{"url_path":"/sec/ehvvf/10-k/2026/item-4","section_key":"item-4","section_title":"Item 4 INFORMATION ON THE COMPANY**","topic":"sec","document":{"doc_type":"20-F","doc_date":"2026-05-15","source_url":"https://www.sec.gov/Archives/edgar/data/1653606/0001493152-26-023957-index.html","accession_number":"0001493152-26-023957","cik":"0001653606","ticker":"EHVVF","issuer_name":"Ehave, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1653606/0001493152-26-023957-index.html","primary_entity_key":"0001653606","primary_entity_name":"Ehave, Inc."},"word_count":6269,"has_tables":true,"body_markdown":"**ITEM\n4. INFORMATION ON THE COMPANY**\n\n**A.\nHistory and Development of the Company**\n\nWe\nwere incorporated under the laws of the Province of Ontario (specifically under the Business Corporations Act (Ontario)) on October 31,\n2011, in the Province of Ontario, Canada, and did business as Behavioural Neurological Applications and Solutions. Effective November\n4, 2015, we changed our name to Ehave, Inc.\n\nOur\nprincipal office is located at 100 SE 2nd St., Suite 2000, Miami, FL 33131 and our telephone number is (954) 233-3511.\n\nThe\nSEC maintains an Internet site that contains reports and other information regarding us that we file electronically with the SEC website\nat www.sec.gov. We also make available free of charge on our website at www.ehave.com, as soon as reasonably practicable after such reports\nare available on the SEC website.\n\nWe\nare not aware of any indication of any public takeover offers by third parties in respect of our common shares during our last and current\nfinancial years.\n\n16\n\n**Sale\nof Myctopia Therapies (Florida)**\n\nIn\nDecember 2020, Ehave, Mycotopia Therapies Inc., a Florida corporation and wholly owned subsidiary of Ehave (“MYC”) and 20/20\nGlobal, Inc., a Nevada corporation (“20/20 Global”), and the former officers and directors of 20/20 Global, entered into\ndefinitive agreements that provided for: (i) 20/20 Global’s purchase for $350,000 in cash of all of the outstanding stock of MYC\nfrom Ehave under a Stock Purchase Agreement, attached hereto as an Exhibit, resulting in MYC becoming a wholly owned subsidiary of 20/20\nGlobal; and (ii) the change of control of 20/20 Global’s board of directors and management under a Change of Control and Funding\nAgreement. In a related transaction, Ehave agreed to purchase 9,793,754 shares of 20/20 Global common stock, which constitutes approximately\n75.77% of the issued and outstanding shares of 20/20 Global’s common stock, for $350,000 in cash, through a Stock Purchase Agreement\n(“MYC SPA”) with 20/20 Global stockholders Mark D. Williams, Colin Gibson, and The Robert and Joanna Williams Trust. Prior\nto these transactions, neither 20/20 Global nor its officers and directors had a material relationship with Ehave, MYC, or their respective\nofficers and directors. As a result of these transactions, Ehave now controls the board and management of 20/20 Global.\n\nA\nclosing of the transactions contemplated by the above-described documents was initially scheduled for January 4, 2021, and then delayed\nby agreement. All of the above transactions were closed on January 19, 2021.\n\nAs\na result of the MYC SPA, 20/20 Global adopted MYC’s business plan and MYC became a wholly owned subsidiary of 20/20 Global. 20/20\nGlobal is now known as Aibotics Inc., and we maintain voting control over Aibotics. Aibotics main business is the application of artificial\nintelligence in the operation of robotic devices. Its first product is the Philbot, an AI-powered massage robot.\n\n**B.\nBusiness Overview**\n\nWe\nare creating a mental health data platform that integrates with our proprietary and third-party assessment and therapeutic digital applications.\nOur product focus is based on two tiers of activities: (1) MegaTeam and Ninja Reflex, our clinically validated digital assessment and\nrehabilitation software that is engaging for the patient and (2) adaptation of third-party clinically validated digital assessment and\nrehabilitation software for enhanced patient engagement and data modeling. We intend to provide technology solutions to clinicians, patients,\nresearchers, pharmaceutical companies and payors.\n\nMegaTeam\nis currently available on the Apple iOS App Store and Google Play.\n\nThrough\nits KetaDash subsidiary, the Company provides a platform for medical practitioners to administer healthcare services to patients at home\n\n**Ketadash**\n\nKetaDash\nInc. (Ketadash), a wholly owned subsidiary of Ehave, Inc. (Ehave), provides a platform for medical practitioners to administer healthcare\nservices to patients at home. In order to facilitate the launch of Ketadash, Ehave acquired 100% of Rejuv IV inc. (Rejuv IV) through\na stock purchase agreement on January 8, 2021. Ehave then consolidated Rejuv IV into its Ketadash brand. KetaDash addresses the needs\nof patients currently suffering from mental illnesses such as depressive disorder, bipolar disorder and post-traumatic stress disorder.