Successfully Launched World’s First Psilocybin Clinical Trials Initiative for PTSD
DENVER, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE:0NFA) ("Mydecine" “MIG” or the "Company"), is pleased to provide a corporate update regarding recent advancements and achievements that continues to add shareholder value and position Mydecine as a genuine leader in the ever-expanding fungi and psychedelic sectors. Through its leadership, Mydecine is positioning the Company to make a significant role in the future of psychedelic medicine including but not limited to clinical trials focused on PTSD, IP development, fungtional™ consumer goods, and digital health market services.
Mydecine was acquired by the NewLeaf Brands, and shortly afterwards, NewLeaf Brands officially changed the company's name to Mydecine Innovations Group to officially represent it's pivot into the fungi and psychedelic markets
Mydecine closed two back-to-back seed rounds of financings, raising approximately CAD$6 Million to expand operations and completion of its state-of-the-art mycology laboratory to advance its psychedelic medicine initiatives and IP Patent portfolio
Appointed Damon Michaels, a driven thought leader with a 15+ year track record of executing growth strategies with large innovative companies to the role of Chief Operations Officer;
Appointed Rob Roscow, an accomplished scientist with a foundation and keen interest in genetic engineering to the role of Chief Science Officer;
Appointed previous Red Bull Marketing Executive and experienced brand builder, Jim Gunning to role of Chief Marketing Officer
Appointed to Dr. Denton Hoyer, former Pfizer researcher and Director of Chemistry for the Yale Center for Molecular Discovery, the Scientific Advisory Board.
Appointed Vince Polito and Anton Gomez-Escolar as advisors to lead psilocybin microdosing research and development;
Appointed Dr. Mali Reddy (M.S. Reddy) seven-time Nobel Prize Nominee and the "Godfather of Pro-Biotics" to the Scientific Advisory board;
Appointed Dr. Aubrey Oliver to Advisory board to spearhead the company’s expansion into Jamaica, one of the only legal psilocybin markets in the world;
Built out The Mydecine Center of Mycology, a 7,500 sq. ft. state-of-the-art mycology laboratory in Denver, Colorado;
Successfully launched world’s first psilocybin clinical trials initiative for PTSD
Established an R&D partnership with Applied Pharmaceutical Innovation through the faculty of drug discovery and pharmaceutical medicine out of the University of Alberta, providing Mydecine reliable and stable sourcing in the areas of cultivation, research, process, synthesize, and import/export for the company’s various R&D initiatives through API’s Health Canada Schedule 1 Substances and Drugs Dealer's License;
Signed definitive Share Exchange Agreement to acquire Mindleap Health Inc. giving the Company entrance into the fast growing telemedicine market and to virtually connect patients and clinicians for post-care psychedelic therapy;
Signed definitive Share Exchange Agreement to acquire Neuropharm Inc., adding valuable intellectual property, world-class talent and the first ever clinical trials focusing on PTSD utilizing psilocybin;
Retained leading full-service Contract Research Organization Ethica CRO accelerating company’s psychedelic medicine initiatives;
Added three key Scientific advisors in our PTSD clinical trial program:
Dr. Rachel Yehuda, Ph.D., Professor of Psychiatry and Neuroscience, is the Director of the Traumatic Stress Studies Division at the Mount Sinai School of Medicine
Dr. Carl Castro, Ph.D. Director, Center for Innovation and Research on Veterans & Military Families Associate Professor, USC Suzanne Dworak-Peck School of Social Work. Chair of a NATO research group on military mental health training,
Dr. (Alexander) Sandy McFarlane, Director of The University of Adelaide's Centre for Traumatic Stress Studies. An international expert in the field of the impact of PTSD
Psychedelics have the potential to impact and improve mental health. Psychedelic medicine offers the potential to revolutionize mental health treatments and recent regulatory changes and scientific advancements have reduced the historical stigma associated with these substances. Mydecine™ continues to position itself as a thought leader in this ever expanding space to offer solutions to those suffering and better understand the health benefits of fungi's active psychedelic compounds for these various mental health and physical conditions.
Mydecine’s spore-to-sale™ operational extension of the Company, Mydecine Health Sciences™ (“MHS”), is taking a two-pronged approach and focusing on both psychedelic (clinical) and fungtional™(consumer) avenues of commercializing fungi. MHS is developing proprietary blends of the unique active compounds that many varitals of exotic fungi produce. MHS will then infuse these blends into various product SKUs that will be distributed across North America by one of the largest private distribution companies called Alternative Distribution Company that MIG owns a 50% stake in. There are significant opportunities in the fungtional™ mushroom and natural health industry.
