🎉 Health Canada Provides a No Objection Letter for ATMA’s N500 Phase II Clinical Trial Application

CALGARY, Feb. 2, 2021 – ATMA Journey Centers Inc. (“ATMA”), an Alberta-based company focused on delivering innovative psychedelic-assisted therapies internationally, announced today that it has submitted a Group Application for Section 56 Exemption to Health Canada on behalf of Canadians struggling with adverse mental and emotional health conditions.

David Harder, Co-CEO of ATMA, said: “We’ve received close to 300 individual submissions from Canadians over the past 90 days who are struggling deeply with a wide range of psychological, mental and emotional conditions and distress. These are patients who have tried other options that have failed, and COVID-19 has only added to the challenges.”

The Group Application builds on the exemption that ATMA had previously been involved with which allowed the first palliative care patient in Alberta to undergo legal psychedelic-assisted therapy. In 2020, Health Canada approved approximately 25 applications from Canadians seeking an exemption to the current laws that prohibit the use of psychedelics in Canada. ATMA was the first private company in Canada to conduct legal psychedelic-assisted therapy with psilocybin, one of the active hallucinogens found in ‘magic mushrooms’.

According to Harder, the surge in demand for alternative options to traditional mental health support have fueled interest and curiosity in the burgeoning field of psychedelic-assisted therapy. Mounting evidence suggests that when used in conjunction with therapeutic and medical protocols, psychedelics have the potential to bring relief to those whose conditions have been resistant to traditional approaches.

“The potential benefits of psychedelic-assisted therapy are no longer just anecdotal – the science is clear,” added Harder. “The observable outcomes that we have witnessed from our patient work, as well reported outcomes from other patients that received exemptions, speak clearly to the fact that this therapy can be extremely beneficial and that a significant number of Canadians want to explore it.”

ATMA’s recent Group Application included submissions not only for patient exemptions to undergo treatment using psilocybin, but also for MDMA, another promising entheogenic substance that has often been used in alternate mental health therapy. MDMA and psilocybin have both received “breakthrough therapy” designation by the U.S. Food and Drug Administration (FDA) and are the subject of numerous clinical trials around the world.

MDMA has shown particularly great promise for treating PTSD in clinical trials, but both it and psilocybin remain prohibited substances in Canada along with most other psychedelic substances.

The Section 56 Exemption application process involves a patient completing a detailed intake form that covers medical history and background, and also requires the patient to obtain a letter of support from a licensed therapist or professional.

Each patient file is screened and reviewed by ATMA’s medical team, led by Dr. Ravi Bains, ATMA’s Chief Medical Officer. Candidates for which psychedelic-assisted therapy appears to be a viable approach are then assisted through the Section 56 Exemption Process with Health Canada.

Greg Habstritt, President of ATMA, suggested that the use of psychedelics in therapy will “lead the way as one of the most important conversations in mental health” in 2021.

“Mental health is no longer something that people are afraid to talk about or that only affects others. COVID-19 has brought mental health into sharp focus for every Canadian, and everyone is deeply affected by it – our loved ones, our children, our friends, our neighbours, our colleagues. Something has to change, because in my view the trajectory we’re on is terrifying.”

He points out that Health Canada has quickly emerged as one of the global leaders in exploring and furthering the conversation about psychedelics in mental health treatment. “We’re optimistic that this will be the year that Canadians begin to get widespread access to this innovative work, and we believe Health Canada is keenly aware that this relief simply cannot wait.”

In responding to the surging demand and urgency that ATMA is seeing from patients, Harder confirmed that ATMA will be opening a second Group Application Process in mid-February.  “We know that the hundreds of patients who have already been in contact with us are just the tip of the iceberg,” said Harder. “We want to help as many people understand the benefits of psychedelic medicine and to assist as many Canadians as possible to access this extraordinary option.”

Individuals who are struggling with psychological, mental or emotional conditions and who wish to explore the potential that psychedelic medicine offers can visit ATMA’s website at www.atmajourney.com to learn how to be part of the next Group Application process.

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