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What changed in SS Innovations International, Inc.'s 10-K2022 vs 2023

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Paragraph-level year-over-year comparison of SS Innovations International, Inc.'s 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+73 added126 removedSource: 10-K (2024-03-22) vs 10-K (2023-03-31)

Top changes in SS Innovations International, Inc.'s 2023 10-K

73 paragraphs added · 126 removed · 4 edited across 3 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings. Currently there are no material legal proceedings pending or threatened against us. However, from time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in any such matter may harm our business. Item 4.
Biggest changeHowever, from time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in any such matter may harm our business. Item 4. Mine Safety Disclosures. Not applicable. 20 PART II
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Mine Safety Disclosures. Not applicable. 5 PART II
Added
Item 3. Legal Proceedings. In 2014, Avra Surgical Robotics, Inc., a Delaware corporation (“ Avra Surgical ”), of which Barry F.
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Cohen, our Chief Operating Officer – Americas and a director, was Chief Executive Officer, a director and a principal stockholder, got into a dispute with the law firm of Quinn Emmanuel Urquhart & Sullivan LLP (“ Quinn Emmanuel ”) over legal fees allegedly due Quinn Emmanuel.
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Avra Surgical, which was seeking to develop a robotic surgery system using certain technology developed in Germany by then had ceased operations. These events occurred prior to the formation of the Company as Avra Medical Robotics, Inc. Other than the facts that both Avra Surgical and our Company shared the Avra name and that Mr.
Added
Cohen was an officer, director and principal stockholder of both companies, there was no relationship between the two companies. On May 26, 2020, Quinn Emmanuel filed a petition in the Supreme Court of the State of New York, New York County against Avra Surgical, the Company (then known as Avra Medical Robotics, Inc.), Barry F. Cohen, Jared B.
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Stamell, an attorney affiliated with Avra Surgical and various individuals who at that time were or had been affiliated with Avra Surgical and or the Company (collectively, “ Respondents ”). The petition sought to recover the legal fees from the Respondents on the basis that they were “alter egos” of Avra Surgical.
Added
Other than the commonality of the Avra name and Mr. Cohen having been an officer, director and principal stockholder of both companies, there was no relationship between the two companies. As the Company and Mr.
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Cohen never received notice of filing of the petition or of subsequent proceedings (although Quinn Emmanuel filed affidavits with the Court stating that they had been duly served), neither the Company nor Mr. Cohen entered an appearance in the matter.
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The Company recently learned from a third party that in November 2020, the Court had rendered a decision holding that the Company and Messrs. Cohen and Stamell were “alter egos” of Avra Surgical and therefore were liable for payment of the Quinn Emmanuel legal fees.
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In addition, the Company also recently learned that in December 2023, the Court ordered the entry of a judgment against Avra Surgical, the Company and Messrs. Cohen and Stamell in the amount of $296,000 plus interest from November 2020. The Company is currently evaluating its legal options with respect to the matter. Notwithstanding the foregoing, Mr.
Added
Cohen and the Company have entered into an Indemnification Agreement, pursuant to which Mr. Cohen has agreed to fully indemnify the Company for any damages and costs (including legal fees) it incurs in connection with the action. Other than the foregoing, there are no legal proceedings currently pending or threatened against us.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information From July 2018 through September 2018, our common stock traded on the OTC Pink tier of the over-the counter market operated by OTC Markets Group, Inc.
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is currently quoted on the OTCPink tier of the over-the counter market maintained by OTC Markets Group, Inc. under the symbol SSII. However, the trading market for our common stock is sporadic and extremely limited.
Securities Authorized for Issuance under Equity Compensation Plans Plan category Number of securities to be issued upon exercise of outstanding options, warrants and rights Weighted- average exercise price of outstanding options, warrants and rights Number of securities remaining available for future issuance under equity compensation plans(excluding securities reflected in column (a)) Equity compensation plans approved by security holders 14,818,777 shares (1) $ $0.269 5,181,223 shares (1) Equity compensation plans not approved by security holders 0 shares -- 0 shares Total 14,818,777 (1) $ 0 5,181,2230 (1) (1) Represents shares of common stock under our 2016 Incentive Stock Plan. 6 Recent Sales of Unregistered Securities.
(Securities Authorized for Issuance under Equity Compensation Plans) Plan category Number of securities to be issued upon exercise of outstanding options, grants warrants and rights Weighted- average exercise price of outstanding options, grants warrants and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) Equity compensation plans approved by security holders 12,181,226 shares (1) $ 3.692 4,891,213 shares (1) Equity compensation plans not approved by security holders 0 shares 0 shares Total 12,181,226 (1) $ 0 4,891,213 (1) (1) Represents shares of common stock under our 2016 Incentive Stock Plan (the Incentive Plan ”).
Holders of our Common Stock As of March 30, 2023, we had 53,887,738 shares of common stock issued and outstanding and 191 holders of record of our common stock.
Holders of our Common Stock As of the date of this Annual Report, we had 170,724,381 shares of common stock issued and outstanding and 341 holders of record of our common stock.
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From September 2018 until September 2020, our common stock traded on the OTC QB tier of the over-the-counter market and from September 2020 until September 2021, our common stock again traded on the OTC Pink tier of the over-the-counter market.