By 2025, the global mushroom market is projected to grow to $86.6 billion, at a CAGR of 8.04%. The psychedelic medicine market alone is projected to grow at a CAGR of 16.3% to reach $6.85 billion by 2027. The key factors that will fuel this growth include the increasing prevalence of depression and other mental health disorders in the U.S. (which have been dramatically compounded with COVID-19) and a growing acceptance of psychedelic medicine as a highly effective treatment for mental conditions like depression, OCD, and addiction.
“Our team aims to be at the forefront of the efficient development of psychedelic medicine derived from fungi and therapeutic solutions. In such a short time, we have been able to accomplish advancement for the potential use of psilocybin in the treatment of PTSD with the clinical trials that we just initiated in the Netherlands,” explained Josh Bartch, CEO and Director of Mydecine™. “Our major acquisitions have been strategic to our company’s mission and growth. We recently acquired psychedelic digital health platform Mindleap Health™ and the Canadian-based psychedelic healthcare company NeuroPharm Inc. and are closer to seeing our vision as well as adding significant talent, intellectual property, incremental revenue growth and shareholder value. Our team is proud to work on groundbreaking research with the promise of changing the lives of millions.”
Recent Corporate Advancement Highlights:
The Mydecine™ team has been very efficient over the last several months to establish a strong foothold in several major fast growing markets. Mydecine has identified and locked up acquisition targets that have strengthened its competitive positioning and provide opportunities for future growth and shareholder value.
The Company entered into a definitive agreement to acquire Mindleap Health Inc. ("Mindleap") in Q2, 2020 to further its initiatives in telehealth, specifically in the areas of therapist and therapeutic support. Mindleap™ is developing an advanced digital telehealth platform to provide support for those people looking to achieve personal transformations and overcome mental health challenges. Mindleap™ is the only digital telehealth platform that combines telemedicine with mood, emotion, and habit tracking with a unique focus on psychedelic aftercare.
Mindleap™ is focused on making a considerable difference in people's lives by making access to mental health services more convenient and affordable, and by providing more personalized and effective treatments utilizing modern technology. In September, the launch of the Mindleap™ platform will provide:
An easier way to access mental health services
Psychedelic aftercare, addiction, and holistic wellness services
Automated appointment booking and international payments
Secure and confidential video sessions
Critical tools for improved outcomes and personalized care
Easy to use software with fast learning curve for specialists
Secured encrypted system that is HIPAA and GDPR compliant
High engagement features and gamification that improve user experience
"Our mission is to simplify, modernize and improve access to mental health treatments. At our core, we are a technology innovator backed by amazing people – software developers, customer engagement experts and futurists who are passionately committed to customer success. We are thrilled to be a part of Mydecine Innovations group of companies, ” said Nikolai Vassev, Mindleap Founder and CEO.
The Company entered into a definitive agreement for the acquisition of NeuroPharm Inc. in Q3, 2020, to further strengthen its preclinical and clinical trial studies within global test sites for PTSD. The Canadian-based psychedelic healthcare company NeuroPharm Inc., is focused on developing unique mental health therapies and approaches for veterans wellness, with a specific focus on the use of psilocybin. NeuroPharm continues to advance its research and development underpinned by IP strategy to treat various mental health conditions that are frequently experienced by veterans such as PTSD.
NeuroPharm has been privileged, through its Scientific Advisory Board, to establish an extensive network of relevant relationships within many of the world's veterans and military organizations allowing for a better understanding of the challenges our veterans face regardless of borders.
Through NeuroPharm’s Scientific Advisory Board, they have been able to expand upon continued military relationships and successfully launch the world's first psilocybin clinical trials initiative for Post-Traumatic Stress Disorder.
Medical & Scientific Advisory Board:
Dr. Rakesh Jetly, OMM, CD, MD, FRCPC, Dr. Rakesh Jetly is currently the Head of the Centre of Excellence on Mental Health in Ottawa, Ontario, and an associate professor of psychiatry at Dalhousie University (Halifax); and the University of Ottawa
Prof. dr. H.G.J.M. Eric Vermetten MD, PhD, Prof. Eric Vermetten is professor of Medical-Biological and Psychiatric Aspects of Psych trauma at LUMC/University of Leiden. Pro. Vermetten is also psychiatrist at the MGGZ in Utrecht (Military Mental Health care)
Dr. Rachel Yehuda, Ph.D. Dr. Rachel Yehuda is the Director of the Traumatic Stress Studies Division at the Mount Sinai School of Medicine which includes the PTSD clinical research program and the Neurochemistry and Neuroendocrinology laboratory at the James J. Peters Veterans Affairs Medical Center
Dr. Carl Castro Dr. Carl Castro is chair of the NATO research group on military mental health training and serves as an advisor for several Department of Defense research panels focused on psychological health. He is also the research director for the USC Center for Innovation and Research on Veterans and Military Families and has authored more than 150 scientific articles and reports in numerous research areas
Dr. (Alexander) Sandy McFarlane Dr. (Alexander) Sandy McFarlane is Director of The University of Adelaide's Centre for Traumatic Stress Studies. An international expert in the field of the impact of PTSD. His research has focused on the epidemiology and longitudinal course of PTSD as well as the neuroimaging of the cognitive deficits in this disorder. He has published over 250 articles and chapters in various refereed journals and has co-edited three books.
