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Company Overview
Guardion Health Sciences Inc (GHSI) applies advanced science, technology, and research to develop condition-specific solutions through the creation of medical foods. Specializing in the development of nutritional supplements using a rigorous pharmaceutical approach, the company is dedicated to addressing life-diminishing health issues faced predominantly by the aging baby boomer generation. Its pioneering approach is underscored by a strong scientific foundation, leveraging insights from an esteemed advisory board to guide the development of safe, standardized, and effective products that address specific health challenges.
Scientific and Pharmaceutical Approach
At its core, Guardion Health Sciences embraces a deeply analytical and research-oriented methodology. The company integrates a scientific discipline with a pharmaceutical mindset to formulate products that are designed to support overall nutritional health and specific conditions. This approach is reflected in its flagship medical food, which has been formulated to restore and maintain the macular protective pigment—a critical factor in sustaining eye health. The formulation is based on contemporary scientific studies and clinical insights, making the company a knowledgeable source for medical foods aimed at combating degenerative conditions such as age-related macular degeneration (AMD) and other related eye health issues.
Market Position and Industry Impact
Guardion Health Sciences occupies a unique niche at the intersection of nutritional science and healthcare. Its focus on medically formulated nutritional products positions it distinctly within the growing market of condition-specific medical foods. This market segment continues to expand as consumers increasingly seek scientifically validated products that contribute to overall health maintenance and disease prevention. The company’s commitment to evidence-based practice and research-driven product development has established it as a credible participant in both the nutritional and pharmaceutical industries.
Business Model and Revenue Generation
The company generates revenue through the development and commercialization of specialty medical foods and nutritional products. By concentrating on products that enhance specific health outcomes, Guardion Health Sciences aims to meet a clearly defined customer need. The business model rests on the combination of scientific development, quality control in formulation, and strategic distribution to healthcare providers and consumers who value research-backed nutritional solutions.
Scientific Advisory and Expertise
An integral component of Guardion Health Sciences’ strategy is its collaboration with a diverse and experienced group of scientific advisors. These experts contribute collective knowledge from various fields of medicine and nutrition, ensuring that every product is developed with a robust foundation in current scientific research. This collaboration not only reinforces the company’s credibility but also serves as a platform to educate both healthcare professionals and the public about the benefits of medical foods in managing health challenges.
Integration with Healthcare and Nutrition
Guardion Health Sciences actively contributes to a broader understanding of how nutrition can influence health outcomes. Its educational initiatives are designed to advise healthcare professionals on the role of targeted nutrition in maintaining good health. The company emphasizes that proper nutritional support can be a critical element in a comprehensive approach to managing age-related health conditions, thereby reinforcing its significance in the integrated field of healthcare and nutritional science.
Competitive Differentiation
While numerous players operate within the nutritional products and pharmaceutical sectors, Guardion Health Sciences stands out due to its unwavering focus on condition-specific medical foods and its commitment to a research-intensive product development strategy. Unlike competitors that may offer generalized supplements, the company’s targeted approach—underscored by a deep understanding of nutritional biochemistry and clinical research—ensures that its products are tailored to address specific health issues, particularly those associated with aging and ocular health.
Educational Initiatives and Consumer Guidance
The company not only develops nutrition-based products but also acts as an educational resource within the healthcare community. By disseminating scientifically accurate information on the benefits of medical foods, Guardion Health Sciences helps to demystify complex nutritional strategies and promotes well-informed decision-making among consumers and healthcare practitioners alike. This dedication to education further augments its position as a trusted expert in the evolving field of nutritional science.
Conclusion
Guardion Health Sciences Inc exemplifies a well-defined integration of scientific research with nutritional product development. With its emphasis on medical foods and a pharmaceutical approach tailored to address age-related health challenges, the company provides a nuanced and effective solution designed to support eye health and overall wellness. Grounded in scientific discipline and committed to robust advisory collaboration, Guardion Health Sciences enriches the market with products that are both innovative and grounded in clinical evidence, making it a noteworthy entity in the domains of healthcare and nutritional science.
