VANCOUVER – Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN), developers of a vertically integrated mushroom brand targeting functional and novel psychedelic compounds for the health and wellness sector, reported that Optimi Labs Inc., a wholly-owned subsidiary of Optimi Health Corp, been granted a Dealer’s License by Health Canada.
The Dealer’s License allows for possession, production, assembling, sale, and delivery of psilocybin within the regulated framework set forth by Health Canada. Optimi will now launch vertically integrated operations at its facility in Princeton, B.C. Once fully commercialized, Optimi’s purpose-built, 10,000 sq. ft. EU GMP-compliant research and production facility will be dedicated to cultivating, extracting, and processing the highest-grade all-natural psilocybin in North America. Guiding Optimi’s stringent research and drug development process, the Company’s GMP and EU-GMP-compliant facility will expand its domestic and global reach in compliance with Health Canada regulations and favourable international regulatory regimes.
“This is a proud and exciting moment for all of us at Optimi,” exclaimed Bryan Safarik, COO and Director of Optimi. He continued, “We purposely overbuilt this facility surpassing clean room pharma grade specifications, allowing us to grow and process the purest, most consistent, safest, and efficacious mushrooms in the industry. I have always believed in our ability to be a Canadian leader in the production of natural-grade psilocybin, so I am truly grateful for all the hard work, insight, and continued effort to get this world-class facility commissioned.” Safarik also praised Health Canada’s leadership role in working with Canadian drug producers as they continue to expand the science and safety of therapeutic psilocybin mushrooms through research and clinical trials.
As noted in the recently filed annual financials, as of September 30, 2021, $8,586,465 CAD in cumulative expenditures were incurred in connection with the construction of the combined 20,000 sq. ft. facilities. Optimi’s Dealer’s License EU GMP-compliant facility contains an impressive Region III, Schedule 8 security level vault capable of securing 1,250kg of psilocybin which carries an approximate value of $53MM CDN. Other features include an Argus environmental control system which provides software and hardware features for real-time monitoring and optimization, advanced HVAC equipment and controls, fire suppression, clean room technology, 700KW backup electrical power systems, robust chain-link fencing with smart system technology including perimeter intrusion detection, wireless gate access and magnetic locks.
Optimi is poised to become the only large-scale Canadian manufacturer, and the premier supplier, of all-natural psilocybin therapies to patients, research groups, universities, licensed clinics and holders of other Dealer’s Licenses and Section 56 exemptions in Canada. While the prescription model of psilocybin delivery is dependent on further clinical trial data from the industry, Optimi will be able to supply patients by way of their physicians and the Special Access Program today. The Company has begun outreach to potential psilocybin clients in Canada and is actively seeking commercial opportunities for its products in select markets with favourable regulatory regimes.
With Health Canada’s recent amendment of the Special Access Program, physicians will be able to request patient access to restricted psychoactive substances like psilocybin and MDMA for psychedelic-assisted therapy. Optimi is taking an active leadership role in finding solutions for the ongoing Canadian mental health crisis, including access to psilocybin for therapeutic purposes. Furthermore, Optimi is committed to being proactive concerning education about the safety and efficacy of psychedelic medicines and this is exemplified through its initial phase 1 dosing study.
“Optimi is focused on providing safe, pure and reliable psychedelic products for all those in need,” said Bill Ciprick, CEO. “Achieving our approved Dealer’s License is a significant milestone in our journey to becoming a leader in the psychedelic industry. We look forward to providing further communications over the coming weeks as production begins, and our 2022 growth strategy is deployed.”
Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also been granted a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production.