Guardion Health Sciences, Inc. (NASDAQ: GHSI)

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Guardion’s Lumega-Z Formula Associated with Substantial Clinical Improvement in Patients Contrast Sensitivity Visual Function (CSF) vs AREDS 2

In a recent study presented at the Association for Research in Vision and Ophthalmology (ARVO) 2019 annual meeting, improvements in visual function (CSF) in the Lumega-Z Group were statistically significant and definitive. The AREDS 2 Group showed no statistical change.

 

 

San Diego, CA – May 9, 2019 – Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the “Company”), an ocular health sciences and technologies company that develops, formulates and distributes condition-specific medical foods and testing technologies supported by evidence-based protocols, today announced the results of a study from research scientists at the Western University  College of Optometry to clinically evaluate the visual benefits of the Company’s micronized liquid formula Lumega-Z as compared to the AREDS 2 softgel supplement in individuals with retinal drusen and at risk of developing Age-Related Macular Degeneration (AMD).

 

Dr. David Evans, Ph.D., Guardion’s Chief Science Officer, commenting on the results of the study, stated, “We are pleased to present for the first-time clinical data showing the beneficial effects of our liquid lipid-based formula Lumega-Z as compared to the AREDS 2 softgel supplement. This data supports numerous clinical reports that we have showing substantial clinical improvements in patients who switched from the AREDS 2 softgel to Lumega-Z. This data also extends the important work conducted by the National Eye Institute emphasizing the importance of nutritional therapy in combating the growing epidemic of vision loss from Age-Related Macular Degeneration.”

 

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 Securities and Exchange Commission (“SEC”) at www.sec.gov.

 

About Guardion Health Sciences, Inc.

 

Guardion is an ocular health sciences company that develops, formulates and distributes condition-specific medical foods supported by evidence-based protocols, with an initial medical food product, Lumega-Z, that addresses a depleted macular protective pigment, a known risk factor for age-related macular degeneration (“AMD”) and a significant component of functional vision performance.  Guardion Health Sciences, Inc. has also developed a proprietary medical device, the MapcatSF®, which accurately measures the macular pigment density, therefore providing the only two-pronged evidence-based protocol for the treatment of a depleted macular protective pigment.

 

About VectorVision®

 

VectorVision®, operating through a wholly-owned subsidiary of the Company, 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 CSV-1000 device is considered the standard of care for clinical trials.

 

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.  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 and its 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.

 

Michael Favish

Chief Executive Officer

Telephone: (858) 605-9055 x 201

E-mail: mfavish@guardionhealth.com

 

Investor Relations Contact:

Matthew Abenante

Porter, LeVay & Rose, Inc.

Telephone: (212) 564-4700

E-mail: matthew@plrinvest.com

 

Source: Guardion Health Sciences, Inc.

Guardion’s Lumega-Z Formula Associated with Improved Vision in Patients with Severe Glaucoma

In a recent study presented at the Association for Research in Vision and Ophthalmology (ARVO) 2019 annual meeting, treatment with Lumega-Z was associated with significant improvement in Visual Field function among patients with severe glaucoma

 

San Diego, CA – May 7, 2019 – Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the “Company”), an ocular health sciences and technologies company that develops, formulates and distributes condition-specific medical foods and testing technologies supported by evidence-based protocols, today announced the results of a study from research scientists at the University of Texas, San Antonio (USTA), Texas, on the effects of the Company’s Lumega-Z medical food on pericentral FDT (i.e. tests of visual field) among patients with severe glaucoma who had previously shown degeneration despite having controlled intraocular pressure.

 

Dr. David Evans, Ph.D., Guardion’s Chief Science Officer, commenting on the results of the study, stated, “Patients with advanced glaucoma often have no hope for maintaining their vision.  This new data, presented by Dr. William E. Sponsel, at ARVO, shows that certain patients with advanced stages of glaucoma treated with Lumega-Z can preserve and even recover some vision function.  This is an important development in the treatment of patients with advanced glaucoma.”

 

Dr. William E. Sponsel, M.D., M.B., Ch.B, F.R.A.N.Z.C.O, F.A.C.S., is a member of Guardion’s Science Advisory Board.  Dr. Sponsel established the Glaucoma Research and Diagnostic Laboratory at Indiana University in 1991, and was later recruited to the University of Texas Health Science Center at San Antonio in 1994, where he became Professor and Director of Clinical Research.  He is presently Professor of Vision Sciences at University of Incarnate Word and Adjunct Professor of Biomedical Engineering at UTSA.

 

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 Securities and Exchange Commission (“SEC”) at www.sec.gov.

 

About Guardion Health Sciences, Inc.

Guardion is an ocular health sciences company that develops, formulates and distributes condition-specific medical foods supported by evidence-based protocols, with an initial medical food product, Lumega-Z, that addresses a depleted macular protective pigment, a known risk factor for age-related macular degeneration (“AMD”) and a significant component of functional vision performance.  Guardion Health Sciences, Inc. has also developed a proprietary medical device, the MapcatSF®, which accurately measures the macular pigment density, therefore providing the only two-pronged evidence-based protocol for the treatment of a depleted macular protective pigment.

 

About VectorVision®

VectorVision®, operating through a wholly-owned subsidiary of the Company, 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 CSV-1000 device is considered the standard of care for clinical trials.

