SS Innovations International, Inc. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. When used in this report, unless otherwise indicated, the terms “ Avra ,” “ the Company ,” “ we ,” “ us ” and “ our ” refer to Avra Medical Robotics, Inc. Note Regarding Forward Looking Statements This report contains forward-looking statements that reflect our current views about future events. We use the words “ anticipate ,” “ assume ,” “ believe ,” “ estimate ,” “ expect ,” “ will ,” “ intend ,” “ may ,” “ plan ,” “ project ,” “ should ,” “ could ,” “ seek ,” “ designed ,” “ potential ,” “ forecast ,” “ target ,” “ objective ,” “ goal ” or the negatives of such terms or other similar expressions. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. 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 ”). 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. 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. 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. 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. 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. 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. 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. 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. 19 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 20 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. 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 ”). 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. This could lead to a less onerous, more de-risked regulatory path to approval, particularly if strong preclinical results are achieved. 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. 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. 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. 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. 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. 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. Since 2016, we had a research partnership with the University of Central Florida (“ UCF ”) to develop a prototype intelligent medical robotic system. 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. 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 a graduate to join Avra’s engineering development team. Effective October 11 th , 2021 Avra executed a Sponsored Student Project Agreement which included two payments of $8,030 each covering Fall semester in 2021 and Spring semester in 2022. We believe we can rapidly develop and commercialize our initial medical robotic system in the aesthetic skin resurfacing market because of the following advantages and progress made to date, including: ● Our team is experienced in medical robotic engineering. ● We are working in conjunction with preeminent physicians, engineers and scientific institutions. ● We have substantially completed the design phase and are ready to complete a final, integrated prototype for the regulatory approval process which has been initiated. ● Our robotic arm was built under the required medical device standards of the FDA and has already received a CE Mark in Europe. ● Our strategy is to integrate the robotic arm with FDA approved devices for skin resurfacing, which we anticipate will allow for a more expedited regulatory approval, with the FDA approval process primarily focused upon validation of the medical robotic system’s software control. We held a pre-collaboration meeting with the FDA in August 2019, which should allow us to better focus on only the meaningful required activities, saving both resources and time. ● 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 AVRA’s medical robotic system. MDSAP, which we plan to employ, is a single inspection that, when completed, is expected to support market access to the six most important medical device marketplaces. ● We believe that our treatment-independent medical robotics platform system will be compatible with currently and yet to be approved end-effectors and/or surgical tools enabling rapid entry into the skin resurfacing and other markets with new and improved devices. See “ Note10. Subsequent Events ” to our unaudited Condensed Financial Statements included in Item 1 of this report with respect the definitive Merger Agreement entered into on November 7, 2022 (the “ Merger Agreement ”), by and among AVRA, AVRA-SSI Merger Corporation, a Delaware corporation and wholly-owned subsidiary of AVRA, CardioVentures, Inc., a Delaware corporation (“ SSI - DE ”) and Dr. Sudhir Srivastava (“ Dr. 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 ”). 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, Avra (which will change its name to SS Innovations International, Inc.), will acquire an indirect controlling interest in SSI India and ownership of the SSI Intellectual Property and Dr. Srivastava will become the Company’s controlling shareholder. 21 Results of Operations Introduction The financial statements appearing elsewhere in this report 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. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The following table provides selected balance sheet data for our Company at June 30, 2022 (unaudited) and December 31, 2021: Balance Sheet Data: As of As of June 30, December 31, 2022 2021 Cash $ 261,089 $ 405,774 Total Assets $ 279,336 $ 428,607 Total Liabilities $ 221,585 $ 287,281 Total Stockholders’ Deficit $ 57,752 $ 141,326 To date, the Company has relied on debt and equity raised in private offerings and shareholder loans to finance operations and no other sources of capital has been identified. If we experience a shortfall in operating capital, we could be faced with having to limit our research and development activities. Three months ended June 30, 2022, as compared to three months ended June 30, 2021 Revenues. We had no revenues during either the three months ended June 30, 2022, or the three months ended June 30, 2021. Research and Development Expenses. Research and development expenses during the three months ended June 30, 2022 and June 30, 2021 were $0. General and Administrative Expenses. We incurred $103,504 and $85,316 in general and administrative expenses during the three months ended June 30, 2022 and June 30, 2021, respectively. 