOSSES OR damages AND REGARDLESS OF THE FORM OF ACTION, OR (III) AMOUNT IN EXCESS OF THE ESCROW FUNDS.

Section 2.4. Resignation and Termination of the Escrow Agent. The Escrow Agent may resign at any time by giving 30 days’ prior written notice of such resignation to Placement Agent and the Company. Upon providing such notice, the Escrow Agent shall have no further obligation hereunder except to hold as depositary the Escrow Funds that it receives until the end of such 30-day period. In such event, the Escrow Agent shall not take any action, other than receiving and depositing the Investor’s checks and wire transfers in accordance with this Agreement, until the Company has designated a banking corporation, trust company, attorney or other person as successor. Upon receipt of such written designation signed by Placement Agent and the Company, the Escrow Agent shall promptly deliver the Escrow Funds to such successor and shall thereafter have no further obligations hereunder. If the Company and Placement Agent have failed to appoint a successor escrow agent prior to the expiration of thirty (30) days following the delivery of such notice of resignation or removal, the Escrow Agent shall be entitled, at its sole discretion and at the expense of the Company and/or Placement Agent, to (a) return the Escrow Funds to the Company, or (b) petition any court of competent jurisdiction for the appointment of a successor escrow agent or for other appropriate relief, and any such resulting appointment shall be binding upon the parties. In either case provided for in this paragraph, the Escrow Agent shall be relieved of all further obligations and released from all liability thereafter arising with respect to the Escrow Funds.

Section 2.5 Termination. The Company and Placement Agent may terminate the appointment of the Escrow Agent hereunder upon written notice specifying the date upon which such termination shall take effect, which date shall be at least 30 days from the date of such notice. In the event of such termination, the Company and Placement Agent shall, within 30 days of such notice, appoint a successor escrow agent and the Escrow Agent shall, upon receipt of written instructions signed by the Company and Placement Agent, turn over to such successor escrow agent all of the Escrow Funds Upon receipt of the Escrow Funds, the successor escrow agent shall become the escrow agent hereunder and shall be bound by all of the provisions hereof and the Escrow Agent shall be relieved of all further obligations and released from all liability thereafter arising with respect to the Escrow Funds and under this Agreement. If the Company has failed to appoint a successor escrow agent prior to the expiration of thirty (30) days following the delivery of the notice of termination, the Escrow Agent shall be entitled, at its sole discretion and at the expense of the Company, to (a) return the Escrow Funds to the Company, or (b) petition any court of competent jurisdiction for the appointment of a successor escrow agent or for other appropriate relief, and any such resulting appointment shall be binding upon the parties.

Section 2.6 Compensation. Escrow Agent shall be entitled, for the duties to be performed by it hereunder, to compensation as stated in the schedule attached hereto as Schedule III, which fee shall be paid by the Company upon the signing of this Agreement. In addition, the Company shall be obligated to reimburse Escrow Agent for all fees, costs and expenses incurred or that become due in connection with this Agreement or the Escrow Account, including attorney’s fees. Neither the modification, cancellation, termination, resignation or rescission of this Agreement nor the resignation or termination of the Escrow Agent shall affect the right of Escrow Agent to retain the amount of any fee which has been paid, or to be reimbursed or paid any amount which has been incurred or becomes due, prior to the effective date of any such modification, cancellation, termination, resignation or rescission. To the extent the Escrow Agent has incurred any such expenses, or any such fee becomes due, prior to any closing, the Escrow Agent shall advise the Company and the Company shall direct all such amounts to be paid directly at any such closing. As security for the due and punctual performance of any and all of the Company’s obligations to the Escrow Agent hereunder, now or hereafter arising, the Company, hereby pledges, assigns and grants to the Escrow Agent a continuing security interest in, and a lien on and right of setoff against, the Escrow Funds and all distributions thereon, investments thereof or additions thereto. If any fees, expenses or costs incurred by, or any obligations owed to, the Escrow Agent hereunder are not promptly paid when due, the Escrow Agent may reimburse itself therefor from the Escrow Funds, and may sell, convey or otherwise dispose of any Escrow Funds for such purpose. The security interest and setoff rights of the Escrow Agent shall at all times be valid, perfected and enforceable by the Escrow Agent against the Parties and all third parties in accordance with the terms of this Escrow Agreement. The terms of this paragraph shall survive termination of this Agreement.

Section 2.7. Merger or Consolidation. Any corporation or association into which the Escrow Agent may be converted or merged, or with which it may be consolidated, or to which it may sell or transfer all or substantially all of its corporate trust business and assets as a whole or substantially as a whole, or any corporation or association resulting from any such conversion, sale, merger, consolidation or transfer to which the Escrow Agent is a party, shall be and become the successor escrow agent under this Agreement and shall have and succeed to the rights, powers, duties, immunities and privileges as its predecessor, without the execution or filing of any instrument or paper or the performance of any further act.

