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Mydecine to Launch Special Access Support and Supply Program in Canada Expanding Access to Psychedelic-Assisted Psychotherapy For Patients

Mydecine to Launch Special Access Support and Supply Program in Canada Expanding Access to Psychedelic-Assisted Psychotherapy For Patients

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.”

If you are interested in more information on Mydecine’s program, please complete this form or send an email to contact@mydecineinc.com.

Sign up for Mydecine’s newsletter by scrolling to the bottom of this page.

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.

Learn more at: www.mydecine.com and follow the company on Twitter, Instagram, and LinkedIn.

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:

Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com 

Investor Relations
contact@mydecineinc.com 

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com 

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.

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Psychedelic therapy just got A LOT more accessible for Canadians

BREAKING: Canada Opens New Legal Pathways For Access To Psychedelics Treatment With Psilocybin And MDMA

Until now, the only way for patients to access psychedelic therapy outside a clinical trial was to apply for a Section 56 exemption and wait months on end to (possibly) receive approval from Health Canada.

Despite six more patients receiving the exemption over the holidays, the system remains flawed.

Thankfully, this Wednesday, Health Canada made an amendment to this thing called the Special Access Program (SAP), which enables healthcare practitioners to request access to drugs that are not yet approved, but have shown promise in clinical trials.

The amendment allows practitioners to request access to psilocybin and MDMA for their patients with serious, life-threatening, or treatment-adverse conditions. And the best part: requests are typically processed in just 1 day! 🎉

While this does not guarantee access for patients, it certainly feels like a big step in the right direction.

To learn more about the amendment, check out TheraPsil’s free webinar on Jan. 19th.

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Benzinga
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You no longer have to be on your deathbed to eat mushrooms!

Exclusive: Three Canadians with mental health conditions receive legal access to psilocybin mushrooms

Up until this week, the only people in Canada that could legally access psilocybin therapy were patients with terminal illnesses. 

Things changed on Monday, when the non-profit organization TheraPsil helped three Canadians with mental health issues get Section 56 exemptions, granting them access to psilocybin therapy.

“This is a very clear indication that exemptions are now available for people who have anxiety, depression, addiction, and chronic pain,” says TheraPsil’s CEO. “It opens it up to everyone.”

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Way2Grow (W2G) Biopharma Corp. Receives Health Canada Approval Notice for Construction of a Controlled Substances Dealer’s Licence Level 8 Psychedelic Secure Environ and Psilocybin Production Campus

Way2Grow (W2G) Biopharma Corp. Receives Health Canada Approval Notice for Construction of a Controlled Substances Dealer’s Licence Level 8 Psychedelic Secure Environ and Psilocybin Production Campus

Way2Grow Biopharma, a private BC company, received a license from Health Canada to create a psychedelic production campus. The company can produce up to $30 worth of compounds to sell to pharmacies and clinics.

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Way2Grow (W2G) Biopharma Corp. Receives Health Canada Approval Notice for Construction of a Controlled Substances Dealer’s Licence Level 8 Psychedelic Secure Environ and Psilocybin Production Campus

Way2Grow (W2G) Biopharma Corp. Receives Health Canada Approval Notice for Construction of a Controlled Substances Dealer’s Licence Level 8 Psychedelic Secure Environ and Psilocybin Production Campus

OSOYOOS, British Columbia, Nov. 17, 2021 (GLOBE NEWSWIRE) — via InvestorWire — Way2Grow Biopharma Corp. (“W2G” or the “Company”), a privately held therapeutic corporation existing under the laws of British Columbia, is pleased to announce approval of a Health Canada Dealer’s Licence Application, in which Health Canada issued notice to W2G to complete the construction of a Level 8 Secure Environ and Psilocybin Production Campus. A Health Canada Dealer Licence and production facility will allow W2G to procure psychedelics as well as propagate, cultivate, harvest and sell psychedelics to pharmacies, clinics and other licenced research facilities for allowable research purposes pursuant to the Controlled Drugs and Substances Act (the “CDSA”).

