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Psyched Wellness Announces July 19th, 2022 as the Official Date To Commence Pre-Orders for Calm

Psyched Wellness Announces July 19th, 2022 as the Official Date To Commence Pre-Orders for Calm

The announcement comes on the company’s second anniversary, marking its growth and success

Toronto, Ontario–(Newsfile Corp. – July 13 2022, 2022) – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“), a life sciences company focused on the production and distribution of health and wellness products derived from the Amanita Muscaria mushroom, is celebrating its second anniversary and is thrilled to share that the previously announced pilot run of its Amanita Muscaria derived product, Calm is nearly complete and the company is ready to move forward with pre-orders. Starting July 19th, 2022, the company will begin accepting pre-orders, with products anticipated to reach consumers in the United States in the Fall of 2022.

Calm is the company’s flagship product, and is the first legal Amanita Muscaria mushroom extract approved for sale in the USA. It does not require a prescription, leaving the retail landscape open to many possibilities for distribution and listing potential.

“With today being Psyched Wellness’ 2nd anniversary as a company, we felt it was perfect timing to set a date for consumers in the United States to be able to pre-order Calm.” says Jeffrey Stevens, CEO of the company. “It has been a long journey to get to this point, and I would like to take this opportunity to thank my co-founder, David Shisel, our team, KGK Science and Vantage Hemp for all of their hard work and commitment to get us to where we are today. The most exciting part for me is that we have just scratched the surface with respect to potential uses and delivery forms for AME-1. Stay tuned for more to come from Psyched.”

Sign up to be notified of the launch here.

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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

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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Psyched Wellness announces date for their pilot production run of the first legal Amanita Muscaria tincture product, Calm

Psyched Wellness announces date for their pilot production run of the first legal Amanita Muscaria tincture product, Calm

Utilizing their proprietary extraction method, Psyched will launch a line of products with AME-1, their Amanita Muscaria extract for sale in the United States

Toronto, Ontario–(Newsfile Corp. – June 29th, 2022) – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“), a life sciences company focused on the production and distribution of health and wellness products derived from the Amanita Muscaria mushroom, is excited to announce the initial pilot production run of their first-to-market AME-1 product, Calm is scheduled for July 7th. Calm is presented as an extract which harnesses the mushroom’s ability to de-stress and facilitate restful sleep.
The inaugural production of Calm signals the company is on track to transition from an R&D organization to a full-scale commercial consumer packaged goods (CPG) entity, generating revenue. All Amanita Muscaria products produced by Psyched Wellness will be available over-the-counter and without a prescription. This means the retail landscape is uncapped, maximizing distribution and listing potential. Calm will be the first legal Amanita Muscaria mushroom product sold in North America.

Chief Commercial Officer, Matthew Singh, commented: “The final formulation for Calm underwent many calibrations over the last few months. We feel an inherent responsibility to bring the absolute best product to market. Each calibration that improved our offering motivated the R&D, Operations, and Production teams to continue reformulating and optimizing until Calm reached its current form. It was important for our team to stay focused and not rush what is arguably the most integral part of product development. Our entire company is excited to share this version of Calm with the world (starting with a release in the United States).”

Assuming a successful pilot production, this will be a “first-ever” on multiple fronts. The team at Psyched plans on producing a craft number of units that will be used to test all flavor profiles and share them with opinion leaders. Updates on the pilot run can be expected 24 to 48 hours after production.

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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

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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Psyched Wellness Announces Key Findings from the 90-Day Oral Toxicity Study on AME-1

Psyched Wellness Announces Key Findings from the 90-Day Oral Toxicity Study on AME-1