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Moreover, until the review of the Form 15c2-11 which has been filed with FINRA on our behalf is completed and cleared (as to which no assurance can be given), our common stock is not eligible for proprietary broker-dealer quotations and may only be bought or sold in unsolicited customer orders. This further limits the trading market for our common stock.
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As a result of the death of the principal of our independent registered public accounting firm in December 2019 and the subsequent cessation of that firm’s operations, we temporarily ceased filing our periodic reports under the Exchange Act. Accordingly, commencing September 28, 2021, our common stock commenced trading on the Expert Market.
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One of these holders is CEDE and Company which is the mechanism used for brokerage firms to hold securities in book entry form on behalf of their clients and as of the date of this Annual Report, they held approximately 2,840,257 shares of common stock for these shareholders.
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In early December 2022, the Company became current again in our Exchange Act filings and our common stock began trading again on the OTC Pink tier of the over-the counter market. The trading symbol for our common stock is AVMR.
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As of the date of this Annual Report, 12,181,226 shares of common stock (comprised of 7,880,059 stock options and 4,301,167 stock grants) were issued under the Incentive Stock Plan.
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Regardless of which market our common stock has traded on, the trading market for our common stock has been sporadic and extremely limited. There can be no assurance that a liquid public trading market for our shares will develop or if developed, that it will be sustained.
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As of the date of this Annual Report, an additional 4,891,213 shares of common stock are available for future issuances under the Incentive Stock Plan. 21 Recent Sales of Unregistered Securities In October 2023, the Company issued 90,514 shares of our common stock upon the exercise of warrants previously sold to two accredited investors at an exercise price of $4.00 per share generating $362,056 in total proceeds.
Removed
During the quarter ended December 31, 2022, the Company issued and sold 4,401,000 shares of our common stock to 21 accredited investors at $0.25 per share receiving $1,100,250 in total proceeds.
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In October 2023, the Company issued 3,000 shares of common stock to a consultant in exchange for advisory services to be rendered over a 12-month period effective June 2023. In October 2023, the Company issued 50,000 shares of common stock to an investor relations firm for investor relations and digital marketing services.
Removed
On October 1, 2021, the Company’s CEO, converted a total of $595,000 of accrued salary into 5,950,000 shares of common stock at a price of $0.10 per share and agreed to receive 450,000 shares of common stock for $45,000 of the remaining salary due for the three months ending December 31, 2021 at a price of $0.10 per share.
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In November 2023, the Company issued 116,348 shares of common stock to Dr. S.P. Somashekhar, a director, in exchange for advisory services to be rendered over a five-year period. In November 2023, the Company issued a total of 22,541 shares of common stock to five physician consultants, in exchange for advisory services to be rendered over a five-year period.
Removed
On October 1, 2021, a former employee now a consultant elected to convert a total of $251,500 of accrued consulting fees into 2,515,000 shares of common stock at a price of $0.10 per share, converted $161,500 of accrued salary into 1,615,000 shares of common stock at a price of $0.10 per share. and $4,500 of expenses into 45,000 shares of common stock at a price of $0.10 per share.
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In November 2023, the Company issued 75,000 shares of common stock to a firm that conducted online investment seminars in which the Company participated. In December 2023, the Company issued 12,500 shares of common stock upon the exercise of warrants previously sold to three accredited investors at an exercise price of $4.00 per share, generating $50,000 in total proceeds.
Removed
On July 1, 2022 the Company paid $5,000 and issued to a consultant an option for 2,520,000 common shares with an exercise price of $0.10 per share as a performance bonus and for foregoing all accrued and unpaid fees due for 2022 and for foregoing a portion of the fees due for the remaining five months of calendar year 2022.
Added
All of the foregoing securities were issued in accordance with the exemption from registration afforded by Section 4(a)(2) of and/or Regulation D under the Securities Act, as amended, as the persons receiving such shares having provided the Company with appropriate representations as to their investment intent and their status as “ accredited investors ” as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.
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The option vested immediately. On July 1, 2022 the Company issued to its CEO an option for 5,400,000 common shares with an exercise price of $0.10 per share as a performance bonus and for foregoing all of his 2022 salary. The option vested immediately.
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On July 1, 2022 the Company issued to its Chief Medical Officer an option for 500,000 common shares with an exercise price of $0.10 per share as a performance bonus. The option vested immediately.
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On July 1, 2022 the Company issued to its Chief Strategy Advisor an option for 500,000 common shares with an exercise price of $0.10 per share as a performance bonus. The option vested immediately. On July 1, 2022 the Company issued 240,270 shares of common stock as payment in full for the accrued but unpaid fees due to its Counsel.
Removed
On July 1, 2022 the Company issued 27,250 shares of common stock to its patent attorney per their fee agreement. On July 1, 2022 the Company issued 160,000 shares of common stock to its Chief Strategy Officer as required by his Stock Grant Award dated April 15, 2019 and his Employment Agreement dated March 1, 2018.
Removed
On July 1, 2022 the Company issued 40,000 shares of common stock to its Chief Medical Officer as required by his employment agreement dated September 15, 2021 On July 1, 2022 the Company issued a total of 569,747 shares of common stock to several consultants.
Removed
In July 2022, four investors exercised their put options obtained from the Offering dated October 26, 2021, transferred their Membership Units in Avra Air LLC back to AVRA and received 301,027 shares of the Company’s common stock in return.
