Institutional Review Board (IRB) reviews proposed research protocols to protect human subjects involved in research.
MIAMI, July 09, 2021 (GLOBE NEWSWIRE) — Ehave, Inc. (OTC Pink: EHVVF) (the “Company”), a provider of digital therapeutics for the psychedelic and mental health sectors, announced today the Company Ehave has hired an Institutional Review Board (IRB) as it prepares to launch ketamine clinical Trials in Miami with Tristar Wellness.
RELATED: CBS I-Team: Inside psychedelic Ketamine therapy sessions at Tristar Wellness.
The IRB will review all research involving human subjects and implement policies and procedures regarding such research. The primary function of the IRB is to protect the rights of human subjects. Review and approval by the IRB will help subjects and researchers assess research protocols by a peer group who can objectively identify potential risks and the accommodations made to minimize them. The IRB will be responsible for:
- The review and approval of applications to conduct research involving human subjects.
- Continuing review of approved protocols.
- Monitoring of reported adverse events involving subjects in approved protocols.
Tristar Wellness is an upscale Miami Beach Florida based medical facility with an experienced team of doctors focused on implementing the latest in medical technology and research. Ehave previously announced it is ahead of schedule and plans launch its KetaDASH www.ketadash.com ketamine IV therapy by the end of the second quarter.
In addition to hiring the IRB, Ehave has engaged legal counsel to advise the Company on the rollout of KetaDASH and secured an umbrella policy to cover liability and malpractice insurance on each home delivery service. Within the next 60 days, KetaDASH plans to begin signing up customers and start referring to local clinics. Ehave is currently in negotiations with multiple entities to franchise the KetaDASH platform, or buy license across the United States.
Dane Jackman, Managing Director of Tristar Wellness, said, “This partnership marks the first in a line of Ketamine related micro-trials slated at Tristar Wellness, Miami Beach. We truly believe there is immense opportunity to explore the benefits of ketamine treatment beyond helping for the known ailments such as depression, anxiety, PTSD, etc. We’re gearing up to explore more research into Ketamine therapy and other neurological conditions such as Parkinson’s disease and addiction to name a few.”
The KetaDASH platform allows licensed ketamine clinics and patients who have been prescribed ketamine by a physician to administer the treatment at home intravenously. This gives the clinic an opportunity to increase revenues by treating patients who are unable to come to their office. KetaDASH will provide the platform for medical practitioners to administer Ketamine intravenously to patients at home.
Ketamine is currently used to help ease pain and allows sedatives to be effective at lower doses, lessening the amount of potentially addictive pain medication required after certain medical procedures. Ketamine is now being studied as a treatment for major depression, though it has not yet been approved by the FDA to treat depression.
Ehave Chief Executive Officer, Ben Kaplan, said, “Hiring an IRB is a very important step in our ketamine clinical Trials in Miami with Tristar Wellness. The safety of the individuals participating in our trials is of utmost importance to both Ehave and Tristar Wellness. This is a tremendous milestone for our shareholders, and we are pleased with the progress we have made.” Mr. Kaplan continued, “KetaDASH will give us the ability to provide ketamine as a psychedelic-assisted therapy for individuals suffering from depression, anxiety, PTSD or other mental or emotional health challenges. We look forward to building a revenue producing platform.”
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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.
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. Not currently a client, though negotiating. 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.
Contact: Ehave Inc.
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