Dr. Gary Wynn, MD, COL, MC, USA Dr. Wynn is Professor of Psychiatry and Neuroscience, Assistant Chair of the Department of Psychiatry, and Senior Scientist at the Center for the Study of Traumatic Stress. He is also a Distinguished Fellow of the American Psychiatric Association and on the editorial board of the Journal of Neuroscience Research. Dr. Wynn received his education at the United States Military Academy at West Point and Uniformed Services University of the Health Sciences
Dr. Ruth Lanius, MD, Ph.D. Dr. Ruth Lanius is the director of the posttraumatic stress disorder (PTSD) research unit at Western University. Established the Traumatic Stress Service and the Traumatic Stress Service Workplace Program, services that specialize in the treatment and research of PTSD.
Dr. Margaret McKinnon Ph.D., CPSYCH Dr. Margaret McKinnon is Homewood Chair in Mental Health and Trauma, Associate Chair of Research and Associate Professor, Department of Department of Psychiatry & Behavioral Neurosciences, Psychologist, Mood Disorders Program, St Joseph’s HealthCare
Dr Paul Frewen, Md Ph.D. Dr Paul Frewen is a Psychiatry and psychology professor at Western University. Currently chair of the Traumatic Stress Section of the Canadian Psychological Association (CPA). He has authored over 100 peer-reviewed articles on the subjects of trauma, aﬀect regulation, mindfulness, and dissociation
Key Strategic Partnership with API
API is a not-for-profit commercial medicine development institute that works within the University of Alberta's Faculty of Pharmacy and Pharmaceutical Sciences as well as research and post-secondary institutions across Canada. API draws on an interdisciplinary network of over 30 pharmaceutical world-class researchers that include scientists, clinicians, regulatory, patent, and market experts in a variety of fields and disease areas to bring life-saving research to the real world. This agreement provides Mydecine™ with:
Ability to accelerate product R&D
Access to a full cGMP certified pharmaceutical manufacturing facility
Ability to import/export, extract, and analyze psychedelic medicine with full government approval through Health Canada
Access to a wide range of world-class scientific researchers focusing on discovery, pharmaceutical analysis, medicine action, disposition, formulation, and clinical development
Artificial intelligence capabilities to identify biosynthesis pathways for medicine discovery, optimize targeted medicine delivery systems and to design marketable medicinal compounds
The Mydecine Center of Mycology
Mydecine's laboratory and U.S. headquarters in Denver, Colorado will serve the needs for the genetic study, as well as selection and cultivation of valuable and rare fungi. The lab will incorporate state-of-the-art analytical chemistry, molecular biology, next-gen sequencing, and tissue culture. We believe that the potential in fungi is known, but more research is still needed to fully bring it into the market. This lab will facilitate those efforts to scale and commercialize the highest quality fungi fortified health and vitality products to the masses. The capabilities of our lab will serve as a cornerstone for Mydecine's research and development efforts.
Mydecine™ isn’t just researching one mushroom; it has the entire fungal kingdom (~144,000 known species) on its radar and the artificial intelligence lab of the University of Alberta to screen the variety prospects fast and efficiently.
Looking forward to the remainder of 2020, Mydecine™ would like to assure our investors that the entire management team is focused on building shareholder value and on executing upon their milestones. The Mydecine™ team firmly believes in the potential for clinical trials, IP development and digital health strategies and are committed to moving forward. Ensuring that we have the capital to execute on our plans, we believe shareholders will be rewarded as we continue to execute on our strategy.
About Mydecine Innovations Group Inc.
Mydecine Innovations Group™ is a publicly traded life sciences parent company dedicated to the development and production of adaptive pathway medicine, natural health products and digital health solutions stemming from fungi. Mydecine’s experienced cross functional teams have the dynamic capabilities to oversee all areas of medicine development including synthesis, genetic research, import/export, delivery system development, clinical trial execution, through to product commercialization and distribution. By leveraging strategic partnerships with scientific, medical, military, and clinical organizations, Mydecine is positioned at the forefront of psychedelic medicine naturally derived from fungi, therapeutic solutions, and fungtional™ mushroom vitality products. Our portfolio of unified companies, including Mydecine Health Sciences™, Mindleap Health™, and NeuroPharm™ focus on providing innovative and effective options that can provide millions of people with a healthier quality of life.
For further information about Mydecine Innovations Group Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.
The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward- looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company's ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company's products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.
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