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REGISTRATION STATEMENT PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934
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ANNUAL REPORT PURSUANT TO SECTION 13(a) OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Shares, no par value
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TMDI
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The NASDAQ Stock Market LLC
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Annual information form
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Audited annual financial statements
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the Company’s technology and research and development objectives, including development milestones, estimated costs, schedules for completion and probability of success;
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the Company’s intention with respect to updating any forward‑looking statement after the date on which such statement is made or to reflect the occurrence of unanticipated events;
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the Company’s business plan consists of the development of robotic-assisted surgical technologies for application in minimally invasive surgery (“MIS”) comprising its Enos
system;
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the Enos system under development includes a surgeon-controlled patient cart that includes a 3D high definition vision system and multi-articulating instruments for performing MIS procedures;
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the Enos system under development includes a surgeon workstation that provides the surgeon with an ergonomic interface to the patient cart and a 3D high-definition view of the MIS procedures;
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the Company’s intent to initially pursue gynecologic surgical indications for use of its Enos system;
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the Company’s plan to continue development of a robust training curriculum and post-training assessment tools for surgeons and surgical teams;
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the training curriculum, which is planned to include cognitive pre-training, psychomotor skills training, surgery simulations, live animal and human cadaver lab training, surgical team training, troubleshooting
and an overview of safety;
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post-training assessment, which will include validation of the effectiveness of those assessment tools;
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the Company will likely proceed with a De Novo classification submission for the Enos system, while continuing to evaluate its options for use of the 510(k) submission pathway;
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the Company’s intention to continue with the De Novo classification process if the 510(k) submission pathway is not available to the Company or would otherwise present other difficulties;
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the outcome of any review by the FDA and the time required to complete activities necessary for regulatory approval or clearance;
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the Company’s plans on further communications with the FDA and to file additional Pre-Submissions to clarify the requirements for the IDE clinical study protocol and understand any special controls which the FDA
may apply;
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the performance of human surgeries with the Enos system will require an Investigational Device Exemption (“IDE”) from the Food and Drug Administration (“FDA”), which must be submitted and approved in advance;
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the recruitment of surgeons from multiple hospital sites will be necessary to perform the surgeries. Each of these sites will require approval of their independent Institutional Review Board (“IRB”) to approve the studies;
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an application to the IRB of each hospital will be made once the FDA has approved the Company’s IDE application;
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the Company’s intention to submit to the FDA an application for marketing authorization upon successful completion of the IDE clinical study;
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the Company’s ability to secure required capital to fund development and operating costs in a timely manner;
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actual costs and development times, which will exceed those previously set forth by the Company in years prior to 2020;
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the fact that the Company cannot produce an accurate estimate of the future costs of the development milestones and regulatory phases for the Enos system beyond the year 2022;
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the Company’s technology and research and development objectives and milestones, including any estimated costs, schedules for completion and probability of success and including without limitation the table set
forth herein under the heading, “Development Plan” in the AIF, and the footnotes thereunder;
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the indication of additional specific milestones as the development of the Enos system progresses;
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the Company’s plan to further expand its patent portfolio by filing additional patent applications as it progresses in the development of robotic-assisted surgical technologies and, potentially, by licensing
suitable technologies;
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the Company’s intention to secure additional financing to continue the Company’s research and development program through to completion and take advantage of future opportunities;
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the Company’s expectation that it will be able to finance its continuing operations by accessing public markets for its securities;
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the Company’s intention with respect to not paying any cash dividends on the Company’s common shares (the “Common Shares”) in the foreseeable future; and
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the Company’s intention to retain future earnings, if any, to finance expansion and growth.
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the Company will require additional financing which may not be available to us on acceptable terms, or at all;
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the Company has a history of losses and there is no guarantee that the Company will be able to achieve profitability;
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the Company relies on contractual arrangements and there can be no assurance that these arrangements will achieve their goals;
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the Company depends on key personnel and the loss of the service of such personnel could have a negative impact on the Company’s business;
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the Company expects to increase the size of the Company’s management team in the future and the Company’s failure to attract and retain new members of the Company’s management team could adversely affect the
Company’s business;
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the Company’s trade secrets or other confidential information may be compromised;
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the Company relies on third parties for a number of important aspects of the Company’s business and there are a range of issues that are outside of the Company’s direct control;
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the Company’s industry is highly competitive, and a number of the Company’s competitors have significantly greater financial and human resources than the Company;
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the Company’s commercial success depends significantly on the Company’s ability to operate without infringing the patents and other proprietary rights of third parties;
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should the Company be unable to obtain and enforce its patent rights, the Company’s business could be materially harmed;
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the Company may be unable to obtain or maintain the Company’s trademarks and may incur substantial costs attempting to defend and enforce the Company’s rights in this regard;
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certain of the Company’s directors and officers also serve as directors and/or officers of other companies, creating the possibility that a conflict of interest could arise;
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the Company’s financial results and results of operations have fluctuated in the past and may continue to be volatile going forward;
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the Company is targeting a rapidly evolving robotic assisted surgical device market, and it is not clear that surgeons or hospitals will choose the Enos system over those offered by the Company’s competitors;
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the introduction of more technologically advanced products and/or new entrants to the market could impact the Company’s operating and financial results;
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the Company may become subject to potential product liability claims, and the Company may be required to pay damages that exceed the Company’s insurance coverage;
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the Company’s technology may depend on third party licenses for certain functions or procedures and there can be no guarantee that the Company will be able to secure and maintain those licenses;
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government and agency regulation controls all aspects of the Company’s product and business, and changes in policies and additional regulations may be enacted that could prevent or delay regulatory clearance or