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On July 25, 2022 the Directors and Shareholders holding a majority of the issued and outstanding common shares of the Company adopted, by joint written consent, a resolution to increase the Company’s common stock reserved for issuance under the Company’s 2016 Incentive Stock Plan to 20,000,000. On August 5, 2022, AVRA entered into a non-binding letter of intent with Dr.
Removed
Sudhir Srivastava (“Dr. Srivastava”), Cardio Ventures Pvt. Ltd., a Bahamian private limited company of which Dr. Srivastava is the sole stockholder(“Cardio”), Otto Pvt, Ltd., a Bahamian private limited company and direct subsidiary of Cardio (“Otto”) and Sudhir Srivastava Innovations Pvt.
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Ltd., an Indian private limited company and indirect subsidiary of Cardio (“SSI,” and together with Cardio and Otto, the “SSI Parties”) with respect to a business combination between AVRA and the SSI Parties (the “Transaction”).
Removed
SSI, based in Haryana, India is engaged in the development, commercialization, manufacturing and sale of medical and surgical robotic systems utilizing patents, trademarks and other intellectual property held by Dr. Srivastava (the “SSI Intellectual Property”). 7 If and when the transaction is consummated, the business of the SSI Parties, including the SSI Intellectual Property will be owned by AVRA.
Removed
The shareholders of the SSI Parties will own 95% of the common stock of post-transaction AVRA and the current shareholders of AVRA will own 5% of the common stock of post-transaction AVRA.
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In addition, there will be changes in composition of the board of directors, implementation of corporate governance policies and changes in management, all with a view to listing the common stock of AVRA on the Nasdaq Stock Market, LLC or another National Securities Exchange.
Removed
In addition, AVRA will change its name to “SS Innovations International, Inc.” On November 7, 2022, AVRA entered into a definitive Merger Agreement (the “Merger Agreement”), by and among AVRA, AVRA-SSI Merger Corporation, a Delaware corporation and wholly-owned subsidiary of AVRA (“Merger Sub”), Cardio Ventures, Inc., a Delaware corporation (“SSI - DE”) Dr. Sudhir Srivastava (“Dr.
Removed
Srivastava”), who, through his holding company, owns a controlling interest in SSI-DE SSI-DE, through a subsidiary, owns a controlling interest in Sudhir Srivastava Innovations Pvt. Ltd., an Indian private limited company (“SSI - India”).
Removed
Based in Haryana, India, SSI-India is engaged in the development, commercialization, manufacturing and sale of medical and surgical robotic systems utilizing patents, trademarks and other intellectual property held by Dr. Srivastava (the “SSI Intellectual Property”). Pursuant to the Merger Agreement, Merger Sub will merge with and into SSI – DE (the “Merger”).
Removed
In the Merger, holders of the outstanding shares of common stock of SSI – DE at closing (including certain parties providing Interim Financing as described below), will receive in exchange for their SSI – DE shares, such number of shares of AVRA common stock as will result in such holders owning 95% of the outstanding post-Merger shares of AVRA common stock, with the current shareholders of AVRA owning 5% of the outstanding post-Merger shares of AVRA common stock.
Removed
In addition to the foregoing, upon completion of the Merger, the holders of SSI – DE common stock will receive, pro rata, shares of newly designated Series A Non-Convertible Preferred Stock (the “Series A Preferred Shares”).
Removed
The Series A Preferred Shares will vote together with Shares of our common stock as a single class on all matters presented to a vote of stockholders, except as required by law and entitle the holders of the Series A Preferred Shares to exercise 51.0% of the total voting power of the Company.
Removed
The Series A Preferred Shares are not convertible into common stock, do not have any dividend rights and have a nominal liquidation preference. The Series A Preferred Shares also have certain protective provisions, such as requiring the vote of a majority of Series A Preferred Shares to change or amend their rights, powers, privileges, limitations and restrictions.
Removed
The Series A Preferred Shares are automatically redeemable by the Company for nominal consideration at such time as the holder owns less than 50% of the shares of AVRA common stock received in the Merger. Concurrent with consummation of the Merger, Dr. Srivastava will assign the SSI Intellectual Property to AVRA or a subsidiary of AVRA.
Removed
Moreover, the current directors and executive officers will resign, other than Barry Cohen, who will continue as a director and in a new executive capacity, and the designees of the SSI – DE stockholders will be appointed to AVRA’s board of directors and management.
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Post – Merger, AVRA intends to focus a significant part of its efforts on expanding and further developing the business of SSI-India, which will be an indirect majority-owned subsidiary of AVRA. In addition to customary closing conditions, consummation of the Merger is subject to the following conditions to be satisfied or waived by SSI – DE and Dr.
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Srivastava at or prior to consummation of the Merger: ● AVRA shall have changed its corporate name to “SS Innovations International, Inc.;” ● AVRA shall have implemented a one for ten reverse stock split; and ● AVRA shall have increased its authorized common stock to 250,000,000 shares. 8 The Merger Agreement, the Merger and the above corporate actions have been approved by AVRA’s board of directors and majority stockholders.
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They are subject to the filing with and processing of an Issuer Company – Related Action Notification Form with the Financial Industry Regulatory Authority and the filing of appropriate amendments to our Articles of Incorporation with the Florida Secretary of State.
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On December 1, 2022, 10,000 shares of restricted common stock were issued for services to Farhan Taghizadeh, per his employment agreement dated September 15, 2020. During the quarter ended December 31, 2022, 60,000 shares of restricted common stock were issued to Nikhil Shah per his consulting agreement dated March 1, 2018.
