Optimi Health Reports First MDMA-Assisted Treatments of 2026 are Underway Across an Expanded Network of Australian Clinics

Executive Summary

• Optimi Health reports that the first patients of 2026 have been treated with its MDMA capsules at authorised clinics across Australia under the Authorised Prescriber Scheme.
• No serious adverse events (SAEs) have been recorded among patients receiving MDMA‑assisted therapy in Australia as of 16 Sept 2025, according to TGA data obtained via a Freedom‑of‑Information request.
• The Australian Department of Veterans’ Affairs has announced a $740 million veterans rehabilitation plan that includes support for psychedelic‑assisted therapy for eligible PTSD patients.

Key Details

• Patient Treatment Launch: First 2026 patient treatments commenced in Australia using Optimi’s 60 mg and 40 mg MDMA capsules supplied directly to authorised clinics.
• Safety Profile: Aggregated TGA data (FOI request) show zero serious adverse events reported for patients treated under the Authorised Prescriber Scheme up to 16 Sept 2025.
• Regulatory Framework: Optimi supplies finished MDMA product directly to clinics within Australia’s regulated prescribing framework, maintaining manufacturing oversight and cost‑effectiveness.
• Veterans Rehabilitation Funding: Australian DVA announced a $740 million plan that incorporates psychedelic‑assisted therapy for veterans with PTSD, potentially expanding the addressable market.
• Real‑World Evidence (RWE) Program: Patient‑Reported Outcomes are being collected by the Australian National University (ANU) as part of an expanding RWE initiative focused on MDMA‑assisted PTSD treatment.
• Market Potential: Australian Bureau of Statistics estimates 5–6 % annual prevalence of PTSD (~1.3–1.5 million people), with higher rates among veterans and first responders, underscoring a sizable target population.
• Licensing: Optimi holds a Health Canada Drug Establishment Licence authorising manufacture of MDMA capsules for regulated therapeutic use.

Notable Quotes

“Entering 2026 with active treatments underway across a growing clinic network is an important step in the continued development of regulated MDMA‑assisted therapy,” – Dane Stevens, CEO & Co‑Founder, Optimi Health

Materiality Assessment: Non‑Material – Positive (operational update with favorable safety data and market expansion signals, but no immediate financial impact disclosed).