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.

 

PORTFOLIO

 

HomeLumega-Z

Lumega-Z is the first and only Medical Food designed to restore and replenish the macular pigment. Treatment is designed for patients who have or who are at risk for a depleted macular pigment; primarily patients with macular degeneration but also those at risk for macular degeneration.

 

 

HomeVectorVision

VectorVision is a wholly owned subsidiary of Guardion Health Sciences and is the world leader in standardized contrast sensitivity, glare and ETDRS testing. Its CSV-1000 is the worldwide standard for FDA clinical trials and is used clinically in more than 60 countries.

 

 

HomeGlaucoCetin

Glaucocetin is the first and only Medical Food designed to reverse mitochondrial dysfunction in optic nerve cells. The purpose of treatment in glaucoma patients is to stop the underlying damage occurring in optic nerve cells and stop or reverse vision loss.

 

 

HomeMapcatSF

The MapcatSF is the most accurate, reliable and repeatable measure of macular pigment optical density (MPOD). This device is protected by patents in the US and Europe.

 

 

HomeTranscranial Doppler

Transcranial Doppler Solutions is a wholly owned subsidiary of Guardion Health Sciences. Transcranial Doppler technology is used to detect blood flow anomalies in the eye and brain and to track the benefits of Guardion’s Medical Food treatments.

 

 

Our Team

 

Guardion Health Sciences is directed by a Science Advisory Board with advice from a Medical Advisory Board consisting of practicing physicians. Both teams are committed to unraveling and validating the connections between health and nutrition and then developing products based on these findings. Their joint goal is the integration of a medical model incorporating nutritional therapy into clinical practice.

 

richard_boneRichard A. Bone, BSc, PhD, FARVO, is a distinguished experimental biophysicist and professor in the department of physics at Florida International University in Miami. Highlights from his 30-year research career include discoveries that have changed the standard of care for both macular degeneration (AMD) and cataract treatment. With other researchers, he identified the biologic mechanisms responsible for the protective role of lutein and zeaxanthin in the eye (published in 2003 in the Annual Review of Nutrition) and devised a way to measure the protective pigments in the macula of the eye. These two related discoveries led to the invention of a non-intrusive device to measure macular pigment density and cataract formation and an eye-care supplement for cataract and AMD patients containing a specific combination of lutein, zeaxanthin and meso-zeaxanthin. He is co-owner of patents for both the device and the supplement formula, which he shares with fellow researcher John T. Landrum, Ph.D.

 

His current research continues to focus on the bioavailability of different macular carotenoid formulations and improved, non-invasive methods of measuring macular pigment density and cataract development.

 

Bone has published more than 40 scholarly articles in leading journals as well as a number of contributed chapters in books devoted to carotenoids, the health of the eye and the cumulative light distribution on the human retina. He has been the recipient of numerous research grants including continuous funding by the National Institutes of Health since 1984.

 

In 2010, he was invited to become a Fellow of the Association for Research in Vision and Ophthalmology (FARVO), the leading organization for vision and ophthalmology world-wide.

 

*Bone was just awarded The Presidential Award for achievement in macular pigment research and dedicated service to the carotenoid field.

 

 

john_landrumJohn T. Landrum, BS, MS, PhD, FARVO, is an internationally recognized research scientist and professor of Chemistry and Biochemistry at Florida International University (FIU). He is among the world’s leading experts in the study of the carotenoid components of the human macula and the transport and metabolism of carotenoids. He served in 2004 as the vice-chairman for the distinguished Gordon Research Conference on Carotenoids and in 2007 was chairman of that conference. He is the current treasurer for the International Carotenoid Society. Among his career accomplishments Dr. Landrum lists the identification of lutein and zeaxanthin in the human retina and the discovery, with his collaborator, Dr. Richard A. Bone, Ph.D. that meso-zeaxanthin is uniquely a protective component of the human macular pigment. In a 2001 landmark paper (1), Bone and Landrum published experimental evidence that the macular pigment is responsible for protection of the retina against age-related macular degeneration. Dr. Landrum’s demonstration that diet can effectively increase the levels of the protective carotenoids in the retina (2) has laid the foundation for reducing the risk for age-related macular degeneration using dietary supplements of lutein and zeaxanthin.

 

Active projects in his lab at Florida International University include research to understand the development of the macular pigment in young eye, study of the bioavailability of carotenoids in supplement formulations, and animal models of carotenoid transport and metabolism.

