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US DEA OKs Use of Psychedelics by This Mental Health Network

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Clinics that deliver novel psychiatric treatment and host clinical trials of psychedelic medicine have positioned Novamind for breakthroughs in mental health treatment.

News Flash, Nov. 10: Novamind announced today that it has been green-lighted to directly bill four major insurance providers for IV ketamine treatments. The approval represents a major advance for psychotherapy and long-term outcomes for patients who experience treatment-resistant depression. Read more here.

 

 

Since 2016, the company has provided ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry Clinics. It also operates Cedar Clinical Research, a contract research organization specializing in clinical trials and evidence-based research for psychedelic medicine.
 
 
“As an investor, I don’t often get involved at the board level, but this is a company worth that effort.”
— Jesse Kaplan, Novamind Director  
 
 
 
 
 
 
 
 
Just last month, the U.S. Drug Enforcement Administration (DEA) granted Novamind Schedule 1 licenses for psilocybin, a naturally occurring psychedelic compound produced by fungi.
 
While there are thousands of sites for clinical research trials in oncology, respiratory, and other disorders, Novamind’s CEO, Yaron Conforti, told Streetwise Reports “there are currently few clinical research sites focused on psychedelic medicine, and only a select group with the DEA licensing and expertise that are required to host clinical trials using psilocybin.
 
Novamind’s chief medical officer, Reid Robison, MD, added, “This milestone reflects our expertise and enables us to continue on our mission to create breakthroughs in mental health treatment.”
 
The company anticipates announcing its first clinical research trial for psilocybin-assisted psychotherapy in 2022 according to Conforti.
 
That trial will be launched at Novamind’s third clinical research site, in Murray, Utah, which opened in September 2021. The Murray clinic is also the company’s sixth integrative psychiatry clinic. Two more clinics are slated to open between this year and early 2022, in Salt Lake City and Park City, Utah. This will increase the company’s clinic footprint to eight. The Park City clinic, designed to offer a “retreat-like setting,” will also facilitate increased capacity for the company’s group therapy services.
 
“Bringing cost-effective and innovative psychedelic therapies to market requires a large base of patients,” Conforti said. To that end, Novamind saw over 20,000 visits to its clinics in 2020, and Conforti expects continued growth at both its clinics and clinical research sites as the company expands  its footprint to other states in 2022.
 
"Psychedelic medicine generally has fewer side effects [standard anti-depression and anti-anxiety treatments] and acts more quickly."
Paul Thielking, MD, Chief Scientific Officer, Novamind
The DEA licenses also support Novamind’s newest service offering: psychedelic palliative care, a first-of-its-kind program to support the mental health of patients and families struggling with serious illness. The palliative care program combines psychedelic medicine with psychotherapy, multiday immersive retreats, and group support for patients and families.
 
“Patients receiving palliative care have higher rates of depression than the general population. Unfortunately, standard anti-depression and anti-anxiety treatments do not work for everyone, can cause side effects, and can take up to eight weeks to work,” Paul Thielking, MD, Novamind’s chief scientific officer told Streetwise Reports.
 
In contrast, psychedelic medicine generally has fewer side effects and acts quickly, two advantages for patients who may have limited life expectancy.
 
Novamind’s latest investment underscores its “radically different” approach to mental health treatment: an investment of US$1 million in Alto Neuroscience, a clinical-stage biopharmaceutical company.
 
“Alto's model for precision psychiatry has enormous potential to help remove the trial-and-error process associated with the diagnosis and treatment of mental health conditions."
— Reid Robison, MD, Chief Medical Officer, Novamind
 
Alto is developing personalized and highly effective medicines to help patients get better, faster.
 
Its artificial-intelligence-enabled platform
measures biomarkers including electroencephalography, as well as wearable data monitors, behavioral patterns, genetics, and other real-world data, to match patients with the treatment they are most likely to respond to. Its pipeline includes 11 clinical-stage drug candidates.
 
“Alto's model for precision psychiatry has enormous potential to help remove the trial-and-error process associated with the diagnosis and treatment of mental health conditions," Dr. Robison noted.
 
Novamind’s combined business model of clinical research operations and integrative psychiatric clinics and its accelerated timeline appeal to Jesse Kaplan, a Novamind director and a cofounder and partner at Plaza Capital Ltd.
 
“As an investor, I want exposure to the growing psychedelic-assisted psychotherapy sector, but I want to reduce the risk that comes with drug development that may — or may not — pay off in 10 years. Alongside its longer-term research efforts, Novamind has a proven, scalable business model that already earns millions in revenue each quarter.”
 
Novamind’s combined business model of clinical research operations and integrative psychiatric clinics, as well as its accelerated timeline, have a unique appeal to Kaplan. “I don’t often get involved at the board level, but this is a company worth that effort.”
 
Kaplan and Conforti previously worked together on the startups Abacus Health Products (sold to Charlotte’s Web) and IM Cannabis. That history, Kaplan told Streetwise Reports, “gives us a level of trust in each other. We are comfortable disagreeing, having tough discussions to reach the right decisions.”
 
Novamind benefits from a resurgence of scientific and popular interest in psychedelics. Johns Hopkins Medicine recently received the first federal grant for psychedelic research in 50 years to explore the potential impact of psilocybin on tobacco addiction. Books like This Is Your Mind on Plants, by bestselling author Michael Pollan, have captured the public imagination.
 
Kaplan also suggested that “deregulation has made people more comfortable and curious about the medicinal properties of these substances. Marijuana was legalized, and the world didn’t fall apart. Indeed, it may have gotten better.”
 
As of September 24, 2021, Novamind shares became eligible for electronic clearing and settlement through the Depository Trust Company in the U.S., a move toward more liquidity for the stock.
 
With a $CA36.545 million market cap and no debt, the company has 42.8 million shares outstanding and 37% insider ownership. Revenue in Q3 2021 reached CA$1.85, a 43% rise over Q3 2020.
 
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Disclosures:
1) Diane Fraser compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor/employee. He/she or members of his/her household own securities of the following companies mentioned in the article: None. He/she or members of his/her household are paid by the following companies mentioned in this article: None. His/her company has a financial relationship with the following companies referred to in this article: None.
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4) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Novamind Inc., a company mentioned in this article.
5) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

 




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