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On December 1, 2022, 60,000 shares of restricted common stock were issued for services to a corporate services consultant. During the quarter ended December 31, 2022, 50,000 shares of restricted common stock were issued to legal counsel as a bonus for general corporate advisory and legal services.
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During the quarter ended December 31, 2022, 25,000 shares of restricted common stock were issued to each of Ettore Tomassetti and Alen York, in consideration for their services as members of the Board.
Removed
During the quarter ended December 31, 2022, 2,060,000 shares of restricted common stock were issued to Barry Cohen as a bonus for his services as Chief Executive Officer for an approximately eight year period.
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During the quarter ended December 31, 2022, 2,125,000 shares of restricted common stock were issued to an independent administrative consultant as a bonus for rendering services over and above those required pursuant to an agreement with the Company.
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During the quarter ended December 31, 2022, 15,000 shares of restricted common stock were issued to a third-party consultant as a bonus per a services agreement with the Company dated March 15, 2022.
Removed
During the quarter ended December 2022, 20,000 shares of restricted common stock were issued for services to Farhan Taghizadeh dated November 1, 2022 as per his employment agreement with the Company dated September 15, 2020.
Removed
During the quarter ended December 31, 2022, 18,146 shares of restricted common stock were issued for services completed through September 17, 2022 to an independent consultant, per a services agreement dated June 16, 2022.
Removed
During the quarter ended December 31, 2022, 11,641 shares of restricted common stock were issued for services completed through September 17, 2022 to another independent consultant, per a services agreement dated June 16, 2022. During the quarter ended December 31, 2022, the Company issued to a business consultant 1,000,000 shares of restricted common stock in exchange for services rendered.
Removed
The offer and sale of the above securities were made in private transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the “ Securities Act ”), in reliance on exemptions afforded by Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder. Item 6. [Reserved] Item 7.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations. Results of Operations Introduction The financial statements appearing elsewhere in this prospectus have been prepared assuming the Company will continue as a going concern. The Company was recently formed and has not established sufficient operations or revenues to sustain the Company.
Removed
These conditions raise substantial doubt about the Company’s ability to continue as a going concern. 9 The following table provides selected financial data about our Company at December 31, 2022 and December 31, 2021: Balance Sheet Data As of As of December 31, December 31, 2022 2021 Cash $ 1,351,364 $ 405,774 Total Assets $ 4,371,441 $ 428,607 Total Liabilities $ 4,051,229 $ 287,281 Total Stockholders’ Equity $ 320,213 $ 141,326 To date, the Company has relied on debt and equity raised in private offerings to finance operations and no other source of capital has been identified or sought.
Removed
If we experience a shortfall in operating capital, we could be faced with having to limit our research and development and marketing activities. Year ended December 31, 2022, as compared to year ended December 31, 2021 Revenues. We had no revenue during the years ended December 31, 2022 and December 31, 2021. Research and Development Expenses.
Removed
Research and development expenses during year ended December 31, 2022 were $72,959 as compared to $1,000 for the year ended December 31, 2021. Research and development expenses reflect continuing development work on the Company’s prototype robotic system at its facilities at UCF’s incubator in Orlando, Florida. Compensation Expense.
Removed
We had compensation expenses of $1,135,468 and $947,237 during year ended 2022 and 2021 respectively. This includes compensation for the management staff and stock-based compensation expense related to the Company’s 2016 Stock Incentive Plan. General and Administrative Expenses.
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We incurred $1,239,179 in general and administrative expenses during the year ended December 31, 2022, as compared to $458,801 for the year ended December 31, 2021. General and administrative expenses include legal and other professional expenses related to the Company’s filings as a public company with the Securities and Exchange Commission (the “ SEC ”). Other Income (Expenses) .
Removed
We have earned $234,594 during the year ended 2022 as compared to $118 during 2021. The increase in other income is primarily result of origination fees on notes. Net Loss. We incurred a net loss of $2,213,012 for 2022 as compared to a net loss of $1,484,313 for 2021.
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The increase in net loss from 2022 to 2021 is primarily a result of the increase in consulting fees, payroll expenses, compensation expenses. Liquidity and Capital Resources The Company expects to require substantial funds for research and development, to continue to develop its initial proposed medical robotic system.
Removed
The Company plans to meet its operating cash flow requirements by raising additional funds from the sale of our securities and, if possible, on favorable terms, by entering into development partnerships to assist the Company with its technology development activities.
Removed
Between October 5, 2021 to December 8, 2021 the Company sold a total of 2,229,231 shares of common stock at prices ranging between $0.13 and $0.52 per share.
Removed
The Company received proceeds of $315,200. 10 During the quarter ended December 31, 2022, the Company issued and sold 4,401,000 shares of our common stock at $0.25 per share to 21 purchasers in a private offering. The Company received proceeds of $1,100,250.
Removed
While we have been successful in raising funds to fund our operations since inception and we believe that we will be successful in obtaining the necessary financing to fund our operations going forward, we do not have any committed sources of funding and there are no assurances that we will be able to secure additional funding.
Removed
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern; however, if the efforts noted above are not successful, it would raise substantial doubt about the Company’s ability to continue as a going concern.
Removed
If we cannot obtain financing, then we may be forced to further curtail our operations or consider other strategic alternatives. Even if we are successful in raising the additional financing, there is no assurance regarding the terms of any additional investment and any such investment or other strategic alternative would likely substantially dilute our current shareholders.
