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.
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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.”
ABOUT HEMPFUSION
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.
Follow HempFusion on Twitter, Facebook and Instagram and
Probulin on Twitter, Facebook and Instagram.
ABOUT VALIDCARE
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.
FORWARD-LOOKING STATEMENTS
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.
Neither the TSX nor its Regulation Services Provider (as that
term is defined in the policies of the TSX) accepts responsibility
for the adequacy or accuracy of this release.
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Jason Mitchell, N.D. Chief Executive Officer and Director Email:
ir@hempfusion.com Phone: 416-803-5638
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