\nKetaDash improves brain wellness and cognitive function with psychedelic medicine administered by a registered nurse in the comfort of\nyour own home with Ketadash’s mobile wellness therapies. Ketadash provides Ketamine treatments, as well as IV infusions with fluids,\nessential vitamins, minerals, and electrolytes to enhance the health and wellness of its patients. In addition to Ketamine treatments,\nKetadash generates revenue by offering its clients and patients IV Drip Detox and Hangover Cures, IV Vitamin Therapy for pain management,\nHydration Therapy for Health & Wellness, and IV Therapy for athletic advantage and fitness recovery. Ketadash uses certified nurses,\nwho are always prompt and will arrive on time to administer a patient’s IV drip of choice in the comfort of their home. Ketadash’s\nproducts and services have been made public through their website https://ketadash.com/ .\n\n**MegaTeam\nand Ninja Reflex Digital Assessment and Rehabilitation Applications**\n\nOur\nMegaTeam and Ninja Reflex assessment and rehabilitation products are built on established methodologies for the measurement of cognitive\nabilities in populations with attention deficit and hyperactivity disorder, or ADHD. Methodologies commonly used today involve repetitive\nperformance of tasks using digital interface. These tasks are repeatedly administered to the patient in order to obtain accurate measures.\nMany of the assessments used today had been developed using programming methodologies whereby the task is simply exhibited on screen\nand the patient is instructed to respond to stimuli. Our research has found that patients, in particular those with symptoms of ADHD,\nhave difficulty completing the necessary regiment of tasks due to lack of engagement. Additionally, these tasks are often administered\nin a clinical setting, often resulting in the patient and their accompanying parent or guardian staying in clinical settings for an extended\ntime. Our products have been developed to address these primary concerns as well as to enable a breadth of cognitive tasks to be assessed\nand an individualized cognitive rehabilitation program to be administered remotely.\n\n17\n\nThe\nMegaTeam and NinjaReflex applications involve the imbedding of cognitive assessment and rehabilitation tasks within an engaging video\ngame environment. MegaTeam and NinjaReflex were designed and programmed with the intention of providing comparable engagement to video\ngame play. In the design, narrative and programming of our MegaTeam and NinjaReflex games, we utilize experts in children’s digital\ncontent and programming. Our tools have been developed on Unity, a common game development platform that can be used on most fixed and\nmobile devices, enabling the expansion of narrative and the adaptation of new character and game environments to maintain long-term engagement\nof product differentiation. The underlying cognitive tools and data remain unchanged as the “skin” is adapted for future\nversions and client profiles. A significant part of the MegaTeam and NinjaReflex development involved assessing user engagement and consultation\non characters, narrative and graphic design.\n\nMegaTeam\nand NinjaReflex applications have been designed for deployment on multiple digital interfaces including PC, Mac, Android and iOS systems.\nOur applications may be used in a clinic or a patient’s home or remotely, provided there is an adequate data connection.\n\nBased\non feedback from users and clinical psychologists regarding strong user engagement of our MegaTeam and NinjaReflex products, we believe\nthat our products have a strong capacity for training compliance.\n\nDeveloped\nMegaTeam and NinjaReflex products include: (1) Stop Signal Reaction Time Assessment (2) N Back Assessment (3) Inhibitory Control Rehabilitation\n(4) and Working Memory Rehabilitation. We are planning the development of a broader suite of cognitive tasks and rehabilitation mechanisms\nin order to increase the addressable mental health indications.\n\n**Third\nParty Content**\n\nWe\nbelieve that it is critical to partner across the mental healthcare community, and we have secured partnerships with industry leaders.\n\n*Partnership\nwith MHS*\n\nIn\nDecember 2016, we signed an agreement with MHS, a leading provider of psychological assessment tools. We have licensed MHS’s gold\nstandard Connors® suite of ADHD assessments, as well as the Davidson Trauma Scale and SPAN assessments for PTSD. We expect to offer\nMHS’s entire catalogue of tests in time, and in so doing we believe that we can enhance the evaluation of any mental health indication.\nWe plan to move into areas such as anxiety, depression, OCD, autism, and more.\n\n*The\nHospital for Sick Children*\n\nIn\nDecember 2011, we entered into a collaboration with Toronto’s Hospital for Sick Children to identify the clinical needs, design\nand processes required to create clinical grade toolsets. In addition to specific tools, we have developed a content delivery and patient\ndata platform, known as Resource Knowledge Information Access that enables content to be deployed, monitored, analyzed and accessed remotely\nby clinicians and patients. These tools were used during randomized control studies of the MegaTeam game and will be used in future trials\nwith the Hospital for Sick Children.