Removed
Critical Accounting Policies Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
Removed
Actual results could differ from those estimates. Significant estimates included deferred revenue, costs incurred related to deferred revenue, the useful lives of property and equipment and the useful lives of intangible assets. Income Taxes The Company accounts for income taxes in accordance with ASC 740, Accounting for Income Taxes, as clarified by ASC 740-10, Accounting for Uncertainty in Income Taxes.
Removed
Under this method, deferred income taxes are determined based on the estimated future tax effects of differences between the financial statement and tax basis of assets and liabilities given the provisions of enacted tax laws. Deferred income tax provisions and benefits are based on changes to the assets or liabilities from year to year.
Removed
In providing for deferred taxes, the Company considers tax regulations of the jurisdictions in which the Company operates, estimates of future taxable income, and available tax planning strategies. If tax regulations, operating results or the ability to implement tax-planning strategies vary, adjustments to the carrying value of deferred tax assets and liabilities may be required.
Removed
Valuation allowances are recorded related to deferred tax assets based on the “more likely than not” criteria of ASC 740. ASC 740-10 requires that the Company recognize the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit.
Removed
For tax positions meeting the “more-likely-than-not” threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority.
Removed
Off-Balance Sheet Arrangements There are no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors. 11 Item 7A. Quantitative and Qualitative Disclosures About Market Risk Not applicable.
Removed
Item 8. Financial Statements and Supplementary Data. See the Index to the Financial Statements beginning on page F-1 below. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations .” We undertake no obligation to revise or update publicly any forward-looking statements for any reason.
Added
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. Introduction The Company is engaged in the business of developing, manufacturing, and selling a surgical robotic system under our proprietary brand “ SSi Mantra ,” together with allied accessories and a wide range of surgical instruments capable of supporting cardiac and a variety of other surgical procedures.
Removed
Unless the context otherwise requires, references in this report to “ AVRA ,” “ the Company ,” “ we ,” “ us ” and “ our ” refer to Avra Medical Robotics, Inc. ii PART I Item 1 Business.
Added
Having commenced commercial sales of our surgical robotic system in the second half of 2022, the year 2023 was our first full year of commercial sales of our surgical robotic system and its allied instruments and accessories.
Removed
Overview We are a medical robotics company developing a fully autonomous medical robotic system using proprietary software which integrates Artificial Intelligence (“ AI ”) and Deep Learning, or machine learning, (“ DL ”).
Added
Accordingly, the operating results detailed below largely reflect the impact of the consummation of the CardioVentures Merger in April 2023, when compared with operating results for the corresponding period in 2022.
Removed
By using an AI and DL enhanced software program, we are creating an intelligent robotic system that we believe can “ robotize ” a wide range of medical procedures currently being performed by human hands.
Added
Our financial performance is largely driven by increasing awareness of the benefits of robotically assisted surgery, reduced learning curves for robotic surgeons and the affordability and accessibility of surgical robotic technology. Our financial performance is also dependent on our obtaining regulatory approvals in various regulated markets where we have plans to sell our products.
Removed
We are concentrating our research and development efforts to meet rising expectations of patients and practitioners alike for the precision, safety and speed offered by an AI enhanced robotics platform system that can be combined with proven medical devices, end-effectors and surgical instruments.
Added
Robotically assisted surgeries are increasingly being recognized as an approved treatment modality from an insurance coverage perspective. Our manufacturing operations being based in India derive significant operating cost advantages in terms of availability of quality and cost-effective fabrication/3D printing solutions, electronic/electrical/mechanical components, outsourced services and skilled manpower.
Removed
We believe that progress in mechanical and software engineering has made possible lightweight and relatively inexpensive robotic devices for difficult procedures in various medical fields. Medical robots are already being successfully employed in several areas of surgery, including Urology (Prostate), Colo-Rectal, Gynecology, Thoracic, General Surgery, Orthopedics, and Neuro and Spine Surgery.
Added
All these factors help us in having lower costs of production which eventually helps us make our surgical robotic system cost effective and relatively affordable. 22 During the years ended December 31, 2023, and December 31, 2022, we sold twelve and three surgical robotic systems, respectively.
Removed
Robots are also being used for Telemedicine and assistive robotic methods are addressing the delivery of healthcare in inaccessible locations, ranging from rural areas lacking specialist expertise to post-disaster scenarios, and battlefield areas.
Added
In addition, during the year ended December 31, 2023, we also installed four systems in four hospitals, belonging to well-known hospital groups in India, for their clinical evaluation in anticipation of orders from these hospital groups. In addition to this, we also installed three systems on a pay-per-use basis.
Removed
With the aging population dominating demographics in the U.S. across all spectrums of healthcare, robotic technologies are being developed toward promoting improved function, lower morbidity and improved overall outcomes.
Added
These systems were installed in December 2023 and accordingly had not generated any revenues as of December 31, 2023. We also installed one system at the Johns Hopkins Hospital, in Baltimore, Maryland at no cost, for clinical training and ongoing research and development purposes.
Removed
We are developing a treatment-independent autonomous robotics system utilizing our proprietary AI-driven precision guidance system, applicable to a variety of minimally and non-invasive procedures, with an initial focus on skin resurfacing aesthetic procedures utilizing several FDA approved skin enhancing techniques robotized for superior performance and optimal results.