 

He is the editor of a recently published book, Carotenoids: Physical, Chemical, and Biological Functions and Properties and an associate editor for Archives of Biochemistry and Biophysics. He and has served as the guest editor of three Highlight Issues on Carotenoids for that journal, including the recent December 1, 2010 Fourth Highlight Issue on Carotenoids. (3) Dr. Landrum has published over 50 research publications in prominent, peer reviewed journals and edited volumes. He is the co-owner of patents on supplement formulas and devices for measurement of the macular pigment with his colleague and collaborator, Richard A. Bone, Ph.D.

 

*Landrum was just appointed president of the International CarotenoidSociety for the next 3 years.

 

 

donald_gaglianoDon is a graduate of the United States Military Academy at West Point, the Chicago Medical School, Penn State University and the United States Army War College. Initially commissioned in the Corps of Engineers, he served as a Platoon Leader, Executive Officer and Company Commander. Following medical school, he completed a residency in Ophthalmology and a fellowship in Retinal Diseases and Surgery. He is the author of multiple publications and book chapters, a Fellow of the American Academy of Ophthalmology, and a longstanding member of the Retina Society and the American Society of Retinal Specialists.

 

Don has served at the CEO level of leadership as the Commander of a directed energy research laboratory, Commander of three hospitals, and Commander of the combat medical brigade during the initial occupation of Iraq. As the first Iraq Theater Surgeon, he was the architect and implementer of all components of medical operations and support in Iraq during the first year of the war, which included coordinating reconstruction with the Ministries of Health, Defense and Higher Education, as well as managing an integrated health care system for over 350,000 coalition forces from 33 nations and thousands of enemy prisoners of war and terrorist detainees in Iraq. He was individually recognized as having been “directly responsible for saving countless lives, both Coalition and Host Nation.”

 

Don subsequently served as the Chairman of the Medical Education and Training Campus Executive Committee and was responsible for overseeing the execution of $1B in the development of a new state-of-the-art military medical training facility and the implementation of the largest Joint training integration in the history of the Department of Defense. In November 2008, Don was appointed by the Assistant Secretary of Defense for Health Affairs as the first Executive Director of the Joint Department of Defense (DoD) and Department of Veterans Affairs (VA) Vision Center of Excellence (VCE) and was responsible for overseeing the clinical care, research, prevention, treatment and rehabilitation of military eye injuries in the DoD and VA healthcare systems. Under his leadership, the VCE successfully established the first ever Joint DoD and VA integrated database and clinical registry.

 

From 2009-2013 Don was appointed to the National Advisory Eye Council for the National Eye Institute (NEI), part of the National Institute of Health. The council advises the NEI about conducting and supporting research, training, health information dissemination, and other programs that address blinding eye diseases and disorders, visual function mechanisms, sight preservation, and health needs of visually impaired individuals. Don is an active advocate for Visually Impaired Veterans and currently serves on the Board of the Blinded Veterans Association and the Prevention of Blindness Society of Metropolitan Washington.

 

 

SPONSELOphthalmologist William E. Sponsel, M.D., M.B., Ch.B., F.R.A.N.Z.C.O., F.A.C.S., is driven by a passion to help save people’s eyesight. After establishing the Glaucoma Research and Diagnostic Laboratory at Indiana University in 1991, he was recruited to the University of Texas Health Science Center at San Antonio in 1994, where he became Professor and Director of Clinical Research. He has been keynote lecturer at hundreds of scientific meetings worldwide, has won numerous honors, and has been regularly listed among The Best Doctors in America for the past 20 years. He is presently Professor of Vision Sciences at UIW and Adjunct Professor of Biomedical Engineering at UTSA in San Antonio, Texas.

 

Dr. Sponsel routinely performs innovative surgery upon a referral patient’s only functioning eye, on newborns with congenital glaucoma, and victims of ocular trauma. Dr. Sponsel has pioneered the design and placement of a new generation of retrobulbar tube shunts (JG 2014) and was among the fist American surgeons to perform artificial iris implantation (JCRS 2012).  He has helped lead new multidisciplinary research effort to extend our understanding of the forces at work in ocular trauma using empirical testing and supercomputer modeling (IOVS 2011a-c, 2014). His recent clinical research work bridges the basic and clinical sciences, with the first published glaucoma filtering surgery case series to document statistically significant visual field improvement (BJO 2013), and a refined data analysis of clinical data confirming that the two eyes and brain work together to conserve the binocular visual field in patients with bilaterally stabilized advanced glaucoma (TVST 2014). The latter work has received worldwide recognition and may help redirect approaches to combat a range of age-related neurodegenerative disorders that utilize biochemical mechanisms for programmed cell death similar to those at work in chronic glaucoma.

 

SOURCE:  https://guardionhealth.com/

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