\n\n**Third-party\nContract Services**\n\nWe\nbelieve that we have the expertise of understanding the complexities of mental health assessments and rehabilitation methodologies, along\nwith game design and programming. Researchers and developers of digital applications for mental health may recognize the advantage of\nengaged users but lack the expertise in game based translation. We intend to market our company to researchers and developers with fee-based\nservices to enhance their digital applications. We are working closely with mental health research networks to avail our existing MegaTeam\nand NinjaReflex tools as well as our programming expertise to enhance and commercialize new products and services.\n\n18\n\n**Business\nStrategy**\n\nEhave,\nInc. is a provider of digital therapeutics delivering evidence-based therapeutic interventions to patients. Our primary focus is on improving\nthe standard care in therapeutics to prevent or treat brain disorders or diseases through the use of digital therapeutics, psychedelics,\nindependently or together, with medications, devices, and other therapies to optimize patient care and health outcomes meeting privacy\nand HIPAA & GDPR Compliant. Our main product is the Ehave Dashboard which is a mental health informatics platform that allows clinicians\nto make objective and intelligent decisions through data insight using Blockchain technology. The Ehave dashboard offers Offline Encrypted\nDigital Records Empowering Healthcare providers and patients and it’s a powerful machine learning and artificial intelligence platform\nusing artificial intelligence to extract deep insights from audio, video and text to improve research with a growing set of advanced\ntools and applications developed by Ehave and its leading partners. This empowers patients, healthcare providers, and payers to address\na wide range of conditions through high quality, safe, and effective data-driven involvement with intelligent and accessible tools.\n\nOur\nbusiness strategy is to develop and MegaTeam and Ninja Reflex in an effective and timely manner and gain access to additional technologies\nat a time and in a manner that we believe is best for our development. We intend to achieve our business strategy by focusing on these\nkey areas:\n\n●\nDevelopment of the Ehave Dashboard, an extensible platform upon which powerful, condition-specific applications can be designed, built,\nclinically validated, and deployed\n\n●\nexpanding MegaTeam and Ninja Reflex with additional game titles, and participate in further clinical studies with Hospital for Sick Children\non the CHILD-BRIGHT network, which is a Canadian research network that aims to improve the lives of children with brain-based development\ndisabilities we are a partner to and provider of in-kind services and support);\n\n●\nforming strategic alliances with publishers of psychological assessments, at a time and in a manner where such alliances may complement\nand expand our research and development efforts on the product and provide sales and marketing capabilities;\n\n●\ndeveloping relationships with pharmaceutical and insurance companies that could be instrumental in deploying our technology to drug development\nand treatment monitoring; and\n\n●\ndeveloping relationships with companies that could be instrumental in assisting us to access other innovative therapeutics.\n\n●\ndevelop a Multi-Tier Global Partnership with MyLifeID that will allow individuals to carry their health and mental health records with\nthem at all times. This partnership allows individuals to store their health and mental health history on the MyLifeID Pocket Cloud™,\nwhich will be able to be accessed by medical providers through Ehave’s dashboard.\n\n●\nplans to utilize its mental health informatics platform and assets acquired from CureDash Inc., in January 2021, to optimize patient\ncare and health outcomes in conjunction with Ketamine therapy for mental health. Ehave plans to advance Ketamine therapy research and\ncommercialization through its wholly-owned subsidiary, KetaDash.\n\nOur\nbusiness strategy is based on attaining a number of commercial objectives, which, in turn, are supported by a number of product development\ngoals. Our product development presently being conducted is primarily of a research and development nature.\n\n**Market**\n\nWe\nanticipate that the principal markets for our software products will initially include North America. Thereafter, we hope to expand our\nmarkets to Europe and Asia. Currently our products are being deployed in Canada. Currently, Ketadash operates in California, though the\nCompany intends to expand to other states.\n\n19\n\nMental\nhealthcare, including its assessment and treatment, is a significant market. Forty-four million adults in the United States are estimated\nto experience mental illness per year, which is 20% of the population. The size of the U.S. mental health treatment market is $113 billion,\nand the size of private insurance spending on mental health is $32 billion. The size of the cognitive assessment market world-wide is\nover $2.4 billion. *(Source: Mental Health America - State of Mental Health Report, 2016; SAMSHA Spending Estimates Project, 2010;\nMarketsandMarkets, 2015).