Section 2.8. Attachment of Escrow Funds; Compliance with Legal Orders. In the event that any Escrow Amount shall be attached, garnished or levied upon by any court order, or the delivery thereof shall be stayed or enjoined by an order of a court, or any order, judgment or decree shall be made or entered by any court order affecting the Escrow Funds , the Escrow Agent is hereby expressly authorized, in its sole discretion, to respond as it deems appropriate or to comply with all writs, orders or decrees so entered or issued, or which it is advised by legal counsel of its own choosing is binding upon it, whether with or without jurisdiction. In the event that the Escrow Agent obeys or complies with any such writ, order or decree it shall not be liable to any Party or to any other person, firm or corporation, should, by reason of such compliance notwithstanding, such writ, order or decree be subsequently reversed, modified, annulled, set aside or vacated.

Section 2.9 Force Majeure. The Escrow Agent shall not be responsible or liable for any failure or delay in the performance of its obligation under this Agreement arising out of or caused, directly or indirectly, by circumstances beyond its reasonable control, including, without limitation, acts of God; earthquakes; fire; flood; wars; acts of terrorism; civil or military disturbances; sabotage; epidemic; pandemics; riots; interruptions, loss or malfunctions of utilities, computer (hardware or software) or communications services; accidents; labor disputes; acts of civil or military authority or governmental action; hacking, cyber-attacks or other unauthorized infiltration of Escrow Agent’s information technology infrastructure it being understood that the Escrow Agent shall use commercially reasonable efforts which are consistent with accepted practices in the banking industry to resume performance as soon as reasonably practicable under the circumstances.

Section 2.10 No Financial Obligation. Escrow Agent shall not be required to use its own funds in the performance of any of its obligations or duties or the exercise of any of its rights or powers, and shall not be required to take any action which, in Escrow Agent's sole and absolute judgment, could involve it in expense or liability unless furnished with security and indemnity which it deems, in its sole and absolute discretion, to be satisfactory.

ARTICLE 3
MISCELLANEOUS

Section 3.1. Successors and Assigns. This Agreement shall be binding on and inure to the benefit of each Party and the Escrow Agent and their respective successors and permitted assigns. No other persons shall have any rights under this Agreement.  No assignment of the interest of any of the Parties shall be binding unless and until written notice of such assignment shall be delivered to the other Parties and Escrow Agent and shall require the prior written consent of the other Parties and Escrow Agent (such consent not to be unreasonably withheld).

Section 3.2. Escheat. Each Party is aware that under applicable state law, property which is presumed abandoned may under certain circumstances escheat to the applicable state. The Escrow Agent shall have no liability to any of the Parties, their respective heirs, legal representatives, successors and assigns, or any other party, should any or all of the Escrow Funds escheat by operation of law.

Section 3.3. Notices. All notices, requests, demands, and other communications required under this Escrow Agreement shall be in writing, in English, and shall be deemed to have been duly given if delivered (i) personally, (ii) by facsimile transmission with written confirmation of receipt, (iii) by overnight delivery with a reputable national overnight delivery service, (iv) by mail or by certified mail, return receipt requested, and postage prepaid, or (v) by electronic transmission; including by way of e-mail (as long as such email is accompanied by a PDF or similar version of the relevant document bearing the signature of an Authorized Representative for the Party sending the notice) with email confirmation of receipt. If any notice is mailed, it shall be deemed given five business days after the date such notice is deposited in the United States mail. If notice is given to a party, it shall be given at the address for such party set forth below. It shall be the responsibility of the Company to notify the Escrow Agent in writing of any name or address changes. In the case of communications delivered to the Escrow Agent, such communications shall be deemed to have been given on the date received by the Escrow Agent.:

If to Placement Agent:

Rialto Markets, LLC

Name Ryan Simmons

Title Head of Operations

Company Rialto Markets LLC

Address       42 Broadway, Ste 12-129, NY, NY 1004

Telephone # (917) 279-7453

Email Address ryan@rialtomarkets.com

If to the Company:

Name

Title        

Company

Address       

Telephone #

Email Address

Copy:

Name

Title

Company

Address

Telephone #

Email Address

If to Escrow Agent:

WILMINGTON TRUST, NATIONAL ASSOCIATION

99 Wood Avenue South, 10^th Floor

Iselin, NJ 08830

Attention: Boris Treyger

Phone: (212) 941-4416

Email: btreyger@wilmingtontrust.com

Section 3.4. Governing Law and Jurisdiction. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware. Each Party and Escrow Agent hereby consents to the exclusive personal jurisdiction of the courts located in the State of Delaware in the event of a dispute arising out of or under this Agreement. Each Party and Escrow Agent hereby irrevocably waives any objection to the laying of the venue of any suit, action or proceeding and irrevocably submits to the exclusive jurisdiction of such court in such suit, action or proceeding.

