Guardion Health Sciences Announces Investigator-Initiated Clinical Trial of Lumega-Z
Guardion Health Sciences (GHSI) has announced an investigator-initiated clinical trial for Lumega-Z, its flagship nutritional product, aimed at evaluating its impact on restoring macular pigment and stabilizing vision. Conducted by Dr. Rick Sponsel, the trial will involve glaucoma patients comparing those taking Lumega-Z daily against a control group over 12 months. Dr. Sponsel's expertise in ocular physiology enhances the study's credibility. Guardion aims to differentiate its offerings through measurable clinical outcomes to influence the ocular health market.
- Initiation of a clinical trial for Lumega-Z, potentially strengthening product credibility.
- Conducted by Dr. Rick Sponsel, a recognized expert in ocular physiology.
- Focus on glaucoma patients may provide valuable insights into product effectiveness.
- Potential for measurable clinical outcomes to enhance market positioning.
- The company faces significant competition from established players like Abbott and Nestle.
- Future results of the trial are uncertain and depend on various factors.
- Dependent on patient enrollment and compliance, which may affect study outcomes.
SAN DIEGO, Oct. 26, 2020 (GLOBE NEWSWIRE) -- 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:
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Scott Arnold
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Media Relations Contact:
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FAQ
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