*\n\nADHD\nis a common affliction with worldwide prevalence estimated at approximately 7% (*Source: “Prevalence of Attention- Deficit/Hyperactivity\nDisorder: A Systematic Review and Meta-analysis”, Rae Thomas, Sharon Sanders, Jenny Doust, Elaine Beller, Paul Glasziou, Pediatrics\nFeb 2015, peds.2014-3482; DOI: 10.1542/peds.2014-3482*). ADHD symptoms typically start or are first noticed in preschool age children\n*(“Prevalence of Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-analysis”, Rae Thomas, Sharon Sanders,\nJenny Doust, Elaine Beller, Paul Glasziou, Pediatrics Feb 2015, peds.2014-3482; DOI: 10.1542/peds.2014-3482). While symptoms may decline\nwith age, ADHD symptoms and impairments can persist into adolescence and adulthood (Source: “A lifetime of attention-deficit/hyperactivity\ndisorder: diagnostic challenges, treatment and neurobiological mechanism”, Julia Geissler and Klaus-Peter Lesch, Expert Review\nOf Neurotherapeutics Vol. 11 , Iss. 10,2011).*\n\nOn\nMarch 5, 2019, the Food and Drug Administration (FDA) approved the first new medication for major depression in decades, a nasal spray\ncalled esketamine, derived from ketamine.\n\nBecause\ntreatment with esketamine might be so helpful to patients with treatment-resistant depression (meaning standard treatments had not helped\nthem), the FDA expedited the approval process to make it more quickly available. In a study of patients with treatment resistant depression,\n22 patients were examined after they finished the induction phase of 8–10 repeated intravenous ketamine infusions. They showed\na 47.2% reduction response in depression, showing significantly decreased depression symptoms without impairing cognitive performance.\nDai, D., Miller, C., Valdivia, V. et al. *Neurocognitive effects of repeated ketamine infusion treatments in patients with treatment\nresistant depression: a retrospective chart review*. BMC Psychiatry 22, 140 (2022). https://doi.org/10.1186/s12888-022-03789-3\n\n**Competition**\n\nFor\nour MegaTeam and Ninja Reflex game applications, we are aware of a few competitors, including Akili Interactive, Attentiv, Myndlift and\nC8Sciences. Many of these companies are currently conducting clinical trials. Our strategy for game development starts from using known\nproven clinical measures rather than creating new measures, and we believe that the advantage of this methodology is that broad normative\ndata does not need to be established and the barrier to clinical adoption may be lower with known measures that clinicians are already\ncomfortable with.\n\nWhile\nour KetaDash program is not intended to compete generally with Electronic Health Records (EHR) systems, we view general EHR systems as\nour main competition. Such systems from Epic, Allscripts and GE Healthcare are leaders in the EHR market, have been in business for many\nyears and are better funded than our offering. However, because we intend to focus on specifically on Ketamine clinics, we believe our\nsoftware will be attractive to the market we intend to serve and will offer specializations not readily available in more general EHR\nsystems.\n\nThere\nare several companies offering Ketamine infusion therapy for the treatment of mental illness, including Novamind and Field Trip Health.\nKetaDash differentiates itself from these companies as Ketadash provides Ketamine treatments in a patient’s home instead of making\nthem go to a clinic. This will allow us to expand more quickly as we do not require physical locations and are not burdened with the\nongoing rent expense.\n\n**Product\nDifferentiation**\n\nWe\nstrive to provide the best tools and resources for today’s populations suffering from mental illness. Many of the incumbent products\nhave been developed and validated in their academic forms, which, we believe, lack appeal for today’s clients and practitioners.\nWe believe there is a demand for real time, data-rich digital tools that enable individual treatment and ongoing monitoring, while a\nsignificant portion of the existing market for cognitive assessment and therapy relies upon paper-based tools and checklists that have\nlittle or no connected monitoring capacity or real-time progress reporting. As such, we seek to develop products with the following key\nfeatures: (1) user engagement, (2) data richness, (3) clinically validated, and (4) multi-screen and mobile deployment.\n\nOur\nassessment products are derived from designs and methods clinically studied. Our plans include the study of our derived products and\ncognitive rehabilitation software through clinical studies led by hospitals. These studies include multiple phases from pilot studies\nthrough affected population studies and allow the measurement, using various criteria and techniques, of the effect of our cognitive\nrehabilitation program on target populations.\n\nLikewise\nwe are applying the same methodology to our KetaDash offering. As the use of Ketamine in the treatment of mental health is an emerging\nfield, we intend the KetaDash software to provide the data richness necessary to evaluate patient progress and outcomes.