Palm Beach, FL –December 14, 2021 – FinancialNewsMedia.com News Commentary  – The prevalence of mental health disorders has risen exponentially, and the development of novel medications has not kept pace, precipitating a crisis in psychiatric medicine. A novel innovation is psychedelic drug-assisted psychotherapy – the medically approved use of MDMA, psilocybin, and LSD as a component of elevated psychotherapy programs.  A study conducted by Yale on mice determined that one dose of psilocybin immediately increased neural connections in the brains. Doctors believe this helps the brain “reorganize and adapt” to different situations, improving response time. MDMA has recently been designated a breakthrough treatment for post-traumatic stress disorder (PTSD) by the U.S. Food and Drug Administration (FDA), opening the way for its approval within two years. In a study published in Nature Medicine, symptoms of depression were significantly reduced after three doses of MDMA given at monthly intervals. Although there are risks to treatment with psychedelic-assisted therapy, it is likely that psychiatry will be profoundly altered by such medication in the days ahead.  According to a report from ResearchAndMarkets, the psychedelic drugs market is expected to grow at a robust rate of 14.5% CAGR during the forecast period and reach a value of $6330 million in 2026 from $3210 million in 2021 as there is a large unmet need for treatment driving the adoption of psychedelic drugs.   Active companies in the markets this week include: Mind Cure Health Inc. (OTCQX: MCURF) (CSE: MCUR), Atai Life Sciences N.V. (NASDAQ: ATAI), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), COMPASS Pathways plc (NASDAQ: CMPS), Field Trip Health Ltd. (NASDAQ: FTRP) (TSX: FTRP).

The ResearchAndMarkets report added: “Ketamine eyes CAGR of 16.0% amongst all products in terms of value as it has a robust clinical trials portfolio in multiple diseases viz. depression (MDD, TRD), bi-polar disorder, suicidal ideation, drug and alcohol dependence, and social anxiety. Products with natural origin are anticipated to gain 90 BPS in terms of value market share by the end of the forecast period. However, synthetic products will maintain their dominant market position with an 85% market share in 2026.  Depression is estimated to hold the largest chunk of the disease indication segment with more than 40% market share in 2021. Oral drugs are estimated to contribute more than 55% to the global psychedelic drugs market, wherein the intranasal route of administration exhibit a strong growth rate of 17% CAGR with the commercial arrival of Spravato.  North America is predicted to remain the largest region in the psychedelic drugs market due to a surge of clinical trials, massive investments, regulatory support, and widespread public awareness. The continent accounts for half of the revenue in the global psychedelic drugs market and should be worth $3184.0 Mn by the end of the forecast period. The strong presence of companies and ongoing clinical trials are also expected to bode well for the regional market.”

Mind Cure Health Inc. (CSE: MCUR.CNQ) (OTCQX: MCURF) BREAKING NEWS:  MINDCURE Appoints Dr. Doron Sagman as Chief Medical Officer – Mind Cure Health Inc, a leader in advanced proprietary technology and research for psychedelics, announces the appointment of Doron Sagman, MD, FRCPC, as the Company’s new Chief Medical Officer (“CMO”). Dr. Joel Raskin who was acting CMO will transition into an advisory role for MINDCURE.

As CMO, Dr. Sagman will play a vital role in furthering MINDCURE’S mission to reinvent the mental health care model for patients and practitioners, along with advancing psychedelic-assisted therapy into common and accepted care.  A trained psychiatrist with an expertise in mood and anxiety disorders, as well as an experienced leader in pharmaceutical drug development and clinical trials, Dr. Sagman brings three decades of clinical and research and regulatory experience to MINDCURE.

“Dr. Sagman’s distinguished career in both mental health and the pharmaceutical industries will enable him to lead the development of innovative therapies to potentially treat a range of mental health conditions,” said Kelsey Ramsden, President & CEO of MINDCURE.  “His proven experience as a leader who has built and led diverse teams, as well as his deep understanding of the drug research and development process, will be critical as MINDCURE advances on our path to research digital therapeutic and neuro-supportive solutions,” Ramsden added.

Throughout the span of his 18-year career in the pharmaceutical industry, Dr. Sagman held leadership positions across medical research, clinical development, regulatory affairs and medical affairs.  Most recently, Dr. Sagman held the position of Senior Medical Director/Vice-President, R&D and Medical Affairs at Eli Lilly Canada, leading the medical affairs, clinical and regulatory affairs divisions across a broad therapeutic span, including neuroscience, immunology, oncology, and diabetes.

On his appointment, Dr Sagman said, “We are entering a pivotal and historical phase of medical discovery for patients who suffer from mental health disorders. I am delighted to join MINDCURE’s leadership team and work to advance innovative solutions to best meet unmet mental health needs.”

