STOCK TITAN

Optimi Health Completes Largest-to-Date MDMA Export to Australia for PTSD Therapy

(Very Positive)
Tags

Optimi Health (OPTHF) has completed its largest international MDMA export to Australia, delivering 1,000 GMP-certified capsules for PTSD treatment. The shipment, conducted with Mind Medicine Australia, includes both 40mg and 60mg strength capsules and received approval from Australia's Therapeutic Goods Administration (TGA) and Health Canada.

In a significant development, the Australian Department of Veterans' Affairs (DVA) has announced it will fund MDMA-assisted therapy for veterans diagnosed with PTSD, marking the first time a federal agency in Australia has committed to reimbursing psychedelic-assisted treatment. The capsules will be distributed through authorized pharmacy networks and clinics across Australia under Optimi's Drug Establishment Licence (DEL).

Loading...
Loading translation...

Positive

  • Largest international MDMA export completed with 1,000 GMP-certified capsules
  • First-ever Australian federal agency (DVA) commitment to fund psychedelic-assisted treatment
  • Secured regulatory approvals from both TGA and Health Canada
  • Established distribution network through licensed pharmacies and clinics across Australia

Negative

  • None.

News Market Reaction – OPTHF

+19.28%
+19.28% Session move

In the trading session that priced this news, OPTHF gained 19.28%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

1,000 GMP doses of MDMA now reaching patients with PTSD under Australia's Authorised Prescriber Scheme; Department of Veterans' Affairs to fund treatment for veterans

Vancouver, British Columbia--(Newsfile Corp. - May 8, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian drug manufacturer and formulator of GMP-grade MDMA and natural psilocybin, has completed its largest international export to date of MDMA capsules to Australia, supporting the treatment of Post-Traumatic Stress Disorder (PTSD) under the country's Authorised Prescriber Scheme.

The shipment, conducted in partnership with Mind Medicine Australia, included 1,000 GMP MDMA capsules in both 40mg and 60mg strengths. Import approval was granted by Australia's Therapeutic Goods Administration (TGA), with matching export permits issued from Health Canada. The capsules were manufactured and shipped under Optimi's Drug Establishment Licence (DEL), authorizing global distribution for PTSD treatment through licensed pharmacy networks and authorised clinics across Australia.

In a major step forward for access, the Australian Department of Veterans' Affairs (DVA) recently announced that it will fund MDMA-assisted therapy for veterans diagnosed with PTSD. This marks the first time a federal agency in Australia has committed to reimbursing psychedelic-assisted treatment, reinforcing national momentum toward broader mental health care solutions and highlighting the need for safe, GMP-supplied medicines.

Source: https://www.theaustralian.com.au/health/mental-health/dva-to-fund-psychedelic-medicine-for-veterans-with-ptsd-depression/news-story/4a56bca1577561bf22fe6368f3d2fb91

Mind Medicine Australia welcomed the announcement as a meaningful step toward broadening access to care for those who need it most.

"The announcement from the Department of Veterans' Affairs to fund MDMA-assisted therapy is a major endorsement of this treatment approach," said Peter Hunt AM, Chair of Mind Medicine Australia. "It demonstrates growing recognition at the highest levels of government that these therapies can offer meaningful recovery for people living with PTSD."

"Our team has worked hard to reach this point, and it's incredibly meaningful to know that patients are now being treated with the MDMA capsules we've manufactured and delivered into the country," said Dane Stevens, CEO of Optimi. "The support of the Department of Veterans' Affairs is a major step forward for patient access, and we're proud to work alongside Mind Medicine Australia to ensure this treatment is delivered safely and responsibly within a regulated framework."

Key Highlights

  • Shipment includes 1,000 GMP-certified MDMA capsules in 40mg and 60mg strengths
  • Department of Veterans' Affairs to fund MDMA-assisted therapy for Australian veterans with PTSD
  • Import approval granted by Australia's TGA, with matching export permits from Health Canada
  • Export conducted under Optimi's Drug Establishment Licence, authorizing prescription for the defined therapeutic indication of PTSD
  • Capsules to be dispensed through authorised pharmacy networks and clinics nationwide

Ordering From Optimi

Entities interested in accessing Optimi's GMP 40mg and 60mg MDMA capsules can contact:

Australia: Mind Medicine Australia

Global Inquiries: sales@optimihealth.ca

About Optimi Health Corp.

Optimi Health Corp. is a Health Canada-licensed, GMP-compliant manufacturer and supplier of natural psilocybin and MDMA. Dedicated to producing high-quality psychedelic products, the Company aims to support the global advancement of mental health therapies through rigorous compliance, innovation, and collaboration.

Cannot view this image? Visit: https://images.newsfilecorp.com/files/10615/251151_68f97ff2a4003842_001.jpg

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/10615/251151_68f97ff2a4003842_001full.jpg

On Behalf of the Board
JJ Wilson, Chair of the Board

For more information, please contact:
Optimi Health Corp.
Telephone: (778) 761-4551
investors@optimihealth.ca
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"). 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 Optimi'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 long form prospectus dated February 12, 2021, a copy of which is available on SEDAR+ at www.sedarplus.ca. Except as expressly required by applicable law, Optimi 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 Optimi 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/251151

FAQ

What is the size of Optimi Health's (OPTHF) MDMA export to Australia in 2025?

Optimi Health exported 1,000 GMP-certified MDMA capsules to Australia in both 40mg and 60mg strengths.

How will the Australian Department of Veterans' Affairs support MDMA therapy for PTSD?

The DVA will fund MDMA-assisted therapy for veterans diagnosed with PTSD, becoming the first federal agency in Australia to reimburse psychedelic-assisted treatment.

What regulatory approvals did Optimi Health receive for its MDMA export to Australia?

Optimi received import approval from Australia's Therapeutic Goods Administration (TGA) and matching export permits from Health Canada, operating under their Drug Establishment Licence.

How will Optimi Health's MDMA be distributed in Australia?

The MDMA capsules will be distributed through licensed pharmacy networks and authorized clinics across Australia under the country's Authorised Prescriber Scheme.