 

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.  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 and its 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.

 

Michael Favish

Chief Executive Officer

Telephone: (858) 605-9055 x 201

E-mail: mfavish@guardionhealth.com

 

Investor Relations Contact:

Matthew Abenante

Porter, LeVay & Rose, Inc.

Telephone: (212) 564-4700

E-mail: matthew@plrinvest.com

 

Source:  Guardion Health Sciences, Inc.

Guardion Health Sciences, Inc. Receives Official Trademark Registrations in China

Guardion’s Lumega-Z product and MapcatSF device are key components of its two-pronged evidence-based protocol for the treatment of a depleted macular protective pigment, a known risk factor for age-related macular degeneration

 

San Diego, CA – May 01, 2019 – Guardion Health Sciences, Inc. (“Guardion” or the “Company”) (Nasdaq: GHSI), an ocular health sciences and technologies company that develops, formulates and distributes condition-specific medical foods and testing technologies supported by evidence-based protocols, today announced that it was recently notified by the State Intellectual Property Office of the People’s Republic of China (“China”) that it has been granted trademark registrations in China for its proprietary medical food, Lumega-Z (Registration No. 27151643), and for its proprietary medical device, the MapcatSF (Registration No. 27151644).

 

The trademark registration for Lumega-Z is effective from November 7, 2018 to November 6, 2028, and the trademark registration for the MapcatSF is effective from October 28, 2018 to October 27, 2028. The granting of these trademark registrations in China is an important step in the Company’s efforts to introduce the Company’s proprietary products and services to the Chinese marketplace.

 

Michael Favish, Guardion’s President and Chief Executive Officer, commenting on the granting of the trademark registrations in China, stated “We believe that China, with its large and growing aging population, represents a substantial market opportunity for us, and the establishment of intellectual property rights for our products and services in China will help Guardion in its efforts to gain market acceptance for Lumega-Z and the MapcatSF. This development is an important first step in what are expected to be further investments by Guardion in China as we introduce our products and services to this important and dynamic market.”

 

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 Securities and Exchange Commission (“SEC”) at www.sec.gov.

 

About Guardion Health Sciences, Inc.

Guardion is an ocular health sciences company that develops, formulates and distributes condition-specific medical foods supported by evidence-based protocols, with an initial medical food product, Lumega-Z, that addresses a depleted macular protective pigment, a known risk factor for age-related macular degeneration (“AMD”) and a significant component of functional vision performance. Guardion Health Sciences, Inc. has also developed a proprietary medical device, the MapcatSF®, which accurately measures the macular pigment density, therefore providing the only two-pronged evidence-based protocol for the treatment of a depleted macular protective pigment.

 

About VectorVision®

VectorVision®, operating through a wholly-owned subsidiary of the Company, 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 CSV-1000 device is considered the standard of care for clinical trials.

 

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. 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 and its 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.

 

Company Contact:

Michael Favish

Chief Executive Officer

Telephone: (858) 605-9055 x 201

E-mail: mfavish@guardionhealth.com

 

Investor Relations Contact:

Matthew Abenante

Porter, LeVay & Rose, Inc.

Telephone: (212) 564-4700

E-mail: matthew@plrinvest.com

 

Source: Guardion Health Sciences, Inc.

About Guardion Health Sciences

Guardion Health Sciences is at the forefront of early detection, intervention and monitoring of a range of eye diseases. The company combines targeted ocular nutrition with innovative evidence-based diagnostic technology. Located in San Diego, Guardion boasts one of the most impressive Scientific and Medical Advisory Boards in the world. This combination of expertise and scientific knowledge has catapulted Guardion into a leadership position within the eye care industry. Further, the company is led by seasoned business executives with many years of experience in running and expanding public companies.

 

This combination of expertise and scientific knowledge has catapulted Guardion into a leadership position within the eye care industry.

 

Guardion owns a number of, industry-leading proprietary technologies and novel treatments. The most notable include:

 

Lumega-Z, the only micronized lipid-base nutritional formulation designed to restore and maintain the condition of a depleted macular pigment. This unique delivery platform ensures the highest level of absorption as well as rapid patient response to treatment.

 

The Mapcat, which is the most repeatable and accurate measuring technology for the MPOD (macular pigment optical density). Mapcat is now protected by patents in the United States and Europe. 

 

VectorVision is the most widely used and respected clinical contrast sensitivity test.

 

Next generation VectorVision products have two patents protecting proprietary methodologies for the standardization of vision testing. These patents will provide for a much wider adoption of new and more accurate vision tests for everyday clinical use and, for the first time due to standardization, allow comparison of vision test results between different doctors and locations.

 

Copyright protection for the presentation format and methodologies of the VectorVision contrast sensitivity test, the most widely used and respected contrast sensitivity test in the world. 

 

GlaucoCetin, the first regulated vision-specific Medical Food designed to support and protect the mitochondrial function of optic nerve cells in patients with glaucoma.

 

Guardion uses only the highest quality ingredients in its products. Qualifying as Medical Foods validates the impeccable quality of Lumega-Z and Glaucocetin and ensures these formulas are precisely tailored to treat or manage a specific disease or condition. Medical Foods must be recommended and administered under the supervision of a physician or professional healthcare provider, once deemed necessary after medical evaluation.

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