Approved multicenter study sponsored by Sheba Medical Center to compare group and individual MDMA-assisted therapy for 168 patients experiencing trauma-related PTSD
Vancouver, British Columbia--(Newsfile Corp. - November 26, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of pharmaceutical-grade psychedelics, including MDMA and naturally derived psilocybin, has been selected to supply the MDMA capsules for MAPS Israel's Healing October 7th project, which includes a clinical trial for Post-Traumatic Stress Disorder (PTSD) that has received formal approval from the Israeli Ministry of Health.
The open-label, multicenter, non-inferiority study will evaluate the safety and effectiveness of individual versus group MDMA-assisted therapy for PTSD in patients diagnosed in the context of recent collective trauma. The trial is being conducted as part of MAPS Israel's Healing October 7th initiative, which supports survivors, veterans, and community-based care.
The study will enroll 168 participants, with initial approval already granted by the Israeli Ministry of Health for the first 20 patients. Each participant will receive three MDMA-assisted therapy sessions supported by Optimi's GMP 40mg and 60mg MDMA capsules, in accordance with the clinical protocol.
Optimi has completed the first export of its GMP 40mg and 60mg MDMA capsules to Israel in support of this clinical program, which is sponsored by Sheba Medical Center and conducted across two clinical sites: Lev Hasharon Mental Health Centre and Be'er Sheva Mental Health Centre.
Dr. Revital Amiaz, a key sponsor and Head of Psychiatry at Sheba Medical Center, stated:
"MDMA-assisted therapy offers a meaningful clinical advantage in treating PTSD. Unlike traditional approaches that focus on exposure or symptom management, MDMA reduces fear and emotional reactivity, allowing patients to process traumatic memories more effectively and achieve more durable improvement.
"In light of the rise in PTSD cases in Israel since October 7, this study aims to evaluate a group-based MDMA-assisted therapy model that may enable clinicians to treat more patients simultaneously and expand access to care. The study will also increase the sample size, helping us better understand the effectiveness of this treatment approach. These developments mark an exciting step forward for trauma care and for Israeli psychiatry."
"Two years ago, we embarked on a journey to bring a scalable solution for this massive PTSD wave, and since then have built this group therapy protocol, developed the needed clinical partnerships, and trained the necessary teams," added Eyal Gura, volunteering Engineer-In-Residence at MAPS Israel and co-founder of the Healing October 7 initiative. "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."
"This collaboration is a meaningful step forward for Optimi's MMDA drug product," said Dane Stevens, CEO of 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 that meet the standards of modern clinical research."
About the Healing October 7th Clinical Trial Initiative
Established immediately after October 7 to prepare for substantial PTSD treatment needs, the initiative brings together leading medical centers and internationally recognized experts in PTSD and psychedelic-assisted therapies. Its purpose is to rigorously validate a cost-effective, scalable treatment model that, once proven, can reach large populations in need.
For more details, please visit: https://www.maps-israel.org/healingoct7
For trial enrollment information: https://www.maps-israel.org/healingoct7
About MAPS Israel
MAPS Israel operates as a charitable project fiscally sponsored by the Multidisciplinary Association for Psychedelic Studies, Inc., a U.S.-based 501(c)(3) public charity (Federal Tax ID: 59-2751953).
Donations supporting the Healing October 7th initiative can be made directly to MAPS at: https://giving.maps.org/campaign/695604/donate
About Sheba Medical Center
Sheba Medical Center, the clinical sponsor, was ranked #8 in Newsweek's 2025 World's Best Hospitals list. It serves patients from more than 100 countries and is internationally recognized for delivering advanced care across multiple specialties.
How to Access Optimi's Capsules
To learn more about accessing Optimi's psilocybin or MDMA capsules, please contact: sales@optimihealth.ca
For more information, please contact:
Dane Stevens, CEO
Optimi Health Corp.
Telephone: (778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca
Investor Relations Contact:
Lucas A. Zimmerman
Managing Director
MZ Group - MZ North America
(262) 357-2918
OPTHF@mzgroup.us
www.mzgroup.us
About Optimi Health Corp.
Optimi is a Canadian Good Manufacturing Practices ("GMP") compliant pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. From two 10,000-square-foot facilities in British Columbia and operating under a Drug Establishment License from Health Canada, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and accessible in Canada through the Special Access Program. For more information, please visit www.optimihealth.ca.
