Optimi Health to Supply MDMA to MAPS Israel's Clinical Trial for Trauma-Related PTSD

Executive Summary

• Optimi Health Corp. has been chosen as the exclusive supplier of GMP‑manufactured MD MDMA capsules for MAPS Israel’s “Healing October 7th” PTSD clinical trial.
• The multi‑center, open‑label study will enroll 168 participants (initial approval for 20 patients) and will use Optimi’s 40 mg and 60 mg MDMA capsules in three therapy sessions per patient.
• This marks Optimi’s first export of its GMP MDMA product to Israel and provides a high‑visibility validation of the company’s psychedelic drug manufacturing platform.

Key Details

• Trial Design: Open‑label, multicenter, non‑inferiority study comparing individual vs. group MDMA‑assisted therapy for PTSD.
• Enrollment: Up to 168 participants; Israeli Ministry of Health has approved enrollment of the first 20 patients.
• Dosage Regimen: Each participant receives three MDMA‑assisted therapy sessions using Optimi’s GMP‑certified 40 mg and 60 mg capsules.
• Clinical Sites: Lev Hasharon Mental Health Centre and Be’er Sheva Mental Health Centre, sponsored by Sheba Medical Center.
• Export Milestone: Optimi completed its first export shipment of the GMP MDMA capsules to Israel for this trial.
• Strategic Impact: Provides a high‑profile validation of Optimi’s manufacturing capabilities and supports scaling of psychedelic‑assisted PTSD treatment in a post‑conflict setting.
• Quotes:
• Dane Stevens, CEO, Optimi Health: “To be selected as the supplier for a trial of this importance is an honour… we remain focused on supporting partners like MAPS Israel with high‑quality GMP medicines.”
• Dr. Revital Amiaz, Head of Psychiatry, Sheba Medical Center: Highlighted clinical advantage of MDMA‑assisted therapy and the potential to expand access through group treatment models.

Notable Quotes

• “MDMA‑assisted therapy offers a meaningful clinical advantage in treating PTSD… it reduces fear and emotional reactivity, allowing patients to process traumatic memories more effectively.” – Dr. Revital Amiaz
• “We are happy to share this vision and collaborate with the Optimi team to bring this important group treatment protocol to the next proofing stage.” – Eyal Gura, Engineer‑In‑Residence, MAPS Israel

Materiality Assessment: Material – Positive (significant commercial validation and potential revenue stream from a high‑visibility international clinical program).