\n\n20\n\n**Marketing**\n\nOur\nmarketing channels consist of direct sales and leveraging partners for market outreach. Our current strategy is for direct sales to publishing\npartners, medical device partners, medical professionals and pharmaceutical companies. Through these partnerships, we gain access to\nclinicians and the patients they serve.\n\nWe\nalso engage a public relations firm to help reach media outlets.\n\n**Regulatory\nRequirements**\n\nOur\nfuture business operations and activities in the U.S. may be directly or indirectly subject to subject to certain federal and state laws\nrelating to the privacy and security of health information, and state and federal laws designed to guard against healthcare fraud and\nabuse, including, but not limited to, those described below.\n\n●\nHIPAA,\nas amended by HITECH, established comprehensive requirements related to the privacy, security, and transmission of individually identifiable\nhealth information. It governs patient privacy practices of healthcare providers, health plans, and healthcare clearinghouses (or\n“covered entities”), as well as their respective business associates to the extent that they perform services for or\non behalf of the covered entities that involve the use or disclosure of protected health information. HIPAA also mandates notification\nin the event of a breach and regulates standardization of data content, codes and formats used in healthcare transactions. Covered\nentities and business associates may be subject to significant civil and criminal penalties, as well as enforcement by state attorneys\ngeneral, for violations of HIPAA or its implementing regulations.\n\n●\nHIPAA\nalso imposes federal criminal and civil liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud\nany healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money\nor property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or\nprivate) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially\nfalse statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare\nmatters.\n\n●\nThe\nfederal Anti-Kickback Statute which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering\nor paying remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of\nan individual for, or the purchase, order, or recommendation of, an item or service reimbursable under a federal healthcare program,\nsuch as the Medicare and Medicaid programs.\n\n●\nThe\nfederal Civil False Claims Act imposes liability on any person or entity, which, among other things, knowingly presents, or causes\nto be presented, a false or fraudulent claim for payment by a federal healthcare program. The “qui tam” or “whistleblower”\nprovisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government, alleging that\nthe defendant has submitted a false claim to the federal government, and to share in any monetary recovery.\n\n●\nThe\nfederal Civil Monetary Penalties Law prohibits, among other things, the offering or transfer of remuneration to a Medicare or state\nhealth care program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of\na particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception\napplies.\n\n●\nAnalogous\nstate fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, may apply to items or services reimbursed\nunder Medicaid, other state programs, or, in some states, private third-party payors. In addition, many U.S. states have enacted\npatient confidentiality laws that protect against the disclosure of confidential medical information, and many states have adopted\nor are considering adopting further legislation in this area, including privacy safeguards, security standards, and data security\nbreach notification requirements. These state laws, which may be even more stringent than the HIPAA requirements, many of which differ\nfrom each other in significant ways and are often not preempted by the federal requirements.\n\n21\n\n**FDA’s\nMedical Device Regulation**\n\nThe\nFDA has broad authority over the regulation of medical devices marketed for sale in the United States. The FDA regulates the research,\nclinical testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, promotion, distribution and\nproduction of medical devices. The FDA also regulates the export of medical devices manufactured in the United States to international\nmarkets.\n\nUnder\nthe Food, Drug, and Cosmetic Act, or FDCA, the FDA classifies medical devices into one of three classes: Class 1, Class 2 or Class 3.\nMedical devices deemed to pose lower risk are placed into either Class 1 or Class 2.\n\nClass\n1 medical devices are deemed to pose the lowest risk to the patient. Accordingly, Class 1 medical devices are subject to the lowest degree\nof regulatory scrutiny and need only comply with the FDA’s General Controls. The General Controls include compliance with the registration,\nlisting, adverse event reporting requirements, and applicable portions of the Quality Systems Regulation, or QSR, as well as the general\nmisbranding and adulteration prohibitions. Unless specifically exempted in the regulations, general controls require a company that intends\nto market a Class 1 medical device, like us, to gain clearance for marketing through the 510(k) process. Many Class 1 medical devices,\nhowever, are exempt from 510(k) clearance because the level of risk is low.