FDA Approves Akili Video Game for Kids With ADHD as Prescription Treatment Opening Door for Ehave to Pursue Clearance for its MegaTeam Products
MIAMI, June 18, 2020 (GLOBE NEWSWIRE) — Ehave, Inc., (OTC Pink: EHVVF) (the “Company”), a provider of digital therapeutics delivering evidence-based therapeutic interventions to patients, announced today it plans to continue making progress on its MegaTeam applications. Ehave’s MegaTeam assessment and rehabilitation products are built on established methodologies for the measurement of cognitive abilities in populations with attention deficit hyperactivity disorder (“ADHD”). The MegaTeam products embed cognitive assessment and rehabilitation tasks within an engaging video game environment.
In a major decision, the United States Food and Drug Association (FDA) approved a video game for children with ADHD. On June 15, 2020 the FDA announced it would permit marketing of the first game-based digital therapeutic device to improve attention function in children with ADHD. The game-based device, called EndeavorRx, is available by prescription-only. It is designed for pediatric patients between 8 and 12 years old who are primarily inattentive or combined-type ADHD with a demonstrated attention issue.Dr. Schachar: “I share the tremendous excitement that has surrounded the announcement that has followed the approval of EndeavorRx by the FDA. In my clinical practice, I meet many parents of young children with ADHD who prefer an alternative to medication and many people who are already taking medication for ADHD are seeking strategies for improving their abilities so that they will no longer need drugs. Many doctors would like to access proven non-drug interventions but are convinced that there are no such interventions. EndeavorRx has changed this story. This achievement comes after decades of research into the executive function deficits that are seen in conditions like ADHD and many others. Executive function refers to those complex brain functions that help guide our everyday decisions in rapidly changing circumstances. These are the skills that allow us to make rapid decisions, execute responses, stop what we are doing when our circumstances change and switch to other strategies. A good deal of research indicates that these kinds of problems are central to ADHD and probably to several other mental health challenges. These skills can be learned. The EndeavorRx program is a testament to this possibility and opens the pathway for the development of new therapeutics based on basic science insights into the specific executive function problems seen in ADHD. MegaTeam is on this path with research based digital therapeutics.”Russell Schachar is a practicing child psychiatrist at the Hospital for Sick Children in Toronto, Professor at the University of Toronto and a Senior Scientist in the Research Institute at Sick Kids. He holds the TD Bank Chair in Child and Adolescent Psychiatry. He and his research colleagues study the nature of executive function in individuals with mental and physical health problems, genetics of ADHD and related disorders and the brain basis of executive function. He has developed eMental Health tools for clinical practice, assessment of executive function, and behavior problems such as ADHD, OCD and irritability. Ehave, Inc. has conducted two Clinical Trials for its MegaTeam-videogame as an intervention/treatment for ADHD. One has been closed and the second is ongoing.Our initial trial started in September, 2016 and ended in April, 2017 with a pilot study of 35 participants. The trial showed the longer you practice on the game, the better your ability to stop a speeded motor response is, and the better you get at manipulating information in short-term working memory. https://clinicaltrials.gov/ct2/show/NCT02827188Our second trial started April, 2018 and is ongoing under supervision of Dr. Jennifer Crosbie with over 100 patients recruited to date. The Clinical Trial was sponsored by The Hospital for Sick Children in Ontario, Canada and was titled Cognitive Restructuring in ADHD: Functional Training (CRAFT) study. The objective of the study was to develop a non-pharmacological intervention program for children with ADHD. The Canadian government invested over $1,000,000.00 in grants in this closed study. Investors can find more information on our Clinical Trial on the U.S. National Library of Medicine’s Clinical Trials website at https://clinicaltrials.gov/ct2/show/NCT03502239.The EndeavorRx decision paves the way for Ehave, Inc. to also be considered for FDA approval. The Company is looking to accelerate the process to submit an FDA application.In the FDA’s press release, Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health said, “The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics. The FDA is