Toronto, Ontario–(Newsfile Corp. – April 26, 2022) – Psyched Wellness Ltd. (CSE: PSYC) (the “Company” or “Psyched“), a life sciences company focused on the production and distribution of health and wellness products derived from the Amanita Muscaria mushroom , is pleased to announce the company KGK, a licensed CRO in Canada, has reported recent findings from the analysis of the intestinal epithelial immune receptor expression study performed in conjunction with the 90-day oral toxicity study with Amanita Muscaria Extract (AME-1). The in vivo study via oral supplementation with AME-1 focused on the potential bioactive effects on the immune receptors Toll-like Receptor-2 (TLR-2) and Dectin-1, both of which are found on the surface of gut epithelial cells. The Toll-like receptors are an important family within the innate immune system and play a vital role in host-defense mechanisms against pathogens. The main function of TLRs is the ability to recognize numerous pathogens, thus activating the host-defense mechanism through the induction of antimicrobial activity. Dectin-1 is a cell surface pathogen recognition receptor that recognizes soluble and /or particulate forms of β-1,3 or β-1,6-glucans and, like Toll-like receptors, plays an important role in the host-defense mechanism as well.

The recent results of the in vivo study showed only a modest increase in TLR-2 and Dectin-1 receptors, but this was not a significant finding. It could be interpreted that the challenge of continuous dosing of AME-1 resulted in maximal cell surface expression of TLR-2 and Dectin-1, thus seeing only a modest positive upregulation of cell surface membrane expression. However, the sustained upregulation of both TLR-2 and Dectin-1 receptors indicates innate immune mechanisms that were primed and maintained throughout the course of the 90-day oral study. Furthermore, there was no downregulation of either surface receptor type, nor was there any over priming or stimulating effect which would have negatively impacted the immune system through the production of pro-inflammatory cytokines.

“The importance of these in vivo findings indicates an innate immune priming biological activity, and this is preserved during the 90-day study. The potential priming effect and maintenance result in a more efficient response to an invading pathogen, thus promoting greater gut health and increased health and wellness of the individual. There was no over stimulation or negative effects with long -term use of AME-1 in terms of gut health and wellness. This is another key finding in the further understanding of the effects of AME-1 on health and wellness.” says Brian Tancowny a scientific advisor for Psyched Wellness.

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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; the uses and potential benefits of Amanita Muscaria; the Company completing its studies and reports upon the terms and timelines as disclosed herein; and the Company’s studies and reports generating the intended information and benefits.

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; the continued growth of the Company; the Company completing its studies and reports upon the terms and timelines as disclosed herein; and the Company’s studies and reports generating the intended information and benefits.

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; the risk that there is no potential benefit of Amanita Muscaria consumption; the risk the Company will be unable to develop its products; the inability of the Company to complete their studies and/or reports on the intended timelines; the inability of the Company to generate reliable or positive reports therefrom; and the risk that the Company will not benefit from the studies and/or reports.

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.press

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Psyched Wellness Unveils New Product Name and Visual Identity Elements

Psyched Wellness Unveils New Product Name and Visual Identity Elements

Toronto, Ontario–(Newsfile Corp. – March 30, 2022) – 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, has unveiled its official branding and visuals for its Amanita Muscaria Extract (AME-1) today as the company prepares for a Spring launch in the USA to meet consumer demand for ethically sourced, high-quality Amanita Muscaria products. Introduced as the company’s flagship product, Psyched Wellness will begin using the brand name ‘Calm’ for its proprietary Amanita Muscaria extract. The product, which is being investigated as a sleep-aid, is said to induce feelings of relaxation and balance and should be taken prior to periods of rest or recovery.

“The Calm product visual is a beautiful, gender-neutral design that we loved from the moment we saw it,” says Psyched’s Chief Executive Officer Jeffrey Stevens. “But we wanted our shareholders and customers to be involved in the selection process for Calm’s look and feel. Their ideas and perspective matter to us, and they helped us make the decision about the look of Calm going forward. It was such a great process, full of lively conversation and incredibly thoughtful input. From this dialogue, we are excited to boldly step into the future together.”

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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; the uses and potential benefits of Amanita Muscaria; the Company completing its studies and reports upon the terms and timelines as disclosed herein; and the Company’s studies and reports generating the intended information and benefits.

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; the continued growth of the Company; the Company completing its studies and reports upon the terms and timelines as disclosed herein; and the Company’s studies and reports generating the intended information and benefits.