\n\nClass\n2 medical devices are considered higher risk devices than Class I medical devices. Class 2 medical devices are subject to General Controls\nas well as additional Special Controls. Special Controls may include labeling requirements, mandatory performance standards, and post\nmarket surveillance. Generally, companies that intend to market Class 2 medical devices, like us, must comply with applicable regulations\nand submit a 510(k) premarket submission for review to receive clearance to list and market their medical devices. The 510(k) must establish\nsubstantial equivalence to a predicate medical device. Some Class 2 medical devices are exempt from filing a 510(k) but in some instances,\nClass II medical devices may be required to file a Premarket Approval, or PMA, application.\n\nMedical\ndevices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed\nnot substantially equivalent to a previously cleared medical device, are classified as Class 3 medical devices and require a PMA before\ncommercialization.\n\nAll\nmedical device manufacturers must register their establishments with the FDA; such registrations require the payment of user fees. In\naddition, both 510(k) premarket submissions and PMA applications are subject to the payment of user fees, paid at the time of submission\nfor FDA review.\n\nThe\nuse of forms and tools for the measurement and assessment of behavioral and cognitive abilities are considered computerized cognitive\nassessment aids by the FDA. The FDA currently classifies such products as Class II medical devices. Currently we are engaging in clinical\ntrials of Ehave MegaTeam games outside of the United States. Such clinical trials are being performed to prove efficacy and may have\nsupporting evidence in the event that we filed an marketing application in the United States and the FDA requires this data before we\nare able to market, advertise or sell our Ehave MegaTeam games in the United States.\n\n**510(k)\nClearance Pathway**\n\nIf\nrequired to obtain 510(k) clearance for our Ehave MegaTeam games or any other computerized cognitive assessment aid products in the future,\nsuch products may be classified as medical devices and we would may be required to submit a premarket notification demonstrating that\nthe proposed medical device is substantially equivalent to a previously cleared 510(k) device. FDA’s 510(k) clearance pathway usually\ntakes from three to twelve months. On average the review time is approximately six months, but it can take significantly longer than\ntwelve months in some instances, as the FDA may require additional information, including clinical data, to make a determination regarding\nsubstantial equivalence.\n\nAfter\na medical device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would\nconstitute a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, require\na PMA. The FDA requires each manufacturer to determine whether the proposed change requires submission of a new 510(k) notice, or a premarket\napproval, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees with\na manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or recall the modified device until\n510(k) clearance or premarket approval is obtained. If the FDA requires us to seek 510(k) clearance or premarket approval for any modifications\nto a previously cleared product, we may be required to cease marketing or recall the modified device until we obtain this clearance or\napproval. Also, in these circumstances, we may be subject to significant regulatory fines or penalties. We have made and plan to continue\nto make additional product enhancements to products that we believe do not require new 510(k) clearances, but we cannot guarantee that\nthe future enhancements, should they occur, will be exempt from new 510(k) clearances.\n\n22\n\n**De\nNovo Reclassification**\n\nIf\nwe decide to market, advertise or sell our Ehave MegaTeam games or any other any other computerized cognitive assessment aid products\nin the future, such products may not have a suitable predicate medical device to be cleared as a 510(k) medical device. If the FDA finds\nthat there is no suitable predicate medical device, it will automatically be considered our Ehave MegaTeam games or any other computerized\ncognitive assessment aid products that we apply for clearance to market, advertise or sell in the future a Class III medical device.\nHowever, in instances where a medical device is novel and there is no suitable predicate device, but that medical device is deemed to\nbe of low to moderate risk, the FDA may reclassify the device to Class I or Class II via de novo reclassification petition pathway. This\nprocess involves the submission of a de novo reclassification petition, and the FDA’s acceptance that “special controls”\nare adequate to ensure the product’s performance and safety.\n\nThe\nFDA now allows de novo reclassification petitions, a mechanism by which a sponsor can directly submit a detailed de novo reclassification\npetition as the device’s initial submission without having to first receive a not substantially equivalent, or NSE, decision on\na 510(k) submission. Historically, the de novo reclassification pathway typically would take at least 9 to 12 months from filing to clearance.