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements"), including with respect to the role of psychedelic medicines in insured mental health care. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties, and contingencies, certain of which are unknown. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions, or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct, and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed in the Company's continuous disclosure filings available under its SEDAR+ profile at www.sedarplus.ca. Except as expressly required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for the Company to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/275964
The open-label, multicenter, non-inferiority study will evaluate the safety and effectiveness of individual versus group MDMA-assisted therapy for PTSD in patients diagnosed in the context of recent collective trauma. The trial is being conducted as part of MAPS Israel's Healing October 7th initiative, which supports survivors, veterans, and community-based care.
The study will enroll 168 participants, with initial approval already granted by the Israeli Ministry of Health for the first 20 patients. Each participant will receive three MDMA-assisted therapy sessions supported by Optimi's GMP 40mg and 60mg MDMA capsules, in accordance with the clinical protocol.
Optimi has completed the first export of its GMP 40mg and 60mg MDMA capsules to Israel in support of this clinical program, which is sponsored by Sheba Medical Center and conducted across two clinical sites: Lev Hasharon Mental Health Centre and Be'er Sheva Mental Health Centre.
Dr. Revital Amiaz, a key sponsor and Head of Psychiatry at Sheba Medical Center, stated:
"MDMA-assisted therapy offers a meaningful clinical advantage in treating PTSD. Unlike traditional approaches that focus on exposure or symptom management, MDMA reduces fear and emotional reactivity, allowing patients to process traumatic memories more effectively and achieve more durable improvement.
"In light of the rise in PTSD cases in Israel since October 7, this study aims to evaluate a group-based MDMA-assisted therapy model that may enable clinicians to treat more patients simultaneously and expand access to care. The study will also increase the sample size, helping us better understand the effectiveness of this treatment approach. These developments mark an exciting step forward for trauma care and for Israeli psychiatry."
"Two years ago, we embarked on a journey to bring a scalable solution for this massive PTSD wave, and since then have built this group therapy protocol, developed the needed clinical partnerships, and trained the necessary teams," added Eyal Gura, volunteering Engineer-In-Residence at MAPS Israel and co-founder of the Healing October 7 initiative. "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."
"This collaboration is a meaningful step forward for Optimi's MMDA drug product," said Dane Stevens, CEO of 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 that meet the standards of modern clinical research."
About the Healing October 7th Clinical Trial Initiative
Established immediately after October 7 to prepare for substantial PTSD treatment needs, the initiative brings together leading medical centers and internationally recognized experts in PTSD and psychedelic-assisted therapies. Its purpose is to rigorously validate a cost-effective, scalable treatment model that, once proven, can reach large populations in need.
For more details, please visit: https://www.maps-israel.org/healingoct7
For trial enrollment information: https://www.maps-israel.org/healingoct7
About MAPS Israel
MAPS Israel operates as a charitable project fiscally sponsored by the Multidisciplinary Association for Psychedelic Studies, Inc., a U.S.-based 501(c)(3) public charity (Federal Tax ID: 59-2751953).
Donations supporting the Healing October 7th initiative can be made directly to MAPS at: https://giving.maps.org/campaign/695604/donate
About Sheba Medical Center
Sheba Medical Center, the clinical sponsor, was ranked #8 in Newsweek's 2025 World's Best Hospitals list. It serves patients from more than 100 countries and is internationally recognized for delivering advanced care across multiple specialties.
How to Access Optimi's Capsules
To learn more about accessing Optimi's psilocybin or MDMA capsules, please contact: sales@optimihealth.ca
For more information, please contact:
Dane Stevens, CEO
Optimi Health Corp.
Telephone: (778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca
Investor Relations Contact:
Lucas A. Zimmerman
Managing Director
MZ Group - MZ North America
(262) 357-2918
OPTHF@mzgroup.us
www.mzgroup.us
About Optimi Health Corp.
Optimi is a Canadian Good Manufacturing Practices ("GMP") compliant pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. From two 10,000-square-foot facilities in British Columbia and operating under a Drug Establishment License from Health Canada, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and accessible in Canada through the Special Access Program. For more information, please visit www.optimihealth.ca.
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements"), including with respect to the role of psychedelic medicines in insured mental health care. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties, and contingencies, certain of which are unknown. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions, or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct, and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed in the Company's continuous disclosure filings available under its SEDAR+ profile at www.sedarplus.ca. Except as expressly required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for the Company to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/275964
