Guardion Health Sciences Announces Investigator-Initiated Clinical Trial of Lumega-Z
October 26 2020 - 8:00AM
Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the
“Company”), a specialty health sciences company that develops
clinically supported nutrition, medical foods and medical devices,
with a focus in the ocular health marketplace, announced an
investigator-initiated clinical trial of Lumega-Z, its flagship
nutritional product which is now being marketed under the
NutriGuard brand. This clinical trial, which is part of the
Company’s on-going investigator-driven studies program to support
clinical claims for the Company’s proprietary products, is designed
to evaluate the impact of Lumega-Z on the restoration of the
macular pigment and its relationship to the stabilization or
recovery of vision. Depletion of the macular pigment at the back of
the eye is a risk factor for vision loss related to age-related
macular degeneration (“AMD”), glaucoma and other serious eye
diseases.
The clinical study, which is being conducted by
William E. “Rick” Sponsel, M.D., will focus on patients with eye
disease and will evaluate the impact that the macular pigment has
on stabilizing and/or restoring visual function and other clinical
measures. Dr. Sponsel is a world-renowned expert in ocular
physiology, ocular circulation and innovative techniques for
treating eye diseases. After serving as Director of Clinical
Research at the University of Texas, Dr. Sponsel transitioned into
private practice in San Antonio, Texas. His practice focuses on
patients with advanced ocular disease, including macular
generation, diabetic retinopathy and glaucoma. Dr. Sponsel
continues to serve as Professor of Vision Sciences at UIW and
Professor of Biomedical Engineering at UTSA. Over his 30-year
career, Dr. Sponsel has published more than 100 peer-reviewed
papers and numerous book chapters.
The clinical study will compare the macular
pigment and other clinical measures in patients taking Lumega-Z
against patients not taking Lumega-Z or any other ocular nutrition
product. The study will focus on glaucoma patients with controlled
intraocular pressure, but who continue to have vision problems, and
will compare results from 30 patients who have taken Lumega-Z daily
for 12 months to 30 similar patients who are not on a regimen of
Lumega-Z or any other ocular nutrition product.
“As the nutrition market continues to grow and
attracts more focus from other players like Abbott and Nestle, it
is essential that Guardion continues to differentiate itself
through measurable clinical outcomes provided by our nutrition and
medical food brands,” commented David Evans, Ph.D., Guardion’s
interim President and Chief Executive Officer, and Chief Science
Officer. “Dr. Sponsel’s research project represents a pivotal part
of this differentiation strategy, and we believe that the results
of his study could have a significant impact on how consumers,
patients and physicians use nutritional products as part of an
integrated treatment approach to support ocular health and manage
certain debilitating eye conditions, as well as overall health and
immunity.”
“This clinical study is part of our strategy to
initiate investigator-driven clinical trials conducted with
Guardion’s unique nutritional products,” added Dr. Evans. “We
expect to be announcing further clinical trials, as well as
potential timelines for results in the near-term, and we look
forward to updating our shareholders on additional progress and
developments.”
About Guardion
Health Sciences
Guardion is a specialty health sciences company
that develops clinically supported nutrition, medical foods and
medical devices, with a focus in the ocular health marketplace.
Located in San Diego, California, the Company combines targeted
nutrition with innovative, evidence-based diagnostic technology.
Guardion boasts impressive Scientific and Medical Advisory Boards.
Information and risk factors with respect to Guardion and its
business, including its ability to successfully develop and
commercialize its proprietary products and technologies, may be
obtained in the Company’s filings with the SEC at www.sec.gov.
Forward-Looking Statement
Disclaimer
With the exception of the historical information
contained in this news release, the matters described herein may
contain forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. Statements
preceded by, followed by or that otherwise include the words
“believes,” “expects,” “anticipates,” “intends,” “projects,”
“estimates,” “plans” and similar expressions or future or
conditional verbs such as “will,” “should,” “would,” “may” and
“could” are generally forward- looking in nature and not historical
facts, although not all forward-looking statements include the
foregoing. These statements involve unknown risks and uncertainties
that may individually or materially impact the matters discussed
herein for a variety of reasons that are outside the control of the
Company, including, but not limited to, the Company’s ability to
raise sufficient financing to implement its business plan, the
impact of the COVID-19 pandemic on the Company’s business,
operations and the economy in general, and the Company’s ability to
successfully develop and commercialize its proprietary products and
technologies. Readers are cautioned not to place undue reliance on
these forward- looking statements, as actual results could differ
materially from those described in the forward-looking statements
contained herein. Readers are urged to read the risk factors set
forth in the Company’s filings with the SEC, which are available at
the SEC’s website (www.sec.gov). The Company disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor Relations Contact:CORE IRScott
Arnold516-222-2560scotta@coreir.com
Media Relations Contact:Jules
AbrahamDirector of Public RelationsCORE
IR917-885-7378julesa@coreir.com
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