Added
As such, at the end of December 2023, we had a total of twenty-three installed systems of which 20 were installed during the year ended December 31, 2023. Results of Operations Introduction The financial statements appearing elsewhere in this report have been prepared assuming that the Company will continue as a going concern.
Removed
Our medical robotic system is being developed to deliver skin resurfacing treatments, such as micro-needling and laser therapies with improved efficiency, accuracy and precision over current procedures conducted by human hand, and only requiring the doctor to input or just confirm treatment parameters.
Added
The Company has recently commenced its commercial operations by way of the sale of its product and has not yet established consistent operational revenue cash flows to meet all its fixed operating costs and hence may continue to incur losses for some time. These conditions raise doubt about the Company’s ability to continue as a going concern.
Removed
As a result, use of our medical robotic system is expected to provide improved quality and safety as well as improve patient throughput and workflow.
Added
The following table provides selected financial data about our Company at December 31, 2023 and December 31, 2022: Balance Sheet Data As of As of December 31, December 31, 2023 2022* Cash $ 2,022,276 $ 1,504,049 Restricted Cash** $ 5,010,725 $ 63,492 Total Assets $ 25,479,086 $ 8,676,204 Total Liabilities $ 11,181,102 $ 11,136,752 Total Shareholders’ Equity $ 14,297,984 $ (2,460,547 ) * Amounts for the year ended December 31, 2022, represent consolidated financials for AVRA Medical Robotics, Inc. and CardioVentures Inc. to reflect the effect of the CardioVentures Merger. ** Represents Fixed Deposits held by bank as security for bank facilities and certain performance guarantees.
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Our autonomous medical robotics system is being developed to be compatible with available FDA approved surgical tools and end-effectors, enabling us to initially penetrate a sizable and fast-growing aesthetics market, which includes micro-needling and laser solutions.
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To date, the Company has mainly relied on debt and equity raised in private offerings to finance its operations. During 2024, the company plans to raise additional capital through further private or public offerings.
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Our robotics system will allow doctors, and anyone permitted to treat patients, defined at the State level, such as a licensed aesthetician, to treat damaged skin autonomously by delivering, for example, micro-needling to the skin.
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However, if we are unable to do so and if we experience a shortfall in operating capital, we could be faced with having to limit our expansion plans, research and development and marketing activities. Year ended December 31, 2023, as compared to year ended December 31, 2022 Revenues.
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The micro-needling catalyzes the natural process of collagen remodeling, consisting of formation of new collagen, elastin, and vascularization in the papillary dermis, similar to the effect of laser treatments. 1 We expect our robotic system to eliminate many of the common errors that occur during handheld procedures, such as over- or under- exposure of the needles or energy-based instruments that can have terrible cosmetic results and even injure the patient.
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During the year ended December 31, 2023, the Company had revenues of $5,879,710 (comprising $5,692,721 of system and instrument sales and $186,989 of warranty sales), compared to revenues of $1,458,315 (comprising $1,438,969 of system and instrument sales and $19,346 of warranty sales) during the year ended December 31, 2022.The increase in revenue is primarily due to sale of increased number of surgical robotic systems and instruments in the year ended December 31, 2023 as compared to the year ended December 31, 2022.
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In addition, our system is being designed to continuously adjust treatment parameters, such as penetration depth, time, and energy in order to individualize the outcome based on our algorithms. Our robotic system has been designed and developed through a seamless collaboration of the surgeon, the engineer and the scientist.
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Research and Development Expenses. Research and Development expenses during the year ended December 31, 2023, were $576,168, as compared to $83,282 for the year ended December 31, 2022.
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Since the medical robotic industry has progressed greatly in miniaturization, adaptability and lower costs, we believe that the Avra “ brains ” technology component can lead to dramatic opportunities in all of medicine. The advantages of robotizing already FDA approved aesthetic devices are many.
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The increase in the Research and Development expenses as compared to the previous year is in line with the Company’s continued focus on improving the design and technological capabilities of its existing SSi Mantra system and further expanding its product offerings. 23 Stock Compensation Expense.
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In contrast to a human using a handheld device, our aesthetics robotic system has the potential to perform each and every procedure with unsurpassed precision without constraint of age, proficiency, experience or fatigue.
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We had stock compensation expenses of $13,425,319 and $1,135,468 during the years ended December 31, 2023, and December 31, 2022 respectively.
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Likewise, in many skin related treatments the amount of energy delivered, distance and/or depth of the instrument to, or into, the skin, and treating only the affected area are critical to the outcome. The robotic system can maintain these parameters with unparalleled accuracy. The system can also replicate the same procedure time and again precisely.
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The substantial increase in the stock compensation expense in 2023 is primarily the result of the award of stock grants to employees of the Company and its subsidiaries and the issuance of stock awards and stock options to executive officers of the Company and its subsidiaries in November 2023 under our Incentive Stock Plan, in recognition of their efforts in developing and commercializing our SSi Mantra system.
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Delivery of certain aesthetic treatments by robotic systems is believed to be the most efficient option, requiring fewer visits per patient while increasing patient throughput — a benefit for patients and practitioners alike.
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Salaries and Payroll Expense . We had salary and payroll expense of $2,215,620 for the year ended December 31,2023, as compared to $1,698,283 in the year ended December 31, 2022.
