VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, is proud to announce the signing of an international natural psilocybin supply agreement with New Zealand-Based Mātai Medical Research Institute (Mātai), on behalf of the Tū Wairua Project. This agreement marks Optimi's first supply deal to New Zealand, a significant milestone for the company's global expansion efforts.

Under the terms of the agreement, Optimi will provide Mātai with a quantity of its validated GMP Full Spectrum Natural Psilocybin extract. Further, the agreement includes tracked stability of the extract, ensuring the highest standards of GMP quality and compliance.

This follows Optimi's recent announcement that three validation batches of its Natural Psilocybin extract had successfully undergone full release testing, resulting in the issuance of the Certificate of Analysis (COA).

In November 2023, the Tū Wairua project, a collaborative effort involving a diverse array of individuals, whānau (families), community groups, and institutions, convened at Rangiwaho Marae, a tribal meeting place in the Tairāwhiti region of New Zealand. The project team has since designed a clinical trial protocol and secured ethics and regulatory approval for its inaugural clinical study.     

Scheduled for mid-2024, the trial, titled "Pilot Study of Psilocybin Administration in Healthy Volunteers within a Marae Setting," aims to evaluate the feasibility, acceptability, and safety of administering psychedelic-assisted therapy to Māori patients in a marae setting. The insights gained from this trial will inform potential future controlled trials involving Māori patients with methamphetamine use disorder.

Bill Ciprick, CEO of Optimi Health, expressed his enthusiasm about the agreement, stating, "We are excited to collaborate with Mātai and the Tū Wairua team on this groundbreaking venture. This agreement marks our entry into a new market and underscores the historical and cultural importance of the work being undertaken by our colleagues in New Zealand to honour and respect the indigenous heritage of the Māori people. This project holds special significance for Optimi, and we are honoured to be part of it."

Dr Patrick McHugh, Community Liaison for Mātai, confirms that the trial will centre on training local clinicians, rongoa (traditional Māori medicine) specialists and marae community members as kaitieki (guides) in psychedelic assisted therapy. Additionally, it will involve integrating the associated kawa and tikanga (cultural practices and protocols) into the therapeutic experience, making this the first trial of its kind in Aotearoa.

“We recognise that, alongside many First Nations peoples, we have a relationship with native flora and fauna as a source of healing and reconnection to our respective indigenous cultural practices,” says Jody Toroa, trustee of Rangiwaho Marae. "Optimi medicines provide the closest natural fungi to the marae’s local, indigenous species, which for Rangiwaho Marae and the Tū Wairua collective, is key to the integrity of the project. Synthetic products, by comparison, are not conducive to our reclaiming of cultural knowledge and customary practice,” says Jody.

In New Zealand, any registered prescriber can apply through the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) for permission to administer an unapproved medicine.

As the only fully equipped Canadian psychedelics pharmaceutical manufacturer, Optimi is well-positioned to meet large-scale demand for GMP psilocybin and MDMA drug products through its 10,000 sq ft cultivation and formulation facility.

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ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. IS a leading Health Canada licensed psychedelics pharmaceutical manufacturer specializing in controlled substances such as GMP-grade natural psilocybin and MDMA for clinical research purposes and patient access programs, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe and compliant GMP drug candidates throughout the world. Optimi’s products are grown and manufactured at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

ABOUT MATAI MEDICAL RESEARCH INSTITUTE:

Established in October 2020, Mātai is a distinguished not-for-profit research and innovation center located in Gisborne Tairāwhiti, New Zealand. Renowned for its cutting-edge medical imaging facilities, including a state-of-the-art GE 3-Tesla MRI machine and a team of expert researchers, Matai is at the forefront of medical innovation.

ABOUT KAUPAPA TŪ WAIRUA:

The project is an evolving collaboration between a diverse group of individuals, whānau, community groups and institutions.

Organisations involved include:

Rangiwaho Marae
Rua Bioscience
ESR
Manaaki Whenua Landcare Research
University of Auckland
University of Waikato
Mātai Medical Research Institute
Tūranga Health
Io Limited

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”) that relate to Optimi’s current expectations and views of future events. 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 and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. forward-looking statements made in this news release include the proposed use of the proceeds of the Offering. 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. 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 such 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 Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.