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 ”). Compensation Expense. We had compensation expenses of $66,526 and $326,035 during three months ended June 30, 2022 and June 30, 2021, respectively. This includes compensation for the management staff and stock-based compensation expenses related to the Company’s 2016 Stock Incentive Plan. Other Income/Expenses . We had $29 in interest earned in the three months ended June 2022 as compared to $38 of interest during the three months ended June 30, 2021. Net Loss. We incurred a net loss of $170,001 for the three months ended June 30, 2022, as compared to a net loss of $412,314 for the three months ended June 30, 2021. The decrease in net loss from the 2021 quarter to the 2022 quarter is in large part due to an increase in stock-based compensation expense. 22 Six months ended June 30, 2022, as compared to six months ended June 30, 2021 Revenues. We had no revenues during either the six months ended June 30, 2022 or the six months ended June 30, 2021. Research and Development Expenses. Research and development expenses during the six months ended June 30, 2022 were $0, as compared to $1,000 for the six months ended June 30, 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. General and Administrative Expenses. We incurred $155,719 and $165,794 in general and administrative expenses during the six months ended June 30, 2022 and June 30, 2021, respectively. 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 ”). Compensation Expense. We had compensation expenses of $94,766 and $545,636 during the six months ended June 30, 2022 and June 30, 2021, respectively. This includes compensation for the management staff and stock-based compensation expense related to the Company’s 2016 Stock Incentive Plan. Other Income/Expenses . We had $64 interest earned in the six months ended June 2022 as compared to $60 of interest during the six months ended June 30, 2021. Net Loss. We incurred a net loss of $250,421 for the six months ended June 30, 2022, as compared to a net loss of $712,370 for the six months ended June 30, 2021. The decrease in net loss from the 2021 period to the 2022 period is in large part due to decreases in stock-based compensation expense. Liquidity and Capital Resources The Company expects to require substantial funds for research and development, to continue to develop, secure marketing approval for and ultimately manufacture and market its initial medical robotic system. Until the Company is able to generate revenues from the sale of its initial medical robotic system, it expects to meet its operating cash flow requirements from the net proceeds of this Offering and if necessary, from future public or private sales of its securities and, if possible, on favorable terms, by entering into development partnerships to assist the Company with its technology development activities. During the period from inception (February 4, 2015) through June 30, 2022, the Company raised (a) $1,900 from an initial private offering of its common stock in February 2017; (b) $480,000 from the private offering of the convertible notes completed in June 2017; (c) $135,000 from a private offering of 135,000 shares of common stock at a price of $1.00 per share completed in February 2017; (d) $542,260 from a private offering of 433,808 shares of stock in a private offering at a price of $1.25 per share completed in September 2017; and (e) $20,000 from the private sale of 16,000 shares of our common stock at a price of $1.25 per share in August 2018. 23 In March 2019, the Company sold 7.5 Units in a private offering of ten (10) units (“ Units ”), each Unit consisting of a $10,000 principal amount six-month promissory note bearing interest at the rate of 5% per annum and a three-year warrant to purchase 5,000 shares of common stock at an exercise price of $1.25 per share. In addition to the foregoing, from December 2018 through June 2021, the Company obtained fourteen loans from Barry F. Cohen, our Chief Executive Officer totaling $468,500. The loans were due 12 months from the funding date and did not bear interest. With the exception of two loans totaling $145,000, all of these loans were subsequently repaid in full via conversions into restricted company shares or Units including one loan for $100,000 which was used to exercise a stock option for 1,000,000 shares held by Mr. Cohen. In October 2020 the Company raised $301,027 through the sale of 301,027 Units. Each Unit gave the investor four restricted common shares, five warrants with an exercise price of $0.40 per share, and one put option for one of the Company’s restricted common shares. In December 2020 the Company raised $227,700 through the sale of 227,700 Units. Each Unit gave the investor four restricted common shares and five warrants with an exercise price of $0.40 per share. The Company’s CEO participated in this investment by agreeing to use 202,700 of Notes due to him from the Company to purchase 202,700 Units. In January 2021 the Company raised $235,000 through the sale of 235,000 Units. Each Unit gave the investor four restricted common shares and five warrants with an exercise price of $0.40 per share. In the fourth quarter of 2021 the Company raised a total of $315,200 from six accredited investors by selling 2,229,231 shares of the Company’s restricted common stock at prices ranging from $0.13 per share to $0.52 per share. 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. 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. 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. 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. 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. 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. 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. Valuation allowances are recorded related to deferred tax assets based on the “more likely than not” criteria of ASC 740. 24 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. 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. 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. Item 3. Quantitative Disclosures About Market Risks. As a “ smaller reporting company, ” we are not required to provide the information required by this Item.