\nSince the enactment of the 21st Century Cures Act, de novo classification petitions may be submitted to the FDA at any time and does\nnot require a FDA finding of not substantially equivalent to a 510(k) application before the petition is made. FDA must respond to any\nde novo classification requests within 120 days of a completed petition.\n\nIn\nthe future, we may decide to submit a de novo reclassification petition for our Ehave MegaTeam games or any other computerized cognitive\nassessment aid products that we may develop. To support a de novo reclassification petition, our objective would be to demonstrate that\nthe proposed medical device poses a low to moderate risk to patients. If the FDA determines that such a product is not a candidate for\nde novo reclassification, it will require approval of the device for market through the PMA application process.\n\nAlternatively,\nif we seek 510(k) clearance and our medical device is found not substantially equivalent, or NSE, the FDA will consider a de novo petition\nif our proposed medical device has been determined to be NSE due to: (1) the lack of an identifiable predicate medical device, (2) a\nnew intended use, or (3) different technological characteristics to a predicate device that raise different questions of safety and effectiveness.\nThe de novo classification request should include a description of the medical device, labeling for the device, reasons for the recommended\nclassification and information to support the recommendation. Should the FDA believe our proposed medical device’s general controls\nor general and special controls provides reasonable assurance of safety and effectiveness, the FDA may classify our medical device as\na Class II medical device. If the FDA classifies the device into Class II, we will then receive an approval order to market the device.\nThis device type can then be used as a predicate device for future 510(k) submissions. However, if the FDA subsequently determines that\nthe device will remain in the Class III category, then we may not be marketed until we have obtained a PMA.\n\n**Premarket\nApproval Pathway**\n\nA\nPMA application must be submitted if a medical device cannot be cleared through the 510(k) process or by de novo reclassification petition.\nThe PMA application process is generally more costly and time consuming than the 510(k) process. A PMA application must be supported\nby extensive data including, but not limited to, analytical, preclinical, clinical trials, manufacturing, statutory preapproval inspections,\nand labeling to demonstrate to the FDA’s satisfaction the safety and effectiveness of the medical device for its intended use.\n\n23\n\nAfter\na PMA application is sufficiently complete, the FDA will accept the application and begin an in-depth review of the submitted information.\nBy statute, the FDA has 180 days to review the “accepted application,” although, generally, review of the application can\ntake between one and three years, but it may take significantly longer. During this review period, the FDA may request additional information\nor clarification of information already provided. Also during the review period, an advisory panel of experts from outside the FDA may\nbe convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the medical device.\nThe preapproval inspections conducted by the FDA include an evaluation of the manufacturing facility to ensure compliance with the QSR,\nas well as inspections of the clinical trial sites by the Bioresearch Monitoring group to evaluate compliance with good clinical practice\nand human subject protections. New premarket approval applications or premarket approval application supplements are required for modifications\nthat affect the safety or effectiveness of the medical device, including, for example, certain types of modifications to the medical\ndevice’s indication for use, manufacturing process, labeling and design. Significant changes to an approved PMA require a 180-day\nsupplement, whereas less substantive changes may utilize a 30-day notice, or the 135-day supplement. PMA supplements often require submission\nof the same type of information as a PMA application, except that the supplement is limited to information needed to support any changes\nfrom the medical device covered by the original PMA application, and may not require as extensive clinical data or the convening of an\nadvisory panel. None of our products are currently approved under a premarket approval and we do not believe that we will ever have a\nproduct that requires a PMA.