On Dr. Sagman’s appointment, Dr. Joel Raskin added, “Dr Sagman’s experience in managing clinical operations, regulatory, quality, people and all aspects of research in Canada makes him the perfect candidate to lead MINDCURE’s  research and brings a competitive edge as the company grows.”

In addition to receiving his medical degree from University of Calgary, Dr. Sagman completed his psychiatric residency at the University of Toronto. He is a Fellow of the Royal College of Physicians & Surgeons of Canada (FRCPC) and an Adjunct Clinical Lecturer in the Department of Psychiatry at the University of Toronto, as well as being a staff psychiatrist at the Michael Garron Hospital in Toronto.  CONTINUED… To read this and more news for Mind Cure Health, please visit  https://www.financialnewsmedia.com/news-mcur/

Other recent developments in the markets include:

atai Life Sciences N.V. (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, recently announced the launch of TryptageniX. This new platform company will specialize in both the discovery of new chemical entities (NCEs) for the atai pipeline through bioprospecting and on biosynthesis of atai’s naturally derived development candidates. Both approaches are expected to further strengthen atai’s already robust intellectual property (IP) portfolio spanning psychedelic and non-psychedelic compounds.

Bioprospecting refers to the search for natural products from which medicines can be developed, while biosynthesis is the production of complex molecules within living organisms or cells. Both are central to TryptageniX’s approach to the development of NCEs. In addition, the development of innovative biosynthetic methods will further optimize the scalability of compound manufacturing, allowing atai to address the escalating mental health crisis in an ecologically sustainable manner.

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), a leading biotech company developing psychedelic-inspired therapies recently met with the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) with consultation from the Center for Drug Evaluation and Research (CDER) concerning several key points for ongoing development of the MindMed Session Monitoring System (MSMS) in a device pre-submission meeting that took place on October 25, 2021.

MindMed presented FDA with a working Indications for Use statement (IFU), and a development roadmap. These describe technology and infrastructure for the collection of precise, multimodal, multivalent data that can be processed via machine learning, artificial intelligence, signal processes, and other statistical methods to yield clinically meaningful output to satisfy the requirements of the IFU. FDA provided key feedback regarding the draft IFU and the research methods that will lay the foundation for regulatory submissions.

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently announced the results from its exploratory study of COMP360 psilocybin therapy in conjunction with SSRI use. This single-arm open label study of 19 patients taking concomitant SSRI therapy with COMP360 psilocybin therapy using a single dose of 25mg saw comparable treatment outcomes to patients in COMPASS’s phase IIb trial where patients were withdrawn from their SSRI prior to COMP360 psilocybin therapy.

“The results of this study challenge the widely-held belief that the use of SSRI medication together with psilocybin could interfere with psilocybin’s therapeutic effect. Our findings provide a strong signal that COMP360 psilocybin therapy could be an adjunctive treatment to SSRI antidepressant as well as a monotherapy. For some patients with treatment-resistant depression, withdrawal is a difficult step even though, by definition, ‘treatment-resistant’ means that those antidepressants are not working. This is exactly why we conduct rigorous research to help guide our clinical trial design – including addressing barriers to adoption of COMP360 therapy,” stated Guy Goodwin, COMPASS Pathways’ Chief Medical Officer. “We are now looking forward to meeting with the FDA early in the new year in light of these new data to finalise our plans for the phase III programme, which we expect to begin in Q3 2022.”

Field Trip Health Ltd. (NASDAQ: FTRP) (TSX: FTRP), a global leader in the development and delivery of psychedelic therapies, recently announced the opening of their Seattle clinic, their sixth in the United States, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC. As the largest provider of psychedelic-assisted therapies globally, Field Trip continues to distinguish itself as a leader in the emerging psychedelic industry with continued expansion and growing demand.

Mental health continues to be a national health crisis as rates of anxiety, depression and PTSD keep climbing. Since opening its first location in March 2020, Field Trip’s ketamine-assisted therapy (KAP) protocols have generated rapid and meaningful improvements for many Field Trip clients as measured by depression and anxiety scales. Based on the data collected to date, Field Trip clients have reported that their depression symptoms improved significantly from “severe” to “mild” on average (with the Mean PHQ9 score of respondents decreasing from 17 to 6), and among respondents such benefits were sustained for 120 days or longer from commencement of treatment. These results suggest that the benefits of Field Trip’s KAP program may compare favorably to ketamine infusions. Each Field Trip Health center is designed to provide an oasis-like setting with elements of nature to give Field Trip clients a space for healing, growth and transformation through psychedelic therapies. The entire experience is supported by Field Trip’s digital technology and tools that guide people through the process from before treatment is approved until after their treatment program is complete, and beyond.

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