Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the “Company”), a specialty health sciences company that develops clinically supported nutrition, medical foods, nutraceuticals and medical devices, with a focus in the ocular health marketplace, announced that its exclusive distributor in Malaysia, Ho Wah Genting Berhad (HWGB), has advised Guardion that Astramern Astra H (formerly Astramern Nutra H), an immune support dietary supplement designed and produced by the Company, has been granted product registration approval by the Malaysian National Pharmaceutical Regulatory Agency (“NPRA”).

The product registration, which is valid for five years and is renewable, is an important step toward commercialization by HWGB. Astramern Astra H comes in capsule form and contains specifically formulated herbs that are believed to help boost the body’s immune system.

This product registration approval is the second such approval received by HWGB using a Guardion-developed product. In August 2020, the Company announced the product registration approval of the vitamin formulation Astramern Nutra V. Previously, in early 2020, HWGB had entered into a Manufacturing and Supply Agreement for Guardion to design and manufacture both immune support dietary supplements, which are to be packaged together for sale by HWGB in Malaysia. HWGB’s healthcare subsidiary, Astramern Sdn Bhd, has an exclusive license to use and distribute these products in certain territories. Guardion fulfilled HWGB’s initial product order of $890,000 in June 2020.

“We have been advised that this product registration will allow HWGB to package both the Nutra V and Astra H products together to provide a more complete immune support product offering to its customers. Importantly, this development helps to expand Guardion’s presence in the Asian nutraceutical market,” said Bret Scholtes, President and CEO of Guardion. “A key part of our strategy includes expansion into foreign markets, either through licensing, supply and distribution agreements, or direct marketing opportunities. Additionally, this relationship with HWGB is important, as it allows the Company to develop new products that widen our scope in terms of health applications. We are very pleased to have a leading role in expanding into immune support in the Asian markets and anticipate a continued expansion of our product offerings that are supported by verified science and superior product development.”

About Guardion Health Sciences

Guardion is a specialty health sciences company that develops clinically supported nutrition, medical foods, nutraceuticals 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 are not limited to, the Company’s ability to raise sufficient financing to implement its business plan, the integration of a new management team, the impact of the COVID-19 pandemic on the Company’s business, operations and the economy in general, the Company’s ability to successfully develop and commercialize its proprietary products and technologies, and the Company’s ability to maintain compliance with Nasdaq’s listing requirements. 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 U.S. Securities and Exchange Commission (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:CORE IRScott Arnold516-222-2560scotta@coreir.com

Media Relations Contact:Jules AbrahamDirector of Public RelationsCORE IR917-885-7378julesa@coreir.com

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