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Advantages of using our medical robotic approach to procedures include: ● Reduced cost per treatment. ● Better treatment accuracy. ● Better treatment outcomes. ● Increased patient throughput and revenue generation for the physician. ● Easier multi-platform integration. ● Addresses shortfall of physicians/surgeons. ● Easier future integration of medical and technological advancements such as molecular biologics.
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This increase in salary and payroll expense is a reflection of the increase in Company’s employee count from 102 at December 31, 2022 to 221 at December 31, 2023, commensurate with the expansion in the Company’s manufacturing and commercial sales operations during 2023 Salaries and payroll expense includes salaries and payroll expense related to executive officers of the Company.
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We believe that our initial medical robotic system for the aesthetics market should find rapid acceptance based on the aforementioned advantages of using the attribute of robotics versus traditional manual applications. Furthermore, there is general acceptance by consumers for fee-for-service cash payments in the facial aesthetics market thereby avoiding medical insurance reimbursement issues.
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General and Administrative Expenses. We incurred $5,164,713 in general and administrative expenses during the year ended December 31, 2023, as compared to $3,251,794 for the year ended December 31, 2022.
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Our medical robotic system utilizes a robotic arm that has 7-degrees of freedom integrated with our proprietary AI-driven control software and algorithms. The robotic arm was designed and built under the required medical device standards of the U.S. Food and Drug Administration (the “ FDA ”).
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General and administrative expenses include sales, marketing and travel-related expenses, rent for the manufacturing facility offices, legal and other professional expenses related to the Company’s filings as a public company with the SEC. The increase in general and administrative expenses resulted from the increased scale of commercial operations during 2023. as compared to the year ended December 31, 2022.
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Our strategy is to integrate the robotic arm with FDA approved devices, which is expected to allow for a more expedited approval of the integrated system. We believe that the FDA approval process will primarily focus upon validation of the medical robotic system’s software control.
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Other Income (Expenses) . We have incurred $273,599 in interest expenses during the year ended December 31,2023 as compared to net interest income of $77,729 during the year ended December 31, 2022. The increase in interest expense from 2022 to 2023 resulted from an increase in bank borrowings for working capital from HDFC Bank in India. Net Loss.
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This could lead to a less onerous, more de-risked regulatory path to approval, particularly if strong preclinical results are achieved.
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We incurred a net loss of $20,941,972 for the year ended December 31, 2023, as compared to a net loss of $5,601,504 for the year ended December 31, 2022. The increase in net loss from 2022 to 2023 is primarily the result of the increase in stock compensation expenses as set forth above.
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Subsequent to the completion of the FDA preclinical work, estimated to take six months, we believe that we will be able to additionally modify and robotize certain non-invasive instruments that do not require FDA approvals and proceed to the cosmetic treatments marketplace. This action could sharply reduce the time to commercial operations and revenues.
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The net loss for the year ended December 31, 2023, was also higher due to $1,668,146 of system sales revenue that stands to be transferred to unrealized deferred revenue pursuant to the application of ASC606.
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We previously retained the services of The Horizon Phoenix Group (“ HPG ”), a consulting firm experienced in securing U.S. and foreign regulatory approvals for medical devices, in order to initiate the regulatory process.
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Liquidity and Capital Resources The Company expects to require substantial funds for scaling up its operations, incurring capital expenditures to have its own manufacturing facility for in-house machining and tooling capacity and to continue to finance its research and development work in the field of surgical robotics.
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Working with HPG, we prepared and filed an application with the FDA for our initial medical robotic system and in August 2019 held an initial pre-collaboration meeting with the FDA. We believe that this is the first of a series of meetings where the Avra system and its regulatory requirements will be discussed in ever-increasing specificity.
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On April 15, 2023, the Company executed a Convertible Promissory Note (the “ Line of Credit Note ”) with Sushruta Pvt Ltd. (“ Sushruta ”), the Bahamian holding company owned by Dr. Sudhir Srivastava, our Chairman, Chief Executive Officer and principal shareholder.
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This should allow for a more focused regulatory process, saving both resources and time. The robotic arm that we intend to utilize for our system has already been granted approval in the EU and received a CE mark.
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Pursuant to the Line of Credit Note, Sushruta, in its discretion could make multiple advances to the Company through December 31, 2023 (the “ Maturity Date ”), in an aggregate amount of up to $20 million for working capital purposes.
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We have begun implementing a quality and regulatory system that will serve as the foundation for U.S., Canadian, European, Australian, Japanese, and Brazilian market access for our medical robotic system.
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The advances under the Line of Credit Note did not bear interest and were due and payable on or before the Maturity Date.
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The Medical Device Single Audit Program(“ MDSAP ”), which we plan to employ, is a single inspection that, when completed, is expected to support market access to these six most important medical device marketplaces. 2 Since 2016, we had a research partnership with the University of Central Florida (“ UCF ”) to develop a prototype intelligent medical robotic system.
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During the year ended December 31, 2023, Sushruta made advances aggregating to $16,980,000 under the Line of Credit Note and exercised its option to convert the full amount of advances made into shares of our common stock at a conversion price of $0.74 per share.
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UCF is recognized particularly for its work in the area of medical robotic research and design, with a focus on the guidance systems. Avra has paid UCF a one-time fee for outright ownership of work developed by UCF in the collaboration. The Research Agreement was extended several times and expired on April 30, 2021.
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Accordingly, 22,945,946 shares of our common stock were issued to Sushruta during the year ended December 31, 2023.