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; the risk that there is no potential benefit of Amanita Muscaria consumption; the risk the Company will be unable to develop its products; the inability of the Company to complete their studies and/or reports on the intended timelines; the inability of the Company to generate reliable or positive reports therefrom; and the risk that the Company will not benefit from the studies and/or reports.

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.press

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Psyched Wellness and the National Research Council of Canada Announce Preliminary Data from Studies of Neuroprotective Properties of AME-1

Psyched Wellness and the National Research Council of Canada Announce Preliminary Data from Studies of Neuroprotective Properties of AME-1

Toronto, Ontario, March 24, 2022 – Psyched Wellness Ltd. (CSE:PSYC, OTCQB:PSYCF, FRANKFURT: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 the preliminary data from the National Research Council of Canada (NRC), from studies on the neuroprotective properties of AME-1, Psyched’s proprietary extract from the Amanita Muscaria mushroom.

The study was the first in a series planned to explore the neuroprotective properties of AME-1 and examine if the anti-inflammatory properties would indeed have any potential neuroprotective activities. The preliminary findings continue to demonstrate the anti inflammatory properties of AME-1, and indicate that AME-1 does not cause apoptosis while also having a neuroprotective effect at the cellular level.

“The preliminary evidence of this investigative study revealed more key functional properties of the AME-1 extract and its broader health and wellness benefits. The neuroprotective effect found in this study is unique, and the potential impacts from a natural product such as AME-1 are novel. The Amanita Muscaria mushroom’s functional properties will be further explored, and will we continue to build our knowledge base on the amazing potential healing power of AME-1,” said Brian Tancowny, Scientific Advisor to Psyched.

The first part of the analysis focused on the ability of AME-1 to protect neuronal microglial cells from inflammatory mediator-induced apoptosis (the process whereby the cell undergoes a cell programmed cell death), and monitored the cell surface expression of apoptotic markers using annexin V and propidium iodide. The results of the study showed at the cellular level that AME-1 did have a neuroprotective effect on microglial cells that were treated with a pro-inflammatory mediator, and this was determined to be concentration dependence.

The second part of the study was to determine whether AME-1 has any direct inhibitory effects on one of the pro-apoptotic cellular pathways, such as the induction of caspase 3. Caspase-3 has been published to be important in the apoptotic process and is responsible for proteolytic cleavage of key proteins in the cell nucleus. AME-1 did not increase caspase-3 activity, and thus in this pathway being investigated, did not induce any apoptotic or cell death effects. However, there was no inhibition of this pathway which can be explained by the fact AME-1 may influence another apoptotic pathway not investigated yet.

“It is exciting to see continued positive results from the studies we are conducting with the NRC, and further work is being done to examine the mechanisms of this neuroprotection as we learn more about the Amanita Muscaria,” said Jeffrey Stevens, CEO of the Company. “As we focus on commercialization of our AME-1 tinctures in the United States this Spring, these studies provide evidence for the potential of many additional future uses of AME-1 to ensure we can offer consumers options for their health and wellness needs.”

The NRC is an agency of the Government of Canada, and specializes in providing vital scientific and technological services to the research and industrial communities of Canada. The NRC was hired to provide their expertise in biomedical nanotechnology, but all the results of the research will belong to Psyched, and the NRC does not endorse the findings or Psyched products.

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Psyched Wellness Announces Key Findings from the 90-Day Oral Toxicity Study on AME-1

Psyched Wellness Announces Key Findings from the 90-Day Oral Toxicity Study on AME-1

Toronto, Ontario–(Newsfile Corp. – February 15, 2022) – 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 the key results from the 90-day oral toxicity preclinical study on its proprietary extract of the Amanita Muscaria mushroom (AME-1), with its contract research organization (CRO) partner.

The study was the third set of a group of thorough assessments on AME-1 conducted to determine the systemic toxicity potential of the Amanita Muscaria extract when administered once daily for 90 consecutive days, and summarizes the NOAEL (No Observed Adverse Event Level).

