Guardion Health Sciences, Inc. (“Guardion” or the “Company”)
(Nasdaq: GHSI), a company that (i) develops medical foods and
medical devices in the ocular health marketplace and (ii) is
developing nutraceuticals that the Company believes will provide
health benefits to consumers, announced today the publication of
study data comparing the efficacy of the Company’s micronized
liquid formula Lumega-Z®, to the current standard AREDS 2 soft gel
supplement.
Results from the study concluded that Guardion’s
unique, proprietary formulation, Lumega-Z, provided significantly
higher blood concentration levels of carotenoids, which have been
shown by studies sponsored by the National Eye Institute to be
important for slowing the progression of macular degeneration in
certain patients, and the MPOD, which has been shown in studies to
be an important and modifiable biomarker to track the progression
of macular degeneration and other eye diseases.
Dr. David Evans, Chief Science Officer, stated,
“This positive head-to-head study demonstrates the superiority of
our formula over the current standard off-the-shelf AREDS 2 gel
caps, specifically finding that despite only a 2.3-fold higher
carotenoid concentration, Lumega-Z supplementation provides
approximately 3–4-fold higher absorption, which leads to a
significant elevation of MPOD levels, a known biomarker for several
retinal pathologies.”
Lumega-Z, the Company’s proprietary medical
food, is the only micronized lipid-base nutritional formulation
designed to restore a depleted macular pigment. This unique
delivery platform ensures the highest level of absorption as well
as rapid patient response to treatment.
“We firmly believe Lumega-Z has the potential to
address the significant unmet needs of age-related macular
degeneration, a leading cause of vision loss, affecting a large
population worldwide. The results demonstrated by Lumega-Z bolster
our confidence in the potential to provide more effective and
efficient eye health treatments, clearly representing an important
breakthrough in the growing importance of MPOD and the increasing
role of medical foods as an integral component of the physicians’
armamentarium of treatments for maintaining and restoring eye
health,” commented Michael Favish, CEO of Guardion Health Sciences.
“We are pleased to have another important study published in a tier
one peer-reviewed journal.”
Participants in the study (two groups of 15
participants in each group) were given a 24-week supply of a
lipid-based micronized liquid medical food, Lumega-Z®, containing
28 mg of the macular carotenoids lutein (L), zeaxanthin (Z) and
meso-zeaxanthin (MZ), or given PreserVision™ AREDS 2 Formula
(gel-caps; PV) containing 12 mg of the macular carotenoids L and Z,
but no reported MZ. Serum levels of L, Z and MZ were obtained at
baseline and after 12 weeks. Macular pigment optical densities and
visual function were assessed at baseline and after 24 weeks.
Results from the study were recently published
in the peer-reviewed journal, Nutrients, titled, “Efficacy of
Commercially Available Nutritional Supplements: Analysis of Serum
Uptake, Macular Pigment Optical Density and Visual Functional
Response.”About Lumega-Z®
Lumega-Z, is the only micronized lipid-base
nutritional formulation designed to restore a depleted macular
protective pigment. This unique delivery platform ensures an
elevated level of absorption as well as rapid patient response to
treatment. Data demonstrated to date has shown that patients who
used Lumega-Z for 12 consecutive months were associated with
significant improvement in Frequency Doubling Technology
pericentral function among patients with severe glaucoma who had
previously shown degeneration despite having had excellent
intraocular pressure control. Additional data has shown that
patients with drusen and at risk of vision loss from macular
degeneration treated with Lumega-Z for 6 months showed improvements
in vision, as measured by contrast sensitivity.
About Guardion Health Sciences, Inc.
Guardion is a specialty health sciences company
(i) that develops medical foods and medical devices in the ocular
health marketplace and (ii) that is developing nutraceuticals that
the Company believes will provide medicinal and health benefits to
consumers. 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.
About VectorVision®
VectorVision® specializes in the standardization
of contrast sensitivity, glare sensitivity, low contrast acuity,
and ETDRS acuity vision testing. Its patented standardization
system provides the practitioner or researcher the ability to
delineate very small changes in visual capability, either as
compared to the population or from visit to visit. VectorVision’s®
patented technology is considered the standard of care for clinical
trials. VectorVision® is a wholly owned subsidiary of Guardion.
Guardion has completed development of the
proprietary VectorVision® CSV-2000 standardized contrast
sensitivity test and recently introduced the commercial product to
the marketplace. The CSV-2000 is the only computer-generated vision
testing instrument available that will provide the optical
marketplace with the Company’s proprietary, industry-standard
contrast sensitivity test, along with a full suite of standard
vision testing protocols. The proprietary standardization
methodology incorporated into the CSV-2000 includes a patented
technology known as AcQviz that automatically and constantly
measures and adjusts screen luminance to a fixed standard light
level for vision testing.
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 coronavirus (COVID-19) on the Company’s business 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:Jenene Thomas JTC
Team, LLCTelephone: (833) 475-8247E-Mail: GHSI@jtcir.com
Porter, LeVay & Rose, Inc.
Michael PorterTelephone: (212) 564-4700 E-mail:
mike@plrinvest.com
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