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To further the depth of our research and development we also began a partnership in 2021 with Florida Polytechnic University and are actively working with them on developing our system. Avra recently brought in two Associate Professors and three graduates to join Avra’s engineering development team.
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As of December 31, 2023, the Company had shareholders’ equity of $14.3 million and a working capital surplus of $9.1 million as compared to shareholders’ deficit of $2.46 million and a working capital deficit of $4.42 million as of December 31, 2022. 24 Cash Flows Used in Operating Activities During the year ended December 31, 2023, net cash used in operating activities was $13,572,758 resulting from our net loss of $20,941,972, partially offset by non-cash charges of $ 14,193,327 comprised mainly of depreciation, stock compensation expense and expenses for which common stock issued.
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Effective October 11th, 2021 Avra executed a Sponsored Student Project Agreement which includes two payments of $8,030 each covering Fall semester in 2021 and Spring semester in 2022.
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During the year ended December 31, 2023, we had net cash invested in our operating assets and liabilities of $6,962,654 primarily as a result of increases in prepaid expenses and other current assets to the extent of $9,200,688, including fixed deposits provided to HDFC bank to secure working capital facilities and an increase in accounts payable and accrued expenses of $2,238,034.
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Recent Developments On November 7, 2022, AVRA entered into a definitive Merger Agreement (the “ Merger Agreement ”), by and among AVRA, AVRA-SSI Merger Corporation, a Delaware corporation and wholly-owned subsidiary of AVRA (“ Merger Sub ”), CardioVentures, Inc., a Delaware corporation (“ SSI - DE ”) Dr. Sudhir Srivastava (“ Dr.
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During the year ended December 31, 2022, net cash used in operating activities was $5,555,345, resulting from our net loss of $5,601,504, partially offset by non-cash charges of $994,369 comprised mainly of depreciation and stock compensation expense.
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Srivastava ”), who, through his holding company, owns a controlling interest in SSI-DE. SSI-DE, through a subsidiary, owns a controlling interest in Sudhir Srivastava Innovations Pvt. Ltd., an Indian private limited company (“ SSI - India ”).
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During 2022 we had net cash invested in our operating assets and liabilities of $948,209. primarily as a result of increased prepaid expenses and other current assets.
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Based in Haryana, India, SSI-India is engaged in the development, commercialization, manufacturing and sale of medical and surgical robotic systems utilizing patents, trademarks and other intellectual property held by Dr. Srivastava (the “SSI Intellectual Property”). Pursuant to the Merger Agreement, Merger Sub will merge with and into SSI – DE (the “ Merger ”).
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Cash Flows from Investing Activities During the year ended December 31, 2023, we had net cash used in investing activities of $2,299,356, resulting mainly from investment of $563,967 in purchases of equipment, $2,199,418 towards the value of a Right of Use asset, as well as long term loans and advances and long-term receivables of $2,535,971 and receipt of funds through Note receivables – acquisition of $3,000,000.
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In the Merger, holders of the outstanding shares of common stock of SSI – DE at closing (including certain parties providing Interim Financing as described below), will receive in exchange for their SSI – DE shares, such number of shares of AVRA common stock as will result in such holders owning 95% of the outstanding post-Merger shares of AVRA common stock, with the current shareholders of AVRA owning 5% of the outstanding post-Merger shares of AVRA common stock.
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During the year ended December 31, 2022, we had net cash used in investing activities of $2,735,814, resulting mainly from investment of $220,324 in purchases of fixed assets, reduction in Notes Receivable – Acquisition of $3,000,000 and realization of $484,510 from sale of fixed assets.
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In addition to the foregoing, upon completion of the Merger, the holders of SSI – DE common stock will receive, pro rata, shares of newly designated Series A Non-Convertible Preferred Stock (the “ Series A Preferred Shares ”).
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Cash Flows from Financing Activities During the year ended December 31, 2023, we had net cash provided by financing activities of $16,734,963, comprised of a $4,947,233 increase in restricted cash (i.e., fixed deposits provided to secure bank facilities and for providing guarantees), partially offset by an increase of $2,895,880 in proceeds from our bank overdraft facility, $808,244 from private securities offerings, $12,360 from the exercise of previously issued warrants, $22,980,000 in proceeds from promissory notes converted to common stock, $100,000 in proceeds from the exercise of stock options, as well as the reduction by conversion of promissory notes of $7,000,000.
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The Series A Preferred Shares will vote together with Shares of our common stock as a single class on all matters presented to a vote of stockholders, except as required by law and entitle the holders of the Series A Preferred Shares to exercise 51.0% of the total voting power of the Company.
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We also had an increase in right of use liability (non-current portion) of $1,910,432.
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The Series A Preferred Shares are not convertible into common stock, do not have any dividend rights and have a nominal liquidation preference. The Series A Preferred Shares also have certain protective provisions, such as requiring the vote of a majority of Series A Preferred Shares to change or amend their rights, powers, privileges, limitations and restrictions.
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During the year ended December 31, 2022, we had net cash provided by financing activities of $9,294,395, comprised of $145,000 in repayment of promissory notes, $2,583,798 of proceeds from our bank overdraft facility, $1,500,431 in proceeds from private securities offerings, $7,000,000 in proceeds from the issuance of 7% convertible promissory notes, $26,000 in common stock issued and a decrease of $1,670,834 in related party loans.

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