Guardion Health Sciences (GHSI) announced a 1-for-6 reverse stock split effective March 1, 2021, to comply with Nasdaq's minimum bid price rule. The company also completed at-the-market financings, raising a total of $37.2 million, providing it with over $44 million in cash for future growth and acquisitions. The reverse split aims to enhance the attractiveness of GHSI's stock and maintain compliance for continued listing on Nasdaq. The company has approximately 24.4 million shares outstanding post-split, with a focus on ocular health and clinical nutrition.
Guardion Health Sciences (GHSI) announced that its exclusive distributor in Malaysia, Ho Wah Genting Berhad (HWGB), received product registration approval for the immune support dietary supplement Astramern Astra H from the Malaysian National Pharmaceutical Regulatory Agency. This approval, valid for five years, signifies an important step toward commercialization and allows HWGB to package it with another product, Nutra V, enhancing their immune support offerings. Guardion aims to expand its presence in the Asian nutraceutical market through strategic partnerships and product development.
Guardion Health Sciences (GHSI) announced it received a Nasdaq extension until March 15, 2021, to comply with the $1.00 Minimum Bid Price Rule. The company expressed optimism regarding a recent share price increase, believing it may regain compliance soon. Should the share price fail to meet the requirements, a reverse stock split, previously approved by shareholders, will be enacted to maintain Nasdaq listing. The company focuses on ocular health through clinically supported nutrition and medical devices. Compliance with Nasdaq rules remains crucial for GHSI's market presence.
Guardion Health Sciences (Nasdaq: GHSI) announces the appointment of Bret Scholtes as President and CEO, effective January 6, 2021. Scholtes, with nearly a decade in the nutritional products industry, is expected to drive growth and profitability. His previous role at Omega Protein Corporation saw significant revenue and stock price increases. The Board aims to align Scholtes's compensation with shareholder value objectives. The leadership change comes at a challenging time but promises a focus on product development and market expansion.
Guardion Health Sciences (GHSI) is advancing its new vision support drink, Epiq-V, targeting both adult and youth markets. The drink, which contains Lutein, aims to support ocular health and enhance attention for video gaming. Following successful initial testing, final testing is expected to conclude by Q1 2021, with product availability projected 12 to 16 weeks post-testing. Trademark registration for Epiq-V has been secured in China, with U.S. registration pending. The company’s strategy emphasizes innovative product development for domestic and international markets.
Guardion Health Sciences, Inc. (GHSI) reported a significant revenue increase of 57% for the three months ending September 30, 2020, totaling approximately $253,000, up from $161,000 year-over-year. Medical device sales surged by 147% while medical foods grew by 26%. Despite these gains, the net loss decreased to approximately ($2,143,000) or ($0.02) per share. The company is poised for potential Nasdaq delisting due to a share price below $1.00 and is appealing for an extension. Notably, promising clinical data for Lumega-Z® supports product differentiation in the ocular health market.
Guardion Health Sciences announced a new study published on October 26, 2020, in the journal Nutrients. The research compared the efficacy of Lumega-Z®, Guardion's micronized carotenoid liquid supplement, against the AREDS-2 soft gel (PreserVision®). Conducted over six months, results showed Lumega-Z® significantly improved contrast sensitivity (p < 0.001), while AREDS-2 showed no significant change (p > 0.05). The study indicates Lumega-Z® may better meet the needs of those at risk for age-related macular degeneration. Dr. David Evans highlighted the rapid benefits of Lumega-Z® in visual performance.
Guardion Health Sciences, Inc. (NASDAQ: GHSI) is urging stockholders to vote for Proposal 4 at the Annual Stockholders’ Meeting on October 29, 2020. This proposal seeks an extension to effectuate a reverse stock split to maintain compliance with Nasdaq's minimum bid price requirement of $1.00 per share, crucial to avoid potential delisting by November 30, 2020. If declined, delisting risks would increase, adversely impacting stock liquidity. The board stresses that every vote is vital for the company's future.
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.
Guardion Health Sciences, Inc. (NASDAQ: GHSI) has announced strategic initiatives to enhance shareholder value. The company will focus on differentiation of brands and the integration of an E-commerce platform, alongside expanding clinically supported nutritional products internationally. Guardion has retained Corporate Finance Associates as a financial advisor to explore strategic transactions. The Board has also formed a Strategy Committee to assess business opportunities. Additionally, Guardion is committed to developing direct-to-consumer sales and evidence-based therapies while enhancing its management team.