“This is the final step in the toxicological assessment of AME-1 that will form the foundation for the effective safe dose for human consumption and provides the necessary information for any future clinical studies,” said Brian Tancowny, Scientific Advisor for Psyched Wellness. “With no adverse effect reported over the period, the study results reinforce our earlier findings about AME-1’s safety and allows continued development of our products for human consumption.”

A summary of the key findings in the report are as follows:

  • No adverse clinical signs of toxicity and neither mortality nor morbidity observed in both genders for vehicle and test item treated animals during the study period.
  • No treatment-related adverse effects on body weight and normal body weight gain were observed in all the treatment groups of both genders in comparison with the vehicle control groups during the study period.
  • No treatment-related adverse effects on feed consumption were observed in all the treatment groups of both genders in comparison with the vehicle control groups during the study period.
  • No treatment-related adverse effects on hematology parameters, coagulation, clinical chemistry, gross necropsy, and organ weights. All parameters studied were found to be normal during the duration of the study period.
  • No observed adverse event level occurred. This significant set of information obtained has resulted in the determination of the NOAEL and thus identified the safe effective dose for human consumption.

Jeffrey Stevens, CEO of the Company, said, “In addition to undertaking the 90-day toxicity study, Psyched has been focused on preparing the Self-Gras dossier which will position the Company to be able to sell products into the U.S. market and generate revenues in the first half of 2022. Our CRO partner was diligent in updating us on preliminary results throughout the study, advising that there were no findings of concern being recorded. We were very pleased that there were no adverse effects found in the toxicity study, and are grateful to our investors for their patience while the report was being finalized.”

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Mario’s secret revealed 🍄

Psyched Wellness Provides Update on Anti-Inflammatory Study with the National Research Council of Canada

The iconic red and white spotted mushroom (officially called Amanita Muscaria and unofficially called the Super Mario mushroom) is showing potential to treat arthritis.

Psyched Wellness (PSYC) is working with the National Research Council of Canada (NRC) to study the mushroom’s properties. It doesn’t contain psilocybin, but has a different psychoactive component called muscimol.

Preliminary data suggests that Amantia Muscaria could reduce inflammation in the skin, gut, brain, and lungs. The company believes it has potential to treat chronic inflammatory conditions like arthritis.

Maybe that’s why Mario can jump so high without destroying his joints 😉

PDF of article

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Psyched Wellness Announces Path to Market for AME-1-derived Products in the USA

Psyched Wellness Announces Path to Market for AME-1-derived Products in the USA

Toronto, Ontario – December 16, 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 it is moving forward with its regulatory strategy to launch its Amanita Muscaria extract (“AME-1“)-derived consumer products in-stores in the United States market in the second quarter of 2022.

To achieve this, the Company is having a self-Generally Recognized As Safe (“GRAS“) dossier reviewed by an external GRAS panel of experts for the AME-1. The self-GRAS review process, which was recently upheld in federal court in the Southern District of New York, permits substances that are self-determined to be GRAS to be exempt from pre-market review by the FDA.

The self-GRAS process will permit AME-1 to be sold in specific foods outlined in the dossier and provide an exemption from pre-market notification as a New Dietary Ingredient (“NDI“) in dietary supplement products. Despite this allowable exemption from NDI notification, Psyched will proceed with plans to notify the FDA with an NDI notification and submit to Health Canada for a Natural Health Product Number (“NHPN“).

As AME-1 is a food supplement, Psyched is able to run parallel paths and sell in multiple food categories and jurisdictions: (i) completing a self-determined GRAS for inclusion of the ingredient in US conventional foods, (ii) submitting an NDI notification to the FDA for use and marketing in US dietary supplements, and (iii) applying to Health Canada for marketing as a natural health product.

“The ruling in late September on the FDA’s GRAS Self-Determination process is significant as it was upheld in the federal court in the Southern District of New York. The self-GRAS and NDI pathways will allow the Company to market AME-1 in conventional foods (Nutrition Facts) outlined in their GRAS, as well as dietary supplements (Supplement Facts), a category of food. These plans, as well as their application for an NHPN, will provide for greater penetration into additional food categories,” said KGK Science Chief Executive Officer, Najla Guthrie.