committed to providing regulatory pathways that enable patients’ timely access to safe and effective innovative digital therapeutics.”iDr. Krishna: “This is a major land mark approval in the field of Neuro-science specifically Psychiatry. This is a testament that non-pharmacological interventions such as EndeavorRx and MegaTeam are effective in targeting cognitive deficits seen in psychiatric conditions such as ADHD/ADD, thus paving the way for Neuro-Modulation using digital therapeutics in other conditions such as Alzheimer’s and Schizophrenia. As a parent of two young kids I always look for non-pharmacological intervention for my kids, which is a common sentiment for all parents when addressing very common conditions such as ADHD and ADD. I have personally talked to many parents who seek treatment for their children’s ADHD/ADD using neuro-feedback and bio-feedback, via off label prescriptions. These parents attest to the effectiveness, although scientifically it still remains to be proven, it is very possible EndeavorRx and MegaTeam utilizes similar mechanisms of action.”Dr. Nithin Krishna CEO of Psych Associates of Maryland says Psych Associates of Maryland will partner with Ehave to develop, commercialize innovate interventions for mental health. Psych Associates of Maryland has been leading the company toward an innovative and exciting future. We are expanding our services to include specialty centers like the Autism Behavior or Applied Behavior Analysis, Women’s Mental Health Center, Disaster Psychiatry Center, Interventional Psychiatry Center, and Geriatric Psychiatry Center and exciting new interventions and treatments, such as Botox for depression, sensory pods, ketamine treatments, and more. We have also established a number of research collaborations and utilizing PAM’s large patient population is contributing to the scientific understanding of psychiatric illness and the efficacy of new and exciting treatments. Inspiration is always smacking you in the face, here at PAM and there are endless opportunities! Alfred Farrington, Ehave’s CIO commented, “Ehave’s MegaTeam games are essential to a non-drug option for assessing symptoms associated with ADHD in children. We have partnered with some great developers from MIT COVID-19 Challenge https://covid19challenge.mit.edu/ to further innovate our product. Within our pilot program we are upgrading scoring and reward system to keep participants engaged. All games are to have compatibility across desktops, tablets, and mobile phones. We are adding visualized dashboards for participant to download, save, and export results. The feature that drives data-driven results is the “Executive Function Engine” that measures:Stop Signal Reaction Time AssessmentN-Back AssessmentInhibitory Control RehabilitationWorking Memory RehabilitationWe are looking to continuously innovate our games as our participants deliver results.”“I would like to congratulate the people at EndeavorRx for successfully receiving FDA approval for a non-drug treatment for ADHD,” said Ben Kaplan, CEO of Ehave, Inc. Mr. Kaplan continued, “Our own ADHD products were developed in conjunction with the largest children’s hospital in Canada. We plan to explore ways to monetize our MegaTeam products in both Canada and the USA.”About Ehave, Inc.Ehave, Inc. is a provider of digital therapeutics delivering evidence-based therapeutic interventions to patients. Our primary focus is on improving the standard care in therapeutics to prevent or treat brain disorders or diseases through the use of digital therapeutics, psychedelics, independently or together, with medications, devices, and other therapies to optimize patient care and health outcomes meeting privacy and HIPAA & GDPR Compliant. Our main product is the Ehave Dashboard which is a mental health informatics platform that allows clinicians to make objective and intelligent decisions through data insight using Blockchain technology. The Ehave dashboard offers Offline Encrypted Digital Records Empowering Healthcare providers and patients and it’s a powerful machine learning and artificial intelligence platform using artificial intelligence to extract deep insights from audio, video and text to improve research with a growing set of advanced tools and applications developed by Ehave and its leading partners. This empowers patients, healthcare providers, and payers to address a wide range of conditions through high quality, safe, and effective data-driven involvement with intelligent and accessible tools.Forward-Looking Statement DisclaimerThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading “Risk Factors” in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC’s website, http://www.sec.gov.Media and Investors Relations, please contact:Gabe RodriguezPhone: (623) 261-9046Email: email@example.com________