Section 3.5. Entire Agreement. This Agreement and the Exhibits attached hereto (as updated from time to time in accordance herewith) set forth the entire agreement and understanding of the parties related to the Escrow Amount. If a court of competent jurisdiction declares a provision invalid, it will be ineffective only to the extent of the invalidity, so that the remainder of the provision and Escrow Agreement will continue in full force and effect.

Section 3.6. Amendment. This Agreement may be amended, modified, superseded, rescinded, or canceled only by a written instrument executed by each of the Parties and the Escrow Agent.

Section 3.7. Waivers. The failure of any party to this Agreement at any time or times to require performance of any provision under this Agreement shall in no manner affect the right at a later time to enforce the same performance. A waiver by any party to this Agreement of any such condition or breach of any term, covenant, representation, or warranty contained in this Agreement, in any one or more instances, shall neither be construed as a further or continuing waiver of any such condition or breach nor a waiver of any other condition or breach of any other term, covenant, representation, or warranty contained in this Agreement.

Section 3.8. Headings. Section headings of this Agreement have been inserted for convenience of reference only and shall in no way restrict or otherwise modify any of the terms or provisions of this Escrow Agreement.

Section 3.9. Electronic Signatures; Facsimile Signatures; Counterparts. This Escrow Agreement may be executed in one or more counterparts. Such execution of counterparts may occur by manual signature, electronic signature, facsimile signature, manual signature transmitted by means of facsimile transmission or manual signature contained in an imaged document attached to an email transmission, and any such execution that is not by manual signature shall have the same legal effect, validity and enforceability as a manual signature. Each such counterpart executed in accordance with the foregoing shall be deemed an original, with all such counterparts together constituting one and the same instrument. The exchange of executed copies of this Escrow Agreement or of executed signature pages to this Escrow Agreement by electronic transmission, facsimile transmission or as an imaged document attached to an email transmission shall constitute effective execution and delivery hereof. Any copy of this Escrow Agreement which is fully executed and transmitted in accordance with the terms hereof may be used for all purposes in lieu of a manually executed copy of this Escrow Agreement and shall have the same legal effect, validity and enforceability as if executed by manual signature.

Section 3.10. Waiver of Jury Trial. EACH OF THE PARTIES HERETO AND THE ESCROW AGENT EXPRESSLY WAIVES THE RIGHT TO TRIAL BY JURY IN RESOLVING ANY CLAIM OR COUNTERCLAIM RELATING TO OR ARISING OUT OF THIS AGREEMENT.

Section 3.11 Termination. This Agreement will terminate upon the Final Termination Date.

Section 3.12 Anti-Terrorism/Anti-Money Laundering Laws.

IMPORTANT INFORMATION ABOUT PROCEDURES FOR OPENING A NEW ACCOUNT - To help the United States government fight the funding of terrorism or money laundering activities, Federal law requires all financial institutions to obtain, verify, and record information that identifies each person who opens a new account. What this means for the parties to this Agreement: the Escrow Agent will ask for your name, address, date of birth, and other information that will allow the Escrow Agent to identify you (e.g., your social security number or tax identification number.) The Escrow Agent may also ask to see your driver’s license or other identifying documents (e.g., passport, evidence of formation of corporation, limited liability company, limited partnership, etc., certificate of good standing.)

[The balance of this page intentionally left blank – signature page follows]

IN WITNESS WHEREOF, the parties have duly executed this Agreement as of the date first set forth above.

(Company) Rialto Markets Inc. (Placement Agent)

By: ______________________________ By: _______________________

Name: Name: Ryan Simmons

Title: Title: Head of Operations

WILMINGTON TRUST, NATIONAL ASSOCIATION

as Escrow Agent

By: ______________________________

Name:

Title: Vice President

Schedule I

Form 1 a

EXHIBIT B

Certificate as to Authorized Signatures

of COMPANY / rialto markets llc

Company/Rialto Markets LLC hereby designates each of the following persons as its Authorized Representative for purposes of this Agreement, and confirms that the title, contact information and specimen signature of each such person as set forth below is true and correct. Each such Authorized Representative is authorized to initiate and approve transactions of all types for the Escrow Account[s] established under the Agreement to which this Exhibit A is attached, on behalf of [Company]/[Placement Agent].