“While Psyched Wellness would have exemptions from having to file a NDI notification after completing a self-determined GRAS, the Company is going above and beyond their regulatory requirement by also planning to submit an NDI notification to the FDA. These are the actions of a company setting the bar high for food ingredient safety standards,” said KGK Science Chief Regulatory Officer, Corey Hilmas, MD/PhD.

“This is an important and logical step forward as we pursue our strategy to create premium Amanita Muscaria mushroom-derived products and become a leading North American brand in the emerging functional food category,” said Jeff Stevens, Chief Executive Officer of Psyched. “Working closely with KGK Science, we determined that applying for a self-GRAS, in addition to our NDI and NHPN action plans, de-risks and expedites our path to market in the United States.”

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: (347) 487-6788
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

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; the uses and potential benefits of Amanita Muscaria; the Company executing its plan to have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; the Company completing the GRAS review process upon the terms and timelines as disclosed herein; the Company following its regulatory strategy and submitting the associated applications as disclosed herein; the Company running parallel paths and selling in multiple food categories and jurisdictions; and the Company becoming a leading North American brand in the emerging functional food category.

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; the continued growth of the Company; the Company executing its plan to have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; the Company completing the GRAS review process upon the terms and timelines as disclosed herein; the Company following its regulatory strategy and submitting the associated applications as disclosed herein; the Company running parallel paths and selling in multiple food categories and jurisdictions; and the Company becoming a leading North American brand in the emerging functional food category.

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; the risk that there is no potential benefit of Amanita Muscaria consumption; risks that the Company will be unable to execute its plan and will not have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; risk that the Company will be unable to complete the GRAS review process upon the terms and timelines as disclosed herein; risks that the Company will be unable to follow or will deviate from its regulatory strategy and be unable to submit some or all of the associated applications as disclosed herein; risk that the Company will be unable to run parallel paths and sell in multiple food categories and jurisdictions; and risks that the Company will not become a leading North American brand in the emerging functional food category.

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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Psyched Wellness Hires Del Mahabadi as Digital Marketing Consultant to Drive AME-1 Product Launch

Psyched Wellness Hires Del Mahabadi as Digital Marketing Consultant to Drive AME-1 Product Launch

Toronto, Ontario – December 14, 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 it has hired Del Mahabadi as Digital Marketing Consultant to drive the launch of the Company’s AME-1 products to market next year.

Ms. Mahabadi is a highly successful marketer and leader with a long track record of helping organizations effectively develop and execute marketing strategies, enabling growth. Her specialties lie in using digital marketing to raise a company’s public profile, increase consumer engagement and develop powerful and profitable ways to further connect with consumers. She has led several creative digital marketing strategies over a variety of industries, including cosmetics, government, and arts and culture.

Ms. Mahabadi holds a Bachelor of Science degree from Ryerson University, a Postgraduate Degree in Communications and Digital Marketing, and a Diploma in Data Science. In addition, she runs a nonprofit organization, supported by Google for Nonprofits, the Federal Government of Canada, and Factor Canada. In 2021, Del was a finalist for the Arts and Cultural Leadership award of the Ontario Arts Council.

Psyched Wellness Chief Commercial Officer, Matthew Singh, commented, “Del joining our team is an integral step as we transition to a CPG entity and bring our AME-1 products to market. She has a wealth of experience creating brands that disrupt the status-quo and then evolve to become household names. Del has facilitated the growth of tincture-based products, like Deciem, and we are eager to learn from her knowledge and experience. We are also excited to launch our new website, product pre-sales, and evolved brand strategy, in the coming weeks.”

Ms. Mahabadi added, “Psyched Wellness is driving innovation in the psychedelic mushrooms industry with the aim of developing products that can help with stress relief, relaxation and restful sleeping. I am delighted to join the Psyched Wellness team at such a pivotal time of growth, and look forward to bringing about change with the launch of our AME-1 products next year.”

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: (347) 487-6788
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.