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Guardion’s Lumega-Z Formula Associated with Substantial Clinical Improvement in Patients Contrast Sensitivity Visual Function (CSF) vs AREDS 2
May 09, 2019 10:14 ET | Source: Guardion Health Sciences, Inc.
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 09, 2019 (GLOBE NEWSWIRE) -- 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 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.”
Guardion Health Sciences, Inc., a specialty health sciences company, develops, formulates, and distributes condition-specific medical foods in the United States and internationally. It operates in two segments, Medical Foods and Vision Testing Diagnostics. The Medical Foods segment offers Lumega-Z, a medical food that replenishes and restores the macular protective pigment; MapcatSF, a medical device that measures the macular pigment optical density; and GlaucoCetin, a vision-specific medical food to support and protect the mitochondrial function of optic nerve cells, as well as improve blood flow in the ophthalmic artery in patients with glaucoma. The Vision Testing Diagnostics segment develops, manufactures, and sells equipment and supplies for standardized vision testing for use by eye doctors in clinical trials, real-world vision evaluation, and industrial vision testing. Its products include VectorVision CSV-1000, an instrument for contrast sensitivity testing; and ESV-3000 ETDRS, a device for early treatment diabetic retinopathy study in visual acuity testing. The company distributes its products through direct sales force, as well as through its guardionhealth.com Website. Guardion Health Sciences, Inc. was founded in 2009 and is headquartered in San Diego, California.
Organization and Business
Guardion Health Sciences, Inc. (the “Company”) was formed in December 2009 as a California limited liability company under the name P4L Health Sciences, LLC. On June 30, 2015, the Company converted from a California limited liability company to a Delaware corporation, changing its name from Guardion Health Sciences, LLC to Guardion Health Sciences, Inc.
The Company is a specialty health sciences company that develops, formulates and distributes condition-specific medical foods with an initial medical food product on the market under the brand name Lumega-Z® that replenishes and restores the macular protective pigment. The Company also developed a proprietary medical device called the MapcatSF® that accurately measures the macular pigment optical density.
On September 29, 2017, the Company, through its wholly owned subsidiary VectorVision Ocular Health, Inc. (“VectorVision”), completed its acquisition of substantially all of the assets and certain liabilities of VectorVision, Inc. (an Ohio corporation), a company that specialized in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and early treatment diabetic retinopathy study (“ETDRS”) visual acuity testing. VectorVision develops, manufactures and sells equipment and supplies for standardized vision testing. The acquisition expands the Company’s technical portfolio. CSV-1000 and CSV-3000 instruments offer auto-calibrated tests to ensure correct testing luminance and contrast levels for consistent, highly accurate and repeatable results. Recently issued patents the Company received for continuously calibrating the light source will be incorporated into the new CSV-2000, in which the proprietary standardized contrast sensitivity test patterns can be presented to the patient using a computer monitor as opposed to the current calibrated backlit system.
In August 2018, the Company created a wholly owned subsidiary, Transcranial Doppler Solutions, Inc. (“TDSI”). TDSI is dedicated to the pursuit of early predictors resulting in, the Company believes, valuable therapeutic intervention for practitioners and their patients, and additional revenue streams generated from the testing and sale of Company products to appropriate customers. The Company has established operations with selected clinics and is focusing on expanding its client base.
In November 2018, the Company launched a new medical food product, GlaucoCetinTM, which the Company believes is the first vision-specific medical food designed to support and protect the mitochondrial function of optic nerve cells and improve blood flow in the ophthalmic artery in patients with glaucoma.
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