The capsules were produced at Optimi’s GMP-certified facility in Princeton, British Columbia, under authorization from Health Canada. Since Australia became the first nation to reschedule psilocybin as a controlled medicine in July 2023, the drug has moved from prohibited status to a therapeutic option for treatment-resistant depression. Optimi CEO Dane Stevens noted that the company is currently one of the few Nasdaq-listed entities supplying the substance outside of clinical trials.

Under the Therapeutic Goods Administration’s Authorized Prescriber Scheme, the therapy is increasingly integrated into the Australian healthcare system. More than 750 clinicians are now trained to administer the treatment, with costs covered by both private and public payers, including the Department of Veterans’ Affairs and the National Disability Insurance Scheme. According to company data collected through the end of 2025, there have been no reports of serious adverse events associated with these regulated commercial shipments.