approval of the Company’s products;
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should the Company be granted FDA marketing authorization, the Company may subsequently decide to make certain modifications to the Company’s products for a number of reasons including those based on customer
feedback and/or in view of competitive offerings;
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a recall of the Company’s products, either voluntarily or at the direction of the FDA or another governmental authority or regulatory body, or the discovery of serious safety issues with the Company’s products,
could have a significant adverse impact on the Company;
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compliance with accounting regulations and tax rules across multiple jurisdictions is resource intensive and expensive and could expose the Company to penalties and fines;
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contingent liabilities could have a negative impact on the Company’s financial position;
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there can be no certainty that the Company will meet the Company’s established product development and commercialization milestones, and failure to do so may affect the Company’s operational and financial results;
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Commercial manufacturing of the Enos system is expected to be an extremely detailed and complex process with the potential for delays, interruptions, or cost overruns;
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the Company’s reliance on suppliers and development firms for execution of the Company’s development programs means that the Company do not control all aspects of the development;
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a product malfunction, including in any clinical studies, could result in delays, liability and negative perceptions of the Enos system and the Company;
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certain reusable instruments, camera components and other accessories require repeated cleaning and sterilization;
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as the Company is a Canadian company, it may be difficult for U.S. shareholders to effect service on the Company or to realize on judgments obtained in the U.S.;
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the Company is subject to risks related to additional regulatory burden and controls over financial reporting;
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fluctuations in foreign currency exchange rates may adversely affect the Company’s financial results;
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the Company may not be able to maintain the Company’s status as a “Foreign Private Issuer”;
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the Company is an “emerging growth company” and cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make it less attractive to investors;
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the Company is likely a “passive foreign investment company”, which may have adverse U.S. federal income tax consequences for U.S. investors;
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the Company may face or otherwise be exposed to cyber-security risks and threats;
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the Company’s financial condition and results of operations for fiscal 2021 may be adversely affected by the global COVID-19 pandemic;
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the global COVID-19 pandemic creates substantial uncertainty as to the willingness and ability of hospitals, health maintenance organizations (HMOs), ambulatory care facilities and other prospective customers to
purchase and implement robotic surgical systems; and
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material weaknesses in the Company’s internal controls over financial reporting.
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general business and current global economic conditions;
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future success of current research and development activities;
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achieving development milestones;
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ability to achieve product cost targets;
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competition;
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no significant changes to regulatory clearance or approval processes in the United States and Europe;
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stable tax rates and benefits;
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the availability of financing on a timely basis;
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the Company’s and competitors’ costs of production and operations;
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the Company’s ability to attract and retain skilled employees;
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the Company’s ongoing relations with its third-party service providers;
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the design of the Enos system and related platforms and equipment;
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the progress and timing of the development of the Enos system;
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costs related to the development of the Enos system;
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receipt of all applicable regulatory approvals or clearances;
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estimates and projections regarding the robotic-assisted surgery equipment industry;
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protection of the Company’s intellectual property rights;
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market acceptance of the Company’s systems under development;
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the Company’s ability to meet the continued listing standards of NASDAQ and the TSX; and
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the type of specialized skill and knowledge required to develop the Enos system and the Company’s access to such specialized skill and knowledge.
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the Company did not have sufficient accounting resources with relevant technical accounting skills to address issues relating to the assessment of IFRS treatment for complex accounting issues, specifically
relating to a material amendment to a contract with an external development firm;
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the Company did not have sufficient accounting resources with relevant technical accounting skills to address and review issues relating to the valuation of warrant liabilities; and
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the Company did not sufficiently design internal controls to provide the appropriate level of oversight regarding the financial recordkeeping and review of the Company’s cut-off procedures as they relate to
accounts payable and valuation of supplier liabilities.
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engagement of one or more qualified and independent consulting firms with subject matter experts to assist with the Company’s internal accounting and reporting over complex accounting issues;
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institution of business systems to support the work associated with the valuation and reporting of the warrant liabilities and other equity-based securities; and
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engagement of an external consulting firm to assist with increasing the Company’s in-house resources to increase the number of qualified personnel involved in financial accounting and reporting.
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reviewing compensation payable to the Chief Executive Officer of the Company and other executives;
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reviewing the compensation payable to directors;
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overseeing the administration of compensation plans;
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reviewing executive and director compensation disclosure to be made in the proxy circular prepared in connection with the Company’s annual meeting of shareholders; and
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reviewing the Company’s compensation standards, along with management’s annual recommendations, to ensure each are consistent with each other and currently appropriate.
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TITAN MEDICAL INC.
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By:
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/s/ Monique L. Delorme
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Name: Monique L. Delorme
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Title: Chief Financial Officer
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Exhibit Number
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Description
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101.INS
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XBRL Instance
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101.SCH
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XBRL Taxonomy Extension Schema
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101.CAL
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XBRL Taxonomy Extension Calculation Linkbase
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101.DEF
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XBRL Taxonomy Extension Definition Linkbase
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101.LAB
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XBRL Taxonomy Extension Label Linkbase
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101.PRE
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XBRL Taxonomy Extension Presentation Linkbase
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