Name (print):
Specimen Signature:
Title:
Telephone Number (required): If more than one, list all applicable telephone numbers.	Office:   Cell:
E-mail (required): If more than one, list all applicable email addresses.	Email 1: Email 2:

Name (print):
Specimen Signature:
Title:
Telephone Number (required): If more than one, list all applicable telephone numbers.	Office: Cell:
E-mail (required): If more than one, list all applicable email addresses.	Email 1: Email 2:

Name (print):
Specimen Signature:
Title:
Telephone Number (required): If more than one, list all applicable telephone numbers.	Office: Cell:
E-mail (required): If more than one, list all applicable email addresses.	Email 1: Email 2:

Additional Email Addresses:

The following additional email addresses also may be used by Escrow Agent to verify the email address used to send any Payment Notice to Escrow Agent:

Email 1:

Email 2:

Email 3:

COMPLETE BELOW TO UPDATE EXHIBIT A

If Company wishes to update this Exhibit A, Company must complete, sign and send to Escrow Agent an updated copy of this Exhibit A with such changes. Any updated Exhibit A shall be effective once signed by Company and Escrow Agent and shall entirely supersede and replace any prior Exhibit A to this Agreement.

[____________________________________]

By:_________________________

Name:

Title:

Date:

WILMINGTON TRUST, NATIONAL ASSOCIATION (as Escrow Agent)

By:_________________________

Name:

Title:

Date:

Schedule III

Fees of Escrow Agent

Acceptance Fee:                                                       Waived

Initial Fees as they relate to Wilmington Trust acting in the capacity of Escrow Agent – includes review of the Escrow Agreement; acceptance of the Escrow appointment; setting up of Escrow Account(s) and accounting records; and coordination of receipt of Escrow Information for deposit to the Escrow Account(s). Acceptance Fee payable at time of Escrow Agreement execution.

Escrow Agent Administration Fee: $8,000

For ordinary administrative services by Escrow Agent – includes daily routine account management; monitoring claim notices pursuant to the agreement; and disbursement of Escrow Information in accordance with the agreement.

Wilmington Trust’s bid is based on the following assumptions:

· Number of Escrow Accounts to be established: 1

· Est. Term: Under 12 months

· Escrow funds remain un-invested

Out-of-Pocket Expenses: Billed At Cost

Exhibit A

FORM OF ESCROW DISBURSEMENT INSTRUCTIONS

AND RELEASE NOTICE

Date:

WILMINGTON TRUST, NATIONAL ASSOCIATION

99 Wood Avenue South, 10^th Floor

Iselin, NJ 08830

Attention: Boris Treyger

Dear Mr./Ms _______:

In accordance with the terms of Section 1.2 of the Escrow Agreement dated as of _______, 2021 (the "Escrow Agreement"), by and between ______ (the “Company”), ______ (“Placement Agent”) and WILMINGTON TRUST, NATIONAL ASSOCIATION (the "Escrow Agent"), the Company and Placement Agent hereby direct the Escrow Agent to distribute all of the Escrow Funds (as defined in the Escrow Agreement) in accordance with the following wire instructions:

________________________: $

________________________: $

________________________: $

Very truly yours,

Company

By:__________________

Name: _________________

Title: ________________

Placement Agent

By:__________________

Name: _______________

Title: ________________

EX1A-11 CONSENT

CONSENT OF INDEPENDENT AUDITOR

We consent to the use, in this Offering Circular on Form 1-A, of our independent auditor’s report dated January 31, 2022, with respect to the audited balance sheets of Medical 21, Inc. as of December 31, 2021 and 2020, and the related statements of operations, changes in stockholders’ equity, cash flows and related notes to the financial statements for the years then ended.

Very truly yours,

Assuarance Dimensions

/s/ Assurance Dimensions

Tampa, Florida

March 9, 2022

EX1A-12 OPN CNSL

TRAE O’NEIL HIGH LEGAL SERVICE PC

Licensed in Texas Only

(347) 663-8063

thigh@tohlspc.com

CORPORATE ● SECURITIES ● MERGERS & ACQUISITIONS ● CONTRACTS

March 9, 2022

Medical 21, Inc.

Manny Villafaña, CEO

15070 23rd Avenue North

Minneapolis, MN 55447

Re: Regulation A Offering

Dear Mr. Villafaña:

In connection with the Regulation A offering of Common Stock of Medical 21, Inc. dated on or about March 9, 2022 (the “Offering”), please accept this letter as my opinion as to the legality of the securities covered by the Offering Circular associated therewith.

It is my opinion that the shares of Common Stock offered in the Offering will, when sold, be legally issued, fully paid and non-assessable under the laws of the State of Minnesota,^** in which Medical 21, Inc. is incorporated.

Very truly yours,

s/Trae O'Neil High Legal Services PC

Trae O'Neil High, Attorney

For the Firm

^**Not licensed in the State of Minnesota