MIAMI, April 16, 2021 (GLOBE NEWSWIRE) -- Ehave, Inc. (OTC Pink: EHVVF) (the “Company”), a provider of digital therapeutics for the psychedelic and mental health sectors, announced today plans to launch brain mapping ketamine clinical trials using Brain Scientific technology later this year. The clinical trial will establish the statistical correlation between the ketamine treatment and patient improvement from the disorders.
The trial, which is designed to enroll 35 patients, is expected to start in the second half of 2021. Ehave is currently completing the necessary preclinical studies necessary to begin enrolling patients in the trial. The average drop out ratio of clinical trials is around 15 % and Ehave will need at least 25-30 patients’ egg data to establish statistical significance of the efficacy of the ketamine over the indication, such as PTSD and Major Refractory Depression. Ehave will partner with Brain Scientific Inc. to leverage both data and AI to correlate biomarkers for the Identification of Chronic pain, Depression (major and persistent), PTSD, Bipolar disorder, General anxiety, ADHD and Schizophrenia. The two companies will collaborate to exploit graph based AI, linked data protocols with respect to such AI and leverage such data and AI to develop neural net algorithms.
Ketamine has been used in the past to reduce the amount of potentially addictive pain medication required after certain medical procedures, but it is now being studied as a treatment for major depression, though it has not yet been approved by the FDA to treat depression. In March 2019 the U.S. Food and Drug Administration approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers and was approved by the FDA in 1970. The FDA granted the approval of Spravato to Janssen Pharmaceuticals, Inc., a pharmaceutical company headquartered in Beerse, Belgium and owned by Johnson & Johnson. Ketamine clinks to treat depression are becoming common in many cities in the U. S. and Canada. Ehave intends to provide Ketamine clinics and medical practitioners with software, staffing, protocols, and equipment as part of the KetaDASH platform.
Dr. Manideep Gopishetty, Medical Advisor and Chief Medical Officer of Ehave said, "The brain mapping of the patients to measure the efficacy of the ketamine treatment would help us to identify the biomarkers of the brain which shows the changes in neuroplasticity of the brain areas impacted by the treatment and could pave pathway to new forms of treatment using the drug and would also help companies to bring ketamine treatment to fore front to address chronic mental health disorders based on the outcomes of the study."
The study’s primary goal is to assess the candidate therapy’s safety and tolerability. Both Ehave and Brain Scientific have expressed a commitment to provide regular progress updates regarding the clinical trial process, activities related to the study’s launch, and any expected timelines. Depression is a common mental disorder affecting more than 264 million people worldwide. Mental health experts find a strong link between loneliness and depression and drug overdoses. According to national drug abuse data, drug overdoses have increased 42% since Covid-19 reared its ugly head. As a result, mental health disorders are on the rise in every country and could cost the global economy up to $16 trillion annually by 2030.
Alfred Farrington II, CIO of Ehave, Inc. said, “Ehave's goal is to help practitioners make more informed decision about mental health care. We believe the data from this clinical trial will provide longitudinal insights that can link brain analysis and psychedelics. This clinical trial in conjunction with Brain Scientific has the potential to revolutionize mental health by digitizing and analyzing data in order to give the health industry the opportunity to learn from it and help mental health researchers make informed decisions for better outcomes.”
Ben Kaplan, CEO of Ehave said, “We are very grateful to all families who volunteer to take part in research and drug development efforts. We look forward to continuing our remarkable partnership with Brain Scientific as we advance towards a treatment for major depression.”
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About Ehave, Inc.
Ehave, Inc. (EHVVF) is a leader of digital therapeutics delivering evidence-based therapeutic interventions to patients. Our primary focus is on improving the standard care in therapeutics to prevent or treat brain disorders or diseases through the use of digital therapeutics, independently or together, with medications, devices, and other therapies to optimize patient care and health outcomes. Our main product is the Ehave Telemetry Portal, which is a mental health informatics platform that allows clinicians to make objective and intelligent decisions through data insights. The Ehave Infinity Portal offers a powerful machine learning and artificial intelligence platform with a growing set of advanced tools and applications developed by Ehave and its leading partners. This empowers patients, healthcare providers, and payers to address a wide range of conditions through high quality, safe, and effective data-driven involvement with intelligent and accessible tools. Additional information on Ehave can be found on the Company’s website at: www.ehave.com.
About Brain Scientific:
Brain Scientific is a commercial-stage healthcare company with two FDA-cleared products, providing next-gen solutions to the neurology market. The Company’s smart diagnostic devices and sensors simplify administration, shorten scan time and cut costs, allowing clinicians to make rapid decisions remotely and bridge the widening gap in access to neurological care. To learn more about our corporate strategy, devices or for investor relations please visit: www.brainscientific.com or email us at info@memorymd.com.
Forward-Looking Statement Disclaimer
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading "Risk Factors" in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC's website, http://www.sec.gov.
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