\n\n**Clinical\nTrials**\n\nClinical\ntrials are almost always required to support a PMA application or de novo reclassification petition and are sometimes required for a\n510(k) premarket notification. If we decide to market, advertise or sell our Ehave MegaTeam and NinjaReflex games or any other any other\ncomputerized cognitive assessment aid products that we may develop in the future, and if the FDA believes that such product presents\na potential “significant risk” to health, safety, or the welfare of a human subject, the FDA may require us to collect safety\nand effectiveness data on human subjects regardless of our device’s classification. If we are required to collect data on human\nsubjects, the FDA will require us to file an application for an Investigational Device Exemption, or IDE with the FDA and obtain IDE\napproval prior to commencing the human clinical trials. The IDE application must be supported by appropriate pre-clinical data, such\nas animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically\nsound. The IDE application must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a\n“non- significant risk” device and eligible for more abbreviated investigational device exemption requirements. Clinical\ntrials for a significant risk device may begin once the IDE application is approved by the FDA and the appropriate institutional review\nboards at the clinical trial sites. Future clinical trials of our motion preservation designs will require that we obtain an IDE from\nthe FDA prior to commencing clinical trials and that the trial be conducted under the oversight of an institutional review board at the\nclinical trial site. Our clinical trials must be conducted in accordance with FDA regulations and other federal and state regulations\nconcerning human subject protection, including informed consent and healthcare privacy. A clinical trial may be suspended by the FDA\nor the IRB at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits of participation\nin the study. Even if a study is completed, the results of our clinical trials may not demonstrate the safety and efficacy of the medical\ndevice, or may be equivocal or otherwise not be sufficient to obtain approval of our Ehave MegaTeam and NinjaReflex game or any other\ncomputerized cognitive assessment aid products that we may develop in the future. At this time, we do not plan on marketing, advertising\nor selling our Ehave MegaTeam and NinjaReflex games or any other computerized cognitive assessment aid products in the United States\nand therefore, do not anticipate performing clinical trials in the United States.\n\n**Patents\nand Trade Secrets**\n\nThe\npatent positions and proprietary rights of pharmaceutical and biotechnology firms, including us, are generally uncertain and involve\ncomplex legal and factual questions. We believe there will continue to be significant litigation in the industry regarding patent and\nother intellectual property rights.\n\nWe\nhave not registered any patents in respect of Megateam and NinjaReflex; however, we maintain our proprietary server architecture and\nmobile applications as trade secrets. We have registered the trade name “Ehave, Inc.” and own the domain “ehave.com.”\n\nWe\nrely on unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop and maintain\nour competitive position. No assurance can be given that others will not independently develop substantially equivalent proprietary information\nand techniques, or otherwise gain access to our trade secrets or disclose such technology, or that we can meaningfully protect our rights\nto our unpatented trade secrets.\n\n24\n\nWe\nrequire our employees and consultants to execute confidentiality agreements upon the commencement of employment and consulting relationships\nwith us. These agreements provide that all confidential information developed by or made known to an individual during the course of\nthe employment or consulting relationship generally must be kept confidential. In the case of employees, the agreements provide that\nall inventions conceived by the individual, while employed by us, relating to our business are our exclusive property. While we have\nimplemented reasonable business measurements to protect confidential information, these agreements may not provide meaningful protection\nfor our trade secrets in the event of unauthorized use or disclosure of such information.\n\n**Seasonality\nof Business**\n\nOur\nresults of operations have not been materially impacted by seasonality.\n\n**C.\nOrganizational Structure**\n\nThe\nfollowing is a list of our principal subsidiaries and consolidated affiliated entities as of the date of this annual report on Form 20-F:\n\nName\n\nPlace\nof Formation\n\nRelationship\n\nAibotics,\nInc.\n\nNevada\n\nMajority\nOwned Subsidiary (1)\n\nKetaDash\nLLC\n\nFlorida\n\nWholly\nOwned Subsidiary\n\nHPPD\nInc.\n\nFlorida\n\nWholly\nOwned Subsidiary\n\n(1)\nOn January 19, 2021, we sold Mycotopia Therapies, Inc. (Florida) to 20/20 Global, Inc. (now known as Aibotics, Inc., a Nevada corporation)\nfor $350,000 in cash. Simultaneously, we purchased a majority of the issued and outstanding stock of 20/20Global for its majority stockholders.\nWe own approximately 66% of Aibotics Inc. and Mycotopia Therapies, Inc. (Florida) is a wholly owned subsidiary of Aibotics Inc., formerly\nknown as 20/20 Global.\n\n**D.\nProperty, Plants and Equipment**\n\nHistorically,\nwe reimbursed our CEO for office space that he had under lease. Our lease expense was $4,000 per month. We do not currently own or lease\nany other office space, manufacturing facilities or equipment and do not have any current plans to construct or acquire any facilities."}