Licensing

W2G is pioneering a comprehensive Life Science Therapeutic Production Campus with the goal of researching, advancing and manufacturing life science therapeutics. W2G’s Therapeutic Production Campus supports small room, closed-loop, evidence-based therapeutic research and production. The Company’s pure cultivation approach is rooted in science, is empirically based, organically grown and evidence driven. W2G’s approach uses standardized tissue culture and micropropagation to cultivate and extract pure organic cannabis and psychedelic therapeutics. Completion of the Level 8 Controlled Substances Dealer’s Licence will allow W2G to cultivate, extract and store up to $30 million in value of psychedelics compounds, including psilocybin/psilocin (magic mushrooms), N, N-Dimethyltryptamine (DMT), Ololiuqui (Morning Glory), mescaline and peyote.

W2G will be the first comprehensive Life Science Therapeutic Production Campus specializing in psychedelic and cannabis production, micropropagation, organic cultivation, processing and therapeutic manufacturing in North America.  Approval of the Controlled Substances Dealer’s Licence allows W2G to procure controlled substances by synthesis, propagation, cultivation and harvesting of psychedelic substances. W2G will be permitted to sell psychedelic compounds to other licenced dealers, authorized hospitals, research facilities and academic institutions until such time that psychedelics are prescribed by authorized physicians.

To fulfill W2G’s innovative research plans in psychedelic formulations, the Company’s plans include EU-GMP-compliant facility construction to allow for the import and export of psychedelics therapeutics to expand evidence-based psychedelics research through global partnerships. W2G’s research plans include improving breeding programs, standardizing psilocybin production, and the examination of psychedelics’ combinative efficacy on treating certain health conditions.

W2G’s cultivation relies on a small, closed room approach to growing consistent organic medical psilocybin. Each W2G cultivar or spore starts with a consistent germplasm developed though natural breeding and tissue culture. The future of W2G germplasm development will integrate the use of advanced genomic and genetic engineering to produce novel biotechnologies. Each cultivation room operates under specific growing conditions to maintain optimal production and consistent quality of medicinal compounds.

W2G has pioneered a new and strategic comprehensive Life Science Therapeutic Production Campus by combining its expertise in organic cultivation technology with an experienced genetic advancement team, innovative pharmaceutical research plans and intellectual property development, coupled with the highest level of security.

“We are excited to enter this next phase of life science therapeutics, and we believe this unique combination will lead to the highest-quality targeted organic therapeutic products. As we enter this next phase of our company’s evolution, we will focus on building strategic partnerships to help disseminate our psychedelics research and to expand our distribution,” stated W2G CEO Jamie Filipuzzi.

About W2G

W2G is a privately held therapeutic company in the life science industry. W2G began with a vision to help patients gain better access to high-quality, consistent, organic therapeutics. To achieve this vision, W2G has developed a consistent growth plan using tissue culture and molecular biology. These methods allow for the standardization of the procedures used to ensure quality and consistency of W2G’s therapeutics.

W2G’s extensive research and intellectual property approach are focused on the development of several new plant-based cultivation techniques, hybrid cultivar development, genetic profiling and tissue culture. By developing a molecular breeding and genetics program, we can identify new bioactive compounds to determine interaction with specific genes responsible for chronic diseases.

W2G is located in Osoyoos, British Columbia, and is federally regulated in Canada under the Cannabis Act (S.C. 2018, c. 16) and the Cannabis Regulations (SOR/2018-144)).

FORWARD-LOOKING STATEMENTS

This news release may contain “forward-looking statements.” These statements relate to future events or future performance of Way2Grow. Statements which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, outlook, expectations or intentions regarding the future, including words or phrases such as “anticipate,” “may,” “will,” “might,” “should,” “could,” “can,” “intend,” “expect,” “believe,” “plan,” “project,” “continue” or similar expressions that suggest future outcomes or the negative thereof or similar variations. Such forward-looking statements include, but are not limited to, statements concerning W2G’s research, development and expansion plans, including its Health Canada application for the Dealer Licence and Section 56 Exemption, and the potential results from such Licensing.

