HempFusion Wellness Inc. (TSX:CBD.U) (OTCQX:CBDHF) (FWB:8OO) (“HempFusion” or the “Company”), a leading health and wellness company offering premium probiotic supplements and products containing CBD, is pleased to announce that Validcare, the organization coordinating the execution of what the Company believes to be the largest human observational, liver and human toxicology study to date, has released its initial findings from the industry sponsored, decentralized human safety study of hemp derived CBD products. The preliminary findings are validating and encouraging, and according to the study’s investigators, there was no evidence of liver toxicity in the 839 participants in the clinical trials.
“We will continue to analyze this real-world data. Due to the overwhelming success, we are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions”
After seven months of clinical investigation, Validcare announced that its team of principal investigators met with members of the United States Food and Drug Agency’s Cannabis Product Council (formerly known as the Cannabis Work Group) (“FDA” or “Agency”) to share initial findings from the clinical study. This study was commissioned and designed in response to the FDA’s requests, including the Agency’s March 5, 2020 report to the United States Congress for science-based data, so the FDA can confidently determine the appropriate regulatory path(s) for hemp derived CBD products.
“Participating in what is believed to be the largest human liver toxicology study on CBD was a tremendous honor, and the initial findings are incredibly validating for consumer safety,” commented Jason Mitchell, N.D., HempFusion’s Co-Founder and Chief Executive Officer. “We believe this is a pivotal step forward for the CBD industry, and we look forward to continuing to find ways to provide consumers with safe and quality products. When specifically looking at how our products performed in the study, having no liver toxicity only bolsters what we have always stated about our products. We believe they are safe,” continued Dr. Mitchell.
“We are encouraged by these findings and are hopeful this study provides the FDA with sufficient science-based data to determine and take action on a safe regulatory path forward,” commented Dr. Aqua, M.D., Co-Principal Investigator of this IRB-approved study. “We will continue to analyze this real-world data. Due to the overwhelming success, we are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions,” continued Dr. Aqua.
Principal investigators met with the FDA on March 15, 2021 and reviewed preliminary liver safety study results in the form of an abstract. The parties also discussed establishing a direct communication feed to FDA so it can receive raw, blinded, aggregate data for its analysis.
“We understand the significance, importance and immediate need for CBD safety research for the FDA, industry and the US consumer. Validcare is proud to act as a trusted convener for all involved. This first of its kind, industry led, multi-branded study required trust, collaboration, operational excellence, innovation, and resilience. It demonstrates the incredible potential for decentralized clinical research to increase participant access and accelerate results – even during the most challenging times,” said Patrick McCarthy, CEO of Validcare. “We are excited for our principal investigators to continue, expand, and report on this foundational work over the next few months. Once completed, safety results of this study will be shared with participating brands and the FDA. The investigators also plan to publish in a peer reviewed journal.”
HempFusion is a leading health and wellness CBD company utilizing the power of whole-food hemp nutrition. HempFusion distributes its family of brands, including HempFusion, Probulin Probiotics, Biome Research, and HF Labs, to approximately 4,000 retail locations across all 50 states of the United States and select international locations. Built on a foundation of regulatory compliance and human safety, HempFusion’s diverse product portfolio comprises 48 SKUs including tinctures, proprietary FDA Drug Listed Over-The-Counter (OTC) Topicals, Doctor/Practitioner Lines and more. With a strong focus on research and development, HempFusion has an additional 30 products under development. HempFusion is a board member of the US Hemp Roundtable, and HempFusion’s wholly-owned subsidiary, Probulin Probiotics, is one of the fastest-growing probiotics companies in the United States, according to SPINs reported data. HempFusion’s CBD products are based on a proprietary Whole Food Hemp Complex™ and are available in-store or by visiting HempFusion online at www.hempfusion.com or www.probulin.com.
Validcare offers sponsors, CRO’s and investigators a brandable, real-time 21CFR Part 11 compliant platform as a service to power patient centric clinical research. Founded by experts with more than 20 years of industry experience spanning pharmaceuticals, biologics, medical products, medical devices and supplements, Validcare leverages technology and best practices to ensure measurable results for its clients from study design through completion. As an organization, Validcare is passionate about improving patient access, diversity and participation in clinical research that powers creation of life changing healthcare products. For more information, visit www.validcare.com or call 844-825-4322.
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, “forward-looking statements”) that relate to HempFusion’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective” and “outlook”) are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward-looking statements relating to the Company’s plans, focus and objectives.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond HempFusion’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID-19 pandemic and other factors set forth under “Forward-Looking Statements” and “Risk Factors” in the final long form prospectus of the Company dated December 17, 2020 and available under the Company’s profile on SEDAR at www.sedar.com. HempFusion undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for HempFusion to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
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