With the addition of psilocybin and MDMA to Health Canada’s Special Access Program, Mydecine looks to offer a package of cGMP products and support services promoting responsible administration to patients and creating near-term revenue potential
VANCOUVER, British Columbia, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today they would be launching The Special Access Support and Supply Program (SASSP) to provide products and services to physicians, clinics, and hospitals in Canada who are looking to treat patients through psychedelic-assisted psychotherapy. With the new addition of psilocybin and MDMA to the approved list of substances under Health Canada's Special Access Program (SAP), the company aims to fill a critical gap in the market by allowing thousands of healthcare professionals and clinics the resources needed to bring these treatments to patients in need.
Last week, Health Canada announced
an amendment to federal regulations, granting practitioners and pharmacists the ability to request and prescribe psilocybin and MDMA for treatment-resistant patients. This means patients who have not seen success from other treatments can now access additional treatment options. To re-enforce safe and effective integrations of these treatments, Mydecine’s SASSP will offer A-Z support to medical practices across Canada.
Through the Company’s SASSP, healthcare practitioners can purchase a package including cGMP psilocybin and MDMA, investigative brochures, therapy manuals, protocol training, advisory services, and post-therapy support for patients through Mydecine’s wholly-owned subsidiary Mindleap Health. Mindleap is a digital health platform that combines therapeutic and educational content with virtual 1-on-1 professional support for psychedelic integration.
Mydecine is currently producing cGMP certified pharmaceutical grade psilocybin and MDMA with coverage under a Health Canada Schedule 1 Drugs and Substances Dealer’s License in Alberta. With multiple clinical trials launching this year utilizing psychedelic compounds, as well as their partnership with Johns Hopkins University, the Company is well-positioned to help physicians, clinics, and hospitals use Canada’s new regulations.
Mydecine’s Chief Medical Officer, Dr. Rakesh Jetly, stated, “While we are committed to demonstrating the safety and efficacy of these medicines for specific indications through our clinical trials, we do recognize that in the meantime, there are people that are suffering from mental illnesses that haven’t responded to the evidence-based treatments that are currently accessible to them. I believe through our program, we can help treat a significant patient population who are in need of alternative options. Our global team of scientists, doctors, and advisors have extensive experience in administering these types of treatments, and we look forward to sharing that knowledge and expertise to promote responsible and successful use of psilocybin and MDMA.”
CEO Josh Bartch added, “The goal of our Special Access Support and Supply Program, is to help physicians who want to prescribe these treatments to their patients but might not have access to the drug product in Canada or experience implementing psychedelic-assisted psychotherapy. It’s extremely encouraging to see these much-needed treatments gaining government acceptance, and now we need to enable successful therapy outcomes. Outside of safe drug products, practitioners need access to the resources and the proper training to provide these treatments to their patients. By launching this program, we are providing the resources the thousands of non-psychedelic clinics and hospitals will need in order to safely and effectively integrate these therapies into existing medical practices.”
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About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group's business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group's vision is to bridge the current gap between what the cognitive healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.
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About Mindleap Health
Mindleap Health Inc. is a wholly-owned subsidiary of Mydecine. Mindleap’s virtual healthcare platform offers technology solutions to allow people to improve their mental health and wellbeing. The Mindleap platform provides remote telemedicine services for mental health coaching through its international network of mental health specialists along with mental health tracking and analytics. The Mindleap platform brings convenience, improves access to treatments, and can lead to more personal breakthroughs. In addition, Mindleap’s proprietary platform is designed to provide professional support and personalized medicine for every user. The company’s mission is to upgrade mental health by simplifying, modernizing, and improving access to mental health treatments for millions of people worldwide.
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Learn more at: mindleap.com
For more information, please contact:
Morgan Kervitsky, Director of Marketing
On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
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
This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect,” “intends,” “anticipated,” “believes,” or variations (including negative variations) of such words and phrases, or state that specific actions, events or results “may,” “could,” “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made 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, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to protect and enforce its intellectual property adequately, the Company's ability to bring its products to commercial production, the 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, other factors may cause effects 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. 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.