Forward-looking statements are based on management’s current expectations and may materially differ from actual results. Further, such forward-looking statements are subject to risks and uncertainties that could negatively affect our business, operating results and financial condition, including, without limitation, risks arising from a delay in Licensing and financing risks. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact Information:

JJ Filipuzzi, Investor Relations
Phone: (403) 554-5973
Email: info@w2g.ca
Website:  www.w2g.ca

Wire Service Contact
InvestorWire (IW)
Los Angeles, California
www.InvestorWire.com
212.418.1217 Office
Editor@InvestorWire.com

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Psyched Wellness Announces That the Amanita Muscaria Mushroom Has Been Successfully Added to the Natural Health Products Ingredients Database (NHPID) of Canada

Psyched Wellness Announces That the Amanita Muscaria Mushroom Has Been Successfully Added to the Natural Health Products Ingredients Database (NHPID) of Canada

Toronto, Ontario – November 3, 2021 – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“), a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce that Health Canada has approved the Company’s submission to have the Amanita Muscaria mushroom added to The Natural Health Products Ingredients Database (NHPID) of Canada.

Following Psyched’s extensive scientific work in testing and data-gathering on the Amanita Muscaria mushroom and its unique extract – AME-1, the Company had submitted the request to Health Canada to add the Amanita Muscaria mushroom (Fly Agaric) to NHPID as a medicinal organism.

Health Canada has approved the request and classified the Amanita Muscaria mushroom as a Natural Health Product under Schedule 1, Item 1 (a fungus) of the Natural Health Products Regulations. To read more about the classification, please visit this link:

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/ingredReq.do?id=18056&lang=eng

Jeff Stevens, CEO of Psyched Wellness said, “The addition of Amanita Muscaria to the NHPID is a significant achievement and is the result of extensive research that Psyched has undertaken to demonstrate its natural medicinal properties. This milestone moves us closer to being able to bring our Amanita-based CPG products to market which we are developing to promote stress relief, relaxation and assist with restful sleeping through the natural calming powers of AME-1.”

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
t: (647) 400-8494
e: jstevens@psyched-wellness.com
Website: http://www.psyched-wellness.com

Investor Contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
t: (978) 505-2478
e: PsychedWellness@kcsa.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

About Psyched Wellness Ltd.:

Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.

Cautionary Statement Regarding Forward-Looking Information and Statements

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and (ii) the uses and potential benefits of Amanita Muscaria.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the Company’s ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; and the continued growth of the Company.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company’s operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and the risk that there is no potential benefit of Amanita Muscaria consumption.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

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This is why Gen Z should be in charge…

19-Year-Old New Hampshire Lawmaker Prepares Bills To Decriminalize Psilocybin And All Drugs

Some of the youngest state legislators in the US want to decriminalize all drugs.

Tony Labranche, a 19-year-old Rep. of New Hampshire, is pushing to establish a regulated cannabis sales system and decriminalize the possession of magic mushrooms, as well as all other controlled substances. The reform proposals are bold for a GOP-controlled state, but they’re sparking more dialog about the need to end the war on drugs.

Back in February, a 20-year-old lawmaker filed a bill to broadly decriminalize drug possession in Kansas, noting that drug use should be treated as a mental health problem rather than a criminal one.

Canada is following suit, with the city of Toronto preparing to ask Health Canada to decriminalize all drugs, similar to Vancouver’s request in May.

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Another BC company joins the psilocybin space

Surrey company receives licence to produce magic mushrooms

A functional mushroom company based in Surrey, BC is joining the psychedelic space.

After 17 months of waiting, Eversio Wellness finally received a “Controlled Substances Dealer’s Licence” from Health Canada, which allows the company to produce psilocybin, DMT, and mescaline.

The company will focus on standardizing the production of natural psilocybin and will likely supply physicians and pharmacies with psychedelics for research purposes.

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No more excuses for Health Canada

B.C. non-profit challenges Health Canada to end 50-year prohibition on magic mushrooms

Several non-profits are doing Health Canada’s dirty work to speed up the legalization of psilocybin.

TheraPsil sent 165 pages of proposed psilocybin regulations to Health Canada, which were based on the medicinal cannabis regulations created 20 years ago. The document addresses regulations around selling and growing magic mushrooms, such as how to qualify for a license, quality control processes, security measures, and packaging requirements.

Other non-profits including the Multidisciplinary Association of Psychedelic Studies (MAPS) and the Canadian Psychedelic Association (CPA) are drafting their own legal frameworks.

“This will hopefully be a gift to them to have done their work for them,” said a CPA board member.
“All they have to do is agree, but of course, it’s never that simple. The bureaucrats will have to go over it with a fine tooth comb,” said a former federal treaty negotiator and psilocybin exemption applicant.